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HCW Biologics requests FDA meeting for T-cell engager HCW11-018b

Thu, 23 Jul 2026 08:04:39 -0400

HCW Biologics Inc. (NASDAQ: HCWB) has requested a Type B pre-IND meeting with the U.S. Food and Drug Administration to discuss the development and regulatory strategy for its investigational drug candidate HCW11-018b, a tetravalent T-cell engager targeting solid tumors.

The Miramar, Florida-based company said it is on track to initiate clinical trials in the first half of 2027. HCW11-018b is administered by subcutaneous injection and is designed to target tissue factor-expressing cancer cells, including those associated with gynecologic and pancreatic cancers.

In preclinical studies, the compound showed the ability to activate CD3-positive effector T cells while reducing immunosuppression in the tumor microenvironment.

HCW Biologics requests FDA meeting for T-cell engager HCW11-018b

Thu, 23 Jul 2026 08:04:39 -0400

In preclinical studies, the compound showed the ability to activate CD3-positive effector T cells while reducing immunosuppression in the tumor microenvironment.

HCW Biologics Reaches Milestones for Its Proprietary Tetravalent Second-Generation T-Cell Engager Program On Track To Initiate Clinical Trials in First Half 2027

Thu, 23 Jul 2026 08:00:00 -0400

Company requested Type B pre-IND meeting with U.S. FDA to discuss development and regulatory strategy for its investigational tetravalent T-cell engager, HCW11-018b

HCW11-018b has demonstrated potential for treating solid tumors that overexpress human tissue factor, including gynecologic and pancreatic cancers

Company has developed a streamlined, robust manufacturing process designed to produce high-quality cGMP material at a lower cost than current methods

MIRAMAR, Fla., July 23, 2026 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”), (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical company developing transformative fusion immunotherapeutics to treat diseases

HCW Biologics Reaches Milestones for Its Proprietary Tetravalent Second-Generation T-Cell Engager Program On Track To Initiate Clinical Trials in First Half 2027

Thu, 23 Jul 2026 08:00:00 -0400

Company requested Type B pre-IND meeting with U.S. FDA to discuss development and regulatory strategy for its investigational tetravalent T-cell engager, HCW11-018b

HCW11-018b has demonstrated potential for treating solid tumors that overexpress human tissue factor, including gynecologic and pancreatic cancers

Company has developed a streamlined, robust manufacturing process designed to produce high-quality cGMP material at a lower cost than current methods

HCW Biologics Reaches Milestones for Its Proprietary Tetravalent Second-Generation T-Cell Engager Program On Track To Initiate Clinical Trials in First Half 2027

Thu, 23 Jul 2026 08:00:00 -0400

Company requested Type B pre-IND meeting with U.S. FDA to discuss development and regulatory strategy for its investigational tetravalent T-cell engager, HCW11-018b

HCW11-018b has demonstrated potential for treating solid tumors that overexpress human tissue factor, including gynecologic and pancreatic cancers

Company has developed a streamlined, robust manufacturing process designed to produce high-quality cGMP material at a lower cost than current methods

HCW Biologics Reaches Milestones for Its Proprietary Tetravalent Second-Generation T-Cell Engager Program On Track To Initiate Clinical Trials in First Half 2027

Thu, 23 Jul 2026 08:00:00 -0400

Company requested Type B pre-IND meeting with U.S. FDA to discuss development and regulatory strategy for its investigational tetravalent T-cell engager, HCW11-018b

HCW11-018b has demonstrated potential for treating solid tumors that overexpress human tissue factor, including gynecologic and pancreatic cancers

Company has developed a streamlined, robust manufacturing process designed to produce high-quality cGMP material at a lower cost than current methods

Form POS AM HCW Biologics Inc.

Thu, 16 Jul 2026 06:13:00 -0400

si-local-file:///var/storage/secattach/20260716/26776115.html

Form POS AM HCW Biologics Inc.

Thu, 16 Jul 2026 06:13:00 -0400

si-local-file:///var/storage/secattach/20260716/26776115.html

Form 8-K HCW Biologics Inc. For: Jul 01

Wed, 01 Jul 2026 08:30:00 -0400

si-local-file:///var/storage/secattach/20260701/26717422.html

Form 8-K HCW Biologics Inc. For: Jul 01

Wed, 01 Jul 2026 08:30:00 -0400

si-local-file:///var/storage/secattach/20260701/26717422.html

Form 8-K HCW Biologics Inc. For: Jun 29

Tue, 30 Jun 2026 08:30:00 -0400

si-local-file:///var/storage/secattach/20260630/26710211.html

Form 8-K HCW Biologics Inc. For: Jun 29

Tue, 30 Jun 2026 08:30:00 -0400

si-local-file:///var/storage/secattach/20260630/26710211.html

HCW Biologics regains Nasdaq bid price compliance, plans reverse split

Tue, 30 Jun 2026 08:26:44 -0400

HCW Biologics Inc. (Nasdaq: HCWB) announced that the Nasdaq Hearings Panel found the company regained compliance with Nasdaq Listing Rule 5550(a)(2), known as the Bid Price Rule, on June 29, 2026.

The panel's determination follows a decision letter dated May 29, 2026. The company is now subject to a mandatory monitoring period through June 17, 2027.

To maintain long-term compliance with the Bid Price Rule, the Miramar, Fla.-based clinical-stage biopharmaceutical company said it will execute a one-for-six reverse stock split on June 30, 2026.

The company stated it is now compliant with all continued listing rules for Nasdaq.

HCW Biologics regains Nasdaq bid price compliance, plans reverse split

Tue, 30 Jun 2026 08:26:44 -0400

HCW Biologics Inc. (Nasdaq: HCWB) announced that the Nasdaq Hearings Panel found the company regained compliance with Nasdaq Listing Rule 5550(a)(2), known as the Bid Price Rule, on June 29, 2026.

The panel's determination follows a decision letter dated May 29, 2026. The company is now subject to a mandatory monitoring period through June 17, 2027.

To maintain long-term compliance with the Bid Price Rule, the Miramar, Fla.-based clinical-stage biopharmaceutical company said it will execute a one-for-six reverse stock split on June 30, 2026.

The company stated it is now compliant with all continued listing rules for Nasdaq.

HCW Biologics Regained Compliance with Bid Price Rule Per Nasdaq Compliance Letter

Tue, 30 Jun 2026 08:25:00 -0400

Company now compliant with all continued listing rules for Nasdaq

MIRAMAR, Fla., June 30, 2026 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (Nasdaq: HCWB), a U.S.-based clinical-stage biopharmaceutical company developing transformative fusion immunotherapeutics to support or treat diseases promoted by chronic inflammation, focusing on autoimmune disorders and other inflammatory diseases, cancer and senescence-associated dysplasia, today reported that, on June 29, 2026, the Nasdaq Hearings Panel (the “Panel”) of The Nasdaq Stock Market LLC (“Nasdaq” or the “Exchange”) found that the Company regained compliance with Listing Rule 5550(a)(2), the “Bid Price Rule,” per the terms

HCW Biologics Regained Compliance with Bid Price Rule Per Nasdaq Compliance Letter

Tue, 30 Jun 2026 08:25:00 -0400

Company now compliant with all continued listing rules for Nasdaq

HCW Biologics Regained Compliance with Bid Price Rule Per Nasdaq Compliance Letter

Tue, 30 Jun 2026 08:25:00 -0400

Company now compliant with all continued listing rules for Nasdaq

HCW Biologics Regained Compliance with Bid Price Rule Per Nasdaq Compliance Letter

Tue, 30 Jun 2026 08:25:00 -0400

Company now compliant with all continued listing rules for Nasdaq

Form 8-K HCW Biologics Inc. For: Jun 24

Fri, 26 Jun 2026 09:00:00 -0400

si-local-file:///var/storage/secattach/20260626/26695536.html

Form 8-K HCW Biologics Inc. For: Jun 24

Fri, 26 Jun 2026 09:00:00 -0400

si-local-file:///var/storage/secattach/20260626/26695536.html

HCW Biologics sets 1-for-6 reverse stock split for June 30

Fri, 26 Jun 2026 08:55:16 -0400

HCW Biologics Inc. (NASDAQ: HCWB) announced that its board of directors has approved a 1-for-6 reverse stock split of its common stock, effective at 12:01 a.m. Eastern Time on June 30, 2026. The shares will trade on the Nasdaq Capital Market on a split-adjusted basis under the existing ticker symbol "HCWB" beginning that same day.

The reverse stock split will reduce shares of common stock issued and outstanding from 9,581,079 to approximately 1,596,849. The total authorized share count will remain at 250,000,000, and the par value will remain at $0.0001 per share. The new CUSIP number following the split will be

HCW Biologics Announces 1-for-6 Reverse Stock Split Effective on June 30, 2026

Fri, 26 Jun 2026 08:55:00 -0400

Company completed 28 consecutive trading days above $1.00 per share on June 25, 2026

Reverse stock split effectuated to ensure ongoing compliance with the Bid Price Rule and additional requirements from Nasdaq Hearings Panel

MIRAMAR, Fla., June 26, 2026 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical company developing transformative fusion immunotherapeutics to support or treat diseases promoted by chronic inflammation, focusing on autoimmune disorders and other inflammatory diseases, cancer and senescence-associated dysplasia, today announced that its Board of Directors has approved a

HCW Biologics Announces 1-for-6 Reverse Stock Split Effective on June 30, 2026

Fri, 26 Jun 2026 08:55:00 -0400

Company completed 28 consecutive trading days above $1.00 per share on June 25, 2026

Reverse stock split effectuated to ensure ongoing compliance with the Bid Price Rule and additional requirements from Nasdaq Hearings Panel

HCW Biologics Announces 1-for-6 Reverse Stock Split Effective on June 30, 2026

Fri, 26 Jun 2026 08:55:00 -0400

Company completed 28 consecutive trading days above $1.00 per share on June 25, 2026

Reverse stock split effectuated to ensure ongoing compliance with the Bid Price Rule and additional requirements from Nasdaq Hearings Panel

HCW Biologics Announces 1-for-6 Reverse Stock Split Effective on June 30, 2026

Fri, 26 Jun 2026 08:55:00 -0400

Company completed 28 consecutive trading days above $1.00 per share on June 25, 2026

Reverse stock split effectuated to ensure ongoing compliance with the Bid Price Rule and additional requirements from Nasdaq Hearings Panel