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.

On May 6, 2025 Adcentrx Therapeutics ("Adcentrx"), a clinical-stage biotechnology company redefining Antibody-Drug Conjugate (ADC) therapies for cancer treatment and other life-threatening diseases, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead program, ADRX-0706, for the treatment of patients with locally advanced or metastatic squamous cell cervical cancer (Press release, Adcentrx Therapeutics, MAY 6, 2025, View Source [SID1234652606]).

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ADRX-0706 is a Nectin-4 ADC being evaluated in the Phase 1b portion of an ongoing Phase 1a/b clinical trial (NCT06036121) for the treatment of select advanced solid tumors, including cervical cancer. The company will present interim data from the completed Phase 1a dose escalation portion at the upcoming 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Early findings demonstrated a differentiated safety and pharmacokinetic profile, including a notably lower incidence of adverse events such as peripheral neuropathy, along with preliminary efficacy signals across multiple tumor types.

Cervical cancer represents a significant unmet need, particularly for patients whose disease progresses following initial treatment. Nectin-4 is highly expressed in cervical cancer, making it a compelling tumor type for treatment with a Nectin-4 ADC.

"The Fast Track designation granted by the FDA underscores the significant unmet need in advanced cervical cancer and marks another meaningful milestone for Adcentrx," said Hui Li, Ph.D., Founder and Chief Executive Officer of Adcentrx. "This recognition, together with the early clinical signals observed for ADRX-0706, reinforces the best-in-class potential of our Nectin-4 ADC and provides the opportunity for enhanced regulatory dialogue as we continue advancing this important program through clinical development."

The FDA’s Fast Track program is designed to accelerate the development and review of therapies for serious conditions with unmet medical needs, with the goal of getting important new treatments to patients sooner. The designation enables earlier and more frequent communication with the FDA throughout development and may offer regulatory advantages such as eligibility for Accelerated Approval, Priority Review, and Rolling Review, which allows completed sections of a New Drug Application (NDA) or Biologic License Application (BLA) to be reviewed, rather than waiting for the entire completed application.

About ADRX-0706
ADRX-0706 is a fully proprietary ADC product candidate discovered by Adcentrx. The antibody component is a novel fully human IgG1 targeting Nectin-4, a cell surface adhesion protein with high expression in multiple solid tumors and limited expression in normal tissues. Nectin-4 is associated with poor disease prognosis and is a validated target for ADCs.

The ADRX-0706 antibody is linked to a proprietary tubulin inhibitor payload, AP052, through Adcentrx’s innovative i-Conjugation technology platform – a core component in the design of the company’s ADCs. The platform utilizes a cleavable linker and stable conjugation chemistry to enhance payload delivery. This novel technology enables a highly stable ADC with a drug-antibody ratio of eight (DAR 8) with a substantially expanded therapeutic window as demonstrated in preclinical studies.

ADRX-0706 has a favorable pharmacokinetic and safety profile in preclinical models and has demonstrated significant efficacy across a variety of tumor indications in vitro and in vivo.

For more information about the ongoing ADRX-0706 Phase 1a/b clinical trial, please refer to the Study ID NCT06036121 on ClinicalTrials.gov.

On May 6, 2025 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported it has entered into an exclusive patent license agreement with UTHealth Houston granting Genprex exclusivity and commercial rights relating to its lead drug candidate, Reqorsa Gene Therapy (quaratusugene ozeplasmid) for the potential treatment of glioblastoma (Press release, Genprex, MAY 6, 2025, View Source [SID1234652574]). The subject patent is co-owned by Genprex and UTHealth Houston, and the license provides Genprex with patent exclusivity.

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"We are pleased to expand our portfolio of licensed patents and add a technology that uses REQORSA to treat glioblastoma," said Thomas Gallagher, Senior Vice President of Intellectual Property and Licensing. "With this license agreement, Genprex has obtained exclusive commercial rights to REQORSA in glioblastoma while also adding to our patent estate. The role of TUSC2 in lung cancer has been well established, and this latest license enables Genprex to expand the use of REQORSA into a new indication, in which the cancer can be difficult to treat and there are unmet medical needs."

REQORSA may be a potential therapeutic treatment for glioblastoma.

REQORSA may be a potential therapeutic treatment for glioblastoma. Genprex previously reported positive preclinical data on the efficacy of REQORSA in glioblastoma in October 2024 at the 2024 EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics. Research collaborators from UTHealth Houston previously reported TUSC2 as a novel tumor suppressor for glioblastoma, the most common and deadliest primary brain tumor in adults which is associated with a poor prognosis. In their latest study, UTHealth Houston researchers used patient-derived glioblastoma (GBM) cell lines and patient-derived glioma stem cell (PD-GSC) lines. REQORSA was used to restore TUSC2 expression.

Researchers at UTHealth Houston observed that REQORSA significantly reduced GBM cell viability, and the results of a migration assay demonstrated that REQORSA suppressed GBM cell migration independent of its ability to suppress cell viability. In conclusion, REQORSA demonstrates promising in vitro efficacy in GBM and PD-GSCs, and these results support further evaluation of its in vivo anti-tumor efficacy in malignant gliomas using mouse models.

About Reqorsa Gene Therapy

REQORSA (quaratusugene ozeplasmid) consists of a plasmid containing the TUSC2 gene encapsulated in non-viral lipid-based nanoparticles in a lipoplex form (the Company’s Oncoprex Delivery System), which has a positive charge. REQORSA is injected intravenously and specifically targets cancer cells. REQORSA is designed to deliver the functioning TUSC2 gene to negatively charged cancer cells while minimizing uptake by normal tissue. Laboratory studies conducted at The University of Texas MD Anderson Cancer Center show that the uptake of TUSC2 in tumor cells in vitro after REQORSA treatment was 10 to 33 times the uptake in normal cells.

On May 6, 2025 Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, reported its financial results for first quarter ended March 31, 2025, and provided an update on its clinical development pipeline and other corporate developments (Press release, Prelude Therapeutics, MAY 6, 2025, View Source [SID1234652590]).

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"The first quarter of 2025 represented another strong period of execution across our organization," stated Kris Vaddi, Ph.D., Chief Executive Officer of Prelude. "We are making rapid progress with the development of our SMARCA2 degraders and are on track to determine the most optimal path forward for the overall program as we continue to strengthen our knowledge and understanding of potential opportunities for these novel, first-in-class drug candidates in highly aggressive SMARCA4 mutated cancers."

Continued Vaddi, "Additionally, we were very pleased to present at the most recent American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, the first preclinical data from our highly selective, oral KAT6A degraders. Selectively degrading KAT6A may hold the key to enhancing the efficacy and improving the safety profile for cancer patients beyond what has previously been demonstrated by non-selective KAT6A/B inhibitors. Our goal is to advance these potential growth driving assets towards points of value inflection in a strategic and financially disciplined manner."

Clinical Program Updates and Upcoming Milestones

PRT3789 – A first-in-class, highly selective, intravenous SMARCA2 Degrader

PRT3789 is designed to treat patients with a SMARCA4 mutation. Patients with SMARCA4-mutated cancer, a particularly aggressive form of the disease, have a very poor clinical prognosis. Approximately 10% of all non-small cell lung cancers and 5% of all cancers broadly, harbor a SMARCA4 mutation. In NSCLC, these patients tend to have poor response to standard of care chemoimmunotherapy and are largely ineligible for other targeted therapies. We believe that this represents an area of high unmet medical need.

PRT3789 is in Phase 1 clinical development in patients with biomarker selected SMARCA4-mutated cancers. The Company has completed enrollment of monotherapy dose escalation at the 665 mg once weekly IV dose and has selected 500 mg once weekly as the recommended Phase 2 dose. In addition, the Company has completed dose escalation in the combination of PRT3789 with docetaxel and is nearing completion of backfill cohorts. Updated data from the trial is expected to be presented at a major medical meeting in the second half of 2025.

The Company is enrolling patients in a Phase 2 clinical trial evaluating PRT3789 in combination with KEYTRUDA (pembrolizumab) in patients with SMARCA4-mutated cancers, per the previously announced collaboration with Merck (known as MSD outside of the US and Canada).

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Interim Phase 1 data presented at the 2025 Japanese Society of Medical Oncology Annual Meeting

As previously reported, the Company presented an encore oral presentation titled: PRT3789, a First-in-Class Intravenous SMARCA2 Degrader, in Advanced Solid Tumors with a SMARCA4 Mutation: Phase 1 Trial at the 2025 Japanese Society of Medical Oncology Annual Meeting on March 8, 2025, highlighting the favorable safety profile and responses seen in both NSCLC and upper GI cancers. The presentation can be found at Publications – Prelude Therapeutics.

PRT7732 – A potent, highly selective and orally bioavailable SMARCA2 Degrader

PRT7732 is a highly selective and orally bioavailable SMARCA2 degrader with a distinct chemical composition to PRT3789. In the fourth quarter of 2024, the Company initiated and enrolled the first patients in a phase 1 multi-dose escalation trial of PRT7732 (NCT06560645) in biomarker selected SMARCA4 mutated cancers. Enrollment has advanced rapidly, and the company is currently enrolling patients in the fifth dose escalation cohort (60 mg once daily). The Company expects to provide an initial first-in-human data update at a major medical meeting in the second half of 2025.

Highly selective KAT6A oral degrader program

Prelude discovered and is developing a series of highly potent, selective and orally bioavailable KAT6A degraders, which the Company believes is the industry’s first report of a KAT6 degrader based on currently published patents and literature. Optimized lead compounds are advancing to candidate nomination in the second quarter of 2025 with intent to file an IND in 2026. KAT6 is a clinically validated target with promising activity in breast cancer and other solid tumors. Recently, a dual KAT6A/B inhibitor demonstrated robust clinical activity in combination with fulvestrant in previously treated ER+/HER2- breast cancer patients, albeit with potential safety and tolerability considerations, in particular neutropenia.1 Hematologic toxicity is believed to be driven by the dual inhibition of KAT6A and KAT6B.

Prelude believes that selectively degrading KAT6A has the potential for improved efficacy, tolerability and combinability with other agents. The Company recently presented preclinical data validating this hypothesis at the AACR (Free AACR Whitepaper) Annual Meeting 2025. The presentation can be found at Publications – Prelude Therapeutics.

Precision ADCs with SMARCA2/4 dual degrader payload

Prelude is developing potent SMARCA2/4 dual degraders that robustly inhibit cancer cell growth and induce cell death across multiple cancer types as payloads for precision ADCs. The Company presented the first preclinical data from its precision ADC platform at the 36th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium in October. These data demonstrated that SMARCA2/4 dual degrader antibody conjugates have potential for significantly better in vivo efficacy and tolerability when compared to a traditional cytotoxic ADCs when tested head-to-head in xenograft models. Prelude and its partner AbCellera anticipate nominating the first development candidate from this program in 2025. The presentation can be found at Publications – Prelude Therapeutics.

Upcoming Investor Conference

The Company will participate in the Citizens 2025 Life Sciences Conference taking place in New York. On Wednesday, May 7, 2025 at 11:00 AM ET, Kris Vaddi, Ph.D., Chief Executive Officer, and Jane Huang, M.D., President and Chief Medical Officer, and Peggy Scherle, Ph.D., Chief Scientific Officer, will participate in a fireside chat.

A live webcast of the fireside chat can be accessed on the Company’s website under Events and Presentations. The recording will be archived and available on the Company’s website for 90 days.

First Quarter 2025 Financial Results 

Cash, Cash Equivalents, Restricted Cash and Marketable Securities:

Cash, cash equivalents, restricted cash and marketable securities as of March 31, 2025 were $103.1 million. The Company anticipates that its existing cash, cash equivalents, restricted cash and marketable securities will fund Prelude’s operations into the second quarter of 2026. 

Research and Development (R&D) Expenses:

For the first quarter of 2025, R&D expense increased to $28.8 million from $27.4 million for the prior year period. Included in the R&D expense for the three months ended March 31, 2025 was $2.3 million of non-cash expense related to stock-based compensation expense, including employee stock options, compared to $3.0 million for the three months ended March 31, 2024. Research and development expenses increased primarily due to an increase in expense related to our SMARCA2 clinical trials. Research and development expenses may fluctuate from period to period depending upon the stage of certain projects and the level of preclinical and clinical trial-related activities.

General and Administrative (G&A) Expenses:

For the first quarter of 2025, G&A expenses decreased to $5.8 million from $6.9 million for the prior year period. Included in general and administrative expenses for the three months ended March 31, 2025, was $1.6 million of non-cash expense related to stock-based compensation expense, including employee stock options, compared to $2.5 million for the three months ended March 31, 2024. The decrease in general and administrative expenses was primarily due to a decrease in stock-based compensation due to lower valuation on more recent grants due to the decrease in our stock price.

Net Loss:

For the three months ended March 31, 2025, net loss was $32.1 million, or $0.42 per share compared to $31.4 million, or $0.42 per share, for the prior year period. Included in the net loss for the three months ended March 31, 2025, was $3.8 million of non-cash expenses related to the impact of expensing share-based payments, including employee stock options, as compared to $5.5 million for the same period in 2024.

On May 6, 2025 Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company, reported that its product portfolio of FDA-approved brands delivered combined net revenues of $11.7 million during the first quarter of 2025, a 38% increase over the prior year period (Press release, Cumberland Pharmaceuticals, MAY 6, 2025, View Source [SID1234652607]). As a result the Company generated a net profit of $1.3 million for the quarter, adjusted earnings of $2.4 million, and cash flow from operations of $3.9 million.

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Cumberland ended the quarter with approximately $70 million in total assets, $41.6 million in liabilities and $28.7 million of shareholders’ equity.

"We are entering an exciting time for our company, as we continue to build momentum and capitalize on a range of promising opportunities," said Cumberland Pharmaceuticals CEO A.J. Kazimi. "Our optimism is driven by strong performance from our approved brands, the expansion of international partnerships, meaningful progress across our clinical development programs and the potential for strategic acquisitions."

RECENT COMPANY DEVELOPMENTS INCLUDE:

Top-Line DMD Study Results

In February 2025, Cumberland announced positive top-line results from the Phase II study evaluating its ifetroban product candidate in patients with Duchenne muscular dystrophy (DMD). This marks a breakthrough for these patients, as it’s the first successful Phase II study specifically targeting the cardiac complications of their condition.

These study results were selected for a late-breaking presentation in March at the Muscular Dystrophy Association’s Clinical & Scientific Conference. That platform allowed Cumberland to share the promising results with the global DMD community, including leading researchers, clinicians and patient advocates who are working tirelessly to improve outcomes for those affected by this devastating disease.

Next steps for Cumberland’s DMD program include further data analysis and completion of a full study report in preparation for an end-of-Phase-II meeting with the FDA to determine the requirements for the product’s approval.

Vibativ Approval in China

Cumberland’s potent antibiotic, Vibativ, received approval from the regulatory authorities in China. This provides Cumberland access to the world’s second-largest pharmaceutical market. The company expects the product to launch by the end of the year.

FINANCIAL RESULTS:

Net Revenue: For first quarter of 2025, net revenues were $11.7 million and included $3.5 million for Kristalose, $2.3 million for Sancuso, $1.4 million for Vibativ and $1.3 million for Caldolor.

Operating Expenses: Total operating expenses for the quarter were $10.4 million.

Net Income: The net income for the first quarter of 2025 was approximately $1.3 million.

Adjusted Earnings: Adjusted earnings for the quarter were $2.4 million, or $0.16 per share.

Balance Sheet: At March 31, 2025, Cumberland had approximately $70 million in total assets, including $15.1 million in cash and cash equivalents. Liabilities totaled $41.6 million, including $5.2 million on the company’s credit facility. Total shareholders’ equity was $28.7 million on March 31, 2025.

EARNINGS REPORT CALL:

A conference call will be held today, May 06, 2025, at 4:30 p.m. Eastern Time to provide a company update and discuss the financial results.

The link to register is: View Source

Registered participants can dial in from their phone using a dial-in and PIN number that will be provided to them. Alternatively, they can choose a "Call Me" option to have the system automatically call them at the start of the conference.

A replay of the call will be available for one year and can be accessed via Cumberland’s website or by visiting:

View Source