Respirator has developed VAL001 – an oral pre-treatment to the established R-CHOP treatment for patients with DLBCL, or diffuse large B-cell lymphoma. DLBCL is the most common form of non-Hodgkin's lymphoma (NHL), affecting more than 52 people in the US, Europe and Japan each year.
With an aggressive disease progression and a five-year survival rate of approximately 67 percent, there is a great medical need, especially for patients who do not respond to, or relapse after, standard treatment.
Today's standard treatment
The standard first-line treatment consists of R-CHOP – rituximab in combination with cyclophosphamide, doxorubicin, vincristine and prednisone. Approximately 60 percent of patients with DLCBL are cured by R-CHOP, while up to 15 percent are refractory and 35 percent relapse. Subsequent treatments use costly therapies such as CAR-T or HSCT, and even with their help, both of these groups have a bleak prognosis and up to 80 percent die from the complications of the disease. The need for new treatment options that can improve survival without increasing toxicity is therefore significant.
This is where Respiratorius and VAL001 come into the picture.
VAL001 and its path forward
Early clinical data show that VAL001 as pretreatment to R-CHOP improves efficacy without increasing the risk of side effects. In a phase I/II study, a 1-year survival of 100 percent and a 2-year survival of 96,8 percent was achieved among 32 patients, which compares to 89,6 percent and 81,7 percent, respectively, in a matched reference population from the Swedish Lymphoma Registry who received R-CHOP alone. The difference corresponds to an 80 percent reduction in mortality risk, which is a clinically relevant improvement that surpasses the typical treatment by 20-30 percent improvement.
The results were so good that the European Medicines Agency, EMA, considered that a Phase III study can be initiated without first undergoing a conventional Phase IIb study. This, together with orphan drug designation in both the US and Europe – and the market exclusivity and regulatory benefits that this entails – means that VAL001 is ready for a final pivotal study.
Welcomed by prescribing physician
The fact that VAL001 increases the treatment effect of R-CHOP without increasing the frequency of side effects makes the drug candidate attractive to a broad patient group. In a major international survey commissioned by the company, physicians treating DLCBL indicated a high willingness to prescribe the preparation – motivated by the advantageous oral administration, the good safety profile and its good clinical effect.
Since these specialist doctors will largely influence prescribing, this information is of great importance for sales forecasts.
Respiratorius is currently in active dialogue with potential partners who can complete the development plan and take the candidate to the market and clinical reality. The company has already identified a financial partner, who has stated that he is prepared to co-finance a phase III study and the next step will be to land a strategic partner who can be on the journey and also have the muscle to potentially take the project all the way to market.
Confirmed market potential
At the same time, Respiratorius is clearly targeting the American market, as the company believes that the large revenue potential lies there. The global market for drugs against DLBCL was appreciated 2024 to USD 4,7 billion, and is expected to grow to USD 6,5 billion in 2029. In this context, VAL001 will be positioned as a cost-effective, oral add-on treatment.
Respiratorius has had the company's business case (or business model) analyzed and estimates annual sales of a maximum of approximately USD 190 million in the US alone in the base scenario. The outcome is based on a pricing of USD 87 per patient and treatment and a market uptake of 610 percent among low-risk patients, 6 percent in the medium-risk group and 12 percent in the highest-risk patient group. The pricing is based on several anchor points, i.e. the arguments that are commonly used in pricing in the US and have been confirmed by two independent analysis houses.
The cumulative revenue estimate therefore indicates USD 2,3 billion from 2029 to 2043, assuming launch in 2029 and patent expiration in 2044.
Raising capital and looking ahead
The company is currently working to optimize the design of the upcoming Phase III study after receiving comments from the FDA at the pre-IND meeting held earlier this month.
In parallel, Respiratorius is carrying out a 55 percent guaranteed rights issue, totaling approximately SEK 19 million. By improving the company's financial position, the rights issue provides increased room for maneuver, reduces risks in the development process and enables the next step towards a phase III study and future commercialization of VAL001. Respiratorius' goal is for the capital from the issue to finance the business until positive cash flow, which is expected to be achieved via a licensing deal for VAL001.
Use of issue proceeds
The net proceeds of approximately SEK 16 million, after deduction of issue costs of approximately SEK 3 million, are intended to finance the following activities, listed in order of priority:
- Operational costs 24 months – 65 percent
- Collaborations and business development – 20 percent
- Regulatory development –10 percent
- Securing the patent portfolio for potential launch and licensing deals – 5 percent
Offer summary
| Terms & conditions | All shareholders receive one subscription right for each share held on the record date of August 19, 2025, and one subscription right gives the right to subscribe for one new share. |
| Subscription period | 21 August – 4 September |
| Subscription price | SEK 3,70 per share. |
| Volume | SEK 18,9 million |
Information & drawing
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