On February 25, 2025 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported focused registrational clinical development plans for its two lead programs, an extension of projected cash runway into 2027 (from previous guidance of late 2026), and accelerated/augmented corporate milestones (Press release, ORIC Pharmaceuticals, FEB 25, 2025, View Source [SID1234650544]).

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"Based on the initial data we have generated with ORIC-944 and ORIC-114 and recent clinical data reported with other programs in mCRPC and NSCLC, we have refined our registrational plans to focus on the most promising opportunities for both programs," stated Jacob M. Chacko, M.D., president and chief executive officer. "For ORIC-944, based on both internal and external data that validate the combination of PRC2 inhibitors with AR inhibitors in mCRPC, we intend to initiate our first Phase 3 trial in 1H 2026. For ORIC-114, we intend to initiate registrational trial(s) in 2026 with a focus on areas of highest unmet need in first-line NSCLC settings. With these focused registrational plans, we have extended our projected cash runway into 2027."

Registrational Clinical Development Plans and Updated Corporate Milestones:

ORIC-944: a potent and selective allosteric inhibitor of PRC2

Given the recently reported encouraging early safety and efficacy data from an ongoing dose escalation trial for ORIC-944 in combination with apalutamide in patients with metastatic castration resistant prostate cancer (mCRPC) and favorable enrollment trends, ORIC now expects to report dose escalation data of ORIC-944 both in combination with apalutamide and in combination with darolutamide in 1H 2025, followed by an additional update in 2H 2025.
Expected timing for the previously communicated milestone of ORIC-944 dose optimization data in combination with AR inhibitor(s) has been accelerated/narrowed to 4Q25 or 1Q26 (previously 4Q25 or 1H 2026).
ORIC expects to initiate its first Phase 3 trial for ORIC-944 in mCRPC in 1H 2026.
ORIC-114: a brain penetrant, orally bioavailable, irreversible EGFR/HER2 inhibitor

Given favorable enrollment for ORIC-114 in the 1L EGFR exon 20 monotherapy cohort and the 2L+ atypical EGFR cohort, ORIC now expects to provide a comprehensive data update during 2H 2025 that will include these two cohorts along with cohorts for 2L EGFR exon 20 and 2L+ HER2 exon 20.
ORIC-114 in combination with subcutaneous (SC) amivantamab in patients with 1L EGFR exon 20 has recently been initiated. Initial data from this trial in addition to ORIC-114 data as a monotherapy in 1L EGFR atypical mutations are expected in mid-2026.
ORIC expects to initiate Phase 3 trial(s) for ORIC-114 in 1L NSCLC in 2026, in EGFR exon 20, HER2 exon 20, and/or atypical EGFR mutations. ORIC does not currently plan to pursue registrational trials of ORIC-114 in 2L EGFR and 2L+ HER2 exon 20 NSCLC given the more significant commercial opportunity in first-line settings and the current state of capital markets.
Corporate Highlights:

Cash, cash equivalents and investments totaled $256 million as of December 31, 2024; based on the refined operating plan, projected cash runway has been extended into 2027.

On February 25, 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 year ended December 31, 2024 and provided an update on recent business progress (Press release, Nuvectis Pharma, FEB 25, 2025, View Source [SID1234650543]).

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Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, "In 2024, Nuvectis made important progress in the development of our two clinical-stage drug candidates, NXP800 and NXP900. NXP800 was granted Orphan Drug Designation by the U.S. FDA for the treatment of ARID1a-deficient ovarian, fallopian tube and primary peritoneal cancers. Enrollment is ongoing in the Phase 1b clinical trial, in which patients with platinum resistant, ARID1a-mutated ovarian cancer are currently being treated with a dose of 75mg/day, on an intermittent dosing schedule. We intend to provide an update from this study in the second quarter and plan to provide the first data from the investigator-initiated study in cholangiocarcinoma later this year."

Mr. Bentsur continued, "For NXP900, enrollment continues in the Phase 1a dose escalation clinical trial and we are pleased with the emerging clinical profile of NXP900, based on safety, pharmacokinetics and pharmacodynamics information to date. In parallel, preparations are underway to begin the Phase 1b program in mid-year. This program is designed to evaluate NXP900 as monotherapy in YES1/SRC-driven solid tumors, and in combination with EGFR and ALK inhibitors, in patients with non-small cell lung cancer. Positive results could showcase NXP900’s potential broad applicability in these large oncology markets.

Mr. Bentsur concluded, "Our successful follow-on offering, completed this month, provided Nuvectis with $15.5M in gross proceeds, which extend our cash runway into 2027. Based on the continued progress with the NXP800 and NXP900 programs, the strength and drug development expertise of our team, and expanded cash resources, I believe Nuvectis is well-positioned to generate meaningful results in our clinical portfolio in 2025 and beyond."

Full Year 2024 Financial Results

Cash and cash equivalents were $18.5 million as of December 31, 2024, compared to $19.1 million as of December 31, 2023. The decrease of $0.6 million was a result of the Company’s continued operations, offset by access to our at-the-market offering facility.

The Company’s net loss was $19.0 million for the year ended December 31, 2024, compared to $22.3 million for the year ended December 31, 2023, a decrease in net loss of $3.3 million. Net loss for the 2024 fiscal year included $4.9 million in non-cash stock-based compensation.

Research and development expenses, including non-cash stock-based compensation were $12.9 million for the year ended December 31, 2024, compared to $15.4 million for the year ended December 31, 2023, a decrease of $2.5 million.

General and administrative expenses, including non-cash stock-based compensation were $6.9 million for the year ended December 31, 2024, compared to $7.5 million for the year ended December 31, 2023, a decrease of $0.6 million.

Interest income was $0.8 million for the year ended December 31, 2024, compared to $0.6 million for the year ended December 31, 2023, an increase of $0.2 million.

On February 25, 2025 Nusano, a physics company transforming the production of radioisotopes, reported company management will present at the B. Riley Precision Oncology & Radiopharma Conference on Friday, Feb. 28, 2025 in New York City (Press release, Nusano, FEB 25, 2025, View Source [SID1234650542]).

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The presentation will take the form of a fireside chat-style update that will highlight Nusano’s 2025 commercialization plans and provide an overview of how the company is leveraging its proprietary technologies to make new supplies of rare and hard-to-produce radioisotopes available for medical and commercial markets.

WHO:
Nusano Management

WHAT:
Fireside Chat

WHEN:
Friday, Feb. 28, 2025
2:00-2:30 PM Eastern Time

WHERE:
B. Riley Precision Oncology & Radiopharma Conference
New York, N.Y.

Nusano’s executives are also participating in one-on-one meetings with institutional investors at the conference. Meeting requests should be sent via the conference portal, or by emailing [email protected].

On February 25, 2025 Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies, reported its participation in the following investor conferences (Press release, Nkarta, FEB 25, 2025, View Source [SID1234650541]):

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TD Cowen 45th Annual Health Care Conference
March 3, 2025
3:10 p.m. ET – fireside chat

Leerink Partners 2025 Global Healthcare Conference
March 10, 2025
3:00 p.m. ET – fireside chat

A simultaneous webcast of the events will be available on the Investors section of Nkarta’s website, www.nkartatx.com, and a replay will be archived on the website for approximately 90 days.

On February 25, 2025 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, reported it has entered into a securities purchase agreement with an institutional investor for the purchase and sale of 3,271,029 shares of common stock (or pre-funded warrants in lieu thereof) in a registered direct offering and warrants to purchase up to 6,542,058 shares of common stock in a concurrent private placement (together with the registered direct offering, the "Offering") at a combined purchase price of $1.07 per share and accompanying warrants (Press release, Moleculin, FEB 25, 2025, View Source [SID1234650540]). The warrants issued pursuant to the concurrent private placement will have an exercise price of $1.07 per share, will be exercisable upon the receipt of shareholder approval following the date of issuance and will expire 5 years from the initial exercise date.

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Roth Capital Partners is acting as the exclusive placement agent for the Offering.

The closing of the Offering is expected to occur on or about February 26, 2025, subject to the satisfaction of customary closing conditions. The gross proceeds from the Offering are expected to be approximately $3.5 million before deducting placement agent fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from the Offering for working capital and general corporate purposes.

The common stock (or pre-funded warrants in lieu thereof) will be issued in a registered direct offering pursuant to an effective shelf registration statement on Form S-3 (File No. 333-280064) previously filed with the U.S. Securities and Exchange Commission (the "SEC"), under the Securities Act of 1933, as amended (the "Securities Act"), and declared effective by the SEC on July 1, 2024. The warrants will be issued in a concurrent private placement. A prospectus supplement describing the terms of the proposed registered direct offering will be filed with the SEC and once filed, will be available on the SEC’s website located at View Source or by contacting Roth Capital Partners, LLC at 888 San Clemente Drive, Newport Beach CA 92660, by phone at (800) 678-9147.

The private placement of the warrants and the underlying shares will be made in reliance on an exemption from registration under Section 4(a)(2) of the Securities Act and/or Regulation D thereunder. Accordingly, the securities issued in the concurrent private placement may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release shall 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 offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.