Replimune Presents Late-Breaking Abstract and Additional Posters on RP1 at 40th Annual Meeting of the Society for the Immunotherapy of Cancer (SITC 2025)




Replimune Presents Late-Breaking Abstract and Additional Posters on RP1 at 40th Annual Meeting of the Society for the Immunotherapy of Cancer (SITC 2025)

Oral presentation of biomarker data shows RP1 plus nivolumab reverses multiple resistance mechanisms to PD-1 blockade in advanced melanoma following definitive anti-PD-1 failure

WOBURN, Mass., Nov. 07, 2025 (GLOBE NEWSWIRE) — Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that biomarker data and updated clinical data from the IGNYTE clinical trial of RP1 plus nivolumab was presented as a late-breaking abstract during an oral session at the 40^th Annual Meeting of the Society for the Immunotherapy of Cancer (SITC 2025) in National Harbor, Maryland. Two additional posters on RP1 are also being presented.

“These data are important because they demonstrate that RP1 plus nivolumab can potentially reprogram the tumor microenvironment and reverse mechanisms of resistance to immune checkpoint blockade,” said Kostas Xynos, M.D., Ph.D., Chief Medical Officer of Replimune. “Low T cell levels in tumors, tumor PD-L1 expression, T-cell activation and IFNy gene signature expression, as well as the loss of antigen presentation machinery are well known mechanisms of resistance to immune checkpoint blockade.”

Data from the late-breaking abstract (#1327) presented by Trisha Wise-Draper, M.D., Ph.D., show:

• Pharmacodynamic changes that were not achieved during prolonged prior anti–PD-1 therapy demonstrate that the addition of RP1 reverses multiple resistance mechanisms to PD-1 blockade and highlights the contribution of RP1 in melanoma patients who previously failed such treatment.
• Treatment with RP1 plus nivolumab led to upregulation of gene signatures associated with responsiveness to PD-1 blockade.
• With additional follow-up (7 months), RP1 combined with nivolumab continues to demonstrate a clinically meaningful response rate (ORR: 33.6%) and durability (median duration of response: 24.8 months).
• Consistent duration of response was observed across PD-L1–positive and negative tumors, as well as in both primary and secondary resistance settings. Median duration of response for PD-L1-negative patients was 24.8 months and for patients with primary resistance was 22.6 months.

Additional posters being presented at the meeting include:

• Abstract 611: RP1 plus nivolumab in patients with and without prior BRAF-directed therapy: A subgroup analysis of patients with anti-PD-1 failed BRAF-mutant melanoma from the IGNYTE clinical trial (Katy Tsai, M.D.)
  • RP1 plus nivolumab demonstrated comparable efficacy in BRAF-mutant and BRAF–wild-type advanced melanoma.
  • Greater activity was observed in BRAF-naïve patients – similar to findings from the SECOMBIT and DREAMseq trials.
• Abstract 600: Retreatment with RP1 in combination with nivolumab in patients with advanced anti-PD-1- failed melanoma (Gino K. In, M.D.)
  
  • Extended RP1 treatment beyond 8 doses was well tolerated providing clinical benefit in a majority of patients.

About IGNYTE
The IGNYTE phase 2 cohort enrolled 140 patients with stage IIIB-IV cutaneous melanoma and confirmed progression on anti-PD1- based therapy for > 8 weeks as the last prior treatment. RP1 was administered intratumorally into superficial and/or deep/visceral tumors once every 2 weeks for up to 8 doses (≤10 mL per cycle) with intravenous nivolumab (240 mg); nivolumab was then given alone (240 mg every 2 weeks or 480 mg every 4 weeks) for up to 2 years, with further RP1 allowed if indicated.

About RP1
RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R^–) and GM-CSF, intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

About Replimune
Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of novel oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is intended to ignite local activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to then activate a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.

Forward Looking Statements
This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the design and sufficiency of our clinical trials and outcomes, the potential applicability of our product candidates to treat certain indications, the proposed mechanism of action of our product candidates and biologic effect, and other statements identified by words such as “could,” “expects,” “intends,” “hope,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to generate positive clinical trial results for our product candidates, the costs and sufficient continuous operation of our in-house manufacturing facility to produce the necessary quality and quantity of our product candidates for continuous clinical trial supply, the timing and scope of regulatory approvals, if any, our ability to resolve the issues identified in the CRL and the Type A meeting in a manner satisfactory to the FDA and to us and the timing thereof, the availability of combination therapies needed to conduct our clinical trials, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, political and global macro factors including the impact of a global pandemic and related public health issues and the ongoing political and military conflicts, including trade conflicts, and other risks as may be detailed from time to time in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other reports we file with the Securities and Exchange Commission. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements.

Investor Inquiries
Chris Brinzey
ICR Healthcare
339.970.2843
chris.brinzey@icrhealthcare.com

Media Inquiries
Arleen Goldenberg
Replimune
917.548.1582
media@replimune.com

Spyre Therapeutics Announces Grants of Inducement Awards




Spyre Therapeutics Announces Grants of Inducement Awards

WALTHAM, Mass., Nov. 07, 2025 (GLOBE NEWSWIRE) — Spyre Therapeutics, Inc. (NASDAQ: SYRE) (the “Company” or “Spyre”), a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases, today announced that Spyre’s independent Compensation Committee of the Board of Directors approved the grant of stock options to purchase 19,600 shares of common stock of Spyre to one non-executive employee as equity inducement awards under the Spyre Therapeutics, Inc. 2018 Equity Inducement Plan, as amended (the “2018 Plan”). The stock options were approved on November 3, 2025 and were material to the employee’s acceptance of employment with Spyre, in accordance with Nasdaq Listing Rule 5635(c)(4).

The stock options were granted with a 10-year term and an exercise price equal to $23.78, the closing price per share of Spyre’s common stock as reported by Nasdaq on November 3, 2025. The options granted to the employee shall vest and become exercisable as to one-fourth (1/4th) of the shares subject to the respective options on the first anniversary of the employee’s start date, and one-forty-eighth (1/48th) of the shares subject to the respective options shall vest and become exercisable monthly thereafter, in each case, subject to continuous service with Spyre through the applicable vesting dates. The stock options are subject to the terms of the 2018 Plan.

About Spyre Therapeutics

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre’s pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.

For more information, please visit http://spyre.com.

For Investors:     
Eric McIntyre
VP of Finance and Investor Relations
Spyre Therapeutics
Eric.mcintyre@spyre.com

Vera Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)




Vera Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

BRISBANE, Calif., Nov. 07, 2025 (GLOBE NEWSWIRE) — Vera Therapeutics, Inc. (Nasdaq: VERA) today announced that, on November 4, 2025, the Compensation Committee of the Board of Directors of Vera Therapeutics granted inducement awards consisting of non-qualified stock options to purchase 79,050 shares of Class A common stock and restricted stock units (RSUs) underlying 39,915 shares of Class A common stock to six (6) new employees under the Vera Therapeutics, Inc. 2024 Inducement Plan (Inducement Plan). The Compensation Committee approved the awards as an inducement material to the new employees’ employment in accordance with Nasdaq Listing Rule 5635(c)(4).

Each stock option granted on November 4, 2025 has an exercise price per share equal to $24.35, Vera Therapeutics’ closing trading price on November 4, 2025. Each stock option will vest over four years, with 25% of the underlying shares vesting on the first anniversary of the applicable vesting commencement date and the balance of the underlying shares vesting monthly thereafter over 36 months, subject to the new employee’s continued service relationship with Vera Therapeutics through the applicable vesting dates. Each of the RSU awards will vest over four years, with 25% of the underlying shares vesting on each anniversary of November 20, 2025, subject to the new employee’s continued service relationship with Vera Therapeutics through the applicable vesting dates. The awards are subject to the terms and conditions of the Inducement Plan and the terms and conditions of an applicable award agreement covering the grant.

About Vera Therapeutics
Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera Therapeutics’ mission is to advance treatments that target the source of immunological diseases in order to change the standard of care for patients. Vera Therapeutics’ lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both B-cell Activating Factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including immunoglobulin A nephropathy (IgAN) and lupus nephritis. Beyond IgAN, Vera Therapeutics is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove clinically meaningful. In addition, Vera Therapeutics holds an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B-cell-mediated diseases. Vera Therapeutics is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK virus, which can have devastating consequences in kidney transplant recipients. Vera Therapeutics retains all global developmental and commercial rights to atacicept, VT-109 and MAU868. For more information, please visit www.veratx.com.

For more information, please contact:

Investor Contact:
Joyce Allaire
LifeSci Advisors 
212-915-2569
jallaire@lifesciadvisors.com

Media Contact:
Debra Charlesworth
Vera Therapeutics
415-854-8051
corporatecommunications@veratx.com

Nanox to Report Third Quarter 2025 Financial Results on November 20, 2025




Nanox to Report Third Quarter 2025 Financial Results on November 20, 2025

PETACH TIKVA, Israel, Nov. 07, 2025 (GLOBE NEWSWIRE) — NANO-X IMAGING LTD (“Nanox” or the “Company”, Nasdaq: NNOX), an innovative medical imaging technology company, today announced that it will report its financial results for the quarter ended September 30, 2025, before market open on Thursday, November 20, 2025. Erez Meltzer, Chief Executive Officer and Acting Chairman, and Ran Daniel, Chief Financial Officer, will host a conference call to review these results and provide a business update beginning at 8:30 a.m. ET.

Interested parties may register for the conference call using the following link:  Nanox Q3 2025 Conference Call. The live webcast of the conference call may be accessed by using the following link: Nanox Q3 2025 Webcast.

The link will also be posted in the Investor Relations section of the Nanox website at Events and Presentations. 

About Nanox

Nanox (NASDAQ: NNOX) is focused on driving the world’s transition to preventive health care by bringing a full solution of affordable medical imaging technologies based on advanced AI and proprietary digital X-ray source.

Nanox’s vision encompasses expanding the reach of Nanox technology both within and beyond hospital settings, providing a seamless end-to-end solution from scan to diagnosis, leveraging AI for more accurate diagnostics and maintaining a clinically driven approach. The Nanox ecosystem includes Nanox.ARC – a multi-source digital tomosynthesis system that is cost-effective and user-friendly; Nanox.AI LTD, a subsidiary of Nanox Imaging, with an AI-based suite of algorithms that augment the readings of routine CT imaging to highlight early signs often related to chronic diseases; Nanox.CLOUD – a cloud-based software platform that manages data collected by Nanox devices, and provides users with tools for in-depth imaging analysis; Nanox.MARKETPLACE – a proprietary decentralized marketplace through Nanox’s subsidiary, USARAD Holdings Inc., that provides remote access to radiology and cardiology experts, and a comprehensive teleradiology services platform. By improving early detection and treatment, Nanox aims to enhance better health outcomes worldwide. For more information, please visit www.nanox.vision.

Contacts

Investor Contact
Mike Cavanaugh
ICR Healthcare
mike.cavanaugh@icrhealthcare.com 

Media Contact
ICR Healthcare
NanoxPR@icrinc.com 

Arcadia Biosciences (RKDA) Announces Third Quarter 2025 Financial Results and Business Highlights




Arcadia Biosciences (RKDA) Announces Third Quarter 2025 Financial Results and Business Highlights

— Zola^® year-to-date revenues increase 26% year over year —
— Arcadia gross profit margins exceed 30% for 11^th straight quarter —
— Arcadia cash balance declines by only $257K to $1.1M —

DALLAS, Nov. 07, 2025 (GLOBE NEWSWIRE) — Arcadia Biosciences, Inc.^® (Nasdaq: RKDA), a producer and marketer of innovative wellness products, today released its financial and business results for the third quarter of 2025.

“We are very pleased with our performance for the third quarter of 2025.” said T.J. Schaefer, CEO of Arcadia. “Zola^® coconut water revenues were flat year-over-year in the third quarter as we overlapped the initial sell-in to Zola’s largest customer during the third quarter of 2024. However, on a year-to-date basis, Zola coconut water revenues have grown 26% and more than offset $700,000 in GLA sales in 2024 that did not occur in 2025. Additionally, our gross margins have now exceeded 30% for eleven consecutive quarters, SG&A expenses are at an all-time low and our cash management exceeded our expectations.

“In addition to our strong operating performance, we continue to own 2.7 million shares of Above Food Ingredients Inc. stock as a partial repayment of the $6 million principal amount of the note receivable related to the sale of GoodWheat^TM assets in the second quarter of 2024 and are pursuing resolution of the remaining outstanding balance.

“Our pending business combination with Roosevelt Resources is still in progress,” Schaefer continued, “but uncertainty exists regarding the timing due to several factors including the ongoing federal government shutdown that went into effect over a month ago. We continue to monitor events closely, but the shutdown is obviously a situation that is outside of our control.”

Arcadia Biosciences, Inc.
Financial Snapshot
(Unaudited)

($ in thousands)

Certain previously reported financial information has been reclassified to conform to the current year presentation. Reclassifications are related to the presentation of the financial results of our former GoodWheat^TM brand as discontinued operations. The financial information above and narrative that follows relate to continuing operations unless stated otherwise.

More detailed financial information is included in the company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC), available in the Investors section of the company’s website under SEC Filings.

Revenues
Revenues decreased $235,000, or 15%, during the third quarter of 2025 compared to the same period in 2024 due to $217,000 in sales of GLA oil in 2024 that were absent in 2025. In addition, Zola third quarter sales in 2024 had the benefit of an incremental $165,000 driven by the initial sell-in to a large customer.

Revenues increased $128,000, or 3%, and consisted entirely of Zola coconut water sales during the first nine months of 2025 compared to the same period in 2024. Zola revenues increased $820,000, or 26% during the first nine months of 2025 compared to the same period in 2024. This was primarily driven by an increase in distribution resulting in higher sales volume. The company did not implement any price increases during 2024 or 2025. Revenues for the first nine months of 2024 included $701,000 from sales of GLA oil that were absent in 2025.

Operating Expenses
Cost of revenues decreased $148,000, or 14%, during the third quarter of 2025 compared to the same period in 2024 driven by a write-down of $154,000 related to hemp and GoodWheat seed in 2024. There was no such write-down of inventory in 2025. Cost of revenues for the same period in 2024 included $18,000 from GLA oil.

Cost of revenues increased by $253,000, or 12%, and consisted primarily of Zola coconut water costs during the first nine months of 2025 compared to the same period in 2024. Zola cost of revenues increased $472,000, or 25% during the first nine months of 2025 compared to the same period in 2024 driven by a 26% increase in Zola sales. Cost of revenues for the first nine months of 2024 included $64,000 of costs from GLA oil as well as a write-down of $154,000 related to hemp and GoodWheat seed.

SG&A decreased by $671,000 and $1.6 million during the third quarter and first nine months of 2025, respectively, compared to the same periods in 2024, driven primarily by operating costs and employee related costs in 2024 that were absent in 2025.

Other operating expenses (income) increased by $1.2 million during the first nine months of 2025 compared to the same period in 2024. This was driven by a $4.0 million gain on the sale of RS durum wheat patents to Corteva that occurred in 2024, compared to a $2.8 million gain recognized in 2025 related to the agreement with Bioceres Crop Solutions Corp to transfer rights related to reduced gluten and oxidative stability patents, as well as the agreement with Bioseed Research India to terminate the license agreement for certain intellectual property.

Credit Loss and Common Stock Received
On May 1, 2025, Arcadia delivered a notice to Above Food Corp. to exercise a stock election option provided for in the Above Food Promissory Note related to the sale of GoodWheat assets in May 2024. The notice indicated that pursuant to the provisions of the Promissory Note, the number of shares issuable was approximately 3.5 million shares of common stock of Above Food Ingredients Inc. (ABVE), satisfying the final $2 million installment payment obligation under the Promissory Note. In June 2025, ABVE issued approximately 2.7 million shares to Arcadia, partially satisfying the stock election, and the company believes approximately 800,000 shares relating to the company’s stock election notice remain issuable.  

Additionally, the first payment of principal and accrued interest under the Promissory Note was due on May 14, 2025, and as of September 30, 2025, had not been paid. As such, Arcadia recognized a credit loss of $4.7 million for the remaining outstanding principal amount, accrued interest, and other related receivables that would remain after fulfillment of the stock election.

Net Income / Loss Attributable to Common Stockholders
Net income attributable to common stockholders for the third quarter of 2025 was $856,000, or $0.63 per share, a $2.5 million improvement from the $1.6 million net loss, or $1.18 per share, for the third quarter of 2024. The improvement in net income attributable to common stockholders for the third quarter of 2025 compared to the same period in 2024 was primarily driven by other income of $1.7 million related to an unrealized gain of the same amount on the ABVE common stock.

Net loss attributable to common stockholders for the first nine months of 2025 was $1.0 million, or $0.73 per share, a $2.0 million improvement from the $3.0 million net loss, or $2.18 per share, for the first nine months of 2024. The improvement in net loss attributable to common stockholders for the first nine months of 2025 compared to the same period in 2024 was primarily driven by the $4.7 million credit loss related to the note receivable from Above Food recognized during the first nine months of 2025, partially offset by the $4.0 million gain on the sale of RS durum wheat patents to Corteva that occurred during the first nine months of 2024.

Conference Call
In light of the ongoing transaction with Roosevelt Resources and the related registration statement on Form S-4 (initially filed with the SEC on February 14, 2025, and amended July 31, 2025), the company will not hold a conference call to discuss third quarter results.

About Arcadia Biosciences, Inc.
Since 2002, Arcadia Biosciences (Nasdaq: RKDA) has been innovating high-value, healthy ingredients to meet consumer demands for healthier choices. With its roots in agricultural innovation, Arcadia cultivates next-generation wellness products. For more information, visit www.arcadiabio.com.

Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 about the company and its products, including statements relating to the company’s growth, cash position, operating costs, financial performance, commercialization of products, strategic transactions, our ability to obtain sufficient funding required to continue our operations and planned activities, our ability to obtain the stockholder approvals required to complete the proposed business combination transaction with Roosevelt Resources, LP and to satisfy the closing conditions contained in the agreements relating to the transaction, the occurrence of any event, change or other circumstance or condition that could give rise to the termination of the proposed business combination transaction, and the anticipated timing of the closing of the proposed business combination transaction with Roosevelt Resources. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to, the risks set forth in filings that the company makes with the Securities and Exchange Commission from time to time, including in Arcadia’s Annual Report on Form 10-K for the year ended December 31, 2024 as amended, the registration statement on Form S-4 initially filed with the SEC on February 14, 2025 and amended July 31, 2025, and other filings that the company makes with the SEC. These forward-looking statements speak only as of the date hereof, and except as required by law, Arcadia Biosciences, Inc. disclaims any obligation to update these forward-looking statements.

No Offer or Solicitation
As previously reported on a Report on Form 8-K filed by the company with the SEC, on December 4, 2024, the company, Roosevelt Resources, LP, a Texas limited partnership, and certain other parties entered into a Securities Exchange Agreement (as the same may be amended, the Exchange Agreement) providing for the combination of the two companies in an all-stock transaction. Under the terms of the Exchange Agreement, at the closing of the transactions contemplated by the Exchange Agreement, Arcadia will issue to the partners of Roosevelt shares of Arcadia common stock in exchange for all of the equity interests in Roosevelt. 

This press release, including the information contained herein, is not intended to and does not constitute (i) a solicitation of a proxy, consent or approval with respect to any securities or in respect of the proposed transaction or (ii) an offer to sell or the solicitation of an offer to subscribe for or buy or an invitation to purchase or subscribe for any securities pursuant to the proposed transaction or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. No offer of securities shall be made except by means of a prospectus meeting the requirements of the Securities Act of 1933, as amended, or an exemption therefrom.

Subject to certain exceptions to be approved by the relevant regulators or certain facts to be ascertained, no offer will be made directly or indirectly, in or into any jurisdiction where to do so would constitute a violation of the laws of such jurisdiction, or by use of the mails or by any means or instrumentality (including without limitation, facsimile transmission, telephone and the internet) of interstate or foreign commerce, or any facility of a national securities exchange, of any such jurisdiction.

Additional Information for Stockholders
In connection with the proposed transaction, Arcadia intends to file relevant materials with the SEC and previously filed a Registration Statement on Form S-4 that includes a preliminary proxy statement/prospectus, with the SEC on February 14, 2025, and filed a pre-effective amendment to the Registration Statement on July 31, 2025. After the Registration Statement is declared effective by the SEC, Arcadia intends to mail a definitive proxy statement/prospectus to the stockholders of Arcadia relating to a meeting of stockholders to consider matters relating to the proposed transaction and other matters. This press release is not a substitute for the proxy statement/ prospectus or the Registration Statement or for any other document that Arcadia may file with the SEC and send to Arcadia’s stockholders in connection with the proposed transaction. INVESTORS AND SECURITY HOLDERS OF ARCADIA ARE URGED TO CAREFULLY AND THOROUGHLY READ THE REGISTRATION STATEMENT AND THE PROXY STATEMENT/PROSPECTUS, AS EACH MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME, AND OTHER RELEVANT DOCUMENTS FILED BY ARCADIA WITH THE SEC, WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT ARCADIA, ROOSEVELT, THE PROPOSED TRANSACTION, THE RISKS RELATED THERETO AND RELATED MATTERS.

Investors will be able to obtain free copies of the Registration Statement and proxy statement/prospectus, as each may be amended from time to time, and other relevant documents filed by Arcadia with the SEC (when they become available) through the website maintained by the SEC at www.sec.gov. Copies of documents filed with the SEC by Arcadia will be available free of charge from Arcadia’s website at www.arcadiabio.com under the “Investors” tab. In addition, investors and stockholders should note that Arcadia communicates with investors and the public using its website. Stockholders are urged to read the proxy statement/prospectus and the other relevant materials when they become available before making any voting or investment decision with respect to the proposed transactions.

Participants in the Proxy Solicitation
Arcadia, Roosevelt and their respective directors, partners and certain of their officers and other members of management and employees may be deemed, under SEC rules, to be participants in the solicitation of proxies from Arcadia’s stockholders in connection with the proposed transactions. Information regarding the officers and directors of Arcadia is included in Arcadia’s most recent Annual Report on Form 10-K, as amended, filed with the SEC, including any information incorporated therein by reference, its definitive proxy statement for its 2024 annual meeting filed with the SEC on May 16, 2024, and in the Registration Statement initially filed with the SEC on February 14, 2025 and as amended July 31, 2025, and any amendments thereto as filed with the SEC. Additional information regarding such persons, as well as information regarding Roosevelt’s directors, managers and officers and other persons who may be deemed participants in the proposed transaction, will be set forth in the Registration Statement and proxy statement/prospectus, and any amendments thereto, and other materials, when they are filed with the SEC in connection with the proposed transaction. Free copies of these documents may be obtained from the sources indicated above.

Arcadia Biosciences Contact:
T.J. Schaefer
ir@arcadiabio.com

Surrozen Reports Third Quarter 2025 Financial Results and Provides Business Update




Surrozen Reports Third Quarter 2025 Financial Results and Provides Business Update

SOUTH SAN FRANCISCO, Calif., Nov. 07, 2025 (GLOBE NEWSWIRE) — Surrozen, Inc. (“Surrozen” or the “Company”) (Nasdaq: SRZN), a biotechnology company pioneering targeted therapeutics that selectively modulate the Wnt pathway for tissue repair and regeneration, with a focus on severe eye diseases, today announced financial results for the third quarter ended September 30, 2025, and provided a business update.

Business Highlights
Surrozen remains focused on its ophthalmology pipeline, leveraging its Wnt biology expertise and antibody technologies to develop novel treatments for severe eye diseases.

Key Third Quarter Events and Planned Fourth Quarter Scientific Meetings in 2025

• Ophthalmology Pipeline:
  • The Company continues to progress its lead candidates, SZN-8141 and SZN-8143 in retinal diseases and remains on track to submit an Investigational New Drug (IND) application for SZN-8141 in 2026
• Scientific Presentations Highlighting Next Generation Surrozen Wnt Therapeutics for Retinal Diseases
  • The Company’s Vice President of Clinical Development, Daniel Chao, M.D., Ph.D. presented an overview of Next Generation Wnt Therapeutics in Retinal Diseases at Eyecelerator (American Academy of Ophthalmology) Meeting on October 16, 2025
  • The Company is scheduled to present an overview of Next Generation Wnt Therapeutics in Retinal Diseases at the Ophthalmology Innovation Source (OIS) conference on November 22, 2025

Key Leadership Roles Strengthened to Support the Next Phase of Surrozen’s Growth, Expand Strategic Capabilities, and Bolster Surrozen’s Long-Term Success
Chief Financial Officer:
Andrew Maleki has joined the Surrozen management team as Chief Financial Officer (CFO). Mr. Maleki brings more than a decade of experience in the biotech industry spanning corporate strategy, business development and operational leadership, including playing a key role in raising over $500 million in capital. Most recently, he led corporate development and program leadership at Lassen Therapeutics, where he helped shape portfolio strategy and business development efforts. Prior to Lassen Therapeutics, Mr. Maleki held positions of increasing responsibility at Jazz Pharmaceuticals, where he led collaborations, licensing deals, and acquisitions across various therapeutic areas. Earlier in his career, he worked at PureTech Health and ClearView Healthcare Partners, where he developed a strong track record of guiding growth-stage biotechnology companies through critical inflection points.

Mr. Maleki holds a B.A. in Biology and Economics with distinction from Yale University and an M.B.A. from Harvard Business School.

Chief Operating Officer:
Charles Williams, who has served in the dual role of Chief Operating Officer (COO) and CFO, will continue solely as COO. In this dedicated capacity, Mr. Williams will intensify his focus on strategic initiatives, corporate development and enterprise execution, working closely with the executive team to advance Surrozen’s corporate objectives and development programs.

“We continue to make significant progress with our ophthalmology pipeline and to further strengthen the depth and breadth of our management team to drive enterprise-wide execution focused on long-term growth and success” said Craig Parker, President and Chief Executive Officer of Surrozen. “With the addition of Andrew Maleki to our strong leadership team, we are well positioned to advance our novel therapeutics toward clinical development while expanding our strategic capabilities and execution.”

Third Quarter 2025 Financial Highlights
– Cash Position: Cash and cash equivalents were $81.3 million as of September 30, 2025, compared to $90.4 million as of June 30, 2025.
– Revenue:

• Collaboration and License Revenue: Collaboration and license revenue was zero for the quarter, compared to $10.0 million for the same period in 2024, attributable to the recognition of a milestone achieved under a collaboration and license agreement with Boehringer Ingelheim International GmbH in September 2024.
• Research Service Revenue – Related Party: Research service revenue from a related party was $1.0 million for the quarter, compared to zero for the same period in 2024, driven by the collaboration with TCGFB, Inc. for TGF-β antibodies.

– Operating Expenses:

• Research and Development Expenses: R&D expenses were $7.8 million for the quarter, compared to $5.2 million for the same period in 2024, reflecting a $2.7 million increased in manufacturing costs, lab expenses and consulting fees for our ophthalmology programs, and a $0.6 million increase in employee-related expenses, offset by a $0.8 million decrease in clinical expenses as a result of the discontinuation of clinical development of SZN-043.
• General and Administrative Expenses: G&A expenses were $4.1 million for the quarter, compared to $3.6 million for the same period in 2024, due to the increase in professional service fees.

– Other Income and Expenses:

• Interest Income: Interest income was $1.0 million for the quarter, compared to $0.4 million for the same period in 2024, as a result of an increase in cash and cash equivalents.
• Loss on Change in Fair Value of Tranche Liability: Loss on change in fair value of tranche liability was $40.7 million, compared to zero for the same period in 2024, driven by the non-cash change in fair value of tranche liability.
• Other Expense, Net: Other expense, net was $20.9 million, compared to $3.1 million for the same period in 2024, primarily driven by the non-cash change in fair value of warrant liabilities.

– Net Loss: Net loss was $71.6 million, or ($8.36) per share for the quarter, compared to a net loss of $1.4 million, or ($0.44) per share, for the same period in 2024.

Surrozen’s Ophthalmology Portfolio
About SZN-8141 for retinal diseases 
SZN-8141 combines Frizzled 4 (Fzd4) agonism and Vascular Endothelial Growth Factor (VEGF) antagonism, which has the potential to provide benefits over treatment with single agents for Diabetic Macular Edema (DME) and neovascular Age-Related Macular Degeneration (wet AMD). The current standard of care for diabetic retinopathy (including DME), retinal vein occlusion and wet AMD is intravitreal administration of anti-VEGF monotherapies. In addition, Fzd4 monotherapy has demonstrated proof of concept in DME in clinical trials. We believe SZN-8141 has the potential to treat multiple retinal vascular diseases and be differentiated from existing therapies. Data generated in preclinical models of retinal vascular diseases demonstrated that SZN-8141 stimulated Wnt signaling and induced normal retinal vessel regrowth while suppressing pathological vessel growth.

About SZN-8143 for retinal diseases 
SZN-8143 combines Fzd4 agonism, VEGF antagonism, and interleukin-6 (IL-6) antagonism which may have benefits over single agents for treatment of DME/wet AMD/uveitic macular edema (UME). The current standard of care for diabetic retinopathy (including DME), retinal vein occlusion and wet AMD is intravitreal administration of anti-VEGF monotherapies. In addition, Fzd4 monotherapy has demonstrated proof of concept in clinical trials for retinal disease. We believe SZN-8143 has the potential to treat multiple retinal vascular diseases and be differentiated from existing therapies. Data generated in preclinical models of retinal vascular diseases demonstrated that SZN-8143 stimulated Wnt signaling and induced normal retinal vessel regrowth while suppressing pathological vessel growth.

About SZN-413 for Retinal Diseases and Corporate Partnership with Boehringer Ingelheim
SZN-413 is a bi-specific antibody targeting Fzd4-mediated Wnt signaling designed using Surrozen’s SWAP™ technology. It is currently being developed for the treatment of retinal diseases through a strategic partnership (and agreement) with Boehringer Ingelheim (BI). Data generated by Surrozen with SZN-413 in preclinical models of retinopathy demonstrated that SZN-413 could potently stimulate Wnt signaling in the eye, induce normal retinal vessel regrowth, suppress pathological vessel growth and reduce vascular leakage. This novel approach could thus potentially allow for regeneration of healthy eye tissue, not only halting retinopathy, but possibly allowing for a full reversal of the patient’s disease.

Under the terms of the agreement, Boehringer Ingelheim received an exclusive, worldwide license to develop SZN-413 and other Fzd4-specific Wnt-modulating molecules for all purposes, including as a treatment for retinal diseases, in exchange for an upfront payment to Surrozen of $12.5 million and up to $586.5 million in success-based development, regulatory, and commercial milestone payments, in addition to mid-single digit to low-double digit royalties on sales.

About Surrozen
Surrozen is a biotechnology company, pioneering a new class of Wnt-based therapeutics designed to repair and restore tissue function, focused in ophthalmology. Built on deep scientific expertise and a proprietary antibody-engineering platform, Surrozen develops multifunctional biologics that selectively activate Wnt signaling — alone or in combination with other key disease pathways — to address serious ophthalmic diseases with high unmet medical need. Our approach aims to deliver best-in-class, durable therapies that have the potential to transform patient outcomes and create significant long-term value. For more information, visit www.surrozen.com.

Forward-Looking Statements 
This press release contains certain forward-looking statements within the meaning of the federal securities laws. Forward-looking statements generally are accompanied by words such as “will,” “plan,” “intend,” “potential,” “expect,” “could,” or the negative of these words and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding Surrozen’s discovery, research and development activities, in particular its development plans for its product candidates (including anticipated clinical development plans and timelines, the availability of data, the potential for such product candidates to be used to treat human disease or address unmet needs in serious eye diseases, as well as the potential benefits and potential differentiation from existing therapies of such product candidates); Surrozen’s intention to submit an IND application for SZN-8141 in 2026; and expectations regarding Surrozen’s partnership with Boehringer Ingelheim, including the potential for future success-based development, regulatory, and commercial milestone payments, in addition to mid-single digit to low-double digit royalties on sales. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management of Surrozen and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Surrozen. These forward-looking statements are subject to a number of risks and uncertainties, including the initiation, cost, timing, progress and results of research and development activities, preclinical and clinical trials with respect to its product candidates and potential future drug candidates; the Company’s ability to fund its preclinical and clinical trials and development efforts, whether with existing funds or through additional fundraising; Surrozen’s ability to identify, develop and commercialize drug candidates; Surrozen’s ability to successfully complete preclinical and clinical studies for its product candidates; the effects that arise from volatility in global economic, political, regulatory and market conditions; and all other factors discussed in Surrozen’s Annual Report on Form 10-K for the year ended December 31, 2024 filed, and Surrozen’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 to be filed with the Securities and Exchange Commission (“SEC”) under the heading “Risk Factors,” and other documents Surrozen has filed, or will file, with the SEC. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Surrozen presently does not know, or that Surrozen currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect Surrozen’s expectations, plans, or forecasts of future events and views as of the date of this press release. Surrozen anticipates that subsequent events and developments will cause its assessments to change. However, while Surrozen may elect to update these forward-looking statements at some point in the future, Surrozen specifically disclaims any obligation to do so, except as required by law. These forward-looking statements should not be relied upon as representing Surrozen’s assessments of any date after the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

Investor/Media Contact:
Email: Investorinfo@surrozen.com

⁽¹⁾ Derived from the audited consolidated financial statements, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.

Altimmune Presents AI-Based Analysis of Liver Fibrosis Reduction from IMPACT Phase 2b Trial of Pemvidutide in MASH in Late-breaking Poster at AASLD The Liver Meeting® 2025




Altimmune Presents AI-Based Analysis of Liver Fibrosis Reduction from IMPACT Phase 2b Trial of Pemvidutide in MASH in Late-breaking Poster at AASLD The Liver Meeting® 2025

AI-based digital pathology analysis provides high-resolution quantification of hepatic fibrosis and objective measurement of fibrosis improvement

Pemvidutide demonstrated significant reductions in liver fibrosis and improvements in non-invasive tests vs. placebo at 24 weeks

GAITHERSBURG, Md., Nov. 07, 2025 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic diseases, today announced results from an artificial intelligence (AI)-based analysis of biopsies from the IMPACT Phase 2b trial of pemvidutide in patients with metabolic dysfunction-associated steatohepatitis (MASH).

The AI-based pathology tool Liver Explore™ showed that pemvidutide treatment resulted in significant reductions in the proportionate areas of early, advanced and total liver fibrosis compared to placebo at 24 weeks. These data are supported by significant improvements in non-invasive markers of fibrosis compared to placebo. The AI-based analysis will be presented on Saturday, November 8, in a late-breaking poster session at The Liver Meeting 2025, hosted by the American Association for the Study of Liver Diseases (AASLD) in Washington, D.C.

“Changes in fibrosis can be difficult to quantify by traditional histological methods, which are semi-quantitative and prone to observer variability. AI-based methods can provide an automated, sensitive and truly quantitative analysis of changes in fibrosis in patients with MASH,” said Vlad Ratziu, MD, PhD, Professor of Hepatology at Sorbonne University and Pitié-Salpêtrière Hospital in Paris, France. “It is exciting to see this technology being used to accelerate the development of potential new therapies for MASH.”

Highlights from the AI-based analysis of biopsies from patients in the IMPACT Phase 2b trial include:

• Data for total fibrosis showed 31% of patients in the pemvidutide 1.8 mg group (n = 85), and 12% of patients in the pemvidutide 1.2 mg group (n = 41) achieved a ≥ 60% reduction in the area of fibrosis compared to 8% of placebo-treated patients (n = 86, p = 0.0003 and p = 0.5, respectively).  
• Data for early fibrosis showed 34% of patients in the pemvidutide 1.8 mg group (n = 85), and 24% of patients in the pemvidutide 1.2 mg group (n = 41) achieved ≥ 60% reduction in the area of fibrosis compared to 9% of placebo-treated patients (n = 86, p < 0.0001 and p = 0.017, respectively). 
• Data for advanced fibrosis showed 27% of patients in the pemvidutide 1.8 mg group (n = 85), and 5% of patients in the pemvidutide 1.2 mg group (n = 41) achieved ≥ 60% reduction in the area of fibrosis compared to 11% of placebo-treated patients (n = 86, p = 0.0063 and p = 0.32, respectively).

Additional analyses showed significant reductions in non-invasive tests (NITs) of liver fibrosis with pemvidutide compared to placebo, including in the PRO-C3:CTX-III ratio, consistent with fibrosis regression, and in PRO-C6, a fibrosis marker that may be linked to cardiovascular risk.

“In our 24-week IMPACT MASH Trial, we achieved MASH resolution in up to 58% of patients, suggesting that the balanced 1:1 ratio of glucagon/GLP-1 in pemvidutide can lead to rapid MASH resolution,” said Christophe Arbet-Engels, M.D., Ph.D., Chief Medical Officer of Altimmune. “Using this powerful AI-based technology to examine liver biopsies, we found compelling reductions in total liver fibrosis as well, with statistically significant reductions in both early and advanced fibrosis (for 1.8 mg pemvidutide) at 24-weeks. We look forward to the upcoming 48-week IMPACT trial readout which will include longer-term NIT and weight loss data.”

About the IMPACT Phase 2b Study
The randomized, placebo-controlled, double-blind IMPACT Phase 2b trial (NCT05989711) enrolled 212 participants with biopsy-confirmed metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis stages F2 or F3, with and without diabetes. Study participants were randomized 1:2:2 to receive weekly subcutaneous pemvidutide doses at either 1.2 mg, 1.8 mg or placebo for 48 weeks. Key efficacy endpoints, measured at 24 weeks, were MASH resolution without worsening of fibrosis, or fibrosis improvement without worsening of MASH. Secondary endpoints included non-invasive tests of fibrosis and weight loss. Participants will receive a total of 48 weeks of treatment, and a final readout of longer-term NITs and weight loss is anticipated in the fourth quarter of 2025.

About Pemvidutide
Pemvidutide is a novel, investigational peptide with balanced 1:1 glucagon/GLP-1 dual receptor agonist activity, in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD) and alcohol-associated liver disease (ALD). The activation of glucagon results in direct effects on the liver, including reductions in liver fat, inflammation, and fibrosis, while GLP-1 receptors mediate metabolic effects such as appetite suppression and weight loss.

The FDA granted Fast Track designations to pemvidutide for the treatment of MASH and AUD, both areas of significant unmet medical need. The 48-week readout from the ongoing IMPACT Phase 2b MASH trial is expected in fourth quarter 2025. Phase 2 trials in AUD (RECLAIM) and ALD (RESTORE) were initiated in May 2025 and July 2025, respectively, and are currently ongoing.

About Altimmune
Altimmune is a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic diseases. The Company’s lead product candidate is pemvidutide, a glucagon/GLP-1 dual receptor agonist for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD) and alcohol-associated liver disease (ALD). For more information, please visit www.altimmune.com.

Forward Looking Statements
Any statements made in this press release related to the development or commercialization of pemvidutide, an investigational product candidate, and other business, regulatory and financial matters including without limitation, the timing of key milestones for the Company’s clinical assets, future plans or expectations for pemvidutide for the treatment of MASH, AUD and ALD, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Altimmune, Inc. may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements, or historical experience include risks and uncertainties, including risks relating to: delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, enrollment, adverse effects on healthcare systems and disruption of the global economy; the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company’s product candidates; the Company’s ability to manufacture clinical trial materials on the timelines anticipated; and the success of future product advancements, including the success of future clinical trials. Further information on the factors and risks that could affect the Company’s business, financial conditions and results of operations are contained in the Company’s filings with the U.S. Securities and Exchange Commission, including under the heading “Risk Factors” in the Company’s most recent annual report on Form 10-K, quarterly report on Form 10-Q and the Company’s other filings with the SEC, which are available at www.sec.gov.

Follow @Altimmune, Inc. on LinkedIn
Follow @AltimmuneInc on X

Investor Contact:
Lee Roth
Burns McClellan
Phone: 646-382-3403
lroth@burnsmc.com

Media Contact:
Savannah Valade
Real Chemistry
altimmune@realchemistry.com

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

IMUNON R&D Day: Opportunity to Hear Clinical Trial Investigators Discuss Significant Potential of IMNN-001 to Redefine Ovarian Cancer Treatment




IMUNON R&D Day: Opportunity to Hear Clinical Trial Investigators Discuss Significant Potential of IMNN-001 to Redefine Ovarian Cancer Treatment

Investors and stakeholders invited to attend in person in New York City or via live webcast on Monday, November 10^th at 8:00 a.m. ET

LAWRENCEVILLE, N.J., Nov. 07, 2025 (GLOBE NEWSWIRE) — IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, will host an R&D Day on Monday, November 10, 2025 at 8:00 a.m. ET in New York City featuring in-depth discussions with experts including principal investigators leading the Phase 3 OVATION 3 clinical trial and Phase 2 minimal residual disease (MRD) trial of IMNN-001, a novel IL-12 immunotherapy in development for the treatment of women with advanced ovarian cancer.

“This is an opportunity to hear directly from the investigators driving IMNN-001 clinical progress forward—physicians who see firsthand the urgent need for new ovarian cancer treatment options and the potential clinical impact of our novel IMNN-001 immunotherapy,” said Stacy R. Lindborg, Ph.D., president and chief executive officer of IMUNON. “The data and insights shared will be consequential for understanding the future of ovarian cancer treatment and how we are leading the effort to bring the first advance in the standard of care that could transform frontline treatment, which has not seen innovation for about 30 years.”

The event will include presentations from:

• Premal H. Thaker, M.D. (Washington University School of Medicine) – Unmet need and OVATION 2 trial data including survival benefits
• Amir A. Jazaeri, M.D. (MD Anderson Cancer Center) – Phase 2 MRD study results and immune activation mechanism overview
• Giorgio Paulon, Ph.D. (Berry Consultants, LLC) – Phase 3 trial statistical design and path to approval
• Douglas V. Faller, M.D., Ph.D. (IMUNON) – Phase 3 trial enrollment momentum and clinical milestones

To register to attend the event in person or virtually, please RSVP by clicking here.

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 conducting 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 news 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 the timing of 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:

Treace Announces Participation in Two Upcoming Investor Conferences




Treace Announces Participation in Two Upcoming Investor Conferences

PONTE VEDRA, Fla., Nov. 07, 2025 (GLOBE NEWSWIRE) — Treace Medical Concepts, Inc. (“Treace” or the “Company”) (NasdaqGS: TMCI), a medical technology company driving a fundamental shift in the surgical treatment of bunions and related midfoot deformities, today announced it will participate in the following upcoming investor conferences.

• The UBS Global Healthcare Conference on Monday, November 10, 2025, with a fireside chat at 11:45 am ET; and
• The Stifel 2025 Healthcare Conference on Tuesday, November 11, 2025

A live webcast and replay of the fireside chat will be available on the Company’s investors relations website at https://investors.treace.com/.

Internet Posting of Information
Treace routinely posts information that may be important to investors in the “Investor Relations” section of its website at www.treace.com. The Company encourages investors and potential investors to consult the Treace website regularly for important information about Treace.

About Treace Medical Concepts

Treace Medical Concepts, Inc. is a medical technology company with the goal of advancing the standard of care for the surgical management of bunion and related midfoot deformities. Bunions are complex 3-dimensional deformities that originate from an unstable joint in the middle of the foot and affect approximately 65 million Americans, of which Treace estimates 1.1 million are annual surgical candidates. Treace has pioneered and patented the Lapiplasty^® 3D Bunion Correction^® System – a combination of instruments, implants, and surgical methods designed to surgically correct all three planes of the bunion deformity and secure the unstable joint, addressing the root cause of the bunion and helping patients get back to their active lifestyles. To further support the needs of bunion surgeons and address the four classes of bunions, Treace introduced its Adductoplasty^® Midfoot Correction System, designed for reproducible surgical correction of midfoot deformities, the SpeedMTP™ Rapid Compression Implant for addressing bunions through big toe joint fusions, and two systems for minimally invasive osteotomy surgeries: the Nanoplasty™ 3D Minimally Invasive Bunion Correction System and the Percuplasty™ Percutaneous 3D Bunion Correction System. Treace continues to expand its footprint in the foot and ankle market with the introduction of its SpeedPlate^® Rapid Compression Implants, an innovative fixation platform with broad versatility across Lapiplasty^®, Adductoplasty^® and SpeedMTP™ procedures, as well as other common bone fusion procedures of the foot. For more information, please visit www.treace.com.

To learn more about Treace, connect with us on LinkedIn, X, Facebook and Instagram.

Contacts:

Treace Medical Concepts
Mark L. Hair
Chief Financial Officer
mhair@treace.net 
(904) 373-5940

Investors:
Gilmartin Group
Philip Trip Taylor
IR@treace.net 

Celldex to Present at Upcoming Investor Conferences




Celldex to Present at Upcoming Investor Conferences

HAMPTON, N.J., Nov. 07, 2025 (GLOBE NEWSWIRE) — Celldex (NASDAQ:CLDX) announced today that management will participate in fireside chats at the following upcoming investor conferences:

• Guggenheim 2^nd Annual Healthcare Innovation Conference on Tuesday, November 11 at 10:00 am ET
• TD Cowen Immunology & Inflammation Summit on Thursday, November 13 at 9:30 am ET
• 8^th Annual Evercore Healthcare Conference on Tuesday, December 2 at 3:00 pm ET

Live webcasts of the presentations will be available on the “Events & Presentations” page of the “Investors” section of the Celldex website. Replays will be available for 90 days following the event.

About Celldex
Celldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders.
Visit www.celldex.com.

Company Contact
Sarah Cavanaugh
Senior Vice President, Corporate Affairs & Administration
(508) 864-8337
scavanaugh@celldex.com

Patrick Till
Meru Advisors
(484) 788-8560
ptill@meruadvisors.com