On May 6, 2025 Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) ("Day One" or the "Company"), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, reported its first quarter 2025 financial results and highlighted recent corporate achievements (Press release, Day One, MAY 6, 2025, View Source [SID1234652572]).

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"We continued our successful launch of OJEMDA in 2025 and are energized by the growing impact we are bringing to patients every day," said Jeremy Bender, Ph.D., chief executive officer of Day One. "This is an exciting time of growth for Day One. We remain focused on creating value at every level of the organization, and we are executing on our objectives with urgency and fiscal discipline."

Program Highlights

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OJEMDA net product revenue was $30.5 million in the first quarter of 2025.
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U.S. OJEMDA net product revenue increased 11% from the fourth quarter of 2024.
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OJEMDA prescriptions increased to over 900 (+16%) in the first quarter of 2025.

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Achieved $87.7 million in OJEMDA net product revenue since launch, representing over 2,500 OJEMDA prescriptions.

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In April 2025, Ipsen announced the regulatory filing for tovorafenib was accepted by the European Medicines Agency for review in the European Union, marking an important step forward for tovorafenib’s development outside of the U.S.

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DAY301, our PTK7-targeted ADC, cleared the first dose cohort (a single-patient accelerated titration cohort) in the Phase 1a portion of the Phase 1a/b clinical trial.

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Day One’s pivotal Phase 3 FIREFLY-2 clinical trial is expected to be fully enrolled in the first half of 2026.

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Day One presented two posters at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in Chicago, April 25-30, 2025.

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A preclinical study provided evidence for the efficacy of sequencing of MEK inhibitor treatment after tovorafenib by demonstrating mice bearing AGK::BRAF fusion tumors maintained significant tumor regression with no emergent tumors when treated with tovorafenib (25 mg/kg) once daily followed by MEK inhibitor treatment. Additionally, long-term efficacy was maintained with continuous dosing of tovorafenib in vivo; significant tumor regression was maintained with no emergent tumors indicating no evidence of emerging resistance. The study results demonstrate that anti-tumor activity with MEK inhibitors is observed after treatment with tovorafenib and suggest that acquired resistance may be less common in BRAF fusion-driven tumors treated with tovorafenib. (Abstract 1727: Sequencing MEK inhibitor therapy after tovorafenib in BRAF fusion-driven cancers: Preclinical evidence of sustained tumor regression)
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A clinical trial-in-progress poster on DAY301-001 the first-in-human Phase 1a/1b trial with DAY301 to evaluate its safety, tolerability, pharmacokinetics (PK) and antitumor activity in patients with locally advanced or metastatic solid tumors. (Abstract CT196: Phase I dose escalation and expansion study of the PTK-7 targeted antibody-drug conjugate DAY301 in patients with locally advanced or metastatic solid tumors)

First Quarter 2025 Financial Highlights

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Product Revenue, Net: OJEMDA net product revenue was $30.5 million for the first quarter of 2025.

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License Revenue: License revenue from the sale of ex-U.S. commercial rights for tovorafenib was $0.3 million for the first quarter of 2025.

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R&D Expenses: Research and development expenses were $39.6 million for the first quarter of 2025 compared to $40.2 million for the first quarter of 2024. The difference was primarily due to a decrease in license agreement payments and employee compensation costs.

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SG&A Expenses: Selling, general and administrative expenses were $29.3 million for the first quarter of 2025 compared to $26.6 million for the first quarter of 2024. The increase was primarily due to employee compensation costs and professional service expenses to support the launch of OJEMDA.

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Net Loss: Net loss totaled $36.0 million for the first quarter of 2025 with non-cash stock-based compensation expense of $12.9 million, compared to a net loss of $62.4 million for the first quarter of 2024, with non-cash stock-based compensation expense of $12.6 million.

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Cash Position: The Company’s cash, cash equivalents and short-term investments totaled $473.0 million as of March 31, 2025.

Upcoming Events

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Bank of America Securities 2025 Health Care Conference
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Management will participate in a fireside chat on Tuesday, May 13 at 8:00 a.m. PT. A live and archived audio webcast of the discussion will be available by visiting the Events section of the Company’s website.

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Society for Neuro-Oncology’s 8th Biennial Pediatric Neuro-Oncology Conference, May 15-17, 2025
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A poster sponsored by Day One, "Managing side effects of MAPK inhibitor therapies in pediatric populations: a Delphi consensus initiative," will be presented on May 16 at 6:15 p.m. PT.

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2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, May 30-June 3, 2025
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Abstract #10029 titled "Growth recovery in patients with BRAF altered pediatric low-grade gliomas (LGG) after discontinuation of tovorafenib" will be presented in a poster session on Saturday, May 31 from 9:00-12:00 p.m. CDT in Hall A.
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Abstract #10037 titled "Post hoc analysis of rashes reported in patients (pts) with BRAF-altered relapsed/refractory (r/r) pediatric low-grade glioma (pLGG) treated with the type II RAF inhibitor tovorafenib in FIREFLY-1" will be presented in a poster session on Saturday, May 31 from 9:00-12:00 p.m. CDT in Hall A.

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46th Annual Goldman Sachs Global Healthcare Conference
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Management will participate in a fireside chat on Tuesday, June 10 at 8:40 a.m. ET. A live and archived audio webcast of the discussion will be available by visiting the Events section of the Company’s website.

Conference Call

Day One will host a conference call and webcast today, May 6 at 4:30 p.m. ET. To access the live conference call by phone, dial 877-704-4453 (domestic) or 201-389-0920 (international), and provide the access code 13745150. Live audio webcast will be accessible from the Day One Media & Investors page. To ensure a timely connection to the webcast, it is recommended that participants register at least 15 minutes prior to the scheduled start time. An archived version of the webcast will be available for replay on the Events section of the Day One Investors & Media page for 30 days following the event.

About OJEMDA

OJEMDA (tovorafenib) is a Type II RAF kinase inhibitor of mutant BRAF V600, wild-type BRAF, and wild-type CRAF kinases.

OJEMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Tovorafenib was granted Breakthrough Therapy and Rare Pediatric Disease designations by the FDA for the treatment of patients with pLGG harboring an activating RAF alteration, and it was evaluated by the FDA under priority review. Tovorafenib has also received Orphan Drug designation from the FDA for the treatment of malignant glioma and from the European Commission for the treatment of glioma.

For more information, please visit www.ojemda.com.

On May 6, 2025 Pasithea Therapeutics Corp. (NASDAQ: KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor for the treatment of neurofibromatosis type 1 (NF1) and other MAPK pathway driven cancer indications, reported positive interim pharmacodynamic (PD) data from its ongoing Phase 1 trial of PAS-004 in advanced cancer patients (Press release, Pasithea Therapeutics, MAY 6, 2025, View Source [SID1234652588]). The data includes results from cohorts 3 and 4A, evaluating 8mg and 15mg capsules, as well as cohort 4B evaluating 4mg tablets, and demonstrates strong target engagement consistent with PAS-004’s favorable pharmacological profile.

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Inhibition of ERK phosphorylation (pERK) is widely recognized as a gold-standard PD biomarker for assessing MEK inhibitor activity. To evaluate target engagement, pERK levels were measured in peripheral blood mononuclear cells (PBMCs) collected from patients at baseline and steady-state at day 22.

Preliminary results demonstrate robust pERK inhibition, with reductions in pERK levels of up to 91% even at the 8mg dose level, in line with a previous developed PK/PD model, confirming substantial target engagement in patients receiving PAS-004.

Pharmacodynamic activity is supported by encouraging preliminary clinical observations, with several patients achieving stable disease and tumor shrinkage while on PAS-004 treament. Notably, one patient in cohort 4A (15mg capsule) with stage 4 KRAS G12R-mutated pancreatic cancer, having progressive disease while on three prior lines of therapy, achieved a tumor volume reduction of -9.8% over 5 months of PAS-004 treatment and currently remains on study.

"With today’s update, we are pleased that PAS-004 has demonstrated clinically meaningful reductions in pERK levels at dose levels that are both well-tolerated and safe, with no rash observed," said Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea. "We believe PAS-004’s profile offers the potential to finely modulate MAPK pathway activity, enabled by its previously reported long half-life and favorable pharmacokinetic (PK) profile with a Cmax/Cmin ratio below 2. We’re also encouraged by the emerging clinical signals we’re seeing across multiple cancer types and look forward to sharing further safety, PK and PD data in the coming months."

The ongoing Phase 1 clinical trial is a multi-center, open-label, dose escalation 3+3 study design to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of PAS-004 in patients with MAPK pathway driven advanced solid tumors with a documented RAS, NF1 or RAF mutation or patients who have failed BRAF/MEK inhibition (NCT06299839).

On May 6, 2025 CStone Pharmaceuticals ("CStone", HKEX: 2616), an innovation-driven biopharmaceutical company focused on anti-cancer therapies, reported that poster presentations of preclinical data of CS2011 (EGFR/HER3 bispecific antibody), CS5007 (EGFR/HER3 bispecific ADC), CS5005 (SSTR2 ADC) and CS5006 (ITGB4 ADC), key assets in CStone Pipeline 2.0, have been delivered at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, CStone Pharmaceauticals, MAY 6, 2025, View Source [SID1234652605]).

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Key Highlights:

CS2011 (EGFR/HER3 bispecific antibody):
EGFR and HER3 are members of the human epidermal growth factor receptor (HER) family and are validated therapeutic targets in advanced solid tumors. EGFR overexpression drives tumor progression in approximately 70% of colorectal cancers (CRC), 60% of lung cancers, and over 90% of head and neck squamous cell carcinomas (HNSCC). Meanwhile, HER3 upregulation frequently emerges as a resistance mechanism to MAPK/PI3K inhibitors, EGFR tyrosine kinase inhibitors (TKIs), and hormone therapies. CS2011 is a bispecific antibody with high binding affinity to both EGFR and HER3. It effectively blocks downstream signaling of both targets, thereby inhibiting tumor growth on EGFR/HER3 positive tumor cells.

1. CS2011 targets almost all HER family signaling except HER2 homodimers, addressing tumor heterogeneity effectively.

2. CS2011 demonstrates potent binding affinity to EGFR and/or HER3 individually and enhanced dual binding affinity to EGFR and HER3 concurrently driven by avidity-based synergy.

3. CS2011 inhibits tumor growth by binding to EGFR and/or HER3-positive tumor cells.

4. CS2011 shows superior in vivo and in vitro anti-tumor activity versus potential major competitors.

（1） Compared to anti-EGFR, anti-HER3 and competing bispecific antibody, CS2011 induces faster and deeper internalization in tumor cells across varying EGFR & HER3 expression levels.

（2） CS2011 demonstrated potent inhibition of EGFR downstream signaling, comparable to anti-EGFR antibodies, and superior inhibition of HER3-mediated signaling compared to competitive bispecific antibody.

（3） CS2011 exhibited robust anti-proliferative activity in tumor cells with diverse EGFR and HER3 expression levels.

（4） In in vivo CDX tumor models, CS2011 demonstrated superior tumor-growth inhibition compared to anti-EGFR or anti-HER3 monoclonal antibodies alone and showed comparable efficacy to the combination treatment.

5. CS2011 exhibited a pharmacokinetic (PK) profile comparable to those of monoclonal antibodies in rodents.

In summary, CS2011 has demonstrated potent blockage activity on EGFR and HER3 and exhibited synergistic effects on their downstream signaling. It thereby shows the potent tumor growth inhibitory effects in in vitro and in vivo experiments. The patent of CS2011 has been filed in March 2025, and its Investigational New Drug (IND) application is expected to be submitted in the near term.

CS5007 (EGFR/HER3 bispecific ADC):
CS5007 is a bispecific ADC targeting both EGFR and HER3, developed with CStone’s proprietary ADC platform. It is composed of EGFR/HER3 bispecific antibody backbone (CS2011), a hydrophilic β-glucuronide linker and a clinically validated topoisomerase I inhibitor, Exatecan. This integrated approach, featuring precise targeting, optimized linker stability, and proven therapeutic payload, positions CS5007 as a potential best-in-class candidate for precision oncology.

1. CS5007 targets almost all human epidermal growth factor receptor (HER) family signaling except for HER2 homodimers, covering broad tumor types and effectively addressing tumor heterogeneity.

2. CS5007 demonstrated high-affinity binding to EGFR single-positive, HER3 single-positive, and EGFR/HER3 double-positive tumor cells.

3. CS5007 triggered high-rate internalization on tumor cells.

4. CS5007 demonstrated potent, antigen-dependent cytotoxicity against tumor cells in vitro across varying EGFR and HER3 expression levels and showed robust tumor-growth inhibition in CDX models.

5. CS5007 exhibited superior in vitro stability compared to ADCs conjugated with tetrapeptide and dipeptide linkers. After 7 days of incubation in human/monkey serum, it retained approximately 70% of its drug payload, indicating a minimal release rate.

6. CS5007 exhibited comparable pharmacokinetic (PK) profile to those ADCs composed of monoclonal antibodies in rodents.

CS5007 demonstrates strong affinity for EGFR- and/or HER3-positive tumor cells and induces efficient internalization. Preclinical studies have shown excellent antitumor activity, favorable safety, and pharmacokinetic profiles. The patent of CS5007 has been filed in March 2025. Preclinical findings support further IND-enabling studies and clinical investigations in various advanced solid tumors.

CS5005 (SSTR2 ADC):
Somatostatin receptor 2 (SSTR2) is a G protein-coupled receptor (GPCR) that is overexpressed in various solid tumors, including neuroendocrine tumors (NETs), neuroendocrine carcinomas (NECs), and small cell lung cancer (SCLC). Due to its tumor-selective expression profile, SSTR2 has emerged as a promising target in the field of precision oncology.

CS5005 is a first-in-class, SSTR2-targeting ADC, composed of CStone’s proprietary anti-SSTR2 antibody with high affinity and selectivity, hydrophilic β-glucuronide linker, and potent topoisomerase I inhibitor, Exatecan. In preclinical studies, CS5005 demonstrated potent, antigen-dependent tumor growth inhibition that was not affected by co-administration with SSA-derived therapies. Additionally, CS5005 exhibited superior stability, monoclonal antibody-like pharmacokinetic (PK) properties, and favorable tolerability in preliminary non-human primate toxicity studies.

1. CS5005 demonstrated high affinity to SSTR2-positive cell lines and induced high-rate internalization on tumor cells.

2. CS5005 exhibited cross-reactivity with SSTR2-expressing cells in non-human primates and demonstrated selective binding to SSTR2 with minimal interaction with other SSTRs.

3. CS5005 demonstrated potent antigen-dependent cytotoxic activity against tumor cells in vitro and robust tumor-growth inhibition in CDX tumor model.

4. The antitumor activity of CS5005 (SSTR2-DXd) is not compromised by concomitant ligand-derived treatments (e.g., octreotide, Lutathera), thereby avoiding drug-drug interference commonly observed with current anti-SSTR2 therapies.

5. CS5005 demonstrated superior in vitro stability due to its proprietary linker, outperforming ADCs conjugated with well-validated dipeptide and tetrapeptide linkers.

6. Superior pharmacokinetic (PK) properties of CS5005 in rodents.

7. Bioinformatics analysis of SCLC samples supports DLL3/SSTR2 dual targeting as a strategy to overcome tumor heterogeneity and expand the treatable patient population.

In summary, CS5005 is a first-in-class, SSTR2-targeting ADC designed to selectively eliminate SSTR2-positive tumors, including small cell lung cancer, neuroendocrine carcinoma, and neuroendocrine tumors. It is composed of CStone’s proprietary high-affinity, high-selectivity anti-SSTR2 antibody, CStone’s proprietary hydrophilic β-glucuronide linker, and potent TOP1 inhibitor payload. CS5005 has demonstrated robust antitumor activity in both in vitro and in vivo studies, supporting its progression toward IND submission and clinical development. The patent of de novo antibody backbone of CS5005 has been filed in the first half of 2024. CS5008, an SSTR2/DLL3 bispecific ADC is under development. By simultaneously targeting SSTR2 and DLL3 that frequently co-express in SCLC, NETs, NECs and others, CS5008 aims to overcome tumor heterogeneity, a challenge faced by mono-specific therapies.

CS5006 (ITGB4 ADC):
CS5006 is a first-in-class antibody-drug conjugate (ADC) targeting the novel antigen integrin β4 (ITGB4), developed using CStone’s proprietary ADC platform. Leveraging an internally developed machine learning-based bioinformatics algorithm alongside rigorous in-house experimental validation, CStone identified elevated ITGB4 expression across multiple tumor types—including non-small cell lung cancer (NSCLC), colorectal cancer (CRC), esophageal squamous cell carcinoma (ESCC), and head and neck squamous cell carcinoma (HNSCC)—with minimal expression observed in normal tissues. Preclinical in vivo and in vitro studies have demonstrated CS5006’s promising therapeutic potential, highlighting its ability to effectively killing tumor cells.

1. Bioinformatics analysis identified high ITGB4 expression in colorectal tumor tissues, supporting ITGB4 as a promising tumor-associated antigen for CRC. In the tumor microenvironment, ITGB4 was selectively overexpressed on tumor cells while remaining low expression in normal tissues.

2. Immunohistochemistry (IHC) staining confirmed limited ITGB4 expression in normal tissue but high expression in tumor tissues from patients with CRC, sq-NSCLC, HNSCC and ESCC.

3. ITGB4 antibody demonstrated high affinity and internalization rate.

4. CS5006 preclinical proof-of-concept models using ITGB4-vedotin and ITGB4-DXd showed potent antitumor activity in both in vitro and in vivo studies, along with favorable pharmacokinetic (PK) profiles.

（1） ITGB4-vedotin exhibited strong antigen-dependent cytotoxicity in ITGB4-positive tumor cell lines in vitro and demonstrated potent antigen-dependent tumor inhibition in CDX models in vivo.

（2） ITGB4-DXd also exhibited potent antigen-dependent cytotoxicity in vitro and strong tumor-inhibitory effects in vivo CDX tumor models.

（3） Both ITGB4-vedotin and ITGB4-DXd exhibited favorable PK characteristics.

In summary, CS5006 is a first-in-class ADC targeting the novel tumor antigen ITGB4 and is currently undergoing comprehensive preclinical evaluation. Preclinical data have demonstrated strong antitumor activity across multiple animal models, particularly in solid tumors such as non-small cell lung cancer, head and neck squamous cell carcinoma, and esophageal squamous cell carcinoma. The compound also exhibited good tolerability, providing strong support for its further clinical development. The patent of CS5006 has been filed in April 2023.

Poster Information:

Poster Title

Poster Number

CS2011: A novel bispecific antibody targeting EGFR and HER3 that
demonstrates promising anti-tumor activity in preclinical evaluation

2927

CS5007: A novel EGFR and HER3 dual-targeted antibody-drug
conjugate (ADC) with potent antitumor activity in preclinical studies

2954

CS5005: A novel SSTR2-targeted antibody-drug conjugate (ADC) with
robust anti-tumor activity in preclinical studies

4751

CS5006: A novel integrin β4-targeted antibody-drug conjugate (ADC)
with robust antitumor activity in preclinical studies

2953

On May 6, 2025 Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for cardiometabolic diseases and GI oncological therapeutics, reported that the first set of oncology studies has shown that Aramchol enhances the liver / colorectal cancer-approved therapeutic Regorafenib effects in liver and colon cancers in-vitro and in-vivo models (Press release, Galmed Pharmaceuticals, MAY 6, 2025, View Source [SID1234652573]).

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Aramchol interacted with the multi-kinase inhibitors Sorafenib, Regorafenib and Lenvatinib, to kill GI tumor cells, with Regorafenib exhibiting the greatest effect. Aramchol enhanced both flux and autolysosome formation caused by Regorafenib, activating ATM and AMPK and inactivating mTORC1 and mTORC2 pathways. In addition, Regorafenib and Aramchol interacted to suppress tumor growth in hepatoma models without normal tissue toxicities.

Paul Dent, Ph.D. Professor School of Medicine Biochemistry and Molecular Biology Virginia Commonwealth University commented: "The key molecular mechanisms by which Aramchol and Regorafenib killed GI tumor cells were defined in the study. Aramchol acts to enhance autophagy through mechanisms that are different to those of Regorafenib. The interaction between Aramchol and Regorafenib, causing more autophagic flux and autolysosome formation, is required for the enhanced killing of tumor cells by the drug combination."

Allen Baharaff, President and CEO of Galmed Pharmaceuticals commented: "Targeting lipid metabolism with Aramchol, a potent SCD1 inhibitor, is a promising emerging strategy to overcome TKIs, such as Sorafenib, Regorafenib or Lenvatinib, for therapy resistance in HCC and colorectal cancers. A combination of Bayer’s Regorafenib and Aramchol could potentially become a cost-effective first line treatment for HCC and other liver and colorectal cancers. The mechanisms by which the combination of Aramchol and Regorafenib kills tumor cells provide the scientific foundation for a Phase Ib clinical trial in GI tumors. We look forward to taking these findings forward in a new clinical program, alongside the recently announced Semaglutide GLP-1 sublingual development."

On May 6, 2025 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported financial results for the first quarter of 2025 ended March 31, 2025, and provided recent business highlights (Press release, Personalis, MAY 6, 2025, View Source [SID1234652589]).

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Recent Business Highlights

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Delivered 2,184 total molecular tests in the first quarter of 2025, an increase of 52%, compared with 1,441 tests delivered in the fourth quarter of 2024, signifying increasing adoption of Personalis’ technology

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Highlighted compelling performance of NeXT Personal for resectable Stage I-IV colorectal cancer (CRC) in a study of 71 patients with British Columbia Cancer and an oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in Chicago in April

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100% of patients that eventually recurred were detected as ctDNA positive by NeXT Personal, prior to detection on imaging

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87% of eventual clinical recurrences were detectable within the early landmark window, 2 to 8 weeks after surgery, with 85% detectable by 4 weeks

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64% of the positive detections in the landmark window were in the ultrasensitive range, below 100 parts per million

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100% of challenging distant metastatic recurrences prior to imaging were detected, including lung metastasis

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Published pivotal breast cancer study (Royal Marsden) using NeXT Personal in the Annals of Oncology and dossier submission was made to Medicare for reimbursement in early-stage breast cancer

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Published results from TRACERx study in Nature Medicine, showing ctDNA levels linked to lung cancer recurrence and highlighting NeXT Personal’s detection in early-stage patients

"This year is off to a great start, with strong first quarter testing growth, and we remain confident that our "Win-in-MRD" strategy is working," said Chris Hall, Chief Executive Officer and President. "We crossed the milestone of 2,000 tests delivered and submitted breast cancer data for Medicare coverage with expectations of a favorable outcome by the end of the year. In addition, we showed compelling clinical evidence in colorectal cancer suggesting our ultrasensitive approach can provide a leap in performance. We are pleased with how rapidly NeXT Personal is growing in the marketplace."

First Quarter 2025 Financial Results Compared with 2024
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Revenue of $20.6 million for the first quarter of 2025 compared with $19.5 million, an increase of 6%, primarily due to the growth in revenue from pharma tests and services and population sequencing from the U.S. Department of Veterans Affairs Million Veterans Program (VA MVP) •
Pharma tests and services, and other customers of $13.6 million for the first quarter of 2025 compared with $9.8 million, an increase of 39%

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Population sequencing and enterprise sales of $6.7 million for the first quarter of 2025 compared with $9.5 million, a decrease of 29% due to the expected decline in volume from Natera

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Gross margin of 35.0% for the first quarter of 2025 compared with 28.1%, an increase of 6.9% primarily due to favorable revenue mix from the increase in pharma tests and services combined with lower enterprise sales

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Net loss of $15.8 million, and net loss per share of $0.18 based on a weighted-average basic and diluted share count of 87.5 million in the first quarter 2025 compared with a net loss of $13.0 million, and net loss per share of $0.26 based on a weighted-average basic and diluted share count of 50.7 million

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Cash, cash equivalents, and short-term investments of $185.7 million as of March 31, 2025

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Raised $17.8 million in net proceeds from selling common stock under the Company’s At-The-Market (ATM) program at a weighted-average price of $5.89 per share during the first quarter of 2025

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Cash usage of $20.5 million from operations and capital equipment additions in the first quarter of 2025

Second Quarter and Full Year 2025 Outlook

Personalis expects the following for the second quarter of 2025:

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Total company revenue to be in the range of $19.5 to $20.5 million

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Revenue from pharma tests and services, and all other customers to be in the range of $13 to $14 million

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Revenue from population sequencing and enterprise sales of approximately $6.5 million

Personalis expects the following for the full year of 2025 (no change to our prior revenue guidance):

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Total company revenue in the range of $80 to $90 million

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Revenue from pharma tests and services, and all other customers in the range of $62 to $64 million

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Revenue from population sequencing and enterprise sales in the range of $15 to $16 million

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Revenue from clinical tests reimbursed in the range of $3 to $10 million

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Gross margin in the range of 22% to 24% (increased from our 21% to 23% prior guidance), which is lower than the 32% gross margin for the full year of 2024 as we invest to drive clinical usage ahead of reimbursement.

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Net loss of approximately $83 million (decreased from our $85 million prior guidance)

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Cash usage of approximately $75 million (decreased from our $75 to $80 million prior guidance), which is an increase from the $47 million used in the full year of 2024 primarily due to investments in the next phase of our "Win in MRD" strategy, inclusive of growing our test volume, expanding clinical studies, and investing in commercial capabilities to drive growth

Webcast and Conference Call Information

Personalis will host a conference call to discuss the first quarter financial results, as well as plans for 2025, after market close on Tuesday, May 6, 2025, at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live by dialing 877-413-2411 for domestic callers or 201-389-0882 for international callers. The live webinar can be accessed at View Source A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website.