August 19, 2024

 

Letter from the CEO to the DIPG Community

​

Dear DIPG Community,

 

We are so humbled you all have embraced our company and the SonALAsense Sonodynamic Therapy Trial since its inception. We are deeply grateful for your encouragement, interest, and financial support. As many of you are aware, our small start-up company has faced significant financial challenges over the past six months. We deeply appreciate the community's support during these trying times. You deserve a straightforward update on our clinical trial and financial situation.

 

Unfortunately, we had to make the difficult decision to terminate our SDT-202 clinical trial in recurrent glioblastoma in order to focus our resources on our SDT-201 trial in DIPG. Sadly, our financial challenges have forced us to terminate our DIPG trial as well.

 

Originally, the DIPG trial was designed for a one or two treatment regimen. The physicians in charge of SDT-201 saw the lack of apparent side effects and the way patients tolerated treatment and felt along with us that monthly treatments might improve tumor control. As we progressed with treating patients every month, the costs associated with our DIPG trial escalated significantly. Each procedure now amounts to $102,000, with a total per-patient cost of $1,224,000 for the twelve required sonodynamic therapy (SDT) sessions contemplated by our clinical trial protocol. Breaking down the $102,000 per procedure, we have $58,000 in clinical trial site costs, $34,000 in clinical contract research organization (CRO) costs, and $10,000 in costs associated with SonALAsense clinical operations personnel. We firmly believe that this monthly treatment frequency is optimal for achieving FDA-accelerated approval for SDT in DIPG.

 

The SDT-201 trial has provided us with encouraging clinical data to support a recommended Phase 2 dose that can be used in a subsequent clinical trial that we hope will support an FDA approval of our sonodynamic therapy in DIPG. However, we need to raise $35 million before we can begin this next trial.

 

Despite two years of efforts and discussions with over 100 VC firms to raise the additional $35 million needed to advance sonodynamic therapy through a potential FDA approval, we have struggled to gain traction. Common feedback from VCs includes statements like "we do not invest in drug-device combinations," "brain tumors are un-investable," "DIPG is not a big enough market," and "brain tumors are risky investments." We have looked at every possible avenue and left no stone unturned to continue our study.

 

Transparency is one of our core values. To provide clarity on our sources of funding to date for Phase 1, we have raised $35 million from our management team, friends, family, and a few small venture capital (VC) firms and family offices to fund both studies. We have received two federal grants that have partially funded our DIPG trial: $2 million from the National Cancer Institute (NCI) for the trial at Children’s National Hospital and $1.6 million for the trial at Nicklaus Children’s Hospital. Additionally, we have received approximately $450,000 in grants from the Rally Foundation, Cure Starts Now, and the DIPG/DMG Research Funding Alliance. We also received a $150,000 loan from the DIPG/DMG Research Funding Association and a $100,000 investment from the Pediatric Brain Tumor Foundation. We are committed to ensuring the continuity of the work we've started and are exploring a couple of alternative financing options as well as licensing/partnering options.

 

The economic environment for biotech startups is not ideal, but the community is no stranger to battling against all odds. We cannot begin to compare our financial challenges to the daily challenges faced by the families with children we aim to treat.

 

We have communicated all of this to our clinical trial sites and to the FDA. We have told our clinical trial site investigators that we will support them with our investigational drug product and technical support if they wish to continue to treat patients under individual IND exemptions.

 

We cannot accomplish what we do without the support of the DIPG ecosystem as we strive to provide better treatment options for current and future generations. We thank all the investigators, clinical trial staff, patients, and their families for helping us to evaluate the safety and efficacy of sonodynamic therapy in DIPG and glioblastoma. We are profoundly grateful to the DIPG community for your unwavering support. We remain dedicated to our mission of transforming cancer patients into cancer survivors.

 

Sincerely,

 

Mark de Souza, PhD

CEO, SonALAsense