NASDAQ: DCOY

Prior to January 8, 2026, we were known as Salarius Pharmaceuticals, Inc. (“Salarius”). In November 2025, Salarius completed a Merger (as defined below) with Legacy Decoy and conducted financings to raise capital for its business (together, along with future steps set forth elsewhere in this 10-K annual report, the “Decoy Transaction”). We refer herein to the post-transaction entity as the “Combined Company.” In connection with the Decoy Transaction, on January 8, 2026, Salarius filed an amendment to its amended and restated certificate of incorporation to change its name to Decoy Therapeutics Inc. (the “Name Change”). Prior to the Name Change, the Combined Company’s shares of common stock traded on the Nasdaq Capital Market (“Nasdaq”) under the symbol “SLRX.” Following the Name Change, the Combined Company’s shares of common stock now trade on the Nasdaq under the symbol “DCOY.”

The Merger (as defined below) combines our complementary approaches to create a comprehensive drug development platform. The Decoy IMP³ACT platform is generating a pipeline of Designable Multi-Antivirals ("D-MAV") candidates across respiratory viruses, designed to be extended, not rebuilt, when the next threat emerges. Additionally, two small molecule drugs that address gene dysregulation: (1) SP-3164, a targeted protein degrader, and (2) seclidemstat (“SP-2577”), a targeted protein inhibitor are legacy Salarius clinical candidates. We supported The University of Texas MD Anderson Cancer Center (“MDACC”) in MDACC’s sponsored clinical trial evaluating SP-2577 in combination with azacytidine in adult patients with myelodysplastic syndromes and chronic myelomonocytic leukemia through December, 2025. No further enrollment is planned. We intend to seek strategic alternatives for this program including potential out-licensing.

We plan to integrate SP-3164 to expand our opportunities in creating a novel class of peptide conjugates called peptide-based proteolysis targeting chimeras (“P-PROTACs”). We believe the synergies from the Merger are evident in our combined approach to drug development, integrating expertise in peptide conjugates with our small molecule assets. This combination enables us to address a wider range of diseases and potentially “undruggable” targets.

Recent Developments

Nasdaq Listing

On December 31, 2025, the Company received written notice from Nasdaq that it was not in compliance with Nasdaq Listing Rule 5550(a)(2) because the closing bid price of the Company’s common stock for the last 30 consecutive business days was below the $1.00 per share minimum bid price requirement (the “Minimum Bid Price Requirement”). The Company appealed the delisting determination by requesting a hearing before a Nasdaq Hearings Panel (the “Hearings Panel”). The company presented its appeal to the Hearings Panel in early February 2026 and submitted a plan to regain compliance by March 20, 2026, including conducting a reverse stock split.

On March 13, 2026, the Company received a written notice from the Hearings Panel notifying the Company that it has been granted until March 20, 2026 to regain compliance with the Minimum Bid Price Requirement. Pursuant to the Hearings Panel's decision, the continued listing of the Company's securities is subject to the condition that the Company must demonstrate compliance with the Minimum Bid Price Requirement on or before March 20, 2026. In connection with its compliance plan, the Company completed the 2026 Reverse Stock Split (as defined below) on March 6, 2026, and subsequently achieved a closing bid price of $7.47 on March 20, 2026, thereby demonstrating compliance with the Minimum Bid Price Requirement.

Closing of Decoy Merger

On January 10, 2025, the Company entered into an Agreement and Plan of Merger, as amended by the First Amendment on March 28, 2025, by the Second Amendment on June 10, 2025, by the Third Amendment on July 18, 2025, by the Fourth Amendment on July 29, 2025, and by the Fifth Amendment dated September 17, 2025 (as amended, collectively, the “Merger Agreement”) with Decoy Therapeutics MergerSub I, Inc. (“MergerSub I”), Decoy Therapeutics MergerSub II, LLC (“MergerSub II”), and Legacy Decoy. On November 12, 2025, pursuant to the Merger Agreement, MergerSub I merged with and into Legacy Decoy, and immediately thereafter Legacy Decoy merged with and into MergerSub II (the “Merger”), resulting in the Legacy Decoy business becoming a wholly owned subsidiary of the Company.

In connection with the Merger, the Company issued 877.709 shares of the Series A Preferred Stock and 796.306 shares of the Series B Preferred Stock to former Legacy Decoy stockholders and debtholders and reserved 45.098 shares of Series A Preferred Stock for assumed in-the-money options and warrants of Legacy Decoy. In connection with the adjustment to the conversion ratio in the certificate of designations for the Series A and Series B Preferred Stock triggered by the offering, the number of Company common shares underlying the issued and reserved shares of Series A and Series B Preferred Stock is 401,126. The shares of Series A Preferred Stock and Series B Preferred Stock are not convertible into common stock until such time as the Company’s stockholders approve such conversion in accordance with Nasdaq Rule 5635 and the approval of the Company’s initial listing application with Nasdaq. When converted, the conversion ratio pursuant to which the new common shares will be issued has been adjusted pursuant to the 2026 Reverse Stock Split (as defined below) ratio of 1-for-12.

Management and Director Changes

In connection with the Merger closing on November 12, 2025, Mr. Frederick E. Pierce was appointed Chief Executive Officer and Director; Dr. Barbara Hibner was appointed Chief Scientific Officer; and Mr. Peter Marschel was appointed Chief Business Officer. Mr. Mark Rosenblum will continue to serve as Executive Vice President and Chief Financial Officer (including as principal financial officer and principal accounting officer).

November 2025 Financing

On November 11, 2025, we entered into an underwriting agreement (the “Underwriting Agreement”) with Ladenburg Thalmann & Co. Inc., as the sole underwriter (the “Representative”), relating to the issuance and sale in a public offering (the “November 2025 Offering”) of: (i) 209,528 shares of the Company’s common stock, par value $0.0001 per share (“Common Stock”), (ii) pre-funded warrants to purchase up to 179,361 shares of Common Stock, (iii) Series A warrants to purchase up to 388,889 shares of Common Stock, (iv) Series B warrants to purchase up to 388,889 shares of Common Stock, and (v) up to 699,999 additional shares of Common Stock, Series A warrants to purchase up to an additional 699,999 shares of Common Stock and Series B warrants to purchase up to an additional 699,999 shares of Common Stock that may be purchased pursuant to a 45-day option to purchase additional securities granted to the Representative by the Company. The Representative exercised this option on November 11, 2025 for 55,477 shares of Common Stock, Series A warrants to purchase up to 58,333 shares of Common Stock and Series B warrants to purchase up to 58,333 shares of Common Stock. The combined public offering price of each share of Common Stock, together with the accompanying Series A warrants and Series B warrants, was $18, less underwriting discounts and commissions. The combined public offering price of each pre-funded warrant, together with the accompanying Series A warrants and Series B warrants, was $17.9988, less underwriting discounts and commissions. Subject to limited exceptions, a warrant holder may not exercise any portion of its warrants to the extent that the holder would beneficially own more than 4.99% (or, at the election of the holder prior to the date of issuance, 9.99%) of the Company’s outstanding Common Stock after exercise.

The November 2025 Offering, including the additional shares of Common Stock, Series A warrants and Series B warrants sold pursuant to the exercise of the Representative’s option, closed on November 12, 2025.

The net proceeds from the Offering, including the additional shares of Common Stock, Series A warrants and Series B warrants sold pursuant to the exercise of the Representative’s option, after deducting underwriting discounts and commissions and other estimated Offering expenses payable by the Company and excluding any net proceeds from the exercise of the Series A warrants, Series B warrants and pre-funded warrants, were approximately $6.3 million.

In connection with the November 2025 Offering, the Company and Equiniti Trust Company, LLC entered into a Warrant Agency Agreement pursuant to which Equiniti agreed to act as warrant agent with respect to the Series A warrants, the Series B warrants and the pre-funded warrants.

On November 12, 2025, pursuant to the Underwriting Agreement, the Company issued warrants to the Representative to purchase up to 22,218 shares of Common Stock at an exercise price of $27.90, subject to adjustments (the “Representative Warrants”). The Representative Warrants are exercisable at any time and from time to time, in whole or in part, until November 11, 2030, and have substantially similar terms to the Series A warrants.

All securities issued in the November 2025 Offering (including the shares of Common Stock issuable from time to time upon exercise of the warrants and the Representative Warrants) were offered pursuant to a registration statement on Form S-1, as amended, which became effective on November 10, 2025.

Reverse Stock Splits

On August 15, 2025, the Company filed a Certificate of Amendment to the Company’s restated certificate of incorporation, as amended, with the Secretary of State of the State of Delaware to effect a 1-for-15 reverse stock split of the Company’s issued and outstanding shares of common stock, par value $0.0001 per share (the “2025 Reverse Stock Split”) which became effective on that date. All historical share and per share amounts reflected throughout this report have been adjusted to reflect the 2025 Reverse Stock Split.

On March 5, 2026, the Company filed a Certificate of Amendment to the Company’s amended and restated certificate of incorporation, as amended, with the Secretary of State of the State of Delaware to effect a 1-for-12 reverse stock split of the Company's issued and outstanding shares of Common Stock, par value $0.0001 per share (the “2026

Reverse Stock Split”) which became effective as of March 6, 2026. All historical share and per share amounts reflected throughout this report have been adjusted to reflect the 2026 Reverse Stock Split.

Strategy

Decoy focuses on viral diseases that drive widespread health, economic and societal disruption, shaping programs not only around scientific potential, but around affordability, reimbursement, and the ability to reach patients at scale.

Our IMP³ACT platform creates peptides that target what enveloped viruses share, integrating AI-enabled peptide design with rapid synthesis to advance candidates faster than traditional approaches. What that means in practice:

AI-accelerated design that learns and improves with each candidate

Research synthesis timelines measured in days, not months

A proprietary data advantage that compounds across programs

Built-in adaptability to novel and emerging viral threats

Faster time to market, and potential for follow-on indications

We select D-MAV targets based on the following criteria:

Potential for a therapeutic that can address multiple disease indications with one drug.

The presence of a natural “starting peptide” that our platform can rapidly optimize into a promising therapeutic.

Potential to create a peptide conjugate therapeutic with a novel and differentiated value proposition that meets a significant unmet medical need.

We believe this target selection strategy will maximize return on investment from the IMP3ACT platform by efficiently advancing paradigm-creating D-MAVs, changing the way we protect against and treat viral diseases.

Our goal is to become a fully integrated biopharmaceutical company with a pipeline of novel therapeutics. We intend to achieve this through the following strategic objectives:

Achieve clinical proof-of-concept by bringing our lead pan-Coronavirus antiviral forward through a Phase 2 human challenge trial. Despite COVID-19 moving to an endemic phase, significant global unmet medical need remains among immune-suppressed populations. To date, this program has been largely supported by non-dilutive funds, and we believe the program will continue to attract such funds to advance this program clinically.

Bring forward one additional transformative program to IND-enabling status within two years, leveraging our platform's speed and efficiency to advance potentially transformative peptide conjugate therapeutics meeting our target selection criteria.

Build a platform manufacturing capability: We intend to pursue collaborations with major commercial peptide manufacturing organizations, allowing rapid scale-up of novel D-MAV drug candidates for pre-clinical and clinical studies in a repeatable, cost-effective manner.

Continue to access non-dilutive funding. To date, we have attracted significant non-dilutive funding from The Gates Foundation, BARDA, Google, and the IMI-Care Consortium, and expect to continue to seek such funds.

Pursue value-enhancing partnerships. We believe we can rapidly create and validate novel therapeutic assets, and aim to attract capital and capabilities in later-stage development and commercialization through selective partnerships.

Maintain Pandemic Readiness: preserve the pandemic “Call-Option” embedded with the IMP3ACT Platform. Our platform is well-positioned to rapidly advance antiviral therapeutics in response to novel viral pathogens, especially in viral families considered most likely sources of such pathogens (e.g., avian influenza). We will continue to work with governmental and non-governmental organizations to provide funding for developing D-MAVs against global threats. Given financial returns from therapeutic assets like mRNA vaccines and Paxlovid during COVID-19, we consider this capability a valuable ‘Call Option’ on the next epidemic or pandemic.

Program Development

We intend to leverage the proprietary compound SP-3164, which binds to the E3 ligase complex CRLCBRN, together with our peptide engineering platform to create ‘peptide-based Proteolysis Targeting Chimeras’ (“PROTACs”, “P-PROTACS”).

PROTACs are typically bifunctional molecules: one side binds to a targeted protein while the other binds to an E3 ligase, with a linker between the two. When both are brought together, the targeted protein is ubiquitinated (“tagged”) by the E3 ligase and marked for destruction via proteasomal degradation. SP-3164, a novel immunomodulatory drug molecule, has advantageous properties including potent cereblon binding, low molecular weight, high oral bioavailability, and well-characterized binding mechanisms. Using IMP3ACT platform-engineered peptides instead of small molecules to target disease-causing proteins offers several advantages: peptides can be precisely engineered to bind specifically to one protein or a pre-determined set (e.g., across mutated Ras proteins), whereas small molecules typically bind to many “off-target” proteins, decreasing selectivity and increasing toxicity. Peptides can bind to the active enzymatic site or be engineered to bind to other sites under lower selective mutational pressure, reducing resistance mechanisms. We believe using peptides instead of small molecules vastly expands protein targeting opportunities and dramatically shortens P-PROTAC candidate development timelines.

The PROTAC mechanism is “event-driven”-one PROTAC molecule can induce degradation of multiple copies of the protein target. Even small concentrations can be highly effective, potentially avoiding toxicity from high drug concentrations. By degrading rather than inhibiting the protein target, both enzymatic and other functions are disrupted, with effects lasting until the cell synthesizes new proteins-dramatically expanding duration of action. P-PROTACs are an exploratory arm of the IMP³ACT platform, applying D-MAV design principles to intracellular viral and host protein targets, including those considered undruggable. Early investigative programs are underway, deepening the D-MAV antiviral thesis into a new modality.

Drug Development Programs

We are developing D-MAVs (designable multi-antivirals) targeting the conserved fusion mechanism shared across enveloped virus families. We have demonstrated multi-virus in vitro and in vivo activity. The same platform and design tools will support early investigative antiviral P-PROTAC candidates.

COV: Pan-Coronavirus Prophylactic for Immunocompromised Patients. Our lead program, a nasally inhaled pan-Coronavirus prophylactic, has demonstrated in vitro activity against all human-infecting Coronaviruses tested, including representatives of all variant strains of concern of COVID-19 that have emerged as of the date of this report. This program has primarily been funded by grants from The Gates

Foundation, the Center for the Biologic Advanced Research and Development Authority’s Blue Knight Program (“BARDA”), and support from the IMI Care Consortium, Google, and NVIDIA computing programs. The Company plans to file an Investigational New Drug ( “IND”) application with the United States Food and Drug Administration ( “FDA”) or the European equivalent clinical trial application (“CTA”) during the first half of 2027 and to continue to pursue non-dilutive funding and a development partner for clinical development.

TRI: Broad Respiratory Antiviral (Flu/COVID-19/RSV). We aim to exploit structural similarities across these three viral families to create a peptide conjugate antiviral broadly applicable to most influenza-like-illnesses (“ILI”), which drive an estimated 15 to 20 million medical visits annually in the United States alone. Building on our work creating peptide conjugate antivirals with broad activity in the Coronavirus and Paramyxovirus (RSV) viral families, we believe this program could represent a fundamental shift in respiratory virus treatment.

Our Exploratory Stage Program

P-TAC: Exploratory P-PROTAC Conjugates: We aim to explore the use of SP-3164 as the E3 ligase binding component in peptide based PROTACs, using engineered peptides to target intracellular proteins involved in viral replication and latent virus activation.

Legacy Small Molecule Program

SP-2577: SP-2577 is a legacy small molecule LSD-1 inhibitor program from pre-Merger Salarius’ portfolio. As a legacy product, it does not utilize Legacy Decoy’s integrated technology. We intend to continue monitoring The University of Texas MD Anderson Cancer Center (“MDACC”) in its sponsored investigator-initiated clinical trial evaluating seclidemstat (SP-2577) in combination with azacytidine in adult patients with myelodysplastic syndromes and chronic myelomonocytic leukemia. In July 2024, the FDA placed the trial on partial clinical hold following a serious grade 4 adverse event. In February 2025, we announced that MDACC had addressed the FDA’s questions and the partial clinical hold was lifted, with patient enrollment resumed. Enrollment for this clinical trial ended in January of 2026; we intend to seek strategic alternatives for this program including potential out-licensing.

Grant Agreements

The grant agreement between Legacy Decoy and The Gates Foundation (the “Gates Grant Agreement”) was entered into on September 9, 2021 and subsequently amended on August 29, 2023 and February 26, 2025, entitling us to approximately $5 million in the aggregate. We have received approximately $4.4 million in multiple tranches as we reached specific research milestones, and expect to receive the final tranche of approximately $600,000 in the first half of 2026. The use of grant funds is governed by a budget approved in conjunction with The Gates Foundation, and material deviations (i.e., 10%) require their approval. The expiration date is December 31, 2026. The Gates Foundation may modify, suspend, discontinue, or terminate the Gates Grant Agreement if: (a) not reasonably satisfied with our progress; (b) significant changes to leadership or other factors threaten the project’s success; (c) a change in control occurs; (d) a change in our tax status; or (e) we fail to comply with the agreement. Any unused funds must be returned promptly upon expiration or termination.

We have received multiple awards from the BLUE KNIGHT™ Resident QuickFire Challenge (the “QFC”) and entered into letter agreements with Johnson & Johnson Innovation LLC (“JJI”) on January 31, 2023, July 28, 2023, and March 11, 2024 to investigate various ancillary program elements. We have supplied final reports for all three grants in accordance with the letter agreements.

Market Opportunity for Our Current Drug Development Programs

We see opportunities in each of the four main areas of our drug discovery program efforts:

COV: Pan-Coronavirus Inhibitor for Immunocompromised Patients

According to the December 2024 World Health Organization publication on COVID-19, SARS-CoV-2 continues to infect and cause severe acute disease and post COVID-19 condition (long COVID).[1]Current tools include mRNA vaccines and Paxlovid, which are effective at avoiding severe outcomes in high-risk patients. However, Paxlovid cannot be used prophylactically and has a significant Drug-Drug Interaction[2](“DDI”) profile, leaving a treatment gap for immune-suppressed patients or those with high-risk comorbidities who do not respond significantly to vaccines. Early pandemic antibody prophylactics like Evusheld became obsolete due to rapid SARS-CoV-2 evolution. The recently authorized prophylactic antibody Pemgarda is at risk of losing efficacy as the virus continues to mutate-the most recent variants have approximately 150 mutations compared to the original viral sample.

We commissioned market research in 2022[3] that indicated important unmet medical needs in COVID-19 treatment and prevention:

Prophylaxis for current and future variants in high-risk patients: Health care providers (“HCPs”) are concerned about preventing severe cases in at-risk patients, particularly critical if new variants arise.

Easy-to-use route of administration: Key opinion leaders noted the need for non-injectable preventative products to enable broad availability and avoid high-risk patients visiting healthcare facilities for administration.

Effective treatments with better Drug-Drug Interaction ("DDI") profile: DDIs, such as those with Paxlovid, are a concern for HCPs, especially given that high-risk patients tend to have comorbidities and are likely on other treatments.

This market research, which included HCP and payer studies across the United States and European Union, indicated that 20 million or more patients in the U.S. and Europe are at ‘highest risk’ from COVID-19 and other respiratory viral infections, with favorable reimbursement outlook for therapeutics filling treatment gaps.

Our lead program is a broad-acting antiviral nasal spray to prevent or mitigate COVID-19 infections in high-risk, immunocompromised populations with limited treatment options. This agent has shown in vitro activity against all human-infecting Coronaviruses, including all COVID-19 variants to date, would be conveniently self-administered, and is expected to provide 8-24 hours of antiviral activity with low cost of goods.

We expect multiple potential attractive development and commercialization options for an inhaled pan-Coronavirus fusion inhibitor, including:

Pre- and post-exposure prophylaxis (“PrEP”/”PEP”) for highly immunocompromised populations facing elevated risks from severe immune deficiencies associated with hematological malignancies and immunosuppressive medical treatments in hematopoietic stem cell transplantation and solid organ transplants, with potential for label expansion. Market research suggests over 5 million such patients in the U.S. and EU, with an estimated net price of up to $500 per 30-day supply in the U.S. feasible.

Post-infection treatment as an alternative to Paxlovid with a superior DDI profile. Morningstar projects full year 2024 revenues exceeding $5 billion[1] for Paxlovid, despite notable DDIs with widely prescribed drugs such as statins (over 90 million Americans) and calcium channel blockers (more than 20 million Americans). Many high-risk patients cannot take Paxlovid due to DDI concerns. Paxlovid’s U.S. list price is $1,390 for a 5-day course[2] as of October 18, 2023.

We also believe there may be additional opportunities for a pan-Coronavirus fusion inhibitor to generate revenue from public health authority stockpiling of drug for pandemic preparedness and military readiness purposes.

Our plan is to initially develop this agent as a pre- and post-exposure prophylactic for targeted immunocompromised subsets, such as patients with hematological malignancies and post-transplant patients, who have high unmet medical need and can be accessed in the U.S. by a small, specialized sales force focusing on cancer treatment and transplant centers. We then plan to expand to additional indications.

We recognize the rapid evolution of the COVID landscape and will continue to engage key opinion leaders, health care providers, payers, and patient market research and potentially adjust our plans based on those findings.

[1] https://www.who.int/publications/m/item/covid-19-epidemiological-update---24-december-2024

[2] https://paxlovid.pfizerpro.com/drug-interactions

[3] Primary market research performed by Bionest Partners in Oct/Nov 2022: 13 HCPs, 13 Payers in the US, DE, FR, IT, and the U.K.

TRI: Broad Respiratory Antiviral (Flu/COVID/RSV)

We are engineering a groundbreaking approach to combat Flu/COVID/RSV infections with a single D-MAV antiviral potentially effective against all three major respiratory viruses, including pandemic flu strains if possible.

By addressing three viral families with a single therapy, we aim to revolutionize respiratory illness management. Respiratory tract infections represent a significant unmet medical need. The seasonal convergence of influenza, respiratory syncytial virus (“RSV”), and COVID-19 (the “tripledemic”) has intensified the burden of these infections, which are often vectors to dangerous lower respiratory infections. Despite vaccine availability, with decreasing uptake, hospitalizations and fatalities from respiratory viruses continue to strain healthcare resources.

Our single therapy with broad activity approach potentially offers several key advantages:

A single therapy with proven efficacy against all three viruses could potentially eliminate the need for multiple treatments, streamlining patient care and reducing complexity for healthcare providers.

Our therapy is expected to be self-administered, offering convenience and autonomy to patients.

Peptide conjugates to date have a favorable safety and tolerability profile.

Given the expected ease of use and safety profile, we intend to pursue a commercialization approach that will make this product, if approved, broadly accessible to symptomatic patients, leveraging emerging channels such as telehealth, digital patient engagement, and at-home delivery.

In the United States, the combined impact of influenza, RSV, and COVID-19 results in an estimated 15 to 20 million medical visits annually among patients aged 18 and older. This significant healthcare utilization underscores the burden of respiratory tract infections on the healthcare system.

Expanding the market to include individuals with symptomatic illness who may not physically visit a doctor's office approximately doubles the number of eligible adult patients. With the increasing adoption of telehealth services and the advancement of wearables signaling very early respiratory infections, there is a tangible opportunity to expand the market for respiratory tract infection treatments beyond patients who traditionally seek in-person medical care.

Given these factors, we believe our ‘tripledemic’ D-MAV antiviral program could represent the cornerstone of a significant global franchise.

Our IMP3ACT Platform

Overview of Peptides and Peptide Conjugate Therapeutics

A key advantage of D-MAVs engineered by our IMP3ACT Platform is ‘polypharmacology,' in which a single molecule can activate or inhibit multiple targets/receptors in an additive or synergistic manner to achieve superior or multi-indication efficacy.

The success of multi-targeting peptide conjugates is due to careful peptide design based on structural similarity between viruses, an advantage difficult to match with other modalities, and in contrast to the often unpredictable off-target effects of small molecules.

An FDA-approved polypharmacology example is Eli Lilly’s blockbuster ZepBound™, a single peptide conjugate demonstrating agonism of both GLP-1R and gastric inhibitory peptide receptor. Another example is our lead program, a D-MAV demonstrating activity against multiple human infecting coronaviruses.

Peptides are short chains of amino acids linked by peptide (amide) bonds, typically less than 50 amino acids long, playing vital roles in biological processes.[4] Secondary interactions cause peptides to fold into complex 3-dimensional structures, including the common α-helical coil. α-helical peptides and proteins are ubiquitous in biology, and α-helices often interact chemically with other α-helices driving protein-protein and protein-nucleic acid interactions, making α-helical peptides effective therapeutic bases.

Peptides have important advantages compared to small molecules and antibody-based therapeutics[5]:

High potency and specificity: Peptides bind a larger surface area of the target than small molecules, providing high selectivity with tight binding.

Excellent safety profile with predictable metabolism: Small molecules easily diffuse across cell membranes and often have off-target toxicities. Peptides typically do not passively diffuse and are usually metabolized into non-toxic compounds.

High tissue penetration vs. antibodies: Antibody-based therapeutics are very large (~30x the size of peptides) and have difficulty diffusing deep into tissues from blood vessels.

Simpler manufacturing, lower cost of goods: Peptides are manufactured using synthetic chemistry, whereas antibody-based therapeutics require complex, intensively regulated biological processes.

Small peptides as drugs, however, have an intrinsic limitation; they are subject to rapid enzymatic digestion and clearance from the GI tract or in the bloodstream, limiting their half-life and oral bioavailability.

Peptide conjugates solve this problem by chemically linking a peptide, typically via a polyethylene glycol (PEG) structure, to additional molecules (e.g., another peptide, nucleic acid, or fatty acid), enhancing drug-like properties by improving enzymatic stability, half-life, and bioavailability while maintaining low immunogenicity.

The IMP3ACT Platform

The Immediate Peptide/PPMO/P-PROTAC Alpha-helical Conjugate Technology (“IMP3ACT”) platform leverages peptide ‘coiled-coils’ chemistry and physics to design α-helical peptides through computational and ML tools. Starting from naturally existing peptide ligands, we optimize their structure and transform them into multimeric conjugates by chemically linking peptides to lipids and other anchor moieties, enhancing drug-like properties with extended pharmacokinetics. Our technology has produced single peptide conjugates active against multiple human coronaviruses, including all SARS-CoV-2 major variants to date, and a second conjugate active against RSV A, RSV B, and hPIV3. By integrating ML algorithms to assist in peptide design and synthesis, our platform accelerates creation of lead molecules for preclinical evaluations, simultaneously optimizing for enhanced affinity, binding specificity, protease resistance, pharmacokinetic properties, and manufacturability.

Our IMP3ACT platform may achieve peptide conjugate manufacturing readiness faster than conventional processes, reducing costs and accelerating delivery of broad-spectrum drug candidates to IND. The modular nature means each new drug candidate improves the overall platform, and success likelihood should grow as the ML/AI models learn. By employing solid phase peptide synthesis in an “All-in-One” manufacturing approach, we optimize assembly of complex peptide-linker-functionalized compounds, enhancing platform speed, efficiency, and predictive value.

The Design-Build-Test-Learn Engine

We have integrated advancements in data science, peptide conjugate chemistry, and manufacturing processes to create our IMP3ACT platform. The core is the Design-Build-Test-Learn Cycle: “Design” utilizes AI in silico approaches to analyze protein and genomics datasets and make structure-function predictions; “Build” implements fast-flow synthesizers generating peptide candidates faster than industry standard; “Test” incorporates experimental testing via reliable assays to characterize peptide-candidates; and "Learn" capitalizes on experimental data to redesign improved in silico candidates.

This integrated, multiparameter approach streamlines drug discovery, making it faster and more efficient with greater attention to drug-like and commercialization properties. Continuing to iterate on our Design-Build-Test-Learn loop will generate valuable proprietary data driving in silico models to generate design solutions otherwise unavailable from computational approaches. Our hypothesis is that the key to ML/AI-driven drug design value-creation is well-structured, useful, proprietary data and knowledge on which tools to use-not the computational models themselves. Our platform strategy will help us become leaders in designing and developing α-helical D-MAV peptide-conjugate therapeutics.

Starting from Existing Peptide Ligands

A key platform strategy element is starting from naturally existing peptides, leveraging ‘nature’s starting points’ to improve program timelines and reduce risk. We can rapidly synthesize a D-MAV incorporating a naturally existing peptide sequence that is immediately active against the target in question. We believe this is an excellent starting point for the Design-Build-Test-Learn loop because it significantly decreases the size of the peptide conjugate design space, making it computationally tractable to rapidly optimize for drug-like properties.

Our in silico engine uses ML, AI, and physics-based computational tools to identify helical motifs within metagenomics data shared across targets. This enables rapid design of polypharmacologic peptide conjugates where one drug can interact with multiple targets, unlocking broad activity across several indications from a single conjugate. These ML-driven α-helical drug candidates can inhibit a wide range of viruses by targeting shared viral fusion machinery, critical for enveloped virus entry and replication. We will leverage the virally trained α-helical database to explore targeting intracellular viral targets with innovatively designed P-PROTACs incorporating the Salarius molecular degrader, SP-3164.

Multiparameter Optimization of Drug Properties

The IMP3ACT Platform acts as an iterative feedback loop and incorporates data from multiple in vitro experiments to improve candidate peptide design parameters. The platform is designed to optimize against multiple parameters simultaneously. Traditional drug development relied on ‘one step at a time’ optimization, often leading to restricted chemical design space where important downstream attributes like pharmacokinetic behavior cannot be easily enhanced. By using all experimental data relevant to making a drug to train the ML engine, more drug-like peptide conjugates with optimized functionality and commercialization potential may be designed. This multiparameter optimization reduces costs and significantly decreases probability of pre-clinical or clinical failures by avoiding ‘dead end’ development paths.

Rapid synthesis

We use fast-flow automated process coupled with a proprietary “All-in-One” method (patent pending) to synthesize multiple peptide-conjugates on lab-based machines. The yield (5-100 mg depending on desired scale) and purity is sufficient for multiple in vitro tests including physicochemical properties and biological function. This innovation dramatically decreases cycle time to learn structure-activity relationships for different peptide designs and enables construction of a multiparameter structure-activity-drug-like proprietary database on α-helical peptides.

Compared to standard industrial solid phase synthesis, fast-flow synthesis leverages a heated reactor to accelerate speed, allowing amide bond formation creation in just 7 seconds per amino acid, compared to around 1 hour per cycle traditionally. Fast-flow synthesis can be automated to eliminate human intervention and errors and work in high throughput fashion. Mijalis et al demonstrated fast-flow machines can generate peptides 45 times faster than standard batch synthesis (40 minutes versus 30 hours[6]) with better crude peptide output and yields. This automated approach enables rapid peptide conjugate production while maintaining high quality, shortening overall time to optimize clinical drug candidates.

We have invented a multi-arm linker compatible with solid phase peptide synthesis methods that can build complex biomacromolecules containing branched peptides and other functionalities in one synthetic run. These molecules can be differentially functionalized while attached to solid phase resin; our proprietary “All-In-One” manufacturing. When the desired molecule is built, the intact, desired compound can be cleaved from the resin, purified, and isolated for formulation and administration.

Using fast-flow synthesis with this process, the research scale synthesis of a peptide conjugate is reduced from several months (typical at a standard CDMO) to days or hours. Our IMP3ACT platform is a unique lead optimization engine that can rapidly design from natural peptide ligands and identify optimized drug-like lead molecules. Additionally, we are currently evaluating the use of our “All-In-One” process at commercial scale for further time savings in the transition from preclinical to GLP and cGMP scale-up.

Testing

We focus on using in silico and empirical assays with predictive value. In the design engine, in silico tools have been validated against actual data (e.g., binding affinity, solubility, protease resistance, manufacturability) to ensure reliability. The screening cascade for each program relies on predictive assays to streamline decision making. Where possible, human organoid and epithelial tissue models are incorporated to improve predictive power, as rodent models have moderate predictive value and translation to human tissues is difficult, especially for intranasal or inhaled programs. Organoid models are also significantly less expensive and easier to scale than animal models.

The human airway epithelial (“HAE”) model is a cell culture system grown at an air-liquid interface (“ALI”). This in vitro culture system mimics human airway epithelium more closely than traditional submerged cell cultures. In the ALI setup, the basal surface of human airway cells contacts a liquid culture medium while the apical surface is exposed to air, promoting differentiation into a mucociliary phenotype characteristic of human respiratory tract pseudostratified epithelium. The ALI culture system is used for studying respiratory epithelium cell biology, modeling respiratory diseases, and studying drug effects.

SARS-CoV-2 HAE-ALI experiments demonstrate this model recapitulates human data: infection kinetics peak between days 4 and 8 in HAE-ALI culture, consistent with human SARS-CoV-2 viral kinetics in the nasal epithelium.[7]Multiple coronaviruses have been tested, with growth kinetics and cellular effects correlating to human experience across seasonal versus pandemic viruses. Both influenza and RSV have been modeled in HAE for testing infectivity and therapeutic efficacy.

Additional preclinical work will include quantitative pharmacology and model-based approaches in conjunction with toxicology information in both human model systems and animal studies to project human starting doses for Phase 1 studies.

Scale-Up Manufacturing

We are working internally and with multiple Contract Manufacturing Organizations (“CMOs”) to develop and scale-up proprietary GMP-compatible manufacturing processes. The efficiency of our IMP3ACT platform enables D-MAV manufacturing readiness faster than conventional processes, reducing costs and accelerating delivery of broad-spectrum drug candidates.

By employing solid phase peptide synthesis in an “All-in-One” manufacturing approach, we optimize assembly of complex peptide-linker-functionalized compounds. We are working with a major peptide manufacturer to scale the process to quantities useful for preclinical development through early-stage clinical trials; we anticipate new intellectual property from this collaboration. Our goal is preclinical manufacturing readiness within significantly shorter timelines than traditional processes, aiming to meet or exceed the 100-day goal for vaccine manufacturing-moving from initial natural peptide ligand to drug lead in a single quarter.

Formulation Flexibility

Traditionally peptides as drugs have suffered from very low bioavailability, limiting delivery to intravenous or subcutaneous routes. We are exploring multiple self-administered routes including:

Intranasal, including nose-to-brain delivery;

Inhaled/pulmonary delivery (local and systemic applications);

Subcutaneous patches for extended systemic release; and

Oral.

We are engineering D-MAVS to possess physicochemical and pharmaceutical properties enabling each delivery route, including solubility, chemical stability, protease resistance, and excipient compatibility. Results indicate our peptide conjugates can be formulated into both liquid and dry powder dosage forms that are room temperature stable and suitable for various delivery devices.

Competitive Strengths of the IMP3ACT Platform

We believe the IMP3ACT platform has several key advantages compared to other drug-discovery approaches:

Proprietary Data: Continuing to run our Design-Build-Test-Learn loop results in an expanding proprietary data set giving the IMP3ACT platform a differentiated, difficult-to-duplicate capability to design novel therapeutic candidates against α-helical targets in viruses.

Faster & Lower Cost Discovery: Our ML/AI engine applies computational tools to model structures, energy costs, binding affinities and specificity, protease resistance, and manufacturability to design lead-quality molecules in a fraction of the time, making significantly fewer candidate molecules than required in traditional drug discovery methods.

Streamlined & Repeatable Manufacturing: We are working to scale-up the “All-in-one” manufacturing process to repeatably utilize the same CMC processes for each new drug candidate. We have applied for the FDA Emerging Technology program based on the Food and Drug Omnibus Reform Act of 2022. Our goal is to manufacture 30g of active pharmaceutical ingredient (“API”) of a new therapeutic candidate-typically enough through preclinical activities-in 30 days.

Low Commercial Cost of Goods: Our manufacturing process is fully chemically synthetic and runs on standard peptide synthesis machinery, avoiding the bioprocess and regulatory complexities of recombinant biological processes. We expect very low COGS at commercial scale-for example, targeting total COGS of less than $1/dose in our lead pan-Coronavirus inhibitor program.

Flexible Formulation: We intend to formulate peptide-conjugate therapeutics in a variety of self-administered formats, including nasal and oral inhalation and extended-release dermal patches, optimizing delivery route for indication and market.

Increased Probability of Success: Multi-parameter optimization from the beginning of design and discovery should help avoid “dead-ends” which result in expensive, time-consuming drug development failures.

Drug Development Programs

Through our IMP3ACT platform, we aim to create a diverse and expanding development portfolio of antiviral and GPCR-targeted peptide conjugates. Our initial programs are outlined below.

Pan-Coronavirus Prophylactic for Immunocompromised Patients

We are developing this program for prophylactic prevention of SARS-CoV-2 infection in immunocompromised patients, currently in late lead optimization stage. This program is supported through IND-enabling studies by grants from the Gates Foundation and Blue Knight Program totaling $6.5 million. We intend to seek additional non-dilutive funding through Phase 2a proof-of-concept (antiviral challenge) studies and a development partner.

The SARS-CoV-2 pandemic demonstrated that vaccines and antiviral therapeutics are complementary tools. Rapid COVID-19 vaccine development saved millions of lives. However, continued SARS-CoV-2 immune escape variant evolution, growing ‘vaccine hesitancy,’ and immune-suppressed sub-groups at risk regardless of vaccination status are treatment gaps only antiviral therapeutics can fill.

Our target product profile for this program, developed in conjunction with the Gates Foundation, is:

Prevention of infection by all SARS-CoV-2 variants and other human infecting coronaviruses including MERS-CoV;

Convenient self-administration via intranasal spray;

Over 8 hours of protection from a single dose; and

Cost of goods of less than $1 per dose.

We have demonstrated through in vitro pseudotype, live virus, HAE assays and in vivo Syrian hamster models that multiple D-MAVs inhibit viral infection and demonstrate multifold decrease in viral infectious particles when delivered before (pre-exposure prophylaxis or PrEP) or after (post exposure prophylaxis or PEP) viral challenge. DCOY101 and its analogs have demonstrated infection inhibition in cell-based assays against all major SARS-CoV-2 variants of concern and other human-infecting coronaviruses, including SARS-CoV-1, Middle Eastern Respiratory Syndrome (“MERS”), and the “cold-causing” coronaviruses OC43 and NL63, as expected due to strong similarity of fusion region structure across coronaviruses.

The initial indication will be PrEP and PEP prevention of COVID-19 in immunocompromised patients. The Company plans to file an IND application with the FDA or the European equivalent CTA during the first half of 2027, then initiate a Phase I clinical trial in adult healthy volunteers followed by a proof-of-concept Phase 2a human “challenge” study in which healthy volunteers are infected with SARS-CoV-2 under controlled conditions[8]. We expect to partner this program after demonstrating human proof-of-concept.

Immunocompromised Populations

SARS-CoV-2 initially infects ciliated cells in the nasopharynx; most people have mild to moderate illness with viral replication restricted to the upper airways. However, COVID-19 can progress to life-threatening pneumonia in people with predispositions including hypertension, heart failure, cardiac arrhythmia, diabetes, kidney failure, chronic pulmonary disease, old age, and/or compromised immune systems. Severe illness typically begins one week after symptom onset, potentially leading to Acute Respiratory Distress Syndrome (ARDS). COVID-19 can also lead to disease beyond the respiratory tract, including gastrointestinal, acute cardiac, kidney, and liver injury. COVID-19 can lead to Long COVID (Post COVID Condition or “PCC”), a multisystemic condition persisting for weeks to years. The

risk of Long COVID increases with each infection; approximately 6% of symptomatic infections resulted in PCC despite vaccination.[9]

Immunocompromised patients face several distinct challenges:

Patients post-hematopoietic stem cell transplants or CAR-T therapy are at higher risk of severe COVID-19 within 100 days of treatment, even with rigorous infection control and social avoidance practices.

Patients with cancer have an impaired immune response to COVID-19 vaccination and are thus at significant risk from SARS-CoV-2 infection.

Prolonged SARS-CoV-2 infection has been observed in patients with lymphoid or hematological malignancies.

COVID-19 infections may lead to disruptions of care, for example an interruption in cancer treatment or a delay in a transplant procedure, that can have significant life-altering consequences for patients.

Chronic, persistent SARS-CoV-2 infections in immunocompromised patients are also of public health concern, as continued viral evolution within these patients may be a key source of novel variants of concern.

SARS-CoV-2 Burden of Disease Post-Pandemic

SARS-CoV-2 continues to cause significant morbidity and mortality. Between September 2023 and March 2024, approximately 561,000 people were hospitalized in the U.S. from COVID-19, resulting in approximately 42,000 deaths.[10] By comparison, during the 2023-2024 flu season, there were 470,000 influenza-associated hospitalizations and 28,000 deaths. This suggests COVID-19 prevalence may equal or exceed influenza for the foreseeable future.

Current Treatment Landscape and Opportunity

We are not aware of any antiviral that can prevent SARS-CoV-2 infection. The prophylactic monoclonal antibody Pemivibart was recently authorized under emergency use for immunocompromised patients, but given continued SARS-CoV-2 evolution, it is unclear how long this antibody will remain effective.

Therefore, immunocompromised patients, including those facing transplants or cancer treatments, are at particularly high risk of significant morbidity and mortality upon infection with few options. There is a clear unmet medical need for additional safe, novel prophylactic treatments that can act across multiple SARS-CoV-2 variants.

Our Solution - a pan-Coronavirus D-MAV

We are designing and synthesizing α-helical peptides simultaneously optimized for binding affinity, broad activity against human coronaviruses, potency in cell-based antiviral assays, physicochemical features important for pharmacokinetic durability, formulation, and manufacturability. These peptides are linked via a PEG-based linker to a cholesterol molecule, demonstrated in scientific literature to significantly improve peptide conjugate pharmacokinetic properties.

Mechanism of Action

Viral fusion is required for enveloped viruses to enter human host cells and initiate viral replication. Without fusion, infection will not occur. Treatment with a fusion inhibitor interrupts the infectious cycle, decreasing viral replication. Our pan-Coronavirus peptide conjugates recognize the HRN helical region of the coronavirus spike protein and bind to it, precluding natural binding of spike HRC to HRN and preventing fusion and viral entry.

The basic viral fusion “machinery” structure is highly conserved across enveloped viruses, comprising 11 viral families and 250+ human-infecting viruses[11], presenting opportunity to apply fusion inhibition to other viruses and viral families.

Summary of Proof-of-Concept Preclinical Data

In vitro cell-based assays:

We demonstrated that a single D-MAV targeting fusion machinery can inhibit viral infection for multiple SARS-CoV-2 variants in pseudotype and live virus infection assays. We have also shown activity against 5/6 other human-infecting coronaviruses: SARS-CoV-1, MERS, OC43, NL63, and 229E. The final human-infecting coronavirus, HKU1, is difficult to culture in vitro and so has not been tested to date.

Figure 1: In Vitro Antiviral Activity of pan-Coronavirus Peptide Conjugates

Human Airway Epithelial Model:

The HAE-ALI system is a HAE cell culture grown at an air-liquid interface (“ALI”), designed to mimic human airway epithelium more closely than traditional submerged cell cultures. In the ALI setup, the basal surface of the human airway (nasal, bronchial, or alveolar) cells is in contact with a liquid culture medium, while the apical surface is exposed to air. This configuration supports cellular differentiation into a mucociliary phenotype characteristic of human respiratory tract pseudostratified epithelium. The ALI culture system is physiologically relevant for studying respiratory epithelium, modeling respiratory diseases, and studying drug efficacy.

[1] https://www.morningstar.com/news/business-wire/20241029363831/pfizer-reports-strong-third-quarter-2024-results-and-raises-2024-guidance

[2] https://www.reuters.com/business/healthcare-pharmaceuticals/pfizer-price-covid-19-drug-paxlovid-1400-five-daycourse-wsj-2023-10-18/

[3] Susini, C. & Buscail, L. Rationale for the use of somatostatin analogs as antitumor agents. Ann. Oncol. 17: 1733-1742 (2006).

[4] Insel, PA et. al. GPCRomics: GPCR Expression in Cancer Cells and Tumors Identifies New, Potential Biomarkers and Therapeutic Targets. Front Pharmacol. 9:431 (2018).

[5] PLoS ONE 17(3): e0255753. https://doi.org/10.1371/journal.pone.0255753

[6] Mijalis AJ, et. al. A fully automated flow-based approach for accelerated peptide synthesis. Nat Chem Biol. 13(5):464-466 (2017).

[7] Lindeboom, R.G.H., Worlock, K.B., Dratva, L.M. et al. Human SARS-CoV-2 challenge uncovers local and systemic response dynamics. Nature 631, 189-198 (2024). https://doi.org/10.1038/s41586-024-07575-x

[8] Nature Medicine (2022) 28:1031-1041.

[9] Wulf Hanson, S. et al. JAMA. (2022) 328(16):1604-1615

[10] https://covid.cdc.gov/covid-data-tracker/#trends_weeklydeaths_weeklyhospitaladmissions100k_00

[11] https://en.wikipedia.org/wiki/Viral_envelope

DCOY101 D-MAV Inhibits Infection in a Human SARS-CoV-2 HAE-ALI Infection Model:

DCOY101 prevented infection in the HAE model with dose response across 25 nM, 125 nM, and 625 nM. The compound was delivered apically at the same time as viral challenge (prophylactic treatment). DCOY101 demonstrated a dose-dependent decrease in viral load at 48 and 72 hours post-infection, reducing viral load by ~4 logs compared to vehicle. Remdesivir was used as a positive control, demonstrating significant inhibition as expected based on previous prophylactic HAE-ALI results[1], though delivered basolaterally at an 8x higher dose than DCOY101.

Figure 2: Activity of DCOY101 in the Human Airway Epithelial Model

The dose-responsive antiviral efficacy shown in the above graph is due to DCOY101’s anti-fusion mechanism, not cellular toxicity. Toxic effects were measured with five different endpoint assays showing no impact on cellular junctions/epithelial layer integrity, no lactate dehydrogenase increase, no inflammatory response induction, and no mucociliary clearance impact after treatment with DCOY101.

In vivo Efficacy Evaluations:

Administration of DCOY101+ reduced pathological body weight loss and decreased viral infectious genomes and live virus particles in vivo in intranasal prophylactic (dosing before viral exposure) and post-exposure prophylactic (dosing after exposure but before symptoms) Syrian hamster models of SARS-CoV-2 delta variant infection.

Syrian Golden hamsters are susceptible to SARS-CoV-2 infection and will become sick, though typically clearing infection by day 7. SARS-CoV-2 infects the hamster nose and causes lung lesions by day 4. Hamsters lose weight, thought to be equivalent to human symptoms.

In the first study (Pre-Exposure Prophylaxis or PrEP), hamsters were dosed intranasally at different dose levels once daily, starting two days before viral challenge and continuing until day 7. By day 7, vehicle-treated animals lost 5-10% body weight as they stopped eating due to illness. Animals treated with DCOY101 maintained or gained weight at the highest dose level, indicating protection from viral effects. Viral load showed significant reduction at all dose levels tested, measured by RT-qPCR on a log scale.

[1] Antiviral Research (2021) 192:105122.

Figure 3: DCOY101 Prevents SARS-CoV-2 Infection in the PrEP Syrian Hamster Model

In the second study (PEP), hamsters were dosed intranasally beginning at various timepoints after viral challenge (2, 12, 24, and 36 hours post-challenge). Control animals began losing weight between 24 and 48 hours. Animals treated with DCOY101 maintained weight throughout the study across all timepoints tested, even when dosing started 36 hours after virus-within the symptomatic timeframe. This result suggests our pan-Coronavirus intranasal D-MAV could also have therapeutic activity.

Figure 4: DCOY101 Prevents SARS-CoV-2 Infection up to 36 hours Post Exposure

Preclinical Research Plans

We have demonstrated in vitro activity across human-infecting coronaviruses with significant antiviral activity. SARS-CoV-2 infection can be significantly inhibited with prophylactic DCOY101 treatment in the human organoid HAE-ALI model and in vivo in pre-exposure and PEP hamster models.

Lead Optimization:

The IMP3ACT Platform acts as an iterative feedback loop incorporating data from in vitro experiments to improve candidate peptide design. Typical data includes SPR binding potency, cell-based activity via pseudotype or live virus assays, and molecular parameters. By incorporating experimental data, more potent and drug-like peptide binders can be designed with multiple parameter optimization simultaneously. This ML/AI-enhanced design approach reduces combinatorial research costs and allows lower-cost manufacturing due to improvements in synthesis speed and scale. The platform achieves manufacturing readiness within significantly shorter timelines, aiming to meet or exceed a 100-day goal for vaccine manufacture.

Use of Physiologically Relevant Human Tissue Models:

The HAE model uses primary differentiated human biopsy tissue with appropriate architecture and cellular complexity, allowing infections from standard respiratory viruses including RSV, SARS-CoV-2, and influenza.[1] SARS-CoV-2 replication kinetics in HAE-ALI cultures is similar to that observed in humans. We believe this human-based model will be useful to optimize pharmacokinetic properties, with human nasal tissue providing the most predictive tool versus rodent models. This medium-throughput system allows careful evaluation of tissue residence time and formulation excipient effects.

CMC

Drug Substance: Continuous Manufacturing - IMP3ACT Platform:

We use a proprietary patent pending manufacturing technology which, by thoughtful design and differentiation of chemically active sites, allows complete manufacture of the target compound from beginning to end without intermediate isolation or purification. Both the peptide component and the final cholesterol linker/anchor are assembled in one continuous operation, with the compound isolated only after the target is fully assembled.

The advantages of the continuous manufacturing process are several:

1. A single continuous operation to produce a very complex molecule.

2. Overall improvement of synthesis speed

Continuous manufacturing process time to final product is approximately 5-6 days, versus approximately 8 weeks for similar compounds requiring numerous isolations and purifications.

3. In-process analytical and quality checks can be performed to check on progress of the assembly of the target molecule.

High quality of process output is assured by continuous monitoring of combined unit operations.

4. Simplicity of overall process.

Instead of as many as roughly 70-unit operations and numerous purifications, this continuous process requires only material inputs and a single isolation and purification.

Drug Substance: Distributed Manufacturing - IMP3ACT platform

We project that IMP3ACT, described above, can become a modular, distributed manufacturing platform if the following process development criteria are met:

1. Experience with multiple product manufactures enables continuous processing from start to finish to be optimized to maximize yield and purity of the final product.

2. This experience leads to an understanding of the critical process parameters, variables and attributes affecting product quality which can be applied to efficient continuous processing.

3. Robust and predictive in-process controls are developed.

4. Process concentrations are high.

5. Final purification and isolation of the agent produced can be made efficient and robust; and

6. The above criteria having been met, modular, portable standalone manufacturing skids with modest utility requirements are assembled and shown to be viable for the process.

This type of modular, distributed manufacturing has been demonstrated for vaccine production “in-country” where the vaccines are urgently required. We propose developing a similar modular, portable continuous manufacturing platform for use “in-country” where viral outbreaks occur. We intend this process to be straightforward enough that deep chemical processing knowledge is not required to produce needed medicines.

Drug Product

For drug product development, we are developing and optimizing multiple nasal candidate formulations containing our D-MAVs, including liquid and dry powder. We have demonstrated suitability of our peptide conjugates in shelf-stable aqueous nasal formulations containing typical pharmaceutical excipients and identified multiple lead formulation candidates. We have demonstrated delivery at therapeutic doses via conventional nasal spray devices such as the VP7 Spray Pump and Unidose Liquid Nasal Spray devices from Aptar Pharma Inc. (“Aptar”). We are also developing dry powder formulations for nasal delivery via the Unidose Powder Nasal Spray device available from Aptar.

Clinical Development Plan

We expect to file an IND application with the FDA or the European equivalent CTA for our optimized pan-Coronavirus peptide conjugate within the first half of 2027 and initiate a Phase 1 trial shortly thereafter. Our planned Phase 1 trial is expected to be randomized, placebo-controlled with single ascending daily intranasal dose and multiple ascending dose in up to 40 healthy volunteers (part A), followed by a 12-healthy volunteer cohort given daily intranasal dose for 28 days (part B).

Primary endpoints are expected to determine safety and tolerability of the optimized clinical candidate administered daily as an intranasal spray. Secondary endpoints will include evaluation of pharmacokinetic profiles in the nose and oropharyngeal cavity over 12 hours, device delivery characterization, mucociliary clearance, and nasal residence time.

We anticipate taking two dose levels into a Phase 2 proof-of-concept human challenge trial with up to 250 healthy volunteers, who are administered SARS-CoV-2 under carefully controlled and monitored conditions to establish the PK/efficacy relationship and proof of concept.

Other Indications for our pan-Coronavirus Antiviral

We believe there may be opportunities to develop DCOY101+ in additional indications, including:

Inhaled COVID-19 Therapeutic: DCOY101 has demonstrated activity in hamsters against SARS-CoV-2 infection even when administered up to 36 hours after viral challenge, when significant symptoms have emerged. DCOY101+ may have utility as a COVID-19 treatment alternative to Paxlovid with a significantly superior DDI profile, benefiting immunocompromised, high-risk, and elderly patients already taking drugs contraindicated to Paxlovid.

Middle Eastern Respiratory Syndrome (“MERS”) Therapeutic: DCOY101+ has shown activity against MERS-CoV coronavirus in live virus cell-based assays. MERS symptoms range from mild respiratory illness to severe disease with approximately 35% case fatality rate-much higher than SARS-CoV-2.

Broad Respiratory Antiviral (Flu/COVID-19/RSV): Influenza, RSV, and SARS-CoV-2 continue to pose significant global health threats. There is urgent need for potent, versatile antiviral agents targeting multiple viral strains. A single peptide-conjugate therapeutic active against major respiratory viruses from these three viral families with an excellent safety profile could fill a significant unmet medical need, particularly in immunocompromised patients and children.

Clinical Rationale and Disease Description

Globally, acute lower respiratory tract infections (“LRTI”) are among the top three causes of death and disability in children and adults, causing nearly 4 million deaths annually and leading deaths in children under 5.[2] Viruses are estimated causative in up to 50% of respiratory infections, with influenza, RSV, and coronaviruses identified often.

Current Treatment Landscape and Opportunity

Current medical approaches include vaccination and antiviral treatment where applicable. Vaccination coverage appears to be decreasing globally. Influenza vaccination among healthcare professionals increased during COVID-19 up to ~90% but has since decreased to 81% in 2022-23. By late 2023, only 14% of American adults got the latest SARS-CoV-2 vaccine, despite vaccinated individuals being 54% less likely to get COVID-19. RSV vaccine uptake appears substantially less than flu rates.

Antiviral medications for influenza (Tamiflu, Relenza, Repivab) and COVID-19 (Paxlovid) exist, but influenza drugs are subject to resistance and Paxlovid is underutilized due to DDI concerns. Society's reluctance to maintain vaccinations can have significant public health repercussions, including increased disease burden, outbreak risks, and resistant strain transmission.

Our D-MAV therapeutic that treats LRIs from three major respiratory endemic and epidemic viruses would be unprecedented and could fill a significant medical need given the morbidity and mortality associated with LRIs globally.

Our Solution

We intend to explore combining fusion inhibitory peptides for SARS-CoV-2 (coronaviruses), RSV (paramyxoviruses), and flu (orthomyxoviruses) in a single molecule, investigating several approaches to optimize breadth of activity.

Mechanism of Action

Figure 5: Conservation of the 6-helix bundle across class I fusion proteins from 3 viral families

Figure 5 adapted from Igoneta, S. et. al., Proc Natl Acad Sci U S A. 2011 Dec 13;108(50):19967-72. doi: 10.1073/pnas.1108910108.

We target the conserved fusion machinery common to influenza A&B, paramyxoviruses (RSV A&B, hMPV, hPIV, measles), and coronaviruses (SARS-CoV-2, OC43, NL63). We believe a single molecule targeting all three major respiratory viral families is possible, given the highly conserved protein structure of the 6-helix post-fusion bundle common to these viruses as shown in Figure 5. By focusing on this shared mechanism, our project aims to pioneer a versatile D-MAV antiviral agent significantly impacting global health by mitigating the LRTI threat.

Summary of Proof-of-Concept Preclinical Data

Significant progress has been made with our leading antiviral peptide conjugate series, DCOY101+, showing strong in vitro effectiveness against all tested SARS-CoV-2 variants and other human coronaviruses including MERS, SARS-CoV-1, OC43, and NL63 (see Fig. 1, 2). In vivo, DCOY101+ has demonstrated antiviral effects and maintained therapeutic levels for over 8 hours when administered intranasally in Syrian golden hamsters (Figures 3, 4).

Recently, our rapid discovery engine has produced broad-spectrum paramyxovirus inhibitors with promising in vitro proof-of-concept results against RSV-A, RSV-B, and HPIV3 (Fig. 6). Synthesis of these novel D-MAVs was completed in just four days with the “All-in-one” synthesis process.

Figure 6: Activity of our Peptide Conjugate Antivirals Against 3 viruses from the Paramyxovirus Family

On March 26, 2025, we announced that these antiviral drug candidates also showed promising in silico activity against the measles and Nipah viruses based on molecular dynamics modeling. AlphaFold2 multimer predicted that the possibility of expected six helical bundle formation with measles or Nipah HR1 domains is very high. Molecular Dynamics simulations and MMGBSA calculations showed the rationally designed fusion inhibitor can bind to measles or Nipah HR1 domains with similar affinity to the native complex, and approximately the same as its calculated binding energy to hPIV3, RSV A, and RSV B (which have demonstrated in vitro activity with EC50 <1 uM). We believe there is reasonable probability the fusion inhibitor will show similar activity against measles and Nipah in vitro, though this cannot be confirmed until relevant experiments are performed.

We have demonstrated D-MAV with broad-based antiviral POC against two of the three respiratory viral families targeted. Based on in silico tools, we believe it will be possible to design a single molecule also targeting influenza.

Clinical Development Plan

We intend to follow a similar clinical program structure as our pan-Coronavirus prophylactic. Phase 1 would focus on safety and tolerability of an inhaled formulation. Phase 2 would include a healthy volunteer human challenge trial using multiple arms to interrogate all three viral families (flu A, RSV, SARS-CoV-2) to determine PK/efficacy relationship and establish human dose levels and proof of concept.

Potential Future Indications

Upon establishing proof of concept as outlined above, we believe there would be several attractive commercial indications for this candidate, including:

Therapeutic treatment of early LRTIs in immunocompromised patients via inhaled administration (mortality rates can be as high as 50%[1] in some severely immunocompromised populations);

Prophylactic use in highly immunocompromised patient populations, including immunocompromised pediatric populations;

Therapeutic use in large populations that are susceptible to LRTIs, including people who are 65+ or who are suffering from high-risk conditions such as Type II diabetes, chronic kidney disease, congestive heart failure, and chronic obstructive pulmonary disease; and

Broad use among otherwise healthy populations during seasonal surges in ‘influenza-like illness.’

Competitors and Competitive Advantage

The biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition, and emphasis on proprietary products. While we believe our technologies, knowledge, experience, and scientific resources provide competitive advantages, we face potential competition from major pharmaceutical, specialty pharmaceutical, and biotechnology companies, academic institutions, governmental agencies, and public and private research institutions. Any potential product candidates we successfully develop and commercialize will compete with existing and new therapies.

Our potential competitors include large pharmaceutical and biotechnology companies, as well as specialty and generic or biosimilar drug companies. Many have significantly greater financial and human resources and expertise in R&D, manufacturing, preclinical testing, clinical trials, regulatory approvals, and marketing. Smaller companies may also prove significant competitors through collaborations with established companies. These competitors compete with us in recruiting qualified personnel, establishing clinical trial sites, and acquiring complementary products or technologies.

Each of our pipeline candidates faces a unique but, in our view, favorable competitive landscape because of our emphasis on unique value propositions. Specifically:

COVID-19 Prevention & Treatment for Immune-Suppressed Patients: Despite being four years from the COVID-19 pandemic, there are still limited prophylactic options for people with highly suppressed immune function. mRNA vaccines are less effective for immune-suppressed patients[1]. Vaccine efficacy remains at risk from viral evolution, and uptake continues to decline.[2]Long-lasting antibody prophylactics like Evusheld rapidly became obsolete due to viral evolution,[3] and this is likely for pemivibart. Our therapeutic candidate is effective against all SARS-CoV-2 variants and expected to continue effective based on limited evolution in the targeted genome portion. With convenient administration and no requirement for functional immune system, we believe this therapeutic will deliver a unique solution for highly immune-suppressed patients.

Broad Respiratory Antiviral (COVID-19/Flu/RSV): There is significant competition in each area, both from commercialized drugs and pipeline candidates. While vaccines exist, usage continues to be low. We believe our strategy of treating all three viruses-and potentially additional human Coronaviruses and Paramyxoviruses causing influenza-like symptoms-with a single therapeutic will deliver a unique value proposition during seasonal ILI surges. A therapeutic that can safely treat a large percentage of ILI-causing viruses would be uniquely useful for healthcare providers.

Intellectual Property

We strive to protect our proprietary technology, inventions, improvements, platforms, program candidates, therapeutic candidates, methods of use, and manufacturing processes by obtaining, maintaining, defending, and enforcing patent and other intellectual property rights in the United States and foreign jurisdictions. We also rely on trade secrets and confidentiality agreements to protect information and know-how not amenable to, or not appropriate for, patent protection.

Our future commercial success depends in part on our ability to:

obtain, maintain, enforce and defend patent and other intellectual property rights for our important technology, inventions and know-how; preserve the confidentiality of our trade secrets and other confidential information;

obtain and maintain licenses to use and exploit intellectual property owned or controlled by third parties;

operate without infringing, misappropriating or otherwise violating any valid and enforceable patents and other intellectual property rights of third parties; and defend against challenges and assertions by third parties challenging the validity or enforceability of our intellectual property rights, or our rights in our intellectual property, or asserting that the operation of our business infringes, misappropriates or otherwise violates their intellectual property rights.

Our portfolio currently consists of solely owned patents and applications. As of December 31, 2025, our intellectual property portfolio includes six patent families covering compositions of matter, manufacturing, and uses relevant to our business, including 17 granted patents and four pending applications acquired through our January 2022 agreement with DeuteRx, LLC. Additionally, our portfolio contains wholly-owned patents and applications related to our IMP3ACT platform. In the United States, we have two compositions of matter patents and one method of use patent with respect to SP-2577 and related compounds expiring in 2032, owned by the University of Utah Research Foundation and exclusively licensed to us. We also have patents covering the composition of SP-3164 with patent term expiration of January 14, 2034.

Patent Prosecution

A PCT patent application filed under the Patent Cooperation Treaty (“PCT”) is not eligible to become an issued patent until national stage applications are filed in jurisdictions where patent protection is sought, within prescribed timelines (generally 30-32 months). To date, we have filed national stage applications in Australia, Canada, Europe, and New Zealand. If national stage applications are not timely filed, we may lose priority date and patent protection on disclosed inventions.

A provisional patent application is not eligible to become an issued patent. It may serve as a priority filing for non-provisional and/or PCT applications filed within 12 months. If non-provisional or PCT applications are not timely filed, we may lose priority date and patent protection.

While we intend to timely file additional provisional, PCT, national stage, and non-provisional patent applications, we cannot predict whether any will result in issued patents. If we do not successfully obtain patent protection, or if scope is insufficient, we will be unable to prevent others from using our technology or developing competing products and technologies.

Our ability to stop third parties from making, using, selling, or importing our technology, inventions, and improvements depends in part on our success in obtaining, maintaining, defending, and enforcing patent claims covering our technology.

Patent positions of companies like ours are generally uncertain and involve complex legal and factual questions. Protection afforded by a patent varies product-by-product, jurisdiction-by-jurisdiction, and depends on many factors including patent type, scope, term adjustments and extensions, available remedies, and validity and enforceability. Patent laws and enforcement outside the U.S. are uncertain and may not protect our rights to the same extent. Changes in patent laws and rules may affect our ability to protect inventions and obtain, maintain, defend, and enforce patent rights.

The patent and intellectual property area in biotechnology is evolving with many risks and uncertainties. Third parties may have blocking patents that could prevent commercializing our platform and therapeutic candidates. Our patent

rights may be challenged, narrowed, circumvented, invalidated, or ruled unenforceable. Third parties may independently develop similar technologies.

Because of the extensive time required for development, testing, and regulatory review, any related patent may expire or remain in force for only a short period following commercialization, reducing any competitive advantage. For additional risks, see “Risk Factors- Risks Related to the Discovery, Development and Commercialization of Potential Product Candidates.”

Patent Term

The term of individual patents depends on the jurisdiction. In most jurisdictions where we file, patent term is 20 years from the PCT application filing date or, if no PCT application is filed, the earliest non-provisional application priority date. U.S. patents may be extended or adjusted for FDA compliance delays or USPTO prosecution delays. A patent claiming an NCE or biologic product may be eligible for limited patent term extension under the Hatch-Waxman Act for up to five years beyond normal expiration, but cannot extend the remaining term past 14 years from approval date. Only one patent per approved product is eligible for extension. Some foreign jurisdictions, including Europe and Japan, have analogous patent term extension provisions. If and when any therapeutic candidates receive FDA approval, we expect to apply for patent term extensions on issued patents.

We intend to seek patent term adjustments and extensions for issued patents in any jurisdiction where available. However, there is no guarantee that authorities will agree with our assessment of whether such adjustments and extensions should be granted, or their length.

Trade Secrets

In addition to patent protection, we rely on trade secrets, know-how, unpatented technology, and other proprietary information to strengthen our competitive position. We may share trade secrets and proprietary information with third parties assisting in development and manufacturing and may enter collaborations requiring such sharing. We take steps to protect trade secrets, including non-disclosure and invention assignment agreements with employees, consultants, collaborators, contract organizations, and advisors. We also maintain physical security of premises and electronic security of IT systems.

Despite these efforts, third parties may independently develop substantially equivalent information and techniques or gain access to our trade secrets. Non-disclosure and invention assignment agreements may not have been duly executed, and counterparties may breach them. Agreements or security measures may be inadequate, and we may not have adequate remedies for breaches. Disputes may arise regarding rights in inventions arising from work by employees, contractors, or consultants using intellectual property owned by others. For more information, see “Risk Factors- Risks Related to the Discovery, Development and Commercialization of Potential Product Candidates.”

U.S. Patent Term Restoration and Extension and Marketing Exclusivity

In the United States, a patent claiming a new biologic or pharmaceutical product may be eligible for limited patent term extension under the Hatch-Waxman Act, permitting extension of up to five years for patent term lost during development and FDA regulatory review. The restoration period is typically one-half the time between the effective Investigational New Drug (“IND”) date and the submission date of New Drug Application (“NDA”) or Biologics License Application (“BLA”) , plus the time between submission and ultimate approval, except for time when the applicant failed to exercise due diligence. Patent term restoration cannot extend the remaining term past 14 years from approval date. Only one patent per approved product is eligible, and the extension application must be submitted prior to patent expiration. The USPTO reviews and approves extensions in consultation with the FDA.

Marketing exclusivity provisions under the Federal Food, Drug, and Cosmetic Act (the “FDCA”) also can delay submission or approval of certain applications. The FDCA provides five-year non-patent marketing exclusivity for an NDA for a New Chemical Entity ("NCE"). During exclusivity, the FDA may not accept an ANDA or 505(b)(2) NDA for another version of such drug, though an application may be submitted after four years with a certification of patent invalidity or non-infringement. The FDCA also provides three years of marketing exclusivity for an NDA, 505(b)(2) NDA, or supplement if new clinical investigations essential to approval were conducted-this three-year exclusivity covers only the conditions of use associated with the new clinical investigations. Five-year and three-year exclusivity will not delay submission or approval of a full NDA.

Patent Term Extensions in the European Union and Other Jurisdictions

The European Union provides patent term extension through Supplementary Protection Certificates (“SPCs”). An SPC may extend patent term for up to five years after scheduled expiration, providing up to a maximum of fifteen years of marketing exclusivity. In certain circumstances, periods may be extended six additional months for pediatric exclusivity; orphan medicinal products may have a two-year extension of orphan market exclusivity available. SPCs are available throughout the EU, but sponsors must apply country-by-country. Similar patent term extension rights exist in certain other foreign jurisdictions.

We received non-dilutive investments from the Gates Foundation, the Center for the Biologic Advanced Research and Development Authority and Johnson & Johnson through the U.S. Government’s Blue Knight Program, with some additional support from the European Union’s IMI-CARE Consortium and the Massachusetts Life Sciences Seed Fund.

Machine Learning and Artificial Intelligence computing support: Google AI Startup Program and the NVIDIA Inception Program include computing credits as well as hardware and software discounts.

Sales and Marketing

While we are not a commercial-stage biotechnology company at this time, we believe the structure of our drug development pipeline and emerging pharmaceutical marketing trends could allow efficient implementation of a commercial model addressing high-revenue markets without building a traditional 'big pharma' sales organization.

Small, Specialized Sales Force

Many immune-suppressed, high-risk, or orphan cancer patient groups that would be key early commercial targets are typically served by specialist HCPs in easy-to-identify medical settings. In the United States:

The great majority of solid organ transplants are performed at one of approximately 250 transplant centers[4]

Leukemia/Lymphoma patients are typically associated with one of approximately 70 NCI-designated cancer centers[5]

Should pipeline candidates reach commercialization, we believe it will be feasible to build a small, specialized sales force working across our portfolio to target these patient settings in a financially efficient manner, driving revenue while maintaining cost-effective commercial and medical affairs footprints.

Emerging “Telehealth” Commercial Model

We believe we will be well-positioned to implement an innovative commercialization strategy leveraging emerging technologies to optimize patient engagement, HCP access, and product delivery. Key components could include:

Digital Patient Engagement: Leveraging digital channels such as social media and paid search to efficiently educate patients about our products, ensuring broad reach and accessibility.

Telehealth Partnerships: Collaborating with telehealth providers to enable convenient and immediate access to HCPs, complementing direct-to-consumer campaigns and facilitating seamless patient engagement.

At-Home Delivery: Implementing a streamlined process for at-home delivery of our products following prescription, potentially facilitated through telehealth visits, enhancing patient convenience and adherence.

Streamlined Distribution: Aligning with industry trends to establish a streamlined distribution strategy aimed at enhancing efficiency and optimizing gross to net.

Such an innovative commercial model would align with our status as an emerging biotechnology organization and reflect broader industry trends. By integrating these channels, we would orchestrate a streamlined patient journey, reducing time and in-person contact required to access therapies-mitigating infectious disease transmission risks while enhancing operational efficiency and return on investment.

Manufacturing

We do not currently own or operate manufacturing facilities for clinical or commercial quantities of our potential product candidates. We rely, and expect to continue to rely, on third parties for product manufacturing, research, preclinical and clinical testing, and these third parties may not perform satisfactorily or dedicate adequate resources.

Government Regulation and Product Approvals

United States Government Regulation

In the United States, pharmaceutical products are subject to extensive regulation by the FDA. The Federal Food, Drug, and Cosmetic Act, the FDA’s implementing regulations, and other federal and state statutes and regulations, govern, among other things, research, development, testing, manufacture, quality control, safety, effectiveness, storage, recordkeeping, approval, labeling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling and import and export of pharmaceutical products. We cannot market a drug product candidate in the United States until the drug has received FDA approval.

The failure to comply with applicable U.S. requirements at any time during the product development process, approval process or after approval may subject an applicant and/or sponsor to a variety of administrative or judicial sanctions, including refusal by the FDA to approve pending applications, withdrawal of an approval, imposition of a clinical hold, issuance of warning letters and other types of letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement of profits, or civil or criminal investigations and penalties brought by the FDA and the Department of Justice or other governmental entities.

Drug Development Process

The process required before a drug may be marketed in the United States generally includes the following:

completion of extensive non-clinical laboratory tests and animal studies in accordance with the FDA’s Good Laboratory Practices (GLP) regulations, applicable requirements for the humane use of laboratory animals, such as the Animal Welfare Act or other applicable regulations;

submission to the FDA of an Investigational New Drug Application (IND) for human clinical testing, which must be deemed effective before human clinical trials may begin;

approval by an independent institutional review board (IRB) overseeing each clinical site before each trial may be initiated at that site;

performance of adequate and well-controlled human clinical trials in accordance with Good Clinical Practices (GCP) requirements, and any additional requirements for the protection of human research subjects and their health information, to establish the safety and efficacy of the drug for each proposed indication;

submission to the FDA of a New Drug Application (NDA) for marketing approval that includes substantial evidence of safety and effectiveness from results of clinical trials, as well as the results of preclinical testing, detailed information about the chemistry, manufacturing and controls, and proposed labeling and packaging for the product candidate;

consideration by an FDA Advisory Committee, if applicable;

satisfactory completion of potential FDA audits of the preclinical study and clinical trial sites that generated the data in support of the NDA;

satisfactory completion of an FDA pre-approval inspection of the nonclinical, clinical and/or manufacturing sites or facilities at which the active pharmaceutical ingredient, (API), and finished drug product are produced and tested to assess compliance with current Good Manufacturing Practices (cGMP); and

FDA review and approval of the NDA prior to any commercial marketing or sale of the drug in the United States, including agreement on post-marketing commitments, if applicable.

Before testing any drugs with potential therapeutic value in humans, the drug enters the preclinical testing stage. Pre-clinical tests include laboratory evaluation of product chemistry, formulation and toxicity, as well as animal trials to assess the characteristics and potential safety and efficacy of the product. The conduct of the pre-clinical tests must comply with federal regulations and requirements, including GLP and the Animal Welfare Act.

Before commencing the first clinical trial in humans, an IND must be submitted to the FDA, and the IND must become effective. An IND sponsor must submit the results of pre-clinical testing to the FDA as part of an IND along with other information, including information about product chemistry, manufacturing and controls and a proposed clinical trial protocol. Long term pre-clinical tests, such as animal tests of reproductive toxicity and carcinogenicity, may continue after the IND is submitted. A 30-day waiting period after the submission of each IND is required prior to the commencement of clinical testing in humans. If the FDA has neither commented on nor questioned the IND within this 30-day period, the clinical trial proposed in the IND may begin if all other requirements, including IRB review and approval, have been met. If the FDA raises concerns or questions about the conduct of the trial, such as whether human research subjects will be exposed to an unreasonable health risk, the IND sponsor and the FDA must resolve any outstanding FDA concerns or questions before clinical trials can proceed. Even after the IND has gone into effect and clinical testing has begun, the FDA may also impose clinical holds on clinical trials due to safety concerns or non-compliance. If the FDA imposes a clinical hold, studies may not recommence without FDA authorization and then only under terms authorized by the FDA.

Clinical trials involve the administration of the new investigational drug to healthy volunteers or patients under the supervision of a qualified investigator. Clinical trials must be conducted in compliance with state and federal regulations, including GCP requirements, which include the requirement that all research subjects provide their informed consent in writing for their participation in any clinical trial. Clinical trials are conducted under protocols detailing the objectives of the trial, dosing procedures, subject selection and exclusion criteria, and the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated, including stopping rules that ensure a clinical trial will be stopped if certain adverse events (AEs) should occur. Each protocol and subsequent protocol amendments must be submitted to the FDA as part of the IND.

The FDA may order the temporary or permanent discontinuation of a clinical trial at any time, or impose other sanctions, if it believes that the clinical trial either is not being conducted in accordance with FDA requirements or presents an unacceptable risk to the clinical trial patients. The study protocol and informed consent information for patients in clinical trials must also be submitted to an IRB, for approval of each site at which the clinical trial will be conducted. An IRB may also require the clinical trial at the site to be halted, either temporarily or permanently, for failure to comply with the IRB’s requirements, or may impose other conditions. Information about certain clinical trials must be submitted within specific timeframes to the National Institutes of Health (NIH) for public dissemination on their www.clinicaltrials.gov website.

Clinical trials to support NDAs for marketing approval are typically conducted in three sequential phases, but the phases may overlap. In Phase 1, the initial introduction of the drug into healthy human subjects or patients, the drug is tested to assess pharmacological actions, safety and side effects associated with increasing doses and, if possible, early evidence of effectiveness. Phase 2 usually involves trials in a larger but limited patient population to study metabolism of the drug, pharmacokinetics, the effectiveness of the drug for a particular indication, dosage tolerance and optimum dosage, and to identify common adverse effects and safety risks. If a compound demonstrates evidence of effectiveness and an acceptable safety profile in Phase 2 evaluations, Phase 3 clinical trials, also called pivotal trials, are undertaken to obtain the additional information about clinical efficacy and safety in a larger number of patients, typically at geographically dispersed clinical trial sites, to permit the FDA to evaluate the overall benefit-risk relationship of the drug and to provide adequate information for the labeling of the drug.

Post-approval studies, or Phase 4 clinical trials, may be conducted after initial marketing approval. These studies may be required by the FDA as a condition of approval and are used to gain additional experience from the treatment of patients in the intended therapeutic indication. The FDA has expressed statutory authority to require post-market clinical studies to address safety issues.

During all phases of clinical development, regulatory agencies require extensive monitoring and auditing of all clinical activities, clinical data and clinical trial investigators. Annual progress reports detailing the results of the clinical trials must be submitted to the FDA. Written IND safety reports must be promptly submitted to the FDA and the investigators for serious and unexpected AEs, any findings from other studies, tests in laboratory animals or in vitro testing and other sources that suggest a significant risk for human subjects, or any clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator brochure. The sponsor must submit an IND safety report within 15 calendar days after the sponsor determines that the information qualifies for reporting. The sponsor also must notify the FDA of any unexpected fatal or life-threatening suspected adverse reaction within seven calendar days after the sponsor’s initial receipt of the information. Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, if at all. The FDA or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the drug has been associated with unexpected serious harm to patients.

In limited circumstances, the FDA also permits the administration of investigational drug products to patients under its expanded access regulatory authorities. Under the FDA’s expanded access authority, patients who are not able to participate in a clinical trial may be eligible for accessing investigational products, including through individual compassionate or emergency use in concert with their requested physician.

Concurrent with clinical trials, companies usually complete additional animal studies, develop additional information about the physical characteristics of the product candidate and finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life.

FDA Review and Approval Process

After completion of the required clinical testing, a sponsor may prepare and submit an NDA to the FDA. FDA approval of the NDA is required before marketing of the product may begin in the United States. The NDA must include the results of all non-clinical, clinical and other testing and a compilation of data relating to the product’s toxicology, pharmacology, chemistry, manufacture and controls. In addition, under the Pediatric Research Equity Act, as amended, an NDA or supplement to an NDA generally must contain data to assess the safety and effectiveness of the product for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective. The FDA may grant deferrals for submission of data or full or partial waivers depending on the designated pathway for submission. The cost of preparing and submitting an NDA is substantial. The submission of most NDAs is additionally subject to a substantial application user fee, and the manufacturer and/or sponsor under an approved NDA are also subject to annual product and establishment user fees. These fees are typically increased annually. Fee waivers or reductions are available in certain circumstances, including a waiver of the application fee for the first application filed by a small business. Under the Prescription Drug User Fee Act (PDUFA) performance goals that are currently in effect, the FDA has a goal of ten months from the date of “filing” of a standard NDA for a new molecular entity to review and act on the submission. This review typically takes twelve months from the date the NDA is submitted to FDA, because the FDA has approximately two months to make a “filing” decision. That deadline can be extended under certain circumstances, including by the FDA’s requests for additional information. The targeted action date can also be shortened to six months of the “filing” date for products that are granted priority review designation because they are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. Within 60 days following submission of the application, the FDA reviews all NDAs submitted to ensure that they are sufficiently complete for substantive review before it accepts them for filing. The FDA may issue a refuse-to-file letter and request additional information rather than accept an NDA for filing. In this event, the NDA must be resubmitted with additional information. The resubmitted application also is subject to be reviewed before the FDA accepts it for filing. Once the submission is accepted for filing, the FDA begins an in-depth substantive review. The FDA reviews an NDA to determine, among other things, whether the drug is safe and effective and whether the facility(ies) in which it is manufactured, processed, packaged or held meets standards designed to assure the product’s continued safety, quality and purity. The FDA may also refer applications for novel drug products, or drug products that present difficult questions of safety or efficacy, to an advisory committee – typically a panel that includes clinicians and other experts – for consideration, discussion and a vote on specific questions relevant to the approval decision. The FDA is not bound by the recommendation of an advisory committee, but it considers such recommendations carefully when making decisions. Before approving an NDA, the FDA will typically inspect one or more clinical sites to assure compliance with GCPs. Additionally, the FDA will inspect the facility or the facilities at which the drug is manufactured. The FDA will not approve the product unless compliance with cGMP requirements is satisfactory and the NDA contains data that provides substantial evidence that the drug is safe and effective in the indication studied.

During the NDA review process, the FDA also will determine whether a Risk Evaluation and Mitigation Strategy (REMS) is necessary to assure safe use of the product. If the FDA concludes a REMS is needed, the sponsor must submit a proposed REMS; the FDA will not approve the NDA without a REMS, if required. A REMS could include a medication guide, communication plan or elements to assure safe use, such as required healthcare provider or pharmacy certification, a patient registry and other safe use conditions. The requirement for a REMS can materially affect the potential market and profitability of the product.

After the FDA evaluates the NDA and the manufacturing facilities, it issues either an approval letter or a complete response letter. A complete response letter generally outlines the deficiencies in the submission and may require substantial additional clinical data, or information, in order to resubmit the application for another cycle of FDA review. If a complete response letter is issued, the applicant may either resubmit the NDA, addressing all of the deficiencies identified in the complete response letter, or withdraw the application. If those deficiencies have been addressed to the FDA’s satisfaction in a resubmission of the NDA, the FDA will issue an approval letter. The FDA has committed to reviewing such resubmissions in two or six months depending on the type of information included.

An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications. Even if the FDA approves a product, it may limit the approved indications for use of the product, require that contraindications, warnings or precautions be included in the product labeling, require that post- approval studies, including Phase 4 clinical trials, be conducted to further assess a drug’s safety after approval, require testing and surveillance programs to monitor the product after commercialization, or impose other conditions, including distribution and use restrictions or other risk management mechanisms under a REMS to ensure that the benefits of the drug outweigh the potential risks. The FDA may prevent or limit further marketing of a product based on the results of post-marketing studies or surveillance programs. Once granted, product approvals may be withdrawn if compliance with regulatory standards is not maintained, FDA determines the risk outweighs the benefits of the product or other problems are identified following initial marketing.

Changes to some of the conditions established in an approved application, including changes in indications, labeling, or manufacturing processes or facilities, require submission and FDA approval of a new NDA or NDA supplement before the change can be implemented. An NDA supplement for a new indication typically requires clinical data similar to that in the original application, and the FDA uses the same procedures and actions in reviewing NDA supplements as it does in reviewing NDAs. Such supplements are typically reviewed within 10 months of receipt or 6 months of receipt for priority efficacy supplements.

Orphan Drug Status

Under the Orphan Drug Act, the FDA may grant orphan drug designation to drug candidates intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000 individuals in the United States and for which there is no reasonable expectation that costs of research and development of the drug for the indication can be recovered by sales of the drug in the United States. Orphan drug designation must be requested before submitting an NDA. After the FDA grants orphan drug designation, the generic identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA. Although there may be some increased communication opportunities, orphan drug designation does not convey any advantage in or shorten the duration of the regulatory review and approval process.

If a drug candidate that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan drug exclusivity, which means that the FDA may not approve any other applications, including a full NDA, to market the same drug for the same indication for seven years, except in limited circumstances, such as if the second applicant demonstrates the clinical superiority of its product or if FDA finds that the holder of the orphan drug exclusivity has not shown that it can assure the availability of sufficient quantities of the orphan drug to meet the needs of patients with the disease or condition for which the drug was designated. Orphan drug exclusivity does not prevent the FDA from approving a different drug for the same disease

or condition, or the same drug for a different disease or condition. Among the other benefits of orphan drug designation are tax credits for certain research and a waiver of the NDA application user fee.

As in the United States, designation as an orphan drug for the treatment of a specific indication in the European Union, must be made before the application for marketing authorization is made. Orphan drugs in Europe enjoy economic and marketing benefits, including up to 10 years of market exclusivity for the approved indication unless another applicant can show that its product is safer, more effective or otherwise clinically superior to the orphan designated product.

The FDA and foreign regulators expect holders of exclusivity for orphan drugs to assure the availability of sufficient quantities of their orphan drugs to meet the needs of patients. Failure to do so could result in the withdrawal of marketing exclusivity for the orphan drug.

Expedited Development and Review Programs

The FDA has a Fast Track program that is intended to expedite or facilitate the process for development and review of new drug products that meet certain criteria. Specifically, new drug products are eligible for Fast Track designation if they are intended to treat a serious or life-threatening disease or condition and demonstrate the potential to address unmet medical needs for the disease or condition. Fast Track designation applies to the combination of the product and the specific indication for which it is being studied. The sponsor of a new drug may request that the FDA designate the drug as a Fast Track product at any time during the clinical development of the product. For a Fast Track-designated product, the FDA may consider for review sections of the marketing application on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the application, the FDA agrees to accept sections of the application and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the application. Fast Track designation may be rescinded if FDA determines the program no longer meets the qualifying criteria for Fast Track.

Any product submitted to the FDA for marketing, including under a Fast Track program, may be eligible for other types of FDA programs intended to expedite development and review, such as priority review and accelerated approval. A product is eligible for priority review if it is intended to treat a serious condition and, if approved, would provide a significant improvement in safety or effectiveness. The FDA will attempt to direct additional resources to the evaluation of an application for a new drug product designated for priority review in an effort to facilitate the review on a six-month, rather than the standard ten-month, timeline. Currently, the Company has no FDA approved products.

Additionally, a product may be eligible for accelerated approval under subpart H if it treats a serious or life-threatening disease or condition, provides meaningful advantage over existing treatments, and demonstrates an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit or on an intermediate clinical endpoint. If a product qualifies for accelerated approval, the product may be approved based on an effect on a surrogate endpoint or intermediate clinical endpoint that is reasonably likely to predict the drug’s clinical benefit. As a condition of accelerated approval, the FDA will require that a sponsor of a drug product subject to accelerated approval perform an adequate and well-controlled post-marketing clinical trial to confirm clinical benefit. The Food and Drug Omnibus Reform Act of 2022 (FDORA), enacted in December 2022, provided the FDA with streamlined authority to withdraw accelerated approval if a sponsor fails to conduct any required post-approval confirmatory trial with “due diligence”, or if such trial fails to verify clinical benefit. In addition, the FDA currently requires as a condition for accelerated approval that promotional materials be submitted in advance of initial dissemination, which could adversely impact the timing of the commercial launch of the product.

In addition, under the provisions of the FDA Safety and Innovation Act (FDASIA), the FDA established the Breakthrough Therapy Designation which is intended to expedite the development and review of products that treat serious or life-threatening diseases or conditions. A breakthrough therapy is defined as a drug that is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies

on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. The designation includes all of the features of Fast Track designation, as well as more intensive FDA interaction and guidance. The Breakthrough Therapy Designation is distinct from both accelerated approval and priority review, but these can also be granted to the same product candidate if the relevant criteria are met. The FDA may take certain actions, such as holding timely meetings and providing advice, intended to expedite the development and review of an application for approval of a breakthrough therapy. Requests for breakthrough therapy designation will be reviewed within 60 days of receipt, and the FDA will either grant or deny the request. Breakthrough Therapy designation may be rescinded if the FDA determines the program no longer meets the qualifying criteria for breakthrough therapy.

Fast Track designation, priority review, accelerated approval and Breakthrough Therapy Designation do not change the standards for approval, but may expedite the development or approval process. Even if we receive Fast Track or Breakthrough designations for our potential product candidates, the FDA may later decide that our potential product candidates no longer meet the conditions for qualification. In addition, these designations may not provide us with a material commercial advantage.

Post-Approval Requirements

Once an NDA is approved, a product is subject to extensive continuing post-approval requirements. Any drug products manufactured or distributed by us pursuant to FDA approvals are subject to continuing regulation by the FDA, including, among other things, record-keeping requirements, reporting of adverse experiences with the drug, providing the FDA with updated safety and efficacy information, drug sampling and distribution requirements, complying with certain electronic records and signature requirements, and complying with FDA promotion and advertising requirements. For example, as a condition of approval of the NDA , the FDA may require post-marketing testing and surveillance to monitor the product’s safety or efficacy.

Adverse event reporting and submission of periodic reports is required following FDA approval of an NDA. The FDA also may require post-marketing testing, known as Phase 4 testing, REMS or other surveillance to monitor the effects of an approved product, or restrictions on the distribution or use of the product. In addition, quality control, drug manufacture, packaging and labeling procedures must continue to conform to cGMP after approval. Drug manufacturers and certain of their subcontractors are required to register their establishments with the FDA and certain state agencies. Registration with the FDA subjects’ entities to periodic unannounced inspections by the FDA, during which the agency inspects manufacturing facilities to assess compliance with cGMP. Accordingly, manufacturers must continue to expend time, money and effort in the areas of production and quality-control to maintain compliance with cGMP. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or failure to comply with regulatory requirements, may result in mandatory revisions to the approved labeling to add new safety information, imposition of post-market studies or clinical trials to assess new safety risks or imposition of distribution or other restrictions under a REMS program. Other potential consequences include, among other things:

restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls;

fines, untitled letters, warning letters or clinical holds on post-approval clinical trials;

refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of product approvals; and

product seizure or detention, or refusal to permit the import or export of products; or injunctions or the imposition of civil or criminal penalties.

The FDA strictly regulates marketing, labeling, advertising and promotion of products that are placed on the market. Drugs may be promoted only for the approved indications and in accordance with the provisions of the approved label. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability.

In addition, the distribution of prescription pharmaceutical products is subject to the Prescription Drug Marketing Act (PDMA) and its implementation regulations, as well as the Drug Supply Chain Security Act (DSCSA), which regulates the distribution of and tracing of prescription drugs and prescription drug samples at the federal level, and sets minimum standards for the regulation of drug distributors by the states.

Foreign Regulation

In order to market any product outside of the United States, we would need to comply with numerous and varying regulatory requirements of other countries and jurisdictions regarding quality, safety and efficacy and governing, among other things, clinical trials, marketing authorization, commercial sales and distribution of our products. Whether or not we obtain FDA approval for a product, we would need to obtain the necessary approvals by the comparable foreign regulatory authorities before we can commence clinical trials or marketing of the product in foreign countries and jurisdictions.

Some countries outside of the United States have a similar process that requires the submission of a clinical trial application (CTA), much like the IND prior to the commencement of human clinical trials. In Europe, for example, a CTA must be submitted to a single EU portal for harmonized assessment at EU level with additional ethics review on each country’s national level, much like the FDA and an IRB, respectively. Once the CTA is approved in accordance with a country’s requirements, a clinical trial may proceed in that country. To obtain regulatory approval to commercialize a new drug under European Union regulatory systems, we must submit a marketing authorization application (MAA). The MAA is similar to the NDA, with the exception of, among other things, country-specific document requirements.

To obtain marketing approval of a product under European Union regulatory systems, an applicant must submit an MAA either under a centralized or decentralized procedure. The centralized procedure provides for the grant of a single marketing authorization by the European Commission that is valid for all E.U. member states. The centralized procedure is compulsory for specific products, including for medicines produced by certain biotechnological processes, products designated as orphan medicinal products, advanced therapy products and products with a new active substance indicated for the treatment of certain diseases. Under the centralized procedure, the Committee for Medicinal Products for Human Use (the “CHMP”), established at the European Medicines Agency (“EMA”), is responsible for conducting the initial assessment of a product. The maximum timeframe for the evaluation of an MAA under the centralized procedure is 210 days, excluding clock stops. The decentralized procedure is available to applicants who wish to market a product in various E.U. member states where such a product has not previously received marketing approval in any E.U. member state.

In the European Union, under the existing framework, new chemical entities qualify for eight years of data exclusivity upon marketing authorization and an additional two years of market exclusivity. This data exclusivity, if granted, prevents regulatory authorities in the European Union from referencing the innovator’s data to assess a generic application for eight years, after which generic marketing authorization can be submitted, and the innovator’s data may be referenced, but not approved for two years. The overall ten-year period will be extended to a maximum of eleven years if, during the first eight years, the marketing authorization holder obtains an authorization for one or more new therapeutic indications which are held to bring a significant clinical benefit in comparison with existing therapies.

The approval process varies between countries and jurisdictions and can involve additional product testing and additional administrative review periods. The time required to obtain approval in other countries and jurisdictions might differ from and be longer than that required to obtain FDA approval. Regulatory approval in one country or jurisdiction does not ensure regulatory approval in another, but a failure or delay in obtaining regulatory approval in one country or jurisdiction may negatively impact the regulatory process in others.

Pharmaceutical Coverage, Pricing and Reimbursement

Significant uncertainty exists as to the coverage and reimbursement status of products approved by the FDA and other government authorities. Sales of products will depend, in part, on the extent to which third-party payors, including government health programs in the United States such as Medicare and Medicaid, commercial health insurers and managed care organizations, provide coverage, and establish adequate reimbursement levels for, such products. The process for determining whether a payor will provide coverage for a product may be separate from the process for setting the price or reimbursement rate that the payor will pay for the product once coverage is approved. Third-party payors are increasingly challenging the prices charged, examining the medical necessity, and reviewing the cost-effectiveness of medical products and services and imposing controls to manage costs. Third-party payors may limit coverage to specific products on an approved list, or formulary, which might not include all of the approved products for a particular indication.

In order to secure coverage and reimbursement for any product that might be approved for sale, a company may need to conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of the product, in addition to the costs required to obtain FDA or other comparable regulatory approvals. Additionally, a payor’s decision to provide coverage for a drug product does not imply that an adequate reimbursement rate will be approved. The containment of healthcare costs has become a priority of federal, state and foreign governments and the prices of drugs have been a focus in this effort. Governments have shown significant interest in implementing cost-containment programs, including price controls, restrictions on reimbursement and requirements for substitution of generic products. Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit our net revenue and results.

Outside the United States, pricing of prescription pharmaceuticals is subject to governmental control in many countries. In the European Union, pricing and reimbursement schemes vary widely from country to country. Some countries provide that drug products may be marketed only after a reimbursement price has been agreed. Any country that has price controls or reimbursement limitations for drug products may not allow favorable reimbursement and pricing arrangements.

Other Healthcare Laws

Although we currently do not have any products on the market, our current and future business operations may be subject to additional healthcare regulation and enforcement by the federal government and by authorities in the states and foreign jurisdictions in which we conduct our business. Such laws include, without limitation, state and federal anti-kickback, fraud and abuse, false claims, privacy and security, price reporting and physician sunshine laws. Some of our pre-commercial activities are subject to some of these laws.

Such restrictions under applicable federal and state healthcare laws and regulations include, among others: the federal Anti-Kickback Statute, which prohibits persons and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration to induce or reward referrals for services covered under federal healthcare programs such as Medicare and Medicaid; the federal civil and criminal false claims laws, including the civil False Claims Act, which prohibit knowingly presenting false or fraudulent claims for payment to the federal government; the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended by the Health Information Technology for Economic and Clinical Health Act, which imposes obligations with respect to safeguarding the privacy, security and transmission of individually identifiable health information; and the federal transparency requirements known as the Physician Payments Sunshine Act, which requires certain manufacturers to report annually to the Centers for Medicare

& Medicaid Services information related to payments and other transfers of value to physicians and teaching hospitals. Analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, may also apply to healthcare items or services reimbursed by non-governmental third-party payors, including private insurers.

Healthcare Reform

A primary trend in the United States healthcare industry and elsewhere is cost containment. In March 2010, the United States Congress enacted the Affordable Care Act (the “ACA”), which, among other things, includes changes to the coverage and payment for drug products under government health care programs. Among the provisions of the ACA of potential importance to our potential product candidates are: an annual, non-deductible fee on entities that manufacture or import specified branded prescription drugs and biologic agents; expansion of eligibility criteria for Medicaid programs; expanded manufacturers’ rebate liability under the Medicaid Drug Rebate Program; expanded types of entities eligible for the 340B drug discount program; and establishment of the Medicare Part D coverage gap discount program. Since enactment of the ACA, there have been numerous legal challenges and Congressional actions to repeal and replace provisions of the law, and we will continue to evaluate the effect that the ACA and any changes thereto could have on our business.

In August 2022, the Inflation Reduction Act of 2022 was signed into law and requires the federal government to negotiate prices for some high-cost drugs covered under Medicare, requires drug manufacturers to pay rebates to Medicare if they increase prices faster than inflation for drugs used by Medicare beneficiaries, and caps Medicare beneficiaries’ out-of-pocket spending under the Medicare Part D benefit. We will monitor this issue to determine the effects of this legislation on our business.

Facilities

We lease offices in the Texas Medical Center Houston, Texas, under a month-to-month lease. Currently, this facility consists of approximately 300 square feet and accommodates our financial and general administrative activities. We also maintain offices at One Broadway, 14th Floor, Cambridge, MA 02142. Additionally, we lease laboratory space at 45-18 Ct Square W, Long Island City, NY 11101. The Company does not own any physical property, plants, or laboratories.

Employees and Human Capital Resources

As of March 20, 2026, we had eleven full-time employees. We also utilize the services of a similarly sized team of contractors with whom we have ongoing multi-year relationships, and a three-person scientific advisory board consisting of academic clinicians that can be considered key opinion leaders in the therapeutic areas in which we plan to operate. We have never had a work stoppage, and none of our employees are represented by a labor organization or under any collective bargaining arrangements. We consider our employee relations to be good.

Legal Proceedings

We are not currently a party to any legal proceedings, the outcome of which we believe, if determined adversely to us, would individually or in the aggregate, have a material adverse effect on our business, financial condition, or results of operations. From time to time, we may become involved in legal proceedings arising in the ordinary course of business.

Corporate Information and Web Site Access to SEC Filings

Decoy Therapeutics Inc. (formerly known as Salarius Pharmaceuticals, Inc.) was incorporated as Flex Pharma, Inc. (“Flex Pharma”), in Delaware in February 2014. In July 2019, the Company’s wholly owned subsidiary, Falcon Acquisition Sub, LLC, merged with and into Salarius Pharmaceuticals, LLC (“Private Salarius”), with Private Salarius becoming the Company’s wholly owned subsidiary, and the Company changed its name to Salarius Pharmaceuticals, Inc. On November 12, 2025, pursuant to the Merger Agreement, MergerSub I merged with and into Legacy Decoy, and immediately thereafter Legacy Decoy merged with and into MergerSub II, resulting in the Legacy Decoy business becoming a wholly owned subsidiary of the Company. On January 8, 2026, the Company changed its legal name from “Salarius Pharmaceuticals, Inc.” to “Decoy Therapeutics Inc.” by filing a Certificate of Amendment to the Amended and Restated Certificate of Incorporation with the Secretary of State of the State of Delaware. The Company’s principal executive offices are located at 2450 Holcombe Blvd., Suite X, Houston, Texas 77021 and its telephone number is (713) 913-5608. The Company’s website address is www.decoytx.com.

Information on this website is not a part of this Form 10-K. Our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, Forms 3, 4 and 5 filed on behalf of directors and executive officers, and any amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934 ("Exchange Act") are available free of charge on our website as soon as reasonably practicable after we electronically file such material with, or furnish it to, the Securities and Exchange Commission ("SEC"). The SEC maintains a website (www.sec.gov) that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC, including us.

[1] https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00142-6/fulltext

[2] https://www.cdc.gov/respiratory-viruses/data-research/dashboard/vaccination-trends-adults.html

[3] https://www.cnbc.com/2023/01/27/covid-fda-pulls-evusheld-because-its-not-effective-against-subvariants.html

[4] https://optn.transplant.hrsa.gov/about/search-membership/

[5] https://www.cancer.gov/research/infrastructure/cancer-centers