On March 27, 2025 Arbutus Biopharma Corporation (Nasdaq: ABUS) ("Arbutus" or the "Company"), a clinical-stage biopharmaceutical company focused on infectious disease, reported fourth quarter and year end 2024 financial results and provided a corporate update (Press release, Arbutus Biopharma, MAR 27, 2025, View Source [SID1234651518]).

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"With my recent appointment as CEO of Arbutus, I am excited to lead the company into its next chapter," said Lindsay Androski, President and CEO of Arbutus. "Along with Arbutus’ new directors, my focus is on evaluating strategies to accelerate the development and potential approval of imdusiran, alongside several subject matter experts being retained to assist with this evaluation. As part of this review, we have implemented a reduction in our workforce of 57%, retaining a core team well-positioned to advance imdusiran into a Phase 2b trial, and have taken additional related steps to improve our financial and operational efficiency. We will provide an update on our pipeline and development timeline upon completion of our review of our chronic hepatitis B virus (cHBV) programs."

Ms. Androski continued, "I am also excited to welcome Tuan Nguyen to our leadership team as Chief Financial Officer. Tuan’s appointment reinforces our renewed focus on advancing our pipeline efficiently and delivering value to patients and our stakeholders. In addition, the Company announced today the departure of David Hastings, Karen Sims and Christopher Naftzger, and I would like to thank them for their valuable contributions over the past years.

We will continue to consult closely with and support our exclusive licensee Genevant Sciences to protect and defend our intellectual property, including through recently filed international lawsuits against Moderna for patent infringement in the development of its COVID-19 and RSV vaccines. We expect 2025 to be a transformative year for Arbutus."

2024 Clinical Development Milestones

Imdusiran (AB-729)

At the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting in November 2024, the Company presented new data from its IM-PROVE I Phase 2a clinical trial showing that six doses of imdusiran and 24 weeks of pegylated interferon alfa-2α (IFN), a standard-of-care immunomodulator, added to ongoing nucleos(t)ide analogue (NA) therapy led to a functional cure rate of 50% (3/6) in HBeAg-negative patients with baseline HBsAg levels less than 1000 IU/mL, and an overall functional cure rate of 25% (3/12). Those patients that achieved a functional cure also seroconverted with high anti-HBs antibody levels. The data from this trial indicated that the combination of imdusiran, IFN and NA therapy was generally safe and well-tolerated.
The Company also presented data from its IM-PROVE II Phase 2a clinical trial at AASLD showing that the addition of low dose nivolumab increased rates of HBsAg loss in cHBV patients that were first treated with imdusiran, ongoing NA therapy and Barinthus Biotherapeutics’ VTP-300, an HBV antigen-specific immunotherapy. In this clinical trial, 23% (3/13) of patients that received imdusiran, VTP-300, NA therapy and nivolumab achieved HBsAg loss by week 48. The Company is evaluating functional cure in these patients.
The Company is reviewing development plans for a Phase 2b clinical trial of imdusiran, including potential ways to accelerate the development timeline. To assist with its review, the Company is currently retaining experts in virology, hepatitis B, and in the clinical development and approval of antiviral treatments. The Company will provide a further update once its review is complete.
AB-101 (oral PD-L1 inhibitor)

AB-101-001 is a Phase 1a/1b double-blind, randomized, placebo-controlled clinical trial designed to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single- and multiple-ascending doses of AB-101, the Company’s oral PD-L1 inhibitor, in healthy subjects and patients with cHBV.
Based on data from Part 2 of this clinical trial reported in November 2024 showing that AB-101 was generally well-tolerated with evidence of dose-dependent receptor occupancy in healthy subjects, Arbutus has moved into Part 3 which evaluates repeat doses of AB-101 for 28 days in patients with cHBV. Next steps for AB-101 will be determined upon completion of the Company’s review of its cHBV programs.
LNP Litigation

Arbutus will continue to consult closely with and support our exclusive licensee Genevant Sciences to protect and defend Arbutus’s intellectual property, which is the subject of on-going lawsuits against Moderna and Pfizer/BioNTech. The Company, together with Genevant, is seeking fair compensation for Moderna’s and Pfizer/BioNTech’s use of Arbutus’s patented LNP technology that was developed with great effort and at a great expense, and without which Moderna’s and Pfizer/BioNTech’s COVID-19 vaccines would not have been successful.
The claim construction hearing for the lawsuit against Pfizer/BioNTech occurred in December 2024. The court is expected to provide its ruling on the claim construction and issue a further scheduling order in 2025.
The jury trial in the Moderna U.S. litigation is currently scheduled for September 2025. Expert discovery continues in this lawsuit. On March 3, 2025, the Company announced that alongside Genevant Sciences, it filed five international lawsuits seeking to enforce patents protecting their innovative LNP technology across 30 countries.
Corporate Updates

In March 2025, the Company’s Board took action to reduce the Company’s workforce by 57% resulting in a total workforce after reductions of 19 employees. The Board also decided to exit the Company’s corporate headquarters in Warminster, PA, and to discontinue in-house scientific research. In connection with these actions, the Company expects to incur a one-time restructuring charge in the first quarter of 2025 of approximately $11 million to $13 million.
Also in March 2025, the Board appointed Tuan Nguyen as Chief Financial Officer effective March 28, succeeding David C. Hastings. Additionally, the Company announced the departure of J. Christopher Naftzger as General Counsel and Chief Compliance Officer and Dr. Karen Sims as Chief Medical Officer.
Tuan Nguyen has almost two decades of experience in biopharma working on small molecules and AAV gene therapies. Most recently, he served as Chief Financial Officer of Kinevant Sciences, a subsidiary of Roivant Sciences, dedicated to treating rare inflammatory and autoimmune diseases with significant unmet need. Prior to that he held various senior finance leadership roles at Adverum, Intarcia Therapeutics, Fibrogen, and UCB. He has helped raise over $2 billion in dilutive and non-dilutive capital. Mr. Nguyen earned his MBA with dual concentrations in Finance and Entrepreneurship, Innovation, & Change from Emory University. Mr. Nguyen will report directly to Lindsay Androski, President and CEO.
Financial Results

Cash, Cash Equivalents and Investments

As of December 31, 2024, the Company had cash, cash equivalents and investments in marketable securities of $122.6 million compared to $132.3 million as of December 31, 2023. During the year ended December 31, 2024, the Company used $64.9 million in operating activities, which was partially offset by $44.1 million of net proceeds from the issuance of common shares under its "at-the-market" (ATM) offering program and $7.5 million of proceeds from the exercise of employee stock options. The Company expects to significantly reduce its net cash burn in 2025 when compared to 2024. Given the Company’s review of its pipeline and development plans for its cHBV programs and refocused operations, the Company has terminated its ATM offering program.

Revenue

Total revenue was $6.2 million for the year ended December 31, 2024, compared to $18.1 million for the same period in 2023. The decrease of $11.9 million was due primarily to a $9.3 million decrease in revenue recognition of the upfront license fee received in 2022 from Qilu, the Company’s collaboration partner in China, Hong Kong, Macau and Taiwan, as less effort was required from the Company in 2024 compared to 2023 to support Qilu’s progress towards achieving its own imdusiran manufacturing capability. Additionally, license royalty revenues decreased $2.6 million in 2024 compared to 2023 due to a decrease in Alnylam’s sales of ONPATTRO.

Operating Expenses

Research and development expenses were $54.0 million for the year ended December 31, 2024 compared to $73.7 million for the same period in 2023. The decrease of $19.7 million was due primarily to: i) a decrease in clinical expenses related to the discontinuation of the Company’s coronavirus and AB-161 programs during the fourth quarter of 2023; ii) a decrease in research activities and preclinical study costs for AB-101 which is now in a Phase 1a/1b clinical trial; and iii) cost savings from the Company’s decision in August 2024 to streamline the organization to focus its efforts on advancing the clinical development of imdusiran and AB-101, which included ceasing all discovery efforts, discontinuing its IM-PROVE III clinical trial and reducing its workforce by 40%. These actions in August 2024 resulted in the Company incurring a one-time restructuring charge of $3.7 million in the third quarter of 2024.

General and administrative expenses were $22.1 million for the year ended December 31, 2024, compared to $22.5 million for the same period in 2023. This decrease was due primarily to decreases in employee compensation-related expenses, partially offset by an increase in litigation-related legal fees.

Net Loss

For the year ended December 31, 2024, our net loss was $69.9 million, or a loss of $0.38 per basic and diluted common share, as compared to a net loss of $72.8 million, or a loss of $0.44 per basic and diluted common share, for the year ended December 31, 2023.

Outstanding Shares

As of December 31, 2024, the Company had 190.0 million common shares issued and outstanding, as well as 16.9 million stock options and unvested restricted stock units outstanding. Roivant Sciences Ltd. owned approximately 20% of the Company’s outstanding common shares as of December 31, 2024.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF LOSS
(in thousands, except share and per share data)

Year Ended December 31,
2024 2023
Revenue
Collaborations and licenses $ 3,919 $ 14,274
Non-cash royalty revenue 2,252 3,867
Total revenue 6,171 18,141
Operating expenses
Research and development 54,037 73,700
General and administrative 22,108 22,475
Change in fair value of contingent consideration 2,625 69
Restructuring costs 3,720 —
Total operating expenses 82,490 96,244
Loss from operations (76,319 ) (78,103 )
Other income (loss)
Interest income 6,585 5,688
Interest expense (137 ) (459 )
Foreign exchange gain (49 ) 25
Total other income 6,399 5,254
Net loss $ (69,920 ) $ (72,849 )
Net loss per common share
Basic and diluted $ (0.38 ) $ (0.44 )
Weighted average number of common shares
Basic and diluted 185,608,874 165,960,379

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)

December 31, 2024 December 31, 2023
Cash, cash equivalents and marketable securities, current $ 122,623 $ 126,003
Accounts receivable and other current assets 4,693 6,024
Total current assets 127,316 132,027
Property and equipment, net of accumulated depreciation 3,309 4,674
Investments in marketable securities, non-current — 6,284
Right of use asset 1,048 1,416
Other non-current assets 34 —
Total assets $ 131,707 $ 144,401

Accounts payable and accrued liabilities $ 7,564 $ 10,271
Deferred license revenue, current 7,571 11,791
Lease liability, current 483 425
Total current liabilities 15,618 22,487
Liability related to sale of future royalties 4,829 6,953
Deferred license revenue, non-current 2,863 —
Contingent consideration 10,225 7,600
Lease liability, non-current 806 1,343
Total stockholders’ equity 97,366 106,018
Total liabilities and stockholders’ equity $ 131,707 $ 144,401

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)

Twelve Months Ended December 31,
2024
2023
Net loss $ (69,920 ) $ (72,849 )
Non-cash items 7,899 5,146
Change in deferred license revenue (1,357 ) (10,664 )
Other changes in working capital (1,472 ) (7,569 )
Net cash used in operating activities (64,850 ) (85,936 )
Net cash provided by investing activities 22,948 50,773
Issuance of common shares pursuant to the Open Market Sale Agreement 44,123 29,852
Cash provided by other financing activities 7,873 795
Net cash provided by financing activities 51,996 30,647
Effect of foreign exchange rate changes on cash and cash equivalents (49 ) 25
Increase/(decrease) in cash and cash equivalents 10,045 (4,491 )
Cash and cash equivalents, beginning of period 26,285 30,776
Cash and cash equivalents, end of period 36,330 26,285
Investments in marketable securities 86,293 106,002
Cash, cash equivalents and marketable securities, end of period $ 122,623 $ 132,287

About Imdusiran (AB-729) 

Imdusiran is an RNAi therapeutic specifically designed to reduce all HBV viral proteins and antigens including hepatitis B surface antigen, which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to the virus. Imdusiran targets hepatocytes using Arbutus’ novel covalently conjugated N-Acetylgalactosamine (GalNAc) delivery technology enabling subcutaneous delivery. In a Phase 2a clinical trial, imdusiran achieved meaningful functional cure rates in patients with cHBV when combined with pegylated interferon (IFN) alfa-2α and nucleos(t)ide analogue (NA) therapy. Clinical data generated thus far has shown imdusiran to be generally safe and well-tolerated, while also providing meaningful reductions in hepatitis B surface antigen and hepatitis B DNA. The Company is currently reevaluating plans for a Phase 2b clinical trial of imdusiran combined with IFN and NA therapy.

About AB-101 

AB-101 is an oral PD-L1 inhibitor candidate that is designed to allow for controlled checkpoint blockade while minimizing the systemic safety issues typically seen with checkpoint antibody therapies. Immune checkpoints such as PD-1/PD-L1 play an important role in the induction and maintenance of immune tolerance and in T-cell activation. Preclinical data generated thus far indicates that AB-101 mediates re-activation of exhausted HBV-specific T-cells from cHBV patients. AB-101 is currently being evaluated in a Phase 1a/1b clinical trial.

About HBV 

Hepatitis B is a potentially life-threatening liver infection caused by the hepatitis B virus (HBV). HBV can cause chronic infection which leads to a higher risk of death from cirrhosis and liver cancer. Chronic HBV infection represents a significant unmet medical need. The World Health Organization estimates that over 250 million people worldwide suffer from chronic HBV infection, while other estimates indicate that approximately 2 million people in the United States suffer from chronic HBV infection. Approximately 1.1 million people die every year from complications related to chronic HBV infection despite the availability of effective vaccines and current treatment options.

On March 27, 2025 Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a biotechnology company pioneering the development of novel therapeutics targeting tumor necrosis factor (TNF) superfamily receptors for the treatment of patients with inflammatory and immune-mediated diseases, reported financial results for the fourth quarter and full year ended December 31, 2024 and provided recent business highlights (Press release, Shattuck Labs, MAR 27, 2025, View Source [SID1234651539]).

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"Shattuck made the difficult but appropriate decision to terminate our SL-172154 program in 2024, and rapidly transitioned to our potential first-in-class DR3 blocking antibody, SL-325," said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. "In February, we presented preclinical results from our IND-enabling GLP toxicology study for SL-325 at ECCO, demonstrating differentiation from TL1A blocking monoclonal antibodies, along with a favorable safety profile, full receptor occupancy, and lack of DR3 agonism. Our encouraging preclinical data underscore SL-325’s potential for DR3 blockade to provide potentially best-in-class clinical remission rates for IBD patients. We are on track for an IND filing in the third quarter of this year and are excited to begin generating data with the first-ever DR3 blocking antibody to enter clinical trials. Shattuck remains well-positioned to fund operations and clinical development of SL-325 into 2027."

DR3 Program Development in 2025

•Shattuck’s lead product candidate, SL-325, is a potentially first-in-class DR3 antagonist antibody. SL-325 is a DR3 blocking antibody for the treatment of IBD and other inflammatory and immune-mediated diseases.
◦IND filing expected in the third quarter of 2025.
◦Phase 1 clinical trial will evaluate safety, tolerability, and pharmacokinetics, and determine the recommended Phase 2 dose and dosing schedule of SL-325, with complete enrollment expected in the second quarter of 2026.
•Shattuck continues to develop multiple preclinical DR3-based bispecific antibodies, which are designed to inhibit both the DR3/TL1A axis and another biologically relevant target for the treatment of patients with IBD. Shattuck plans to nominate a lead bispecific candidate from its preclinical pipeline in 2025.

Fourth Quarter 2024 Business Highlights and Other Recent Developments

DR3 Program Development
•Shattuck Labs participated in an oral presentation at ECCO in February 2025.
◦Preclinical studies of SL-325 in NHP demonstrated a favorable safety profile with no infusion-related reactions observed, no changes in clinical pathology parameters, gross pathology, or histopathology analysis, and a No Observed Adverse Effect Level determined to be 100mg/kg, the top administered dose;
◦Full receptor occupancy at 1 mg/kg or greater, durable for >28 days, no Treg expansion or activation of CD3 T cells observed; and •Differentiation from TL1A blocking monoclonal antibodies may yield a distinct profile for bispecific antibody development. Notably, by targeting DR3, immune complex formation and stabilization of TL1A is not expected with SL-325, which may improve the immunogenicity profile as compared to TL1A targeting agents and allow for the development of DR3-based bispecific antibodies. Durable blockade of constitutively expressed DR3 may translate to higher complete remission rates.
•Shattuck Labs presented a poster at the 2025 Crohn’s & Colitis Foundation Congress in February.
◦Data from in vitro preclinical development and characterization of SL-325 were presented.
◦SL-325 is a fully Fc-silenced humanized immunoglobulin G monoclonal antibody that demonstrated high affinity binding to human DR3 and potent antagonistic properties with no evidence of residual agonism.
Upcoming Events
•Shattuck plans to attend the following investor conference. Details will be included on the Events & Presentations section of the Company’s website.
◦24th Annual Needham Virtual Healthcare Conference, April 7–10, 2025. Taylor Schreiber, M.D., Ph.D., CEO of Shattuck Labs, will participate in a presentation on April 9, 2025.

Fourth Quarter and Full-Year 2024 Financial Results

•Cash and Cash Equivalents and Investments: As of December 31, 2024, cash and cash equivalents and investments were approximately $73.0 million, as compared to $130.6 million as of December 31, 2023.

•Research and Development (R&D) Expenses: R&D expenses were $15.4 million for the quarter ended December 31, 2024, as compared to $15.2 million for the quarter ended December 31, 2023. R&D expenses for the year ended December 31, 2024 were $67.2 million, as compared to $74.3 million for the year ended December 31, 2023. This decrease for the full year was primarily driven by decreases in manufacturing costs associated with SL-172154 and research expenses associated with other research programs.
•General and Administrative (G&A) Expenses: G&A expenses were $4.2 million for the quarter ended December 31, 2024, as compared to $4.4 million for the quarter ended December 31, 2023. General and administrative expenses for the year ended December 31, 2024 were $19.1 million, as compared to $19.3 million for the year ended December 31, 2023. This decrease for the full year was primarily the result of a decrease in insurance, software, and information technology costs.

•Net Loss: Net loss was $18.7 million for the quarter ended December 31, 2024, or $0.37 per basic and diluted share, as compared to a net loss of $17.7 million for the quarter ended December 31, 2023, or $0.41 per basic and diluted share. Net loss for the year ended December 31, 2024 was $75.4 million, or $1.49 per basic and diluted share, as compared to $87.3 million, or $2.05 per basic and diluted share, for the year ended December 31, 2023.

Financial Guidance

As of December 31, 2024, cash and cash equivalents and investments were approximately $73.0 million. Shattuck’s current cash and cash equivalents are expected to fund operations into 2027. This cash runway guidance is based on the Company’s current operational plans and excludes any additional capital that may be received, proceeds from business development transactions, and/or additional costs associated with clinical development activities that may be undertaken.

About SL-325
SL-325 is a potential first-in-class Death Receptor 3 (DR3) blocking antibody designed to achieve a complete and durable blockade of the clinically validated DR3/TL1A pathway. Shattuck’s preclinical studies demonstrate high affinity binding and superior activity over TL1A antibodies, and offer a data-driven rationale for targeting the TNF receptor, DR3, versus its ligand, TL1A. SL-325 has completed a GLP toxicology study in non-human primates, with an IND filing expected in the third quarter of 2025.

On March 27, 2025 BeyondSpring Inc. (NASDAQ: BYSI) ("BeyondSpring" or the "Company"), a global clinical-stage biopharmaceutical company developing innovative cancer therapies, reported its financial results for the year ended December 31, 2024, and provided a business update on key clinical and corporate developments (Press release, BeyondSpring Pharmaceuticals, MAR 27, 2025, View Source;utm_medium=rss&utm_campaign=beyondspring-reports-2024-year-end-financial-results-and-highlights-key-clinical-strategic-milestones [SID1234651519]).

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"2024 was a pivotal year for BeyondSpring, with significant clinical progress for our first-in-class agent Plinabulin and strategic advancements for SEED Therapeutics (SEED), which BeyondSpring co-founded and owns an equity stake in. We believe these developments create value benefiting all stakeholders," said Dr. Lan Huang, Co-Founder, Chairman, and CEO of BeyondSpring.

"Plinabulin demonstrated a statistically significant survival benefit in patients with second- and third-line non-small cell lung cancer (NSCLC) (EGFR wild-type), a setting where no new therapies have been approved in over a decade. This Phase 3 data, now published in The Lancet Respiratory Medicine, strengthens our regulatory strategy as we prepare for submission to the Chinese National Medical Products Administration (NMPA) and potentially regulatory authorities in other jurisdictions."

"BeyondSpring is also advancing Plinabulin’s potential as a next-generation immuno-oncology agent, with its potent effect in dendritic cell maturation. An ongoing Phase 2 study showed that Plinabulin, in combination with a PD-1 inhibitor and docetaxel, produced promising efficacy in patients with metastatic NSCLC who had progressed on prior PD-1/PD-L1 inhibitors with good tolerability. While PD-1 and PD-L1 antibody annual sales have exceeded $50 billion, with most sales coming from lung cancer, 60% of patients across multiple cancer indications develop acquired resistance to checkpoint inhibitors, which we believe represents a significant opportunity for Plinabulin to impact the treatment landscape and create substantial value."

"SEED also made significant progress in 2024, securing a strategic research collaboration with Eisai Co., Ltd. ("Eisai"), a second global pharma partnership in addition to the Eli Lilly and Company ("Lilly") partnership. Under this collaboration, SEED will be eligible to receive upfront payments and potential preclinical, clinical, regulatory and sales milestone payments of up to $1.5 billion, plus tiered royalties on net sales. In parallel, SEED is advancing its internal lead oncology asset, RBM39 degrader, toward clinical development. SEED’s recognition in two Nature review papers as a leader in targeted protein degradation (TPD), along with recent granting of Rare Pediatric Disease and Orphan Drug Designations by the FDA for its RBM39 degrader ST-01156, further underscore its unique platform and reinforce its leadership in this emerging field."

"With strongly anchored pipelines, key global partnerships and deliberate plans to navigate regulatory pathways, we believe BeyondSpring and SEED are well-positioned to drive transformative advancements in oncology and TPD in 2025," Dr. Lan Huang concluded.

Recent Clinical and Business Updates
Plinabulin Clinical Updates
Plinabulin Phase 3 Data Published in The Lancet Respiratory Medicine and Presented at the IASLC 2024 conference
Demonstrated a statistically significant overall survival, PFS and ORR benefit in second- and third-line NSCLC (EGFR wild-type) compared to standard-of-care docetaxel.
Supports planned regulatory submissions to NMPA and potentially regulatory authorities in other jurisdictions.
Plinabulin Combination Therapy in multiple cancers which failed PD-1/PD-L1 therapies at MD Anderson Cancer Center
Phase 1 investigator-initiated study of Plinabulin + PD-1/PD-L1 inhibitor + radiation showed encouraging data in re-sensitizing NSCLC, Head and Neck cancer, and Hodgkin’s Lymphoma.
Responding patients showed dendritic cell maturation.
Plinabulin Combination Therapy in NSCLC
Ongoing Phase 2 investigator-initiated study (Study 303) of Plinabulin + PD-1 inhibitor + Docetaxel showed encouraging efficacy and safety outcomes in metastatic NSCLC patients who had progressed on prior PD-1/PD-L1 inhibitors.
Supports Plinabulin’s potential to resensitize tumors to checkpoint inhibitors.
Other Ongoing Clinical Trial
Enrolled first patient in a Phase 2 investigator-initiated study (Study 302) of Plinabulin + PD-1 inhibitor + Etoposide/Platinum (EP) for first-line extensive-stage small-cell lung cancer (ES-SCLC).d
BeyondSpring Business Update
Entered into definitive agreements to sell a portion of BeyondSpring’s Series A-1 Preferred Shares of SEED for gross proceeds of approximately $35.4 million to advance late-stage clinical development of Plinabulin. First closing of approximately $7.35 million completed in February 2025.
SEED Updates
Strategic Collaborations & Financing
Research collaboration with Eisai to develop molecular glue degraders for oncology and neurodegenerative diseases with potential payments to SEED of up to $1.5 billion.
$24 million Series A-3 financing first close, led by Eisai.
Achieved third milestone with Lilly R&D collaboration.
Industry Recognition & FDA Designations
SEED was recognized in two Nature review articles as a leading company in TPD.
Received Rare Pediatric Disease and Orphan Drug Designations from the FDA for RBM39 degrader ST-01156, reinforcing its potential as a breakthrough therapy for hard-to-treat cancers.
Full-Year 2024 Financial Results1
Continuing operations:

R&D expenses: $2.6 million (vs. $7.3 million in 2023), reflecting completion ofPlinabulin Dublin-3 and Protective Studies.
G&A expenses: $6.1 million (vs. $7.8 million in 2023), driven by cost optimization measures.
Net loss: $8.9 million (vs. $14.0 million in 2023).
Cash, cash equivalents, and short-term investments: $2.9 million as of December 31, 2024.

Discontinued operations:

Net loss: $7.8 million (vs. $7.9 million in 2023).
Current assets: $25.3 million as of December 31, 2024.

Expected 2025 Milestones
Plinabulin
1H 2025: Updated data from Phase 2 of Study 303 in metastatic NSCLC progressed on PD-1/PD-L1 inhibitors.
2H 2025: Preliminary data from Phase 2 of Study 302 in 1L ES-SCLC.
SEED
Mid-2025: Expected IND filing of RBM39 degrader.
2H 2025: RBM39 degraderexpected to begin patient enrollment.
2H 2025: Tau degraderexpected to achieve in vivo efficacy.
Note: 1. As a result of BeyondSpring entering into definitive agreements to sell a portion of its Series A-1 Preferred Shares of SEED, SEED’s operations met the criteria as discontinued operations under ASC 205-20 for financial reporting purposes.

On March 27, 2025 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-class1 targeted and immune-mediated therapeutics to fight cancer, reported financial results for the year ended 2024 and provided a corporate update (Press release, Tempest Therapeutics, MAR 27, 2025, View Source [SID1234651540]).

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"2024 was another year filled with significant progress and milestone achievements that position Tempest for a successful future," said Stephen Brady, president and chief executive officer of Tempest. "Despite challenging capital markets, our lean team excelled, reporting key OS data from the ongoing randomized Phase 2 trial of amezalpat in first-line hepatocellular carcinoma. As previously announced, we have secured broad regulatory agreement with both the FDA and EMA on the Phase 3 plan and received both Orphan Drug and Fast Track designations from the FDA. We also advanced our second clinical program, TPST-1495, with a Phase 2 clinical trial for the treatment of patients with FAP, with data expected in 2026. Our focus remains on execution with excellence while securing the resources necessary to drive these promising drug candidates forward."

2024 & Recent Accomplishments

Amezalpat (TPST-1120) (clinical PPARα antagonist):

Granted both Orphan Drug and Fast Track designations by the U.S. Food and Drug Administration (FDA) for amezalpat for the treatment of patients with HCC.
Received a "Study May Proceed" letter from the FDA to evaluate amezalpat in combination with atezolizumab (TECENTRIQ) and bevacizumab (Avastin), the current standard of care for unresectable or metastatic HCC, in a pivotal Phase 3 trial for the first-line treatment of unresectable or metastatic HCC.
Announced an agreement with F. Hoffmann-La Roche Ltd. (Roche) to advance the evaluation of amezalpat in combination with atezolizumab and bevacizumab into a pivotal Phase 3 trial for the first-line treatment of unresectable or metastatic HCC.
Announced positive feedback from the end-of-Phase 2 meeting with the FDA for amezalpat in combination with atezolizumab and bevacizumab to treat first-line unresectable or metastatic HCC.
Reported new positive survival data from the ongoing global randomized Phase 1b/2 clinical study demonstrating that amezalpat delivered a six-month improvement in median overall survival (OS) when combined with atezolizumab and bevacizumab in comparison to atezolizumab and bevacizumab alone, the standard of care, in the first-line treatment of patients with unresectable or metastatic HCC.
Published positive data from Phase 1 trial of amezalpat in patients with advanced solid tumors in the Journal of Cancer Research Communications. Data showed that amezalpat demonstrated clinical activity, including tumor shrinkage, even in PD-1 inhibitor-refractory and immune-compromised cancers. These data complement the positive Phase 1b/2 data reported in October 2023 and June 2024 from a global randomized study of amezalpat in combination with atezolizumab and bevacizumab in first-line patients with advanced HCC.
Reported new preclinical data at the 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting demonstrating that amezalpat reduces kidney cancer growth as a monotherapy, while also showing increased inhibition when combined with frontline chemotherapy and immunotherapy. These data further support the clinical benefit observed in the amezalpat Phase 1 data presented in an oral presentation at ASCO (Free ASCO Whitepaper) 2022.
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist)
Received a "Study May Proceed" letter from the FDA to evaluate TPST-1495 in a Phase 2 Trial for the treatment of FAP.
Corporate:
Expanded leadership team to strengthen global clinical expertise with the appointments of Troy M. Wagner as Vice President of Quality Assurance and Sheldon Mullins as Vice President of Regulatory Affairs.
Potential Future Milestones

Amezalpat (TPST-1120) (clinical PPARα antagonist)
Plan to advance amezalpat into a registrational study in first-line liver cancer patients, subject to obtaining additional resources.
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist)
Plan to advance TPST-1495 into a Phase 2 study in patients with FAP under the auspices of the Cancer Prevention Clinical Trials Network and funded by the National Cancer Institute (NCI) Division of Cancer Prevention in 2025, with data expected in 2026.
Financial Results

Year End 2024

Tempest ended the year with $30.3 million in cash and cash equivalents, compared to $39.2 million on December 31, 2023. The decrease was primarily due to cash used in operating activities, offset by proceeds from the issuance of common stock of $28.6 million from the at-the-market offering program.
Net loss and net loss per share for the year were $41.8 million and $1.50, respectively, compared to $29.5 million and $1.91, respectively, for the same period in 2023.
Research and development expenses for the year were $28.5 million compared to $17.5 million for the same period in 2023. The $11.0 million increase was primarily due to an increase in costs incurred from engaging contract research and manufacturing organizations in preparation for our pivotal Phase 3 trial of amezalpat for the treatment of first-line HCC.
General and administrative expenses for the year were $13.6 million compared to $11.7 million for the same period in 2023. The $1.9 million increase was primarily due to an increase in stock-based compensation expense due to increased headcount as well as an increase in expenses related to legal and consulting services.

On March 27, 2025 Boundless Bio (Nasdaq: BOLD), a clinical-stage oncology company interrogating extrachromosomal DNA (ecDNA) biology to deliver transformative therapies to patients with previously intractable oncogene amplified cancers, reported financial results and business highlights for the fiscal quarter and full year ended December 31, 2024 (Press release, Boundless Bio, MAR 27, 2025, View Source [SID1234651520]).

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"We made important strides in 2024 as we became a public company and continued to advance BBI-355, our oral, selective CHK1 inhibitor in the Phase 1/2 POTENTIATE trial in patients with oncogene amplified cancers, and we look forward to reporting preliminary proof-of-concept data in the second half of this year," said Zachary Hornby, President and CEO of Boundless Bio. "Additionally, we have continued to identify new targets and are advancing an oral degrader of a novel kinesin identified by our Spyglass platform. We are on track to nominate a development candidate for our Kinesin program by mid-year, with the intention to submit an IND in the first half of 2026. We look forward to the year ahead as we continue to advance our pipeline to address the significant unmet need in patients with oncogene amplified cancers."

Research and Development Highlights and Upcoming Milestones

BBI-355, a novel, oral, potent CHK1 inhibitor designed to target replication stress in oncogene-amplified cancers

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Enrollment in the Phase 1/2 POTENTIATE clinical trial evaluating BBI-355 as a monotherapy and combination agent in patients with locally advanced or metastatic solid tumors with oncogene amplifications is ongoing.
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ECHO, a proprietary diagnostic for the detection of ecDNA amplified oncogenes, is in use in the POTENTIATE trial.
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Boundless expects to report preliminary clinical proof-of-concept safety and antitumor activity data in the second half of 2025.

Novel Kinesin program targeting ecDNA segregation and inheritance

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Boundless is advancing a preclinical program targeting a previously undrugged kinesin that is essential for proper ecDNA segregation and inheritance during cell division.
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Boundless expects to nominate a development candidate by mid-2025 and submit an investigational new drug application (IND) to the FDA in the first half of 2026.

Recent Corporate Highlights

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In February 2025, Boundless appointed Robert Doebele, M.D., Ph.D., as Chief Medical Officer. Dr. Doebele is a medical oncologist and previously served as Chief Medical Officer and Chief Scientific Officer at Rain Oncology, where he led the early and late-stage development of multiple oncology programs using biology-based, tumor-agnostic strategies.

Fourth Quarter and Full Year 2024 Financial Results

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Cash Position: Cash, cash equivalents, and short-term investments totaled $152.1 million as of December 31, 2024.
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Research and Development (R&D) Expenses: R&D expenses were $13.3 million for the fourth quarter of 2024 and $55.3 million for the full year 2024, compared to $10.4 million and $42.6 million for the same periods in 2023.
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General and Administrative (G&A) Expenses: G&A expenses were $5.0 million for the fourth quarter of 2024 and $18.0 million for the full year 2024, compared to $3.4 million and $12.2 million for the same periods in 2023.
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Net Loss: Net loss totaled $16.4 million for the fourth quarter of 2024 and $65.4 million for the full year 2024, compared to $12.1 million and $49.4 million for the same periods in 2023.