Celcuity Announces Upsized Senior Secured Term Loan Facility of $500 Million with Innovatus Capital Partners and Oxford Finance

On September 9, 2025 Celcuity Inc. ("Celcuity"), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, reported that it has entered into an amendment to its existing senior secured credit facility with an affiliate of Innovatus Capital Partners, LLC ("Innovatus") and Oxford Finance LLC ("Oxford") (Press release, Celcuity, SEP 9, 2025, View Source [SID1234655918]). The amendment increases the total term loan facility size to $500 million, including $350 million in committed capital and up to $150 million at the mutual discretion of Celcuity and its lenders. At the closing of the Amendment, the initial funding under the amended credit facility was in a principal amount of $30 million, bringing the total term loan outstanding to $130 million.

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Highlights of the amended credit facility include:

● Increased Capital Availability: Adds $170 million in new committed capital, including an additional $50 million for a total of $100 million available upon U.S. Food and Drug Administration ("FDA") approval of gedatolisib in second-line wild-type advanced breast cancer ("ABC") patients post-CDK4/6 inhibitor therapy, and $120 million upon achievement of certain commercial revenue milestones. An additional up to $150 million is also available at the mutual discretion of Celcuity and its lenders.
● Improved Structure and Financial Flexibility: Extends the interest-only period by 14 months, with an additional seven-month extension available upon FDA approval. The maturity date of the facility was also extended by six months.

The amendment significantly enhances Celcuity’s financial flexibility and access to capital following the positive topline data from the PIK3CA wild-type cohort of the pivotal VIKTORIA-1 Phase 3 clinical study. The upsized facility strengthens Celcuity’s ability to manage its capital structure efficiently while providing additional funding to support the rolling submission to FDA of its New Drug Application ("NDA") via FDA’s RTOR program, commercial launch preparations for gedatolisib, and other strategic initiatives.

Actuate Therapeutics Announces Proposed Public Offering of Common Stock

On September 9, 2025 Actuate Therapeutics, Inc. (NASDAQ: ACTU) ("Actuate" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), reported that it intends to offer and sell shares of its common stock in an underwritten public offering (Press release, Actuate Therapeutics, SEP 9, 2025, View Source [SID1234655915]). The Company also expects to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of shares of its common stock offered in the public offering at the public offering price per share, less underwriting discounts and commissions. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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The Company intends to use the net proceeds from the proposed offering for working capital and general corporate purposes.

Lucid Capital Markets is acting as sole book-running manager for the offering.

The common stock described above is being offered by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-289988), including a base prospectus, previously filed with and subsequently declared effective by the Securities and Exchange Commission (the "SEC"). A preliminary prospectus supplement relating to the offering has been filed with the SEC and is available on the SEC’s website at View Source A final prospectus supplement describing the terms of the offering will be filed with the SEC. The offering will be made only by means of the prospectus supplement and the accompanying base prospectus, as may be further supplemented by any free writing prospectus and/or pricing supplement that the Company may file with the SEC. Copies of the preliminary prospectus supplement, and accompanying base prospectus relating to this offering, may be obtained from Lucid Capital Markets, LLC, 570 Lexington Avenue, 40th Floor, New York, NY 10022.

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

Ridge Biotechnologies Emerges from Stealth with $25 Million in Seed Financing for AI-Enabled Precision Enzyme and Targeted Drug Design

On September 9, 2025 Ridge Biotechnologies (Ridge Bio), a company pioneering enzyme and targeted drug design to power the next wave of precision medicines, reported to have emerged from stealth with an oversubscribed $25 million in seed financing (Press release, Ridge Bio, SEP 9, 2025, View Source [SID1234655903]). Sutter Hill Ventures (SHV) incubated Ridge Bio and led the round, with participation from Overlap Holdings among others.

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The Ridge Bio platform uses proprietary machine learning models informed by high-throughput, cell-free experimentation for a wide range of applications in antibody-drug conjugates (ADCs), in vivo CAR-T therapies, targeted nucleic acid delivery, small molecule biocatalysis, radiotherapies, and enzyme-based therapeutics. Weston Kightlinger, PhD, a serial entrepreneur and pioneer in the fields of cell-free synthesis and enzyme design, is co-founder and Chief Executive Officer of Ridge Bio. Dr. Kightlinger previously co-founded and served as Chief Technology Officer of SwiftScale Biologics, a leader in cell-free manufacturing acquired by Resilience.

"Drug development should never be limited by the complexity of molecules we can precisely construct, off-target toxicities, or binding-based mechanisms of action. Machine learning has dramatically expanded our ability to design enzymatic systems that can solve these problems, but unlocking their full potential requires massive experimental datasets. At Ridge Bio, we generate those datasets at unprecedented speed and scale — up to a million-fold more sequence-function data than conventional methods in a fraction of the time. We use custom-built ML models to apply this data to enzyme and conditionally active drug design, giving our partners powerful tools to create safer, more precise medicines," said Kightlinger, who built Ridge as an Entrepreneur-in-Residence at SHV where he remains a Strategic Advisor. "With the support of great investors and a world-class founding team, we are scaling operations, expanding our technology partnerships in bioconjugates, and advancing our discovery programs towards our longer-term goal of developing a new class of precision-designed therapeutic enzymes. The strong, early interest from leading biopharma companies and CDMOs validates our vision and inspires us to accelerate the delivery of breakthrough medicines that make a real difference for patients." Ridge Bio has also announced its collaboration with a leading ADC-focused biotech to leverage Ridge Bio’s ProTrigger and NativeLink product lines to design and precisely attach linker systems that deliver therapeutic payloads specifically to tumor tissue, sparing healthy cells.

Powering Enzyme and Conditionally Active Prodrug Design

Ridge Bio’s initial offerings include NativeLink enzymes and ProTrigger linkers. NativeLink enzymes are designer biocatalysts that enable drugmakers to site-specifically modify therapeutic proteins, augment them with diverse payloads, extend their half-lives, and add precision targeting systems, all without changing the protein sequence, cell lines, or any upstream manufacturing processes. Ridge Bio’s first product, the NativeLink — AXC enzyme provides homogeneous modification of native antibodies without altering glycans, disulfide bonds, or amino acid sequences, avoiding stability, manufacturing, and functional challenges common with the previous generations of ADC, antibody-oligonucleotide conjugate (AOC), and other antibody conjugate synthesis strategies. The versatile system can achieve user-defined drug to antibody ratios (DARs) and multiple payloads or even upgrade an existing ADC drug product directly into a dual payload ADC without additional process changes. ProTrigger linkers are AI-designed protease-cleavable prodrug systems that release or activate therapeutic payloads at targeted sites in the body. Initial applications of ProTrigger linkers include unlocking new ADC targets, enhancing safety by reducing off-tumor toxicity, and targeting the tumor microenvironment and stroma.

"What used to take years can now be done in weeks, thanks to the combination of cell-free experimentation and machine learning. Together, they have created a step-change in our ability to design and leverage enzymes and prodrugs with exquisite specificity. That specificity is at the heart of Ridge Bio’s technologies and the next generation of precisely designed therapeutics," said Mike Jewett, Professor of Bioengineering at Stanford University and Ridge Bio’s Academic Co-founder and Scientific Advisory Board Chair.

World-Class Investors and Leadership Team

Ridge Bio’s founding team brings together deep expertise across ML-driven protein engineering, cell-free systems, and bioconjugation, combining groundbreaking work in academia with proven experience in industry.

"Ridge Bio is the perfect example of our approach to building companies: back world-class founders and help them attract the incredible teams they need to solve tough technical problems and unlock huge markets. Ridge Bio’s capabilities across machine learning and wet lab bioengineering positions the company to build drugs that no one else can and enable a new class of precisely engineered enzyme-based therapeutics," said Keith Loebner, PhD, Managing Director at SHV. "Each founding member of this team could have started something on their own, but they chose to join Ridge because they recognized that together they could do things no one else could do and, as a group, define the future of precision therapeutics." Founded in 1962, some of Sutter Hill Ventures’ previous investments and incubations include NVIDIA, Snowflake, PureStorage, Corcept Therapeutics, GRAIL, and Forty Seven.

Ridge Bio’s distinguished advisory board includes Carolyn Bertozzi, PhD (Stanford University, 2022 Nobel Laureate in Chemistry); Sangeeta Bhatia, MD, PhD (MIT/HHMI); Michael Jewett, PhD (Stanford University); Gabe Kwong, PhD (Georgia Tech); Mandana Honu, PhD (Atommap and Protillion, formerly Resilience); Hans Wandall, PhD (University of Copenhagen); and Vesna Mitchell, PhD (formerly Codexis). Their founding scientific team includes Grant Landwehr, PhD (pioneered ML-accelerated cell-free enzyme engineering approaches at Stanford University); Antje Kruger, PhD (launched cell-free enabled offerings for drug developers at Resilience); Francesca Li, PhD (built AI-driven protein engineering methods with Frances Arnold, PhD and Yisong Yue, PhD at Caltech); and Josh Walker, PhD (developed novel bioconjugation and ADC platforms at Bolt Therapeutics and insitro).

"Ridge Bio is at the forefront of three key trends, next-generation bioconjugates, protein design, and enzymatic therapeutics," said Dr. Bertozzi, whose work on biorthogonal chemistry won her a Nobel Prize and has been pivotal in guiding the development of modern bioconjugates. "Their AI and experimental platform are very unique and its already generating products that enable drug developers to differentiate themselves from competitors, not only through improved manufacturing but also through improved therapeutic indices while simultaneously unlocking the power of catalytic medicines."

Abdera Therapeutics Presents Initial Phase 1 Clinical Data on ABD-147, a Next-generation DLL3-targeting Radiopharmaceutical Therapy, at IASLC 2025 World Conference on Lung Cancer

On September 9, 2025 Abdera Therapeutics Inc., a clinical-stage biopharmaceutical company leveraging its advanced antibody engineering ROVEr platform to design and develop tunable precision radiopharmaceuticals for cancer, reported initial clinical data from its ongoing Phase 1a trial of ABD-147 in patients with small cell lung cancer (SCLC) and large cell neuroendocrine carcinoma (LCNEC) that support continued dose escalation (Press release, Abdera Therapeutics, SEP 9, 2025, View Source [SID1234655897]). The data were presented in a poster session at the IASLC 2025 World Conference on Lung Cancer in Barcelona, Spain.

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ABD-147 is a targeted radiopharmaceutical biologic therapy designed to deliver Actinium-225 (225Ac), a potent alpha-emitting isotope, to solid tumors expressing delta-like ligand 3 (DLL3) with high affinity. DLL3 is expressed in approximately 85% of patients with SCLC, an intrinsically radiosensitive cancer.

"These data with ABD-147 validate the mechanistic promise of DLL3-targeted alpha radiotherapy and mark an important step toward a modality that could reshape SCLC treatment," said Lisa Bodei, M.D., Ph.D., Nuclear Medicine Physician and Early Drug Development Specialist at Memorial Sloan Kettering Cancer Center. "While early, at the first dose level, we observed selective tumor uptake, predicted biodistribution without evidence of alteration, and disease stabilization in advanced disease following platinum-based therapy. These findings support continued dose escalation and further evaluation in SCLC, where treatment options remain limited."

Phase 1a Trial Overview and Key Findings

The Phase 1 trial is designed to evaluate the safety and tolerability, pharmacokinetics (PK), and preliminary anti-tumor activity of 225Ac-ABD147 in patients with locally advanced or metastatic SCLC and LCNEC following platinum-based chemotherapy. Dosimetry analysis using Indium-111 (111In) was conducted to track ABD-147 distribution in the body and to measure radiation doses to organs.

Data as of data cutoff date of August 15, 2025 from a total of six patients enrolled in the first dose cohort demonstrate:

PK: Human PK was consistent with preclinical models in multiple species, with minimal inter-patient variability
Biodistribution: Favorable tumor uptake with rapid clearance from the blood and key organs, including the kidneys
Dosimetry: Projected administered activity of 225Ac-ABD147 across all planned doses is within established safety limits for all organs, including kidneys, liver and bone marrow
Imaging: CT confirmed ABD-147 uptake in target lesions, supporting DLL3 specificity
Safety: ABD-147 has been tolerated, with no infusion-related events, no dose modifications and no dose-limiting toxicities observed to date. Treatment-related adverse events included one case of paresthesia (tingling sensation) that resolved rapidly, and one case of thrombocytopenia. Five serious adverse events were observed in two patients – three instances of dyspnea and two deaths due to co-morbidities – all of which were deemed unrelated to study drug.
Preliminary anti-tumor activity: Disease stabilization has been observed, including one patient who received multiple cycles of ABD-147 with over four months of follow-up.
Based on these initial data, the independent safety review committee recommended continuation of dose escalation with ABD-147.

"The presentation of our first-in-human data for ABD-147 marks an important milestone for Abdera and reinforces the promise of our precision radiopharmaceuticals for difficult-to-treat cancers," said Philippe Bishop, M.D., chief medical officer of Abdera Therapeutics. "These data highlight the power of our ROVEr platform to engineer finely tunable radiopharmaceuticals with optimal tumor accumulation and healthy tissue clearance. I am incredibly proud of the team’s work to bring ABD-147 to this important stage. As we advance dose escalation, our focus remains on unlocking the full potential of ABD-147 for patients with DLL3-expressing tumors."

About ABD-147

ABD-147 is a targeted radiopharmaceutical biologic therapy designed to deliver Actinium-225 (225Ac), a highly potent alpha-emitting radioisotope, to solid tumors expressing delta-like ligand 3 (DLL3) with high affinity. DLL3 is a protein in the Notch pathway that is critical for the development and regulation of neuroendocrine versus epithelial cell differentiation in the lungs. In certain high grade neuroendocrine carcinomas including small cell lung cancer (SCLC), DLL3 is upregulated and specifically expressed on the cell surface in more than 80% of cases. In contrast, DLL3 is absent or very rarely expressed on the surface of nonmalignant cells. Given the high specificity of DLL3 expression on cancer cells and the distinct mechanism of action, DLL3 represents a compelling target for treating SCLC and other DLL3+ solid tumors with targeted radiotherapy.

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ABD-147 for the treatment of patients with extensive stage small cell lung cancer (ES-SCLC) who have progressed on or after platinum-based chemotherapy and Orphan Drug Designation to ABD-147 for the treatment of neuroendocrine carcinoma. ABD-147 is currently being evaluated in a first-in-human Phase 1 clinical trial in patients with SCLC or large cell neuroendocrine carcinoma of the lung who have previously received platinum-based therapy.

About Small Cell Lung Cancer and Large Cell Neuroendocrine Carcinoma

The global incidence for SCLC and LCNEC has been reported to represent approximately 325,000 patients and is expected to increase 4% annually through 2029. In the U.S., the incidence has been reported to be approximately 35,000 new cases annually. Fifteen percent of all lung cancer cases are high-grade neuroendocrine cancers. These cancers have the most aggressive clinical course of any type of pulmonary tumor and often metastasize to other parts of the body, including the brain, liver and bone. Without treatment, the median survival from diagnosis has been reported to be only two to four months. With treatment, the overall survival at five years is 5% to 10% for SCLC, and 15% to 25% for LCNEC. SCLC and LCNEC generally carry a poor prognosis and new treatment options are urgently needed.

Tubulis Strengthens Leadership Team with Appointment of Halley Gilbert as Chief Legal and Operating Officer

On September 9, 2025 Tubulis reported the appointment of Halley Gilbert, JD, as Chief Legal Officer and Chief Operating Officer (CLO/COO) (Press release, Tubulis, SEP 9, 2025, View Source [SID1234655896]). Bringing over 20 years of transaction and operations experience in the biopharmaceutical industry, Ms. Gilbert will further expand Tubulis’ leadership capabilities at a pivotal stage of clinical and corporate development. In this newly created role, she will leverage her combined expertise as an attorney and seasoned biotech executive to shape Tubulis’ strategy and support the continued growth of the company’s U.S. presence. Ms. Gilbert will be responsible for legal and administrative functions and play a key role in executing strategic transactions for the company.

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"Halley’s extensive legal and operational experience and deep commitment to supporting rapidly growing biotech companies make her an ideal addition to our team as we further expand our clinical and business operations," said Dr. Dominik Schumacher, CEO and Co-founder of Tubulis. "Her industry know-how and strategic leadership will be instrumental as we advance our lead ADC candidates through clinical development and continue to expand our pipeline with new modalities."

"ADCs are transforming the oncology landscape, and Tubulis is leading the way with its differentiated approach to ADC design," said Halley Gilbert, JD, CLO and COO of Tubulis. "Their innovative platforms and exciting research ethos allow them to unlock the full therapeutic potential of this powerful drug class. I am thrilled to be joining such a motivated team and look forward to helping shape the path toward commercialization and delivering a meaningful clinical impact to patients."

Ms. Gilbert brings extensive legal and operational experience within the life sciences industry, having served as CLO and COO at both public and private biotech companies. Most recently, she served as Chief Legal Officer of Cargo Therapeutics and played a key leadership role in the company’s initial public offering and subsequent sale. Prior to Cargo, Ms. Gilbert was the first employee of Invyvid, Inc. (formerly Adagio), where she enabled the company’s rapid growth from launch to IPO, and accelerated its transition from early R&D to late-stage clinical development. In addition, for the past five years, Ms. Gilbert has been a member of the Board of Directors at Vaxcyte, Inc., Arcutis Biotherapeutics, and CytomyX Therapeutics, Inc.