Allarity Therapeutics announces that its collaborative Phase 2 trial with the United States Veteran’s Administration Combining Stenoparib with Temozolomide in Relapsed Small Cell Lung Cancer is Now Open for Enrollment

        

  • This is the first trial combining Allarity’s stenoparib with another anti-cancer agent

  • Stenoparib’s favorable safety profile supports potential for use in combination regimens

  • Trial is fully funded by the U.S. Department of Veterans Affairs and is open to enrollment at 11 VA sites throughout the US

TARPON SPRINGS, Fla., February 3, 2026 – Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib (2X-121)—a differentiated, dual PARP and WNT pathway inhibitor—today announced that enrollment is now open for its new Phase 2 clinical trial evaluating the combination of stenoparib and temozolomide for the treatment of recurrent small cell lung cancer (SCLC).

The trial is being conducted in collaboration with the U.S. Department of Veterans Affairs (VA) and is fully funded through the VA’s Special Emphasis Panel on Precision Oncology. The trial is officially registered as NCT06681220: Biomarker directed trial of temozolomide and stenoparib in relapsed SCLC and is now open for enrollment at 11 VA sites throughout the US.

This Phase 2 study will assess the safety and efficacy of stenoparib in combination with temozolomide, a DNA-alkylating chemotherapy agent, in patients with recurrent SCLC who have progressed after frontline treatment. Prior studies have shown that PARP inhibitors can enhance the activity of temozolomide, but widespread use has been limited by severe hematologic toxicity. The study includes a blood based biomarker developed in the VA Lung Precision Oncology Program to select patients most likely to benefit from this combination.

“The opening of recruitment marks an important step in exploring stenoparib’s potential as a combination agent,” said Thomas Jensen, Chief Executive Officer of Allarity Therapeutics. “Based on clinical data to date from our ongoing trial in ovarian cancer, stenoparib has demonstrated a favorable safety profile, making it a strong candidate for combination therapies — particularly in settings where tolerability has been a limiting factor, as is the case in SCLC. More broadly, we believe stenoparib may offer meaningful clinical benefit in cancers where the WNT signaling pathway plays a key role, which applies to both SCLC and ovarian cancer. We’re particularly enthusiastic about taking this next step in stenoparib’s development as it allows us to explore stenoparib’s enormous potential in other indications and in combination with other agents.”

Shadia Jalal, the study’s Principal Investigator and Professor of Medicine at the Lawrence H. Einhorn Chair in Oncology at Indiana University’s Melvin and Bren Comprehensive Cancer Center said, “We’re excited to explore this novel combination. Patients with relapsed SCLC including veterans have very few effective treatment options. Previous clinical work has shown that the combination of temozolomide with first generation PARP inhibitors is very active but also very limited by the toxicities of the two agents. Stenoparib has not only a unique mechanism of action that could provide benefit to these patients but also has a favorable safety profile that may allow veterans to tolerate this combination therapy and realize meaningful, durable clinical benefit.”

While offering a potentially more favorable safety profile with temozolomide, stenoparib may offer additional anti-tumor benefit through suppression of WNT signaling, a pathway associated with SCLC progression and resistance.

In addition, stenoparib’s ability to cross the blood-brain barrier may offer therapeutic potential for patients with brain metastases, a common and challenging complication in advanced SCLC.

About Stenoparib/2X-121

Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. At present, tankyrases are attracting significant attention as emerging therapeutic targets for cancer, principally due to their role in regulating the WNT signaling pathway. Aberrant WNT/β-catenin signaling has been implicated in the development and progression of numerous cancers. By inhibiting PARP and blocking WNT pathway activation, stenoparib’s unique therapeutic action shows potential as a promising therapeutic for many cancer types, including ovarian cancer, Small Cell Lung Cancer and colorectal cancer. Allarity has secured exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. and was formerly known under the names E7449 and 2X-121. Allarity has two ongoing Phase 2 trial protocols for stenoparib in Ovarian Cancer patients. In the first, patients who had had 2+ lines of therapy were enrolled on stenoparib and given drug twice daily. This protocol has been closed to further enrollment but continues for the enrolled patients who are still receiving benefit from stenoparib administration. The updated data from this study were presented at this AACR special conference on advances in Ovarian Cancer. Note that, as these data are from an ongoing trial, analyses may change as the study fully matures. An amended protocol designed expressly to capitalize on the emerging clinical experience with stenoparib in platinum resistant patients began enrolling patients this summer. This amended protocol enrolls only platinum resistant or platinum-ineligible patients and is designed to accelerate the clinical development of stenoparib toward FDA approval.

About the Drug Response Predictor – DRP® Companion Diagnostic
Allarity uses its drug-specific DRP® to select those patients who, by the gene expression signature of their cancer, may have a high likelihood of benefiting from a specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high, drug-specific DRP score, the therapeutic benefit rate may be enhanced. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines, combined with clinical tumor biology filters and prior clinical trial outcomes. DRP is based on messenger RNA expression profiles from patient biopsies. The DRP® platform has shown an ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients across dozens of clinical studies (both retrospective and prospective). The DRP platform, which may be useful in all cancer types and is patented for dozens of anti-cancer drugs, has been extensively published in the peer-reviewed literature.

About Allarity Therapeutics
Allarity Therapeutics, Inc. (NASDAQ: ALLR) is a clinical-stage biopharmaceutical company dedicated to developing personalized cancer treatments. The Company is focused on development of stenoparib, a novel PARP/tankyrase inhibitor for advanced ovarian cancer patients, using its DRP® technology to develop a companion diagnostic that can be used to select those patients expected to derive the greatest clinical benefit from stenoparib. Allarity is headquartered in the U.S., with a research facility in Denmark, and is committed to addressing significant unmet medical needs in cancer treatment. For more information, visit www.allarity.com.

Follow Allarity on Social Media

LinkedIn: https://www.linkedin.com/company/allaritytx/

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements provide the Company’s current expectations or forecasts of future events. The words “anticipates,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predicts,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, statements regarding the continued clinical development of stenoparib (2X-121) in advanced ovarian cancer and small cell lung cancer; the initiation, enrollment, and expected data readouts from ongoing and future clinical trials; including the trial with the U.S. Department of Veterans Affairs (VA);the potential safety, efficacy, and durability of clinical benefit of stenoparib; stenoparib’s safety and efficacy in combination with temozolomide; the potential for regulatory advancement, including under FDA Fast Track designation; and the expansion and potential commercial application of the Company’s DRP® companion diagnostic platform, including in antibody-based therapies. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to multiple risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks related to clinical development and regulatory review, including the possibility that future clinical data may not support safety or efficacy claims; delays in patient enrollment or trial completion; reliance on third-party investigators and trial sites; the outcome and timing of decisions by regulatory authorities, including under Fast Track designation; the predictive accuracy and clinical utility of the DRP® platform; and the Company’s ability to secure sufficient funding or partnerships to support its operations and development plans. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in our Form 10-K annual report filed with the Securities and Exchange Commission (the “SEC”) on March 31, 2025, and our Form 10-Q quarterly reports filed with the SEC on May 9, 2025, August 15, 2025 and November 14, 2025, available at the SEC’s website at www.sec.gov, and as well as discussions of potential risks, uncertainties and other important factors in the Company’s subsequent filings with the SEC. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law.

###

Company Contact:         
        [email protected]

        
Media Contact:
        Thomas Pedersen
        Carrotize PR & Communications
        +45 6062 9390
        [email protected]

Attachment



Smartkem Welcomes State-Level Support for Carbonium Core’s Proposed Nuclear Graphite Manufacturing Unit

Proposed transaction with Carbonium Core, Inc. to establish domestic nuclear-grade graphite manufacturing in Tennessee, USA


*for illustrative purposes only

MANCHESTER, United Kingdom, Feb. 03, 2026 (GLOBE NEWSWIRE) — Smartkem, Inc. (Nasdaq: SMTK), (“Smartkem” or the “Company”), a leader in advanced materials, today announced that Carbonium Core, Inc. (“Carbonium Core”), with whom Smartkem recently announced a non-binding letter of intent (“LOI”), has received state-level support for its proposed nuclear graphite manufacturing unit. Carbonium Core is a U.S.-based advanced materials company focused on the domestic production of nuclear graphite.

State Senator Jessie Seal, Vice-Chairman of the Tennessee Senate Energy, Agriculture and Natural Resources Committee welcomed Carbonium Core’s planned nuclear graphite manufacturing presence in Tennessee’s Cumberland Gap region and cited its potential to drive job creation and economic growth.

“This upcoming manufacturing unit is a major win for our local community,” Senator Seal said. “This development will bring many quality jobs, outstanding economic growth, and new opportunities for our communities. I would like to offer my full support to Carbonium Core, Inc. and I look forward to working closely with them to ensure everyone’s long-term success.”

If completed, the proposed transaction would combine Smartkem’s advanced materials and process expertise with Carbonium Core’s vertically integrated platform for producing nuclear graphite, a critical material used in next-generation nuclear reactor technologies, including small modular reactors (SMRs) and Generation IV designs.

Carbonium Core is focused on establishing a fully domestic supply chain for nuclear graphite, encompassing purification, graphitization, shaping, and finishing. This end-to-end approach is intended to ensure consistent quality, performance, and security of supply, while reducing reliance on overseas sources of reactor-grade graphite.

“We welcome the strong support from Tennessee leadership for Carbonium Core’s planned nuclear graphite manufacturing presence in the state,” said Ian Jenks, Chief Executive Officer of Smartkem. “If completed, the proposed transaction would bring together Carbonium Core’s vertically integrated nuclear graphite capabilities with Smartkem’s advanced materials and process innovation to help establish a secure, domestic supply chain for a material that is critical to the future of nuclear energy.”

Subject to completion, the transaction is expected to support the development of a U.S.-based nuclear graphite manufacturing footprint in Tennessee, leveraging the state’s industrial infrastructure, skilled workforce, and proximity to advanced energy and manufacturing supply chains. The project is designed to support U.S. energy security objectives through domestic production of nuclear graphite using environmentally responsible processing methods.

Completion of the proposed transaction is subject to satisfactory due diligence, execution of definitive agreements, receipt of required approvals, and other customary closing conditions. There can be no assurance that any definitive agreements will be negotiated or executed, that the proposed transaction will be consummated on the terms described herein, or at all, or as to the timing or final terms of any transaction. Smartkem will provide further updates as appropriate, in accordance with applicable disclosure requirements.

About Smartkem

Smartkem is seeking to change the world of electronics with a new class of transistors developed using its proprietary advanced semiconductor materials. Our TRUFLEX® semiconductor polymers enable low temperature printing processes that are compatible with existing manufacturing infrastructure to deliver low-cost, high-performance electronics. Our semiconductor platform can be used in a range of technologies including MicroLED, LCD and AMOLED, as well as in applications in advanced computer and AI chip packaging, sensors, and logic.  

Smartkem designs and develops its materials at its research and development facility in Manchester, UK and operates a field application office in Hsinchu, Taiwan, close to collaboration partner, The Industrial Technology Research Institute (ITRI), where it provides prototyping services. Smartkem is developing a commercial-scale production process and Electronic Design Automation (EDA) tools to demonstrate the commercial viability of manufacturing a new generation of displays using its materials.   

The company has an extensive IP portfolio including 141 granted patents across 17 patent families, 15 pending patents and 40 codified trade secrets. 

For more information, visit the Smartkem website or follow on LinkedIn.  

About Carbonium Core, Inc.

Carbonium Core, Inc. is a U.S.-based advanced materials company focused on producing nuclear-grade graphite for 4th-generation reactors. Its mission is simple – to secure a resilient, sustainable, and competitive domestic supply of this critical material through science, innovation, and responsible sourcing.

Carbonium Core, Inc. combines: cutting-edge materials engineering, exclusive purification technology, vertically integrated supply chain – from mine to reactor, and sustainable and scalable production – reducing waste, cost, and carbon footprint.

For more information, visit the Carbonium Core, Inc. website.

Forward-Looking Statements

All statements in this press release that are not historical are forward-looking statements, including, among other things, statements regarding the anticipated timing, proposed terms and the Company’s ability to close the proposed transaction with Carbonium Core; the anticipated benefits of the proposed transaction with Carbonium Core; Carbonium Core’s planned nuclear graphite manufacturing presence in Tennessee’s Cumberland Gap region and the facility’s potential to drive job creation and economic growth; Smartkem Inc.’s market position and market opportunity, expectations and plans as to its product development, manufacturing and sales, and relations with its partners and investors. These statements are not historical facts but rather are based on Smartkem, Inc.’s current expectations, estimates, and projections regarding its business, operations and other similar or related factors. Words such as “may,” “will,” “could,” “would,” “should,” “anticipate,” “predict,” “potential,” “continue,” “expect,” “intend,” “plan,” “project,” “believe,” “estimate,” and other similar or elated expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond the Company’s control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including uncertainties inherent in the negotiation of business transactions, the ability to satisfy closing conditions as well as other risks described in the Company’s filings with the Securities and Exchange Commission. The Company undertakes no obligation to revise or update information in this release to reflect events or circumstances in the future, even if new information becomes available, except as required by law.  

Contacts

Selena Kirkwood
Head of Communications for Smartkem
[email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/9831ee03-d1a5-4f2e-8478-382d336be55b



BioCardia Announces Late Breaking Echocardiography Results from the CardiAMP HF Trial to be Presented at Technology and Heart Failure Therapeutics (THT)

SUNNYVALE, Calif., Feb. 03, 2026 (GLOBE NEWSWIRE) — BioCardia®, Inc. [NASDAQ: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced echocardiography data for the CardiAMP Cell Therapy for the treatment of heart failure has been accepted for Late Breaking Clinical Trial Oral Presentation at the Technology and Heart Failure Therapeutics (THT) Meeting, which takes place March 2-4 in Boston, Massachusetts.

On behalf of the CardiAMP HF investigators, the presentation will be made by Dr. Amish Raval, M.D., Professor of Medicine at UW School of Medicine and Public Health and CardiAMP HF Trial National Co-Principal Investigator.

Presentation Title:
“Autologous Cell Therapy May Curb Pathological Ventricular Remodeling in Chronic Ischemic HFrEF Patients Selected for Favorable Cell Characteristics – Late Breaking Echocardiography Results from the CardiAMP HF trial.

Presentation Session: THT Late Breaking Clinical Trial Oral Presentation on March 2 at 2pm EST.

About CardiAMP Autologous Cell Therapy

Granted FDA Breakthrough designation, CardiAMP Cell Therapy uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure intended to increase capillary density and reduce tissue fibrosis of myocardial tissue to address microvascular dysfunction. Clinical development of the CardiAMP Cell Therapy for heart failure is supported by the Maryland Stem Cell Research Fund and is reimbursed by Centers for Medicare and Medicaid Services (CMS). CAUTION – Limited by United States law to investigational use. 

About BioCardia® 

BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three cardiac clinical stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms, and soon the Heart3D™ fusion imaging platform. BioCardia selectively partners on biotherapeutic delivery with peers developing important biologic therapies. For more information visit www.biocardia.com.

Forward Looking Statements 

This press release contains forward-looking statements that are subject to risks and uncertainties. Forward-looking statements include, among other things, the presentation of data and future conferences, the protection of the Company’s intellectual property estate, and references to the Company’s investigational product candidates. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements.

We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 26, 2025, under the caption titled “Risk Factors,” and in our subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

Media Contact: 

Miranda Peto, Investor Relations
Email: [email protected]
Phone: 650-226-0120

Investor Contact:

David McClung, Chief Financial Officer
Email: [email protected]
Phone: 650-226-0120



Replimune Reports Fiscal Third Quarter 2026 Financial Results and Provides Corporate Update

April 10, 2026 Target Action Date for RP1 in Advanced Melanoma

WOBURN, Mass., Feb. 03, 2026 (GLOBE NEWSWIRE) — Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced financial results for the fiscal third quarter ended December 31, 2025 and provided a business update.

The Company’s Biologics License Application (BLA) resubmission for RP1 (vusolimogene oderparepvec) in anti-PD-1 failed melanoma was accepted by the FDA in October 2025 with a Prescription Drug User Fee Act (PDUFA) target action date of April 10, 2026. Commercial readiness activities are well underway to support a potential launch, if approved.

The Company has amended its existing loan agreement with Hercules Capital, Inc. The amendment included the draw down of $35 million upon closing and the potential to draw another $120 million at post approval milestones. The amendment also delays the repayment of debt from 2026 to 2027. The Company has extended its cash runway late into to the first quarter of 2027.

“We have been engaged with the FDA in the review of the BLA resubmission for RP1,” said Sushil Patel, Ph.D., CEO of Replimune. “Advanced melanoma patients can progress quickly and are in urgent need of safe and effective treatment options. Our team remains ready to launch RP1 with commercial supply produced and the commercial organization prepared to engage with our target accounts rapidly, assuming FDA approval.”

Program Highlights & Milestones

RP1 (vusolimogene oderparepvec)

  • IGNYTE-3 Confirmatory Study: The global Phase 3 trial will enroll approximately 400 patients and is assessing RP1 in combination with nivolumab versus physician’s choice in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for anti-CTLA-4 treatment. The primary endpoint of this trial is overall survival, and key secondary endpoints are progression free survival and overall response rate.
  • Acral Melanoma: Recent data for RP1 plus nivolumab was recently presented at the ESMO Congress 2025. The analysis of acral melanoma data from the IGNYTE anti-PD-1 failed melanoma cohort showed treatment with RP1 combined with nivolumab resulted in an objective response rate (ORR) of 44% (8/18) with a median duration of response of 11.9 months. The safety profile was favorable with generally transient grade 1 and 2 treatment related adverse events.
  • Advanced Non-melanoma Skin Cancer (NMSC) Studies: Additionally, a poster from ESMO featuring data from the IGNYTE clinical trial showed that RP1 plus nivolumab provided responses across multiple advanced non-melanoma skin cancer (NMSC) tumor types, including anti–PD-1 naïve and failed disease, as well as both in locally advanced and metastatic disease. The ORR was 100.0%, 33.3%, 66.7%, and 56.3% in patients with anti–PD-1 naïve MCC, BCC, angiosarcoma, and CSCC, respectively. The ORR was 26.3%, 30.0%, 37.5%, and 15.2% in patients with anti–PD-1 failed MCC, BCC, angiosarcoma, and CSCC, respectively. The IGNYTE clinical trial cohort in NMSC is ongoing, however, enrollment was stopped in Q4 2025.
  • ARTACUS Study: Data from the ongoing ARTACUS Phase 2 trial evaluating the potential of RP1 as monotherapy in cutaneous squamous cell carcinoma patients following organ transplant were recently presented during an oral session at the Society for Melanoma Research 22nd International Congress. RP1 monotherapy showed robust anti-tumor activity in locally advanced CSCC with an ORR of 34.6% (CR rate was 23.1%) and 2-year duration of response of 61.0%. RP1 monotherapy was well tolerated, and the safety profile was similar to that observed in non-immunocompromised patients with advanced skin cancers.

RP2

  • REVEAL Study: The registration-directed Phase 2/3 trial of RP2 in metastatic uveal melanoma is actively enrolling. The trial is evaluating RP2 in combination with nivolumab versus ipilimumab in combination with nivolumab in approximately 280 patients. The primary endpoints of the trial are overall survival and progression free survival, and key secondary endpoints are overall response rate and disease control rate. Phase 2/3 transition is expected in Q1 2027, with PFS analysis potentially supporting accelerated approval.
  • Liver-focused Studies: The Phase 2 clinical trial of RP2 combined with atezolizumab and bevacizumab in anti-PD-1/PD-L1 progressed hepatocellular carcinoma is currently enrolling. The protocol was amended to include RP2 as monotherapy with data planned by the end of 2026. The trial is being conducted under a collaboration and supply agreement with Roche. The Company also has enrolled its first patients in a cohort evaluating RP2 in patients with biliary tract cancer. This cohort will evaluate RP2 combined with durvalumab.

Financial Highlights

  • Cash Position
    : As of December 31, 2025, cash, cash equivalents and short-term investments were $269.1 million, as compared to $483.8 million as of fiscal year ended March 31, 2025. The decrease in cash balance was a result of cash burn related to operating activities in advancing the company’s clinical development plans.

    Based on the current operating plan, the Company believes that existing cash, cash equivalents and short-term investments will enable us to fund operations late into the first quarter of calendar 2027. This includes the potential commercialization of RP1 in skin cancers and for working capital and general corporate purposes and excludes any potential revenue.

  • R&D Expenses: Research and development expenses were $53.1 million for the fiscal third quarter and $48.0 million for the fiscal third quarter ended December 31, 2024. This increase was primarily due to an increase in RP1 direct research costs related to the IGNYTE-3 confirmatory study and other study costs including lab and operating supplies, as well as increased RP2 study costs. In addition, personnel-related costs increased as we continued to prepare for a potential commercial launch of RP1. Research and development expenses included $3.6 million in stock-based compensation expenses for the fiscal third quarter ended December 31, 2025.
  • S,G&A Expenses: Selling, general and administrative expenses were $18.7 million for the fiscal third quarter ended December 31, 2025, as compared to $18.0 million for the fiscal third quarter ended December 31, 2024. Selling, general and administrative expenses included $3.4 million in stock-based compensation expenses for the fiscal third quarter ended December 31, 2025.
  • Net Loss: Net loss was $70.9 million for the fiscal third quarter ended December 31, 2025 and $66.3 million for the fiscal third quarter ended December 31, 2024.

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 RP2

RP2 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. RP2 additionally expresses an anti-CTLA-4 antibody-like molecule, as well as GALV-GP R- and GM-CSF. RP2 is intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic-immune-based efficacy on tumors and limiting off-target toxicity.

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 our expectations about our cash runway, the status of the FDA review of our BLA for RP1 or potential approval of such BLA, the design and advancement of our clinical trials, the timing and sufficiency of our clinical trial outcomes to support potential approval of any of our product candidates, the regulatory review process and timing of potential product approval, our goals to develop and commercialize our product candidates, patient enrollments in our existing and planned clinical trials and the timing thereof, and other statements identified by words such as “could,” “expects,” “intends,” “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 the outcome of FDA’s review process, our limited operating history, our ability to generate positive clinical trial results for our product candidates, the costs and timing of operating our in-house manufacturing facility, the timing and scope of regulatory approvals, 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
[email protected]

Media Inquiries

Arleen Goldenberg
Replimune
917.548.1582
[email protected]

Replimune Group, Inc.
Condensed Consolidated Statements of Operations
(Amounts in thousands, except share and per share amounts)
(Unaudited)
       
  Three Months Ended December 31,   Nine Months Ended December 31,
    2025       2024       2025       2024  
Operating expenses:              
Research and development $ 53,140     $ 48,004     $ 168,860     $ 135,472  
Selling, general and administrative   18,728       18,015       77,721       46,827  
Total operating expenses   71,868       66,019       246,581       182,299  
Loss from operations   (71,868 )     (66,019 )     (246,581 )     (182,299 )
Other income (expense):              
Research and development incentives   341       376       1,138       1,222  
Investment income   2,846       5,137       11,256       15,243  
Interest expense on finance lease liability   (514 )     (528 )     (1,553 )     (1,594 )
Interest expense on debt obligations   (1,466 )     (1,450 )     (4,429 )     (4,314 )
Other (expense) income, net   (580 )     (3,281 )     (865 )     (850 )
Total other income (expense), net   627       254       5,547       9,707  
Loss before income taxes $ (71,241 )   $ (65,765 )   $ (241,034 )   $ (172,592 )
Income tax (benefit) provision $ (311 )   $ 575     $ (311 )   $ 575  
Net loss $ (70,930 )   $ (66,340 )   $ (240,723 )   $ (173,167 )
Net loss per common share, basic and diluted $ (0.77 )   $ (0.79 )   $ (2.62 )   $ (2.25 )
Weighted average common shares outstanding, basic and diluted   92,187,581       83,498,892       91,874,481       77,113,695  

Replimune Group, Inc.
Condensed Consolidated Balance Sheets
(Amounts In thousands, except share and per share amounts)
(Unaudited)
       
  December 31,

2025
  March 31,

2025
  (in thousands)
Consolidated Balance Sheet Data:      
Cash, cash equivalents and short-term investments $ 269,137   $ 483,804
Working capital   230,267     433,518
Total assets   333,590     551,328
Total stockholders’ equity   210,539     415,843



Aemetis India Subsidiary Begins Biodiesel Deliveries Under $24 Million Allocation from OMCs

CUPERTINO, Calif., Feb. 03, 2026 (GLOBE NEWSWIRE) — Aemetis, Inc. (NASDAQ: AMTX), a diversified renewable natural gas and biofuels company, announced that its Universal Biofuels subsidiary in India secured allocations of approximately $24 million for the supply of more than 27 million liters of biodiesel to India’s three government-owned Oil Marketing Companies (OMCs) for the period ending March 2026.

Additional OMC fuel supply orders are expected throughout the year to support the India government’s goal of increasing from a 1% biodiesel blend to a targeted 5%, as stated in the current India National Policy on Biofuels.

“Universal Biofuels and other biodiesel producers look forward to continuous support from the government of India to build and expand a healthy biodiesel industry,” stated Sanjeev Duggal, CEO of Universal Biofuels.

“In the past five years, India rapidly grew from about a 1% blend to a 20% blend of ethanol into gasoline. The India government’s 5% biodiesel blending target of more than 1.2 billion gallons per year requires rapid expansion of biodiesel blending from the current levels of less about 1% biodiesel blending,” stated Eric McAfee, Chairman and CEO of Aemetis. “Our Universal Biofuels subsidiary has a long and successful track record of producing and delivering high-quality renewable fuels and pharma-grade glycerin from our India plant.”

The Universal Biofuels subsidiary of Aemetis is one of the largest biodiesel producers in India and has been in operation for more than 17 years. Universal Biofuels has significantly expanded the production capacity of its Kakinada biodiesel plant to 80 million gallons per year, including expansion of its proprietary enzymatic process to produce lower carbon-intensity biodiesel at reduced cost. 

Universal Biofuels is exploring opportunities to expand to other locations throughout India, including diversification into the production of other renewable fuels such as dairy biogas, ethanol, and sustainable aviation fuel. To support this growth, Universal Biofuels is preparing to undertake an Initial Public Offering (IPO) for a sale of a minority equity stake to public investors on the India stock exchange, subject to continued favorable market conditions.

About Aemetis

Headquartered in Cupertino, California, Aemetis is a diversified renewable natural gas and biofuels company focused on the development and operation of innovative technologies that lower energy costs and reduce emissions. Founded in 2006, Aemetis is operating and expanding a California biogas digester network and pipeline system to convert dairy waste gas into Renewable Natural Gas. Aemetis owns and operates a 65 million gallon per year ethanol production facility in California’s Central Valley near Modesto that supplies about 80 dairies with animal feed. Aemetis owns and operates an 80 million gallon per year production facility on the East Coast of India producing high quality biodiesel and refined glycerin. To utilize the byproducts from ethanol production, Aemetis is developing a sustainable aviation fuel plant and a CO2 sequestration project in California. For additional information about Aemetis, please visit www.aemetis.com

Company Investor Relations

Media Contact:

Todd Waltz
(408) 213-0940
[email protected]

External Investor Relations

Contact:

Kirin Smith
PCG Advisory Group
(646) 863-6519
[email protected]

Safe Harbor Statement

This news release contains forward-looking statements, including statements regarding assumptions, projections, expectations, targets, intentions or beliefs about future events or other statements that are not historical facts. Forward-looking statements include, without limitation, projections of financial results; the ability of Universal Biofuels to undertake an IPO; our ability to promote, develop, finance, and construct facilities to produce biodiesel, renewable fuels, and biochemicals; and statements about future market prices and results of government actions. Words or phrases such as “anticipates,” “may,” “will,” “should,” “believes,” “estimates,” “expects,” “intends,” “plans,” “predicts,” “projects,” “showing signs,” “targets,” “view,” “will likely result,” “will continue” or similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on current assumptions and predictions and are subject to numerous risks and uncertainties. Actual results or events could differ materially from those set forth or implied by such forward-looking statements and related assumptions due to certain factors, including, without limitation, competition in the ethanol, biodiesel and other industries in which we operate, commodity market risks including those that may result from current weather conditions, financial market risks, customer adoption, counter-party risks, risks associated with changes to federal policy or regulation, and other risks detailed in our reports filed with the Securities and Exchange Commission, including our Annual Reports on Form 10-K, and in our other filings with the SEC. We are not obligated, and do not intend, to update any of these forward-looking statements at any time unless an update is required by applicable securities laws.



zSpace Career Explorer™ Powered by Career Coach AI™ Receives Tech & Learning’s Best of 2025 Award of Excellence

SAN JOSE, Calif., Feb. 03, 2026 (GLOBE NEWSWIRE) — zSpace, Inc. (NASDAQ: ZSPC), a leading provider of augmented and virtual reality (AR/VR) solutions for education, today announced that zSpace Career Explorer™ Powered by Career Coach AI™ has been named a recipient of Tech & Learning’s Best of 2025 Award of Excellence in the Primary Education category.

The Tech & Learning Best of Awards recognize educational technology solutions that demonstrate exceptional innovation, usability, and impact in supporting teaching and learning. This honor highlights zSpace Career Explorer’s ability to engage upper-elementary through high school students in meaningful, hands-on career exploration while helping districts advance equity, workforce readiness, and measurable student outcomes.

Designed for students in grades 5–12, zSpace Career Explorer™ enables learners to experience high-demand careers through immersive, real-world simulations—moving beyond traditional career talks or static content. Delivered exclusively on zSpace’s headset-free AR/VR laptops, the solution removes the cost, complexity, and safety concerns associated with traditional VR headsets, making immersive career exploration accessible and scalable for classrooms.

Within realistic, community-based environments, students complete interactive tasks aligned to skilled trades, technical, and emerging fields, including welding, vehicle maintenance, robotic programming, carpentry, commercial refrigeration repair, and medical technology. Each experience is paired with dynamic career profiles that outline daily responsibilities, required skills, salary ranges, and education or training pathways—helping students connect classroom learning to real-world opportunities.

Tech & Learning judges praised the platform’s immersive approach and inclusive design, noting:

“zSpace Career Explorer with Career Coach AI is an amazing solution that will help students chart their paths to the future. I particularly like the 3D aspect of performing hands-on, career-oriented tasks. The platform also offers life skills programs for neurodiverse students.”

Career Explorer is enhanced by zSpace Career Coach™, an AI-powered, in-application assistant that provides personalized, on-demand career guidance. Students can ask questions, explore related career pathways based on their interests, and export conversation transcripts for reflection or counselor review—supporting alignment with American School Counselor Association (ASCA) standards and the National Career Development Guidelines.

In 2025, districts implementing zSpace Career Explorer™ reported increased student engagement and participation in career-focused learning, particularly among students who had not previously seen themselves represented in traditional college-bound pathways. Educators and counselors also cited the platform’s built-in engagement metrics and reporting tools as key benefits, enabling them to efficiently measure student interaction, document growth in career awareness, and support data-driven decision-making without increasing administrative workload.

“Being recognized by Tech & Learning validates the impact we’re seeing in classrooms nationwide,” said Paul Kellenberger, CEO at zSpace. “Career Explorer empowers students to explore what’s possible for their futures while giving educators the tools to support equity, engagement, and early career readiness.”

By combining immersive, headset-free AR/VR technology with experiential learning and AI-driven personalization on a single, purpose-built platform, zSpace Career Explorer™ exemplifies the innovation and effectiveness recognized by Tech & Learning’s Best of 2025 Awards of Excellence.

To learn more about zSpace Career Explorer™ Powered by Career Coach AI™, visit:
https://zspace.com/edu/info/career-explorer

About zSpace zSpace, Inc. (NASDAQ: ZSPC) delivers innovative augmented and virtual reality (AR/VR) experiences that drive achievement in STEM, CTE, and career readiness programs. Trusted by over 3,500 school districts, technical centers, community colleges, and universities, zSpace enables hands-on “learning by doing” experiences proven to improve engagement and student outcomes. Headquartered in San Jose, California, zSpace holds more than 80 patents, with research published in the Journal of Computer Assisted Learning (2021) validating the impact of 3D virtual reality technologies on student knowledge gains.

Press Contact:

Amanda Austin
Senior Marketing Director, zSpace, Inc.
[email protected]

Investor Relations Contact:

Gateway Group Cody Slach, Greg Robles
949.574.3860
[email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/dfc65222-e037-4fd7-a9d7-b3532ef34f9e



Kyverna Therapeutics Appoints Mayo Pujols as Chief Technology Officer

Mr. Pujols brings more than 30 years of technical operations expertise to role, scaling commercial manufacturing for CAR T-cell therapies and complex biologics, as Kyverna advances towards launch of miv-cel

EMERYVILLE, Calif., Feb. 03, 2026 (GLOBE NEWSWIRE) — Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a clinical stage biopharmaceutical company developing cell therapies for patients with autoimmune diseases, today announced the appointment of Mayo Pujols as its Chief Technology Officer (CTO), effective February 9, 2026.

Mr. Pujols brings more than 30 years of technical operations experience to the role with a deep background in leading late-stage and commercial manufacturing for cell and gene therapies. His work spans both large-scale and smaller biopharmaceutical companies with a proven track record of successfully advancing programs across their lifecycles. He succeeds Karen Walker, who is retiring. Ms. Walker will serve in a consultative capacity to ensure a seamless transition and continuity for the Company’s biologics license application (BLA) submission for miv-cel (mivocabtagene autoleucel, KYV-101) in stiff person syndrome.

“We are very pleased to welcome Mayo as we transition to a commercial-stage company in preparation for the potential launch of miv-cel in stiff person syndrome, while continuing to innovate with our next-generation pipeline,” said Warner Biddle, Chief Executive Officer of Kyverna. “Mayo’s proven track record of disciplined execution and operational delivery will be instrumental to Kyverna as we seek to advance manufacturing operations and delivery of our CAR T-cell therapies to patients with autoimmune diseases. On behalf of the Kyverna leadership team, I also want to thank Karen for the significant contributions she has made in building our technical operations capabilities, which have supported the Company’s successful execution and leadership position in autoimmune CAR T.”

Most recently, Mr. Pujols served as Chief Operating Officer of Castle Creek Biosciences, where he oversaw late-stage autologous cell therapy operations. Prior to Castle Creek, Mr. Pujols served as CTO at Rocket Pharmaceuticals, where he guided multiple gene therapy programs through key regulatory milestones. He also previously served as CEO of Andelyn Biosciences, a contract development and manufacturing company, where he built and scaled the business to serve cell and gene therapy companies. Earlier in his career, Mr. Pujols held several global technical operations positions, including as the Global Head of Cell and Gene Therapy at Novartis and Vice President of Global CAR T Operations and Technology at Celgene as well as senior roles at Advaxis, Merck, AstraZeneca/MedImmune and Schering Plough.

“I am excited to join Kyverna at this pivotal time and help advance the organization into its next critical phase of growth,” said Mr. Pujols. “The Company has demonstrated remarkable progress in advancing miv-cel towards registration and establishing first-in-class leadership in autoimmune CAR T. I look forward to working with the team to further accelerate our technical operations to support the launch of the Company’s transformative therapies for patients living with autoimmune diseases.”

Mr. Pujols holds an M.S. in Chemical Engineering from Columbia University and a B.E. in Chemical Engineering from Stevens Institute of Technology.

Inducement Grant

In connection with the appointment of Mr. Pujols as Kyverna’s Technology Officer, on his start date, expected to be February 9, 2025, Kyverna will grant Mr. Pujols an option to purchase 300,000 shares of its common stock (Option). The Option will be granted pursuant to the Kyverna Therapeutics, Inc. 2024 Inducement Equity Incentive Plan and will be granted as an inducement material to Mr. Pujols’ employment with Kyverna in accordance with Nasdaq Listing Rule 5635(c)(4). The exercise price of the Option will be the closing price of Kyverna’s common stock on the date of grant. The Option will vest over four years, with 25% of the total number of shares subject to the Option vesting on the one-year anniversary of Mr. Pujols’ appointment and 1/48th of the total number of shares subject to the Option vesting monthly thereafter, subject in each case to Mr. Pujols’ continued service to Kyverna on each vesting date. Kyverna is providing this information in accordance with Nasdaq Listing Rule 5635(c)(4).

About miv-cel (mivocabtagene autoleucel, KYV-101)

Miv-cel is a fully human, autologous, CD19-targeting CAR T-cell therapy with CD28 co-stimulation, designed for potency and tolerability, which is under investigation for B-cell-driven autoimmune diseases. With a single administration, miv-cel has potential to achieve deep B-cell depletion and immune system reset to deliver durable drug-free, disease-free remission in autoimmune diseases. 

About Kyverna Therapeutics

Kyverna Therapeutics, Inc. (Nasdaq: KYTX) is a clinical-stage biopharmaceutical company focused on liberating autoimmune patients through the curative potential of cell therapy. Kyverna’s lead autologous CD19-targeting CAR T-cell therapy candidate, miv-cel (mivocabtagene autoleucel, KYV-101), has demonstrated the potential to fundamentally change the treatment paradigm across multiple B-cell-driven autoimmune diseases. Kyverna is advancing its potentially first-in-class neuroimmunology franchise with its recently completed registrational trial in stiff person syndrome and an ongoing registrational trial for generalized myasthenia gravis. The Company is also harnessing other KYSA trials and investigator-initiated trials, including in multiple sclerosis and rheumatoid arthritis, to inform the next priority indications. Additionally, its next generation pipeline includes CAR T-cell therapies deploying novel innovations to improve patient access and experience. For more information, please visit https://kyvernatx.com.

Forward-Looking Statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words, without limitation, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Forward-looking statements in this press release include, without limitation, those related to: Kyverna’s next phase of growth, including its potential transition to a commercial-stage company; the potential launch of miv-cel in stiff person syndrome; Kyverna’s pipeline opportunities; the potential optimization of Kyverna’s manufacturing and patient delivery of its CAR T-cell therapies to patients with autoimmune diseases and Kyverna’s potentially first-in-class neuroimmunology franchise. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to market conditions, the possibility that results from prior clinical trials, named-patient access activities and preclinical studies may not necessarily be predictive of future results; the possibility that the past track records of Kyverna and its personnel may not be repeated or indicative of future success; and other factors discussed in the “Risk Factors” section of Kyverna’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q that Kyverna has filed or may subsequently file with the U.S. Securities and Exchange Commission. Any forward-looking statements contained in this press release are based on the current expectations of Kyverna’s management team and speak only as of the date hereof, and Kyverna specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Contact:

Investors: [email protected]
Media: [email protected]



aTyr Pharma Announces Scheduling of FDA Type C Meeting to Discuss Efzofitimod Program in Pulmonary Sarcoidosis

Meeting with the FDA to review the results from the Phase 3 EFZO-FIT™ study and determine the path forward for efzofitimod in pulmonary sarcoidosis is scheduled for mid-April 2026.

SAN DIEGO, Feb. 03, 2026 (GLOBE NEWSWIRE) — aTyr Pharma, Inc. (Nasdaq: ATYR) (“aTyr” or the “Company”), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s meeting request to discuss its lead therapeutic candidate, efzofitimod, for the treatment of pulmonary sarcoidosis. The Type C meeting is scheduled for mid-April 2026.

“We look forward to meeting with the FDA in mid-April to review the results of our Phase 3 EFZO-FIT™ study and determine the path forward for efzofitimod in pulmonary sarcoidosis, a major form of interstitial lung disease,” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr Pharma. “We expect to provide an update regarding the outcome of the meeting following the receipt of the official meeting minutes.”

EFZO-FIT™ was a Phase 3 study of efzofitimod in 268 patients with symptomatic pulmonary sarcoidosis. While the study did not meet its primary endpoint of change from baseline in mean daily oral corticosteroid dose at week 48, clinical benefit for 5.0 mg/kg efzofitimod was observed across multiple study efficacy parameters at week 48 compared to placebo, including improvement in change from baseline for the King’s Sarcoidosis Questionnaire (KSQ)-Lung score (p=0.0479), Fatigue Assessment Scale score (p=0.0226), KSQ-General Health score (p=0.0197), and complete steroid withdrawal with KSQ-Lung score improvement (p=0.0196). Additionally, treatment with efzofitimod maintained lung function as a measure of forced vital capacity and was well-tolerated with a safety profile consistent with prior trials conducted to date.

Abo
ut Efzofitimod

Efzofitimod is a novel biologic immunomodulator in clinical development for the treatment of interstitial lung disease (ILD), a group of immune-mediated disorders that can cause inflammation and fibrosis, or scarring, of the lungs. Efzofitimod is a tRNA synthetase derived therapy that selectively modulates activated myeloid cells through neuropilin-2 to resolve inflammation without immune suppression and potentially prevent the progression of fibrosis. In addition to the global Phase 3 EFZO-FIT™ study of efzofitimod in patients with pulmonary sarcoidosis, a major form of ILD, efzofitimod is also being investigated in the Phase 2 EFZO-CONNECT™ study in patients with systemic sclerosis (SSc, or scleroderma)-related ILD. These forms of ILD have limited therapeutic options and there is a need for safer and more effective, disease-modifying treatments that improve outcomes.

About aTyr

aTyr is a clinical stage biotechnology company leveraging evolutionary intelligence to translate tRNA synthetase biology into new therapies for fibrosis and inflammation. tRNA synthetases are ancient, essential proteins that have evolved novel domains that regulate diverse pathways extracellularly in humans. aTyr’s discovery platform is focused on unlocking hidden therapeutic intervention points by uncovering signaling pathways driven by its proprietary library of domains derived from all 20 tRNA synthetases. aTyr’s lead therapeutic candidate is efzofitimod, a novel biologic immunomodulator in clinical development for the treatment of interstitial lung disease, a group of immune-mediated disorders that can cause inflammation and progressive fibrosis, or scarring, of the lungs. For more information, please visit www.atyrpharma.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are usually identified by the use of words such as “anticipate,” “believes,” “can,” “could,” “designed,” “expects,” “intends,” “may,” “plans,” “potential,” “upcoming,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by such safe harbor provisions for forward-looking statements and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements include, among others, statements regarding the potential therapeutic benefits and applications of efzofitimod; and timelines and plans with respect to certain development activities and goals, including the occurrence and timing of our meeting with the FDA to review the results of the Phase 3 EFZO-FIT™ study and determine the path forward for efzofitimod in pulmonary sarcoidosis, as well as our expectations with respect to the outcome of that meeting, the timing of our update for that meeting and next steps for the development of efzofitimod in pulmonary sarcoidosis. These forward-looking statements also reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects, as reflected in or suggested by these forward-looking statements, are reasonable, we can give no assurance that the plans, intentions, expectations, strategies or prospects will be attained or achieved. All forward-looking statements are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain. Furthermore, actual results may differ materially from those described in these forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, uncertainty related to interactions with the FDA in general, uncertainty regarding geopolitical and macroeconomic events, risks associated with the discovery, development and regulation of efzofitimod, the risk that we or our partners may cease or delay preclinical or clinical development activities for efzofitimod for a variety of reasons (including difficulties or delays in patient enrollment in planned clinical trials), the possibility that existing collaborations could be terminated early, and the risk that we may not be able to raise the additional funding required for our business and product development plans, as well as those risks set forth in our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and in our other SEC filings. Except as required by law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact:
Ashlee Dunston
Sr. Director, Investor Relations and Public Affairs

[email protected]



Grocery Outlet Launches First-Ever Shoppable Livestream Series

The Grocery Outlet Xtreme Value Stock Up Show to debut on Facebook and Instagram February 4

EMERYVILLE, Calif., Feb. 03, 2026 (GLOBE NEWSWIRE) — Grocery Outlet Holding Corp. (NASDAQ: GO) (“Grocery Outlet” or the “Company”), one of America’s favorite, extreme value grocers today announced the launch of its first-ever shoppable livestream series: The Grocery Outlet Xtreme Value Stock Up Show designed to help shoppers get ready for the Big Game!

Designed to bring the thrill of bargain hunting directly to shoppers’ screens, the new livestream series offers a fun, interactive Treasure Hunt experience for customers to shop Grocery Outlet’s latest deals in real time, offering a savings of 30% to 70% relative to conventional retailers.

“We’re thrilled to introduce a new, dynamic way for customers to shop the extreme value prices that they count on from us,” said Kevin Miller, Interim Chief Marketing Officer. “The Grocery Outlet Xtreme Value Stock Up Show brings the fun, surprise, and unbelievable savings of our stores directly into the homes of our shoppers—starting with one of the biggest food occasions of the year.”

The series kicks off with a special “Big Game Edition” livestream debuting on February 4, aligning with one of the biggest snacking and celebration moments of the year.

A New, Interactive Way to Score Unbeatable Deals

Viewers tuning into the Grocery Outlet Xtreme Value Stock Up Show will be able to browse and purchase featured products instantly through Instacart while watching, making it easier than ever to stock up on premium, name-brand groceries at exceptional prices.

The livestream will spotlight everything customers need for the ultimate game time gathering, including:

  • Big Game essentials
  • Easy, elevated snacks
  • Desserts and sweets
  • Family-friendly beverages
  • $50 Gift Card Giveaways

Each item showcased on the livestream will be shoppable via the platform’s integrated “Shop” feature:

  • On mobile: Tap the shopping bag icon near the chat
  • On desktop: Browse the dedicated Shop section beside the video

Products featured in the livestream, along with additional recipe ideas for the Big Game, will be available in the Shop section throughout the show.

Shoppers can tune into the show at 12 p.m. PST/3 p.m. EST on February 4 through Instagram, Facebook, or the Grocery Outlet website: https://www.groceryoutlet.com/xvstockupshow.


About Grocery Outlet


Based in Emeryville, California, Grocery Outlet is a high-growth, extreme value retailer of quality, name-brand consumables and fresh products sold primarily through a network of independently operated stores. Grocery Outlet and its subsidiaries have more than 560 stores in California, Washington, Oregon, Pennsylvania, Tennessee, Idaho, Nevada, Maryland, New Jersey, Ohio, North Carolina, Georgia, Alabama, Delaware, Kentucky and Virginia.

Media Contact:

Kyle Noble, [email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/87040ee2-6fae-4bac-846e-c5b7b2e87c35



Milestone Pharmaceuticals Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

MONTREAL and CHARLOTTE, N.C., Feb. 03, 2026 (GLOBE NEWSWIRE) — Milestone Pharmaceuticals Inc. (Nasdaq: MIST) (the “Company” or “Milestone”), today announced that the Company granted equity awards, in the form of a total of 419,000 options (the “Options”) to purchase the Company’s common shares, pursuant to the Company’s 2021 Inducement Plan (the “Plan”), previously approved by the Company’s Compensation Committee and the Board of Directors, as a material inducement to the hiring of two new employees. 

The Options have a grant date of February 2, 2026, and an exercise price of $1.96 per share, which is equal to the closing price of Milestone’s common shares on the grant date. The shares subject to the Options will vest over four years, with 25% of the shares vesting on the one-year anniversary of the vesting commencement date and the balance of the shares vesting in a series of 36 successive equal monthly installments thereafter.

The Option awards are subject to the award holder’s continuous service through each vesting date and to the terms and conditions of the Plan and its standard forms of grant agreements thereunder.

The foregoing equity award was granted as an inducement material to the employees entering into employment with Milestone, in accordance with Nasdaq Listing Rule 5635(c)(4). The Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of Milestone, or following a bona fide period of non-employment, as an inducement material to such individuals’ entering into employment with Milestone, pursuant to Nasdaq Listing Rule 5635(c)(4).

About Milestone Pharmaceuticals

Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is a biopharmaceutical company developing and commercializing innovative cardiovascular medicines to benefit people living with certain heart conditions. Milestone’s lead product is CARDAMYST™ (etripamil) nasal spray, a novel calcium channel blocker, which is FDA approved for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. Etripamil is also in development for the treatment of symptomatic episodic attacks associated with AFib-RVR.

Contact:
Kevin Gardner [email protected]