ACOG vs STRO

ACOG Core

Annual filing released 2025-03-31 · GPT 6 Luna

Alpha Cognition Inc. (the “Company,” “Alpha Cognition,” “we,” or us”) is a biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer’s disease (“Alzheimer’s disease” or “AD”), for which there are limited or no treatment options. On July 26, 2024, the Company received approval by the FDA of the Company’s New Drug Application (the “NDA”) for ZUNVEYL™ (benzgalantamine) previously known as ALPHA-1062 (“ZUNVEYL” or “ALPHA-1062”) a delayed release oral tablet formulation indicated for the treatment mild to moderate dementia of the Alzheimer’s type in adults (Alzheimer’s disease). The Company’s current focus is on the commercial manufacturing and sales of ZUNVEYL oral tablet formulation.

1) Obtain commercial success with the newly FDA-approved ZUNVEYL delayed release oral tablet formulation indicated for the treatment of mild to moderate dementia of the Alzheimer’s type in adults (Alzheimer’s disease). On July 26, 2024, the Company received this FDA approval. The Company will now focus on the development of commercial manufacturing and commercial sales of ZUNVEYL oral tablet formulation. Even though ZUNVEYL was approved, it may not achieve commercial success. The Company hired its Commercial team, and 32 person salesforce in the first quarter 2025. The official commercial launch was announced on March 19th, 2025 and ZUNVEYL is now available by prescription in pharmacies nationwide.

STRO Core

Annual filing released 2025-03-13 · GPT 6 Luna

Item 1. Business Overview We are an oncology company developing site-specific and novel-format antibody drug conjugates, or ADCs, enabled by our proprietary integrated cell-free protein synthesis platform, XpressCF®, and our site-specific conjugation platform, XpressCF+®. We aim to design and develop therapeutics using the most relevant and potent modalities, including ADCs, bispecific ADCs, immunostimulatory ADCs, or iADCs, and dual conjugate ADCs, or ADC2s. Our molecules are directed primarily against clinically validated targets where the current standard of care is suboptimal. We believe that our platform allows us to accelerate the discovery and development of potential first-in-class and/or best-in-class molecules by enabling the rapid and systematic evaluation of protein structure-activity relationships to create optimized homogeneous product candidates.

Our mission is to transform the lives of patients by creating medicines with improved therapeutic profiles for areas of unmet need. Our highest priority wholly owned product candidate is STRO-004. This preclinical product candidate is a single homogeneous ADC directed against tissue factor, or TF, which we intend to develop for the treatment of solid tumors. We anticipate submission of an Investigational New Drug Application, or IND, to the U.S. Food and Drug Administration, or FDA, for STRO-004 in the second half of 2025.

ACOG Core

Annual filing released 2025-03-31 · GPT 6 Luna

Alpha Cognition Inc. (the “Company,” “Alpha Cognition,” “we,” or us”) is a biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer’s disease (“Alzheimer’s disease” or “AD”), for which there are limited or no treatment options. On July 26, 2024, the Company received approval by the FDA of the Company’s New Drug Application (the “NDA”) for ZUNVEYL™ (benzgalantamine) previously known as ALPHA-1062 (“ZUNVEYL” or “ALPHA-1062”) a delayed release oral tablet formulation indicated for the treatment mild to moderate dementia of the Alzheimer’s type in adults (Alzheimer’s disease). The Company’s current focus is on the commercial manufacturing and sales of ZUNVEYL oral tablet formulation.

1) Obtain commercial success with the newly FDA-approved ZUNVEYL delayed release oral tablet formulation indicated for the treatment of mild to moderate dementia of the Alzheimer’s type in adults (Alzheimer’s disease). On July 26, 2024, the Company received this FDA approval. The Company will now focus on the development of commercial manufacturing and commercial sales of ZUNVEYL oral tablet formulation. Even though ZUNVEYL was approved, it may not achieve commercial success. The Company hired its Commercial team, and 32 person salesforce in the first quarter 2025. The official commercial launch was announced on March 19th, 2025 and ZUNVEYL is now available by prescription in pharmacies nationwide.

STRO Core

Annual filing released 2025-03-13 · GPT 6 Luna

Item 1. Business Overview We are an oncology company developing site-specific and novel-format antibody drug conjugates, or ADCs, enabled by our proprietary integrated cell-free protein synthesis platform, XpressCF®, and our site-specific conjugation platform, XpressCF+®. We aim to design and develop therapeutics using the most relevant and potent modalities, including ADCs, bispecific ADCs, immunostimulatory ADCs, or iADCs, and dual conjugate ADCs, or ADC2s. Our molecules are directed primarily against clinically validated targets where the current standard of care is suboptimal. We believe that our platform allows us to accelerate the discovery and development of potential first-in-class and/or best-in-class molecules by enabling the rapid and systematic evaluation of protein structure-activity relationships to create optimized homogeneous product candidates.

Our mission is to transform the lives of patients by creating medicines with improved therapeutic profiles for areas of unmet need. Our highest priority wholly owned product candidate is STRO-004. This preclinical product candidate is a single homogeneous ADC directed against tissue factor, or TF, which we intend to develop for the treatment of solid tumors. We anticipate submission of an Investigational New Drug Application, or IND, to the U.S. Food and Drug Administration, or FDA, for STRO-004 in the second half of 2025.

ACOG Not tagged

Annual filing released 2025-03-31 · GPT 6 Luna

This activity has no positive tag in the selected filing snapshot.

STRO Core

Annual filing released 2025-03-13 · GPT 6 Luna

Item 1. Business Overview We are an oncology company developing site-specific and novel-format antibody drug conjugates, or ADCs, enabled by our proprietary integrated cell-free protein synthesis platform, XpressCF®, and our site-specific conjugation platform, XpressCF+®. We aim to design and develop therapeutics using the most relevant and potent modalities, including ADCs, bispecific ADCs, immunostimulatory ADCs, or iADCs, and dual conjugate ADCs, or ADC2s. Our molecules are directed primarily against clinically validated targets where the current standard of care is suboptimal. We believe that our platform allows us to accelerate the discovery and development of potential first-in-class and/or best-in-class molecules by enabling the rapid and systematic evaluation of protein structure-activity relationships to create optimized homogeneous product candidates.

Beyond these programs and collaborations, we are developing a broader pipeline of next-generation protein therapeutics using our XpressCF® and XpressCF+® platforms. Our protein engineering and chemistry efforts are focused on maximizing therapeutic indices, and our technology allows us to rapidly test our therapeutic hypothesis in significantly more product candidates than conventional protein synthesis allows, with the goal of identifying the best molecule to advance to the clinic. We are also actively pursuing the discovery and development of other novel ADCs and next-generation ADC modalities, including iADCs, bispecific ADCs, and ADC2s. Our Strategy Our goal is to use our proprietary XpressCF® platform to create product candidates primarily against clinically validated targets. Key elements of our strategy are to:

ACOG Not tagged

Annual filing released 2025-03-31 · GPT 6 Luna

This activity has no positive tag in the selected filing snapshot.

STRO Material

Annual filing released 2025-03-13 · GPT 6 Luna

•Manufacturable Dual Conjugations. Our XpressCF+® platform allows us to manufacture antibodies that contain two different non-natural amino acids that are substrates for mutually orthogonal site-specific conjugation reactions. This advantage permits dual conjugation, resulting in homogenous iADC or ADC2 dual conjugate molecules with two different precisely placed payloads. Accordingly, we use our XpressCF® platform to discover and develop cancer therapeutics by empirically determining the optimum structure-activity relationships for cytokine-based immuno-oncology therapeutics, ADCs, iADCs, bispecific ADCs and ADC2s and transitioning those products to cGMP compliant manufacturing. Our Collaborations Validate Our Technology

In June 2022, we entered into a license and collaboration agreement with Astellas, or the Astellas Agreement, for the development of immunostimulatory antibody-drug conjugates for up to three biological targets, to be identified by Astellas. In June 2024, Astellas notified us that it would not be nominating a third target program. This decision was based on Astellas' strategic portfolio considerations. We will conduct research and preclinical development of any compound (as designated by Astellas) in each of the two programs in accordance with the terms of a research plan between us and Astellas. Astellas will have an exclusive worldwide license to develop and commercialize any such designated compound, subject to our rights to participate in cost and profit sharing in the United States, as described below.

ACOG Not tagged

Annual filing released 2025-03-31 · GPT 6 Luna

This activity has no positive tag in the selected filing snapshot.

STRO Material

Annual filing released 2025-03-13 · GPT 6 Luna

Our process development and manufacturing strategies are tailored to rapidly advance our product candidates, including the use of a supply chain of established CMOs to ensure successful execution. The production of antibodies in 2025 will be done by either us or CMOs, depending on our internal cGMP production capacity. We expect to transition these activities entirely to our CMO network by the end of 2025. We have identified multiple CMOs with the ability to produce the antibody component of our products at different scales and we have successfully completed technology transfer of the manufacturing process to one or more of these CMOs. The production of all other necessary elements for the manufacture of our ADC product candidates, and the final manufacture of the ADC drug product, will be handled entirely by CMOs.

In March 2025, we approved a restructuring plan with an associated reduction in workforce as a result of a review of current strategic priorities, resource allocation, and cost reduction intended to reduce operating costs, streamline operations and extend our cash runway. We intend to decommission or otherwise exit our manufacturing facility in San Carlos by the end of 2025 and rely on an external manufacturing strategy where all elements of our product candidates and platform reagents are manufactured by qualified third-party CMOs. Cash Flows The following table summarizes our cash flows during the periods indicated: Year Ended December 31, 2024 2023 (in thousands) Cash used in operating activities $ (191,540 ) $ (111,616 ) Cash provided by (used in) investing activities 218,508 (3,924 )

ACOG Not tagged

Annual filing released 2025-03-31 · GPT 6 Luna

This activity has no positive tag in the selected filing snapshot.

STRO Core

Annual filing released 2025-03-13 · GPT 6 Luna

Item 1. Business Overview We are an oncology company developing site-specific and novel-format antibody drug conjugates, or ADCs, enabled by our proprietary integrated cell-free protein synthesis platform, XpressCF®, and our site-specific conjugation platform, XpressCF+®. We aim to design and develop therapeutics using the most relevant and potent modalities, including ADCs, bispecific ADCs, immunostimulatory ADCs, or iADCs, and dual conjugate ADCs, or ADC2s. Our molecules are directed primarily against clinically validated targets where the current standard of care is suboptimal. We believe that our platform allows us to accelerate the discovery and development of potential first-in-class and/or best-in-class molecules by enabling the rapid and systematic evaluation of protein structure-activity relationships to create optimized homogeneous product candidates.

•Advance STRO-004 through clinical development. We anticipate submission of an IND to the FDA for STRO-004 in the second half of 2025. We intend to develop STRO-004 for the treatment of solid tumors, potentially including cervical cancer, head and neck cancer, non-small cell lung cancer, colorectal cancer, and pancreatic cancer. Given that TF is a clinically validated target for cervical cancer, along with STRO-004’s homogeneous design and preclinical anti-tumor activity and toxicity data, we believe it has the potential to be a best-in-class TF-targeted ADC and provide benefit to a broader patient population than approved TF-targeting agents, as well as potentially greater activity, stability and/or safety as compared to other investigational agents in development.