On May 8, 2025 Takeda (TOKYO:4502/NYSE:TAK) reported financial results for fiscal year 2024 (period ended March 31, 2025) with continued strong momentum in Growth & Launch Products offsetting loss of exclusivity impact to drive revenue and Core Operating Profit growth, supported by robust cost management (Press release, Takeda, MAY 8, 2025, View Source [SID1234652790]).

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Takeda has built a high-value late-stage pipeline with potentially life-transforming new treatment options for patients. Following a positive Phase 3 readout for rusfertide in Oncology in March 2025, the company anticipates a further two Phase 3 readouts in core therapeutic areas this fiscal year.

FY2025 Management Guidance at CER reflects residual carry-over of VYVANSE generic impact, continued efficiency savings and investment in R&D and launch preparation for Takeda’s late-stage pipeline.

Takeda chief executive officer, Christophe Weber, commented:
"Takeda delivered excellent results in FY2024. Our return to Core Operating Profit margin growth underscores the strength of our Growth & Launch Products portfolio and the ability of our multi-year efficiency program to deliver meaningful cost savings.

"FY2025 will be a pivotal year as we invest in launch readiness for the late-stage pipeline, which will contribute to our broadly flat Core Operating Profit outlook for FY2025 but will be key to achieving Takeda’s long-term growth potential."

Takeda chief financial officer, Milano Furuta, commented:
"Takeda’s success in delivering revenue and Core Operating Profit growth in FY2024 and our outlook for broadly flat revenue and profit in FY2025, demonstrates our ability to manage through one of the largest generic impacts on our business in Takeda’s history while progressing a highly promising late-stage pipeline. Our performance and outlook speak to the strength of our Growth & Launch Products, our innovative pipeline and the resilience of our organization as a whole.

"Takeda is now at an inflection point, with multiple anticipated Phase 3 data readouts this fiscal year, and I’m excited about our growth trajectory."

FINANCIAL HIGHLIGHTS for FY2024 Ended March 31, 2025

(Billion yen, except percentages and per share amounts)

FY2024

FY2023

vs. PRIOR YEAR

(Actual % change)

Revenue

4,581.6

4,263.8

+7.5%

Operating Profit

342.6

214.1

+60.0%

Net Profit

107.9

144.1

-25.1%

EPS (Yen)

68

92

-25.8%

Operating Cash Flow

1,057.2

716.3

+47.6%

Adjusted Free Cash Flow (Non-IFRS)

769.0

283.4

+171.3%

Core (Non-IFRS)

(Billion yen, except percentages and per share amounts)

FY2024

FY2023

vs. PRIOR YEAR

(Actual % change)

vs. PRIOR YEAR

(CER % change)

Revenue

4,579.8

4,263.8

+7.4%

+2.8%

Operating Profit

1,162.6

1,054.9

+10.2%

+4.9%

Margin

25.4%

24.7%

+0.6pp

―

Net Profit

775.6

756.8

+2.5%

-3.4%

EPS (Yen)

491

484

+1.5%

-4.3%

FY2025 Outlook

(Billion yen, except percentages and per share amounts)

Item

FY2025 FORECAST

FY2025

MANAGEMENT

GUIDANCE

Core Change at CER

(Non-IFRS)

Revenue

4,530.0

—

Core Revenue (Non-IFRS)

4,530.0

Broadly flat

Operating Profit

475.0

—

Core Operating Profit (Non-IFRS)

1,140.0

Broadly flat

Net Profit

228.0

—

EPS (Yen)

145

—

Core EPS (Yen) (Non-IFRS)

485

Broadly flat

Adjusted Free Cash Flow (Non-IFRS)

750.0-850.0

—

Annual Dividend per Share (Yen)

200

—

Additional Information About Takeda’s FY2024 Results
For more details about Takeda’s FY2024 results, commercial progress, pipeline updates and other financial information, including key assumptions in the FY2025 forecast and management guidance as well as definitions of non-IFRS measures, please refer to Takeda’s FY2024 Q4 investor presentation (available at View Source)

On May 8, 2025 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, reported financial results for the first quarter ended March 31, 2025, and provided a business update (Press release, Cardiff Oncology, MAY 8, 2025, View Source [SID1234652736]).

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"Our lead program for onvansertib has remained on track in 2025 with the successful completion of enrollment in our trial in first-line RAS-mutated mCRC, underscoring our deep commitment to serving a patient population that has seen no therapeutic advancements in decades," said Mark Erlander, Chief Executive Officer of Cardiff Oncology. "Furthermore, we expanded our intellectual property portfolio through the issuance of a second patent covering all mCRC, regardless of tumor mutational status, across all lines of therapy. As we continue to generate clinical data and move toward regulatory discussions with the FDA, we remain focused on our mission to deliver a transformative therapy that could redefine the standard of care for RAS-mutated mCRC and for other cancers."

Upcoming expected milestones

•
Additional clinical data from the ongoing CRDF-004 trial in mCRC expected in 1H 2025
Company highlights for the quarter ended March 31, 2025, and subsequent weeks include:

•
Announced completion of enrollment in Phase 2, randomized, CRDF-004 trial evaluating onvansertib + standard of care (SoC) for the treatment of first-line RAS-mutated mCRC
o
The Phase 2 CRDF-004 trial has reached the targeted enrollment of patients with first-line mCRC across 41 clinical sites in the U.S. Patients in the trial have mCRC and a documented KRAS or NRAS mutation with unresectable disease. Onvansertib is added to SoC consisting of FOLFIRI plus bevacizumab (bev) or FOLFOX plus bev. Patients are randomized to either 20mg of onvansertib plus SoC, 30mg of onvansertib plus SoC, or SoC alone. The primary endpoint is objective response rate (ORR), and the secondary endpoints include progression-free survival (PFS), duration of response (DOR) and safety.
•
Announced a second patent issuance from the United States Patent and Trademark Office (USPTO) for the treatment of mCRC for bev-naïve patients
o
U.S. patent No. 12,263,173 has an expiration date of no earlier than 2043. The claims of the new patent cover the method of using onvansertib in combination with bev in any line of therapy for the treatment of mCRC patients who have not previously been treated with bev.

The newly issued patent encompasses all mCRC patients, with RAS-mutated or RAS wild-type mCRC.
First Quarter 2025 Financial Results:

Liquidity, cash burn, and cash runway

As of March 31, 2025, Cardiff Oncology had approximately $79.9 million in cash, cash equivalents, and short-term investments.

Net cash used in operating activities for the first quarter of 2025 was approximately $12.8 million, an increase of approximately $5.1 million from $7.7 million for the same period in 2024.

Based on its current expectations and projections, the Company believes its current cash resources are sufficient to fund its operations into Q1 2027.

Operating results

Total operating expenses were approximately $14.5 million for the three months ended March 31, 2025, an increase of $3.4 million from $11.1 million for the same period in 2024. The increase in operating expenses was primarily due to costs associated with our CRDF-004 clinical trial, other clinical programs and outside service costs related to the development of our lead drug candidate, onvansertib, as well as professional fees related to strategic advisory services.

On May 8, 2025 Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, reported business highlights and financial results for the first quarter ended March 31, 2025 (Press release, Monte Rosa Therapeutics, MAY 8, 2025, View Source [SID1234652752]).

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"We’ve made significant progress across our entire portfolio in the development of our only-in-class and first-in-class molecular glue degrader therapeutics, targeting diseases poorly addressed by conventional pharmaceutical approaches," said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. "As highlighted in our recent pipeline update, our MRT-6160 Phase 1 study results support the broad potential application of this molecule as a novel treatment approach for immune-mediated diseases, and we are working diligently to advance the program into Phase 2 studies alongside our collaborators at Novartis. For our GSPT1 program, based on encouraging preliminary data from our ongoing Phase 1/2 study of MRT-2359 in MYC-driven solid tumors, we are focused on castration-resistant prostate cancer, an exciting opportunity in a population with widespread c-MYC expression. Study enrollment is ongoing, and we expect to report additional clinical data in H2 2025. Lastly, we continue to make excellent progress with our earlier stage programs. Our NEK7 program, targeting inflammatory diseases driven by IL-1β and the NLRP3 inflammasome, is on track, and we plan to file an IND submission for MRT-8102 in the first half of this year. Recent preclinical data for our CDK2-directed MGD highlight the substantially greater tumor regression achieved with our MGD combined with standard of care therapies compared to standard of care alone. We look forward to an IND submission for our CDK2 and/or CCNE1 cell cycle programs next year."

RECENT HIGHLIGHTS

MRT-6160, VAV1-directed MGD for immune-mediated conditions

•
In March 2025, Monte Rosa announced clinical results from its MRT-6160 Phase 1, single ascending dose / multiple ascending dose (SAD/MAD) study in healthy volunteers (clinicaltrials.gov identifier NCT06597799). The results support a clear path into anticipated Phase 2 studies and broad potential applications in multiple immune-mediated diseases. Further development of MRT-6160 toward Phase 2 studies is ongoing, in collaboration with Novartis.
•
Monte Rosa has a global exclusive development and commercialization license agreement with Novartis to advance VAV1 MGDs including MRT-6160. Monte Rosa is eligible to receive up to $2.1 billion in development, regulatory, and sales milestones, beginning upon initiation of Phase 2 studies. Monte Rosa will co-fund any Phase 3 clinical development and will share any profits and losses associated with the manufacturing and commercialization of MRT-6160 in the U.S., and is also eligible for tiered royalties on ex-U.S. net sales.

MRT-2359, GSPT1-directed MGD for MYC-driven solid tumors

•
In March 2025, Monte Rosa provided updated clinical results in evaluating the safety, pharmacodynamics, and clinical activity of MRT-2359 in various tumor types. The Company has determined castration-resistant prostate cancer (CRPC) to be the primary MRT-2359 development focus. The Company continues to enroll and evaluate patients with CRPC, with the potential to expand enrollment to 20-30 patients if a positive efficacy signal continues to be observed, and expects to present additional results in H2 2025. Monte Rosa also continues to enroll and evaluate patients with HR+ breast cancer and expects to present additional results for this cohort in H2 2025.

NEK7-directed MGDs for inflammatory and CNS diseases driven by IL-1β and the NLRP3 inflammasome

•
Monte Rosa has successfully completed GLP tox studies for MRT-8102, a first-in-class, NEK7-directed MGD for the treatment of inflammatory diseases driven by interleukin-1β (IL-1β) and the NLRP3 inflammasome, supporting a considerable safety margin. The Company is on track to submit an IND application for MRT-8102 in H1 2025 and plans to initiate Phase 1 healthy volunteer and proof-of-concept studies in individuals with high levels of C-reactive protein (CRP) and in cardio-immunology indications. The Company continues to evaluate future Phase 2 proof-of-concept studies in gout, pseudogout (calcium pyrophosphate deposition disease), and osteoarthritis.

Cyclin E1 and CDK2-directed MGD programs for treatment of solid tumors

•
In April 2025, Monte Rosa presented preclinical data on the potential of its highly selective CDK2-directed molecular glue degrader, MRT-51443, to treat HR-positive/HER2-negative breast cancer at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025. MRT-51443 demonstrated superior anti-tumor activity in HR-positive/HER2-negative breast cancer models when combined with CDK4/6 inhibition and anti-estrogen therapy as compared to the standard-of-care combination of CDK4/6 inhibition and anti-estrogen therapy. Results also showed that MRT-51443 displayed superior selectivity compared to clinical-stage CDK2 inhibitors.

QuEEN (Quantitative and Engineered Elimination of Neosubstrates) discovery engine

•
Monte Rosa is advancing novel discovery programs for immunology and inflammation targets that the Company believes have the potential for highly differentiated, oral MGDs degrading undruggable targets in critical I&I pathways. These may include programs with the potential to improve upon the clinical profile of cell therapies, such as CAR-T, or biologics, such as FcRn inhibitors.

ANTICIPATED UPCOMING MILESTONES AND DEVELOPMENT PRIORITIES

•
Continue advancement of MRT-6160 toward Phase 2 initiation, in collaboration with Novartis.
•
Share additional MRT-2359 Phase 1/2 study data in CRPC patients resistant to androgen receptor (AR) therapy and in patients with HR+ breast cancer in H2 2025.
•
Submit an IND application for MRT-8102 in H1 2025.
•
Submit an IND application for the second-generation NEK7-directed MGD with enhanced CNS penetration in 2026.
•
Submit an IND application for a CDK2 and/or cyclin E1-directed MGD in 2026.

FIRST QUARTER 2025 FINANCIAL RESULTS

Collaboration revenue: Collaboration revenue for the first quarter of 2025 was $84.9 million and $1.1 million for the quarter ended March 31, 2024. Collaboration revenue represents amounts earned from our collaboration and license agreements with Roche and Novartis, primarily revenue recognized from the Novartis $150 million upfront payment in the fourth quarter of 2024 based on progress made on our performance obligations defined in the Novartis License Agreement.

Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2025 were $32.2 million, compared to $27.0 million for the first quarter of 2024. These increases were driven by the successful achievement of key milestones in our R&D organization, including the continuation of the MRT-2359 clinical study, the progression and growth of our preclinical pipeline, including research performed in connection with our collaboration with Roche, the advancement of MRT-6160 to enter the clinic, and the continued development of the Company’s QuEEN discovery engine. Approximately $1.0 million included in R&D expenses are to be reimbursed pursuant to our license agreement with Novartis. Non-cash stock-based compensation constituted $3.1 million of R&D expenses for Q1 2025, compared to $2.7 million in the same period in 2024.

General and Administrative (G&A) Expenses: G&A expenses for the first quarter of 2025 were $8.7 million compared to $9.0 million for the first quarter of 2024. G&A expenses included non-cash stock-based compensation of $2.2 million for the first quarter of 2025, compared to $2.2 million in the same period in 2024.

Net Income (Loss): Net income for the first quarter of 2025 was $46.9 million, compared to a net loss of $32.0 million for the first quarter of 2024.

Cash Position and Financial Guidance: Cash, cash equivalents, restricted cash, and marketable securities as of March 31, 2025, were $331 million, compared to cash, cash equivalents, restricted cash, and marketable securities of $377 million as of December 31, 2024. The decrease of $46 million was primarily due to the operational use of cash and one-time payments not recorded in operating expenses, including $12.2 million of value-added tax (VAT) collected from Novartis in the fourth quarter of 2024 in connection with the Novartis $150 million upfront payment and remitted to the Swiss Federal Tax Administration in the first quarter of 2025.

Based on current cash, cash equivalents, restricted cash, marketable securities, the Company expects its cash and cash equivalents to be sufficient to fund planned operations and capital expenditures into 2028.

About MRT-6160
MRT-6160 is a potent, highly selective, and orally bioavailable investigational molecular glue degrader of VAV1, which in preclinical studies has shown deep degradation of its target with no detectable effects on other proteins. VAV1 is a key signaling protein downstream of both the T- and B-cell receptors. VAV1 expression is restricted to immune cells, including T and B cells. MRT-6160 has shown promising activity in preclinical models of multiple immune-mediated conditions. In a Phase 1, single ascending dose / multiple ascending dose (SAD/MAD) study in healthy subjects (clinicaltrials.gov identifier NCT06597799), MRT-6160 demonstrated sustained, dose-dependent VAV1 degradation in peripheral blood T and B cells after single and multiple dose administration. MRT-6160 also substantially inhibited secretion of inflammatory cytokines from whole blood derived T and B cells following ex vivo stimulation. Under the terms of an agreement announced in October 2024, Novartis has exclusive worldwide rights to develop, manufacture and commercialize MRT-6160 and other VAV1 MGDs. Monte Rosa is eligible to receive up to $2.1 billion in development, regulatory, and sales milestones, beginning upon initiation of Phase 2 studies. Monte Rosa will co-fund any Phase 3 clinical development and will share any profits and losses associated with the manufacturing and commercialization of MRT-6160 in the U.S., and is also eligible for tiered royalties on ex-U.S. net sales.

About MRT-2359
MRT-2359 is a potent, highly selective, and orally bioavailable investigational molecular glue degrader (MGD) of GSPT1. MYC transcription factors (c-MYC, L-MYC and N-MYC) are well-established drivers of human cancers that maintain high levels of protein translation, which is critical for uncontrolled cell proliferation and tumor growth. Preclinical studies have shown this addiction to MYC-induced protein translation creates a dependency on GSPT1. By inducing degradation of GSPT1, MRT-2359 is designed to exploit this vulnerability, disrupting the protein synthesis machinery, leading to anti-tumor activity in MYC-driven tumors. MRT-2359 is being investigated in an ongoing Phase 1/2 study (clinicaltrials.gov identifier NCT05546268) in solid tumors, including castration-resistant prostate cancer (CRPC). In CRPC patients resistant to AR therapy, a patient group characterized by widespread expression of c-MYC, MRT-2359 demonstrated encouraging early signals of clinical response.

About MRT-8102
MRT-8102 is a potent, highly selective, and orally bioavailable investigational molecular glue degrader (MGD) that targets NEK7 for the treatment of inflammatory diseases driven by IL-1β and the NLRP3 inflammasome. NEK7 has been shown to be required for NLRP3 inflammasome assembly, activation and IL-1β release both in vitro and in vivo. Aberrant NLRP3 inflammasome activation and the subsequent release of active IL-1β and interleukin-18 (IL-18) has been implicated in multiple inflammatory disorders, including cardiovascular disease, gout, osteoarthritis, neurologic disorders including Parkinson’s disease and Alzheimer’s disease, and metabolic disorders. In a non-human primate model, MRT-8102 was shown to potently, selectively, and durably degrade NEK7, and resulted in near-complete reductions of IL-1β and caspase-1 following ex vivo stimulation of whole blood. MRT-8102 has demonstrated a considerable safety margin (>200-fold exposure margin over projected human efficacious dose) in GLP toxicology studies.

On May 8, 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 reported financial results for the first quarter ended March 31, 2025 (Press release, Xilio Therapeutics, MAY 8, 2025, View Source [SID1234652773]).

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"In the first quarter, we presented encouraging initial Phase 2 data for vilastobart, our tumor-activated anti-CTLA-4, in combination with atezolizumab in patients with late-line MSS CRC. These data included a preliminary 27% objective response rate in late-line MSS CRC patients without liver metastases accompanied by a differentiated safety profile with a low incidence of colitis and other immune-related adverse events, which are common dose-limiting adverse events for other CTLA-4 agents," said René Russo, Pharm.D., president and chief executive officer of Xilio. "MSS CRC is an immunologically cold tumor type that is very difficult to treat and increasing in incidence, particularly in younger people for whom no immunotherapy treatment options are currently available. We look forward to reporting updated Phase 2 data at the upcoming ASCO (Free ASCO Whitepaper) meeting, including additional response assessments and further follow-up on the previously reported data. This quarter was also marked by strong execution across our pipeline, as we continue to advance XTX301, our tumor-activated IL-12, in monotherapy dose escalation in partnership with Gilead, and multiple novel masked T cell engager programs internally and as part of our recently announced collaboration with AbbVie."

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). Vilastobart is currently being evaluated in combination with atezolizumab (Tecentriq ) in Phase 1C combination dose escalation in patients with advanced solid tumors and in a Phase 2 clinical trial in patients with MSS CRC.

● In January 2025, Xilio announced encouraging initial Phase 2 data for vilastobart in combination with atezolizumab in patients with MSS CRC. As of a data cutoff date of January 13, 2025, the combination of vilastobart at 100 mg once every six weeks (Q6W) in combination with atezolizumab at 1200 mg once every three weeks (Q3W) demonstrated a preliminary 27% objective response rate in patients without liver metastases accompanied by a generally well-tolerated safety profile. Patients experienced a low incidence of colitis and other immune-related adverse events, which have historically limited the potential for anti-CTLA-4 therapies. For more information, read the press release here. Based on the promising initial Phase 2 data for vilastobart, Xilio is seeking opportunities to partner the vilastobart program to accelerate and expand further development.

● Xilio plans to report updated data from the ongoing Phase 2 clinical trial in patients with metastatic MSS CRC, including additional response assessments and further follow-up on the previously reported data, at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held in Chicago from May 30 to June 3, 2025.

Title: Vilastobart (XTX101), a tumor-activated, Fc-enhanced anti-CTLA-4 monoclonal antibody, in combination with atezolizumab in patients with MSS CRC

Abstract ID: 3553

Poster Session: Gastrointestinal Cancer – Colorectal and Anal

Poster Board: 222

Session Date and Time: Saturday, May 31, from 9:00 a.m. to 12:00 p.m. CDT

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.

● 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) 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.

● 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. PSMA has demonstrated potential as a T cell engager target for prostate cancer.

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

Corporate Updates

● In the first quarter of 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, and received $52.0 million in total upfront payments from AbbVie. Under the agreement, Xilio is also 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.

First Quarter 2025 Financial Results

● Cash Position: Cash and cash equivalents were $89.1 million as of March 31, 2025, compared to $55.3 million as of December 31, 2024. In the first quarter of 2025, Xilio received $52.0 million in total upfront payments in connection with the collaboration agreement with AbbVie.

● Collaboration and License Revenue: Collaboration and license revenue was $2.9 million for the quarter ended March 31, 2025, which consisted of $2.9 million of total revenue recognized in connection with the collaborations with AbbVie and Gilead. No collaboration and license revenue was recognized for the quarter ended March 31, 2024.

● Research & Development (R&D) Expenses: R&D expenses were $8.3 million for the quarter ended March 31, 2025, compared to $10.4 million for the quarter ended March 31, 2024. The 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 personnel-related costs due to lower headcount and decreased manufacturing costs for XTX301, partially offset by increased spending related to early stage programs and indirect research and development, increased clinical development activities for vilastobart and manufacturing activities for XTX501 in connection with IND-enabling studies.

● General & Administrative (G&A) Expenses: G&A expenses were $8.5 million for the quarter ended March 31, 2025, compared to $6.1 million for the quarter ended March 31, 2024. The increase was primarily driven by an increase in legal fees and personnel-related costs, partially offset by a decrease in costs related to directors’ and officers’ liability insurance.

● Net Loss: Net loss was $13.3 million for the quarter ended March 31, 2025, compared to $17.2 million for the quarter ended March 31, 2024.

Financial Guidance

Based on its current operating plans, Xilio anticipates that its cash and cash equivalents as of March 31, 2025 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 May 8, 2025 HAYA Therapeutics, SA, a biotechnology company pioneering precision RNA-guided regulatory genome targeting therapeutics that reprogram disease-driving cell states for rare, common, chronic and age-related diseases, reported that the company has raised $65 million in Series A funding (Press release, Haya Therapeutics, MAY 8, 2025, View Source [SID1234652791]). The financing will accelerate the clinical development of HAYA’s lead long non-coding RNA (lncRNA) targeting candidate HTX-001 in heart failure and the continued expansion of its RNA-guided regulatory genome pipeline development engine. This investment emphasizes investor confidence in HAYA’s groundbreaking science and positions the company to deliver on its mission of bringing disease-modifying, precision medicines faster and more efficiently to patients. The round was led by Sofinnova Partners and Earlybird Venture Capital, with participation from Eli Lilly and Company (Lilly), ATHOS, +ND Capital, Alexandria Venture Investments and LifeLink Ventures, with additional support from existing investors Apollo Health Ventures, Longview Ventures (an affiliate of Broadview Ventures), 4see ventures, BERNINA Bioinvest and Schroders Capital.

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"This is a defining moment for HAYA as we are advancing our lead program into the clinic. This funding validates our organization, pioneering approach and vision for improving the way chronic and complex diseases are treated by creating a new generation of therapies that reprogram disease-driving cell states into healthy ones," said Samir Ounzain, Ph.D., Co-founder and CEO of HAYA Therapeutics. "We’re excited that Sofinnova Partners, Earlybird and our syndicate of investors share our vision for the potentially industry changing nature of our platform as we move beyond traditional approaches by leveraging novel therapeutic targets emerging from the regulatory genome."

The company will use the funds to initiate clinical trials for HTX-001, HAYA’s first-in-class lncRNA-targeting therapy for heart failure, initially focused on non-obstructive hypertrophic cardiomyopathy (nHCM). In parallel, the company will strengthen its platform capabilities and expand its pipeline of disease-modifying therapies across multiple therapeutic areas—including pulmonary fibrosis, obesity and age-related common and chronic diseases.

"HAYA’s platform unlocks the dark genome’s therapeutic potential by targeting disease-driving cell states via long non-coding RNAs. This novel approach opens a new frontier in precision medicine, moving beyond traditional target classes to address disease at its epigenetic and cellular roots. Leading this round alongside Earlybird reflects our deep conviction in the HAYA team and their mission to develop safer, more effective therapies across a broad range of indications, including their lead program in nHCM, as they advance it toward the clinic to address a major unmet need," noted Henrijette Richter, Managing Partner at Sofinnova Partners.

The core of HAYA’s proprietary platform maps and decodes the biology of the regulatory genome, also referred to as the "genome’s dark matter" or "Dark Genome," which constitutes 98% of the human genome. While the regulatory genome does not code for proteins it is now recognized as the master control layer of gene expression and cell identity. HAYA has developed the most comprehensive atlas of the regulatory genome by combining integrated multimodal functional genomics with a stack of proprietary computational and machine learning methodologies, enabling the precise identification and modulation of pathogenic cell states across diverse diseases. HAYA’s regulatory genome platform enables the development of RNA-guided therapeutics with unprecedented precision, speed and scalability. This next-generation approach is designed to go beyond symptom management and directly reprogram the cellular drivers of disease.

To support its strategic growth, HAYA recently assembled an industry-leading C-level suite to drive scalable growth, business and clinical development and expand strategic collaborations with pharmaceutical and technology partners. The company recently announced a partnership with Lilly, one of the largest collaborations to date in the regulatory genome space, focused on RNA-based drug targets for obesity and metabolic disorders.