Month: September 2026

GARDENA, Calif., Sept. 24, 2026 (GLOBE NEWSWIRE) — Polar Power, Inc. (NASDAQ: POLA) today announced that Arthur D. Sams, the Company’s Founder, President and Chief Executive Officer, has agreed to convert $614,700 of debt owed to him by the Company into 683 Series A Convertible Preferred shares of Polar Power.

The conversion eliminates $614,700 of debt from the Company’s balance sheet, increases shareholders’ equity, and represents an important step toward addressing the Company’s shareholders’ equity compliance issue.

“Converting this debt into equity reflects my confidence in Polar Power’s future and my commitment to the Company’s long-term success,” said Arthur Sams, Founder, President and Chief Executive Officer. “I believe the opportunities ahead of us across telecommunications, data center power, defense and distributed energy markets position Polar Power for meaningful growth.”

In addition to the preferred shares, Polar is also issuing to Mr. Sams a warrant to purchase 382,276 shares of the Company’s common stock at $1.34 per share.

The Company believes the debt-to-equity conversion strengthens its capital structure and supports its efforts to regain and maintain compliance with applicable Nasdaq continued listing requirements. This debt-to-equity conversion was approved by Polar’s Audit Committee, consisting entirely of independent board members.

About Polar Power, Inc.

Polar Power, Inc. (NASDAQ: POLA) designs, manufactures and sells direct-current power generators, renewable energy systems and other power solutions for applications including telecommunications, drone defense, robotics, EV charging, micro-grids military and commercial markets. The Company is headquartered in Gardena, California.

For more information, please visit www.polarpower.com. or follow Polar Power on www.linkedin.com/company/polar-power-inc/.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of applicable federal securities laws. These statements include, among others, statements regarding the Company’s expectation for future growth opportunities and its efforts to regain and maintain compliance with Nasdaq’s continued listing requirements. Forward-looking statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied. These risks and uncertainties include those described in Polar Power’s filings with the U.S. Securities and Exchange Commission. Polar Power undertakes no obligation to update any forward-looking statement except as required by law.

Media and Investor Relations
Polar Power, Inc.
249 E. Gardena Blvd.
Gardena, CA 90248
Tel: 310-830-9153
Email: ir@polarpowerinc.com
www.polarpower.com

8.3

PUBLIC OPENING POSITION DISCLOSURE/DEALING DISCLOSURE BY
A PERSON WITH INTERESTS IN RELEVANT SECURITIES REPRESENTING 1% OR MORE
Rule 8.3 of the Takeover Code (the “Code”)

1.        KEY INFORMATION

(a)   Full name of discloser:	Rathbones Group Plc
(b)   Owner or controller of interests and short positions disclosed, if different from 1(a):         The naming of nominee or vehicle companies is insufficient. For a trust, the trustee(s), settlor and beneficiaries must be named.
(c)   Name of offeror/offeree in relation to whose relevant securities this form relates:         Use a separate form for each offeror/offeree	NextEnergy Solar Fund Ltd
(d)   If an exempt fund manager connected with an offeror/offeree, state this and specify identity of offeror/offeree:
(e)   Date position held/dealing undertaken:         For an opening position disclosure, state the latest practicable date prior to the disclosure	23/09/2026
(f)   In addition to the company in 1(c) above, is the discloser making disclosures in respect of any other party to the offer?         If it is a cash offer or possible cash offer, state “N/A”	No

2.        POSITIONS OF THE PERSON MAKING THE DISCLOSURE

If there are positions or rights to subscribe to disclose in more than one class of relevant securities of the offeror or offeree named in 1(c), copy table 2(a) or (b) (as appropriate) for each additional class of relevant security.

(a)      Interests and short positions in the relevant securities of the offeror or offeree to which the disclosure relates following the dealing (if any)

Class of relevant security:	Ordinary NPV
	Interests		Short positions
	Number	%	Number	%
(1)   Relevant securities owned and/or controlled:	5,793,661	1.00%
(2)   Cash-settled derivatives:
(3)   Stock-settled derivatives (including options) and agreements to purchase/sell:
TOTAL:	5,793,661	1.00%

All interests and all short positions should be disclosed.

Details of any open stock-settled derivative positions (including traded options), or agreements to purchase or sell relevant securities, should be given on a Supplemental Form 8 (Open Positions).

(b)      Rights to subscribe for new securities (including directors’ and other employee options)

Class of relevant security in relation to which subscription right exists:
Details, including nature of the rights concerned and relevant percentages:

3.        DEALINGS (IF ANY) BY THE PERSON MAKING THE DISCLOSURE

Where there have been dealings in more than one class of relevant securities of the offeror or offeree named in 1(c), copy table 3(a), (b), (c) or (d) (as appropriate) for each additional class of relevant security dealt in.

The currency of all prices and other monetary amounts should be stated.

(a)        Purchases and sales

Class of relevant security	Purchase/sale	Number of securities	Price per unit
Ordinary NPV	Sale	18,348	49.3p

(b)        Cash-settled derivative transactions

Class of relevant security	Product description e.g. CFD	Nature of dealing e.g. opening/closing a long/short position, increasing/reducing a long/short position	Number of reference securities	Price per unit

(c)        Stock-settled derivative transactions (including options)

(i)        Writing, selling, purchasing or varying

Class of relevant security	Product description e.g. call option	Writing, purchasing, selling, varying etc.	Number of securities to which option relates	Exercise price per unit	Type e.g. American, European etc.	Expiry date	Option money paid/ received per unit

(ii)        Exercise

Class of relevant security	Product description e.g. call option	Exercising/ exercised against	Number of securities	Exercise price per unit

(d)        Other dealings (including subscribing for new securities)

Class of relevant security	Nature of dealing e.g. subscription, conversion	Details	Price per unit (if applicable)
Ordinary NPV

4.        OTHER INFORMATION

(a)        Indemnity and other dealing arrangements

Details of any indemnity or option arrangement, or any agreement or understanding, formal or informal, relating to relevant securities which may be an inducement to deal or refrain from dealing entered into by the person making the disclosure and any party to the offer or any person acting in concert with a party to the offer: Irrevocable commitments and letters of intent should not be included. If there are no such agreements, arrangements or understandings, state “none”

None

(b)        Agreements, arrangements or understandings relating to options or derivatives

Details of any agreement, arrangement or understanding, formal or informal, between the person making the disclosure and any other person relating to: (i)   the voting rights of any relevant securities under any option; or (ii)   the voting rights or future acquisition or disposal of any relevant securities to which any derivative is referenced: If there are no such agreements, arrangements or understandings, state “none”

None

(c)        Attachments

Is a Supplemental Form 8 (Open Positions) attached?

No

Date of disclosure:	24/09/2026
Contact name:	Lydia Cotterill – Compliance Department
Telephone number:	0151 237 1176

Public disclosures under Rule 8 of the Code must be made to a Regulatory Information Service.

The Panel’s Market Surveillance Unit is available for consultation in relation to the Code’s disclosure requirements on +44 (0)20 7638 0129.

The Code can be viewed on the Panel’s website at.

MIRAMAR, Fla., Sept. 24, 2026 (GLOBE NEWSWIRE) — HCW Biologics Inc. (the “Company” or “HCW Biologics”), (NASDAQ: HCWB), a clinical-stage biopharmaceutical company developing transformative fusion immunotherapeutics to treat autoimmune diseases, cancer and senescence-associated dysplasia, today announced the pricing of its $1.5 million private placement (the “Offering”) with an existing stockholder of the Company, (the “Investor”). Pursuant to a securities purchase agreement entered into on September 23, 2026 with the Investor (the “Purchase Agreement”), the Company agreed to issue and sell an aggregate of 903,614 units (the “Units”), with each Unit consisting of (i) one pre-funded warrant (a “Pre-Funded Warrant”) to purchase one share of the Company’s common stock, par value $0.0001 per share, (“Common Stock”) and (ii) the right to receive one common stock purchase warrant (a “Common Warrant”) to purchase one share of Common Stock, and subject to, stockholder approval of the issuance thereof.

In connection with the Offering, the Company will issue 903,614 Pre-Funded Warrants. Subject to stockholder approval, which the Company is obligated to seek pursuant to the terms of the Purchase Agreement, the Investor will also be entitled to receive Common Warrants to purchase up to an aggregate of 903,614 shares of Common Stock.

Maxim Group LLC is acting as the sole placement agent for the Offering.

The combined purchase price for each Unit consisting of a Pre-Funded Warrant and the right to receive one Common Warrant upon, and subject to, stockholder approval of the issuance thereof, was $1.6599 per Unit. The Pre-Funded Warrants have an exercise price of $0.0001 per share of Common Stock, are exercisable immediately and will not expire until exercised in full. The Common Warrants will have an exercise price of $1.66 per share and will expire on the five and one half (5.5) year anniversary of their issuance. Under Nasdaq Listing Rule 5635(d), the Company is required to obtain stockholder approval before issuing the Common Warrants because the potential issuance of shares upon exercise of the Common Warrants could exceed the thresholds set forth in such rule. Following receipt of stockholder approval, the Company will issue the Common Warrants to the Investor in accordance with the Purchase Agreement.

The Company intends to use the net proceeds from this Offering to continue clinical trials for HCW9302, advance its IND-enabling studies for its T-Cell Engager, HCW11-018b, and its second-generation immune checkpoint inhibitor, HCW11-040, and for general corporate purposes.

On September 23, 2026, the Company also entered into a registration rights agreement with the Investors, pursuant to which the Company agreed to submit to the U.S. Securities and Exchange Commission (the “SEC”) a registration statement on Form S-1 within 15 trading days of the closing of the Offering covering the resale of the shares of Common Stock issuable upon exercise of the Pre-Funded Warrants and the shares of Common Stock issuable upon exercise of the Common Warrants. The Company also agreed to use commercially reasonable efforts to cause the registration statement to be declared effective by the SEC within 60 days following the closing of the Offering.

The number of shares of Common Stock the Company that may be held by the Investor, including those shares issued at closing and upon the exercise of Pre-Funded Warrants from time to time in the Offering, may not exceed 9.99% of the number of shares of the Company’s Common Stock outstanding immediately after giving effect to such issuances.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, 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 HCW Biologics:

HCW Biologics Inc. (the “Company”) (NASDAQ: HCWB) is a clinical-stage biopharmaceutical company developing transformative fusion immunotherapeutics to treat diseases promoted by chronic inflammation, including autoimmune diseases, cancer, and senescence-associated dysplasia. The Company’s immunotherapeutics represent a new class of drugs that it believes have the potential to fundamentally change the treatment of proinflammatory and senescence-associated diseases and conditions that are promoted by chronic inflammation —and in doing so, improve patients’ quality of life and possibly extend longevity. A key aspect of the Company’s clinical development and financing strategy is to focus on its business development programs. See the Company Pipeline at https://hcwbiologics.com/pipeline/

Forward Looking Statements:

Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “expect,” “believe,” “will,” “may,” “should,” “estimate,” “project,” “outlook,” “forecast” or other similar words and include, without limitation, statements regarding the completion of the Offering and the satisfaction of customary closing conditions; the anticipated use of proceeds from the Offering; the Company’s ability to obtain stockholder approval for the issuance of the Common Warrants; the anticipated issuance of the Common Warrants following receipt of stockholder approval; the anticipated filing and effectiveness of registration statements covering the shares of Common Stock issued in the Offering; and the prospective efficacy and success of the Company’s immunotherapeutic candidates and development programs. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties that are described in the section titled “Risk Factors” in the annual report on Form 10-K filed with the SEC on March 31, 2026, and in other filings filed from time to time with the SEC.

Company Contact:

Rebecca Byam
Chief Financial Officer
rebeccabyam@hcwbiologics.com

This press release was published by a CLEAR® Verified individual.

8.3

PUBLIC OPENING POSITION DISCLOSURE/DEALING DISCLOSURE BY
A PERSON WITH INTERESTS IN RELEVANT SECURITIES REPRESENTING 1% OR MORE
Rule 8.3 of the Takeover Code (the “Code”)

1.        KEY INFORMATION

(a)   Full name of discloser:	Rathbones Group Plc
(b)   Owner or controller of interests and short positions disclosed, if different from 1(a):         The naming of nominee or vehicle companies is insufficient. For a trust, the trustee(s), settlor and beneficiaries must be named.
(c)   Name of offeror/offeree in relation to whose relevant securities this form relates:         Use a separate form for each offeror/offeree	Eleco Plc
(d)   If an exempt fund manager connected with an offeror/offeree, state this and specify identity of offeror/offeree:
(e)   Date position held/dealing undertaken:         For an opening position disclosure, state the latest practicable date prior to the disclosure	23/09/2026
(f)   In addition to the company in 1(c) above, is the discloser making disclosures in respect of any other party to the offer?         If it is a cash offer or possible cash offer, state “N/A”	No

2.        POSITIONS OF THE PERSON MAKING THE DISCLOSURE

If there are positions or rights to subscribe to disclose in more than one class of relevant securities of the offeror or offeree named in 1(c), copy table 2(a) or (b) (as appropriate) for each additional class of relevant security.

(a)      Interests and short positions in the relevant securities of the offeror or offeree to which the disclosure relates following the dealing (if any)

Class of relevant security:	1p Ordinary Shares
	Interests		Short positions
	Number	%	Number	%
(1)   Relevant securities owned and/or controlled:	1,155,310	1.36%
(2)   Cash-settled derivatives:
(3)   Stock-settled derivatives (including options) and agreements to purchase/sell:
TOTAL:	1,155,310	1.36%

All interests and all short positions should be disclosed.

Details of any open stock-settled derivative positions (including traded options), or agreements to purchase or sell relevant securities, should be given on a Supplemental Form 8 (Open Positions).

(b)      Rights to subscribe for new securities (including directors’ and other employee options)

Class of relevant security in relation to which subscription right exists:
Details, including nature of the rights concerned and relevant percentages:

3.        DEALINGS (IF ANY) BY THE PERSON MAKING THE DISCLOSURE

Where there have been dealings in more than one class of relevant securities of the offeror or offeree named in 1(c), copy table 3(a), (b), (c) or (d) (as appropriate) for each additional class of relevant security dealt in.

The currency of all prices and other monetary amounts should be stated.

(a)        Purchases and sales

Class of relevant security	Purchase/sale	Number of securities	Price per unit
1p Ordinary Shares	Sale	2,100	229.512p

(b)        Cash-settled derivative transactions

Class of relevant security	Product description e.g. CFD	Nature of dealing e.g. opening/closing a long/short position, increasing/reducing a long/short position	Number of reference securities	Price per unit

(c)        Stock-settled derivative transactions (including options)

(i)        Writing, selling, purchasing or varying

Class of relevant security	Product description e.g. call option	Writing, purchasing, selling, varying etc.	Number of securities to which option relates	Exercise price per unit	Type e.g. American, European etc.	Expiry date	Option money paid/ received per unit

(ii)        Exercise

Class of relevant security	Product description e.g. call option	Exercising/ exercised against	Number of securities	Exercise price per unit

(d)        Other dealings (including subscribing for new securities)

Class of relevant security	Nature of dealing e.g. subscription, conversion	Details	Price per unit (if applicable)
1p Ordinary Shares

4.        OTHER INFORMATION

(a)        Indemnity and other dealing arrangements

Details of any indemnity or option arrangement, or any agreement or understanding, formal or informal, relating to relevant securities which may be an inducement to deal or refrain from dealing entered into by the person making the disclosure and any party to the offer or any person acting in concert with a party to the offer: Irrevocable commitments and letters of intent should not be included. If there are no such agreements, arrangements or understandings, state “none”

None

(b)        Agreements, arrangements or understandings relating to options or derivatives

Details of any agreement, arrangement or understanding, formal or informal, between the person making the disclosure and any other person relating to: (i)   the voting rights of any relevant securities under any option; or (ii)   the voting rights or future acquisition or disposal of any relevant securities to which any derivative is referenced: If there are no such agreements, arrangements or understandings, state “none”

None

(c)        Attachments

Is a Supplemental Form 8 (Open Positions) attached?

No

Date of disclosure:	24/09/2026
Contact name:	Lydia Cotterill – Compliance Department
Telephone number:	0151 237 1176

Public disclosures under Rule 8 of the Code must be made to a Regulatory Information Service.

The Panel’s Market Surveillance Unit is available for consultation in relation to the Code’s disclosure requirements on +44 (0)20 7638 0129.

The Code can be viewed on the Panel’s website at.

Prestigious honor recognizes Dr. Humes’ pioneering work in developing the Selective Cytopheretic Device (SCD) therapy, commercialized by SeaStar Medical as QUELIMMUNE^® for critically ill pediatric patients with acute kidney injury (AKI)

SeaStar Medical’s SCD development pipeline of indications holds promise for multiple additional indications

DENVER, Sept. 24, 2026 (GLOBE NEWSWIRE) — SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transformational treatments for critically ill patients facing organ failure and potential loss of life announced today that H. David Humes, M.D., is being awarded this year’s Distinguished University Innovator of the Year award at Celebrate Invention, an annual event hosted by Innovation Partnerships at the University of Michigan (U-M). The award is the highest honor for U-M faculty members who have developed transformative ideas, processes, or technologies and helps them to reach the market for broad societal impact.  

Dr. Humes discovered and developed the Selective Cytopheretic Device (SCD), a disease-modifying therapeutic device that neutralizes over-active immune cells and stops the cytokine storm that yields destructive hyperinflammation and creates a cascade of events that can rapidly lead to organ failure and death. The SCD therapy was successfully developed by SeaStar Medical in clinical trials of pediatric patients with severe AKI, resulting in the first and only FDA-approved therapy specifically for children with AKI and sepsis or a sepsis like condition. The Company subsequently launched QUELIMMUNE (SCD-PED) into the pediatric critical care community. QUELIMMUNE has demonstrated a 50% reduction in patient mortality at 60 days, compared to the standard of care, in clinical trials and published preliminary outcomes analyses to date. The Company is also conducting the pivotal NEUTRALIZE-AKI clinical trial of the SCD therapy in adult patients with life-threatening AKI receiving continuous renal replacement therapy.

“We extend our warmest congratulations to Dr. Humes on this well-deserved recognition from the University of Michigan,” said Eric Schlorff, Chief Executive Officer of SeaStar Medical. “His visionary science transformed how the medical community views immune system dysregulation in critical illness. By targeting activated white blood cells to stop the hyperinflammatory cascade, his life’s work paved the way for our QUELIMMUNE therapy, giving clinicians an invaluable tool to save the lives of critically ill children. We are proud to build upon his legacy as we advance the SCD therapy beyond the pediatric indication, with clinical development underway for a second indication in adult patients with AKI on continuous renal replacement therapy.”

“It is an immense honor to receive this award from the University of Michigan,” said Dr. Humes. “Translating benchtop discovery into a commercial therapy that reaches patients at the bedside requires a dedicated team of researchers, clinical trialists, and commercial partners. Seeing the SCD therapy make a tangible difference in the pediatric ICU has been the most rewarding chapter of my career.”

Dr. Humes will be formally presented with the award during the University of Michigan’s annual Celebrate Invention event on September 24, 2026, in Ann Arbor, Michigan. In addition to the award, Celebrate Invention will offer attendees a presentation entitled “From Bench to Bedside: A Sepsis Breakthrough Two Decades in the Making” and an accompanying panel discussion. Both Dr. Humes and Mr. Schlorff will be panel speakers along with Dr. Lenar Yessayan, Clinical Professor of Internal Medicine, Director MPLAN – Inpatient Hemodialysis and Director of the MDS Dialysis Unit, Michigan Medicine, and Kelly Sexton, Associate Vice President for Research – Innovation Partnerships and Economic Impact.

About QUELIMMUNE

The QUELIMMUNE^® (SCD-PED) therapy is being commercialized for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are on antibiotics and being treated in the ICU with RRT. It was approved in February 2024 under a Humanitarian Device Exemption application.

Data from two clinical trials of the QUELIMMUNE therapy, published in Kidney Medicine, showed a 77% survival rate in patient treated with QUELIMMUNE versus standard of care, representing an approximate 50% reduction in loss of life compared to historical data in this patient population. No dialysis was required for survivors, and 87.5% of survivors had normal kidney function at Day 60 after ICU discharge. In February 2026, data published in the prestigious, peer-reviewed journal, Pediatric Nephrology, highlighted the early experience from the QUELIMMUNE SAVE Registry, a post-approval surveillance registry, evaluating the role of the QUELIMMUNE therapy in the treatment of critically ill pediatric patients with life-threatening Acute Kidney Injury (AKI) and sepsis requiring renal replacement therapy. Observations from the first 21 pediatric patients with AKI and sepsis requiring renal replacement therapy showed no device-related adverse events or infections and no reports of immunosuppressive effects by the device. In addition, preliminary outcomes analyses show a 76% survival rate at Day 28 and Day 60, and a 71% survival rate at Day 90. These new data are on track to validate a 50% reduction in patient mortality at 60 days compared to historical data, similar to what was observed in the registration study reported in Kidney Medicine.

The patented technology behind QUELIMMUNE is known as the Selective Cytopheretic Device (SCD) therapy and has broad applications for treating the destructive hyperinflammation that shuts down organ function and causes loss of life.

About the SeaStar Medical Selective Cytopheretic Device (SCD) Therapy

The SCD therapy is designed as a disease-modifying device that neutralizes over-active immune cells and stops the cytokine storm that yields destructive hyperinflammation and creates a cascade of events that wreak havoc in the patient’s body. The SCD therapy is designed for broad applications in multiple acute and chronic kidney and cardiovascular diseases, representing patients who today have no FDA-approved options for treating their disease. Unlike pathogen removal and other blood-purification tools, the SCD therapy is integrated with an existing continuous RRT hemofiltration system to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. This unique immunomodulation approach may promote long-term organ recovery, eliminate the need for future continuous RRT, including dialysis, and prevent loss of life.  

About NEUTRALIZE-AKI Pivotal Trial

The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a randomIZEd clinical trial in Acute Kidney Injury) pivotal trial is evaluating the safety and efficacy of the SCD therapy in 339 adults with AKI in the ICU receiving continuous RRT. The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with the SCD therapy in addition to continuous RRT as the standard of care, compared with the control group receiving only continuous RRT standard of care. Secondary endpoints include mortality at 28 days, ICU-free days in the first 28 days, major adverse kidney events at Day 90 and dialysis dependency at one year. The study will also include subgroup analyses to explore the effectiveness of the SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome. 

About Acute Kidney Injury (AKI) and Hyperinflammation 

AKI is characterized by a sudden and temporary loss of kidney function and can be caused by a variety of conditions such as severe infections or other septic conditions, severe trauma, surgery, and organ failures. AKI can cause destructive hyperinflammation, which is the overproduction or overactivity of inflammatory effector cells and other molecules that can be toxic. Damage resulting from this destructive hyperinflammation in AKI can progress to other organs, such as the heart or liver, and potentially to multi-organ dysfunction or even failure that could result in worse outcomes, including increased risk of death. Even after resolution, these patients may face complications including chronic kidney disease or end-stage renal disease (ESRD) requiring dialysis. Extreme hyperinflammation may also contribute to added healthcare costs, such as prolonged ICU stays and increased reliance on dialysis and mechanical ventilation.

About SeaStar Medical

SeaStar Medical is a commercial-stage healthcare company focused on transformational treatments for critically ill patients facing organ failure and potential loss of life. SeaStar Medical’s first commercial product, QUELIMMUNE (SCD-PED), was approved in 2024 by the U.S. Food and Drug Administration (FDA). It is the only FDA approved product for the ultra-rare condition of life-threatening Acute Kidney Injury (AKI) due to sepsis or a septic condition requiring renal replacement therapy (RRT) in critically ill pediatric patients. SeaStar Medical’s Selective Cytopheretic Device (SCD) therapy has been awarded Breakthrough Device Designation for six therapeutic indications by the FDA, enabling the potential for a speedier pathway to approval and preferable reimbursement dynamics at commercial launch.

For more information visit www.seastarmedical.com or visit us on LinkedIn or X.

Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1955. These forward-looking statements include, without limitation, SeaStar Medical’s expectations with respect to commercial acceptance of QUELIMMUNE; the ability of SCD to treat patients with AKI and other diseases; the expected regulatory approval process and timeline for commercialization; and the ability of SeaStar Medical to meet the expected timeline. Words such as “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside SeaStar Medical’s control and are difficult to predict. Factors that may cause actual future events to differ materially from the expected results include, but are not limited to: (i) the risk that SeaStar Medical may not be able to obtain regulatory approval of its SCD product candidates; (ii) the risk that SeaStar Medical may not be able to raise sufficient capital to fund its operations, including current or future clinical trials; (iii) the risk that SeaStar Medical and its current and future collaborators are unable to successfully develop and commercialize its products or services, or experience significant delays in doing so, including failure to achieve approval of its products by applicable federal and state regulators, (iv) the risk that SeaStar Medical may never achieve or sustain profitability; (v) the risk that SeaStar Medical may not be able to secure additional financing on acceptable terms; (vi) the risk that third-party suppliers and manufacturers are not able to fully and timely meet their obligations, (vii) the risk of product liability or regulatory lawsuits or proceedings relating to SeaStar Medical’s products and services, (viii) the risk that SeaStar Medical is unable to secure or protect its intellectual property, and (ix) other risks and uncertainties indicated from time to time in SeaStar Medical’s Annual Report on Form 10-K, including those under the “Risk Factors” section therein and in SeaStar Medical’s other filings with the SEC. The foregoing list of factors is not exhaustive. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and SeaStar Medical assumes no obligation and do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. 

Contact:  
IR@SEASTARMED.COM

QUELIMMUNE is a registered trademark of SeaStar Medical Holding Corporation.

2026 R&D Day presentation highlights include:

• Review of final Randomized Phase 2 overall survival results
• Supportive Preliminary MRD Study Data and translational findings
• Pathway to confirmatory readout in OVATION 3
• Testimonial conversation with an OVATION 1 participant now 10 years from diagnosis

LAWRENCEVILLE, N.J., Sept. 24, 2026 (GLOBE NEWSWIRE) — IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage biotechnology company developing DNA-mediated immunotherapies, today is presenting an update on its IMNN-001 development program for women with newly diagnosed advanced ovarian cancer. The program reviews final overall survival results from the randomized Phase 2 OVATION 2 Study, preliminary clinical and translational findings from the Phase 2 minimal residual disease (MRD) study conducted in partnership with Break Through Cancer and led by investigators at The University of Texas MD Anderson Cancer Center, and enrollment and operational progress in the ongoing pivotal Phase 3 OVATION 3 trial.

“A 14.7-month median overall survival difference observed in a 112-patient randomized Phase 2 study represents an important clinical signal that we believe warrants confirmation in a pivotal Phase 3 trial,” said Stacy R. Lindborg, Ph.D., President and Chief Executive Officer of IMUNON. “For women newly diagnosed with advanced ovarian cancer, it represents the potential for meaningful additional survival at a time when the frontline standard of care has changed very little in more than 25 years.”

Dr. Lindborg added, “If confirmed in Phase 3, IMNN-001 has the potential to become the first locally delivered IL-12 immunotherapy for frontline advanced ovarian cancer. In OVATION 2, women who received IMNN-001 plus neoadjuvant and adjuvant chemotherapy achieved a median overall survival of 45.1 months compared with 30.4 months for standard of care alone. Importantly, this survival signal was observed without the historical systemic safety challenges that limited earlier IL-12 programs. While OVATION 2 was not powered for overall survival, confirming that signal in OVATION 3, where overall survival is the primary endpoint, is the work in front of us.”

R&D Day Program Highlights

Dr. Lindborg opened the event by framing three questions the Company planned to present answers to: why systemic IL-12 failed historically, why IMNN-001 is different, and why the next stretch of OVATION 3 is the value-defining chapter of the program. Dr. Lindborg also closed the event by describing the Company’s near-term catalysts, including two pre-planned event-driven interim analyses in OVATION 3 designed to create a path to an earlier biologics license application for full approval if the survival signal crosses the pre-specified threshold.

Douglas V. Faller, M.D., Ph.D., Chief Medical Officer, IMUNON, reviewed why recombinant IL-12 programs were abandoned after dose-limiting systemic toxicity, and how IMNN-001 — an IL-12 DNA plasmid formulated with IMUNON’s proprietary TheraPlas^® nanoparticle and administered intraperitoneally — is designed to produce durable, local IL-12 in the peritoneal cavity where advanced ovarian cancer lives and spreads. Key points presented included:

• IMNN-001 is not recombinant IL-12 cytokine injected into the bloodstream. Instead, it instructs the patient’s own cells to produce IL-12 locally, activating both innate and adaptive immunity and remodeling a “cold” tumor microenvironment toward a “hot” antitumor state.
• Immune biomarker work from OVATION 1 and OVATION 2 showed increased recruitment of CD8+ T cells, myeloid dendritic cells and M1 macrophages, with decreases in immunosuppressive markers, consistent with the intended mechanism of action.
• The OVATION 2 safety profile did not cause the toxicities that closed earlier systemic IL-12 programs: no cytokine release syndrome, no serious systemic immune-related adverse events of the type that historically halted development, and a consistent, manageable profile dominated by gastrointestinal events, including abdominal pain in a minority of patients associated with intraperitoneal administration.
• Independent data monitoring committees recommended continuation without modification for both OVATION 3 (mid-2026) and the MRD study (August 2026).

Premal H. Thaker, M.D., David & Lynn Mutch Distinguished Professor, Chief of Gynecologic Oncology and Director of Gynecologic Oncology Clinical Research at Washington University School of Medicine, and study chair of OVATION 2 and OVATION 3, while noting that OVATION 2 was not powered for survival, placed the survival results for OVATION 2 and plans for OVATION 3 in the context of a frontline standard that has been essentially unchanged for more than 25 years. Highlights included:

• In the intent-to-treat population of the randomized, 112-patient OVATION 2 study, median overall survival was 45.1 months with IMNN-001 plus neoadjuvant and adjuvant chemotherapy versus 30.4 months with standard of care alone, a 14.7-month difference. The benefit widened as the data matured from the July 2024 readout (11.1 months) to the December 2025 final analysis.
• In the PARP inhibitor maintenance subgroup, median overall survival was 65.6 months versus 41.4 months, a 24.2-month improvement.
• Primary and secondary endpoints and the safety profile in OVATION 2 favored IMNN-001, with translational evidence of local immune activation at the tumor site.
• OVATION 3 is a randomized, 1:1, approximately 500-patient pivotal trial in newly diagnosed Stage IIIB/C or IV epithelial ovarian, fallopian tube or primary peritoneal cancer recommended for neoadjuvant chemotherapy. Overall survival is the primary endpoint. The design includes two pre-planned, event-driven interim analyses intended to support a potential earlier submission for full approval.
• Operational progress: protocol submission to site activation in approximately six months; protocol approval to first patient randomized in approximately two months; observed study-level enrollment of about 0.5 patients per site per month versus a 0.3 planning assumption. The Company is targeting completion of enrollment in the first quarter of 2029.

Amir Jazaeri, M.D., Vice Chair for Clinical Research and Director of the Gynecologic Cancer Immunotherapy Program at MD Anderson Cancer Center, and lead principal investigator of the Phase 2 MRD study, presented preliminary clinical and translational findings, noting that while the sample size is still too small to evaluate efficacy, early results appear encouraging. Among patients who have reached second-look laparoscopy to date:

• Residual Disease (MRD)-positive rate: 44.4% (4/9) in the IMNN-001 arm versus 66.7% (6/9) in the control arm.
• Circulating tumor DNA (ctDNA) clearance: 87.5% (7/8) with IMNN-001 versus 62.5% (5/8) in control.
• No evidence of disease after frontline therapy: 9 of 9 evaluable patients (100%) in the experimental arm versus 5 of 9 (56%) in control.
• Biomarker data indicates IMNN-001 is preferentially taken up by macrophages in peritoneal fluid and tumor tissue, driving local IL-12 expression, remodeling of the tumor microenvironment, and expanding T-cell receptor clones consistent with induction of anti-cancer immunity. These findings are preliminary and based on patients who have reached the SLL assessment point.

William Bradley, M.D., Professor and Vice Chair for Clinical Research in the Division of Gynecologic Oncology at the Medical College of Wisconsin, and a principal investigator across OVATION 1, 2 and 3, joined an OVATION 1 participant in a prerecorded conversation on what diagnosis, successful treatment with IMNN-001, and the years that followed have meant to her in clinic and at home. The participant, treated with IMNN-001 on the Phase 1b OVATION 1 study, is now almost 10 years from diagnosis and reports remaining free of cancer recurrence.

Webcast
A replay webcast of the event and presentation materials will be available on the “Scientific Presentations” page of the IMUNON website at https://investors.imunon.com/scientific-presentations.

About the Phase 3 OVATION 3 Trial
The pivotal Phase 3 OVATION 3 trial is evaluating intraperitoneal IMNN-001 at 100 mg/m² in combination with standard-of-care neoadjuvant and adjuvant chemotherapy versus chemotherapy alone in patients with newly diagnosed Stage IIIB/C or IV epithelial ovarian, fallopian tube or primary peritoneal cancer. The trial is enrolling an all-comers population that includes both homologous recombination-deficient and homologous recombination-proficient patients; eligible patients who respond to first-line platinum-based chemotherapy will proceed to PARP inhibitor maintenance according to applicable guidelines and prescribing information. The primary endpoint is overall survival, with secondary endpoints including chemotherapy response score, surgical response score at interval debulking surgery, time to second-line treatment or death, and objective response rate.

About IMNN-001 Immunotherapy
Designed using IMUNON’s proprietary TheraPlas^® platform technology, IMNN-001 is an IL-12 DNA plasmid encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local production of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity, acting through the induction of T-lymphocyte and natural killer cell proliferation. IMNN-001 has been evaluated as monotherapy and in combination regimens, including the completed Phase 1b OVATION 1 study and the randomized Phase 2 OVATION 2 study of IMNN-001 (100 mg/m² administered intraperitoneally weekly) plus neoadjuvant and adjuvant paclitaxel and carboplatin compared with standard-of-care chemotherapy alone in 112 women with newly diagnosed advanced ovarian cancer. IMNN-001 is now being studied in the pivotal Phase 3 OVATION 3 trial. The program has received Fast Track and Orphan Drug designation in the United States and orphan status in Europe.

About Epithelial Ovarian Cancer
Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S. There are approximately 20,000 new cases of ovarian cancer every year and approximately 70% are diagnosed in advanced stage III/IV. Epithelial ovarian cancer is characterized by dissemination of tumors in the peritoneal cavity with a high risk of recurrence (75%, stage III/IV) after surgery and chemotherapy. Since the five-year survival rates of patients with stage III/IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation.

About IMUNON
IMUNON is a clinical-stage biotechnology company focused on advancing a portfolio of innovative treatments that harness the body’s natural mechanisms to generate safe, effective and durable responses across a broad array of human diseases, constituting a differentiating approach from conventional therapies. IMUNON is developing its non-viral DNA technology across its modalities. The first modality, TheraPlas^®, is developed for the gene-based delivery of cytokines and other therapeutic proteins in the treatment of solid tumors where an immunological approach is deemed promising. The second modality, PlaCCine^®, is developed for the gene delivery of viral antigens that can elicit a strong immunological response.

The Company’s lead clinical program, IMNN-001, is a DNA-based immunotherapy for the localized treatment of advanced ovarian cancer that has completed multiple clinical trials, including one Phase 2 clinical trial (OVATION 2), and is currently being studied in a Phase 3 clinical trial (OVATION 3). IMNN-001 works by instructing the body to produce safe and durable levels of powerful cancer-fighting molecules, such as interleukin-12 and interferon gamma, at the tumor site. Additionally, the Company has completed dosing in a first-in-human study of its COVID-19 booster vaccine (IMNN-101). The Company will continue to leverage these modalities and to advance, either directly or through partnership, the technological frontier of plasmid DNA to better serve patients with difficult-to-treat conditions. For more information, please visit www.imunon.com.

Forward-Looking Statements
IMUNON wishes to inform readers that forward-looking statements in this release are made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, but not limited to, statements regarding expectations regarding the timing and enrollment of the Company’s clinical trials, the potential of any therapies developed by the Company to fulfill unmet medical needs, the market potential for the Company’s products, if approved, the potential efficacy and safety profile of our product candidates, and the Company’s plans and expectations with respect to its development programs more generally, are forward-looking statements. We generally identify forward-looking statements by using words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, uncertainties relating to unforeseen changes in the course of research and development activities and in clinical trials, including the fact that interim results are not necessarily indicative of final results; the uncertainties of and difficulties in analyzing interim clinical data; the significant expense, time and risk of failure in conducting clinical trials; the need for IMUNON to evaluate its future development plans; possible actions by customers, suppliers, competitors or regulatory authorities; and other risks detailed from time to time in IMUNON’s filings with the Securities and Exchange Commission. IMUNON assumes no obligation, except to the extent required by law, to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise.

Contacts
Investors
Valter Pinto
KCSA Strategic Communications
212-896-1254
imunon@kcsa.com