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 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 Pasithea Therapeutics, Corp. ("Pasithea," or the "Company") (Nasdaq: KTTA; KTTAW), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, for the treatment of neurofibromatosis type 1 (NF1) and other cancer indications, reported the pricing of a public offering of 3,571,428 shares of the Company’s common stock (or pre-funded warrants in lieu thereof) and accompanying Series C warrants to purchase up to 3,571,428 shares of common stock and Series D warrants to purchase up to 3,571,428 shares of common stock, at a combined offering price of $1.40 per share of common stock (or per pre-funded warrant in lieu thereof) and accompanying warrants (Press release, Pasithea Therapeutics, MAY 6, 2025, View Source [SID1234652587]).

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The Series C common warrants will have an exercise price of $1.40 per share and will be exercisable upon issuance and will expire five years thereafter. The Series D common warrants will have an exercise price of $1.40 per share and will be exercisable upon issuance and will expire 18 months thereafter. The closing of the offering is expected to occur on or about May 7, 2025, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds to the Company from the offering are expected to be approximately $5.0 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for general corporate purposes, which includes, without limitation, ongoing research and pre-clinical studies, clinical trials, the development of new biological and pharmaceutical technologies, investing in or acquiring companies that are synergistic with or complementary to the Company’s technologies, licensing activities related to its current and future product candidates, and to the development of emerging technologies, investing in or acquiring companies that are developing emerging technologies, licensing activities, or the acquisition of other businesses and working capital.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-286889) originally filed with the Securities and Exchange Commission ("SEC") on May 1, 2025 and declared effective on May 6, 2025. The offering is being made only by means of a prospectus, which is part of the effective registration statement. A preliminary prospectus relating to the offering has been filed with the SEC. When available, electronic copies of the final prospectus may be obtained for free on the SEC’s website located at View Source and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

On May 6, 2025 Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, reported its financial results for the first quarter 2025 and provided an update on recent business progress (Press release, Nuvectis Pharma, MAY 6, 2025, View Source [SID1234652586]).

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Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, "The start of 2025 has been eventful for us at Nuvectis as we continued to advance our two clinical programs." Mr. Bentsur continued, "Last week we provided the first clinical data update for NXP900 from the Phase 1a dose escalation "all comers" study, demonstrating a robust pharmacodynamic response and acceptable safety profile in patients with advanced cancers. We are approaching the conclusion of this portion of the Phase 1 program and are completing our preparations for the Phase 1b portion, into which patients with cancers harboring specific genetic alterations will be enrolled to evaluate, for the first time, the therapeutic potential of single agent NXP900 in target patients. In addition, we continue to advance the combination portion of the Phase 1b program, with recent AACR (Free AACR Whitepaper) preclinical poster presentations highlighting the potential of NXP900 as a combination partner to market-leading EGFR and ALK kinase inhibitors, combinations aimed at overcoming acquired resistance to these treatments in non-small cell lung cancer. On the NXP800 side, enrollment into the Phase 1b study in patients with platinum resistant, ARID1a mutated ovarian cancer continues, and we expect to provide an update from this study in a couple of months." Mr. Bentsur concluded, "We are excited about the upcoming months with NXP900 entering the Phase 1b portion of its clinical development and believe that with the recent financing we have working capital to take us through key clinical development milestones and into 2027."

First Quarter 2025 Financial Results

Cash and cash equivalents were $29.9 million as of March 31, 2025, compared to $18.5 million as of December 31, 2024. The increase of $11.4 million in cash balance in the first quarter of 2025 is a result of the Company’s public offering in February 2025 with net proceeds of $14.0 million, after transaction fees and expenses, and the utilization of the at-the-market facility, partially offset by the operating expenses for the quarter.

The Company’s net loss was $5.3 million for the three months ended March 31, 2025, compared to $4.2 million for the three months ended March 31, 2024, an increase in net loss of $1.1 million. Non-cash stock-based compensation was $1.4 million for the three months ended March 31, 2025 compared to $1.3 million for the three months ended March 31, 2024. The net loss for the three months ended March 31, 2025, also included $0.5 million in one-time non-recurring charges.

Research and development expenses, including non-cash stock-based compensation, were $3.7 million for the three months ended March 31, 2025, compared to $2.7 million for the three months ended March 31, 2023, an increase of $1.0 million.

General and administrative expenses, including non-cash stock-based compensation, were $1.9 million for the three months ended March 31, 2025, compared to $1.7 million for the three months ended March 31, 2024, an increase of $0.2 million.

Interest income was $0.2 million for the three months ended March 31, 2025, compared to $0.2 million for the three months ended March 31, 2024.

On May 6, 2025 NuCana plc (NASDAQ: NCNA), a clinical-stage biopharmaceutical company that focuses on significantly improving treatment outcomes for patients with cancer, reported that it has priced a registered direct offering consisting of 10,845,985 American Depository Shares, or ADSs, (or pre-funded warrants in lieu thereof) with each ADS (or pre-funded warrant) accompanied by (i) a Series A warrant to purchase one (1) ADS at an initial exercise price of $0.8068 per share and (ii) a Series B Warrant to purchase one (1) ADS at an initial exercise price of $1.61 per share (Press release, Nucana, MAY 6, 2025, View Source [SID1234652585]). The combined public offering price of each ADS together with the accompanying Series A and Series B Warrants is $0.6454, and the combined offering price of each pre-funded warrant together with the accompanying Series A and Series B warrants is $0.6454, minus the United States dollar equivalent of £0.01, based on the exchange rate on the date of pricing. The gross proceeds of the offering are expected to be approximately $7 million before deducting placement agent fees and offering expenses and are expected to be used to fund activities relating to the advancement of our drug discovery and development programs, and for other general corporate purposes, including, but not limited to, working capital, capital expenditures, investments, acquisitions, should we choose to pursue any, and collaborations. The closing of the offering is expected to occur on or about May 7, 2025, subject to the satisfaction of customary closing conditions.

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Laidlaw & Company (UK) Ltd. is acting as the sole placement agent for the offering.

This registered offering is being made by the Company pursuant to a registration statement on Form F-1 (File No. 333-286716), which was declared effective by the United States Securities and Exchange Commission ("SEC") on May 5, 2025. The securities may only be offered by means of a prospectus. Copies of the prospectus may be obtained, when available, at the SEC’s website at www.sec.gov or from Laidlaw & Company (UK) Ltd., 521 5th Avenue, 12th Floor, New York, NY 10175, or by telephone at (212) 953-4900, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.