CytoDel's revenue timeline

CytoDel has ongoing development programs with synergistic timelines to cash flow. The nearest to revenue opportunity is Cyto-111, a botulism antidote for biodefense, which will seek FDA approval via the Animal Rule. Next in line for revenue are several active BoNT pharmaceuticals, including 'Biobetter' derivatives with market-relevant clinical advantages. Longer term opportunities are utilizing CytoDel’s Antibody Fusion Protein (AFP) delivery technology to access intra-neuronal targets in neurological disease, without the need for delivery via a viral vector.

Cyto-111 Biodefense

Cyto-111 is an AFP antidote to BoNT intoxication.

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Cyto-011

Cyto-011 a recombinant BoNT with potency similar to wt BoNT. Our technology has created a recombinant BoNT pharmaceutical with identical properties as botulinum products from native bacterial host (clostridia).

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Cyto-014

Cyto-014 is a novel recombinant BoNT pharmaceutical engineered to have an improved safety margin compared to commercially available BoNT products.

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Cyto-020 Family

Cyto-020 family are longer lasting BoNT pharmaceuticals that are currently in lead optimization stage.

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Cyto-111 Biodefense

In a 2016 meeting, the FDA stated that Cyto-111 had established efficacy in mice compared to standard of care (standard antibodies) and suggested a pathway forward to approval. Cyto-111 is likely to be eligible for approval under the Animal Rule, which enables approval without Phase 2 or 3 efficacy studies. Cyto-111 is currently being developed under a Cooperative Research and Development Agreement (CRADA) with the US Department of Defense. Cyto-111 uses the CytoDel Delivery Platform to deliver an antibody to the inside of BoNT-intoxicated neurons, thereby allowing rescue after the toxin has entered neurons and is causing symptoms. This “Trojan horse” approach uses an inactivated BoNT derivative to carry the antibody inside BoNT-intoxicated neurons. No intraneuronal treatments for botulism currently exist. All currently available treatments for botulism are antibody products which can only neutralize toxin in the blood circulation. Once the toxin has entered neurons, generally 24-72 hours after exposure depending on the dose, antibody-based products become ineffective. Standard antibodies cannot access toxin already inside neurons and thus, the available antitoxin is only effective while the toxin remains in the circulation. Cyto-111 can uniquely reverse symptoms because it can deliver its antibody to toxin already inside the neuron. In biodefense scenarios, this significantly extends the period post-exposure during which treatment can reverse symptoms and can save lives by obviating the need for long-term artificial respiration. Intellectual Property: Several US patents granted (methods & composition). Product specific patents are pending.

Cyto-011

The market need: First recombinant neurotoxin modulator with a safer manufacturing process. CytoDel is looking for partners to develop as a bio-similar product in international markets. Intellectual property: US patent granted.

Cyto-014

Cyto-014 is a novel recombinant BoNT pharmaceutical engineered to have an improved safety margin compared to commercially available BoNT products. Preliminary data suggests a significantly improved safety margin compared to wt BoNT in an established animal model for modulation of muscle tonicity. Proof-of-principle for this platform was obtained in an in vivo model using Cyto-012 (a previous generation of Cyto-014) which displayed a 2-fold improved safety margin compared to wt BoNT. Cyto-012 serves as a proof-of-principle demonstrating that BoNTs can be engineered to have an improved safety margin compared to wt BoNT. The market need: Larger therapeutic windows or safety advantages are especially important for BoNT indications that require treatment of large muscle groups, such as spasticity disorders associated with stroke, brain injury and other neurological diseases. The FDA introduced a Black Box warning into BoNT class labeling in 2009 due to serious adverse events and deaths when using the large doses needed to treat large muscle groups, particularly in off-label use for children with cerebral palsy (CP). CytoDel has identified a lead candidate for a “safer” BoNT product. Safety advantages are also expected to impact the market for aesthetic BoNT applications and potentially grow this market. The pathway to FDA approval for BoNT pharmaceuticals is clearly outlined by the published approval summaries for pharmaceutical BoNT products currently on the market. CytoDel intends to follow the well-traveled road of its predecessor products, helping to minimize the time and cost to first FDA approval. Intellectual property: CytoDel has been granted a US patent protecting the engineering principle used to create “safer” BoNT pharmaceuticals.

Cyto-020 Family

Cyto-020 family are longer lasting BoNT pharmaceuticals that are currently in lead optimization stage.