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HCW Biologics Reports Fourth Quarter 2025 and Fiscal Year 2025 Business Highlights and Financial Results

On March 31, 2026 HCW Biologics Inc. (the "Company" or "HCW Biologics") (NASDAQ: HCWB), a clinical-stage biopharmaceutical company developing transformative fusion immunotherapeutics to support or treat diseases promoted by chronic inflammation, reported financial results and recent business highlights for its three months ended December 31, 2025.

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On November 17, 2025, the Company initiated its first-in-human clinical trial to evaluate HCW9302, the lead product candidate for the Company’s program to develop treatments for autoimmune disorders and proinflammatory diseases, in patients with areata alopecia. HCW9302 is a subcutaneously injectable, first-in-kind interleukin-2 ("IL-2") fusion immunotherapeutic. IL-2, the active component of HCW9302, is the cytokine in humans and other vertebrates responsible for maintaining the proper numbers and functions of Treg cells in the body. Treg cells control excessive inflammation caused by other immune cells, which is the etiology of autoimmune diseases.

The Company believes that HCW9302 can suppress the hair-follicle killing activities of the auto-reactive immune cells by activating and expanding regulatory T cells ("Treg") cells. There are no curative FDA approved treatments of this indication. Alopecia areata causes sudden hair loss and can have a significant negative impact on patients’ quality of life and psychological health. The National Alopecia Areata Foundation estimates approximately 160 million people worldwide and 7 million people in the United States have alopecia areata. The condition affects about 2% of the global population at some point in their lifetime.

The Phase 1 multi-center dose-escalation study of HCW9302 is designed to treat up to 30 patients. The primary objectives of the study are to evaluate the safety of HCW9302, injected under the skin (subcutaneously), and to determine the recommended dose level to advance to later phase clinical studies. A preliminary human data read out is expected in the first half of 2026.

Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer said, "We are excited to be the sponsor of this clinical study to evaluate this promising new treatment for alopecia areata. We will be conducting additional ancillary studies to provide further insights into disease responses and the effects of HCW9302 on proliferation and function of immune cells, particularly Treg cells."

Dr. Wong continued, "Based the results of our preclinical studies including non-human primates, we believe the human data read out will show that HCW9302 has superior IL-2Rα affinity and will sustain serum exposure, which could potentially make it favorable for the expansion and in increasing the functionality of Treg for autoimmune disease treatments. HCW9302 was well tolerated in non-human primate studies. If this remains the case in human studies, this would be a significant improvement over conventional IL-2 therapies that have low tolerability profiles. We believe the data will confirm that HCW9302 can achieve strong biological activity at lower therapeutic dose levels, and as a result, will have a favorable tolerability and at the same time can potentially enhance receptor selectivity and reduce off-target effects."

Business Highlights

Upfront License Fee Received for Exclusive Worldwide License for HCW11-006

As of March 16, 2026, we received the full payment of the upfront licensing fee for the exclusive worldwide license for HCW11-006, a preclinical molecule licensed to Beijing Trimmune Biotech Co., Ltd. ("Trimmune"). The Company received $3.5 million in gross proceeds, and $2.9 million net after taxes. In addition to the cash portion of the upfront license fee, the Company received a transferable minority equity interest in Trimmune.

HCW Biologics is eligible to receive additional payments under the license, including development milestone payments and double-digit royalties on future product sales, as well as a portion of the proceeds from certain future transaction(s) involving the licensed molecule, if and when such transaction(s) occur. Upon completion of Phase 1 by the licensee, the Company may exercise its Opt-In Rights to reclaim the rights to the Americas market. For an additional fee, Trimmune may exercise an option to license the China rights to HCW9302, the Company’s clinical-stage molecule, currently being evaluated in a Phase 1 trial in an autoimmune disorder.

Commercial-Ready Molecules Used as Reagents

During the year ended December 31, 2025, the Company launched two of its proprietary fusion protein molecules as commercial-ready molecules used as reagents to be used to support the production of cell-based immunotherapeutics to treat infectious diseases and cancer. While the Company’s focus remains on the development of fusion immunotherapeutics for the treatment of diseases promoted by chronic inflammation, the Company intends to market these reagents directly or through a corporate partnership to generate revenue which could offset development costs for its other immunotherapeutic treatments.

On March 13, 2026, Science Advances, a peer-reviewed, high-impact journal, released a publication with the Company’s data that showed the Company’s proprietary, commercial-ready compound, HCW9206, could fundamentally change how CAR-T cell therapies are manufactured and potential improve their clinical efficacy against diseases such as cancer and HIV. These findings support the Company’s belief that HCW9206 is a leap forward in both clinical potential and manufacturing efficiency.

Fourth Quarter 2025 Financial Results

Revenues: Revenues for the three months ended December 31, 2024 and 2025 were $394,804 and $27,010, respectively. Revenues for the years ended December 31, 2024 and 2025 were $2.6 million and $54,232, respectively. Historically, revenues have been derived exclusively from the sale of licensed molecules to the Company’s licensee, Wugen. In the year ended December 31, 2025, the Company agreed to a one-year suspension of the Wugen License Agreement in exchange for the exclusive right to market HCW9206 and HCW9201 as reagents and potentially identify a new corporate partner during this period.

Research and development (R&D) expenses: R&D expenses for the three months ended December 31, 2024 and 2025 were $1.0 million and $1.3 million, respectively, an increase of $283,491, or 27%. R&D expenses for the years ended December 31, 2024 and 2025 were $6.4 million and $5.4 million, respectively, a decrease of $1.0 million, or 15%. R&D expenses in the year ended December 31, 2024 were higher than in the comparable period in 2025, due to higher expenses incurred for manufacturing and materials.

General and administrative (G&A) expenses: G&A expenses for the three months ended December 31, 2024 and 2025 were $2.0 million and $1.5 million, respectively, a decrease of $526,175, or 26%. G&A expenses for the years ended December 31, 2024 and 2025 were $6.8 million and $7.7 million, respectively, an increase of $884,832 or 13%. The increase in G&A expenses in 2025 was primarily due to salaries and benefits and professional fees related to audit services, tax and other advisory services, as well as required activities to remain in compliance with SEC regulations and Nasdaq listing rules.

Legal expenses (recoveries), net: Legal expenses and recoveries, net represent the legal fees that the Company incurred for an Arbitration which held its hearing in May 2024, was settled on July 13, 2024, and was dismissed on December 24, 2024. Legal expenses (recoveries), net for the three months ended December 31, 2024 and 2025 were $148,949 and $120,136, respectively. Legal expenses (recoveries), net for the years ended December 31, 2024 and 2025 were $15.9 million and a contra expense of ($1.5) million, respectively. In January 2025, the Company received a $2.0 million insurance reimbursement that was paid directly to the law firm involved in representing Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, in the Arbitration. The Company and Dr. Wong reached a settlement agreement in 2025 for the full balance of $7.5 million which was owed for legal fees incurred in connection with the defense for Dr. Wong, resulting in a gain of $5.5 million for the year ended December 31, 2025.

Net (loss) gain: Net (loss) gain for the three months ended December 31, 2024 and 2025 was ($3.4) million and $2.2 million, respectively. Net loss for the years ended December 31, 2024 and 2025 was ($30.0) million and ($6.5) million, respectively.

(Press release, HCW Biologics, MAR 31, 2026, View Source [SID1234664079])

Caribou Biosciences Announces the FDA Granted Regenerative Medicine Advanced Therapy (RMAT) Designation to CB-011, an Allogeneic Anti-BCMA CAR-T Cell Therapy

On March 31, 2026 Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to CB-011 for relapsed or refractory multiple myeloma (r/r MM). CB-011, an allogeneic anti-BCMA CAR-T cell therapy, is being evaluated in the company’s ongoing open-label, multicenter CaMMouflage phase 1 clinical trial evaluating patients with r/r MM.

"Only one in 10 people with multiple myeloma in the U.S. are able to receive CAR-T cell therapies due to long wait times and manufacturing limitations," said Adriana Rossi, MD, director of CAR-T and stem cell transplant clinical program at the center of excellence for multiple myeloma at Mount Sinai and an investigator on the CaMMouflage trial. "This highlights a critical gap in access for patients with relapsed or refractory disease. An off-the-shelf CAR-T cell therapy like CB-011 could help bridge that gap by offering a readily available treatment option to a broader group of patients."

As previously reported in November 2025, 48 patients have been treated in the dose escalation portion of the company’s CaMMouflage phase 1 clinical trial. The 450×106 CAR-T cell dose was selected as the recommended dose for expansion (RDE). In dose escalation, 12 BCMA-naïve patients were treated with the RDE; efficacy outcomes from this cohort included a 92% (11/12) overall response rate (ORR), 75% (9/12) ≥ complete response (CR) rate, and 91% (10/11 evaluable) minimal residual disease (MRD) negativity as of a September 24, 2025, data cutoff. CB-011 has demonstrated a manageable safety profile, with no cases of graft-versus-host disease, immune effector cell-associated enterocolitis, parkinsonism, or cranial nerve palsies observed at any dose level. Treatment emergent adverse events (TEAEs) in ≥25% of all patients treated with CB-011 following the selected lymphodepletion (LD) regimen (N=35) were as follows: neutropenia (80%), anemia (60%), thrombocytopenia (49%), infections (49%), dizziness (31%), cytokine release syndrome (31%), fatigue (31%), leukopenia (29%), decreased appetite (29%), constipation (26%), and pyrexia (26%) as of the data cutoff date.

"The FDA’s RMAT designation for CB-011 recognizes both the significant unmet need in multiple myeloma and the encouraging clinical data we have seen so far in the CaMMouflage trial," said Tina Albertson, MD, PhD, chief medical officer at Caribou Biosciences. "The dose escalation data highlight the potential of CB-011 as the best-in-class allogeneic CAR-T cell therapy for relapsed or refractory multiple myeloma. We look forward to initiating discussion with the FDA regarding future clinical development of CB-011 and to reporting additional data this year as we continue to enroll both BCMA-naïve and BCMA-exposed patients in dose expansion."

RMAT designation is a dedicated program designed to expedite the development and review processes for promising therapeutic candidates intended to address an unmet medical need in patients with serious conditions. This designation provides important benefits in the drug development process and is designed to facilitate and expedite development and regulatory review, including providing eligibility for priority and rolling reviews and accelerated approval, if relevant criteria are satisfied.

About CB-011
CB-011 is an allogeneic anti-BCMA CAR-T cell therapy being evaluated in patients with relapsed or refractory multiple myeloma (r/r MM). To Caribou’s knowledge, CB-011 is the first allogeneic CAR-T cell therapy in the clinic that is engineered to enable activity through an immune cloaking strategy with a B2M knockout and insertion of a B2M–HLA-E fusion protein to blunt immune-mediated rejection. The FDA granted CB-011 Regenerative Medicine Advanced Therapy (RMAT), Fast Track, and Orphan Drug designations for r/r MM.

About the CaMMouflage phase 1 clinical trial
The CaMMouflage clinical trial is a multicenter, open-label phase 1 trial evaluating CB-011 in adults with r/r MM who have been treated with three or more prior lines of therapy. Using a 3+3 dose escalation design, safety and efficacy of CB-011 were evaluated in 48 patients at multiple dose levels and two different lymphodepletion (LD) regimens. Thirteen patients were treated with a single dose of CB-011 (50×106 [N=3], 150×106 [N=7], and 450×106 [N=3] CAR-T cells) with an LD regimen of 300 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for three days, and 35 patients were treated with a single dose of CB-011 (150×106 [N=6], 300×106 [N=13], 450×106 [N=13], and 800×106 [N=3] CAR-T cells) with an LD regimen of 500 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for three days. The ongoing dose expansion portion of the trial will evaluate safety and efficacy of CB-011 at 450×106 CAR-T cells with the selected LD of 500 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for three days. Additional information on the CaMMouflage trial (NCT05722418) can be found at www.clinicaltrials.gov.

(Press release, Caribou Biosciences, MAR 31, 2026, View Source [SID1234664078])

Alpha Tau Announces First-Ever Oral Presentation of Alpha DaRT® Pancreatic Cancer Data at Digestive Disease Week (DDW) 2026

On March 31, 2026 Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT reported that an abstract presenting results of two clinical trials in Jerusalem in patients with pancreatic cancer has been accepted for an oral presentation at Digestive Disease Week (DDW) 2026, the world’s premier international gastroenterology conference. This marks the first time that clinical results of Alpha DaRT in pancreatic cancer patients have been selected for presentation at a major gastroenterology conference.

The abstract, entitled "Updated Results of Feasibility, Safety, and Tumor Control in Two First-In-Human Trials of a Novel Alpha-Emitting Radionuclide for Pancreatic Adenocarcinoma," has been selected for podium presentation in the Pancreatic Cancer I: Diagnosis and Treatment session on Saturday, May 2, 2026 at 10:30am (Central). The presentation will be led by study Principal Investigator Dr. Harold Jacob, Director of Advanced Gastrointestinal Endoscopy at Hadassah University Medical Center, and is based on combined data from two clinical protocols conducted at Hadassah Medical Center in Jerusalem, Israel.

"The acceptance of this abstract for an oral presentation at DDW is an important milestone for Alpha Tau" stated Uzi Sofer, CEO of Alpha Tau, "It reflects the growing recognition of the potential of our technology to address this devastating disease. With the vast majority of pancreatic cancer patients deemed inoperable at diagnosis, Alpha DaRT seeks to offer a truly novel approach for both locally advanced and metastatic patients, and we look forward to sharing these data at DDW."

Dr. Harold Jacob, commented, "I am gratified that our work has been selected for an oral presentation at DDW. As the first clinical data of Alpha DaRT in pancreatic cancer to be presented at a major gastroenterology forum, this acceptance highlights the importance and potential of this technology. Alpha DaRT is designed to be uniquely suited for delivery by gastroenterologists via EUS, hopefully positioning our specialty at the forefront of a new era in pancreatic cancer therapy.

Dr. Robert Den, Chief Medical Officer of Alpha Tau, commented, "The selection of this abstract for an oral presentation at DDW is a testament to the scientific rigor and clinical significance of the work conducted at Hadassah, and of course to Alpha Tau’s excellent investigational technology. These foundational studies have been instrumental in informing our clinical development program, including the IMPACT pilot study now actively enrolling in the U.S., as well as our ongoing work toward a future pivotal study. The full data will be presented at DDW in May."

About DDW 2026

Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers, and academics in the fields of gastroenterology, hepatology, endoscopy, and gastrointestinal surgery. DDW 2026 will be held May 2–5, 2026.

(Press release, Alpha Tau Medical, MAR 31, 2026, View Source [SID1234664077])

Medicilon and Hailu Biotech of Yangtze River Pharmaceutical Group Forge Strategic Cooperation to Accelerate New Drug R&D and Global Outreach

On March 30, 2026 Medicilon reported a strategic cooperation signing ceremony with Suzhou Hailu Biotech, a wholly-owned subsidiary of Yangtze River Pharmaceutical Group. The collaboration will focus on deepening synergy in preclinical new drug R&D, project introduction, and global market expansion, with the goal of jointly building an efficient, open, and international R&D ecosystem spanning from source innovation to IND filing. This partnership is poised to lead the high-quality development and global advancement of China’s biomedical industry.

Key executives from both organizations attended the ceremony and engaged in in-depth discussions on the cooperation’s vision and implementation roadmap. Representatives from Yangtze River Pharmaceutical Group included Ruwei Wang, Special Assistant to the Chairman and Head of the Group’s Pharmaceutical Research Institute; Jian Liu, Assistant to the Dean and Head of the Macromolecule Innovation Center; and Wenjun Shan, Head of the Small Molecule Innovation Center. From Medicilon, attendees included Chunlin Chen, Chairman and CEO; Jinna Cai, Director and Chief Business Officer; Guokai Chen, Director and Vice President of Investment & Financing; Jian Ge, Executive Vice President of the Preclinical Division; and Binbin Liu, Vice President of Operations.

Complementary Strengths to Accelerate One-Stop New Drug R&D

As a core biologic R&D platform and wholly-owned subsidiary of Yangtze River Pharmaceutical Group, Hailu Biotech has established a comprehensive macromolecule innovative drug R&D system covering target discovery, molecular design, and preclinical development. Leveraging its antibody discovery and engineering platforms, Hailu Biotech focuses on cutting-edge technologies such as monoclonal/bispecific antibodies, ADCs, and small nucleic acids, with a focus on oncology, metabolism, autoimmune diseases, and central nervous system disorders. The company is committed to addressing unmet clinical needs and delivering improved treatment options for patients through its leading technological capabilities.

Medicilon, a leading one-stop preclinical R&D CRO, offers end-to-end services spanning drug discovery, pharmaceutical research, and preclinical studies. The company operates a research system compliant with standards set by China’s NMPA, the U.S. FDA, OECD GLP, and AAALAC accreditation. Medicilon has also built specialized R&D service platforms for novel molecular drugs, including antibodies, ADCs, mRNA vaccines, small nucleic acids, PROTACs, and CGT. With a track record of mature technological platforms and successful cases, Medicilon has supported the global launch of multiple innovative drugs.

16 Years of Collaboration: From Project Partnership to Strategic Symbiosis
This strategic cooperation builds on a long-standing partnership between the two parties, which dates back to 2010. Over the past 16 years, Medicilon has established long-term cooperative relationships with Yangtze River Pharmaceutical Group and its subsidiaries, including Shanghai Haiyan Pharmaceutical Technology, Shanghai Hailu Biotechnology, Shanghai Haini Pharmaceutical, Nanjing Hailing Pharmaceutical, Guangzhou Hairui Pharmaceutical. Its services cover the entire preclinical R&D chain, encompassing small nucleic acids, small-molecule chemical drugs, and traditional Chinese medicines, empowering nearly 100 new drug R&D projects and supporting the approval and launch of key drugs such as Dezocine Injection, Omeprazole Enteric-coated Capsules, Levofloxacin Eye Drops, Ticagrelor Tablets, and Tacrolimus.

Shared R&D philosophies, aligned technical services, and consistent quality systems have fostered a mature and efficient collaboration mechanism between the two parties. This foundation of trust and business synergy has elevated their partnership from project-level cooperation to a strategic win-win alliance. Moving forward, the two parties will conduct customized R&D collaboration through flexible models such as commissioned R&D, FTE and FFS, covering one-stop preclinical services including early drug discovery, in vitro and in vivo efficacy studies, Chemistry, CMC, pharmacokinetics, safety evaluation, and regulatory registration. This integration will enable seamless process connection and efficient utilization of R&D resources.

"Bring In & Go Global": Building a Two-Way Ecosystem for Global Drug Outreach
In terms of business development, the two parties will jointly build a "bring in and go global" ecosystem to facilitate the integration of Chinese innovative drugs into the global market, featuring two-way empowerment and mutual promotion. To support global outreach, Medicilon will leverage its mature international platform and global network to connect Hailu Biotech with overseas partners, showcase innovative achievements through participation in top global industry conferences, and accelerate the overseas licensing and development of Hailu Biotech’s drug pipeline.
Meanwhile, Medicilon will use its international perspective and project resources to link Yangtze River Pharmaceutical Group with high-quality overseas innovative drug pipelines and targets, facilitating their development and equity cooperation in the Chinese market. Beyond accelerating the internationalization of individual projects, this ecosystem aims to create a sustainable two-way flow of technologies, resources, and markets, enhancing the global visibility and competitiveness of Chinese innovative drugs.

(Press release, Shanghai Medicilon, MAR 30, 2026, View Source [SID1234664154])

INmune Bio Inc. Announces 2025 Results and Provides Business Update

On March 30, 2026 INmune Bio Inc. (NASDAQ: INMB) (the "Company"), a late-stage biotechnology company focused on inflammation and immunology, reported its financial results for the year ended December 31, 2025 and provides a business update.

Recent Corporate Highlights

CORDStrom Platform:

The CORDStrom program in recessive dystrophic epidermolysis bullosa (RDEB) is on target to file an MAA submission in the UK mid-summer, followed shortly thereafter by anticipated EMA and FDA regulatory submissions.
Hosted KOL led webinar focused on the latest results from the MissionEB Phase III clinical trial highlighting the systemic disease-modifying capabilities of CORDStrom in patients with RDEB.
Announced the publishing of an overview of future applications and research areas for mesenchymal stromal cell (MSC) therapies in the peer-reviewed journal Cytotherapy.
XPro Platform:

Reported new Phase 2 imaging data at the 18th Clinical Trials on Alzheimer’s Disease conference (CTAD), in San Diego, CA. Additional brain imaging analyses are ongoing and expected to be reported in the near future.
Announced FDA alignment to advance to an adaptive Phase 2b/3 registrational pathway with XPro in early Alzheimer’s Disease.
Hosted expert-led webinar on XPro registrational study strategy for early Alzheimer’s Disease, with the discussion focused on results of the Phase 2 MINDFuL trial and alignment with the FDA following the End-of-Phase 2 meeting.
INmune’s MINDFuL trial was featured in a plenary presentation at the AD/PD 2026 conference as a successful example of how aligning patient selection with mechanism of action identifies the patients most likely to respond.
INKmune Platform:

Met primary and two of three secondary endpoints in CARE-PC trial
Continued evaluation of clinical data from the INKmune CARE-PC trial in metastatic castration-resistant prostate cancer.
Ongoing analysis of immune activation and tumor response endpoints to inform future development strategy.
Corporate:

Received Australian R&D rebate of $5.2m AUD ($3.6 million USD) during January 2026.
Company estimates that cash on hand provides runway through Q1 of 2027.
During 2025, the Company sold 4,304,707 shares of common stock in exchange for net cash proceeds of $27.5 million.
Continued alignment of capital allocation with clinical development priorities.
Upcoming Events and Milestones:

The Marketing Authorization Application (MAA) for CORDStrom is scheduled for submission to the UK’s MHRA in mid-summer, followed directly by an EMA filing.
CORDStrom Biologics License Application (BLA) submission to the FDA expected in Q4 2026.
"Reflecting on the progress of 2025 and the momentum of early 2026, it is clear that INmune Bio has reached a defining inflection point," said David Moss, CEO of INmune Bio. "We have transitioned from a mid-stage clinical company into a late-stage, registration-directed organization. Our mission to harness the innate immune system to treat diseases of inflammation has never been more tangible or more urgent. Looking ahead through 2026 and 2027, our strategy is anchored by two late-stage assets that represent significant value for both patients and shareholders: CORDStrom and XPro."

CORDStrom: A Clear Path to Commercialization

CORDStrom, our mesenchymal stromal cell platform for Recessive Dystrophic Epidermolysis Bullosa, is our most immediate commercial catalyst.

2026 Regulatory Milestones: In February, we formally submitted our pre-submission package to the UK’s MHRA. A face-to-face meeting with the MHRA is scheduled for mid-May. We remain on track to file our first Marketing Authorization Application (MAA) in the UK by mid-summer 2026, followed by EU and U.S. (BLA) filings in Q4.
Operational Readiness: We have successfully completed three commercial pilot-scale manufacturing runs at our Stevenage facility, meeting all release criteria. This ensures we are ready to supply the market upon approval.
Financial Strategy: With the recent reauthorization of the Rare Pediatric Disease Priority Review Voucher (PRV) program through 2029, CORDStrom offers a dual-value proposition: a life-changing therapy for "butterfly children" and a high-value PRV that can be monetized to non-dilutively fund our long-term operations.
XPro: Redefining the Alzheimer’s Paradigm

The landscape of Alzheimer’s disease (AD) is shifting toward precision medicine, and INmune Bio is at the forefront.

2026 Focus: Following our successful End-of-Phase 2 meeting with the FDA in February, we have achieved alignment on an integrated Phase 2b/3 registrational pathway. Unlike traditional "all-comer" trials, our program uses a biomarker-enriched design, targeting patients with neuroinflammation. This "precision" approach, validated by our MINDFuL trial data featured at the AD/PD 2026 Plenary, significantly de-risks our path forward.
2027 Horizon: Our Phase 2b/3 program is built to bridge the gap between early cognitive signals (EMACC) and late-stage functional outcomes (CDR-SB). The Phase 2b stage evaluates co-primary endpoints at nine months and serves as a clearly powered go or no-go before we commit to the full Phase 3 registrational portion of the trial. If EMACC and/or pTau-217 readout successfully in the Phase 2b portion of the trial, it advances seamlessly into the registrational stage Phase 3 with CDR-SB at eighteen months (the same primary endpoint used to approve lecanemab and donanemab). The scientific basis for this design is well established: cognitive changes (EMACC) precede and predict functional decline (CDR-SB), which means early cognitive signals at nine months support confidence in functional outcomes at eighteen. We believe this program represents a compelling partnership opportunity, while remaining a viable path for independent development following CORDStrom approval, assuming favorable capital conditions.
Notably, XPro has reported zero cases of ARIA across all clinical studies to date, a critical differentiator in a treatment landscape where ARIA remains a significant limitation of approved therapies.

"From a capital perspective, we remain committed to capital efficiency," said Mr. Moss. "Our strategy is built on hitting clear, data-driven milestones that allow us to maximize shareholder value while minimizing unnecessary burn. We are focused on maintaining the lean, execution-oriented culture that has brought us to this stage."

"2026 is the year of filings and preparation; 2027 will be the year of pivotal execution and potential launch. We thank you for your continued trust and partnership as we work to transform the treatment of inflammatory disease."

Financial Results for the Year Ended December 31, 2025

Net loss attributable to common stockholders for the year ending December 31, 2025 was approximately $45.9 million, compared to approximately $42.1 million during the year ended December 31, 2024.
Research and development expenses totaled approximately $20.7 million for the year ended December 31, 2025, compared to approximately $33.2 million during the year ended December 31, 2024.
General and administrative expenses were approximately $10.3 million for the year ended December 31, 2025, compared to approximately $9.5 million during the year ended December 31, 2024.
Impairment of acquired in-process research and development intangibles assets was $16.5 million during the year ended December 31, 2025, compared to $0 during the year ended December 31, 2024.
As of December 31, 2025, the Company had cash and cash equivalents of approximately $24.8 million.
As of December 31, 2025, the Company had approximately 26.6 million common shares outstanding.
Earnings Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call. Please ask for the INmune Bio Fourth Quarter and Full Year Ended December 31, 2025 Conference Call when reaching an operator.

Date: March 30th, 2026

Time: 4:30 PM Eastern Time

Participant Dial-in: 1-800-343-4136
Participant Dial-in (international): +1-203-518-9843

Conference ID: INMUNE

A live audio webcast of the call can be accessed using this link or clicking here:
View Source;tp_key=96ca7c85d7

A replay will be available approximately 3 hours after the call through April 13, 2026 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 11160807.

About CORDStrom

CORDStrom is a patent-pending cell medicine comprising aseptic, allogeneic, pooled human umbilical cord-derived mesenchymal stromal cells (hucMSCs) in suspension for injection or infusion. The CORDStrom platform leverages, among other things, proprietary screening, pooling and expansion techniques to create off-the-shelf, allogeneic, pooled hucMSCs as medicines to treat complex inflammatory and autoimmune diseases. CORDStrom products are designed to provide high-quality, off-the-shelf, batch-to-batch consistent, scalable, cGMP manufactured, potent cellular medicines that can be produced affordably and with repeatable specification. Pooling allows tuning of different CORDStrom products with different effector functions dependent upon selected donor characteristics. While the first generation CORDStrom product is agnostic to disease indication, the platform enables creation of indication-specific products, which can be tuned for optimization of anti-inflammatory, immunomodulatory, wound healing, and other characteristics.

About XPro

XPro is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and acts differently than currently available TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro could have potential substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication, visit our website at www.inmunebio.com.

(Press release, INmune Bio, MAR 30, 2026, View Source [SID1234664051])