1stOncology™: Cancer Intelligence Service – Page 302 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Rakovina Therapeutics to Present New Data Highlighting CNS-Penetrant ATR and PARP1 Inhibitors at the 2025 Society for Neuro-Oncology Annual Meeting

On November 10, 2025 Rakovina Therapeutics Inc. ("Rakovina" or the "Company") (TSX-V: RKV)(FSE: 7JO0) a biopharmaceutical company advancing cancer therapies through AI-enabled drug discovery, reported that new data will be presented in two posters at the Society for Neuro-Oncology (SNO) Annual Meeting, taking place November 19–23, 2025, in Honolulu, Hawaii.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

The presentations will highlight Rakovina’s AI-driven programs to discover and develop next-generation DNA-damage response (DDR) inhibitors engineered for central nervous system (CNS) penetration, supporting the development of potential new treatment options for primary and metastatic brain cancers.

Presentation Details:

Title: Discovery and development of a novel CNS-penetrating ATR inhibitor
Session: Poster Session – DNA Repair (DNAR-05)
Date/Time: November 21, 2025 | 11:30 a.m.–12:45 p.m. (HST)

Title: Discovery and development of novel CNS-penetrating PARP1-selective inhibitors
Session: Poster Session – DNA Repair (DNAR-06)
Date/Time: November 21, 2025 | 11:30 a.m.–12:45 p.m. (HST)

The first poster presents results from Rakovina Therapeutics’ kt-5000AI ATR inhibitor program, developed in collaboration with Variational AI. The program leverages the ENKI generative AI platform to design and optimize CNS-penetrant ATR inhibitors with favorable pharmacologic properties for the potential treatment of brain cancers. The data highlight the discovery of potent, selective ATR inhibitors that demonstrate activity against treatment-resistant tumor phenotypes.

The second poster presents progress from the Company’s kt-2000AI PARP inhibitor program, developed using the Deep Docking AI-accelerated drug discovery platform. The program applies ultra-large-scale virtual screening to evaluate billions of compounds in silico, rapidly identifying and optimizing PARP1-selective, CNS-penetrant inhibitors with desirable pharmacologic properties. The data illustrate how this approach enables deep exploration of chemical space and efficient discovery of next-generation candidates designed to address the limitations of first-generation PARP inhibitors.

"The Society for Neuro-Oncology Annual Meeting is a premier global forum for advances in brain cancer research, and we’re proud to share our latest data at this year’s conference," said Prof. Mads Daugaard, President and Chief Scientific Officer of Rakovina Therapeutics. "Our participation reflects Rakovina’s ongoing efforts to develop first-in-class DNA-damage response inhibitors designed to reach the brain. By combining AI-accelerated medicinal chemistry with the world-class infrastructure at the University of British Columbia’s Vancouver Prostate Centre, we are advancing next-generation therapies targeting ATR and PARP1 pathways aimed at improving outcomes for patients with aggressive and treatment-resistant brain cancers."

(Press release, Rakovina Therapeutics, NOV 10, 2025, View Source;utm_medium=rss&utm_campaign=rakovina-therapeutics-to-present-new-data-highlighting-cns-penetrant-atr-and-parp1-inhibitors-at-the-2025-society-for-neuro-oncology-annual-meeting [SID1234659728])

Protara Therapeutics Announces Third Quarter 2025 Financial Results and Provides Business Update

On November 10, 2025 Protara Therapeutics, Inc. (Nasdaq: TARA) ("Protara" or the "Company"), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported financial results for the third quarter ended September 30, 2025, and provided a business update.

"We have made important advancements across our clinical programs this year, and with many significant milestones in the near future, we remain focused on disciplined execution across our pipeline of transformative therapies for patients with cancer and rare diseases," said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. "We continue to make progress in our ADVANCED-2 trial of TARA-002 in non-muscle invasive bladder cancer (NMIBC) and remain on track to report interim results from approximately 25 BCG-Unresponsive patients in the first quarter of 2026. With a favorable safety profile and its differentiated ease of administration, we believe TARA-002 has the potential to become a meaningful addition to the evolving NMIBC treatment landscape."

Mr. Shefferman added, "Across our rare disease pipeline, we expect to provide an interim update from our STARBORN-1 trial in pediatric patients with lymphatic malformations (LMs) and dose the first patient in our registrational THRIVE-3 trial of IV Choline Chloride in the fourth quarter of 2025."

Recent Progress and Highlights

TARA-002 in NMIBC

The Company anticipates reporting interim results from approximately 25 six-month evaluable NMIBC patients with carcinoma in situ or CIS (± Ta/T1) who are BCG-Unresponsive in the first quarter of 2026.
The Company expects to provide an update on ongoing discussions with the U.S. Food and Drug Administration (FDA) related to the BCG-Naïve opportunity in the fourth quarter of 2025.
Protara continues to evaluate subcutaneous dosing through priming and maintenance combined with intravesical dosing, as well as exploring combination treatments with TARA-002 in NMIBC patients with CIS.
IV Choline Chloride for Patients on Parenteral Support (PS)

The Company now expects to initiate dosing in THRIVE-3, a registrational Phase 3 clinical trial, by the end of 2025 due to administrative and funding challenges in academic sites in the U.S.
THRIVE-3 is a seamless Phase 2b/3 trial with a dose confirmation portion (n=24) followed by a double-blinded, randomized, placebo-controlled portion to assess the efficacy and safety of intravenous (IV) Choline Chloride over 24 weeks in adolescents and adults on long-term parenteral support (PS) when oral or enteral nutrition is not possible, insufficient, or contraindicated (n=105). IV Choline Chloride was previously granted Fast Track designation by the FDA.
TARA-002 in LMs

Protara continues to advance the Phase 2 STARBORN-1 trial of TARA-002 in pediatric patients with macrocystic and mixed cystic LMs, and the Company expects to provide an interim update from the trial in the fourth quarter of 2025. The Company previously announced the completion of the study’s first safety cohort, in which TARA-002 showed promising results and was generally well-tolerated.
Corporate Update

In November 2025, Protara was recognized among BioSpace’s Best Places to Work, which highlights organizations that excel in culture, career growth, leadership, and innovation.
Third Quarter 2025 Financial Results

As of September 30, 2025, unrestricted cash and cash equivalents and investments in marketable debt securities totaled $133.6 million. The Company expects its cash, cash equivalents, and investments in marketable debt securities will be sufficient to fund operations into mid-2027.
Research and development expenses for the third quarter of 2025 increased to $9.6 million from $8.1 million for the prior year period. The increase was primarily due to a $0.9 million increase in startup costs for our IV Choline Chloride THRIVE-3 clinical trial.
General and administrative expenses for the third quarter of 2025 increased to $5.2 million from $4.3 million for the prior year period. This increase was primarily due to an increase of $0.7 million in personnel-related expenses.
For the third quarter of 2025, Protara incurred a net loss of $13.3 million, or $0.31 per share, compared with a net loss of $11.2 million, or $0.50 per share, for the same period in 2024.
About TARA-002

TARA-002 is an investigational cell therapy in development for the treatment of NMIBC and of LMs, for which it has been granted Rare Pediatric Disease Designation by the U.S. Food and Drug Administration. TARA-002 was developed from the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK-432, a broad immunopotentiator marketed as Picibanil in Japan by Chugai Pharmaceutical Co., Ltd. Protara has successfully shown manufacturing comparability between TARA-002 and OK-432.

When TARA-002 is administered, it is hypothesized that innate and adaptive immune cells within the cyst or tumor are activated and produce a pro-inflammatory response with release of cytokines such as tumor necrosis factor (TNF)-alpha, interferon (IFN)-gamma IL-6, IL-10, IL-12. TARA-002 also directly kills tumor cells and triggers a host immune response by inducing immunogenic cell death, which further enhances the antitumor immune response.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

Bladder cancer is the 6th most common cancer in the United States, with NMIBC representing approximately 80% of bladder cancer diagnoses. Approximately 65,000 patients are diagnosed with NMIBC in the United States each year. NMIBC is cancer found in the tissue that lines the inner surface of the bladder that has not spread into the bladder muscle.

About Lymphatic Malformations (LMs)

LMs are rare, congenital malformations of lymphatic vessels resulting in the failure of these structures to connect or drain into the venous system. Most LMs are present in the head and neck region and are diagnosed in early childhood during the period of active lymphatic growth, with more than 50% detected at birth and 90% diagnosed before the age of three years. The most common morbidities and serious manifestations of the disease include compression of the upper aerodigestive tract, including airway obstruction requiring intubation and possible tracheostomy dependence; intralesional bleeding; impingement on critical structures, including nerves, vessels, lymphatics; recurrent infection, and cosmetic and other functional disabilities.

About IV Choline Chloride

IV Choline Chloride is an investigational, intravenous phospholipid substrate replacement therapy in development for patients receiving parenteral support (PS). Choline is a known important substrate for phospholipids that are critical for healthy liver function that also play an important role in modulating gene expression, cell membrane signaling, brain development and neurotransmission, muscle function, and bone health. PS patients are unable to synthesize choline from enteral nutrition sources, and there are currently no available PS formulations containing choline. Approximately 78% of patients dependent on PS are choline-deficient and of those approximately 63% have some degree of liver dysfunction, which can lead to hepatic failure. Every year in the U.S. there are approximately 90,000 people who require PS at home and of those approximately 30,000 are on long-term PS. IV Choline Chloride has the potential to become the first U.S. Food and Drug Administration (FDA) approved IV choline formulation for PS patients. It has been granted Orphan Drug Designation by the FDA for the prevention and/or treatment of choline deficiency in patients on long-term PN and has been granted Fast Track Designation as a source of choline when oral or enteral nutrition is not possible, insufficient, or contraindicated. The U.S. Patent and Trademark Office has issued Protara a U.S. patent claiming a choline composition and a U.S. patent claiming a method for treating choline deficiency with a choline composition, each with a term expiring in 2041.

(Press release, Protara Therapeutics, NOV 10, 2025, View Source [SID1234659727])

Propanc Biopharma, Inc. Secures up to $100 Million Private Placement to Support Digital Asset Acquisition Strategy & Accelerate Company’s R&D Pipeline

On November 10, 2025 Propanc Biopharma, Inc. (Nasdaq: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing new treatments for patients suffering from recurrent and metastatic cancer, reported that it has entered into a securities purchase agreement with Hexstone Capital LLC ("Hexstone"), a family office that has invested in a significant number of Digital Asset Treasury (DAT) companies across a range of digital assets including BTC, ETH, SOL, DOGE, ATH, OG, and INJ. The agreement is for a private placement of up to $100 Million in convertible preferred stock and will be deployed to support its digital asset acquisition strategy and accelerate the Company’s R&D pipeline, focusing on PRP entering a First-In-Human study second half of 2026. Upon closing, the Company received an initial investment of $1 million based on the issue of 100 shares of newly designated Series C Convertible Preferred Stock, each with a par value of $0.01 and an initial stated value of $10,000.

"We are entering a transformative phase for the Company as we work on building our digital asset base and strengthening our balance sheet, which will enable us to accelerate our unique proenzyme technology to clinical development and beyond," said James Nathanielsz, Propanc’s Chief Executive Officer. "Our business model will revolutionize the way we fund and grow our intellectual property portfolio, fast track our R&D processes and expand our development program so that we can target not only patients suffering from metastatic cancer from solid tumors, but several chronic diseases based upon the mechanism of action of proenzyme therapy. This is our vision. We look forward to updating you as we progress."

Additionally, Propanc will issue 9,900 Warrants to Hexstone, each entitling the purchase of one share of Preferred Stock at $10,000 per share, totaling up to $99 million in potential funding. The Warrants are exercisable, immediately, and will remain valid for 12 months. Subject to equity conditions and beneficial ownership limits, the Company may call up to 500 Warrants per calendar month at $0.01 each, allowing the exercise of up to $5 million in Preferred Stock per month—less any Warrants already exercised by Hexstone during that period.

Further details can be found in the Company’s Form 8-K filed with the SEC and accessible at www.sec.gov.

(Press release, Propanc, NOV 10, 2025, View Source [SID1234659726])

Precision BioSciences Announces $75 Million Offering of Common Stock, Pre-Funded Warrants and Warrants

On November 10, 2025 Precision BioSciences, Inc. (Nasdaq: DTIL) ("Precision"), a clinical stage gene editing company utilizing its novel proprietary ARCUS platform to develop in vivo gene editing therapies for high unmet need diseases, reported that it has agreed to sell by way of an underwritten offering 10,815,000 shares of its common stock and accompanying warrants to purchase up to 5,407,500 shares of common stock at a combined price of $6.14 and, in lieu of common stock to certain investors, pre-funded warrants to purchase up to 1,400,000 shares of its common stock and accompanying one-half of a warrant to purchase up to 700,000 shares of common stock at a combined price of $6.139995, which represents the per share offering price for the shares of common stock less the $0.000005 per share exercise price for each pre-funded warrant. The gross proceeds to Precision from the offering, before deducting the underwriting discounts and commissions and offering expenses, are expected to be approximately $75 million. Each whole warrant has an exercise price of $7.25 per share, is exercisable immediately and will expire five years following the date of issuance. The deal includes participation from new and existing investors, including Aberdeen Investments, Bleichroeder LP, Driehaus Capital Management, Empery Asset Management LP, Lynx1 Capital Management, Octagon Capital, Readout Capital, Sphera Funds Management, Stonepine Capital Management, as well as other leading life sciences investors.

The offering is expected to close on or about November 12, 2025, subject to customary closing conditions. All shares of common stock, pre-funded warrants and accompanying one-half of a warrant to purchase shares of common stock to be sold in the offering will be sold by Precision. Precision intends to use the net proceeds of the offering to help fund ongoing and planned research and development, and for working capital and general corporate purposes.

Guggenheim Securities is acting as sole book-running manager for the offering.

The securities described above were offered by means of a prospectus supplement dated November 10, 2025, and accompanying prospectus dated June 15, 2023, forming part of Precision’s effective shelf registration statement (File No. 333-272540). The prospectus supplement and accompanying prospectus relating to this offering will be filed with the U.S. Securities and Exchange Commission (the "SEC") and will be available on the SEC’s website located at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus may also be obtained, when available, by contacting: Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, the securities in this offering 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.

(Press release, Precision Biosciences, NOV 10, 2025, View Source [SID1234659725])

PDS Biotechnology Announces Translational Data Showing Strong Immunological and Clinical Activity of PDS0101 and PDS01ADC Presented at SITC 2025

On November 10, 2025 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported positive clinical and translational data presented at the 2025 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. The presentations highlight immune-driven mechanisms and biomarkers that explain strong clinical activity of the Company’s investigational HPV16-targeted immunotherapy PDS0101 and its novel, investigational immunocytokine PDS01ADC.

The studies were performed as part of PDS Biotech’s collaborative research and development agreement (CRADA) with the National Cancer Institute (NCI) Center for Cancer Research (CCR). Presentations at SITC (Free SITC Whitepaper) 2025 included one rapid oral abstract, recognized among the top 150 abstracts of the meeting, and two poster presentations.

"The data presented at SITC (Free SITC Whitepaper) further validate the scientific underpinnings of our immunotherapy platforms and confirm that our development approach is achieving the intended immunological and clinical effects," said Frank Bedu-Addo, Ph.D., President and Chief Executive Officer of PDS Biotech. "These findings provide a deeper understanding of how our immunotherapies are generating such promising results in advanced cancers. The ability to measure and model these immune effects enhances confidence in our programs and supports our regulatory strategy to advance these novel, investigational immunotherapies toward commercialization as efficiently as possible for patients with difficult-to-treat cancers."

PDS0101) Data Highlights

Rapid Oral Abstract Presentation Number: 37
Title: Baseline and early changes in serum proteomic profiles predict anti-tumor activity in patients with advanced HPV-associated malignancies treated with novel combination immunotherapy
Authors: Megan Lynch, Meghali Goswami, Charalampos Floudas, Julius Strauss, Yo-Ting Tsai, Jennifer Marte, James Gulley, Jeffrey Schlom, Renee Donahue
Recognition: Selected among the Top 150 abstracts at SITC (Free SITC Whitepaper) 2025

Key findings:

•
Analysis of 50 patients with advanced HPV16-positive cancers treated with the combination of PDS0101, PDS01ADC and an immune checkpoint inhibitor showed strong and broad immune activation, with increases in multiple critical pro-inflammatory cytokines that are essential in recruiting T cells and enhancing their potency.

•
Quantitative measurements of various immunological proteins in the blood were found to predict clinical benefit with good accuracy.

•
The data supports continued evaluation of these biomarkers obtained by blood sampling, and prospective validation of the developed predictive models in future clinical trials.

These translational findings further reinforce the strong clinical activity seen with PDS0101 combinations across three phase 2 trials. By establishing a clear link between specific immune signatures and clinical response, the data provide strong rationale for future biomarker-guided optimization of PDS0101-based immunotherapy combinations.

PDS01ADC (IL-12 tumor-targeting immunocytokine) Data Highlights

Abstract Number: 47
Title: A tumor-targeting IL-12 immunocytokine therapy in patients with advanced solid tumors increases peripheral natural killer (NK) cells with phenotypes associated with increased tumor cell lysis
Authors: Stephanie Pitts, Nicole Toney, Jennifer Marte, James Gulley, Jeffrey Schlom, Renee Donahue

Key findings:

•
PDS01ADC monotherapy promoted generation of multi-functional NK cells that were associated with induction of a clinical response in advanced treatment-resistant patients with solid tumors.

•
Specific types of NK cells associated with effective killing were seen to increase in advanced cancer patients with solid tumors upon treatment with PDS01ADC, and the increases were associated with an improved clinical response.

•
Several types of NK cells associated with poor anti-tumor response were seen to decrease with PDS01ADC therapy, and these decreases were associated with an improved clinical response.

Collectively, these results demonstrate immune reprogramming of NK cells toward killer phenotypes upon treatment with PDS01ADC and provide mechanistic support for PDS01ADC-based combination immunotherapy strategies.

Abstract Number: 168
Title: Increases in peripheral memory T cells with self-renewing properties in patients with advanced solid tumors treated with tumor-targeting IL-12 immunocytokine therapy
Authors: Meghali Goswami, Carolina Celades, Christine Minnar, Asma Khelifa, Lisa Poppe, Dara Bracken-Clarke, Nicole Toney, Megan Lynch, Jennifer Marte, Sofia Gameiro, James Gulley, Jeffrey Schlom, Renee Donahue

Key findings:

•
PDS01ADC monotherapy increased the quantity of stem-like memory, CD8 (killer) and CD4 (helper) T cells that had self-replicating properties in patients with advanced solid tumors

•
In 28 patients with advanced solid tumors, increases in stem-like T cells was associated with stabilization of disease
These translational findings show that PDS01ADC promotes specific types of self-replicating T cells that enhance the durability of anti-tumor immunity.

"The immune signatures we observed with both PDS0101 and PDS01ADC deepen our understanding of how these therapies generate a powerful anti-tumor immune response. We are seeing broad immune activation, including early natural killer cell responses and expansion of durable, stem-like memory T cells, features that are critical for long-term tumor control," said Kirk Shepard, M.D., Chief Medical Officer of PDS Biotech. "The translational data presented at SITC (Free SITC Whitepaper), including early immune biomarker signatures, HPV ctDNA dynamics, and coordinated NK and T cell activation validate our platforms scientifically. These insights will also help us design future studies and combination approaches that fully leverage each therapy’s unique mechanism of action."

Building on these findings, PDS Biotech continues to advance the development of PDS0101 and PDS01ADC. The company is developing PDS0101 in combination with Keytruda (pembrolizumab) in a phase 3 clinical trial of HPV16-positive recurrent/metastatic head and neck cancer. In parallel, PDS Biotech is advancing PDS01ADC via NCI-led Phase 2 clinical trials under PDS Biotech’s CRADA with the NCI in metastatic colorectal cancer, cholangiocarcinoma, biochemically recurrent prostate cancer, and castration resistant and castration sensitive prostate cancer. Collectively, these data presented at SITC (Free SITC Whitepaper) 2025 strengthen the scientific foundation of the Company’s immunotherapy platforms and support continued progress toward future regulatory and clinical milestones.

(Press release, PDS Biotechnology, NOV 10, 2025, View Source [SID1234659723])