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.

On May 6, 2025 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported that it will participate at two upcoming investor conferences in May (Press release, Neurocrine Biosciences, MAY 6, 2025, View Source [SID1234652584]).

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Chief Executive Officer Kyle Gano and Vice-President of Investor Relations Todd Tushla will present at the BofA Securities 2025 Health Care Conference on Tuesday, May 13, 2025 at 11:20 AM Pacific Time in Las Vegas.
Chief Financial Officer Matt Abernethy and Chief Commercial Officer Eric Benevich will present at the RBCCM Global Healthcare Conference on Tuesday, May 20, 2025 at 11:30 AM Eastern Time in New York.

The live webcasts can be accessed on Neurocrine Biosciences’ website under Investors at www.neurocrine.com. A replay of the webcasts will be available on the website approximately one hour after the conclusion of the events and will be archived for approximately one month.