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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). |
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 |
|
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