Dogwood Therapeutics, Inc 8-K, filed Oct 19, 2026
Dogwood Therapeutics, Inc. (DWTX)
About this 8-K
Dogwood Therapeutics, Inc filed this 8-K on October 19, 2026.
Dogwood Therapeutics entered a Subscription Agreement on October 19, 2026, to issue 4,098,360 shares of common stock to Sealbond Limited at $1.22 per share for an aggregate purchase price of $4,999,999.20, expected to close on or before October 29, 2026. AI summary
Items reported
- Item 1.01: Entered into a material agreement
- Item 3.02: Unregistered sale of equity
- Item 8.01: Other events
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported):
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Securities registered pursuant to Section 12(b) of the Act:
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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) | |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
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.
Subscription Agreement
On October 19, 2026, Dogwood Therapeutics, Inc. (the “Company”) entered into a Subscription Agreement (the “Subscription Agreement”) with Sealbond Limited (“Sealbond”), pursuant to which the Company agreed to issue and sell 4,098,360 shares (the “Shares”) of common stock, par value $0.0001 per share (the “Common Stock”), of the Company to Sealbond in a private placement. The Shares are being sold at a purchase price of $1.22 per Share.
The gross proceeds to the Company from the private placement are expected to be approximately $5 million before deducting offering expenses. The Company intends to use the proceeds from the private placement for general working capital. All of the Shares in the private placement are being sold by the Company.
Sealbond beneficially owns approximately 63.9% of the Company’s outstanding Common Stock prior to giving effect to the private placement and is considered an affiliate of the Company.
The issuance of the Shares to Sealbond will not be registered under the Securities Act of 1933, as amended (the “Securities Act”), or under any state securities laws, in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act and/or Rule 506(b) of Regulation D promulgated thereunder. The Company is relying on this exemption from registration based in part on representations made by Sealbond. The Shares may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. Neither this Current Report on Form 8-K nor the exhibits attached hereto constitutes an offer to sell or the solicitation of an offer to buy the Shares described herein.
The closing of the private placement is expected to occur on or prior to October 29, 2026 (the “Closing Date”).
Registration Rights Agreement
On October 19, 2026, the Company entered into a registration rights agreement (the “Registration Rights Agreement”) with Sealbond, pursuant to which the Company agreed to register for resale the Shares issued in the private placement (the “Registrable Securities”). The Company is required to prepare and file a registration statement with the Securities and Exchange Commission (the “SEC”) no later than the 15th day following the date of the Registration Rights Agreement (the “Filing Deadline”) and to use reasonable best efforts to have the registration statement declared effective as soon as reasonably practicable following the filing thereof but in any event no later than the fifth (5th) business day after notice is received from the SEC that it will not review, or has no further comments to, the registration statement.
The Company has agreed to be responsible for all fees and expenses incurred in connection with the registration of the Registrable Securities, other than selling expenses, which will be borne by Sealbond.
The Registration Rights Agreement provides that the Company will indemnify Sealbond and its controlling persons, members, directors, officers, partners, employees, managers, agents, representatives and advisors against certain liabilities, including liabilities under the Securities Act arising from untrue statements or omissions of material fact in the registration statement or related prospectus, or from violations of securities laws by the Company in connection with the registration, except to the extent arising from information furnished in writing by Sealbond for use therein. Sealbond has agreed to indemnify the Company and certain related persons against liabilities arising from such information, limited to the proceeds received by Sealbond from the sale of the Registrable Securities giving rise to the claim.
The foregoing descriptions of the Subscription Agreement and the Registration Rights Agreement do not
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purport to be complete and are qualified in their entirety by reference to the full text of the Subscription Agreement and the Registration Rights Agreement, copies of which are filed as Exhibits 10.1 and 10.2, respectively, to this Current Report on Form 8-K, and are incorporated herein by reference.
The representations, warranties and covenants contained in the Subscription Agreement and the Registration Rights Agreement were made solely for the benefit of the parties thereto and may be subject to limitations agreed upon by the contracting parties. Accordingly, the Subscription Agreement and the Registration Rights Agreement are incorporated herein by reference only to provide investors with information regarding the terms thereof and not to provide investors with any other factual information regarding the Company or its business, and should be read in conjunction with the disclosures in the Company’s periodic reports and other filings with the SEC.
Item 3.02.Unregistered Sale of Equity Securities.
The information contained in Item 1.01 of this Current Report on Form 8-K regarding the private placement is incorporated by reference into this Item 3.02. The Shares have not been registered under the Securities Act and may not be offered or sold absent registration or an applicable exemption from the registration requirements of the Securities Act.
Item 8.01.Other Events.
On October 19, 2026, the Company issued a press release announcing the private placement. A copy of the press release is attached hereto as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.
Item 9.01Financial Statements and Exhibits.
(d)Exhibits.
Exhibit Number | | Description |
* Filed Herewith
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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.
| DOGWOOD THERAPEUTICS, INC. | |
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| By: | /s/ Angela Walsh |
| Name: | Angela Walsh |
| Title: | Chief Financial Officer, Corporate Secretary and Treasurer |
October 19, 2026 | | |
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Exhibit 10.1
DOGWOOD THERAPEUTICS, INC.
SUBSCRIPTION AGREEMENT
This Subscription Agreement (this “Agreement”) is being delivered to you by Dogwood Therapeutics, Inc., a Delaware corporation (the “Company”), in connection with your subscription for shares (the “Shares”) of the Company’s common stock, par value $0.0001 per share (the “Common Stock”), at a purchase price per share set forth on the signature page hereto and in the aggregate purchase price set forth on the signature page hereto to be issued and sold to you by the Company. The Shares being subscribed for by you are being offered and sold by the Company in a transaction (the “Private Placement”) exempt from registration under the Securities Act of 1933, as amended (the “Securities Act”), pursuant to exemptions available under Section 4(a)(2) and/or Rule 506(b) of Regulation D promulgated thereunder, for an offering up to an aggregate amount of $5,000,000. There is no minimum offering amount. Subject to Section 6(a), all subscription proceeds for the sale of the Shares will be directly paid in immediately available funds to the Company.
| 1. | SUBSCRIPTION AND PURCHASE PRICE. |
Incoming Wire:
Beneficiary Bank:PNC Bank, N.A.
Bank Address:249 Fifth Avenue, Pittsburgh, Pa 15222
Account #:5303681483
Bank #:031000053
SWIFT Code: PNCCUS33
Currency:USD
Beneficiary:Dogwood Therapeutics, Inc.
Beneficiary address:44 Milton Ave, Alpharetta, GA 30009
| 2. | ACCEPTANCE AND CLOSING PROCEDURES. |
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| 3. | INVESTOR’S REPRESENTATIONS AND WARRANTIES. |
The undersigned makes the following agreements, representations, declarations, acknowledgments and warranties to the Company in conjunction with the offer and sale of the Shares with the intent that they be relied upon in determining the undersigned’s suitability as a purchaser of the Shares:
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THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), OR ANY APPLICABLE STATE SECURITIES LAWS. SUCH SECURITIES MAY NOT BE OFFERED FOR SALE, SOLD, DELIVERED AFTER SALE, TRANSFERRED, PLEDGED OR HYPOTHECATED UNLESS REGISTERED UNDER THE SECURITIES ACT OR UNLESS AN EXEMPTION FROM THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT IS AVAILABLE.
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| 4. | THE COMPANY’S REPRESENTATIONS AND WARRANTIES. |
The Company hereby acknowledges, agrees with and represents and warrants to the undersigned, as follows:
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| 5. | REGISTRATION RIGHTS |
The Company and the undersigned agree that, on or prior to the Closing Date, the Company and the undersigned shall enter into a registration rights agreement (the “Registration Rights Agreement”), in form and substance reasonably acceptable to the Company and the undersigned, pursuant to which the Company agrees to, subject to certain limitations, mandatory registration of the Shares. The execution and delivery of the Registration Rights Agreement shall be a condition to the obligations of each party to consummate the Closing.
| 6. | COVENANTS |
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| 7. | TERMINATION. |
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This Agreement may be terminated at any time prior to the Closing (a) by mutual written consent of the Company and the undersigned, (b) by either party if the Closing has not occurred on or before November 9, 2026 (the “Outside Date”), provided that the right to terminate pursuant to this clause (b) shall not be available to a party whose breach of this Agreement has been a principal cause of the failure of the Closing to occur on or before the Outside Date, or (c) by either party if any governmental authority of competent jurisdiction has enacted, issued or entered any final and nonappealable order or law permanently restraining, enjoining or otherwise prohibiting the consummation of the transactions contemplated hereby. Upon termination, this Agreement shall be of no further force or effect, except for provisions that by their nature are intended to survive termination and any liability for fraud or willful breach occurring prior to termination.
| 8. | MISCELLANEOUS PROVISIONS. |
If to the Company: | 44 Milton Avenue |
With a copy to: | Duane Morris LLP |
If to the undersigned: | 2 Dai Fu Street, Tai Po Industrial Estate, |
Hong Kong
Attn: General Counsel, Legal Department
Email: ckls.legal@ck-lifesciences.com
With a copy to:Goodwin Procter LLP
100 Northern Avenue
10
Boston, MA 02210
Attn: Marishka DeToy; Caitlin Tompkins
Email: MDeToy@goodwinlaw.com
CTompkins@goodwinlaw.com
Any party may change the address to which notices, requests, demands, claims and other communications hereunder are to be delivered by giving the other parties notice in the manner herein set forth.
[SIGNATURE PAGE FOLLOWS]
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SIGNATURE PAGE
This Subscription Agreement is dated as of this 19th day of October, 2026 at Alpharetta, Georgia.
Price Per Share: $1.22
Number of Shares: 4,098,360
Purchase Price: $4,999,999.20
This Subscription Agreement is accepted as of this 19th day of October, 2026 for the purchase of the Shares.
DOGWOOD THERAPEUTICS, INC.
By: /Greg Duncan/
Greg Duncan
Chief Executive Officer
SEALBOND LIMITED
By: /Alan Yu/
Alan Yu
Director
[Signature Page to Subscription Agreement]
Exhibit 10.2
REGISTRATION RIGHTS AGREEMENT
THIS REGISTRATION RIGHTS AGREEMENT (this “Agreement”), dated as of October 19, 2026, is entered into by and among Dogwood Therapeutics, Inc., a Delaware corporation (the “Company”), and the undersigned investor hereto (the “Investor”). Capitalized terms used herein and not otherwise defined herein shall have the respective meanings set forth in the Subscription Agreement by and among the parties hereto, dated as of or around the date hereof (as amended, restated, supplemented or otherwise modified from time to time, the “Subscription Agreement”).
WHEREAS:
A.Upon the terms and subject to the conditions of the Subscription Agreement, the Company has agreed to issue to the Investor, and the Investor has agreed to purchase shares (the “Shares”) of the Company’s common stock, par value $0.0001 per share (the “Common Stock”) for up to an aggregate amount of $5,000,000 (the “Subscription Price”), pursuant to the Subscription Agreement.
B.To induce the Investor to enter into the Subscription Agreement, the Company has agreed to provide certain registration rights under the U.S. Securities Act of 1933, as amended, and the rules and regulations thereunder, or any similar successor statute (collectively, the “Securities Act”).
NOW, THEREFORE, in consideration of the promises and the mutual covenants contained herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Company and the Investor hereby agree as follows:
For purposes of this Agreement, the following terms shall have the following meanings:
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With respect to the Registration Statement and whenever any Registrable Securities are to be Registered pursuant to Section 2, including on the Initial Registration Statement or on any New Registration Statement, the Company shall use its reasonable best efforts to effect the
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registration of the Registrable Securities in accordance with the intended method of disposition thereof and, pursuant thereto, the Company shall have the following obligations:
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All Registration Expenses incurred in connection with registrations pursuant to this Agreement shall be borne by the Company. All Selling Expenses relating to securities registered on behalf of the Investor shall be borne by the Investor.
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To the extent any indemnification by an indemnifying party is prohibited or limited by law, the indemnifying party agrees to make the maximum contribution with respect to any amounts for which it would otherwise be liable under Section 6 to the fullest extent permitted by law; provided, however, that: (i) no seller of Registrable Securities guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) shall be entitled to contribution from any seller of Registrable Securities who was not guilty of fraudulent misrepresentation; and (ii) contribution by any seller of Registrable Securities shall be limited in amount to the net amount of proceeds (net of all expense paid by the Investor in connection with any claim relating to this Section 7 and the amount of any damages such Investor has otherwise been required to pay by reason of such untrue statement or omission) received by such seller from the sale of such Registrable Securities giving rise to such contribution obligation.
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The Company shall not assign this Agreement or any rights or obligations hereunder (whether by operation of law or otherwise) without the prior written consent of the Investor; provided, however, that in any transaction, whether by merger, reorganization, restructuring, consolidation, financing or otherwise, whereby the Company is a party and in which the Registrable Securities are converted into the equity securities of another Person, from and after the effective time of such transaction, such Person shall, by virtue of such transaction, be deemed to have assumed the obligations of the Company hereunder, the term “Company” shall be deemed to refer to such Person and the term “Registrable Securities” shall be deemed to include the securities received by the Investor in connection with such transaction unless such securities are otherwise freely tradable by the Investor after giving effect to such transaction, and the prior written consent of the Investor shall not be required for such transaction. The Investor may assign its rights under this Agreement, in whole or in part, to any transferee of Registrable Securities; provided that such transferee agrees in writing to be bound by the applicable provisions of this Agreement and the Investor provides prompt written notice of such assignment to the Company.
The provisions of this Agreement, including the provisions of this sentence, may be amended, modified or supplemented, or waived only by a written instrument executed by (i) the Company and (ii) the Investor.
Dogwood Therapeutics, Inc.
44 Milton Avenue
Alpharetta, GA 30009
Attention: Greg Duncan
with a copy (which shall not constitute notice):
Duane Morris LLP
30 South 17th Street
Philadelphia, PA 19103
Attention: Darrick M. Mix
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Email: dmix@duanemorris.com
Any Person may change the address to which notices and communications to it are to be addressed by notification as provided for herein.
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[Signature Page Follows]
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IN WITNESS WHEREOF, the parties have caused this Registration Rights Agreement to be duly executed as of date first written above.
DOGWOOD THERAPEUTICS, INC. | ||
By: | /Angela Walsh/ | |
Name: Angela Walsh | ||
Title: Chief Financial Officer | ||
[Signature Page to Registration Rights Agreement]
IN WITNESS WHEREOF, the parties have caused this Registration Rights Agreement to be duly executed as of date first written above.
INVESTOR:
SEALBOND LIMITED
By: /Alan Yu/
Name:Alan Yu
Title:Director
[Signature Page to Registration Rights Agreement]
Exhibit A
The selling stockholders, which as used herein includes donees, pledgees, transferees or other successors-in-interest selling shares of common stock or interests therein received after the date of this prospectus from a selling stockholder as a gift, pledge, partnership distribution or other transfer, may, from time to time, sell, transfer or otherwise dispose of any or all of their shares of common stock or interests therein on any stock exchange, market or trading facility on which the shares are traded or in private transactions. These dispositions may be at fixed prices, at prevailing market prices at the time of sale, at prices related to the prevailing market price, at varying prices determined at the time of sale, or at negotiated prices.
The selling stockholders may use any one or more of the following methods when disposing of shares or interests therein:
| ● | distributions to members, partners, stockholders or other equityholders of the selling stockholders; |
| ● | ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers; |
| ● | block trades in which the broker-dealer will attempt to sell the shares as agent, but may position and resell a portion of the block as principal to facilitate the transaction; |
| ● | purchases by a broker-dealer as principal and resale by the broker-dealer for its account; |
| ● | an exchange distribution in accordance with the rules of the applicable exchange; |
| ● | privately negotiated transactions; |
| ● | short sales and settlement of short sales entered into after the effective date of the registration statement of which this prospectus is a part; |
| ● | through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise; |
| ● | broker-dealers may agree with the selling stockholders to sell a specified number of such shares at a stipulated price per share; |
| ● | a combination of any such methods of sale; and |
| ● | any other method permitted pursuant to applicable law. |
The selling stockholders may, from time to time, pledge or grant a security interest in some or all of the shares of common stock owned by them and, if they default in the performance of their secured obligations, the pledgees or secured parties may offer and sell the shares of common stock, from time to time, under this prospectus, or under an amendment to this prospectus under
Rule 424(b)(3) or other applicable provision of the Securities Act, amending the list of selling stockholders to include the pledgee, transferee or other successors in interest as selling stockholders under this prospectus. The selling stockholders also may transfer the shares of common stock in other circumstances, in which case the transferees, pledgees or other successors in interest will be the selling stockholders for purposes of this prospectus.
In addition, a selling stockholder that is an entity may elect to make an in-kind distribution of securities to its members, partners or stockholders pursuant to the registration statement of which this prospectus is a part by delivering a prospectus with a plan of distribution. Such members, partners or stockholders would thereby receive freely tradeable securities pursuant to the distribution through a registration statement. To the extent a distributee is an affiliate of ours (or to the extent otherwise required by law), we may file a prospectus supplement in order to permit the distributees to use the prospectus to resell the securities acquired in the distribution.
In connection with the sale of our common stock or interests therein, the selling stockholders may enter into hedging transactions with broker-dealers or other financial institutions, which may in turn engage in short sales of the common stock in the course of hedging the positions they assume. The selling stockholders may also sell shares of our common stock short and deliver these securities to close out their short positions, or loan or pledge the common stock to broker-dealers that in turn may sell these securities. The selling stockholders may also enter into option or other transactions with broker-dealers or other financial institutions or the creation of one or more derivative securities which require the delivery to such broker-dealer or other financial institution of shares offered by this prospectus, which shares such broker-dealer or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).
The aggregate proceeds to the selling stockholders from the sale of the common stock offered by them will be the purchase price of the common stock less discounts or commissions, if any. Each of the selling stockholders reserves the right to accept and, together with their agents from time to time, to reject, in whole or in part, any proposed purchase of common stock to be made directly or through agents. We will not receive any of the proceeds from this offering.
The selling stockholders also may resell all or a portion of the shares in open market transactions in reliance upon Rule 144 under the Securities Act, provided that they meet the criteria and conform to the requirements of that rule, or another available exemption from the registration requirements under the Securities Act.
The selling stockholders and any underwriters, broker-dealers or agents that participate in the sale of the common stock or interests therein may be “underwriters” within the meaning of Section 2(a)(11) of the Securities Act (it being understood that the selling stockholders shall not be deemed to be underwriters solely as a result of their participation in this offering). Any discounts, commissions, concessions or profit they earn on any resale of the shares may be underwriting discounts and commissions under the Securities Act. Selling stockholders who are “underwriters” within the meaning of Section 2(a)(11) of the Securities Act will be subject to the prospectus delivery requirements of the Securities Act.
To the extent required, the shares of common stock to be sold, the names of the selling stockholders, the respective purchase prices and public offering prices, the names of any agent, dealer or underwriter, and any applicable commissions or discounts with respect to a particular offer will be set forth in an accompanying prospectus supplement or, if appropriate, a post-effective amendment to the registration statement that includes this prospectus.
In order to comply with the securities laws of some states, if applicable, the common stock may be sold in these jurisdictions only through registered or licensed brokers or dealers. In addition, in some states the common stock may not be sold unless it has been registered or qualified for sale or an exemption from registration or qualification requirements is available and is complied with.
We have advised the selling stockholders that the anti-manipulation rules of Regulation M under the Exchange Act may apply to sales of shares in the market and to the activities of the selling stockholders and their affiliates. In addition, to the extent applicable, we will make copies of this prospectus (as it may be supplemented or amended from time to time) available to the selling stockholders for the purpose of satisfying the prospectus delivery requirements of the Securities Act. The selling stockholders may indemnify any broker-dealer that participates in transactions involving the sale of the shares against certain liabilities, including liabilities arising under the Securities Act.
We have agreed to indemnify the selling stockholders against liabilities, including liabilities under the Securities Act and state securities laws, relating to the registration of the shares of common stock offered by this prospectus.
We have agreed with the selling stockholders to use commercially reasonable efforts to cause the registration statement of which this prospectus constitutes a part to become effective and to remain continuously effective until the earlier of: (i) the date on which the selling stockholders shall have resold or otherwise disposed of all the shares covered by this prospectus, and (ii) the date on which the securities covered by this prospectus no longer constitute “Registrable Securities” as such term is defined in the Registration Rights Agreement, such that they may be resold by the selling stockholders without registration and without regard to any volume or manner-of-sale limitations and without current public information pursuant to Rule 144 under the Securities Act or any other rule of similar effect.
Exhibit B
Investor Questionnaire
Exhibit 99.1
Dogwood Announces $5 Million Private Placement with CK Life Sciences Int’l., (Holdings) Inc.
- Largest Shareholder Increases Position as Dogwood Advances Halneuron® Toward Topline Phase 2b Data Readout in November 2026 -
- Expected Proceeds from the Investment Enable Acceleration of Phase 3 Preparatory Activities -
ATLANTA, Ga., October 19, 2026 -- Dogwood Therapeutics, Inc. (Nasdaq: DWTX) (“Dogwood” or the “Company”), a company that focuses on developing first-in-class, new non-opioid medicines to treat pain and neuropathy, today announced that the Company has entered into a securities subscription agreement (the “Subscription Agreement”) for a $5 million investment from the Company’s largest shareholder, a subsidiary of CK Life Sciences Int’l., (Holdings) Inc. (“CKLS”). The investment comes as Dogwood continues to advance its ongoing Halneuron® Phase 2b Chemotherapy Induced Neuropathic Pain (“CINP”) trial toward topline data readout in November 2026. Proceeds from this investment will enable the advancement of Phase 3 preparatory activities and extend operational runway through March 2027.
Pursuant to the terms of the Subscription Agreement, Dogwood will issue an aggregate of 4,098,360 shares of Common Stock at a price of $1.22 per share. The private placement is being priced at-the-market under the rules of The Nasdaq Stock Market. No warrants or other derivative securities are included in the transaction. The private placement is expected to close on or prior to October 29, 2026. The Company currently expects to use the net proceeds from the private placement to fund Phase 3 preparatory activities for Halneuron® and for working capital and general corporate purposes.
“This investment by CK Life Sciences reflects their confidence in the potential of Halneuron® and our HAL-CINP Phase 2b program,” said Greg Duncan, Chief Executive Officer of Dogwood Therapeutics. “Upon closing, these proceeds are expected to extend our runway through March 2027, by which time we expect to finalize a pivotal Phase 3 program design for Halneuron® in CINP. We look forward to reporting topline data from the HAL-CINP trial in the coming weeks and value CK Life Sciences’ deepening commitment to Dogwood and Halneuron®.”
Halneuron® CINP Phase 2b Trial (“HAL-CINP”) Overview (NCT06848348)
HAL-CINP is a randomized, phase 2b clinical trial evaluating the efficacy and safety of Halneuron® compared with placebo in 239 patients with moderate to severe neuropathic pain caused by prior platinum and/or taxane-based chemotherapy. Participants received 8 subcutaneous doses of Halneuron® or placebo over a 14-day period and are followed for a total of 28 days for safety and efficacy. The primary endpoint for this study is the change from baseline to week four in the
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weekly average of daily 24-hour recall pain intensity scores. The study is being conducted at approximately 25 sites in the U.S. Secondary measures will assess Halneuron’s® treatment effects on sleep, fatigue, neuropathy symptoms and overall patient health.
The shares of Common Stock described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder, and have not been registered under the Securities Act or applicable state securities laws. Accordingly, the shares may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (the “SEC”) or an applicable exemption from such registration requirements.
This press release shall not constitute an offer to sell or the 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 registration or qualification under the securities laws of any such state or other jurisdiction.
About CKLS
CKLS is listed on The Stock Exchange of Hong Kong Limited (Stock Code: 0775). Bearing the mission of improving the quality of life, CKLS is engaged in the business of research and development, manufacturing, commercialization, marketing, sale of, and investment in products and assets which fall into three core categories – nutraceuticals, pharmaceuticals & diagnostics, and agriculture-related. CKLS is a member of the CK Hutchison Group.
About Dogwood Therapeutics
Dogwood Therapeutics (Nasdaq: DWTX) is a development-stage biopharmaceutical company focused on developing first-in-class, non-opioid medicines to treat pain and neuropathic disorders. The Dogwood research pipeline includes two first-in-class development candidates, Halneuron® and SP16 IV.
Our lead product candidate, Halneuron®, is in Phase 2b development to treat pain conditions including the neuropathic pain associated with chemotherapy treatment. Halneuron® has been granted fast track designation from the FDA for the treatment of chemotherapy-induced neuropathic pain (“CINP”). Halneuron® is a non-opioid, NaV 1.7 analgesic which is a highly specific voltage-gated sodium channel modulator, a mechanism known to be effective for reducing pain transmission. In clinical studies, Halneuron® treatment has demonstrated pain reduction in pain related to general cancer and in pain related to chronic CINP. SP16 IV is a low-density lipoprotein receptor-related protein-1 agonist (“LRP1”) with potential to treat neuropathy and prevent or repair nerve damage following chemotherapy. SP16’s activity as an LRP1 agonist in turn provides alpha-1-antitrypsin-like activity. Consistent with alpha-1-antitrypsin anti-inflammatory and
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immunomodulatory actions, SP16 preclinically demonstrated anti-inflammatory (analgesic) action via potential reductions in IL-6, IL-8, IL1B and TNF-alpha levels, as well as potential to repair damaged tissue via increases in pAKT and pERK that regulate fundamental processes like growth, proliferation and survival. The forthcoming SP16 IV Phase 1b CIPN trial is fully funded by the National Cancer Institute.
For more information, please visit www.dwtx.com.
Forward-Looking Statements:
Statements in this press release contain “forward-looking statements,” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “suggest,” “target,” “aim,” “should,” "will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Dogwood’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including risks related to the satisfaction of customary closing conditions related to the private placement and the Company’s ability to complete the private placement on the anticipated timeline or at all; the anticipated use of proceeds from the private placement; the completion, timing, enrollment, design and results of current and future clinical studies relating to Dogwood’s product candidates; whether interim or final clinical data will support continued development, regulatory submissions or approval; and Dogwood’s ability to finance its operations. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the most recently filed Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Dogwood undertakes no duty to update such information except as required under applicable law.
Investor Relations:
Dan Ferry
Managing Director
LifeSci Advisors, LLC
daniel@lifesciadvisors.com
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