CONFIDENTIAL
Dear Seneca Investors, May 30, 2025
We hope you are doing well.
We wanted to provide a quick update on the company’s progress on a few fronts.
Miami Clinical Trial
As you may have seen from the University of Miami and our own press release, the SVV-001 Phase I/II trial at the University of Miami is now underway, and the first patient has been dosed. As you may recall, this is a dose-escalating Phase I/II safety trial. The trial will have a total of 6 cohorts and will be dosed as follows
· Cohort 1: Single Low Dose of SVV-001
o The first patient will be given a single low dose of SVV-001 intratumorally (i.e., injected directly into the tumor) in combination with standard treatment with Ipi/Nivo (every other week).
o We wait for 3 weeks to see if there are any safety concerns
o If there are no safety concerns, the next two patients can be dosed in parallel, and we wait another 3 weeks to see if there are safety concerns
· Cohort 2: Single Medium Dose of SVV-001
o We repeat the same process of: 1) give a single medium dose to one patient; 2) wait; 3) dose two more patients in parallel; wait.
o Assuming there’s no safety concern, we proceed to the next cohort
· Cohort 3: Single High Dose of SVV-001
o We repeat the same process as before.
If all goes as quickly as Miami believes, we may have the first glimpse of safety and efficacy data in late Fall 2025 and be able to proceed to the multiple dose portion of the trial by the end of the year.
· Cohort 4: Multiple Medium Doses of SVV-001
o The first patient will be given doses of SVV-001 every other week – same schedule as their standard treatment with Ipi/Nivo (every other week).
o We wait for 4-6 weeks to see if there are any safety concerns then proceed with the next 2 patients in parallel.
· Cohort 5: Multiple High Doses of SVV-001
o Repeat process as before, but using the high dose.
· Cohort 6: Multiple High Doses of SVV-001.
o This is essentially the same as Cohort 5, but we will be taking tissue biopsies so we can see what’s happening with the tumor tissues.
It is too early to tell how long cohorts 4-6 will take to complete, but we realistically will not have full efficacy data until the end of 2026.
Fundraising
To recap, we set out at the end of 2024 to raise at least $3 million to complete the Miami trial and convert the notes to the Series B round, but we were only able to raise $1.6 at that time. That is enough for us to “ring fence” sufficient funds to pay for our out-of-pocket expense obligations to support the Miami trial, but not enough to keep the company going until the trial ends. We have reduced all salaries to 50%, cut back on everything, and are working with vendors to pay the absolute minimum possible to address outstanding liabilities – but that’s still not enough.
We currently have $1.2 million in the bank, which gives us runway to about March 2026. We are continuing to fundraise, and we will use such proceeds as follows in priority order:
· $1.8 million: Extend runway to March 2027 and puts the company in a position to expedite and increase the likelihood and value of an exit. This is the highest priority quantum to raise and is the most advantageous for the company as it increases the likelihood that the company could be in the position of having data at the trial and the funds to keep the company running while additional funds were raised. If the company finishes the trial without operating funds required to maintain a skeletal team, maintain the IP, etc., we will unnecessarily face the risk of financial failure in the face of scientific success that I think should be avoided.
· $500,000: Conduct Real World Evidence trial to provide a “comparator arm” for the Miami trial. Miami is a “single arm” study whereby all patients are receiving treatment. The gold standard would be to have a “placebo arm” to compare against to demonstrate the difference between treatment and placebo. We are not doing that because we lack the funds (~$2-3 million), but we may be able to accomplish a similar thing by mining databases to find High Grade Neuroendocrine tumor patients who received just Ipi/Nivo treatments that are “perfectly matched” (e.g., type of tumor, tumor size and progression, etc.) to those in our trial. Since SVV-001 is added on top of Ipi/Nivo, the difference between what we find in the trial vs. the perfectly matched patients in the database would presumably be the treatment effect. There is precedent for gaining FDA approval with this approach. We should note that there’s a chance that Miami may have sufficient internal funding to do this work themselves. If this in fact turns out to be the case, then we would not need to raise this $500,000.
· $500,000: Exploratory research to create an antibody or multiple IV injections. The limitation of SVV-001 is that it’s a virus and thus cannot be administered by IV injection more than once since the body will develop antibodies against it. That’s why we are administering SVV-001 intratumorally in the Miami trial. Furthermore, virtually all new oncology drugs now take the form of antibodies, thus having an antibody would make us more attractive to a potential pharma partner. Having an antibody or a form of SVV-001 that can be administered through multiple IV injections would make the drug dramatically easier to use and make the addressable market much larger.
· $500,000: Expansion cohorts for NET/NEC. The Miami trial is relatively small – only 24 patients. Increasing the number of patients in the trial increases the likelihood that we could get statistically significant data. Statistically significant data demonstrating efficacy could allow us to apply for approval with the FDA.
· $600,000: Move employees to 75% salary instead of the current 50%
· $400,000: Pay off a little more of the outstanding liabilities
· $500,000: Pursue next research topic of armed construct to create an even more potent and effective therapy
· $1.0 million: Expansion to one more tumor type
· $600,000: Return employees to full salary
Next Raise – June 27
With the dosing of the first patient in the SVV-001 trial, the company intends to follow what shareholders have urged us to do – raise the price of Series B shares from the current $1.65 to $1.85 after June 27th. The team has been working hard to recruit new investors into the Series B offering at the current price, and the company hopes to have the next close on June 27. The company will raise up to $6.3MM at the current price of $1.65 per Series B share. On June 27, the company will close on whatever funding is received before raising the Series B offering price to $1.85 after June 27.
While the company has not declared, it is highly likely additional funds raised in the Series B will be at progressively higher prices as the SVV-001 Phase I/II proceeds.