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Grace Therapeutics (Nasdaq: GRCE) completes $10M private placement for GTx-104

(Moderate)
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Grace Therapeutics, Inc. completed a private placement of 4,761,904 shares of common stock at $2.10 per share, generating approximately $10 million in gross proceeds from institutional and accredited investors. Craig-Hallum Capital Group LLC acted as placement agent. The shares were issued under Section 4(a)(2) and Rule 506 exemptions, and the company will file a resale registration statement, using reasonable best efforts to have it declared effective within specified SEC review timelines and to keep it effective until the shares are sold or freely tradable under Rule 144. The company agreed to bear related registration expenses and accepted near-term restrictions on additional equity issuance, reverse stock splits and new registration statements, subject to exceptions.

Grace Therapeutics expects net proceeds, together with existing cash, to extend its cash runway to the end of calendar 2028 and intends to use the funds to support manufacturing and regulatory work for its lead asset, GTx-104, an IV nimodipine formulation for aneurysmal subarachnoid hemorrhage (aSAH). aSAH accounts for about 5% of strokes and an estimated 42,500 U.S. hospital-treated patients annually. GTx-104 has been administered to over 200 patients and volunteers, has Orphan Drug Designation with potential seven years of U.S. marketing exclusivity, and is supported by an intellectual property estate of 52 granted and pending patents as the company pursues an NDA resubmission and a dual-source manufacturing strategy.

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Filing Explained

The August 6 closing completed the financing and placed 4,761,904 new shares into circulation, reducing existing holders’ percentage ownership absent offsetting changes.

The August 4 press-release exhibit described the private placement as expected to close, but the 8-K states that it closed on August 6, 2026. Completion changes the financing from a planned transaction to an issued-share position: Grace Therapeutics sold and issued 4,761,904 shares, increasing total shares and reducing existing holders’ percentage ownership absent offsetting changes.

A separate unresolved milestone is the NDA resubmission: the company says timing will follow whichever manufacturing path reaches readiness first—the existing manufacturer after remediation, or the second U.S. facility after technology transfer and a full CMC package supported by 12 months of stability data.

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 8.01 Other Events Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Shares sold in private placement 4,761,904 shares Common stock sold to institutional and accredited investors
Purchase price per share $2.10 per share Pricing of common stock in the private placement
Gross proceeds $10 million Approximate gross proceeds from the private placement before fees
Cash runway expectation End of calendar 2028 Runway expected from net proceeds plus existing cash
aSAH share of strokes 5% Portion of all strokes represented by aneurysmal subarachnoid hemorrhage
U.S. aSAH patients 42,500 Estimated annual U.S. hospital-treated aSAH patients
GTx-104 exposure Over 200 Number of patients and healthy volunteers who received GTx-104
Orphan exclusivity period 7 years Potential U.S. marketing exclusivity for GTx-104 post-approval
Patents granted and pending 52 Size of the intellectual property estate covering GTx-104
private placement financial
"a private placement financing with new and existing fundamental investors"
A private placement is a sale of securities directly to a selected group of investors, typically institutions or accredited investors, instead of through a public offering. It lets a company raise money faster and with fewer regulatory steps; for existing shareholders it matters because the newly issued shares, often sold at a discount, increase the share count and can dilute their ownership.
Registration Rights Agreement regulatory
"entered into ... a securities purchase agreement and a Registration Rights Agreement"
A registration rights agreement is a contract that gives investors the option to have their ownership stakes officially registered with the government, making it easier to sell their shares later. This agreement matters because it provides investors with a clearer path to cash out their investments if they choose, offering more liquidity and confidence in their ability to sell their holdings when desired.
at-the-market financial
"The private placement is being priced at-the-market under the rules of the Nasdaq Stock Market"
"At-the-market" is a method for companies to sell new shares of stock directly into the open market over time, rather than all at once. It allows companies to raise money gradually, similar to selling slices of a pie instead of the entire pie at once, which can help manage the sale's impact on the stock price. This approach gives investors a steady supply of shares while providing companies with flexible funding options.
New Drug Application (NDA) regulatory
"The timing of New Drug Application (NDA) resubmission will reflect the manufacturing pathway"
A new drug application (NDA) is a formal request submitted to regulatory authorities to gain approval for a new medication to be sold and used by the public. It is a comprehensive review process that examines the drug’s safety, effectiveness, and manufacturing quality. For investors, an NDA approval can signal a potential breakthrough product and influence a company's stock value.
chemistry, manufacturing, and controls (CMC) package technical
"require completion of a full chemistry, manufacturing, and controls (CMC) package"
Complete Response Letter (CRL) regulatory
"items identified in FDA's Complete Response Letter (CRL) to the NDA"
A complete response letter (CRL) is an official communication from a drug or medical device regulator saying an approval application cannot be approved in its current form and listing specific problems that must be fixed. For investors, a CRL is like a referee pausing a game and listing rule violations — it signals extra time, cost and uncertainty before a product can reach market, and it often prompts a reassessment of a company’s near-term prospects.

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FAQ

What financing did Grace Therapeutics (GRCE) complete?

Grace Therapeutics completed a private placement of common stock, issuing 4,761,904 shares at $2.10 per share for approximately $10 million in gross proceeds. The financing involved institutional and accredited investors, with Craig-Hallum Capital Group LLC serving as placement agent.

How will Grace Therapeutics (GRCE) use the $10 million in proceeds?

Grace Therapeutics intends to use the net proceeds from the approximately $10 million financing to support the manufacturing and regulatory work needed to advance its lead drug candidate GTx-104, including activities tied to New Drug Application preparation and related chemistry, manufacturing and controls requirements.

How long does Grace Therapeutics (GRCE) expect its cash runway to last?

Grace Therapeutics expects the net proceeds from the private placement, together with existing cash and cash equivalents, to extend its cash runway to the end of calendar 2028, based on the company’s current operating and development plans for GTx-104.

What are the key terms of the resale registration for GRCE’s new shares?

Grace Therapeutics agreed to register the resale of the private placement shares and to use reasonable best efforts to have the registration statement declared effective within SEC review-based timelines, and to keep it effective until the shares are sold or become freely tradable under Rule 144.

What is GTx-104, Grace Therapeutics’ (GRCE) lead asset?

GTx-104 is a clinical-stage, IV formulation of nimodipine for aneurysmal subarachnoid hemorrhage (aSAH), using nanoparticle technology to enable peripheral IV infusion. It has Orphan Drug Designation, potential seven years of U.S. exclusivity, and is backed by 52 granted and pending patents.

How large is the aneurysmal subarachnoid hemorrhage (aSAH) market GRCE targets?

Aneurysmal subarachnoid hemorrhage (aSAH) represents about 5% of all strokes and an estimated 42,500 U.S. hospital-treated patients annually. Grace Therapeutics is developing GTx-104 for IV infusion in this setting to address significant unmet medical needs in intensive care environments.

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): August 4, 2026

GRACE THERAPEUTICS, INC.
(Exact Name of Registrant as Specified in its Charter)

Delaware
001-35776
98-1359336
(State or Other Jurisdiction of Incorporation)
(Commission File Number)
(IRS Employer Identification No.)

103 Carnegie Center
Suite 300
Princeton, New Jersey
 
08540
(Address of Principal Executive Offices)
 
(Zip Code)

Registrant’s telephone number, including area code: (609) 322-1602

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
GRCE
The Nasdaq Stock Market LLC

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.

Private Placement Offering

On August 4, 2026, Grace Therapeutics, Inc. (the “Company”), in connection with a private placement offering (the “Offering”) of the Company’s common stock, par value $0.0001 (the “Common Stock”), entered into with certain institutional and accredited investors (the “Investors”) (i) a securities purchase agreement (the “Purchase Agreement”), and (ii) a registration rights agreement (the “Registration Rights Agreement”).

Pursuant to the Purchase Agreement, the Company offered and sold in the Offering an aggregate of 4,761,904 shares of Common Stock (the “Shares”) at a purchase price of $2.10 per share.

Craig-Hallum Capital Group LLC acted as placement agent for the Offering. The Company has agreed to pay the placement agent customary placement fees in its capacity as placement agent in the Offering.

The gross proceeds to the Company from the Offering were approximately $10 million, before deducting placement agent fees and other offering expenses. The Offering closed on August 6, 2026 (the “Closing Date”).

Pursuant to the terms of the Registration Rights Agreement, the Company has agreed to register for resale the Shares. The Company has agreed to use reasonable best efforts to cause the registration statement covering the resale of the Shares to be declared effective as promptly as possible after the filing thereof, but no later than the earlier of (a) the 60th calendar day following the initial filing date of the initial registration statement if the Securities and Exchange Commission (the “SEC”) notifies the Company that it will “review” the initial registration statement and (b) the fifth business day after the date the Company is notified by the SEC that the initial registration statement will not be “reviewed” or will not be subject to further review. The Company also agreed to use reasonable best efforts to keep such registration statement effective until the earlier of the date the Shares covered by such registration statement have been sold or may be resold pursuant to Rule 144 without restriction. The Company has agreed to be responsible for all fees and expenses incurred in connection with the registration of the Shares.

Pursuant to the terms of the Purchase Agreement, the Company may not, subject to certain exceptions, until the later of (a) 90 days from the Closing Date and (b) 30 days after the effective date of the registration statement filed pursuant to the Registration Rights Agreement, (i) issue shares of Common Stock or Common Stock equivalents, (ii) effect a reverse stock split, recapitalization, share consolidation, reclassification or similar transaction affecting the outstanding Common Stock or (iii) file with the SEC a registration statement under the Securities Act of 1933, as amended (the “Securities Act”) relating to any shares of Common Stock or Common Stock equivalents, except pursuant to the terms of the Registration Rights Agreement.

The Shares were sold and issued without registration under the Securities Act in reliance on the exemptions provided by Section 4(a)(2) of the Securities Act as transactions not involving a public offering and Rule 506 promulgated under the Securities Act as sales to accredited investors.

The foregoing descriptions of the Purchase Agreement and the Registration Rights Agreement are not complete and are qualified in their entirety by reference to the full text of the Form of Purchase Agreement and the Form of Registration Rights Agreement, which are attached hereto as Exhibit 10.1 and 10.2, respectively, and are incorporated by reference into this Item 1.01.

Item 3.02.
Unregistered Sales of Equity Securities.

The disclosures in Item 1.01 of this Current Report on Form 8-K regarding the Offering are incorporated by reference into this Item 3.02.

Item 8.01.
Other Events.

On August 4, 2026, the Company issued a press release announcing the Offering. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated by reference into this Item 8.01.


Item 9.01.
Exhibits.
 
(d) Exhibits

Exhibit
 
Description
10.1#

Form of Securities Purchase Agreement.
10.2

Form of Registration Rights Agreement.
99.1

Press Release, dated August 4, 2026.
104

Cover Page Interactive Data File (embedded within the Inline XBRL document).

#
Certain schedules/exhibits to this agreement have been omitted in accordance with Item 601(a)(5) of Regulation S-K. A copy of any omitted schedules will be furnished supplementally to the SEC upon request.


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.
 
     
GRACE THERAPEUTICS, INC.
       
Date:
August 6, 2026
By:
/s/ Prashant Kohli
     
Prashant Kohli
   
Chief Executive Officer




Exhibit 99.1

Grace Therapeutics Announces $10 Million Private Placement
 
Expected gross proceeds anticipated to extend the Company’s cash runway to the end of calendar 2028

PRINCETON, N.J., August 4, 2026 Grace Therapeutics, Inc. (Nasdaq: GRCE) (“Grace Therapeutics” or “the Company”), a late-stage, biopharma company advancing GTx-104, a clinical-stage, novel, injectable formulation of nimodipine being developed for IV infusion to address significant unmet medical needs in aSAH patients, today announced that it has entered into a securities purchase agreement for a private placement financing with new and existing fundamental investors. The financing is expected to result in aggregate gross proceeds to the Company of approximately $10 million, before deducting placement agent fees and other offering expenses. The Company intends to use the net proceeds from the financing to support the manufacturing and regulatory work needed to advance GTx-104.

Pursuant to the terms of the securities purchase agreement, Grace Therapeutics will issue an aggregate of 4,761,904 shares of common stock at a price of at $2.10 per share. The private placement is being priced at-the-market under the rules of the Nasdaq Stock Market. The financing is expected to close on August 6, 2026, subject to the satisfaction of customary closing conditions.

The Company expects the net proceeds from the private placement, together with existing cash and cash equivalents, to extend the Company’s cash runway to the end of calendar 2028.

In parallel, the Company has initiated a dual-source manufacturing strategy for GTx-104 to mitigate potential remediation issues from the Company’s current contract manufacturer and provide flexibility. As such, a technology transfer to a second, U.S.-based contract manufacturer is already underway. The timing of New Drug Application (“NDA”) resubmission will reflect the manufacturing pathway that reaches readiness first: either (i) the U.S.-based facility, which would require completion of a full chemistry, manufacturing, and controls (“CMC”) package supported by 12 months of stability data following the technology transfer; or (ii) the Company’s current contract manufacturer, if it successfully remediates its FDA compliance issues and is able to support the NDA sooner. The Company is also advancing efforts to address the remaining CMC and non-clinical items identified in FDA’s Complete Response Letter (“CRL”) to the NDA, though the Company expects that manufacturing readiness, rather than these items, will be the key driver of NDA resubmission timing.

Craig-Hallum is acting as the sole placement agent for the private placement.
 
The offer and sale of the foregoing securities are being made in a transaction not involving a public offering, and the securities have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or applicable state securities laws. Accordingly, the securities 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 of the Securities Act and such applicable state securities laws. The Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock purchased in the private placement.
 

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state.
 
About aneurysmal Subarachnoid Hemorrhage (aSAH)

aSAH is bleeding over the surface of the brain in the subarachnoid space between the brain and the skull, which contains blood vessels that supply the brain. A primary cause of such bleeding is the rupture of an aneurysm in the brain. The result is aSAH, a relatively uncommon type of stroke that accounts for about 5% of all strokes and an estimated 42,500 U.S. hospital treated patients.

About GTx-104
 
GTx-104 is a clinical stage, novel, injectable formulation of nimodipine being developed for IV infusion in aSAH patients to address significant unmet medical needs. The unique nanoparticle technology of GTx-104 facilitates aqueous formulation of insoluble nimodipine for a standard peripheral IV infusion. GTx-104 provides a convenient IV delivery of nimodipine in the Intensive Care Unit potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients. Intravenous delivery of GTx-104 also has the potential to lower food effects, drug-to-drug interactions, and eliminate potential dosing errors. Further, GTx-104 has the potential to better manage hypotension in aSAH patients. GTx-104 has been administered in over 200 patients and healthy volunteers and was well tolerated with significantly lower inter- and intra-subject pharmacokinetic variability compared to nimodipine oral capsules.
 
About Grace Therapeutics
 
Grace Therapeutics, Inc. (Grace Therapeutics or the Company) is a late-stage biopharma company with drug candidates addressing rare and orphan diseases. Grace Therapeutics’ novel drug delivery technologies have the potential to improve the performance of currently marketed drugs by achieving faster onset of action, enhanced efficacy, reduced side effects, and more convenient drug delivery. Grace Therapeutics’ lead clinical asset, GTx-104, is an IV infusion targeting aneurysmal Subarachnoid Hemorrhage (aSAH), a rare and life-threatening medical emergency in which bleeding occurs over the surface of the brain in the subarachnoid space between the brain and skull. GTx-104 has been granted Orphan Drug Designation by the FDA, which provides seven years of marketing exclusivity post-launch in the United States if certain conditions are met at NDA approval, and additional intellectual property protection with 52 granted and pending patents.
 
For more information, please visit: www.gracetx.com.
 

Forward-Looking Statements
 
Statements in this press release that are not statements of historical or current fact constitute “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and “forward-looking information” within the meaning of Canadian securities laws (collectively, “forward-looking statements”). Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Grace Therapeutics to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements containing the terms “believes,” “belief,” “expects,” “intends,” “anticipates,” “estimates,” “potential,” “should,” “may,” “will,” “plans,” “continue,” “targeted” or other similar expressions to be uncertain and forward-looking. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The forward-looking statements in this press release, including statements regarding the financing, the intended use of proceeds from the financing, the total investment amount to be raised in connection with the financing, the timing of the closing of the financing, the future prospects of the Company’s GTx-104 drug candidate; the Company’s belief that the issues identified by the FDA in the CRL can be successfully addressed in the Company’s resubmission of the NDA for GTx-104; the Company’s planned approach to addressing the items cited in the CRL following its Type A meeting with the FDA and receipt of the official meeting minutes; the Company’s dual source manufacturing strategy, including remediation at its current contract manufacturer and technology transfer to a second, U.S.-based contract manufacturer; the timing and outcome of any FDA reinspection of the current contract manufacturer; the Company’s plans to complete the required non-clinical studies; and the Company’s plans to report progress against key milestones; GTx-104’s potential to bring enhanced treatment options to patients suffering from aSAH; the ability of GTx-104 to potentially eliminate the need for nasogastric tube administration in unconscious or dysphagic patients; the potential of GTx-104 to lower food effects, drug-to-drug interactions, and to eliminate potential dosing errors; the potential of GTx-104 to better manage hypotension in aSAH patients; and the Company’s intellectual property estate for GTx-104, are based upon Grace Therapeutics’ current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: (i) the financing may not close due to counterparty risk or otherwise, (ii) the timing and success of any regulatory resubmission of the NDA for GTx-104; (iii) the timing of any FDA reinspection of the Company’s current contract manufacturer, and that facility’s compliance status, which are determined by the FDA and outside the Company’s control, and the FDA’s position that it will not approve the NDA while the facility remains in an unacceptable compliance status; (iv) the ability of a second, U.S.-based contract manufacturer to generate the required stability and analytical data and to complete a product-specific pre-approval inspection; (v) the need to complete additional non-clinical studies; (vi) the requirement that any resubmission comprehensively address all items cited in the CRL and the risk of review delay; (vii) the Company’s potential need for additional capital, which may not be available on acceptable terms; (viii) changes to regulatory pathways; (ix) the Company’s ability to protect its intellectual property for GTx-104; and (x) legislative, regulatory, political and economic developments. The foregoing list of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors detailed in the “Special Note Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s Annual Report on Form 10-K for the fiscal year ended March 31, 2026 filed with the Securities and Exchange Commission (SEC) and other documents that have been and will be filed by Grace Therapeutics from time to time with the SEC and Canadian securities regulators. All forward-looking statements contained in this press release speak only as of the date on which they were made. Grace Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by applicable securities laws.
 

For more information, please contact:
 
Grace Therapeutics Contact:

Prashant Kohli
Chief Executive Officer
Tel: 609-322-1602
Email: info@gracetx.com
www.gracetx.com

Investor Relations:
 
LifeSci Advisors
Mike Moyer
Managing Director
Phone: 617-308-4306
Email: mmoyer@lifesciadvisors.com



Filing Exhibits & Attachments

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