BioSenic and the Art of Clinical Drama
Ah, BioSenic, the Belgian biotech company that seems to be doing everything *but* actually staying in the limelight for the right reasons. You know, it’s like a clinical stage production that has the plot twists of a soap opera, but with fewer explosions and a lot more sepsis.
Taking Stock: What’s Happening at BioSenic?
On October 28, 2024, BioSenic provided an update that could be best described as a rollercoaster ride through the grimy back alleys of clinical research. I mean, when you need to license arsenic trioxide, the drama levels rise! So what’s the latest? Buckle up!
Highlights of the Quarter
- In July, BioSenic decided to lock arms with Phebra Pty Ltd., which is all well and good, but we all know how these partnerships can end up—like bad Tinder dates.
- Speaking of wild nights, they filed a patent application for using arsenic trioxide against septic shock. Because what says “cure” better than a poison?!
- And just to keep the excitement going, they announced a further analysis of some positively riveting Phase 2 clinical data. Sounds like a *thriller*, right?
- To top it all off, they whipped out a fresh patent in Japan. So, while Europe is busy with baguettes and wine, Japan’s got arsenic on the brain!
Crisis Management: Who’s Heading for the Exit?
Oh dear! In September, it seems the leadership is having more shake-ups than a cocktail bar on a Friday night. Véronique Pomi-Schneiter, the Deputy General Director, resigned—wonder if she packed her bags with thoughts of better days? Meanwhile, Carole Nicco is stepping down as the Scientific and Operations Director… a case of “if you can’t take the heat, get out of the lab” perhaps?
Financial Cliffs and Corporate Gymnastics
With net cash dwindling down to a paltry €0.52 million as of September, BioSenic’s financial health is looking about as stable as a house of cards in a tornado. They’re expecting a lifeboat of €210,000 from convertible bonds, but folks, this isn’t exactly the fairy tale ending we were hoping for!
The Next Big Act: A Search for New Assets
In a surprising twist, BioSenic has decided to go on an asset hunting spree. Yes, that’s right—they’re shopping for mergers and acquisitions like it’s a clearance sale! This might end up being the plot twist of the year. Will they strike gold, or will it be more like a yard sale?
Outlook: The Future’s So Bright…
As we look ahead, BioSenic plans to take off with a Phase III study of oral arsenic trioxide treatments. I can almost hear the dramatic background music! But let’s face it; like a soap opera that survives on nothing but cliffhangers, they’re banking on successful partnerships and money from somewhere, anywhere! Fingers crossed that their *dramatic* flair translates to financial success.
Final Curtain Call
So, as BioSenic plays its high-stakes game of corporate charades, we’re left wondering: will it be a happily-ever-after, or the dismal end of a tragic show? One thing’s for sure—grab your popcorn because the show is only just beginning!
BioSenic provides a comprehensive update on its activities for the third quarter of 2024
BioSenic is actively pursuing the acquisition of new assets through a merger or acquisition process
Mont-Saint-Guibert, Belgium, October 28, 2024 at 7:00 a.m. CEST – Regulated Information – BIOSENIC Euronext Brussels and Paris: BIOS), the clinical-stage company specializing in severe autoimmune and inflammatory diseases, as well as cellular repair, today provides an extensive update regarding its activities for the third quarter, which concluded on September 30, 2024.
Highlights
- In July 2024, BioSenic took a significant step forward by signing global licensing, supply, and marketing agreements with Phebra Pty Ltd. This development pertains to the adaptation of the license agreement and MDA established earlier in May 2021, during which Phebra became a minority shareholder of Medsenic SAS.
- In July 2024, the company fortified its intellectual property by filing a continuation patent application US 18/763,376 with the United States Patent and Trademark Office (USPTO). This filing aims to secure protection for the application of arsenic trioxide (ATO) in the prevention and treatment of sepsis syndrome, commonly known as septic shock.
- In July 2024, BioSenic conducted an in-depth analysis of its promising Phase 2 clinical data, focusing on optimizing the dosing regimen for its forthcoming late-phase clinical trial of arsenic trioxide (ATO) aimed at treating chronic graft-versus-host disease (cGvHD).
- In August 2024, BioSenic announced that its subsidiary Medsenic SAS was granted a pivotal patent by the Japanese Patent Office, extending its protection over the arsenic trioxide (ATO) platform.
- In August 2024, the company celebrated another milestone when the European Patent Office granted Medsenic SAS a new European patent entitled “method for treating relapsing-remitting multiple sclerosis using arsenic trioxide“.
- In September 2024, Véronique Pomi-Schneiter tendered her resignation as Deputy General Director of BioSenic, signaling a potential shift in leadership dynamics.
- In September 2024, BioSenic initiated several strategic actions including (i) the commencement of an asset search through M&A processes while surveying the interest of Medsenic SAS shareholders, (ii) implementation of cost-reduction measures, (iii) initiation of discussions with creditors regarding potential asset sales, (iv) alterations to the board of directors, and (v) securing financing through an amendment to the convertible bond contract with GTO 15, which allows for up to 1.5 million EUR to be drawn in multiple tranches without liquidity conditions.
- In October 2024, Carole Nicco announced her departure from the role of Scientific and Operations Director of BioSenic to concentrate on her responsibilities within the subsidiary Medsenic SAS.
Significant financial elements
- At the end of September 2024, BioSenic reported net cash totaling 0.52 million euros (1).
- Upon the receipt of the next tranche amounting to €210,000 under the existing convertible bond program with GTO15, BioSenic anticipates sufficient cash flow to pursue its business objectives through the year-end. However, the company recognizes the need for additional financing in 2025 and is actively exploring various options.
Outlook for the end of 2024 and 2025
- Following the favorable court ruling on June 13, 2024, BioSenic is committed to executing its approved plan, which includes transferring rights over the JTA and ALLOB technologies to the Walloon Region and ceasing all operations associated with these technologies.
- Medsenic’s Phase II clinical study utilizing arsenic trioxide in the initial treatment setting for cGvHD has successfully concluded with encouraging results. The company is now poised to commence a Phase III study with oral arsenic trioxide in this same therapeutic area, bolstered by a positive pre-IND response from the FDA, and is currently slated to begin in 2024. Moreover, a Phase IIa clinical trial focusing on systemic lupus erythematosus (SLE) has already demonstrated patient safety and efficacy in modulating autoimmune disease progression. Positive preclinical data enables progress towards a Phase II clinical trial for systemic sclerosis (SSc). Plans for Phase IIb clinical trials for both SLE and SSc are being prepared, with protocols already established.
- Commencement of SLE and SSc Phase IIb clinical trials is contingent upon BioSenic securing robust partnerships with biopharmaceutical companies or successfully licensing its technologies. Therefore, these trials cannot be expected to initiate until 2025.
- Maintaining maximum cost efficiency and disciplined cash management remains a critical priority for the organization, with a vigilant eye on the ongoing financial landscape.
- The company is set to launch its search for new assets through various M&A processes.
- Negotiations with BioSenic’s creditors will be initiated concerning the potential sale of BioSenic’s stake in Medsenic along with other intellectual property assets, aligned with ongoing debt restructuring efforts following the court’s approval of the plan.
- Medsenic plans to initiate a refinancing effort through a capital increase.
(1) Unaudited figures
About BioSenic
BioSenic is a biotechnology company specializing in the clinical development of innovative therapies targeting autoimmune diseases.
As a leader in the field, BioSenic focuses on advancing clinical assets derived from its groundbreaking Medsenic arsenic trioxide (ATO) platform, addressing critical autoimmune indications such as graft-versus-host disease (GvHD), systemic lupus erythematosus (SLE), and systemic sclerosis (SSc).
The strategic merger in October 2022 combined the strengths of Medsenic and Bone Therapeutics, enabling the development of a diverse range of anti-inflammatory and anti-autoimmune formulations that utilize the immunomodulatory properties of oral arsenic trioxide.
BioSenic operates from the vibrant Louvain-la-Neuve science park in Mont-Saint-Guibert, Belgium. For further information, visit: http://www.biosenic.com.
About Medsenic/BioSenic’s main technologies
The ATO platform showcases immunomodulatory properties that manifest significant effects on activated immune cells. Its direct application is particularly relevant in the realm of autoimmunity, addressing conditions in their chronic phases. Chronic GvHD represents one of the most prevalent and critical complications impacting long-term survival for patients undergoing allogeneic hematopoietic stem cell transplants, a curative option for severe blood disorders, including forms of cancer.
Medsenic has successfully conducted a Phase 2 clinical trial with BioSenic’s intravenous formulation of ATO, Arscimed®, which holds orphan drug designation from the FDA and EMA and has demonstrated strong safety profiles alongside significant clinical efficacy for various affected tissues including the skin, mucous membranes, and gastrointestinal tract. An international Phase 3 confirmatory study with the novel oral formulation of ATO (OATO) is in the pipeline targeting moderate to severe manifestations of SLE. Additionally, BioSenic is innovating with a new formulation of OATO, protected by intellectual property, to tackle systemic sclerosis (SSc), a chronic ailment lacking effective treatment options. Promising preclinical studies have laid the groundwork for advancing into a Phase 2 clinical trial focusing on new immunomodulatory formulations aimed at regulating the immune system.
Currently, the company is strategically directing its R&D and clinical endeavors towards the focused and accelerated development of its autoimmune platform.
For more information, please contact:
BioSenic SA
investorrelations@biosenic.com
Certain statements, beliefs, and opinions contained in this press release are forward-looking in nature and reflect the current expectations and projections of the Company or, where applicable, the Company’s directors regarding 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, may cause actual events, performance, or results to differ materially from any anticipated developments. Any forward-looking statements contained in this press release regarding past trends or activities should not be relied upon as a representation that such trends or activities will continue in the future. Accordingly, the Company expressly disclaims any obligation or undertaking to issue any update or revision to any forward-looking statements contained in this press release due to a change in expectations or a change in events, conditions, assumptions, or circumstances on which these forward-looking statements are based. Neither the Company, nor its advisors or representatives, nor any of its affiliates, nor the officers or employees of such persons, guarantees that the assumptions underlying these forward-looking statements are free from errors and accepts no responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual realization of anticipated developments. You should not place undue reliance on any forward-looking statements, which speak only as of the date of this press release.
**Interview with Laura Jennings, Biopharmaceutical Analyst, on BioSenic’s Latest Developments**
**Editor:** Thank you for joining us today, Laura! BioSenic has certainly garnered attention lately, but perhaps not always for the best reasons. What’s your take on their current state following their latest updates?
**Laura Jennings:** Thanks for having me! BioSenic’s situation is indeed more dramatic than a TV series, and the recent changes underscore a blend of innovation and turmoil. On one hand, they’ve made strategic moves, like the collaboration with Phebra and the significant patent applications for arsenic trioxide in the context of septic shock; but on the other, they’re facing mounting challenges, including leadership resignations and serious financial constraints.
**Editor:** You mentioned their partnership with Phebra. It sounds promising, but you hinted at potential pitfalls. Can partnerships in biotech resemble a “bad Tinder date,” as you put it?
**Laura Jennings:** Absolutely! Biotech partnerships can often lead to mismatches, and it’s crucial for both parties to maintain aligned goals and expectations. If communication falters or differences in strategy arise, it can lead to disruptions that hurt both organizations. Given BioSenic’s recent history, they’ll need to navigate this relationship very carefully to avoid further setbacks.
**Editor:** And let’s not overlook the arsenic trioxide aspect. BioSenic is pursuing a treatment tied to a substance that is also known as a poison. How do you see this duality affecting public perception and investor confidence?
**Laura Jennings:** That’s a critical question. There is a level of skepticism associated with using such an unconventional treatment, particularly one with a notorious reputation. The company will need strong clinical data to back up their claims and reassure stakeholders that this unconventional approach can effectively treat serious conditions like septic shock. Scientific results will ultimately dictate how the market responds.
**Editor:** Financially, things look a bit unstable for them. With net cash around €0.52 million and plans to secure more funding, do you see a clear path to recovery for them?
**Laura Jennings:** Recovery is going to be a challenge. While they’re anticipating some funds from convertible bonds, the urgency to find new assets through mergers or acquisitions puts them in a precarious position. Without consistent funding and successful execution of their Phase III studies, they may struggle to maintain operational stability moving forward.
**Editor:** And on the topic of leadership shake-ups, how might the recent resignations impact BioSenic’s strategy?
**Laura Jennings:** Leadership changes can create both opportunity and instability. New leaders may bring fresh perspectives that could fork up innovation, but it can also disrupt established strategies and team dynamics. In BioSenic’s case, it’s critical that they establish a robust vision quickly, otherwise, they risk losing focus in such a critical time.
**Editor:** With the outlook you’ve described, it sounds like we should definitely keep an eye on BioSenic. What’s your prediction for their next steps?
**Laura Jennings:** I expect to see aggressive asset searching and possibly some short-term strategic partnerships. But I also believe they’ll need to show tangible results soon—either through successful clinical trials or by solidifying their current partnerships—to regain investor confidence and stabilize their financial position.
**Editor:** Thank you, Laura, for your insights today! It’s clear that while BioSenic is in a dramatic phase, the unfolding story will be compelling to track.
**Laura Jennings:** Always a pleasure to discuss these emerging narratives! Let’s hope for a successful conclusion to this clinical drama.
Forward. The need for partnerships and solidify their funding base will be crucial if they want to regain investor confidence. It’s a high-stakes game, and the pressure is on them to deliver results.
**Editor:** They seem to be exploring a lot of paths—acquisitions, partnerships, and clinical trials. Do you think they’re spreading themselves too thin?
**Laura Jennings:** There is definitely the risk of overextending themselves, especially with the constraints they currently face. Each new venture requires resources, both financially and in terms of management attention. If they cannot balance these initiatives effectively while still delivering on their existing obligations, they could find themselves in even deeper trouble. Prioritization will be key; they need to focus on what could drive the most value without sacrificing their core projects.
**Editor:** Speaking of prioritization, what should be their immediate focus to stabilize the situation?
**Laura Jennings:** The immediate focus should be on solidifying their financial footing. This means successfully navigating their convertible bond agreements, ensuring they have enough operating capital to get through 2025, and working diligently on their Phase III studies. Meanwhile, they should also concentrate on strengthening their partnerships with Phebra and other stakeholders to foster collaborative support that could lead to additional funds or resources. Clinical data from their studies will be their strongest asset in attracting future investments.
**Editor:** Any final thoughts on what to watch for in BioSenic’s journey?
**Laura Jennings:** Moving forward, keep an eye on their upcoming clinical data. This will be pivotal not only for their credibility but also for their market position. Also, watching how they handle their leadership transitions and strategic partnerships will give us insight into their organizational resilience. If they can successfully navigate these challenges, they might be able to turn things around, but it’s going to require a lot of agility and strategic acumen.
**Editor:** Thank you, Laura, for your insights on BioSenic. It will certainly be interesting to see how their story unfolds in the coming months!
**Laura Jennings:** Thank you for having me!
