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

Curanex Pharmaceuticals Inc · Nasdaq · Pharmaceutical Preparations · CIK 2025942 · All filings on SEC.gov

Everything below is quoted or computed from Curanex Pharmaceuticals Inc's public SEC filings. It is not a recommendation to buy or sell. Automated comparisons can contain errors; confirm with the original filing.

At a glance

0Form 4 filings reporting open-market purchases (last 180 days)
0Form 4 filings reporting open-market sales (last 180 days)

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What changed in the latest 10-K

Comparison not available: Not available: fewer than two 10-K filings on EDGAR to compare (only one so far)..

What changed in the latest 10-Q

Comparing 10-Q filed 2026-08-14 (period ending 2026-06-30) with 10-Q filed 2026-05-14 (period ending 2026-03-31).

Risk Factors (10-Q Part II, Item 1A)

0new paragraphs
0removed paragraphs
0reworded paragraphs
27 → 27words in section

The section in the latest 10-Q reads in full:

We are a smaller reporting company, as defined by Rule 12b-2 of the Exchange Act, and are not required to provide the information under this item.

No wording changes found in this section.

Full comparison: every changed paragraph (0)

Green = added, red = removed. Unchanged paragraphs and tables are not shown. Read the complete text in the original filing.

Management's Discussion & Analysis (MD&A) (10-Q Part I, Item 2)

29new paragraphs
5removed paragraphs
17reworded paragraphs
2,466 → 4,255words in section

New heading “2026 Equity Incentive Plan”

New heading “Comparison of Results of Operations for the Six Months Ended June 30, 2026 and 2025”

New heading “Revenue and Cost of Sales”

New heading “Operating Expenses”

New heading “General and Administrative Expenses”

New heading “Research and Development Expenses”

New heading “Other Income (Expense)”

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

New text topics: going concern, covenant
“Based on our current operating plan, we do not expect our existing cash and cash equivalents to be sufficient to fund our operations for at least twelve months from the date of issuance of the unaudited interim financial statements included in this Quarterly Report. These conditions raise substantial doubt about our ability to continue as a going concern. There can be no assurance we will be successful in raising additional capital on favorable terms, or at all. …”
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New text topics: covenant, labor
“We will require additional capital to fund our operations. We may seek to raise additional capital through public or private equity offerings, debt financings, strategic collaborations or licensing arrangements. Our ability to raise capital on acceptable terms may be adversely affected by the trading price of our common stock, current deficiency with the Minimum Bid Price Requirement and our ability to regain compliance with that Nasdaq rule and maintain compliance with other Nasdaq listing rules for continued listing, and general market conditions. …”
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Removed text topics: investigation, labor
“We believe our existing cash and access to shareholders’ support are sufficient to fund our operations for at least the next twelve months. However, our ability to continue operating beyond this period is dependent upon the successful implementation of our business plan, including conducting FDA-required good laboratory practice (“GLP”) toxicology and pharmacokinetic studies for Phyto-N in ulcerative colitis, and preparation and submission of an Investigational New Drug application.”
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Removed text topics: going concern
“We have not yet achieved profitability and anticipate continued operating losses in the foreseeable future. Our financial statements include a going concern disclosure due to our recurring losses, accumulated deficit, and reliance on external funding. However, management believes that substantial doubt has been alleviated due to our strong cash position, receipt of the IPO proceeds.”
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New text topics: going concern
“The unaudited interim financial statements included in this Quarterly Report have been prepared assuming we will continue as a going concern and do not include any adjustments to the carrying amounts or classification of assets and liabilities that might result from the outcome of this uncertainty. See Note 1 to our unaudited interim financial statements.”
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New text
“Comparison of Results of Operations for the Six Months Ended June 30, 2026 and 2025”
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Full comparison: every changed paragraph (51)

Green = added, red = removed. Unchanged paragraphs and tables are not shown. Read the complete text in the original filing.

Reworded

On August 27, 2025, the Company completed its initial public offering (the “IPO”) and its shares of common stock are quoted on The Nasdaq Capital Market (“Nasdaq”) under the symbol “CURX.” On September 12, 2025, we completed the additional closing related to the IPO, in which the underwriters in the IPO fully exercised their over-allotment option pursuant to the underwriting agreement dated August 25, 2025 with Dominari Securities, LLC, as representative of the underwriters. The Company is utilizing the net proceeds from the IPO primarily for (i) the development of its lead product candidate, Phyto-N, for the treatment of ulcerative colitiscolitis, atopic dermatitis, rheumatoid arthritis, gouty arthritis, and diabetic foot; (ii) tothe conduct of FDA-required GLP toxicology and pharmacokinetic studies studiesand chemistry, manufacturing, and controls (“CMC”) activities for Phyto-N in ulcerative colitis,colitis and (iii) to preparethe preparation and submitsubmission of an investigational new drug (IND) application.

Reworded

The Company is also expanding its drug development pipeline and willis focusfocusing on a new core indication: cancer cachexia, a serious cancer-associated wasting syndrome marked by progressive weight loss, muscle depletion, weakness and declining physical function. The management believes that the focus on treatment of cancer cachexia aligns with the Company’s broader focus on treatment of serious diseases involving inflammation, metabolic disruption and physical decline. While Curanex remains committed to advancing its lead ulcerative colitis program, the Company believes that by expanding its long-term pipeline potential by also focusing on cancer cachexia treatment, the Company will strengthen its positioning as an emerging therapeutics company.

Reworded

With GMP pilot-scale material now available, the Company ishas actively working on initiatinginitiated formal GLP toxicology and pharmacokinetic studies as part of its IND preparation.

Reworded

In March 2026, the Company announced the successful completion of a dose-range finding toxicology study of Phyto-N, conducted in Sprague-Dawley rats and dogs. The study evaluated repeat-dose oral tolerability over 28 days at multiple dose levels and was designed to inform dose selection and study design for the Company’s subsequent GLP-compliant toxicology studies. The maximum feasible dose identified in this study will serve as the high-dose anchor for the design of the pivotal GLP toxicology studies that will form a core component of the Company’s IND submission. These results keep the program on schedule toward the Company’s target IND filing in the fourth quarter of 2026. The Company’s pivotal GLP repeat-dose toxicology studies of Phyto-N in rats and dogs are currently ongoing, and its GLP safety pharmacology studies evaluating cardiovascular, central nervous system (functional observational battery) and respiratory function are also underway. The Company plans to hold a pre-IND meeting with the FDA in October 2026.

Reworded

Nasdaq Notifications regarding Minimum Bid Price Requirement.Requirement and the Contemplated Reverse Stock Split

Removed

On November 5, 2025, we received a letter from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that the closing bid price for our Common Stock for the previous 30 consecutive business days was below $1.00 per share, which is the minimum closing bid price (the “Minimum Bid Price”) required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Notice”). The Notice indicated that in accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company was provided a compliance period of 180 calendar days from the date of the Notice, or until May 4, 2026, to regain compliance with the Minimum Bid Price requirement.

Reworded

OnAs previously reported by the Company on Current Report on Form 8-K filed with the SEC on May 7, 2026, on May 5, 2026, the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq Staff”) notified the Company that althoughwhile the Company hasdid not regainedregain compliance with the $1.00 minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on Nasdaq (the “Minimum Bid Price Requirement”) by May 4, 2026 (in accordance with the initial 180-day compliance period provided to the Company), Nasdaq granted the Company a second 180-day compliance period to regain compliance with the Minimum Bid Price Requirement, the Company is eligible to receive an additional 180 calendar day period or untilby November 2, 2026,2026. to regain compliance with the Minimum Bid Price Requirement. Nasdaq’sThat determination to grant the Company an additional 180 calendar day period was based on the Company’s satisfaction of the continued listing requirements for the market value of publicly held shares and all other applicable requirements for initial listing on the Nasdaq Capital Market,Nasdaq, with the exception of the Minimum Bid Price Requirement. Additionally, the Company has provided Nasdaq with written notice of its intention to cure the deficiency during the second compliance period, by implementing a reverse stock split, if necessary.

Reworded

If at any time during this second compliance period, the closing bid price of the Company’s Common Stock is at least $1.00 per share for a minimum of ten consecutive business days (unless the Nasdaq staffStaff exercises its discretion to extend this ten business day period pursuant to Nasdaq Listing Rule 5810(c)(3)(H)), Nasdaq Staff will provide the Company written confirmation of compliance with the Minimum Bid Bid Price, and the matter will be closed. If compliance cannot be demonstrated by November 2, 2026, Nasdaq Staff will provide written notification notification that the Company’s securities will be delisted. At that time, the Company may appeal Nasdaq’s determination to a Nasdaq Hearings Panel.

Added

On May 31, 2026, the Board approved a reverse stock split of the issued and outstanding shares of our common stock (the “Reverse Stock Split”) at a ratio of not less than 1-for-10 and not more than 1-for-50 (the “Reverse Split Range”) and a form of an amendment to our Amended and Restated Articles of Incorporation, as amended (the “Certificate of Amendment”), to implement the Reverse Stock Split.

Added

On June 11, 2026, holders of a majority of the outstanding voting power of the Company (the “Majority Stockholders”), acting by written consent, in accordance with the applicable provisions of the Nevada Revised Statutes and the Company’s Amended and Restated Articles of Incorporation and its Bylaws, approved the Reverse Split Range and granted the Board the discretionary authority to determine the exact ratio of the Reverse Stock Split within the Reverse Split Range, to file the Certificate of Amendment with the Nevada Secretary of State, and to effect the Reverse Stock Split at such time and date, if at all, as to be determined by the Board in its sole discretion.

Added

On July 22, 2026, the Board approved the 1-for-20 ratio of the Reverse Stock Split and authorized the Company to proceed with the preparation of the necessary documents and actions, including applying for the new CUSIP, submitting the Event Notification Form with Nasdaq, and the filing of the Certificate of Amendment with the Nevada Secretary of State, to effect the Reverse Stock Split in Nevada and on Nasdaq. The Company is planning that the Reverse Stock Split will become effective on Nasdaq by August 20, 2026.

Added

Upon effectiveness of the Reverse Stock Split, every twenty shares of common stock outstanding immediately prior to the effectiveness will be combined and reclassified into one share of common stock. No fractional shares will be issued in connection with the Reverse Stock Split, and any fractional shares will be rounded to the nearest whole share. The number of authorized shares of common stock and the par value per share will not be affected by the Reverse Stock Split.

Reworded

TheHowever, Companyupon iseffectiveness currently monitoringof the closingReverse bidStock priceSplit, of its common stock and will consider available options, including a reverse stock split, if appropriate, to regain compliance with the Minimum Bid Price Requirement by November 2, 2026. Therethere can be no assurance that the Company will be able to regain compliance with the Minimum Bid Price Requirement,Requirement evenor if it maintainsmaintain compliance with other listing requirements of the Nasdaq Capitallisting Market.rules for continuing listing.

Added

2026 Equity Incentive Plan

Added

On May 31, 2026, our Board of Directors adopted the 2026 Equity Incentive Plan (the “2026 Plan”), which became effective on June 11, 2026, upon approval by the Majority Stockholders. Pursuant to the 2026 Plan, the Company reserved an aggregate of 5,700,000 shares of our common stock for issuance as stock options, restricted stock, restricted stock units and other stock-based awards to our employees, directors and consultants. On July 21, 2026, we filed a Registration Statement on Form S-8 (the “S-8 Registration Statement”) registering 3,000,000 of the shares of common stock reserved under the 2026 Plan, representing approximately 10.58% of our issued and outstanding shares of common stock as of the date of filing. We adopted the 2026 Plan to enable us to attract, retain and incentivize qualified personnel as we advance our development programs toward our targeted IND submission, and to align the interests of our employees, directors and consultants with those of our stockholders. Issuance of awards under the 2026 Plan will dilute the ownership interests of our existing stockholders. As of June 30, 2026, no awards had been granted under the 2026 Plan. See Note 8 to our unaudited interim financial statements. As of the date of this Quarterly Report, all of the 3,000,000 shares of common stock registered under the S-8 Registration Statement were issued by the Company.

Reworded

Comparison of Results of Operations for the Three Months Ended MarchJune 31,30, 2026 and 2025

Reworded

We did not generate any revenue during the three months ended MarchJune 31,30, 2026, or 2025. This is consistent with our focus on advancing the development of our botanical drug candidates and progressing toward our clinical and regulatory milestones.

Reworded

General and administrative expenses were $927,197$731,843 for the three months ended MarchJune 31,30, 2026, compared to $137,452$57,658 for the same period in 2025. The increase was primarily attributable to higher personnel-related expenses, including approximately $466,518$348,072 of increased payroll costs, as our founder and certain members of senior management began receiving compensation following the completion of our IPO, whereas little or no cash compensation had been paid to these individuals prior to that time. The increase also reflects higher professional fees and other costs associated with operating as a public company.

Reworded

Following our initial public offering, we continued to invest in research and development (“R&D”) activities primarily related to FDA-mandated investigational new drug (“IND”) studies targeting ulcerative colitis,colitis as our lead indication and cancer cachexia as our second core indication, as well as atopic dermatitis, rheumatoid arthritis, gouty arthritis, and diabetic foot. For the three months ended MarchJune 31,30, 2026, R&D expenses totaled $2,256,162, $2,593,717, primarily reflecting costs incurred under service agreements for IND-related studies and research activities, with such costs recognized over the respective service period in accordance with the terms of the underlying agreements. As of March 31,June 30, 2026, the Company recorded $3.9$1.8 million in prepaid R&D, representing advance payments to Contract Research Organizations Organizations (“CROs”) and Contract Development and Manufacturing Organizations (“CDMOs”) for services to be rendered rendered under ongoing IND studies. We expect R&D spending to remain significant as these studies progress but to moderate in future periods until FDA approvals are obtained and clinical trial activities commence.

Reworded

For the three months ended MarchJune 31,30, 2026, other income was $33,131,$34,590, primarily interest income earned on cash and cash equivalents. The increase was primarily attributable to higher interest income earned on the Company’s cash balances. The higher interest income primarily reflects increased cash balances following the receipt of net proceeds from the Company’s IPO.

Reworded

As a result of the foregoing, the Company recorded a net loss of $3,150,228$3,290,970 for the three months ended MarchJune 31,30, 2026, compared to $60,346 $137,583 for the three months ended MarchJune 31,30, 2025.

Added

Comparison of Results of Operations for the Six Months Ended June 30, 2026 and 2025

Added

Revenue and Cost of Sales

Added

We did not generate any revenue during the six months ended June 30, 2026, or 2025. This is consistent with our focus on advancing the development of our botanical drug candidates and progressing toward our clinical and regulatory milestones.

Added

We anticipate generating revenue only upon successful commercialization of our product candidates or from entering into strategic licensing agreements. However, there is no assurance as to the timing or likelihood of these events.

Added

Operating Expenses

Added

General and Administrative Expenses

Added

General and administrative expenses were $1,659,040 for the six months ended June 30, 2026, compared to $195,110 for the same period in 2025. The increase was primarily attributable to higher personnel-related expenses, including approximately $814,590 of increased payroll costs, as our founder and certain members of senior management began receiving compensation following the completion of our IPO, whereas little or no cash compensation had been paid to these individuals prior to that time. The increase also reflects higher professional fees and other costs associated with operating as a public company. General and administrative expenses for the six months ended June 30, 2026 also included $9,792 of non-cash stock-based compensation associated with the issuance of 24,000 shares of common stock in March 2026, compared to $nil in the prior year period.

Added

Research and Development Expenses

Added

Following our initial public offering, we continued to invest in research and development (“R&D”) activities primarily related to FDA-mandated investigational new drug (“IND”) studies targeting ulcerative colitis as our lead indication and cancer cachexia as our second core indication, as well as atopic dermatitis, rheumatoid arthritis, gouty arthritis, and diabetic foot. For the six months ended June 30, 2026, R&D expenses totaled $4,849,879, primarily reflecting costs incurred under service agreements for IND-related studies and research activities, with such costs recognized over the respective service period in accordance with the terms of the underlying agreements. As of June 30, 2026, the Company recorded $1.8 million in prepaid R&D, representing advance payments to Contract Research Organizations (“CROs”) and Contract Development and Manufacturing Organizations (“CDMOs”) for services to be rendered under ongoing IND studies. We expect R&D spending to remain significant as these studies progress but to moderate in future periods until FDA approvals are obtained and clinical trial activities commence.

Added

Other Income (Expense)

Added

For the six months ended June 30, 2026, other income was $67,721, primarily interest income earned on cash and cash equivalents. The increase was primarily attributable to higher interest income earned on the Company’s cash balances. The higher interest income primarily reflects increased cash balances following the receipt of net proceeds from the Company’s IPO.

Added

Net loss

Added

As a result of the foregoing, the Company recorded a net loss of $6,441,198 for the six months ended June 30, 2026, compared to $197,929 for the six months ended June 30, 2025.

Added

Since our inception through June 30, 2026, we have funded our operations principally through the issuance of equity and debt securities. We have not generated any revenue since inception and do not expect to generate revenue unless and until we successfully commercialize a product candidate or enter into strategic licensing arrangements.

Removed

Liquidity is the ability of a company to generate funds to support its current and future operations, satisfy its obligations, and otherwise operate on an ongoing basis. Significant factors in the management of liquidity are funds generated by operations, levels of accounts receivable and accounts payable and capital expenditures. Since our inception through March 31, 2026, we have funded our operations, principally with the issuance of equity and debt.

Reworded

On August 27, 2025, we closed theour IPOinitial public offering pursuant to the Underwriting Agreement.Agreement, Thereceiving net cash proceeds toof theapproximately $13.24 Company from the IPO,million after deducting the underwriting discount, the underwriters’ feesdiscounts and expensescommissions and the Company’s estimated offering expensesexpenses. were approximately $12,871,280. In addition, onOn September 12, 2025, we had a closing of the Optionunderwriters exercised Shares,their over-allotment option in full, resulting in theadditional net proceeds of approximately $2.07 million. We have no committed $2,070,000.sources of additional capital and no available credit facility.

Added

As of June 30, 2026, we had cash and cash equivalents of $2,938,463, compared to $4,973,134 as of December 31, 2025, and an accumulated deficit of $11,288,753. We recorded a net loss of $6,441,198 for the six months ended June 30, 2026, compared to $197,929 for the six months ended June 30, 2025.

Added

Our net cash used in operating activities for the six months ended June 30, 2026 of $2,034,671 was substantially lower than our net loss for the period because a significant portion of our operating expenses was funded through the utilization of prepaid research and development balances paid in prior periods rather than through cash expenditures during the period. Our total prepaid expenses declined from $6,254,374 as of December 31, 2025 to $1,854,529 as of June 30, 2026, a reduction of $4,399,844, of which prepaid research and development accounted for $4,347,118. As these prepaid balances are consumed, we expect our cash used in operating activities to increase substantially and to approximate our operating expenses.

Added

We further expect our research and development expenditures to increase in connection with our targeted Investigational New Drug application submission in the fourth quarter of 2026 and the initiation of a Phase I clinical trial thereafter. Clinical trial activities require substantial capital that we have not yet secured.

Added

Awards granted under the 2026 Plan will be settled in shares of our common stock and will not require the use of cash, which we expect will allow us to conserve cash resources in compensating our personnel as we advance our development programs. Any awards granted under the 2026 Plan will, however, dilute the ownership interests of our existing stockholders upon issuance. As of June 30, 2026, no awards had been granted under the 2026 Plan. Between July 27, 2026 and August 7, 2026, the Company issued all of the 3,000,000 shares of our common stock under the 2026 Plan, registered in the S-8 Registration Statement.

Added

We will require additional capital to fund our operations. We may seek to raise additional capital through public or private equity offerings, debt financings, strategic collaborations or licensing arrangements. Our ability to raise capital on acceptable terms may be adversely affected by the trading price of our common stock, current deficiency with the Minimum Bid Price Requirement and our ability to regain compliance with that Nasdaq rule and maintain compliance with other Nasdaq listing rules for continued listing, and general market conditions. Issuance of shares of Common Stock under the 2026 Plan and additional equity financing would dilute our existing stockholders, and debt financing, if available, may involve restrictive covenants. If we are unable to raise additional capital when needed, we would be required to delay, reduce or eliminate certain of our development programs.

Removed

As of March 31, 2026, we had cash and cash equivalents totaling $4,018,574, compared to $198,943 as of March 31, 2025. The increase in cash and cash equivalents was primarily attributable to net proceeds of approximately $15.3 million received from the Company’s IPO completed in August 2025 and the exercise in full of the underwriters’ over-allotment option in September 2025.

Removed

We believe our existing cash and access to shareholders’ support are sufficient to fund our operations for at least the next twelve months. However, our ability to continue operating beyond this period is dependent upon the successful implementation of our business plan, including conducting FDA-required good laboratory practice (“GLP”) toxicology and pharmacokinetic studies for Phyto-N in ulcerative colitis, and preparation and submission of an Investigational New Drug application.

Added

We have not generated any revenue since inception and have incurred recurring net losses and negative cash flows from operations. For the six months ended June 30, 2026, we incurred a net loss of $6,441,198 and used cash in operating activities of $2,034,671. As of June 30, 2026, we had cash and cash equivalents of $2,938,463 and an accumulated deficit of $11,288,753.

Added

As described above, our cash used in operating activities during the six months ended June 30, 2026 was substantially lower than our operating expenses because a significant portion of those expenses was funded through prepaid balances paid in prior periods. As those balances are consumed, we expect our cash requirements to increase materially, and we expect our research and development expenditures to increase further in connection with our planned Investigational New Drug application submission and subsequent clinical trial activities.

Added

Based on our current operating plan, we do not expect our existing cash and cash equivalents to be sufficient to fund our operations for at least twelve months from the date of issuance of the unaudited interim financial statements included in this Quarterly Report. These conditions raise substantial doubt about our ability to continue as a going concern. There can be no assurance we will be successful in raising additional capital on favorable terms, or at all. Because these plans are not considered probable of being effectively implemented, they do not alleviate the substantial doubt about our ability to continue as a going concern. If we are unable to obtain sufficient amount of additional capital, we may be required to reduce the scope of our planned development, If we are unable to raise additional capital when needed, we would be required to delay, reduce or eliminate certain of our development programs and could harm our business, financial condition and operating results. If we obtain additional funds by selling any of our equity, the percentage ownership of our stockholders will be reduced, stockholders may experience additional dilution, or the equity securities may have rights preferences or privileges senior to our common stock. If we issue debt securities, there may be negative covenants which may restrict our company’s activities. If adequate funds are not available to the Company when needed on satisfactory terms, we may be required to cease operating or otherwise modify our business strategy.

Added

The unaudited interim financial statements included in this Quarterly Report have been prepared assuming we will continue as a going concern and do not include any adjustments to the carrying amounts or classification of assets and liabilities that might result from the outcome of this uncertainty. See Note 1 to our unaudited interim financial statements.

Removed

We have not yet achieved profitability and anticipate continued operating losses in the foreseeable future. Our financial statements include a going concern disclosure due to our recurring losses, accumulated deficit, and reliance on external funding. However, management believes that substantial doubt has been alleviated due to our strong cash position, receipt of the IPO proceeds.

Reworded

The lease liability was $311,000$276,359 as of MarchJune 31,30, 2026.

Reworded

We did not have any off-balance sheet arrangements as of MarchJune 31,30, 2026.

CURX insider buying and selling (Form 4)

Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.

No Form 4 stock transactions in this period.

Well-known investors holding CURX (13F)

InvestorQuarterSharesReported value% of their 13FChange vs prior quarter
Citadel Advisors (Ken Griffin) COM2026-06-3095,258$25.3K0.0%Added 88%
Renaissance Technologies COM2026-06-3052,000$13.8K0.0%New position
Two Sigma Investments COM2026-06-3027,354$7.3K0.0%Added 35%

13F reports are filed up to 45 days after quarter end and show long U.S. equity positions only; options positions are omitted here.

Coming soon: email alerts when CURX files, watchlists and downloadable comparisons.