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Merck to Participate in the Bank of America 2025 Global Healthcare Conference

On May 7, 2025 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that Jannie Oosthuizen, president, Human Health U.S., and Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories, are scheduled to participate in a fireside chat at the Bank of America 2025 Global Healthcare Conference on Wednesday, May 14, 2025, at 10:40 a.m. PDT / 1:40 p.m. EDT (Press release, Merck & Co, MAY 7, 2025, View Source [SID1234652642]).

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Immunocore reports first quarter financial results and provides a business update

On May 7, 2025 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, reported its financial results for the first quarter ended March 31, 2025, and provided a business update (Press release, Immunocore, MAY 7, 2025, View Source [SID1234652641]).

"We are thrilled to have achieved strong revenue performance in Q1, marked by year-over-year growth of 33%. This reflects our unwavering dedication to making KIMMTRAK accessible to patients who need it," said Bahija Jallal, Chief Executive Officer of Immunocore. "In R&D, we continue to be laser-focused on execution in our oncology franchise with three ongoing Phase 3 trials and a promising early pipeline. We are also excited to have presented the initial MAD data at CROI from our ongoing HIV trial, which, together with our progress in autoimmune, underscores the breadth of our platform."

First Quarter 2025 Highlights (including post-period)

Financial Results
Total net product revenue (or "net sales") arising from the sales of KIMMTRAK (tebentafusp) was $93.9 million in the first quarter of 2025, an increase of 33% over the first quarter of 2024, of which $56.6 million was generated in the United States, $32.8 million in Europe and $4.5 million in international regions.

Research & development expenses for the three months ended March 31, 2025, were $56.5 million, compared to $57.5 million for the same period in 2024. Selling, general and administrative (SG&A) expenses for the three months ended March 31, 2025, were $40.2 million, compared to $39.3 million in the same period in 2024.

Net income for the first quarter of 2025 was $5.0 million compared to a net loss of $24.4 million in the same period in 2024. The first quarter basic and diluted income/(loss) per share was $0.10, compared to $(0.49) for the first quarter of 2024.

Cash, cash equivalents and marketable securities at March 31, 2025, were $837.0 million.

KIMMTRAK
The Company’s lead product, KIMMTRAK (tebentafusp), is approved in 39 countries and has been launched in 26 countries globally to date for HLA-A*02:01 positive people with metastatic uveal melanoma (mUM). KIMMTRAK continues to be the standard of care in most markets where it is launched.

The Company sees three key growth areas for KIMMTRAK including continued global expansion in mUM, the potential expansion into 2L+ advanced cutaneous melanoma (CM), and the potential expansion into adjuvant uveal melanoma.

Metastatic uveal melanoma

In the first quarter of 2025, KIMMTRAK net product sales were $93.9 million.
Now launched in two additional countries for a total of 26 globally.
13% year-over-year growth in the United States, with demand continuing to grow as outreach extends into the community setting.
Growth in Europe and in international regions driven by increased demand, new country launches, and completion of price negotiations in France and Germany.
2L+ advanced cutaneous melanoma

The Company is currently enrolling the TEBE-AM registrational Phase 3 trial and expects to complete enrollment in the first half of 2026.
The Phase 3 trial is enrolling three arms: tebentafusp monotherapy, tebentafusp in combination with pembrolizumab, and a control (investigator’s choice of therapy including options such as investigator’s choice of clinical trials, chemotherapy, or retreatment with anti-PD1 or BRAF therapy).
There is great unmet need in second- and later-line cutaneous melanoma, with no therapy having shown an Overall Survival (OS) improvement post checkpoint inhibitors in a randomized clinical trial. The Company estimates that there is a potential to address up to 4,000 previously treated advanced CM patients.

Adjuvant uveal (or ocular) melanoma

The European Organisation for Research and Treatment of Cancer (EORTC) is enrolling patients in the Phase 3 Adjuvant Trial in Ocular Melanoma (ATOM).
The Company estimates that the HLA-A*02:01 high-risk adjuvant uveal melanoma patient population could be up to 1,200 patients.
PRAME portfolio
Brenetafusp is the Company’s lead PRAME-A02 ImmTAC bispecific candidate. Brenetafusp is being evaluated in combination with nivolumab in a Phase 3 registrational trial (PRISM-MEL-301) in patients with first-line, advanced cutaneous melanoma, and in a Phase 1/2 clinical trial as monotherapy and in combination across multiple tumor types, including ovarian cancer and non-small cell lung cancer (NSCLC).

PRISM-MEL-301 – First PRAME Phase 3 clinical trial with brenetafusp in first-line advanced cutaneous melanoma

The Company is enrolling patients in the registrational Phase 3 clinical trial evaluating brenetafusp + nivolumab versus a control arm of either nivolumab or nivolumab + relatlimab for HLA-A*02:01 positive patients with first-line, advanced or metastatic cutaneous melanoma.
The trial is currently randomizing to three arms: two brenetafusp dose regimens (40 mcg and 160 mcg) and a control arm. The Company is on track for selection of the go-forward brenetafusp dose in the second half of 2025; this analysis will be conducted by an IDMC.
Despite approved therapies, there remains a need for improved progression-free survival and overall survival, and there is the potential to address an estimated 10,000 patients.

Phase 1/2 clinical trial of brenetafusp in multiple solid tumors

The Company continues to evaluate brenetafusp in a Phase 1/2 trial in combination with non-platinum chemotherapies in platinum-resistant ovarian cancer (PROC) and with bevacizumab or with platinum chemotherapy in earlier lines of platinum-sensitive ovarian cancer (PSOC). In the same trial, the Company continues signal detection in metastatic non-small cell lung cancer (NSCLC) cohorts, including brenetafusp in combination with docetaxel and with osimertinib in earlier-line NSCLC.
The Company estimates that, across all solid tumors, the annual number of patients worldwide who test positive for HLA-A*02:01 and can potentially benefit from this program is up to 150,000.
IMC-P115C (PRAME-A02 Half-Life Extended) & IMC-T119C (PRAME-A24)

The Company is enrolling patients in the Phase 1 dose escalation trial, in multiple solid tumors, with IMC-P115C.
IMC-P115C is the Company’s first half-life extended ImmTAC therapy – targeting the same PRAME peptide and with the same CD3 effector and TCR specificity as brenetafusp. It is designed to improve patient convenience by reducing the frequency of treatment administration.
IMC-R117C (PIWIL1) for colorectal and other gastrointestinal cancers

The Company is enrolling patients in the Phase 1/2 dose escalation trial evaluating IMC-R117C in HLA-A*02:01 positive patients with advanced solid tumors, including colorectal cancer, as a single agent and in combination with standards of care.
PIWIL1 is believed to play a role in tumor progression and is expressed across a range of tumors, including colorectal cancer.
ImmTAV candidates for a functional cure in infectious diseases
The Company’s bispecific TCR technology platform has the potential to offer a new approach for the treatment of certain chronic infections and aims to eliminate evidence of remaining virus in circulation after the patient stops taking medication – known as a "functional cure." Two investigational candidates are in Phase 1 or Phase 1/2 trials for people living with human immunodeficiency virus (HIV) and people with chronic hepatitis B infection (HBV).

Phase 1/2 trial of IMC-M113V (Gag-A02) for people living with HIV

The Company presented data from the initial multiple ascending dose (MAD) portion of the Phase 1/2 dose escalation trial, including 16 people living with HIV (PLWH), at the 2025 Conference on Retroviruses and Opportunistic Infections (CROI).
All doses were well tolerated and no serious adverse events or dose limiting toxicities were observed.
In the 15 evaluable PLWH, delayed viral rebound and/or viremia control at any point during the analytical treatment interruption (ATI) was observed in 0 of 5 PLWH at 60 mcg, 1 of 5 at 120 mcg, and 2 of 5 at 300 mcg.
The 3 PLWH with evidence of viral control had a viral load of approximately 200 copies/mL at week 8. The historical rate for this observation is 5%1. Furthermore, 2 of these 3 PLWH remained off ART for the entire 12-week ATI period that was pre-specified in the protocol.
Patient enrollment continues at higher doses in the multiple ascending dose part of the Phase 1/2 clinical trial to identify a safe and tolerable dose.

Phase 1 trial of IMC-I109V (Envelope-A02) for people living with HBV or HBV-positive hepatocellular carcinoma

The Company plans to report data from the single ascending dose portion of the trial in the second half of 2025.

Tissue-specific down modulation of the immune system for autoimmune diseases
The key differentiator of the ImmTAAI platform is tissue-specific, down modulation of the immune system, as the candidates suppress pathogenic T cells via PD1 receptor agonism only when tethered to the target tissue.

IMC-S118AI (PPI-A02) for type 1 diabetes

The Company is on track to file a CTA or investigational new drug application (IND) for IMC-S118AI (PPI x PD1) in the second half of 2025.
IMC-S118AI is targeted specifically to the pancreatic beta-cell and intended as a disease-modifying treatment in type 1 diabetes. IMC-S118AI recognizes a peptide from pre-pro-insulin protein that is presented by HLA-A02 on beta cells and has a PD1 agonist effector arm.
IMC-U120AI (CD1a) for atopic dermatitis as the initial indication – first universal program

The Company plans to file a CTA/IND for IMC-U120AI (CD1a x PD1) in 2026.
IMC-U120AI is a non-HLA-restricted (i.e. universal for all populations) CD1a-tethered PD1 agonist ImmTAAI therapy. IMC-U120AI has a dual mechanism of action: blocking CD1a (which presents lipids) from activating CD1a-specific T cells and preventing HLA Class I/II (which presents peptides) from activating T cells via PD1 agonism on the T cell.
Financial Results
Basic and diluted income per share was $0.10 for the quarter ended March 31, 2025, as compared to a basic and diluted loss per share of ($0.49) for the same period in 2024. Net income for the quarter ended March 31, 2025, was $5.0 million, as compared to a net loss of $(24.4) million for the same period in 2024.

For the first quarter ended March 31, 2025, the Company generated net product sales of $93.9 million compared to $70.3 million for the same period in 2024, due to sales of KIMMTRAK, of which $56.6 million was in the United States, $32.8 million (including one-time favorable revenue adjustments recorded upon completion of price negotiations in France and Germany of $6.0M) was in Europe, and $4.5 million was in the international regions. The increase in net product sales was due to global country expansion and increased sales volume in the United States, as we continued our commercialization efforts.

For the first quarter ended March 31, 2025, research and development (R&D) expenses were $56.5 million compared to $57.5 million for the same period in 2024.

For the quarter ended March 31, 2025, SG&A expenses were $40.2 million compared to $39.3 million for the same period in 2024.

Cash, cash equivalents and marketable securities were $837.0 million as of March 31, 2025, as compared to $820.4 million as of December 31, 2024.

Geron Corporation Reports First Quarter 2025 Financial Results and Recent Business Highlights

On May 7, 2025 Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, reported financial results for the first quarter of 2025 and recent business highlights (Press release, Geron, MAY 7, 2025, View Source [SID1234652640]).

"We are confident in the long-term potential of RYTELO as an important therapeutic for eligible patients with lower-risk-MDS and are sharply focused on maximizing the U.S. commercial opportunity," said Dawn Carter Bir, Interim President and Chief Executive Officer of Geron. "We have received positive feedback from clinicians who have utilized RYTELO, supporting its strong therapeutic profile. We’ve identified specific opportunities and are making focused investments that we believe will strengthen the U.S. commercial trajectory. We expect our increased commercial investments to bolster uptake across a broader group of prescribers and drive long-term demand. We are also expanding our medical affairs efforts to support increased awareness and education. Looking ahead, our Phase 3 IMpactMF trial evaluating overall survival with imetelstat in patients with JAKi relapsed/refractory myelofibrosis (R/R MF), which we believe represents a tremendous expansion opportunity, is progressing well and the event-driven interim analysis is still expected in the second half of 2026."

Recent Business Highlights

Continued first year of U.S. commercialization of RYTELO, with net product revenue of $39.4 million in the first quarter of 2025. Demand for RYTELO in the 13-week period through the week ending March 28 increased 1% compared to the prior 13 weeks.
Received marketing authorization for RYTELO from the European Commission (EC) as a monotherapy for the treatment of adult patients with transfusion-dependent (TD) anemia due to very low, low, or intermediate risk myelodysplastic syndromes (lower-risk MDS or LR-MDS) without an isolated deletion 5q cytogenetic (non-del 5q) abnormality and who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy (ESAs).
Launch planning is underway and Geron expects to commercialize RYTELO in select EU countries commencing in 2026.
Reached 85% enrollment in Phase 3 IMpactMF clinical trial evaluating imetelstat in patients with JAKi R/R MF. We continue to expect an interim analysis readout for overall survival in the second half of 2026 (when approximately 35% of patient events have occurred), and final analysis in the second half of 2028 (when approximately 50% of patient events have occurred).
The Company believes there is a significant market opportunity for imetelstat to treat JAKi R/R MF patients based on its unique mechanism of action, strong clinical data to date, and the substantial size of the addressable patient population, if the trial is positive and imetelstat is approved in this indication.
Clinical data from the Phase 2 study showed a strong signal regarding prolonged survival and resolution of bone marrow fibrosis in patients treated with imetelstat, suggesting the potential for disease modification.
First Quarter 2025 Financial Results

As of March 31, 2025, Geron had approximately $457.5 million in cash, cash equivalents, restricted cash and marketable securities, compared to $502.9 million as of December 31, 2024.

Net Loss

For the three months ended March 31, 2025, the Company reported a net loss of $19.8 million, or $0.03 per share, compared to $55.4 million, or $0.09 per share, for the three months ended March 31, 2024.

Revenues

Total product revenue, net for the three months ended March 31, 2025, was $39.4 million. There was no product revenue in the prior year period, as RYTELO was approved by the FDA in June 2024. The decline in net product revenue compared to the three months ended December 31, 2024, which was $47.5 million, was primarily due to inventory drawdown among RYTELO distributors from the fourth quarter of 2024 into the first quarter of 2025.

Total net revenue for the three months ended March 31, 2025, was $39.6 million, compared to $0.3 million for the same period in 2024. Total net revenue includes license fees and royalties in addition to any product revenue, net. The increase in revenue is due to product revenue from U.S. sales of RYTELO, which was approved by the FDA in June 2024.

Operating Expenses

Total operating expenses for the three months ended March 31, 2025, were $56.3 million, compared to $56.4 million for the same period in 2024.

Cost of goods sold was approximately $1.2 million for the three months ended March 31, 2025, which consisted of costs to manufacture and distribute RYTELO, compared to nil in the prior year period.

Research and development expenses for the three months ended March 31, 2025, were $15.1 million, compared to $29.4 million for the same period in 2024. The decrease was primarily due to the wind down of clinical trial costs associated with a decrease of activity in our Phase 3 IMerge MDS study after FDA approval of RYTELO in 2024, as well as manufacturing and quality costs that were capitalized in the current period now that RYTELO is approved, versus being expensed in the prior year period.

Selling, general and administrative expenses for the three months ended March 31, 2025, were $40.0 million, compared to $27.1 million for the same period in 2024. The increase in general and administrative expenses in 2025 as compared to 2024 primarily reflects higher personnel expenses related to increased headcount to support commercialization of RYTELO in the U.S.

Interest income was $5.2 million for the three months ended March 31, 2025, compared to $4.2 million for the same period in 2024. The increase in interest income in 2025 compared to 2024 primarily reflects a larger marketable securities portfolio, with the receipt of net cash proceeds from synthetic royalty and debt financings in November 2024. Interest earned in future periods will depend on the size of our marketable securities portfolio and prevailing interest rates.

Interest expense was $8.2 million for the three months ended March 31, 2025, compared to $3.4 million for the same period in 2024. The increase in interest expense primarily reflects $4.8 million in non-cash interest expense related to our synthetic royalty agreement and an increased principal debt balance under our loan agreement and a prior loan agreement, which was repaid in the fourth quarter of 2024. Interest expense reflects interest expense recognized under the synthetic royalty agreement, interest owed under the loan agreements, as well as amortization of associated debt issuance costs and debt discounts using the effective interest method and accrual for an end of term charge.

2025 Financial Guidance

For fiscal year 2025, the Company maintains its previously announced expectations of total operating expenses to be in the range of approximately $270 million to $285 million, which includes non-cash items such as stock-based compensation expense, amortization of debt discounts and issuance costs, and depreciation and amortization.

Based on the current operating plans and assumptions, the Company believes that existing cash, cash equivalents, and marketable securities, together with anticipated net revenues from U.S. sales of RYTELO, will be sufficient to fund projected operating requirements for the foreseeable future.

Conference Call

Geron will host a conference call at 8:00 a.m. ET on Wednesday, May 7, 2025, to discuss business updates and first quarter 2025 financial results.

A live webcast of the conference call and related presentation will be available on the Company’s website at www.geron.com/investors/events. An archive of the webcast will be available on the Company’s website for 30 days.

Participants may access the webcast by registering online using the following link, View Source

About RYTELO (imetelstat)

RYTELO is an oligonucleotide telomerase inhibitor approved in the U.S. for the treatment of adult patients with low-to-intermediate-1 risk myelodysplastic syndromes (LR-MDS) with transfusion-dependent anemia requiring four or more red blood cell units over eight weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESAs). It is indicated to be administered as an intravenous infusion over two hours every four weeks.

In addition, RYTELO is approved in the European Union as a monotherapy for the treatment of adult patients with transfusion-dependent anemia due to very low, low or intermediate risk myelodysplastic syndromes without an isolated deletion 5q cytogenetic (non-del 5q) abnormality and who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy.

RYTELO is a first-in-class treatment that works by inhibiting telomerase enzymatic activity. Telomeres are protective caps at the end of chromosomes that naturally shorten each time a cell divides. In LR-MDS, abnormal bone marrow cells often express the enzyme telomerase, which rebuilds those telomeres, allowing for uncontrolled cell division. Developed and exclusively owned by Geron, RYTELO is the first and only telomerase inhibitor approved by the U.S. Food and Drug Administration and the European Commission.

Exelixis to Webcast Fireside Chats as Part of Investor Conferences in May

On May 7, 2025 Exelixis, Inc. (Nasdaq: EXEL) reported that company management will participate in fireside chats at the following investor conferences in May (Press release, Exelixis, MAY 7, 2025, View Source [SID1234652639]):

BofA Securities 2025 Health Care Conference: Exelixis is scheduled to present at 1:40 p.m. ET / 10:40 a.m. PT on Wednesday, May 14 in Las Vegas.
RBC Capital Markets 2025 Global Healthcare Conference: Exelixis is scheduled to present at 10:30 a.m. ET / 7:30 a.m. PT on Tuesday, May 20 in New York City.
To access the webcast links, log onto www.exelixis.com and proceed to the Event Calendar page under the Investors & News heading. Replays will also be available at the same location for at least 30 days.

C4 Therapeutics Reports First Quarter 2025 Financial Results and Recent Business Highlights

On May 7, 2025 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, reported financial results for the first quarter ended March 31, 2025, as well as business updates (Press release, C4 Therapeutics, MAY 7, 2025, View Source [SID1234652638]).

"2025 has been marked by focused execution across C4T to generate key data to optimize development plans across our clinical portfolio. With cemsidomide demonstrating compelling overall response rates at multiple dose levels, including one multiple myeloma patient at 100 µg who achieved a minimal residual disease negative complete response, we are prioritizing progressing cemsidomide to the next phase of development to realize its potential to be a best-in-class IKZF1/3 degrader," said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. "With the achievement of two preclinical milestones in our Roche collaboration, we continue to demonstrate the productivity of our TORPEDO platform to discover highly catalytic, orally bioavailable, and brain penetrant degraders. We remain focused on maximizing our cash runway, which includes advancing cemsidomide and pursuing our internal discovery pipeline focused on targets with a clear degrader rationale and compelling biology applicable to a broad range of therapeutic areas."

FIRST QUARTER 2025 HIGHLIGHTS AND RECENT ACHIEVEMENTS

Cemsidomide:

Phase 1 dose escalation is complete in multiple myeloma (MM) with the 100 µg once daily (QD) dose level declared safe for expansion; 10 additional patients will be treated in a 100 µg QD expansion cohort to further characterize cemsidomide’s safety and efficacy profile at this dose level.
Cemsidomide MM topline data demonstrate compelling responses rates at multiple doses:
As of the data cutoff date of April 30, 2025, 10 patients have been treated at the 100 µg QD dose level, achieving an overall response rate (ORR) of 50 percent. Notably, one patient who previously progressed on two prior T-cell engager therapies achieved a minimal residual disease (MRD) negative complete response (measured by flow cytometry). Eight patients (80 percent) treated at this dose level received prior CAR-T or T-cell engager therapy.
Since October 11, 2024, six additional patients have been treated for a total of 20 patients treated at the 75 µg QD dose level. As of the data cutoff date of April 30, 2025, the 75 µg QD dose level achieved an ORR of 40 percent.
Cemsidomide remains well-tolerated with manageable neutropenia.
For the non-Hodgkin’s lymphoma (NHL) arm, the Phase 1 dose escalation is ongoing at the 87.5 µg QD dose level and the maximum tolerated dose has not yet been reached.
C4T expects to receive regulatory feedback on registrational development by mid-year 2025.
CFT1946:

Phase 1 dose escalation is complete with 640 mg BID declared as the maximum administered dose. Across the trial, which includes the dose escalation, melanoma and colorectal cancer cohorts, 89 patients were treated.
The pharmacodynamic and safety data, including the data presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024, supports proof of mechanism and the therapeutic potential of degrading the BRAF V600 mutant protein.
Given emerging clinical data and the company’s focus on strategic capital allocation, C4T will not advance CFT1946 beyond the ongoing Phase 1 trial. C4T has made the decision to seek partnership opportunities to advance the BRAF program given the high unmet need and strong degrader rationale for treating BRAF V600 mutant solid tumors.
The CFT1946 Phase 1 data will be presented at a future medical meeting.
CFT8919:

Partner Betta Pharmaceuticals continues to advance the CFT8919 Phase 1 dose escalation trial in Greater China.
Research and Discovery Collaborations:

Advanced Roche collaboration to preclinical milestones. In March 2025, C4T earned a total of $4 million in payments upon achieving certain preclinical milestones for two programs. C4T and Roche continue to advance these programs.
C4T continues to advance its internal research pipeline focused on targets in therapeutic areas in and beyond oncology with a strong degrader rationale and genetic link to disease.
KEY UPCOMING MILESTONES

Present data from completed cemsidomide Phase 1 dose escalation in MM in Q3 2025.
Complete cemsidomide Phase 1 dose escalation in NHL and present data in Q4 2025.
Open expansion cohort(s) in PTCL as part of the current cemsidomide Phase 1/2 trial in the second half of 2025.
Enable initiation of the next phase of clinical development for cemsidomide with new studies expected to initiate in early 2026.
UPCOMING INVESTOR EVENTS

June 4, 2025: Management will participate in the Jefferies Global Healthcare Conference taking place from June 3 – June 5, 2025 in New York, New York.
FIRST QUARTER 2025 FINANCIAL RESULTS

Revenue: Total revenue for the first quarter of 2025 was $7.2 million, compared to $3.0 million for the first quarter of 2024. The increase in revenue was primarily due to our collaborations with Merck KGaA, Darmstadt, Germany (MKDG), which commenced in March 2024, as well as our achievement of two preclinical milestones under our Roche collaboration.

Research and Development (R&D) Expense: R&D expense for the first quarter of 2025 was $27.1 million compared to $22.5 million for the first quarter of 2024. The increase in R&D expense was primarily related to clinical trial expenses for cemsidomide and CFT1946, in addition to increased preclinical spend as our research collaborations continue to advance.

General and Administrative (G&A) Expense: G&A expense for the first quarter of 2025 was $9.3 million compared to $10.3 million for the first quarter of 2024. The decrease was primarily a result of reduced personnel costs related to our 2024 restructuring activities.

Net Loss and Net Loss per Share: Net loss for the first quarter of 2025 was $26.3 million, compared to $28.4 million for the first quarter of 2024. Net loss per share for the first quarter of 2025 was $0.37 compared to $0.41 for the first quarter of 2024.

Cash Position and Financial Guidance: Cash, cash equivalents and marketable securities as of March 31, 2025 were $234.7 million, compared to $267.3 million as of December 31, 2024. The decrease was primarily the result of cash used in operating activities. The balance as of March 31, 2025 is exclusive of the $4.0 million in milestones earned under our Roche collaboration, which the company expects to receive in the second quarter of 2025. The company expects that its cash, cash equivalents and marketable securities as of March 31, 2025 will enable the company to fund its operating plan into 2027.