On March 6, 2025 RAPT Therapeutics, Inc. (Nasdaq: RAPT) ("RAPT" or the "Company") is a clinical-stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing novel therapies for patients living with inflammatory and immunological diseases, reported financial results for the fourth quarter and year ended December 31, 2024 (Press release, RAPT Therapeutics, MAR 6, 2025, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-reports-fourth-quarter-and-full-year-2024 [SID1234650972]).

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"Our focus for 2025 will be on advancing development of RPT904, a novel, potential best-in-class option to treat the large and underserved population of patients suffering from food allergy and chronic spontaneous urticaria," said Brian Wong, President and CEO of RAPT. "We believe RPT904 can be a differentiated product to treat these diseases by targeting IgE, an approach validated by omalizumab. We expect to initiate a Phase 2b clinical trial for RPT904 in food allergy in the second half of 2025 and await clinical data later this year from our partner Jemincare to guide our development strategy in CSU."

Financial Results for the Fourth Quarter and Year Ended December 31, 2024

Fourth Quarter Ended December 31, 2024

Net loss for the fourth quarter of 2024 was $53.2 million, compared to $30.9 million for the fourth quarter of 2023.

Research and development expenses for the fourth quarter of 2024 were $46.5 million, compared to $26.8 million for the same period in 2023. The increase in research and development expenses was primarily due to the $35.0 million upfront license fee for RPT904, partially offset by lower development costs related to zelnecirnon, tivumecirnon and early-stage programs, as well as decreased expenses for personnel, professional services, non-cash stock-based compensation and lab supplies.

General and administrative expenses for the fourth quarter of 2024 were $8.0 million, compared to $6.5 million for the same period in 2023. The increase in general and administrative expenses was primarily due to increases in expenses for professional services, non-cash stock-based compensation, personnel and facilities.

In December 2024, the Company entered into a license agreement with Shanghai Jemincare Pharmaceutical Co., Ltd. ("Jemincare"), a company incorporated in the People’s Republic of China, under which the Company obtained exclusive rights to RPT904 throughout the world, excluding mainland China, Hong Kong, Macau and Taiwan. As consideration for those rights, the Company paid a $35.0 million upfront license fee and could pay up to $672.5 million in additional milestone payments, as well as tiered royalty payments (at percentages ranging from high single-digit to low double-digit) on future net sales.

Also in December 2024, the Company sold through a private placement to a select group of accredited investors 100,000,000 shares of common stock at a price of $0.85 per share and pre-funded warrants to purchase 76,452,000 shares of common stock at a purchase price of $0.8499 per pre-funded warrant, resulting in net proceeds of $143.0 million after deducting offering expenses.

Year Ended December 31, 2024

Net loss for the year ended December 31, 2024 was $129.9 million, compared to $116.8 million for the same period in 2023.

Research and development expenses for the year ended December 31, 2024 were $107.2 million, compared to $101.0 million for the same period in 2023. The increase in research and development expenses was primarily due to the $35.0 million upfront license fee for RPT904 and an increase in non-cash stock-based compensation expense, partially offset by lower development costs related to zelnecirnon, tivumecirnon and early-stage programs, as well as decreased expenses for personnel, professional services and lab supplies.

General and administrative expenses for the year ended December 31, 2024 were $28.9 million, compared to $26.1 million for the same period in 2023. The increase in general and administrative expenses was primarily due to increased expenses for non-cash stock-based compensation, consultants, personnel, and facilities, partially offset by decrease in expenses for insurance premiums.

As of December 31, 2024, the Company had cash and cash equivalents and marketable securities of $231.1 million.

On March 6, 2025 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer, reported a business update and announced full year 2024 financial results (Press release, NextCure, MAR 6, 2025, View Source [SID1234650971]).

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"In 2024 we reprioritized our resources to advance our antibody-drug conjugate ("ADC") program and recently completed cohort 1 of the Phase 1 study evaluating LNCB74 as a potential therapeutic for treating multiple cancers. We look forward to additional progress in 2025, including initiating backfill cohorts in the second half of the year," said Michael Richman, NextCure’s president and CEO.

Business Highlights and Near-Term Milestones

LNCB74 (B7-H4 ADC)

● Presented preclinical data from LNCB74 (B7-H4 ADC) at the Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting in November 2024 to highlight its potential as a therapeutic for treating multiple solid tumor indications.
● The U.S. Food and Drug Administration accepted an Investigational New Drug (IND) application in December 2024.
● Dosed our first patient in January 2025 in the Phase 1 trial, clearing cohort 1 in February 2025 and currently dosing cohort 2.
● We plan to initiate backfill cohorts in the second half of 2025.

Preclinical Non-Oncology Programs Seeking Partnering

● Preclinical data for NC181 (ApoE4), a humanized antibody for the treatment of Alzheimer’s disease, has demonstrated amyloid clearance, prevention of amyloid deposition, plaque clearance and reduced neuroinflammation.

● Preclinical data for NC605 (Siglec-15), a humanized antibody for the treatment of osteogenesis Imperfecta (OI), has demonstrated that NC605 treatment reduced bone loss and enhanced bone quality in mice with OI.
● Both programs could lead to IND filings within 12 to 18 months if financial support from partners or third parties is secured.

Financial Results for Full Year Ended December 31, 2024

● Cash, cash equivalents, and marketable securities as of December 31, 2024 were $68.6 million as compared to $108.3 million as of December 31, 2023. The decrease of $39.7 million was primarily due to cash used to fund operations. We expect current financial resources to fund operating expenses and capital expenditures into the second half of 2026.
● Research and development expenses were $41.5 million for the full year ended December 31, 2024, as compared to $47.9 million for the full year ended December 31, 2023. Higher net costs on the LNCB74 program were more than offset by lower costs on other programs and preclinical development and lower personnel-related costs.
● General and administrative expenses were $15.7 million for the full year ended December 31, 2024, as compared to $19.7 million for the full year ended December 31, 2023. The decrease of $4.0 million was primarily related to lower payroll, lower stock compensation expense and lower insurance costs.
● Net loss was $55.7 million for the full year ended December 31, 2024, as compared to a net loss of $62.7 million for the full year ended December 31, 2023.

On March 6, 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 received a Notice of Intent to Grant for the European patent application titled, "Method of Reconstituting Liposomal Annamycin" (Press release, Moleculin, MAR 6, 2025, View Source [SID1234650970]). The grant is subject to payment of fees and completion of final amendments and formalities. Such grant will enhance the global exclusivity of Annamycin with the potential to be a next generation, non-cardiotoxic treatment for certain cancers.

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When issued, the patent claims will cover methods of making liposomal Annamycin suspension as well as the resulting compositions for use in the treatment of cancers, with a base patent term currently extending until June 2040, subject to extension to account for time required to fulfill requirements for regulatory approval. Moleculin’s novel drug candidate is being positioned to become the first ever non-cardiotoxic anthracycline to be approved and is currently being developed for the treatment of acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases (STS lung mets). Additional preclinical studies performed at a world-renowned cancer center indicate Annamycin may be a potential treatment for many more other types of cancers. The new chemical entity uses a unique lipid-based delivery technology and has shown the potential to be used in a wide range of cancers. In addition to the expected European patent and previously issued U.S. patents, Moleculin has additional patent applications related to Annamycin pending in the U.S., Europe and in major jurisdictions worldwide.

Wally Klemp, Chairman and CEO of Moleculin, said "Acknowledgment by the European Patent Office of the innovation underlying Annamycin is an important milestone for Moleculin, underscoring the importance and proprietary nature of the innovation that makes this next generation anthracycline possible. We expect Europe to be an important market for Annamycin and look forward to making an important new treatment available to patients in this region. This enhancing of our exclusivity for Annamycin is exciting when coupled with our continued expectation for an initial data readout for the MIRACLE trial in the second half of 2025."

The Company is initiating the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) Trial (MB-108), a pivotal, adaptive design Phase 3 trial evaluating Annamycin in combination with cytarabine, together referred to as AnnAraC, for the treatment of relapsed or refractory acute myeloid leukemia. Following a successful Phase 1B/2 study (MB-106), with input from the FDA, the Company believes it has substantially de-risked the development pathway towards a potential approval for Annamycin for the treatment of AML. This study is subject to appropriate future filings with potential additional feedback from the FDA and their foreign equivalents.

Additionally, the Company is developing WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers. Moleculin is also engaged in the development of a portfolio of antimetabolites, including WP1122 for the potential treatment of pathogenic viruses, as well as certain cancer indications.

On March 6, 2025 Integral Molecular, a leader in antibody discovery against membrane proteins, reported that its out-licensed anti-Claudin 6 (CLDN6) bispecific antibody, CTIM-76, has been dosed in the first patient in a Phase 1 clinical trial by its licensing partner, Context Therapeutics Inc (Press release, Integral Molecular, MAR 6, 2025, View Source [SID1234650968]). This milestone is part of a Phase 1 dose escalation and expansion trial enrolling patients with advanced or metastatic ovarian, endometrial, and testicular cancers.

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CLDN6 is a structurally complex protein that is expressed in multiple cancers but absent from healthy tissue, making it an attractive drug target. However, targeting CLDN6 is challenging because numerous related proteins are present in healthy tissues.

Using their MPS Antibody Discovery platform, Integral Molecular isolated a lead molecule targeting a unique CLDN6 epitope to deliver potential best-in-class specificity compared with other molecules undergoing clinical development. Under a licensing agreement, Context Therapeutics Inc. is leading clinical development of CTIM-76, following the successful completion of IND-enabling studies.

CTIM-76 was generated using Integral Molecular’s proprietary technologies for discovering therapeutics against challenging targets:

MPS Antibody Discovery platform tailored to produce robust immune responses even against the most complex proteins and rare epitopes
Bispecific antibody engineering strategies that assess numerous bispecific antibody stoichiometries and formats in vitro and in vivo
Selection for exquisite specificity using Integral Molecular’s Membrane Proteome Array that screens biologics for reactivity against 6,000 native membrane proteins
"Our antibody discovery platform continues to advance untapped targets across oncology, autoimmune diseases, and other therapeutic areas to discover breakthrough treatments for patients," said Joseph Rucker, PhD, Vice President of R&D at Integral Molecular. "We are proud to work with partners like Context Therapeutics who are bringing novel therapeutics to the clinic."

On March 6, 2025 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) reported that it has completed enrollment of its a Phase II trial of fanregratinib (HMPL-453) for intrahepatic cholangiocarcinoma ("IHCC") patients with fibroblast growth factor receptor ("FGFR")2 fusion/rearrangement (Press release, Hutchison China MediTech, MAR 6, 2025, View Source [SID1234650967]).

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The study is a single-arm, multi-center, open-label, Phase II registration study to evaluate the efficacy, safety and pharmacokinetic of fanregratinib in treating advanced IHCC patients with FGFR2 fusion/rearrangement. Primary endpoint is objective response rate (ORR). Secondary endpoints include progression-free survival (PFS), disease control rate (DCR), duration of response (DoR) and overall survival (OS). A total of 87 patients were enrolled into the registration phase of the study. Additional details may be found at clinicaltrials.gov using identifier NCT04353375.

The first patient received the first dose in March 2023 and HUTCHMED expects to announce topline results from the study around the end of 2025. If favorable, the results could enable a New Drug Application submission to China’s National Medical Products Administration (NMPA).

About Fanregratinib

Fanregratinib (HMPL-453) is a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3. Aberrant FGFR signaling has been found to be a driving force in tumor growth, promotion of angiogenesis and resistance to anti-tumor therapies. Abnormal FGFR gene alterations are believed to be the drivers of tumor cell proliferation in several solid tumor settings.

HUTCHMED currently retain all rights to fanregratinib worldwide.

About IHCC with FGFR2 Fusion/Rearrangement

IHCC is one of the subtypes of primary bile duct cancer. In China, an estimated 61,900 newly diagnosed IHCC occurred in 2015 and the overall IHCC incidence increased by 9.2% per year between 2006 and 2015.1 FGFR2 fusion has been reported to have a prevalence of 10-15% in IHCC patients.