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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.

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"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:

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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.

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

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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:

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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.

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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.

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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:

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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

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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])

Olema Oncology Reports Third Quarter 2025 Financial and Operating Results

On November 10, 2025 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, reported financial and operating results for the third quarter ended September 30, 2025.

"We have made significant progress advancing our programs this quarter, highlighted by the initiation of the Phase 3 OPERA-02 trial evaluating palazestrant in combination with ribociclib in the frontline setting and the presentation of compelling data at ESMO (Free ESMO Whitepaper) that further positions palazestrant to become a potential best-in-class backbone endocrine therapy for ER+/HER2- metastatic breast cancer," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "Our clinical trial agreement with Pfizer to combine palazestrant with atirmociclib further underscores our confidence in palazestrant’s activity in combination with other agents in the metastatic setting."

Bohen continued, "Enrollment in the OPERA-01 trial evaluating palazestrant as a monotherapy in second- and third-line ER+/HER2- metastatic breast cancer continues to progress well and we remain on track for top-line data in the second half of next year. The Phase 1/2 study of our KAT6 inhibitor, OP-3136, recently expanded into combinations with fulvestrant and palazestrant and continues to benefit from strong investigator interest. As we look ahead to 2026, we remain focused on sustaining positive momentum across the business, transforming the breast cancer treatment paradigm, and bringing palazestrant to market."

Recent Progress

Announced a clinical trial collaboration and supply agreement with Pfizer to evaluate the safety and combinability of palazestrant plus atirmociclib, Pfizer’s investigational, highly selective-CDK4 inhibitor, in a Phase 1b/2 study in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) metastatic breast cancer.
Initiated the OPERA-02 Phase 3 trial of palazestrant in combination with ribociclib in frontline ER+/HER2- metastatic breast cancer.
Presented updated data from the Phase 1b/2 study of palazestrant plus ribociclib at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, demonstrating encouraging activity in both ESR1 mutant and wild-type patients.
Continued enrollment in the OPERA-01 Phase 3 trial of palazestrant as a monotherapy in second- and third-line ER+/HER2- metastatic breast cancer.
Advanced the Phase 1 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of OP-3136, as a monotherapy and in combination with fulvestrant and palazestrant, in participants with advanced solid tumors.

Anticipated Upcoming Events

Initiate the Phase 1b/2 study evaluating palazestrant with atirmociclib in ER+/HER2- metastatic breast cancer in Q4 2025.
Present trial-in-progress poster entitled "OPERA-02: a phase 3 randomized, double-blind, active-controlled study of palazestrant with ribociclib versus letrozole with ribociclib for the first-line treatment of ER+, HER2- advanced breast cancer" at the San Antonio Breast Cancer Symposium (SABCS) in December 2025.
Report initial clinical results for OP-3136 in mid-2026.
Report top-line data from OPERA-01 in the second half of 2026.

Third Quarter 2025 Financial Results
Cash, cash equivalents, and marketable securities of $329.0 million as of September 30, 2025.

Net loss for the quarter ended September 30, 2025 was $42.2 million, as compared to $34.6 million for the quarter ended September 30, 2024. The increase in net loss for the third quarter was primarily related to increased spending on research and development activities as a result of the ongoing late-stage clinical trials for palazestrant and the advancement of OP-3136, partially offset by higher interest income earned from marketable securities.

GAAP research and development (R&D) expenses were $40.0 million for the quarter ended September 30, 2025, as compared to $33.2 million for the quarter ended September 30, 2024. The increase in R&D expenses was primarily related to increased spending on clinical development-related activities as Olema continues to advance palazestrant through late-stage clinical trials, and the advancement of OP-3136, partially offset by decreases in stock-based compensation expense of $1.7 million.

Non-GAAP R&D expenses were $37.4 million for the quarter ended September 30, 2025, excluding $2.6 million non-cash stock-based compensation expense. Non-GAAP R&D expenses were $28.9 million for the quarter ended September 30, 2024, which excluded $4.3 million non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

GAAP general and administrative (G&A) expenses were $5.9 million for the quarter ended September 30, 2025, as compared to $4.4 million for the quarter ended September 30, 2024. The increase in G&A expenses was primarily due to corporate-related costs, including increases in stock-based compensation expense of $0.3 million.

Non-GAAP G&A expenses were $4.3 million for the quarter ended September 30, 2025, excluding $1.7 million non-cash stock-based compensation expense. Non-GAAP G&A expenses were $3.0 million for the quarter ended September 30, 2024, excluding $1.3 million non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

(Press release, Olema Oncology, NOV 10, 2025, View Source [SID1234659722])

Nkarta Reports Third Quarter 2025 Financial Results and Corporate Highlights

On November 10, 2025 Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biotechnology company developing engineered natural killer (NK) cell therapies to treat autoimmune diseases, reported financial results for the third quarter ended September 30, 2025.

"This quarter marks an important milestone for Nkarta as we advance the NKX019 clinical program to treat autoimmune diseases," said Paul J. Hastings, Chief Executive Officer of Nkarta. "Following productive engagement with the FDA, we streamlined enrollment across our Ntrust-1 and Ntrust-2 clinical trials under a combined iDSMB, which has authorized initiation of the second dose-escalation cohort. This unified approach, combined with the ability to dose multiple patients simultaneously at each dose level and the removal of a patient-by-patient stagger, strengthens the efficiency of our trial enrollment and underscores the consistency of NKX019’s emerging safety profile.

"With the modification of our lymphodepletion regimen to include both fludarabine and cyclophosphamide prior to treatment with NKX019, we are now seeing complete B-cell depletion in all patients treated to date, compared with partial B-cell depletion observed with patients receiving cyclophosphamide alone. Now that our study design modifications have been cleared by the FDA and institutional review boards, we’re enrolling patients with the new regimen at the higher dose.

"We plan to present data with our investigators at a medical conference in 2026. In the interim, we remain focused on disciplined clinical execution. With a strong balance sheet projected to fund operations into 2029, we are now poised to meaningfully advance our clinical program in this challenging capital environment."

NKX019 Clinical Program Progress and Upcoming Milestones

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Following engagement with the U.S. Food and Drug Administration, the patient-by-patient stagger was eliminated, accelerating the ability to dose escalate
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Protocol amendments now allow for simultaneous dosing of multiple participants in parallel within each dose cohort.
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Ntrust-1 and Ntrust-2 enrollment process was streamlined to permit data from both studies to be utilized by a combined, iDSMB to inform dose escalation decisions.
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After unanimous clearance from the combined iDSMB, enrollment has begun in the second dose-escalation cohort.
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NKX019 clinical programs in autoimmune diseases continue to enroll patients. This includes Ntrust-1, Ntrust-2, and two investigator-sponsored trials.
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Preliminary data from the Ntrust-1 and Ntrust-2 clinical trials are expected to be presented at a medical conference in 2026.

Third Quarter 2025 and Recent Financial Highlights

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Nkarta had cash, cash equivalents, restricted cash, and investments in marketable securities of $316.5 million as of September 30, 2025.
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Research and development (R&D) expenses were $20.2 million for the third quarter of 2025. Non-cash stock-based compensation expense included in R&D expense was $0.5 million for the third quarter of 2025.
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General and administrative (G&A) expenses were $7.1 million for the third quarter of 2025. Non-cash stock-based compensation expense included in G&A expense was $1.2 million for the third quarter of 2025.
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Net loss was $21.7 million, or $0.29 per basic and diluted share, for the third quarter of 2025. This net loss includes non-cash charges of $3.5 million that consisted primarily of share-based compensation, right-of-use asset impairment and depreciation expenses.

Financial Guidance

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Nkarta expects its current cash and cash equivalents will be sufficient to fund its current operating plan into 2029.

About the Ntrust℠ Clinical Trials in Autoimmune Disease

Ntrust-1 (NCT06557265) and Ntrust-2 (NCT06733935) are multi-center, open label, dose escalation clinical trials that build on academic studies of durable, drug-free remissions in patients with autoimmune disease after CD19-targeted cell therapy. Both trials will assess the safety of NKX019 in people living with autoimmune diseases as well as its ability to enable durable remissions via a "reset" of the immune system through the elimination of pathogenic B cells.

The Ntrust trials are enrolling up to 12 patients per dose level per disease indication across lupus nephritis, primary membranous nephropathy, systemic sclerosis, idiopathic inflammatory myopathy, and ANCA-associated vasculitis.

In both studies, patients now receive a three-dose cycle of NKX019 on Days 0, 3, and 7 following lymphodepletion with fludarabine and cyclophosphamide or cyclophosphamide alone, if they have significant cytopenia at baseline. Leveraging the engineering of NKX019, no patients in either trial will receive supplemental cytokines or antibody-based therapeutics. This approach is designed to evaluate the single-agent activity of NKX019 and facilitate a more rapid path to regulatory approval. Patients in Ntrust-1 may also receive additional cycles, if necessary, to restore response or enable a deeper response.

About the Investigator-Sponsored Clinical Trial of NKX019 for Generalized Myasthenia Gravis
The single-arm, open-label Phase 1 investigator-sponsored clinical trial is designed to enroll patients with generalized myasthenia gravis and will evaluate safety and clinical outcomes. Translational and biomarker studies, including autoantibodies, cytokine profiles and pharmacokinetics are planned. Patients receive 3 doses of NKX019 following lymphodepletion. The clinical trial is being co-led by Ali A. Habib, M.D., Clinical Professor of Neurology at the University of California, Irvine, and other investigators.

About the Investigator-Sponsored Clinical Trial of NKX019 for Systemic Lupus Erythematosus

The single-center, single-arm, open-label Phase 1 investigator-sponsored clinical trial (NCT06518668) is designed to enroll up to 6 patients with systemic lupus erythematosus, regardless of renal involvement, and will evaluate safety and clinical outcomes in a potentially different population than Ntrust-1. Translational and biomarker studies, including autoantibodies, cytokine profiles and pharmacokinetics are planned. Patients receive 3 doses of NKX019 following lymphodepletion. The clinical trial is being led by Anca D. Askanase, M.D., M.P.H., Director, Lupus Center at Columbia University Irving Medical Center and the Director of Rheumatology Clinical Trials.

About NKX019

NKX019 is an allogeneic, cryopreserved, off-the-shelf immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy adult donors. It is engineered with a humanized CD19-directed chimeric antigen receptor (CAR) for enhanced cell targeting and a proprietary, membrane-bound form of interleukin-15 (IL-15) for greater persistence and activity without exogenous cytokine support. CD19 is a biomarker for normal B cells as well as those implicated in autoimmune disease. Nkarta is evaluating NKX019 in multiple autoimmune conditions.

(Press release, Nkarta, NOV 10, 2025, View Source [SID1234659721])