STOCK TITAN

Polaryx (PLYX) secures $10M PIPE to fund SOTERIA trial and extend runway to Q2 2027

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Polaryx Therapeutics, Inc. entered into a private placement, selling 2,502,696 common shares for aggregate gross proceeds of $10 million, representing about 5.3% of its outstanding shares immediately before the transaction. The weighted average price was approximately $4.00 per share.

The company plans to use the net proceeds, together with existing cash, to fund its Phase 2 SOTERIA basket trial of PLX-200 across multiple lysosomal storage disorders, continue research and development, and for working capital and general corporate purposes. Management states this financing is expected to extend Polaryx’s operating runway through the second quarter of 2027 and support the planned launch of SOTERIA in the second half of 2026.

Positive

  • $10 million PIPE financing strengthens liquidity and, according to management, is expected to extend Polaryx’s operating runway through the second quarter of 2027, giving time to execute the Phase 2 SOTERIA trial and generate mid-stage clinical data on PLX-200.
  • Financing directly supports core asset: proceeds are earmarked to initiate and run the Phase 2 SOTERIA basket trial of lead candidate PLX-200 in multiple lysosomal storage disorders, aligning capital with the company’s main value-driving clinical program.

Negative

  • Equity dilution of approximately 5.3% of pre-transaction outstanding shares results from issuing 2,502,696 new common shares in the private placement, which increases the share count and may weigh on per-share metrics.
  • No concurrent resale registration is planned for the PIPE shares, and the securities are restricted, which can limit near-term liquidity options for participating investors compared with a registered offering.

Insights

$10M PIPE financing funds Polaryx’s key Phase 2 trial and extends cash runway into mid‑2027.

Polaryx completed a $10 million private placement of 2,502,696 shares, equal to about 5.3% of pre-deal outstanding stock. Pricing averaged roughly $4.00 per share, with tiered per-share prices tied to each investor’s committed amount.

The company expects to use proceeds, alongside existing cash, to initiate and run the Phase 2 SOTERIA basket trial of PLX-200 across several lysosomal storage disorders and to fund broader R&D and corporate needs. Management indicates this financing should extend operating runway through Q2 2027, providing time to generate mid-stage clinical data.

MStone Partners Healthcare Limited, Polaryx’s largest shareholder, participated by purchasing 88,453 shares for $360,000, signaling continued backing from a key holder. Subsequent disclosures in future SEC filings will clarify actual cash usage versus plans and any additional financing steps around the planned SOTERIA launch in the second half of 2026.

Item 1.01 Entry into a Material Definitive Agreement Business
The company signed a significant contract such as a merger agreement, credit facility, or major partnership.
Item 3.02 Unregistered Sales of Equity Securities Securities
The company sold equity securities in a private placement or other unregistered transaction.
Item 7.01 Regulation FD Disclosure Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Private placement proceeds $10 million Aggregate gross proceeds from PIPE financing
Shares issued 2,502,696 shares Common stock sold in private placement
Dilution percentage 5.3% Portion of outstanding shares immediately prior to deal
Weighted average price ≈$4.00 per share Average purchase price across PIPE investors
Largest holder participation 88,453 shares; $360,000 MStone Partners Healthcare Limited’s PIPE investment
Lower tier price $3.70 per share Price at $2.2 million commitment level
Upper tier price $4.10 per share Higher price as commitment decreases by $50,000 increments
Runway guidance Through Q2 2027 Management’s stated operating runway after financing
private placement financial
"the Company agreed to sell and issue to the Purchasers in a private placement a total of 2,502,696 shares"
A private placement is a way for companies to raise money by selling securities directly to a small group of investors instead of through a public offering. This process is often quicker and less regulated, making it similar to offering a special, exclusive investment opportunity to select individuals or institutions. For investors, it can provide access to unique investment options that are not available on public markets.
PIPE financing financial
"closed a private investment in public equity (“PIPE”) financing resulting in proceeds of $10 million"
Pipe financing is a way for companies to raise money quickly by selling new shares or bonds directly to investors, often before their stock is publicly traded or in the early stages of a project. It’s similar to a company securing a loan from investors, providing quick capital needed for growth or operations. For investors, it can offer opportunities for early involvement and potentially higher returns, but it may also carry increased risk due to the immediate nature of the deal.
Phase 2 basket trial financial
"to fund the initiation of the Phase 2 SOTERIA trial, evaluating PLX-200 across multiple LSD indications"
A phase 2 basket trial is a mid-stage clinical study that tests one investigational treatment across several different patient groups that share a common biological characteristic, like a specific genetic change, rather than the same disease type. For investors, results can show whether a drug has activity in multiple potential markets at once, helping signal broader commercial opportunity or early failure risk much faster than separate single-disease trials.
lysosomal storage disorders medical
"developing novel, disease-modifying therapies for rare, pediatric lysosomal storage disorders (“LSDs”)"
A group of inherited conditions where cells cannot break down and clear certain molecules, like a clogged recycling center inside cells causing harmful buildup that damages organs and the nervous system. Investors care because these disorders create clear targets for specialized treatments, often qualify for orphan-drug incentives and accelerated review, and can drive focused clinical programs and high-value niche markets if therapies prove safe and effective.
Fast Track Designation regulatory
"with Fast Track Designation from the Food and Drug Administration (“FDA”) in-hand for all four planned indications"
A "fast track designation" is a process that speeds up the review and approval of a product or project, allowing it to reach the market or be completed more quickly than usual. For investors, it can signal that a product may become available sooner, potentially leading to earlier revenue or benefits, and indicating a priority status that might influence company performance and market opportunities.
natural history study medical
"these cohorts will incorporate analyses comparing natural history data as a control arm to PLX-200’s treated arm. A natural history study is a preplanned observational study"
A natural history study is an observational research project that follows people with a specific disease over time to document how the condition develops, what symptoms appear, and typical outcomes without testing a new treatment. Investors care because these studies create a factual map of the disease—like a road atlas for drug developers—helping companies design efficient clinical trials, choose meaningful goals for approval, estimate how many patients could benefit, and reduce the guesswork and risk around a drug’s path to market.
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): May 27, 2026

 

Polaryx Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

Nevada   001-43080   47-3393659
(State or other jurisdiction   (Commission   (IRS Employer
of incorporation)   File Number)   Identification No.)

 

South Tower,140 E Ridgewood Avenue,Suite 415

Paramus, NJ 07652

(Address of principal executive offices) (Zip Code)

 

(201) 940-7236

Registrant’s telephone number, including area code

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common Stock, par value $0.0001 per share   PLYX   The Nasdaq Capital Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 

 

 

 

 

Item 1.01 Entry into a Material Definitive Agreement.

 

On May 27, 2026, Polaryx Therapeutics, Inc. (the “Company”) entered into a Securities Purchase Agreement (the “Purchase Agreement”) with approximately 35 investors, including existing investors (the “Purchasers”), pursuant to which the Company agreed to sell and issue to the Purchasers in a private placement a total of 2,502,696 shares (the “Shares”) of the Company’s common stock, par value $0.0001 per share (the “Private Placement”), representing approximately 5.3% of the Company’s outstanding shares immediately prior to the Private Placement, for aggregate gross proceeds of $10 million. MStone Partners Healthcare Limited, the Company’s largest stockholder, purchased 88,453 shares of common stock in the Private Placement, for gross proceeds to the Company of $360,000. The Private Placement closed on May 28, 2026.

 

The per share purchase price is based on each Purchaser’s committed amount, ranging from $3.70 per share at a $2.2 million investment level, increasing in defined increments up to $4.10 per share as the committed amount decreases by $50,000 increments. The weighted average price per share for all sales in the Private Placement was approximately $4.00.

 

The Purchase Agreement contains customary representations, warranties, and covenants for a transaction of this type.

 

The Company currently expects to use the net proceeds from this Private Placement to fund its Phase 2 proof-of-concept basket trial, SOTERIA (PLX-200-600), as well as for working capital and general corporate purposes.

 

The form of the Purchase Agreement is filed as Exhibit 10.1 to this Current Report on Form 8-K. The foregoing summary of the terms of the Purchase Agreement is subject to, and qualified in its entirety by the Purchase Agreement, the form of which is incorporated herein by reference.

 

Item 3.02 Unregistered Sales of Equity Securities

 

The applicable information related to the Purchase Agreement presented in Item 1.01 of this Current Report is incorporated by reference in this Item 3.02. The Shares will be issued without prior registration in reliance upon the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation S thereunder. In connection with the Purchasers’ execution of the Purchase Agreement, the Purchasers represented to the Company that the Shares to be purchased by them will be acquired solely for their own account and not with a view to or for distributing or reselling such Shares or any part thereof in violation of the Securities Act or any applicable state securities law. Such Shares shall not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements and certificates evidencing such shares of common stock contain a legend stating the same. 

 

Item 7.01. Regulation FD Disclosure.

 

On May 28, 2026, the Company issued a press release announcing the Private Placement. A copy of the press release is furnished herewith as Exhibit 99.1.

 

The information under this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”) or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into the filings of the Company under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in such filing. 

 

Item 9.01 Financial Statements and Exhibits

 

(d) Exhibits

 

Exhibit No.   Exhibit Title or Description
10.1   Form of Securities Purchase Agreement by and between the Company and Purchasers dated May 27, 2026.
99.1   Press release dated May 28, 2026.
104   Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

1

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.

 

  Polaryx Therapeutics, Inc.
   
  /s/ Alex Yang
  Alex Yang
  Chief Executive Officer
   
May 28, 2026  

 

 

2

 

Exhibit 99.1

 

Polaryx Therapeutics Announces Closing of $10
Million Private Placement Equity Financing to
Support Launch of SOTERIA Phase 2 Basket Trial

 

PARAMUS, NJ, May 28, 2026 (GLOBE NEWSWIRE) -- Polaryx Therapeutics, Inc. (the “Company” or “Polaryx”) (Nasdaq: PLYX), a clinical-stage biotechnology company developing novel, disease-modifying therapies for rare, pediatric lysosomal storage disorders (“LSDs”), today announced that it has closed a private investment in public equity (“PIPE”) financing resulting in proceeds of $10 million. The PIPE financing closed on May 28, 2026.

 

The PIPE financing consisted of an aggregate of 2,502,696 shares of common stock at an average purchase price of approximately $4.00 per share.

 

Polaryx intends to use the net proceeds from the PIPE financing, together with existing cash and cash equivalents, to fund the initiation of the Phase 2 SOTERIA trial, evaluating PLX-200 across multiple LSD indications, through key planned clinical milestones along with the continued research and development of its product candidates, as well as for working capital and general corporate purposes.

 

“We are grateful for the confidence expressed by our new and existing investors for their support in Polaryx’s mission to meet the large unmet need for patients and families living with lysosomal storage disorders. Polaryx has now secured the capital necessary to transition into clinical execution mode,” said Alex Yang, Chief Executive Officer of Polaryx. “This financing provides us with the runway to launch and reach key anticipated clinical milestones within the SOTERIA basket trial. Importantly, this financing is expected to extend the Company’s operating runway through the second quarter of 2027.”

 

“With clinical development work with our CRO already underway, this parallel fundraising comfortably positions us for the planned launch of SOTERIA in the second half of 2026,” said Lisa L. Bollinger, M.D., Chief Medical Officer of Polaryx. “We are thrilled with the confidence shown by our investors and with Fast Track Designation from the Food and Drug Administration (“FDA”) in-hand for all four planned indications, we look forward to advancing PLX-200 in the clinic.”

 

The offer and sale of the foregoing securities were made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended, and may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. Polaryx will not file a registration statement with the Securities and Exchange Commission (“SEC”) registering the resale of the shares of common stock in each case sold in the PIPE financing.

 

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

 

About the SOTERIA Trial

 

SOTERIA is a Phase 2, open-label, single arm trial intended to assess the safety, tolerability, and clinical activity of Polaryx’s lead drug candidate, PLX-200, in CLN2, CLN3, Krabbe disease, and Sandhoff disease, four different LSDs whose patient populations Polaryx believes represent approximately one quarter of the LSD population. SOTERIA is designed to be flexible, resource-efficient, and provide important data and information important to PLX-200’s future clinical development. Polaryx received a safe to proceed letter in October 2025 from the FDA and plans to initiate SOTERIA in the second half of 2026 in trial sites in the United States as well as in Europe and Asia or other foreign jurisdictions. Designed with a high degree of flexibility, SOTERIA represents a resource-efficient opportunity to validate PLX-200’s preclinical science across multiple LSDs while gathering data that will be invaluable in planning PLX-200’s future development pathway, including the initiation of potentially pivotal trials. For the CLN2 and CLN3 cohorts, although the entire trial is open label, these cohorts will incorporate analyses comparing natural history data as a control arm to PLX-200’s treated arm. A natural history study is a preplanned observational study intended to track the course of the disease. Should the data demonstrate compelling clinical activity, Polaryx may seek conditional marketing authorization.

 

 

 

About Polaryx Therapeutics

 

Polaryx Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing patient-friendly small molecule and gene therapy treatments for rare orphan lysosomal storage disorders (LSDs). Founded in 2014, Polaryx seeks to deliver safe, effective, and patient-friendly treatments that address the underlying pathophysiology of these catastrophic diseases and their significant unmet need. Our approach integrates small molecule therapies, including a combination therapy, and a gene therapy, positioning us to potentially address both the genetic and downstream pathological features of LSDs. Our small molecule drug candidates share similar modes of action that have been demonstrated to address lysosomal dysfunction, neuroinflammation, and neuronal loss in our validated animal models that closely mimic human clinical phenotypes. Our most advanced product candidate, PLX-200, targets several LSDs and we intend to launch SOTERIA, a Phase 2 basket trial, to evaluate PLX-200’s safety and efficacy. For more information, please visit www.polaryx.com.

 

Forward-Looking Statements

 

Certain statements in this press release are or contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These statements, including, but not limited to, statements regarding Polaryx’s clinical development plans for its product candidates, including PLX-200, including the timing for initiation of the SOTERIA trial, the Company’s cash runway with the proceeds from this PIPE financing and with existing cash and cash equivalents, the anticipated use of proceeds of the PIPE financing, and the registration for resale of the securities issued and sold in the PIPE financing. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Polaryx believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the Company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Polaryx’s filings with the SEC, many of which are beyond the Company’s control and subject to change. Actual results could be materially different. Risks and uncertainties include: global macroeconomic conditions and related volatility, expectations regarding the initiation, progress, and expected results of Polaryx’s clinical trials; expectations regarding the timing, completion and outcome of Polaryx’s clinical trials; the timing or likelihood of regulatory filings and approvals; liquidity and capital resources; and other risks and uncertainties identified in Polaryx’s most recently filed Form 10-K with the SEC and subsequent disclosure documents Polaryx may file with the SEC. Polaryx claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Polaryx expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

 

Media Contact:

 

CORE IR

(212) 655-0924

media@polaryx.com

 

Investor Contact:

 

CORE IR

(212) 655-0924

investor@polaryx.com

 

 

 

 

FAQ

What did Polaryx Therapeutics (PLYX) announce in its latest 8-K filing?

Polaryx announced a private placement of common stock raising $10 million in gross proceeds. The company sold 2,502,696 shares, representing about 5.3% of pre-deal shares, to fund its Phase 2 SOTERIA trial, R&D, and general corporate purposes.

How many shares did Polaryx (PLYX) issue and at what price in the private placement?

Polaryx issued 2,502,696 common shares in the private placement at a weighted average price of about $4.00 per share. Per-share prices ranged from $3.70 to $4.10, depending on each investor’s committed amount under a tiered pricing structure.

How much dilution results from Polaryx’s (PLYX) $10 million financing?

The private placement shares represent approximately 5.3% of Polaryx’s outstanding common stock immediately prior to the transaction. This increases the total share count and modestly dilutes existing shareholders while providing additional capital for clinical development and operations.

How will Polaryx (PLYX) use the $10 million raised in the PIPE financing?

Polaryx intends to use the net proceeds, with existing cash, to fund the Phase 2 SOTERIA basket trial for PLX-200, continue research and development of its product candidates, and for working capital and general corporate purposes, supporting its rare disease pipeline.

How long does Polaryx (PLYX) expect this financing to extend its cash runway?

Management states the $10 million PIPE financing, combined with existing cash and equivalents, is expected to extend Polaryx’s operating runway through the second quarter of 2027. This timeframe is intended to cover key clinical execution for the SOTERIA Phase 2 trial.

Did Polaryx’s largest shareholder participate in the PIPE financing?

Yes. MStone Partners Healthcare Limited, Polaryx’s largest stockholder, purchased 88,453 shares for gross proceeds of $360,000. This participation shows continued involvement from a key existing investor as the company funds its planned Phase 2 SOTERIA trial.

Will the shares sold in Polaryx’s (PLYX) PIPE be registered for resale?

The company states it will not file a resale registration statement for these PIPE shares. The securities were sold in a private transaction and remain restricted, meaning they cannot be resold in the United States without registration or a valid exemption.

Filing Exhibits & Attachments

5 documents