On March 11, 2025 Alpha Teknova, Inc. ("Teknova") (Nasdaq: TKNO), and Pluristyx, Inc., reported that the companies are collaborating to produce and commercialize Pluristyx’s PluriFreeze product line, a cryopreservative and cell wash media system intended for use by customers who are developing next generation allogeneic cell therapies (Press release, panCELLa, MAR 11, 2025, View Source [SID1234651079]). Teknova is a leading producer of critical reagents for the discovery, development, and commercialization of novel therapies, vaccines, and molecular diagnostics, while Pluristyx is a leading provider of induced Pluripotent Stem Cells (iPSCs), including immune evading and safety-switch enabled iPSCs, and other innovative technologies designed to shorten the development lifecycle of tomorrow’s cell therapies.

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Through their development of iPSCs, Pluristyx recognized the critical importance of cellular biopreservation across the cell therapy workflow. In the process, the company identified a novel cryopreservation formulation for the systematic freezing of cells that streamlines the manufacture of cell products. Pluristyx launched the PluriFreeze product line as a protective wash paired with a cryopreservative designed to simplify the scale-up process for companies working to bring allogeneic cell therapies to market. The collaboration between Pluristyx and Teknova will enable wider customer access to PluriFreeze by making Teknova the exclusive manufacturer and distributor in the United States and Canada.

"We’re excited to announce our collaboration with Pluristyx, a true innovator in the development and commercialization of revolutionary cellular therapies," said Stephen Gunstream, Teknova’s President and Chief Executive Officer. "By coming together, we’re able to marry Teknova’s operational and commercial scale with their novel cryopreservation solution. Getting the PluriFreeze products into our customers’ hands will help them streamline the manufacture of allogeneic cell therapies as they move from research, to process development, and into clinical manufacturing."

"With almost 30 years of experience manufacturing high-quality research- and GMP-grade reagents and an established base of more than 3,000 life sciences customers, Teknova is the perfect partner to help us expand access to our proprietary PluriFreeze cryopreservation system," added Benjamin Fryer, Chief Executive Officer of Pluristyx. "As cell therapy developers focus on scaling their solutions into the clinic, it’s critical to use a trusted and scalable supply of products that ensure high cellular viability and function at multiple holding points across the workflow – not only during storage and transport."

The PluriFreeze cryopreservation system is entirely synthetic and animal-origin-free, and consists of a base wash and a freezing medium. PluriFreeze Base is a protective wash that mimics intracellular space and provides end-to-end metabolic support. PluriFreeze PF10 is a low viscosity freezing medium with 10% dimethyl sulfoxide (DMSO) that simplifies scale-up and process automation.

On March 11, 2025 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with cancer, reported financial results and business highlights for the fourth quarter and year ended December 31, 2024 (Filing, 3 mnth, DEC 31, Lyell Immunopharma, 2025, MAR 11, 2025, View Source [SID1234651078]).

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"Last year was transformative for Lyell and now, based on promising emerging clinical data, we are poised to initiate pivotal development of IMPT-314, our next-generation dual-targeting CD19/CD20 CAR T-cell product candidate for patients with aggressive large B‑cell lymphoma," said Lynn Seely, M.D., Lyell’s President and CEO. "We believe IMPT-314 has the potential to deliver improved outcomes for patients by increasing complete response rates and prolonging the duration of response over approved CD19 CAR T-cell therapies, and this year we expect to share more mature data from the ongoing Phase 1/2 trial of IMPT-314. We also plan to initiate two pivotal programs for IMPT-314: one for patients in the 3rd line and later setting by the middle of this year and a second program for patients in the 2nd line setting by early 2026. In addition, we expect to submit a new IND in 2026 for a next-generation solid tumor CAR T-cell product candidate with a new target that is fully-armed with a suite of technologies, including our proprietary clinically-validated anti-exhaustion technology. Our strong cash position enables us to advance our pipeline through important clinical milestones and fund operations into 2027."
Fourth Quarter Updates and Recent Business Highlights
Lyell is advancing a pipeline of next-generation CAR T-cell product candidates. Its lead program, IMPT-314, is in Phase 1/2 clinical development for relapsed or refractory aggressive large B-cell lymphoma (LBCL) and its preclinical programs target solid tumor indications. Lyell’s programs target cancers with large unmet need with substantial patient populations.
IMPT-314: A next-generation dual-targeting CD19/CD20 CAR T-cell product candidate designed to increase complete response rates and prolong the duration of response as compared to the approved CD19‑targeted CAR T-cell therapies for the treatment of LBCL
IMPT-314 is an autologous CAR T-cell product candidate with a true ‘OR’ logic gate to target B cells that express either CD19 or CD20 with full potency and is manufactured with a process that enriches for CD62L+ cells to generate more naïve and central memory CAR T cells with enhanced stemlike features and antitumor activity. The ongoing Phase 1/2 clinical trial is a multi-center, open-label study designed to evaluate the tolerability and clinical benefit of IMPT-314 in patients with relapsed/refractory LBCL and determine a recommended Phase 2 dose. IMPT-314 has received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of relapsed/refractory aggressive B-cell lymphoma in the 3rd line and later (3rd line+) setting.

•A Phase 1/2 clinical trial is ongoing and currently enrolling patients in the 3rd line+ and 2nd line settings who have not previously received CAR T-cell therapy.
•Initial data from the Phase 1/2 trial was presented at the American Society for Hematology 2024 Annual Meeting on December 9, 2024. Data from 23 patients with relapsed or refractory, CAR T-naive LBCL who received IMPT-314 were reported. The efficacy evaluable population consisted of 17 patients. The overall response rate was 94% (16/17 patients), with 71% (12/17 patients) achieving a complete response by three months. The median follow up was 6.3 months (range 1.2 – 12.5 months) and 71% of patients were experiencing a response at last follow-up. In the safety evaluable population of 23 patients, no Grade 3+ CRS was reported. Grade 3 ICANS was reported in 13% (3/23) of patients with a median time to ICANS resolution of 5 days, and rapid improvement to Grade 2 or lower with standard therapy.
•More mature data from the ongoing Phase 1/2 trial in the 3rd line+ setting and initial data from patients in the 2nd line setting are expected to be presented in mid-2025.
•Pivotal trial in the 3rd line+ setting is expected to be initiated in mid-2025 in patients with relapsed/refractory aggressive LBCL who have not previously received CAR T-cell therapy.
•Pivotal trial in the 2nd line setting expected to be initiated by early 2026 in patients with relapsed/refractory aggressive LBCL who have not previously received CAR T-cell therapy.
Preclinical Pipeline, Technologies and Manufacturing Protocols
•The first IND for a fully-armed CAR T-cell product candidate with an undisclosed target for solid tumors is expected in 2026. Lyell is advancing next-generation fully-armed CAR T-cell product candidates, meaning they are armed with multiple technologies, each designed to address different barriers to effective cell therapies, including T-cell exhaustion, lack of durable stemness, as well as immune suppression within the hostile tumor microenvironment.
•Presented nonclinical and clinical data from cell therapy product candidates incorporating anti‑exhaustion and manufacturing technologies that demonstrated the potential of Lyell’s technologies to improve T‑cell function in solid tumors. These presentations, from multiple scientific conferences throughout the year, can be found at View Source
Corporate Updates
•Streamlined expenses and expect net cash use in 2025 to be between $175 million – $185 million. The disciplined expense management will be accomplished by focusing clinical development efforts on the pivotal trials of IMPT-314 and research efforts on developing next-generation fully-armed CAR T-cell programs for solid tumors.
Fourth Quarter and Full Year 2024 Financial Results
Lyell reported a net loss of $191.9 million and $343.0 million for the fourth quarter and year ended December 31, 2024, respectively, compared to a net loss of $52.9 million and $234.6 million for the same periods in 2023. Net loss for the fourth quarter and year ended December 31, 2024 included $87.2 million in acquired in-process research and development (IPR&D) expense as part of our acquisition of ImmPACT Bio USA Inc (ImmPACT Bio) and $51.3 million of long‑lived asset impairment expense. Non‑GAAP net loss, which excludes stock-based compensation, non-cash expenses related to the change in the estimated fair value of success payment liabilities, acquired IPR&D expense, long‑lived asset impairment expense and certain non-cash investment gains and charges, was $45.9 million and $159.5 million for the fourth quarter and year ended December 31, 2024, respectively, compared to $43.9 million and $177.4 million for the same periods in 2023.

GAAP and Non-GAAP Operating Expenses
•Research and development (R&D) expenses were $48.7 million and $171.6 million for the fourth quarter and year ended December 31, 2024, respectively, compared to $47.0 million and $182.9 million for the same periods in 2023. The increase in fourth quarter 2024 R&D expenses of $1.7 million was primarily due to increased facilities costs. The decrease in annual 2024 R&D expenses of $11.3 million was primarily driven by a $14.0 million decrease in personnel-related expenses mainly due to lower headcount following the Company’s November 2023 reduction in workforce, partially offset by a $3.2 million increase in research activities primarily driven by clinical trial activity. Non‑GAAP R&D expenses, which exclude non-cash stock-based compensation and non-cash expenses related to the change in the estimated fair value of success payment liabilities, for the fourth quarter and year ended December 31, 2024 were $45.4 million and $157.3 million, respectively, compared to $42.9 million and $165.7 million for the same periods in 2023. The $2.5 million increase in fourth quarter 2024 non-GAAP R&D expenses was primarily driven by increased facilities costs. The $8.3 million decrease in annual 2024 non-GAAP R&D expenses was primarily driven by the decrease in personnel-related expenses mainly due to lower headcount following the Company’s November 2023 reduction in workforce.
•General and administrative (G&A) expenses were $14.5 million and $52.0 million for the fourth quarter and year ended December 31, 2024, respectively, compared to $13.2 million and $67.0 million for the same periods in 2023. The decrease in annual 2024 G&A expenses of $14.9 million was primarily driven by a decrease in non‑cash stock-based compensation. Non‑GAAP G&A expenses, which exclude non-cash stock‑based compensation, for the fourth quarter and year ended December 31, 2024 were $9.7 million and $33.5 million, respectively, compared to $8.5 million and $38.1 million for the same periods in 2023. The $1.3 million increase in fourth quarter 2024 non-GAAP G&A expenses was primarily driven by acquisition-related personnel expenses. The $4.6 million decrease in annual 2024 non-GAAP G&A expenses was primarily driven by the decrease in personnel-related expenses mainly due to lower headcount following the Company’s November 2023 reduction in workforce.
•Operating expenses for the fourth quarter and year ended December 31, 2024, include $87.2 million of acquired IPR&D expenses recognized as a part of the acquisition of ImmPACT Bio. Additionally, operating expenses for the fourth quarter and year ended December 31, 2024, include an impairment charge of $51.3 million for long-lived assets, resulting from the continued decline in our stock price and related market capitalization.
A discussion of non-GAAP financial measures, including reconciliations of the most comparable GAAP measures to non‑GAAP financial measures, is presented below under "Non-GAAP Financial Measures."
Cash, cash equivalents and marketable securities
Cash, cash equivalents and marketable securities as of December 31, 2024 were $383.5 million compared to $562.7 million as of December 31, 2023. Lyell believes that its cash, cash equivalents and marketable securities balances will be sufficient to meet working capital and capital expenditure needs into 2027.

On March 11, 2025 Champions Oncology, Inc. (Nasdaq: CSBR), a global preclinical and clinical research services provider that offers end-to-end oncology solutions, reported its financial results for its third quarter of fiscal 2025, ended January 31, 2025 (Filing, 3 mnth, DEC 31, Champions Oncology, 2024, MAR 11, 2025, View Source [SID1234651077]).

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Third Quarter and Recent Highlights:

•Total revenue increased 42% to $17.0 million
•Gross profit of $10.4 million; gross margin of 61%
•Net income of approximately $4.5 million
•Adjusted EBITDA of $5.2 million
•Signed first data licensing deal worth up to $8.0 million
•Hired Matt Newman, Executive Vice President and General Manager, to lead and expand the development of Champions’ data licensing platform

Year to Date Highlights:

•Total revenue increased 23% to $44.6 million
•Gross profit of $23.5 million; gross margin of 53%
•Net income of $6.5 million
•Adjusted EBITDA of $8.3 million

Ronnie Morris, CEO of Champions, commented, "Our third quarter was transformational, marked by our first major data licensing agreement – an important milestone toward monetizing our proprietary

Exhibit 99.1
data platform." Added Morris, "Despite ongoing funding constraints in the pharma and biotech sectors, we continue to drive strong performance in our core services business."

David Miller, CFO of Champions, added, "We delivered record breaking financial results this quarter, with revenue surpassing $17.0 million and adjusted EBITDA reaching $5.2 million. While we anticipate some fluctuations in quarterly revenue, our strategic cost realignment positions us for sustained long-term profitability."

Third Fiscal Quarter Financial Results

Total oncology revenue for the third quarter of fiscal 2025 was $17.0 million compared to $12.0 million for the same period last year, an increase of 42%. The increase stemmed from a 4% increase in our research services business and $4.5 million from data license revenue. Total costs and operating expenses for the third quarter of fiscal 2025 were $12.5 million compared to $14.6 million for the third quarter of fiscal 2024, a decrease of $2.1 million or 14.1%.

For the third quarter of fiscal 2025, Champions reported income from operations of $4.5 million, including $256,000 in stock-based compensation and $398,000 in depreciation and amortization expenses, compared to a loss from operations of $2.6 million, inclusive of $379,000 in stock-based compensation and $481,000 in depreciation and amortization expenses, in the third quarter of fiscal 2024. Adjusted EBITDA, which is defined as income from operations excluding stock-based compensation, depreciation and amortization expenses, was $5.2 million for the third quarter of fiscal 2025 compared to an adjusted EBITDA loss of $1.7 million in the third quarter of fiscal 2024.

Cost of oncology revenue was $6.6 million for the three-months ended January 31, 2025, a decrease of $1.2 million, or 15.7% compared to $7.8 million for the three-months ended January 31, 2024. The decrease in cost of oncology revenue was primarily from a decrease in compensation and lab supply costs due to our recent emphasis on improving efficiencies and reducing costs along with a reduction in outsourced lab services which fluctuate quarterly in the ordinary course of business. For the three-months ended January 31, 2025, total margin was 61%, with research services margin of 48% compared to 35% for the three-months ended January 31, 2024. The increase in revenue coupled with our cost reductions led to improved service margins.

Research and development expense for the three-months ended January 31, 2025 was $1.7 million, a decrease of $467,000 or 21.4%, compared to $2.2 million for the three-months ended January 31, 2024. The decrease was primarily due to reduced investment in our wholly owned subsidiary, Corellia, focused on target discovery. Sales and marketing expense for the three-months ended January 31, 2025 was $1.8 million, essentially flat with a nominal increase of $9,000, or 0.5%, compared to $1.8 million for the three-months ended January 31, 2024. General and administrative expense for the three-months ended January 31, 2025 was $2.4 million, a decrease of $366,000, or 13.2%, compared to $2.8 million for the three-months ended January 31, 2024. The decrease was primarily from a decline in compensation expense and non-cash items of stock-based compensation and depreciation and amortization.

Net cash provided by operating activities was approximately $918,000 for the three-months ended January 31, 2025 and was primarily due to net income for the quarter offset by an increase in accounts receivable. Net cash used in investing activities for the three-months ended January 31, 2025 was approximately $470,000 for lab and computer equipment. Net cash provided by financing activities for the three-months ended January 31, 2025 was nil resulting from proceeds from options exercise of approximately $38,000 offset by financing lease payments of approximately $38,000.

On March 11, 2025 Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, reported pipeline progress and business updates and announced financial results for the fourth quarter and full year ended December 31, 2024 (Press release, Xilio Therapeutics, MAR 11, 2025, View Source [SID1234651074]).

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"We started 2025 with multiple promising updates across our pipeline, including encouraging initial Phase 2 combination data for vilastobart, our tumor-activated anti-CTLA-4, in patients with late-line MSS CRC, a difficult to treat, immunologically cold tumor type that is increasing in incidence, particularly in younger people," said René Russo, Pharm.D., president and chief executive officer of Xilio. "These data included a preliminary 27% objective response rate in patients without liver metastases and continue to support a differentiated safety profile, including a low incidence of immune-related adverse events and only 5% of patients reporting colitis. We look forward to reporting additional data from the ongoing Phase 2 trial in the middle of this year."

Dr. Russo added, "In addition, we are excited to be advancing multiple novel masked T cell engager programs internally and as part of our recently announced collaboration with AbbVie. Each of these programs leverages our clinically-validated, tumor-activation technology, which we believe has great potential to enhance the activity and tolerability of T cell engagers and open up promising new targets within this class of immunotherapies."

Pipeline and Business Updates

Vilastobart: tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4

Vilastobart is an investigational tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4 monoclonal antibody designed to block CTLA-4 and deplete regulatory T cells when activated in the tumor microenvironment (TME).

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In January 2025, Xilio announced encouraging initial data from its ongoing Phase 2 clinical trial evaluating vilastobart at a dose of 100 mg once every six weeks (Q6W) in combination with atezolizumab (Tecentriq) at 1200 mg once every three weeks (Q3W) in patients with metastatic microsatellite stable colorectal cancer (MSS CRC). As of a data cutoff date of January 13, 2025, these data demonstrated a preliminary 27% objective response rate in patients without liver metastases, and responses were accompanied by decreases in levels of serum tumor biomarkers (carcinoembryonic antigen and circulating tumor DNA) as well as improvement in clinical symptoms. In addition, as of the data cutoff date, the combination was generally well-tolerated, with patients experiencing a low incidence of immune-related adverse events and only 5% of patients reporting colitis. These safety data continue to support the potential for vilastobart to be a differentiated next-generation anti-CTLA-4 in combination with PD-(L)1 inhibitors. For more information, read the press release here.

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Xilio expects to report updated data from the Phase 2 clinical trial in the middle of 2025, including additional response assessments and follow-up. In addition, Xilio continues to enroll patients in Phase 1C (combination dose escalation) evaluating vilastobart at the 150 mg Q6W dose level in combination with atezolizumab at 1200 mg Q3W.

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Based on the promising initial Phase 2 proof-of-concept data, Xilio plans to seek opportunities for partnering to accelerate and expand further development of vilastobart.

XTX301: tumor-activated IL-12

XTX301 is an investigational tumor-activated IL-12 designed to potently stimulate anti-tumor immunity and reprogram the TME of poorly immunogenic "cold" tumors towards an inflamed or "hot" state. In March 2024, Xilio entered into an exclusive license agreement with Gilead Sciences, Inc. (Gilead) related to Xilio’s tumor-activated IL-12 program, including XTX301.

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In December 2024, Xilio announced preliminary data from its ongoing Phase 1 clinical trial of XTX301 in patients with advanced solid tumors. As of the data cutoff date of November 25, 2024, XTX301 was generally well-tolerated, and no patients experienced a dose limiting toxicity or a dose reduction due to a treatment-related adverse event. In addition, XTX301 showed evidence of sustained interferon gamma signaling without evidence of tachyphylaxis throughout treatment cycles. Tachyphylaxis has historically limited other IL-12 agents. For more information, read the press release here.

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A maximum tolerated dose has not yet been established, and Xilio continues to enroll patients in Phase 1A monotherapy dose escalation and Phase 1B monotherapy dose expansion of the ongoing Phase 1 clinical trial of XTX301.

XTX501: masked PD-1/IL-2 bispecific

XTX501 is a novel, tumor-activated bispecific PD-1/IL-2 designed to selectively stimulate PD-1 positive, antigen-experienced T cells and enhance their function. XTX501 incorporates masking designed to overcome IL-2 receptor-mediated clearance and peripheral activity. In preclinical studies, XTX501 demonstrated robust monotherapy activity (including in settings insensitive to PD-1) and tumor-selective pharmacodynamics consistent with its intended mechanism of action. Xilio is currently advancing XTX501 in investigational new drug (IND) application enabling studies and plans to submit an IND application for XTX501 in the middle of 2026.

Masked T Cell Engager Programs

Xilio is leveraging its proprietary, clinically-validated tumor-activation platform to advance multiple preclinical programs for masked T cell engagers, including wholly-owned programs targeting the tumor-associated antigens for PSMA, CLDN18.2 and STEAP1 and an additional program in collaboration with AbbVie.

Xilio’s masked T cell engager programs include bispecific molecules designed using its advanced tumor-activated cell engager (ATACR) format, which consists of a T cell engager with a masked CD3 targeting domain, and tri-specific molecules designed using its selective effector-enhanced cell engager (SEECR) format. The SEECR format builds upon the ATACR format by adding co-stimulatory signaling designed to further enhance potency and T cell activation.

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PSMA has demonstrated potential as a T cell engager target for prostate cancer. Xilio anticipates nominating a development candidate for its PSMA program in the ATACR format in the third quarter of 2025 and submitting an IND application in the first quarter of 2027.

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CLDN18.2 has broad potential as a T cell engager target for gastric, pancreatic, esophageal and lung cancers. Xilio anticipates nominating a development candidate for its CLDN18.2 program in the ATACR format in the fourth quarter of 2025 and submitting an IND application in the second quarter of 2027.

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STEAP1 has broad potential as a T cell engager target for prostate, colorectal and lung cancers. Xilio anticipates nominating a development candidate for its STEAP1 program in the SEECR format in the first half of 2026 and submitting an IND application in the second half of 2027.

Corporate Updates

•
In February 2025, Xilio announced a collaboration, license and option agreement with AbbVie leveraging Xilio’s proprietary tumor-activation technology and platform to discover and develop novel tumor-activated immunotherapies, including masked T cell engagers. In the first quarter of 2025, Xilio received $52.0 million in upfront payments from AbbVie, including a $10.0 million equity investment, and Xilio will be eligible to receive up to approximately $2.1 billion in total contingent payments for option-related fees and milestones plus tiered royalties. For more information, read the joint press release here.

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In December 2024, Xilio announced the appointment of Caroline Hensley as chief legal officer.

Year-End and Fourth Quarter 2024 Financial Results

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Cash Position: Cash and cash equivalents were $55.3 million as of December 31, 2024, compared to $44.7 million as of December 31, 2023. In the first quarter of 2025, Xilio received $52.0 million in upfront payments in connection with the collaboration agreement with AbbVie.

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License Revenue: License revenue was $1.7 million for the quarter ended December 31, 2024, and $6.3 million for the year ended December 31, 2024, which consisted of revenue recognized under the license agreement and stock purchase agreement with Gilead. No license revenue was recognized for the quarter and year ended December 31, 2023.

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Research & Development (R&D) Expenses: R&D expenses were $8.8 million for the quarter ended December 31, 2024, compared to $11.7 million for the quarter ended December 31, 2023. R&D expenses were $41.2 million for the year ended December 31, 2024, compared to $52.1 million for the year ended December 31, 2023. The year-over-year decrease was primarily driven by decreased clinical development activities for XTX202, a masked IL-2, as a result of discontinuing further investment in XTX202, decreased spending related to early-stage programs and indirect research and development costs, decreased personnel-related costs and decreased manufacturing costs for XTX301, partially offset by increased clinical development activities for vilastobart and XTX301.

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General & Administrative (G&A) Expenses: G&A expenses were $6.5 million for the quarter ended December 31, 2024, compared to $6.4 million for the quarter ended December 31, 2023. G&A expenses were $24.8 million for the year ended December 31, 2024, compared to $27.0 million for the year ended December 31, 2023. The year-over-year decrease was primarily driven by decreases in personnel-related costs, professional and consulting fees and directors’ and officers’ liability insurance, partially offset by an increase in legal fees.

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Net Loss: Net loss was $13.1 million for the quarter ended December 31, 2024, compared to $17.7 million for the quarter ended December 31, 2023. Net loss was $58.2 million for the year ended December 31, 2024, compared to $76.4 million for the year ended December 31, 2023.

Financial Guidance

Based on its current operating plans, Xilio anticipates that its cash and cash equivalents as of December 31, 2024, together with the $52.0 million in upfront payments received in the first quarter of 2025 in connection with the collaboration agreement with AbbVie, will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into the first quarter of 2026.

About Vilastobart and the Phase 1/2 Combination Clinical Trial

Vilastobart is an investigational tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4 monoclonal antibody designed to block CTLA-4 and deplete regulatory T cells when activated in the tumor microenvironment (TME). In 2023, Xilio entered into a co-funded clinical trial collaboration with Roche to evaluate vilastobart in combination with atezolizumab (Tecentriq) in a multi-center, open-label Phase 1/2 clinical trial. Xilio is currently evaluating the safety of the combination in Phase 1C dose escalation in patients with advanced solid tumors and the safety and efficacy of the combination in Phase 2 in patients with metastatic microsatellite stable colorectal cancer with and without liver metastases. Please refer to NCT04896697 on www.clinicaltrials.gov for additional details.

About XTX301 and the Phase 1 Clinical Trial

XTX301 is an investigational masked IL-12 designed to potently stimulate anti-tumor immunity and reprogram the tumor microenvironment (TME) of poorly immunogenic "cold" tumors towards an inflamed or "hot" state. In March 2024, Xilio entered into an exclusive license agreement with Gilead Sciences, Inc. for Xilio’s tumor-activated IL-12 program, including XTX301. Xilio is currently evaluating the safety and tolerability of XTX301 as a monotherapy in patients with advanced solid tumors in a first-in-human, multi-center, open-label Phase 1 clinical trial. Please refer to NCT05684965 on www.clinicaltrials.gov for additional details.

On March 11, 2025 Werewolf Therapeutics, Inc. (the "Company" or "Werewolf") (Nasdaq: HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to stimulate the body’s immune system for the treatment of cancer and other immune-mediated conditions, reported a business update and announced financial results for the fourth quarter and full year ended December 31, 2024 (Press release, Werewolf Therapeutics, MAR 11, 2025, View Source [SID1234651073]).

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"Werewolf made considerable progress in 2024 with promising preliminary evidence of durable anti-tumor activity and tolerability for cytokine therapeutics as we completed the dose-escalation phase of our Phase 1/1b clinical trial in both monotherapy and in combination with pembrolizumab," said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf. "We expect to build on these promising data in 2025, targeting full enrollment in the monotherapy cutaneous melanoma dose-expansion arm of the WTX-124 Phase 1/1b clinical trial by the end of the first half of 2025, and in combination with pembrolizumab by the end of the year. These data will guide conversations with regulators on potential registrational pathways for WTX-124 in the second half of the year. We anticipate providing a clinical data readout for both monotherapy and combination data and providing an update on our plans for further clinical development of WTX-124 in the fourth quarter of 2025. In addition, our PREDATOR platform continues to demonstrate its effectiveness as we presented updated interim safety, pharmacokinetics, biomarker, and efficacy data from the WTX-330 Phase 1 clinical trial at SITC (Free SITC Whitepaper) in November, which demonstrated anti-tumor activity in patients with refractory solid tumors. A Phase 1/2 dose and regimen-finding clinical trial is expected to be initiated by the end of the first quarter of 2025, which includes expansion arms in specific indications."

Recent Highlights and Upcoming Milestones
WTX-124: a systemically delivered, conditionally activated Interleukin-2 (IL-2) INDUKINE molecule being developed as monotherapy and in combination with pembrolizumab in multiple solid tumor types.
•Werewolf continues to evaluate WTX-124 as a monotherapy and in combination with pembrolizumab through the ongoing Phase 1/1b clinical trial evaluating the INDUKINE molecule in multiple solid tumor types.
•WTX-124 has shown promising monotherapy activity and an improved tolerability profile versus high dose IL-2 in heavily pretreated patients refractory to all standard-of-care therapies, including immune checkpoint inhibitors. The Company has selected 18 mg administered intravenously every two weeks (IV Q2W) as the recommended dose for monotherapy expansion arms in metastatic melanoma, renal cell carcinoma (RCC) and cutaneous squamous cell carcinoma (CSCC), as well as combination expansion arms in metastatic melanoma, RCC, and non-small cell lung cancer (NSCLC).

•Of the five previously disclosed objective responses, one monotherapy and two combination responses continue to demonstrate no evidence of disease progression, with the monotherapy complete response ongoing at greater than one year off therapy, one combination response improving from a confirmed partial response to a complete response, and both combination responses ongoing at greater than eight months.
•The cutaneous melanoma monotherapy dose-expansion arm of the Phase 1/1b clinical trial evaluating WTX-124 in a more homogeneous, less heavily pre-treated patient population is expected to be fully enrolled in the first half of 2025, and the cutaneous melanoma dose-expansion arm evaluating WTX-124 in combination with pembrolizumab is expected to be fully enrolled by the end of 2025. The Company expects to use the monotherapy and combination data to engage with regulators to discuss potential registrational pathways for WTX-124, including strategies for accelerated approval, in the second half of 2025.
•Anticipated presentation of interim data from monotherapy and combination expansion arms in the fourth quarter of 2025.
WTX-330: a systemically delivered, conditionally activated Interleukin-12 (IL-12) INDUKINE molecule being developed in advanced or metastatic solid tumors.
•Presented an interim update from the Phase 1 clinical trial highlighting the tolerability profile and monotherapy efficacy signals of WTX-330 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 39th annual meeting in November 2024.
•On track to initiate a Phase 1/2 dose- and regimen-finding clinical trial by the end of the first quarter of 2025 to optimize the exposure of WTX-330 in the tumor microenvironment.
•Pending data from Phase 1/2 dose- and regimen-finding trial, anticipate opening expansion arms in selected tumor types.
Preclinical Portfolio: includes development candidates WTX-712 and WTX-518, our Interleukin-21 (IL-21) and binding protein resistant Interleukin-18 (IL-18) INDUKINE molecules, respectively, for treatment of cancer, and WTX-921, a first-of-its-kind Interleukin-10 (IL-10) INDUKINE molecule for the treatment of inflammatory bowel disease (IBD) and potentially other inflammatory diseases.
Financial Results for the Fourth Quarter and Full Year 2024:
•Cash position: As of December 31, 2024, cash and cash equivalents were $111.0 million, compared to $134.3 million as of December 31, 2023. The Company also had restricted cash and cash equivalents of $1.2 million and $21.2 million as of December 31, 2024 and December 31, 2023, respectively. The Company believes its existing cash and cash equivalents at December 31, 2024 will be sufficient to fund operational expenses and capital expenditure requirements through at least the second quarter of 2026.
•Collaboration revenue: No collaboration was recognized during fourth quarter of 2024 due to the fact that Werewolf substantially completed its performance obligations under the collaboration agreement with Jazz Pharmaceuticals (Jazz) during the second quarter of 2024. Comparatively, collaboration revenue was $1.5 million for the fourth quarter of 2023. Collaboration revenue was $1.9 million for the full year 2024, compared to $19.9 million for the same period in 2023. Collaboration revenue consists of revenue recognized from the Company’s licensing agreement with Jazz and includes fixed payments received from Jazz, plus costs incurred for research services to be reimbursed by Jazz.
•Research and development expenses: Research and development expenses were $15.7 million for the fourth quarter of 2024, compared to $9.6 million for the same period in 2023. Research and development expenses were $56.4 million for the full year 2024, compared to $41.8 million for the full year 2023.
•General and administrative expenses: General and administrative expenses were $4.6 million for the fourth quarter of 2024, compared to $4.8 million for the same period in 2023. General and administrative expenses were $19.0 million for the full year 2024, compared to $18.7 million for the full year 2023.
•Net loss: Net loss was $20.4 million for the fourth quarter of 2024, compared to $12.0 million for the same period in 2023. Net loss was $70.5 million for the full year 2024, compared to $37.4 million for the full year 2023.