On November 10, 2025 Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (Nasdaq: TERN), a clinical-stage oncology company, reported financial results for the third quarter ended September 30, 2025, and provided corporate updates.

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"We’re thrilled with the positive momentum of the CARDINAL program generated by the unprecedented Phase 1 MMR achievement rate and encouraging safety/tolerability profile published in the recent ASH (Free ASH Whitepaper) abstract. These data continue to reinforce our view of the potential of TERN-701 to become a best-in-disease treatment for patients with chronic myeloid leukemia (CML)," said Amy Burroughs, chief executive officer of Terns Pharmaceuticals. "Our team continues to execute with precision and focus towards an updated and expanded CARDINAL readout at ASH (Free ASH Whitepaper), with an ultimate goal of bringing this important new therapy to CML patients."

Recent Pipeline Developments and Anticipated Milestones

TERN-701: Novel investigational allosteric BCR::ABL1 inhibitor for chronic myeloid leukemia (CML)

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In November 2025, Terns announced that an abstract with updated data from the ongoing Phase 1 CARDINAL trial evaluating TERN-701 in patients with relapsed/refractory CML had been selected for oral presentation at the 67th ASH (Free ASH Whitepaper) Annual Meeting and Exposition
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The abstract reported data from the ongoing dose escalation and dose expansion parts of the CARDINAL trial. Highlights include from the abstract include:
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Overall (cumulative) major molecular response (MMR) rate of 75% by 24 weeks, with 64% achieving MMR and 100% maintaining MMR
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Overall (cumulative) MMR by 24 weeks in difficult to treat patient subgroups
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69% in patients with lack of efficacy to last tyrosine kinase inhibitor (TKI)
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60% in patients who had prior asciminib
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67% in patients with prior asciminib / ponatinib / investigational TKI
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No patients had lost MMR at the time of data cutoff
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Encouraging safety and tolerability profile at all doses evaluated
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A more expansive and updated dataset from the CARDINAL trial will be presented at the ASH (Free ASH Whitepaper) Annual Meeting:
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Session Name: 632. Chronic Myeloid Leukemia: Clinical and Epidemiological: Therapeutic agents to enhance patient outcomes
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Session Date: December 8, 2025
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Session Time: 2:45 – 4:15pm ET
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Presentation Time: 2:45 – 3:00pm ET
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The Company will host a conference call to review the data on December 8, 2025 at 4:30pm ET. The event can be accessed live on the investor relations section of Terns’ website, where it will also be archived

TERN-601: Oral, small-molecule glucagon-like peptide-1 receptor agonist (GLP1-RA) for obesity

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In October 2025, Terns announced top-line 12-week data from the Phase 2 study of TERN-601 for the treatment of obesity, which showed maximum placebo-adjusted weight loss of 4.6% with 12% treatment discontinuation due to adverse events
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Asymptomatic, reversible grade 3 liver enzyme elevations occurred in three participants during post-treatment follow-up period, two of which were deemed drug related
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The results of the Phase 2 study did not support the Company’s further development of TERN-601 in obesity
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Terns had previously announced its decision to no longer invest in metabolic disease

Pipeline and Partnering Programs

"As we continue to sharpen our strategic focus in oncology, earlier this year we decided we would discontinue internal clinical development of our metabolic programs. While these metabolic assets have shown promise, we believe their full potential can best be realized through external partnerships," noted Andrew Gengos, chief financial officer of Terns.

TERN-501: Oral, thyroid hormone receptor-beta (THR-β) agonist

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Based on non-clinical studies, THR-β is a complementary mechanism to GLP-1, potentially providing broader metabolic and liver benefits in addition to increased weight loss
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Terns is seeking a strategic partner to advance this program

TERN-801: Oral, small-molecule glucose-dependent insulinotropic polypeptide receptor (GIPR) antagonist

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In the third quarter of 2025, Terns nominated TERN-801, an oral small-molecule GIPR antagonist as a development candidate from the TERN-800 series discovery effort
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Terns is seeking a strategic partner to advance this program

Third Quarter 2025 Financial Results

Cash Position: As of September 30, 2025, cash, cash equivalents and marketable securities were $295.6 million, as compared with $358.2 million as of December 31, 2024. Based on its current operating plan, Terns expects these funds will be sufficient to support its planned operating expenses into 2028.

Research and Development (R&D) Expenses: R&D expenses were $19.9 million for the quarter ended September 30, 2025, as compared with $15.2 million for the quarter ended September 30, 2024.

General and Administrative (G&A) Expenses: G&A expenses were $7.8 million for the quarter ended September 30, 2025, as compared with $9.8 million for the quarter ended September 30, 2024.

Net Loss: Net loss was $24.6 million for the quarter ended September 30, 2025, as compared with $21.9 million for the quarter ended September 30, 2024.

(Press release, Terns Pharmaceuticals, NOV 10, 2025, View Source [SID1234659729])

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.

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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])

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.

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"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])

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])

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.

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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])