Decoy Therapeutics Inc.

05/08/2026 | Press release | Distributed by Public on 05/08/2026 14:46

Quarterly Report for Quarter Ending March 31, 2026 (Form 10-Q)

Management's Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis should be read in conjunction with the unaudited financial information and the notes thereto included herein, as well as our audited financial statements and notes thereto contained in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 31, 2026. This discussion contains forward-looking statements that involve risks and uncertainties. Our actual results and the timing of selected events could differ materially from those anticipated in these forward-looking statements as a result of several factors, including those set forth under "Part I - Item 1A - Risk Factors" discussed in our Annual Report on Form 10-K for the year ended December 31, 2025, in other subsequent filings with the SEC, and elsewhere in this Quarterly Report on Form 10-Q. These statements, like all statements in this report, speak only as of the date of this Quarterly Report on Form 10-Q (unless another date is indicated), and we undertake no obligation to update or revise these statements in light of future developments.

Overview

We are a pre-clinical stage biotechnology company focused on advancing our pipeline of peptide conjugate therapeutics engineered through our proprietary IMP3ACT™ platform. Our IMP3ACT™ platform represents a paradigm shift in peptide conjugate drug discovery and manufacturing, leveraging machine learning ("ML") and artificial intelligence ("AI") tools alongside high-speed synthesis techniques to rapidly engineer, optimize and manufacture peptide conjugates that target serious unmet medical needs. Peptide conjugates are emerging as a major therapeutic drug modality, with the potential to transform multiple therapeutic areas. Utilizing our novel IMP3ACT™ platform that increases the drug development speed and reduces the complexity of variant synthesis, we aim to build a robust portfolio of novel peptide conjugate therapeutics, initially focusing on infectious diseases and oncology, with the goal of becoming a fully integrated biopharmaceutical company at the forefront of this field. Through this approach, we intend to revolutionize the design, development, and commercialization of peptide conjugate therapeutics. We have no products approved for commercial sales and have not generated any revenue from product sales.

Prior to January 8, 2026, we were known as Salarius Pharmaceuticals, Inc. ("Salarius"). In November 2025, Salarius completed a merger (the "Merger") with Legacy Decoy and conducted financings to raise capital for its business (together, along with future steps set forth elsewhere in this 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"). Except where the context otherwise requires or where otherwise indicated, all historical references to "Salarius" in this report refer to the Company prior to 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 combined 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"). As the Company effected the 2025 Reverse Stock Split (as defined below) during the prior one-year period and remains subject to a mandatory panel monitor, the Company is not eligible for a 180-calendar day compliance period under Nasdaq listing rule 5810(c)(3)(A). 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 31, 2026, the Company received a written notice from NASDAQ notifying the Company that it regained compliance with Listing Rule 5550(a)(2), the "Bid Price Rule."

Results of Operations

Three months ended March 31, 2026 Compared to the three months ended March 31, 2025

The following table sets forth the condensed consolidated results of our operations for the three months ended March 31, 2026 compared to March 31, 2025.

Three Months Ended March 31,

$ Change

2026

2025

Research and development expenses

749,813

75,532

674,281

General and administrative expenses

1,533,926

1,643,163

(109,237

)

Interest income, net and other

59,111

9,162

49,949

Net loss

$

2,224,628

$

1,709,533

515,095

Research and Development Expenses

Research and development expenses increased during the three months ended March 31, 2026 compared to the same period in 2025 primarily related to the Company's merger in November 2025 and the resulting addition of the IMP3ACT (Designable Multi-Antivirals) program. We anticipate higher research and development expense in upcoming quarters as the Company continues on its intended path to file an IND application with the FDA or the European equivalent CTA during the first half of 2027.

SP-2577

SP-3164

IMP3ACT

Research and development costs by
candidates and by categories:

Three months ended March 31,

2026

2025

2026

2025

2026

2025

Outsourced research and development costs

1,725

44,785

-

-

135,476

-

Employee-related costs

-

-

-

-

458,649

-

Manufacturing and laboratory costs

6,585

9,710

15,160

21,037

132,218

-

Total research and development costs

$

8,310

$

54,495

$

15,160

$

21,037

$

726,343

$

-

General and Administrative Expenses

General and administrative expenses were $1.5 million during the three months ended March 31, 2026, compared to $1.6 million for the three months ended March 31, 2025. The Company incurred higher professional expense related to the acquisition in 2025 and included Legacy Decoy operations during the current quarter. On January 10, 2025, the Company entered into an Agreement and Plan of Merger and incurred substantial legal and professional fees during the first quarter of 2025, all attributable to Salarius. Current period spending includes combined Company costs, including increased personnel costs, as well as professional fees associated with the Company's special meeting of Shareholders held in February 2026 in connection with the stock split.

Liquidity and Capital Resources

Overview

Since inception, we have incurred operating losses and we anticipate that we will continue to incur losses for the foreseeable future. We have not generated any cash inflows from product sales. We do not know when, or if, we will generate any revenue from product sales. We do not expect to generate any revenue from product sales unless and until we obtain regulatory approval for and commercializes any of our potential product candidates, all of which are in early stages of development.

As of March 31, 2026, cash, cash equivalents, and restricted cash totaled $7.8 million, which were held in bank deposit accounts and a money market account. Approximately $3.0 million of our March 31, 2026 cash position is restricted for use under our Gates Foundation Grant Agreement and can only be used for specific development purposes, not for general or administrative purposes. Working capital totaled $3.8 million as of March 31, 2026. Our cash, cash equivalents, and restricted cash balance decreased during the three months ended March 31, 2026, primarily due to cash used in operating activities. We believe our current cash and cash equivalents will be sufficient to fund our current and restructured operations into late 2026.

During the three months ended March 31, 2025 the Company sold 1,966 shares of common stock in an "at the market offering" with gross proceeds of $0.4 million.

The Company issued 1,593 shares of common stock with proceeds of $0.7 million during the three months ended March 31, 2025 pursuant to the ELOC Agreement. No sales of common stock under either program were made during the three months ended March 31, 2026.

We will need to raise additional capital to continue to fund the further development of product candidates and our operations. We may be unable to raise additional funds or enter into such agreements or arrangements on favorable terms, or at all. Additionally, equity or debt financings may have a dilutive effect on the holdings of our existing stockholders. If we are unable to maintain sufficient financial resources, our business, financial condition and results of operations could be materially and adversely affected. If we are unable to raise additional funds when needed, we may be required to delay, reduce or eliminate our product development or future commercialization efforts.

Cash Flows

Three Months Ended March 31,

Net cash (used in) provided by:

2026

2025

Operating activities

$

(2,889,329

)

$

(1,181,714

)

Financing activities

-

545,566

Net (decrease) in cash, cash equivalents, and restricted cash

$

(2,889,329

)

$

(636,148

)

Operating Activities

Net cash used in operating activities was $2.9 million in the current period, an increase of approximately $1.7 million from the same period in 2025. The increase is primarily due to higher operating expenses during the current period compared to the same period in 2025, including research and development associated with the development of the IMP3ACT Platform, professional costs associated with our Special Meeting of Shareholders in February 2026 and current period payments to lower accrued expense balances.

Financing Activities

Net cash provided by financing activities for the three months ended March 31, 2025 was $0.5 million, mainly resulting from the Company's sale of common shares under the ATM and ELOC program offset by the repayments on notes payable for D&O insurance. The Company did not complete any financing activities in the current period.

Critical Accounting Policies and Estimates

Our management's discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with GAAP. The preparation of these condensed consolidated financial statements requires us to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities as of the date of the condensed consolidated balance sheet and the reported amounts of expenses during the reporting period. In accordance with GAAP, we base our estimates on historical experience and on various other assumptions that we believe are reasonable under the circumstances at the time such estimates are made. Actual results may differ materially from our estimates and judgments under different assumptions or conditions. We periodically review our estimates in light of changes in circumstances, facts and experience. The effects of material revisions in estimates are reflected in our condensed consolidated financial statements prospectively from the date of the change in estimate.

There have been no material changes to our critical accounting policies from those described in "Management's Discussion and Analysis of Financial Condition and Results of Operations" included in our Annual Report on Form 10-K filed with SEC on March 31, 2026.

Readers should refer to our Annual Report on Form 10-K, Note 2, Basis of Presentation and Significant Accounting Policies to the accompanying financial statements for descriptions of these policies and estimates.

Decoy Therapeutics Inc. published this content on May 08, 2026, and is solely responsible for the information contained herein. Distributed via EDGAR on May 08, 2026 at 20:46 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]