Lyell Immunopharma Announces Oral Presentation of New Clinical Data from the Phase 1/2 Trial of LYL314 for the Treatment of Large B-cell Lymphoma at the International Conference on Malignant Lymphoma (ICML) 2025

On May 1, 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 that an abstract highlighting new clinical data from the Phase 1/2 trial of LYL314 (formerly IMPT-314) in large B-cell lymphoma will be presented as an oral presentation at the International Conference on Malignant Lymphoma (ICML) 2025 taking place in Lugano, Switzerland June 17-21, 2025 (Press release, Lyell Immunopharma, MAY 1, 2025, View Source [SID1234652447]).

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LYL314 is a dual-targeting CD19/CD20 chimeric antigen receptor (CAR) T-cell product candidate in development for patients with aggressive large B-cell lymphoma. LYL314 has received Regenerative Medicine Advanced Therapy and Fast Track designations from the U.S. Food and Drug Administration for the treatment of patients with relapsed and/or refractory diffuse large B-cell lymphoma in the 3rd or later line setting.

Details of the presentation are below:

LYL314, a CD19/CD20 CAR T-cell candidate enriched for CD62L+ stem-like cells, achieves high rates of durable complete responses in R/R large B-cell lymphoma

Session Name: Focus on New Cellular Therapies
Presentation Date & Time: June 18, 2025, 5:40 pm CEST (11:40 am ET)
Presenting Author: Akil Merchant, MD, Associate Professor and Co-Director of the Lymphoma Program at the Samuel Oschin Cancer Center, Cedars-Sinai Medical Center, Los Angeles, CA
Presentation Number: 106
Location: Room B

Summit Therapeutics Reports Financial Results and Operational Progress for the First Quarter Ended March 31, 2025

On May 1, 2025 Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") reported its financial results and provides an update on its operational progress for the first quarter ended March 31, 2025 (Press release, Summit Therapeutics, MAY 1, 2025, View Source [SID1234652466]).

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Operational & Corporate Updates

Operational progress continues with ivonescimab (SMT112), an investigational, potentially first-in-class bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule:

In January 2023, we closed our Collaboration and License Agreement with Akeso Inc. (Akeso, HKEX Code: 9926.HK) for ivonescimab (SMT112), with which over 2,300 patients have been treated in clinical studies globally. Summit has rights to develop and commercialize ivonescimab in the United States, Canada, Europe, Japan, Latin America, including Mexico and all countries in Central America, South America, and the Caribbean, the Middle East, and Africa while Akeso retains development and commercialization rights for the rest of the world, including China.
Since in-licensing ivonescimab, we have begun our development for ivonescimab in non-small cell lung cancer ("NSCLC"), specifically launching Phase III clinical trials in the following proposed indications:
HARMONi: Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI)
HARMONi-3: Ivonescimab combined with chemotherapy in first-line metastatic NSCLC patients
HARMONi-7: Ivonescimab monotherapy in first-line metastatic NSCLC patients with high PD-L1 expression
In October 2024, we completed enrollment in our HARMONi clinical trial. We expect to disclose topline results from HARMONi in mid-2025. Enrollment continues in HARMONi-3 and the initial patients have been enrolled in the US in HARMONi-7.
On April 23, 2025, our partner, Akeso, announced that the HARMONi-6 Phase III clinical trial met its primary endpoint of progression-free survival (PFS) at a prespecified interim analysis conducted by an Independent Data Monitoring Committee. This trial evaluated ivonescimab combined with platinum-based chemotherapy against tislelizumab, a PD-1 inhibitor, with the same chemotherapy regimen in patients with locally advanced or metastatic squamous NSCLC, regardless of PD-L1 expression. Conducted in China by our partners at Akeso, the trial showed statistically significant and clinically meaningful improvement in PFS for ivonescimab plus chemotherapy. Akeso noted that no new safety signals were identified.
This study is the first known Phase III trial in NSCLC to show significant improvement over a PD-(L)1 inhibitor combined with chemotherapy in a head-to-head setting. Following the success of Akeso’s HARMONi-2 study, this is the second instance where ivonescimab-based regimens have demonstrated a significant PFS benefit in front-line treatment in NSCLC. The full data set for HARMONi-6 is planned to be presented at an upcoming major medical conference later this year.
On April 25, 2025, Akeso announced that ivonescimab was approved in China by the National Medical Products Administration (NMPA), the Chinese Health Authority, for a second indication based on the results of the HARMONi-2 trial. HARMONi-2 evaluated monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression. HARMONi-2 is a single region, multi-center, Phase III study conducted in China sponsored by Akeso with all relevant data exclusively generated, managed, and analyzed by Akeso.
As a part of the review of the supplemental marketing application submitted by Akeso seeking a label expansion of ivonescimab in China, the NMPA requested that Akeso perform an interim analysis of overall survival (OS). Akeso announced that the results of this interim overall survival analysis included a clinically meaningful, strongly positive trend represented by a hazard ratio of 0.777. The analysis was conducted at 39% data maturity, with a nominal alpha level of 0.0001.
Ivonescimab clinical trial collaborations with leading organizations continue to progress and expand evaluating ivonescimab in solid tumor settings outside of metastatic non-small cell lung cancer.
As part of our strategic collaboration with MD Anderson, two clinical trials sponsored by MD Anderson began enrolling this past quarter in cutaneous squamous cell carcinoma and glioblastoma.
We continue to support investigator-sponsored trials (ISTs) beyond our work with MD Anderson; two ISTs have begun enrolling at the Memorial Sloan Kettering Cancer Center and the Dana Farber Cancer Institute.
As we announced in February, our clinical trial collaboration with Pfizer will evaluate multiple antibody drug conjugates (ADCs) in combination with ivonescimab in unique solid tumor settings. The studies combining ivonescimab with Pfizer’s vedotin ADCs are planned to begin later this year. We plan to review the data generated from these clinical trials as a part of our consideration for advancing our clinical development for ivonescimab beyond non-small cell lung cancer.
In March, we further strengthened our leadership team with the appointment of Robert LaCaze as Chief Commercial Officer. Prior to joining Summit, Mr. LaCaze has held senior positions at major pharmaceutical companies including Executive Vice President and Head of the Oncology Strategic Business Unit overseeing the global oncology franchise at Bayer Healthcare and Senior Vice President and Head of Global Oncology at Bristol-Myers Squibb. He is a seasoned biopharmaceutical executive with over 30 years of extensive leadership experience in commercial strategy and execution. He has a proven track record of launching multi-billion-dollar products, building and growing blockbuster drug franchises, and expanding market presence for various oncology products.
Financial Highlights

Cash and Cash Equivalents & Short-term Investments

Aggregate cash and cash equivalents and short-term investments were $361.3 million and $412.3 million at March 31, 2025 and December 31, 2024, respectively.
GAAP and Non-GAAP Research and Development (R&D) Expenses

GAAP R&D expenses according to generally accepted accounting principles in the U.S. ("GAAP") were $51.2 million for the first quarter of 2025, compared to $30.9 million for the same period of the prior year.
Non-GAAP R&D expenses were $47.1 million for the first quarter of 2025, compared to $28.5 million for the same period of the prior year.
GAAP and Non-GAAP General and Administrative (G&A) Expenses

GAAP G&A expenses were $15.6 million for the first quarter of 2025, compared to $11.5 million for the same period of the prior year.
Non-GAAP G&A expenses were $8.6 million for the first quarter of 2025, compared to $4.4 million for the same period of the prior year.
GAAP and Non-GAAP Operating Expenses

GAAP operating expenses were $66.8 million for the first quarter of 2025, compared to $42.4 million for the same period of the prior year.
Non-GAAP operating expenses were $55.7 million for the first quarter of 2025, compared to $32.9 million for the same period of the prior year. The increase is primarily related to the increase in R&D expenses due to expansion of clinical studies and development costs related to ivonescimab and increases in people costs as we continue to build out our team.
GAAP and Non-GAAP Net Loss

GAAP net loss in the first quarter of 2025 and 2024 was $62.9 million or $(0.09) per basic and diluted share, and $43.5 million or $(0.06) per basic and diluted share, respectively.
Non-GAAP net loss in the first quarter of 2025 and 2024 was $51.8 million or $(0.07) per basic and diluted share, and $34.0 million or $(0.05) per basic and diluted share, respectively.
Use of Non-GAAP Financial Measures

This release includes measures that are not in accordance with U.S. generally accepted accounting principles ("Non-GAAP measures"). These Non-GAAP measures should be viewed in addition to, and not as a substitute for, Summit’s reported GAAP results, and may be different from Non-GAAP measures used by other companies. In addition, these Non-GAAP measures are not based on any comprehensive set of accounting rules or principles. Summit management uses these non-GAAP measures for internal budgeting and forecasting purposes and to evaluate Summit’s financial performance. Summit management believes the presentation of these Non-GAAP measures is useful to investors for comparing prior periods and analyzing ongoing business trends and operating results. For further information regarding these Non-GAAP measures, please refer to the tables presenting reconciliations of our Non-GAAP results to our U.S. GAAP results and the "Notes on our Non-GAAP Financial Information" that accompany this press release.

First Quarter 2025 Earnings Call

Summit will host an earnings call this afternoon, Thursday, May 1, 2025, at 4:30pm ET. The conference call will be accessible by dialing (800) 715-9871 (toll-free domestic) or (646) 307-1963 (international) using conference code 4936739. A live webcast and instructions for joining the call are accessible through Summit’s website www.smmttx.com. An archived edition of the webcast will be available on our website after the call.

About Ivonescimab

Ivonescimab, known as SMT112 in Summit’s license territories, North America, South America, Europe, the Middle East, Africa, and Japan, and as AK112 in China and Australia, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity to PD-1 when in the presence of VEGF.

This could differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Ivonescimab’s tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, SITC (Free SITC Whitepaper), 2023). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design, together with a half-life of 6 to 7 days after the first dose (Zhong, et al, SITC (Free SITC Whitepaper), 2023), is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets.

Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently engaged in multiple Phase III clinical trials. Over 2,300 patients have been treated with ivonescimab in clinical studies globally.

Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), commencing enrollment in 2023 in two multi-regional Phase III clinical trials, HARMONi and HARMONi-3, and the Company has begun to enroll patients in the United States for HARMONi-7.

HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib). Enrollment in HARMONi was completed in the second half of 2024, and top-line results are expected to be announced in the middle of this year.

HARMONi-3 is a Phase III clinical trial which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic, squamous and non-squamous NSCLC.

HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.

In addition, Akeso has recently had positive read-outs in three single-region (China), randomized Phase III clinical trials for ivonescimab in NSCLC: HARMONi-A, HARMONi-2, and HARMONi-6.

HARMONi-A was a Phase III clinical trial which evaluated ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with an EGFR TKI.

HARMONi-2 is a Phase III clinical trial evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression.

HARMONi-6 is a Phase III clinical trial evaluating ivonescimab in combination with platinum-based chemotherapy compared with tislelizumab, an anti-PD-1 antibody, in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous NSCLC, irrespective of PD-L1 expression.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was initially approved for marketing authorization in China in May 2024, and its label was expanded in China in April 2025. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration ("FDA") for the HARMONi clinical trial setting.

Blueprint Medicines Reports First Quarter 2025 Results and Raises AYVAKIT®/AYVAKYT® (avapritinib) Full Year Revenue Guidance

On May 1, 2025 Blueprint Medicines Corporation (Nasdaq: BPMC) reported financial results, provided a business update for the first quarter ended March 31, 2025, and provided corporate updates (Press release, Blueprint Medicines, MAY 1, 2025, View Source [SID1234652428]).

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"Blueprint Medicines strives to be a top-tier standout in biotech, with a core focus on innovation, commercial excellence, and a disciplined approach to global investment across our portfolio. Following strong performance in 2024, we have continued our executional momentum in 2025," said Kate Haviland, Chief Executive Officer of Blueprint Medicines. "AYVAKIT is well on its way to meeting our goal of $2 billion in revenue by 2030, as we continue to capture the substantial and growing multi-billion-dollar systemic mastocytosis opportunity that we anticipate will drive topline revenue growth into the next decade. We also advanced our prioritized pipeline programs, achieving significant portfolio milestones, including the initiation of two proof-of-concept studies for wild-type KIT inhibitor BLU-808 and advancing the HARBOR study of elenestinib in indolent systemic mastocytosis. The combination of our durable and growing commercial revenue, our strong cash position, and our disciplined capital allocation strategy enables us to focus on executing our business to plan and insulates us from broader market volatility."

First Quarter 2025 Highlights and Recent Progress

● Achieved AYVAKIT net product revenues of $149.4 million for the first quarter of 2025, including $129.4 million in the US and $20 million ex-US, representing 61% percent growth year-over-year.
● Initiated two clinical proof-of-concept studies of BLU-808, a highly selective and potent investigational oral wild-type KIT inhibitor for the treatment of mast cell disorders, including:
o A randomized, double-blind, placebo-controlled Phase 2a challenge study of BLU-808 in patients with allergic rhinoconjunctivitis; and
o A Phase 2a proof-of-concept study in chronic urticaria. This study comprises an open-label portion in chronic inducible urticaria and a randomized, double-blind, placebo-controlled portion in chronic spontaneous urticaria.
● Presented 12 poster and two oral data presentations at the American Academy of Allergy, Asthma & Immunology (AAAAI)/World Allergy Organization (WAO) conference. The breadth of data included three-year long-term follow-up data from the PIONEER study of AYVAKIT in patients with indolent systemic mastocytosis (ISM), data showing AYVAKIT-treated patients with ISM achieved improvements in bone health, and data from the healthy volunteer study of BLU-808. Read the presentations here.
● Strengthened cash balance with $78.7 million in connection with the sale of the company’s equity investment in IDRx, Inc. following its acquisition by GSK plc.
● Hosting scientific seminar on mast cell activation syndrome (MCAS) with expert physician Dr. Matt Giannetti on Wednesday, June 4, 2025 at 1:00 p.m.

2025 Financial Guidance

Blueprint Medicines is raising guidance and now anticipates approximately $700 million to $720 million in global AYVAKIT net product revenues in 2025, on the path to achieving $2 billion in global AYVAKIT net product revenues

by 2030. This guidance increase reflects favorability observed in the free versus commercial mix of AYVAKIT sales in the first quarter and continued strength in underlying fundamentals of growth. Blueprint continues to expect a year-over-year reduction in cash burn in 2025, as it continues to invest in advancing its prioritized programs, balancing investments in innovation with financial discipline. Blueprint continues to anticipate that its existing cash, cash equivalents and investments, together with anticipated product revenues, will provide sufficient capital to enable the company to achieve a self-sustainable financial profile.

Key Upcoming Milestones

The company plans to achieve the following remaining milestones in 2025:

Mast cell disorders

● Deliver continued strong and steady AYVAKIT revenue growth.
● Achieve reimbursement of AYVAKYT in ≥ 20 countries overall.
● Activate sites and drive enrollment in HARBOR trial of elenestinib.
● Initiate proof of concept studies of BLU-808 in allergic asthma and MCAS.

Discovery

● Nominate two development candidates, including the company’s first protein degrader.

First Quarter 2025 Results

● Revenues: Revenues were $149.4 million for the first quarter of 2025, generated by net product sales of AYVAKIT/AYVAKYT. Revenues were $96.1 million in the first quarter of 2024, including $92.5 million of net product revenues from sales of AYVAKIT/AYVAKYT and $3.6 million in collaboration revenues.
● Cost of Sales: Cost of sales was $2.8 million for the first quarter of 2025, as compared to $3.2 million for the first quarter of 2024. The decrease was primarily due to lower sales to our collaboration partner offset by an increase in product sales volume.
● R&D Expenses: Research and development expenses were $91.9 million for the first quarter of 2025, as compared to $88.2 million for the first quarter of 2024. This increase was primarily due to the increased investment in our priority programs to advance the associated clinical trials. Research and development expenses included $12.1 million in stock-based compensation expenses for the first quarter of 2025.
● SG&A Expenses: Selling, general and administrative expenses were $95.8 million for the first quarter of 2025, as compared to $83.6 million for the first quarter of 2024. This increase was primarily due to an increase in activities supporting the commercialization of AYVAKIT/AYVAKYT. Selling, general, and administrative expenses included $16.9 million in stock-based compensation expenses for the first quarter of 2025.
● Net Income: Net income was $0.5 million for the first quarter of 2025, as compared to a net income of $89.1 million for the first quarter of 2024. The net income for the first quarter of 2025 was primarily driven by a one-time net gain of $50.0 million recorded in connection with the sale of the company’s equity investment in IDRx, Inc. following its acquisition by GSK plc. The net income for the first quarter of 2024 was primarily driven by a one-time non-cash debt extinguishment gain of $173.7 million recorded in connection with the Royalty Pharma termination agreement.
● Cash Position: As of March 31, 2025, cash, cash equivalents and investments were $899.8 million, as compared to $863.9 million as of December 31, 2024.

Conference Call Information

Blueprint Medicines will host a live conference call and webcast at 8:00 a.m. ET today to discuss first quarter 2025 financial results and recent business activities. The conference call may be accessed by dialing 833-470-1428 (domestic) or 404-975-4839 (international) and referring conference ID 082088. A webcast of the call will also be available under "Events and Presentations" in the Investors & Media section of the Blueprint Medicines website at View Source The archived webcast will be available on Blueprint Medicines’ website

approximately two hours after the conference call and will be available for 30 days following the call.

Upcoming Investor Conferences

Blueprint Medicines will participate in two upcoming investor conferences:

● Citizens JMP Life Science Conference on Wednesday, May 7, 2025 at 12:00 p.m. ET.
● Goldman Sachs 46th Annual Global Healthcare Conference on Wednesday, June 11, 2025 at 10:40 a.m. ET.

Scientific Webinar Series

● Blueprint Medicines will host the third event in its scientific seminar series, focused on mast cell activation syndrome (MCAS), on Wednesday, June 4, 2025 at 1:00 p.m. ET.

A live webcast of the above presentations and any related slides will be available under "Events and Presentations" in the Investors & Media section of the Blueprint Medicines website at View Source A replay of the webcasts will be archived on the Blueprint Medicines website following the events.

MacroGenics to Participate in Upcoming Investor Conference

On May 1, 2025 MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, reported that members of the Company’s management team will participate in the following investor conference this month (Press release, MacroGenics, MAY 1, 2025, View Source [SID1234652448]):

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The Citizens Life Sciences Conference (New York). Members of MacroGenics’ management team will participate in a fireside chat on Thursday, May 8, 2025, at 10:30am ET. Management will also participate in one-on-one meetings.

A webcast of the above presentation may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at View Source The Company will maintain an archived replay of the webcast on its website for 30 days.

Nuvation Bio to Present at The Citizens Life Sciences Conference

On May 1, 2025 Nuvation Bio Inc. (NYSE: NUVB), a global oncology company tackling some of the toughest challenges in cancer treatment, reported that Philippe Sauvage, Chief Financial Officer of Nuvation Bio, will participate in a fireside chat at The Citizens Life Sciences Conference on Thursday, May 8, 2025, at 10:00 a.m. ET in New York, NY (Press release, Nuvation Bio, MAY 1, 2025, View Source [SID1234652467]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A live webcast of the presentation will be available on the Nuvation Bio website at View Source An archived recording will be available for 90 days following each event.