PLYX 10-K & 10-Q changes, risk factors and insider trading

We are advancing PLX-200, our most advanced product candidate, through a Phase 2 proof-of-concept basket trial which we refer to as SOTERIA (PLX-200-600). We expect to initiate this trial in the second half of 2026. SOTERIA is an open-label, multi-indication, master study for the treatment of certain LSDs which we believe represent approximately one quarter of our addressable LSD population, including CLN2, CLN3, Krabbe disease, and Sandhoff disease. We held a pre-IND submission meeting in April 2025. We submitted an IND application to the FDA for the SOTERIA trial in August 2025 and received a safe to proceed letter in October 2025. In July 2026, we amended SOTERIA’s trial design; among other amendments, we expanded the number of participants in each of the Sandhoff disease and Krabbe disease cohorts from three to six, thereby aligning enrollment targets across all four cohorts and increasing the total number of trial participants from 18 to 24. We believe that the increase in number of trial participants will generate additional valuable data. We have additionally opened recruitment for the six-patient sentinel safety group, from three patients each drawn from the CLN2 and CLN3 cohorts to six patients drawn from any of the four cohorts. Data readouts from SOTERIA are expected to provide guidance and a clear pathway for each of the four indications towards potentially registrable trials. Further, with the precedent approval of Brineura, a drug approved to treat CLN2 on the basis of a single-arm, natural history comparator, open-label trial, we believe there may be an opportunity in CLN2 and CLN3 for us to seek expedited approval from the FDA for PLX-200 based on precedent approval for a third-party drug with a similar trial design. Should PLX-200 evidence overwhelming efficacy from the CLN2 and CLN3 cohorts in the SOTERIA trial, we believe there may be a case to seek expedited approval. Products studied for their safety and effectiveness in treating serious or life-threatening diseases or conditions may receive expedited approval upon a determination that the product has demonstrated a clinically meaningful treatment effect. The precedent case of cerliponase alfa, a drug approved by FDA in treatment of CLN2, provides a benchmark for expedited approval based on results generated from an open-label, single arm trial comparing to natural history data studying Batten disease. SOTERIA’s current trial design for the CLN2 and CLN3 cohorts share the same open-label, single-arm design using natural history.

We have incurred significant operating losses since inception and expect to incur losses in the future as we continue our research and development activities. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of any product candidates we may develop. We incurred net losses of approximately $2.5$1.4 million and $5.1$1.0 million for the three months ended MarchJune 31,30, 2026 and 2025, respectively. We incurred net losses of approximately $3.9 million and $6.1 million for the six months ended June 30, 2026 and 2025, respectively. As of MarchJune 31,30, 2026, we had an accumulated deficit of approximately $102.2$103.6 million.

As of MarchJune 31,30, 2026, we had cash and cash equivalents of approximately $3.1$11.5 million. Based on our current operating plan, we estimate that our existing cash and cash equivalents as of the filing date of this Quarterly Report, will be sufficient to enable us to fund our operating expenses and capital expenditure requirements through the thirdfirst quarter of 2026.2027. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.

Comparison of the Three Months Ended March 31,June 30, 2026 and 2025

General and administrative expenses increased by $943$253 thousand to $1,279$661 thousand for the three months ended MarchJune 31,30, 2026, as compared to $336$408 thousand for the three months ended MarchJune 31,30, 2025, primarily due to increased public company related expenses incurred in connection with the direct listing in January 2026 and due to an increase in stock-based compensation.2026. Public company related expenses including legal,accounting audit,advisory, investor relations, board compensation, and directors and officers insurance expenses increased by $435$250 thousand. Stock-basedSalary and wages expenses also increased $75 thousand as a result of the timing of new hires. This is offset by a decrease in stock-based compensation increased by $359$108 thousand due to shares that were issued to a financial advisor in October of 2024. Of the total shares issued, 50% was fully vested upon issuance as compensation for advisory services and concluded in October of 2025 which decreased stock-based compensation by $108 thousand in the first quarter of 2026. The remaining 50% vested upon a public listing of the Company’s common stock. As of March 31, 2026, the remaining 50% was fully vested as our common stock began trading on Nasdaq on February 2, 2026. As such, the Company recorded $467 thousand to stock-based compensation.

Other expense — direct listing offering costs was $586zero for the three months ended June 30, 2026, as compared to $124 thousand for the three months ended MarchJune 31, 2026, as compared to zero for the three months ended March 31,30, 2025 due to legal, accounting, and advisory expenses related to the preparation of the direct listing offering.offering in January 2026.

Since our inception, we have incurred significant operating losses. We expect to incur significant expenses and operating losses for the foreseeable future as we advance the clinical development of our programs. From our inception through the filing date of this Quarterly Report, we have funded our operations primarily with proceeds from the sales of our equity securities totaling approximately $21.7$31.5 million. As of MarchJune 31,30, 2026, we have no outstanding debt.

The following table presents the Company’s cash and cash equivalents as of MarchJune 31,30, 2026 and December 31, 2025:

The following table presents cash provided by (used in) operating and financing activities during the threesix months ended MarchJune 31,30, 2026 and 2025:

Net cash used in operating activities was $2.1$3.4 million for the threesix months ended MarchJune 31,30, 2026 and was primarily due to a net loss of $2.5$3.9 million, offset by anstock-based increase in stock-based compensation of $467 thousand and an increase in working capital changes of $14$25 thousand.

Net cash used in operating activities was $709 thousand$1.6 million for the threesix months ended MarchJune 31,30, 2025 and was primarily due to a net loss of $5.1$6.1 million and a decrease in working capital decreaseschanges of $108$67 thousand related to accounts payable and accrued expenses,thousand, offset by stock-based compensation of $4.5 $4.6 million.

Net cash provided by financing activities was $9.8 million and $250 thousand for the threesix months ended MarchJune 31,30, 20252026 and 2025, respectively, and was due to proceeds from the issuance of common stock. We had no cash provided by or used in financing activities for the three months ended March 31, 2026.

The financial statements have been prepared as though we will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. We have incurred operating losses and negative cash flows from operations since inception. As of MarchJune 31,30, 2026, we had an accumulated deficit of approximately $102.2$103.6 million. Management expects to continue to incur operating losses and negative cash flows.

We believe that our existing capital will enable us to fund our operations through the thirdfirst quarter of 2026.2027. We will need to raise additional capital in connection with our cash needs for capital expenditures and working capital beyond the thirdfirst quarter of 2026.2027. We have based the foregoing estimate on assumptions that may prove to be incorrect, and we could use our capital resources sooner than we expect.

We are an “emerging growth companycompany,”, as defined in the Jumpstart Our Business Startups Act of 2012 (“JOBS Act”). Under the JOBS Act, emerging growth companies can take advantage of an extended transition period for complying with new or revised accounting standards, delaying the adoption of these accounting standards until they apply to private companies. The Company has elected to use this extended transition period for complying with certain new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that it is (1) no longer an emerging growth company or (2) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act.