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Efficacy in triple-negative breast cancer (TNBC) for AVA6000 could significantly enhance the value of Avacta’s pre|CISION™ platform. Here's why:

🔬 Scientific and Clinical Impact

TNBC is a high-unmet-need cancer:

It accounts for ~15% of breast cancers.

It lacks hormone receptors and HER2, making it unresponsive to most targeted therapies. Prognosis is poor, and treatment options are limited to chemotherapy and immunotherapy.

Demonstrated efficacy in TNBC would:

Validate the platform’s ability to deliver chemotherapy selectively to tumors.

Show that the FAP-activated mechanism works in aggressive, hard-to-treat cancers.

Open the door to combination therapies with checkpoint inhibitors or PARP inhibitors.

💰 Commercial and Platform Value

Market Expansion:

TNBC represents a multi-billion-dollar market globally.

Success here could justify premium pricing and accelerated regulatory pathways (e.g., Breakthrough Therapy Designation).

Platform Validation:

Positive TNBC data would de-risk the platform for other solid tumors.

It could attract licensing deals or partnerships with big pharma for other FAP-activated prodrugs.

Investor Confidence:

Efficacy in TNBC could drive a re-rating of the company’s valuation.

It would likely lead to increased institutional interest, especially if paired with a clean safety profile.

“Efficacy in both indications in P1b"

"Clinical development in TNBC slightly lags SGC, due to a requirement for cardiac safety data ahead of enrolling this cohort"

Remember the dose - 310 mg/m²

Dox will be Dox......

It's coming....

1. Advancement to Phase 2 Trials

Given the strong safety profile and promising efficacy—especially in salivary gland cancer patients with a 91% disease control rate—AVA6000 is well-positioned to enter Phase 2 trials. This phase would focus more on confirming efficacy in a larger patient population.

2. Orphan Drug Designation

Since salivary gland cancer is a rare disease, Avacta may seek Orphan Drug status from regulators like the FDA or EMA. This designation offers benefits such as market exclusivity, reduced fees, and regulatory support.

3. Breakthrough Therapy or Fast Track Designation

If the data continues to show significant clinical benefit over existing therapies, AVA6000 could qualify for Breakthrough Therapy or Fast Track designation, which would accelerate its development and review process.

4. Expanded Access or Compassionate Use Programs

For patients with few treatment options, especially those showing strong early responses, Avacta might consider offering AVA6000 under expanded access programs before full approval.

5. Regulatory Engagement for Accelerated Approval Pathways

With compelling Phase 1 data and a differentiated safety profile, Avacta could begin discussions with regulatory bodies about accelerated approval based on surrogate endpoints like tumour shrinkage and progression-free survival.

A 50% reduction in tumour diameter, especially in a spherical tumour, translates to nearly a 90% reduction in volume.

That’s a dramatic shrinkage, indicating a highly significant therapeutic effect.

For a patient with metastatic salivary gland cancer and no prior systemic therapy, this kind of response suggests the treatment is exceptionally promising and could represent a major step forward in managing the disease

"Here are the disease settings that we will be going into. Think triple-negative breast cancer and salivary gland cancer. Then let's look at some of the top indications that we are thinking about for FAP EXD: pancreatic cancer, gastric cancer, small cell lung cancer. These aren't the only ones that we will be taking forward. But if you just add up there the FAP-positive disease settings, we will be impacting with just these two drugs over a million lives a year.

Alan Ho, MD PhD, Chief of the Head and Neck Oncology Service, Memorial Sloan Kettering Cancer Center and member, Avacta Scientific Advisory Board, commented:

"We are very excited to move the development of AVA6000 to the next level to generate data that demonstrates clinically meaningful efficacy and durability of response in patients with previously treated salivary gland cancers. It is important to note the high degree of unmet need in this disease where few agents have shown efficacy. I am happy to participate in the trials of AVA6000 in this disease setting going forward."

"But if we think about more short term option, the opportunity there is to collaborate on the development of another precision medicine. This would be with a potential partner. This means then potentially licencing the technology to a partner, working together, collaborating on the development of a new medicine. It would be based on a partner's proprietary payload and our precision technology. More to come here in the not too distant future. Now, a key aspect of the question was really, why is this taking so long? Well, The key IP that we have, and I talk about this as an enviable IP position, it's important to note that that IP was not filed until September. And so conversations couldn't start until October with that one. The conversations that we're having with potential partners here haven't been going on for very long. It's only been months. These kinds of deals often start with a collaboration, preclinical. Think back to that iceberg analogy. There's a lot going on, I call it, under the surface that we can't disclose"

Trinity Delta view: Avacta’s transition to a pure play oncology biopharma

company is nearly complete, pending conclusion of the Coris divestment. Lead

asset, AVA6000, has successfully demonstrated the pre|CISION platform’s ability

for tumour-specific delivery of potent and toxic actives with minimal systemic

effects and will render further clinical data in H225. Second asset, AVA6103,

should enter the clinic in 2026, and will be the first programme to demonstrate

the pre|CISION platform sustained release mechanism. This new IP, and a better

appreciation of the scope of the pre|CISION platform gleaned from the Tempus

collaboration, provides multiple new opportunities for Avacta to unlock value

through generating and developing a pipeline of highly novel tumour targeting

drug conjugates, subject to securing funding. Our last published Avacta valuation

is £449m ($561m), equivalent to 119p/share (112p fully diluted)

Substantial Shareholders

11 April 2025

Lombard - 0.65%

Conifer - 2.58%

24 April 2025

#AVCT confirmed no 3%+ holders on register

28 May 2025

Richard Hughes joins @avacta’s board

05 June 2025

Lombard - 3.1%

Conifer - 3.1%

Avacta’s story is compelling because it’s not just about developing new drugs—it’s about redefining how existing, powerful drugs are used. By making chemotherapy safer and more targeted, Avacta could significantly improve outcomes for cancer patients.

Richard Hughes’ Future Plans for Avacta

1. Fundraising Expertise

Hughes will leverage his extensive background in capital markets to support Avacta’s fundraising efforts. This is especially important as the company advances its clinical pipeline and may require additional capital to scale operations and pursue regulatory approvals.

2. Scaling the Business

He will help scale Avacta’s operations, drawing on his experience growing companies like boohoo.com and Crawford Healthcare. This includes expanding commercial capabilities and preparing the company for broader market engagement.

3. Enhancing Shareholder Value

Hughes is focused on delivering long-term value for shareholders by supporting strategic decisions that align with Avacta’s transformation into a pure-play therapeutics company.

4. Supporting the pre|CISION® Platform

He believes the pre|CISION® drug delivery platform has the potential to transform the standard of care in oncology by reducing harmful side effects. His role will include helping the company capitalize on this innovation through partnerships, commercialization strategies, and investor engagement.

🧠 In His Words:

“I look forward to utilizing my experience in both fundraising and the scaling of businesses to assist the executive management team in delivering value for all shareholders”