NeOnc Showcases Two Brain Cancer Drug Programs at SNO as FDA Meetings Approach

On November 13, 2026 NeOnc Technologies Holdings (NASDAQ: NTHI) reported an important clinical-development milestone as it presents updated findings from two investigational brain cancer programs at the 31st Annual Meeting of the Society for Neuro-Oncology (SNO) in Philadelphia. The presentations put the company’s intranasal NEO100 and oral NEO212 programs in focus, with additional clinical evidence arriving as NeOnc prepares for important FDA discussions and continues to attract substantial insider buying.

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The first presentation, abstract CTNI-26, titled Durable Radiographic Remission and Prolonged Survival with Intranasal NEO100 in Recurrent WHO Grade III/IV IDH1-Mutant Astrocytoma, provides updated Phase 1/2a and compassionate-use experience. Presented by Chief Medical Officer Thomas C. Chen, MD, PhD, the findings are particularly important because they build on previously reported survival and progression-free survival results in a difficult-to-treat patient population.

In August, NeOnc reported that its Phase 2a study achieved six-month progression-free survival of 48.9%, versus a prespecified historical benchmark of 20% (p=0.0047). Median overall survival was 26.1 months, with estimated survival of 86.7% at six months, 61.5% at 12 months and 54.7% at 24 months. The efficacy population included 24 patients, 21 with grade 4 and three with grade 3 IDH1-mutant astrocytoma. Five patients remained on treatment at the interim database lock.

The company reported no treatment-related Grade 3 or higher adverse events, treatment-related serious adverse events or discontinuations due to treatment-related adverse events. These results provide the clinical foundation for NeOnc’s effort to advance NEO100 toward a potential accelerated approval pathway.

The compassionate-use component provides an additional dimension. In October, NeOnc reported that a critically ill three-year-old boy receiving investigational NEO100 in Abu Dhabi began breathing independently without ventilator support and moving his legs, according to his treating physicians.

The second presentation, abstract CTNI-27, examines oral NEO212 in temozolomide-resistant recurrent glioblastoma and brain metastases. Its focus is Phase 1 safety, pharmacokinetics and early activity.

NEO212 combines temozolomide with perillyl alcohol in an oral formulation intended to improve drug delivery to the brain and address temozolomide resistance. NeOnc reports that Phase 1 dose escalation is complete, with no observed myelosuppression. The company also disclosed two objective responses: one in recurrent glioblastoma and another in a patient with lung-cancer brain metastasis. Both patients reportedly remained on treatment for more than 20 months.

These observations are particularly interesting given the hematologic toxicity associated with conventional temozolomide. NEO212 now represents a second potential clinical opportunity, distinct from NEO100’s intranasal delivery strategy.

NeOnc’s regulatory calendar is becoming increasingly important. The FDA granted a Type B End-of-Phase meeting scheduled for early January 2027 to discuss NEO100’s potential accelerated approval pathway, a proposed randomized Phase 3 trial and the adequacy of its nonclinical safety package. The proposed NEO100-012 study would compare intranasal NEO100 with investigator’s-choice chemotherapy, using overall survival as its primary endpoint.

NEO212 has its own upcoming regulatory milestone: an End-of-Phase 1 Type B FDA meeting scheduled for November 23. NeOnc intends to discuss patient populations, dosing, endpoints and a proposed randomized Phase 2 design covering brain metastases, IDH1-mutant astrocytoma and recurrent IDH1-wildtype glioblastoma.

The clinical developments coincide with continued insider buying. CEO Amir Heshmatpour reported approximately $333,100 in additional open-market purchases across 80,000 shares acquired November 9–11. His directly held position increased to 3,333,000 shares. Chief Medical Officer Chen also purchased 5,016 shares through his IRA for approximately $20,000. The latest activity brings reported 2026 insider purchases to approximately 341,000 shares.

Other factors adding to investor interest include four analyst Buy ratings, with reported price targets ranging from $13 to $20, and short interest exceeding 920,000 shares as of October 30, according to the market data.

International expansion is another developing opportunity. An October memorandum of understanding with the Department of Health – Abu Dhabi establishes a framework for CNS oncology research, clinical collaboration, training and real-world evidence, building on previously granted investigational authorizations for NEO100 and NEO212.

For investors, today’s SNO presentations matter because they bring two distinct clinical programs into the spotlight at the same time. The next tests are whether the updated NEO100 findings strengthen the case for further development, whether NEO212’s early safety and activity observations translate into controlled clinical evidence, and how the FDA responds to both development strategies.

(Press release, Neonc, NOV 13, 2026, View Source [SID1234674770])

Silexion Therapeutics Reports Third Quarter 2026 Financial Results and Provides Business Update

On November 13, 2026 Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers, reported financial results for the three-month and nine-month periods ended September 30, 2026, and provided a business update.

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Ilan Hadar, Chairman and Chief Executive Officer of Silexion, commented: "In the third quarter, we began treating patients with SIL204 in our Phase 2/3 trial in pancreatic cancer. After opening our first clinical site at Tel Aviv Sourasky Medical Center in July, we dosed the first patient at the end of September. At the same time, our laboratory work continued to strengthen the case for SIL204, with new data suggesting it may help the immune system recognize cancer cells, and showing that it uses natural carriers in the blood to enter cancer cells. Our focus now is on enrolling the first group of patients and bringing more hospitals in Israel and Germany into the trial."

Mirit Horenshtein Hadar, Chief Financial Officer of Silexion, added: "During the third quarter, we completed a public offering and a warrant inducement transaction and continued sales under our at-the-market facility, increasing our cash and cash equivalents to $4.8 million and shareholders’ equity to approximately $3.0 million as of September 30, 2026. This financial progress strengthens our balance sheet and supports the continued advancement of SIL204 as we enroll patients in the Phase 2/3 trial."

Recent Milestones & Business Highlights

First Patient Dosed in Phase 2/3 Clinical Trial of SIL204: On July 29, 2026, Silexion initiated its Phase 2/3 clinical trial of SIL204 in locally advanced pancreatic cancer ("LAPC") at Tel Aviv Sourasky Medical Center ("TASMC" or "Ichilov"), and on September 30, 2026, announced that the first patient worldwide had been dosed at TASMC. The prospective, randomized, controlled, multinational, open-label Phase 2/3 study is evaluating SIL204 in combination with standard-of-care chemotherapy, versus chemotherapy alone, in newly diagnosed, treatment-naïve patients with unresectable Stage 3 LAPC whose tumors harbor a confirmed KRAS mutation. SIL204 is administered via a dual-route regimen combining direct EUS-guided intratumoral delivery to the primary tumor with subcutaneous injections designed to provide systemic exposure. The study is structured as an initial safety run-in cohort of approximately 18 patients, followed by expansion into a randomized cohort of approximately 166 patients.

Clinical Site Expansion in Israel and Germany: In Israel, following the approval of the Israeli Ministry of Health, TASMC was activated as the trial’s first clinical site in July 2026, and the first patient was dosed there on September 30, 2026. Additional Israeli oncology centers, alongside leading academic medical institutions in Germany, are progressing through site activation and are expected to join the trial in the coming months.

Expanded Translational Profile of SIL204: In August 2026, Silexion reported preclinical findings showing statistically significant upregulation of FAS (CD95), an immune "death receptor," and downregulation of HLA-G, an established immune checkpoint, in human KRAS-mutant pancreatic and non-small cell lung cancer cell lines. Together with the MHC-I upregulation reported in May 2026, the findings support a coordinated immune-sensitization signature across three immune pathways and four KRAS mutations (G12D, G12V, G12C and G12R), reinforcing the scientific rationale for combining SIL204 with anti-PD-(L)1 checkpoint inhibitor therapies. In September 2026, the Company reported that SIL204 uses naturally circulating lipoproteins to enter cancer cells and silence mutant KRAS without synthetic transfection reagents or artificial carriers, supporting the systemic administration of SIL204. Pharmacokinetic, cellular uptake kinetics and biodistribution studies are ongoing.

Financing Activities: During the third quarter, Silexion completed a registered public offering in August 2026 with gross proceeds of approximately $2.5 million and a warrant inducement transaction in September 2026 with gross proceeds of approximately $0.84 million, and continued sales of ordinary shares under its at-the-market facility for gross proceeds of approximately $1.9 million. Subsequent to quarter end, on November 10, 2026, the Company effected a 1-for-24 reverse share split.

Financial Results for the Three Months Ended September 30, 2026

Research and development ("R&D") expenses for the three months ended September 30, 2026, were approximately $1.3 million, compared to approximately $2.2 million for the three months ended September 30, 2025, a decrease of 40.9%.

General and administrative ("G&A") expenses for the three months ended September 30, 2026, were approximately $1.4 million, compared to approximately $1.1 million for the three months ended September 30, 2025, an increase of 27.3%.

Net loss for the three months ended September 30, 2026, was approximately $2.5 million, compared to approximately $3.3 million for the three months ended September 30, 2025, a decrease of 24.2%.

Financial Results for the Nine Months Ended September 30, 2026

R&D expenses for the nine months ended September 30, 2026, were approximately $4.9 million, compared to approximately $3.8 million for the nine months ended September 30, 2025, an increase of 28.9%. The increase related to the operational ramp-up for the Phase 2/3 clinical trial of SIL204.

G&A expenses for the nine months ended September 30, 2026, were approximately $4.2 million, compared to approximately $3.5 million for the nine months ended September 30, 2025, an increase of 20.0%.

Net loss for the nine months ended September 30, 2026, was approximately $8.8 million, compared to approximately $7.5 million for the nine months ended September 30, 2025, an increase of 17.3%. The increase was mainly due to higher R&D expenses related to the Phase 2/3 clinical trial of SIL204.

Balance Sheet Highlights

As of September 30, 2026, Silexion had cash and cash equivalents of $4.8 million, compared to $6.0 million as of December 31, 2025, and $2.2 million as of June 30, 2026.
Total shareholders’ equity was $3.0 million as of September 30, 2026, compared to $2.6 million as of December 31, 2025.

(Press release, Silexion Therapeutics, NOV 13, 2026, View Source [SID1234674769])

Calidi Biotherapeutics Reports Third Quarter 2026 Financial Results and Recent Business Highlights

On November 13, 2026 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported financial and operating results for the three months ended September 30, 2026, and reviewed recent business highlights.

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"Throughout the third quarter, Calidi continued to advance its RedTail platform for systemic and local delivery and redefine the potential of oncolytic viruses and genetic medicine," said Eric Poma, Ph.D., Calidi Biotherapeutics CEO. "In particular, CLD-401 demonstrated remarkable anti-tumor activity with systemic administration in syngeneic tumor models and continues to progress towards the clinic."

Third Quarter 2026 and Recent Business Developments

Presented two posters at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026 on October 24, 2026. The presentations showcased new data from the Company’s RedTail platform, a systemically delivered virotherapy platform engineered to selectively target tumors, remodel the tumor microenvironment, and enable high-level expression of therapeutic genetic payloads directly within tumors.
Preclinical data on Calidi’s lead program, CLD-401, showed complete tumor eradication in 80% of EMT6 breast cancer tumor-bearing mice versus 0% in the control arm. CLD-401 was engineered for systemic delivery, and new data from an MB49 bladder cancer model show it retains antitumor activity with either systemic intravenous or localized intratumoral administration, supporting flexible delivery approaches across tumor accessibility and disease settings.
Presented preclinical data from Calidi’s in situ T-cell engager ("TCE") platform, including CLD-501, its TROP-2-targeted candidate, and CLD-502, its EpCAM-targeted candidate. Following intravenous delivery, the platform generated approximately 10 ng/mL of EpCAM-targeted TCE directly within tumors, and both targeted TCEs demonstrated antigen-dependent, does-responsive T-cell mediated cytotoxicity.
Received $1.2 million gross proceeds from an at-the-market registered direct offering that closed on September 18, 2026.
Reduced general and administrative expenses by $1.0 million, or 39%, in the third quarter of 2026 versus the same period in the prior year. Reduced general and administrative expenses by $3.6 million, or 42%, in the nine months ended September 30, 2026, versus the same period in the prior year. On November 6, 2026, Calidi executed a restructuring plan, predominantly through a reduction in headcount, that is expected to save $3 million on an annualized basis to extend the Company’s cash runway to reduce costs, extend the Company’s operating runway, and preserve capital while pursuing additional financing.
Third Quarter 2026 Financial Results

Calidi reported a $3.6 million net loss attributable to common stockholders for the third quarter of 2026, compared to a net loss attributable to common stockholders of $10.8 million for the third quarter of 2025, which included a $5.7 million non-cash charge for a deemed dividend on warrants. There was no such charge during the third quarter of 2026.

Research and development expenses were $2.7 million for the third quarter of 2026, compared to $2.4 million for the same quarter in 2025.

General and administrative expenses were $1.6 million for the third quarter of 2026, compared to $2.7 million for the same quarter in 2025.

The Company had $3.9 million in cash and $0.2 million in restricted cash as of September 30, 2026, compared with $5.6 million in cash and $0.2 million in restricted cash as of December 31. 2025.

(Press release, Calidi Biotherapeutics, NOV 13, 2026, View Source [SID1234674768])

Inhibrx Reports Third Quarter 2026 Financial Results

On November 13, 2026 Inhibrx Biosciences, Inc. (Nasdaq: INBX) (Inhibrx or the Company) reported financial results for the third quarter of 2026. The biopharmaceutical company has two programs in ongoing clinical trials.

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Upcoming Clinical Milestones

Ozekibart (INBRX-109) in Ewing sarcoma. The Company plans to present updated results from the Phase 1/2 study evaluating ozekibart (INBRX-109) in combination with irinotecan and temozolomide in refractory Ewing sarcoma at the annual Connective Tissue Oncology Society (CTOS) meeting in Seoul, South Korea from November 19th-20th, 2026.
Ozekibart (INBRX-109) in Chondrosarcoma. Commercial readiness activities advancing in line with the regulatory review timeline for ozekibart in chondrosarcoma.
Ordastobart (INBRX-106) in HNSCC. The Company is currently enrolling the Phase 2 portion of the randomized HexAgon study in head and neck squamous cell carcinoma (HNSCC) in combination with pembrolizumab, which is expected to add approximately 50 additional HPV-positive Oropharyngeal Squamous Cell Carcinoma patients to support a potential accelerated regulatory pathway. The expansion of the HexAgon program is strategically focused on the HPV-positive setting. Inhibrx believes this positioning allows ordastobart (INBRX-106) to maximize its costimulatory activity where immune responsiveness and clinical benefit have proven highest. Following the Phase 2 expansion, the initial read out of which is expected around mid-2027, the Company plans to align with the FDA on this framework and anticipates initiating the Phase 3 portion of the HexAgon trial, which is intended to serve as the confirmatory study.
Ordastobart (INBRX-106) in NSCLC. The Company expects initial results from its Phase 1/2 study of ordastobart (INBRX-106) in the perioperative setting of non-small cell lung cancer (NSCLC) in mid-2027. This readout is expected to provide important clinical insights to inform future development, demonstrating the potential for ordastobart (INBRX-106) to extend well beyond head and neck cancer into broader solid tumor indications.
Financial Results

Cash and Cash Equivalents. As of September 30, 2026, the Company had cash and cash equivalents of $199.5 million.
Revenue. Inhibrx recognized $2.0 million of revenue during the third quarter of 2026 under a license agreement with Pfizer, Inc., in which the Company granted a non-exclusive license for certain of the Company’s patent rights in exchange for a $2.0 million upfront payment which was received in September 2026. The Company did not recognize any revenue during the third quarter of 2025.
R&D Expense. Research and development expenses were $26.0 million for the third quarter of 2026, as compared to $28.5 million for the third quarter of 2025. This decrease was primarily related to a decrease in clinical trial costs due to the timing of the completion of enrollment in our trial for ozekibart (INBRX-109) for the treatment of unresectable or metastatic conventional chondrosarcoma and a decrease in personnel expenses due to a decrease in headcount, offset in part by an increase in contract manufacturing expenses as the Company performs certain manufacturing activities to supports its filing of the Biologics License Application (BLA) for the potential approval of ozekibart (INBRX-109) in conventional chondrosarcoma.
G&A Expense. General and administrative expenses were $7.8 million during the third quarter of 2026, compared to $5.3 million during the third quarter of 2025. This increase is primarily related to additional pre-commercialization expenses related to market access, launch and the development of communication materials as the Company prepares for its potential commercialization of ozekibart (INBRX-109) in conventional chondrosarcoma.
Other Expense. Total other expense was $7.0 million during the third quarter of 2026, compared to $1.4 million during the third quarter of 2025. The increase is primarily due to higher interest expense on the Company’s $275.0 million outstanding loan balance during the third quarter of 2026 as compared to $100.0 million outstanding during the third quarter of 2025.
Net Loss. Net loss was $38.7 million during the third quarter of 2026, or $2.46 per share, basic and diluted, as compared to a net loss of $35.3 million during the third quarter of 2025, or $2.28 per share, basic and diluted.

(Press release, Inhibrx, NOV 13, 2026, View Source [SID1234674767])

Tempest Reports Third Quarter 2026 Financial Results and Provides Business Update

On November 13, 2026 Tempest Therapeutics, Inc. (Nasdaq: TPST) ("Tempest"), a clinical-stage biotechnology company developing a pipeline of advanced in vivo chimeric antigen receptor T-cell ("CAR-T") product candidates to treat cancer and autoimmune disease, reported financial results for the quarter ended September 30, 2026, and provided a business update.

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"The third quarter marked a period of meaningful progress in the advancement of two next-generation in vivo CAR-T platforms with the potential to transform treatment across multiple diseases," said Matt Angel, Ph.D., president and chief executive officer of Tempest. "We made important strides in expanding our pipeline and strengthening our position in the rapidly evolving in vivo CAR-T landscape through our strategic collaboration with Senlang by obtaining exclusive license rights to our clinical-stage BCMA/GPRC5D in vivo CAR-T candidate TPST-4903, while securing access to additional capital to support our development priorities. We also welcomed two accomplished independent directors to our Board, bringing valuable corporate governance and capital markets expertise as we navigate our next phase of growth. Together, these achievements reinforce our commitment to advancing our pipeline, executing on our strategic priorities and unlocking the broad therapeutic potential of in vivo CAR-T therapies for patients."

Recent Highlights

TPST-4903
Exercised option under agreement with Hebei Senlang Biotechnology Co., Ltd. to obtain an exclusive license to develop and commercialize Senlang’s CD7-targeted lentiviral vector platform and associated in vivo CAR-T candidates worldwide, excluding China.
The lead program, TPST-4903, is a BCMA/GPRC5D dual-targeting in vivo CAR-T candidate being evaluated in a Phase 1 dose-escalation study in patients with relapsed or refractory multiple myeloma (rrMM). The initial data demonstrating encouraging preliminary clinical responses are expected to be presented at an upcoming scientific conference.

TPST-4003

Unveiled next-generation in vivo CAR-T pipeline, including lead product candidate TPST-4003, a dual-targeting CD19/BCMA in vivo CAR-T candidate that combines the Company’s proprietary CD7-targeted mRNA/LNP delivery with its clinically validated dual-target CAR architecture for broad B-cell lineage depletion and reset.
Executed a strategic partnership in July 2026 with Hebei Senlang Biotechnology to collaborate on the development of certain of Tempest’s proprietary in vivo CAR-T product candidates, including the Company’s next-generation CD7-targeted TPST-4003. An investigator-initiated trial in China evaluating TPST-4003 in approximately 10 patients with myasthenia gravis or multiple sclerosis is expected to begin in the fourth quarter of 2026.

Corporate:

Completed a private placement in September 2026 of pre-funded warrants and Series C and D warrants for gross proceeds of approximately $2.5 million (approximately $1.8 million net of placement agent fees and offering expenses), excluding up to approximately $5.0 million of gross proceeds that may be received upon the cash exercise of the Series C and D warrants.
Entered into a purchase agreement with Lincoln Park Capital Fund, LLC on August 13, 2026 that gives Tempest the right, but not the obligation, to sell up to $25.0 million of its common stock, increasing to $50.0 million if the initial amount is sold, over a 24-month period that began September 1, 2026.Through September 30, 2026, Tempest sold 350,000 shares to Lincoln Park for gross proceeds of approximately $0.3 million.
Strengthened Board of Directors with the appointments of independent directors, Nancy Freda-Smith and John W. Frederick boosting corporate governance and capital markets expertise.
Financial Results

Third Quarter 2026

Tempest ended the quarter with $0.9 million in cash and cash equivalents, compared to $7.7 million on December 31, 2025. The decrease was primarily due to cash used in operations, including one-time transaction-associated costs incurred prior to or upon closing of the Asset Acquisition in February 2026, offset by the net proceeds from the Company’s private placement of common stock and warrants in March 2026 of $1.7 million, the warrant inducement in May 2026 of $1.7 million, sales of common stock under the Lincoln Park equity line of credit of $0.3 million and the Company’s private placement in September 2026 of $1.8 million. The Company’s existing cash and cash equivalents are expected to fund its projected operating expense requirements for less than 12 months from the date the financial statements were available to be issued, and there is substantial doubt about the Company’s ability to continue as a going concern.
Net loss and net loss per share for the quarter were $3.6 million and $0.21, respectively, compared to $3.5 million and $0.79, respectively, for the three months ended September 30, 2025.
Research and development expenses for the quarter were $0.2 million compared to $0.6 million for the three months ended September 30, 2025. The $0.4 million decrease was primarily due to a decrease in costs incurred as a result of the portfolio re-prioritization after the Asset Acquisition in February 2026, offset by research and manufacturing costs related to the Company’s CAR-T product candidates.
General and administrative expenses for the quarter were $2.6 million compared to $3.0 million for the same period in 2025. The $0.4 million decrease was primarily due to a decrease in one-time separation and other costs incurred in the third quarter of 2025, offset by other administrative expenses.
Financing costs related to the Lincoln Park equity line of credit for the quarter were $0.8 million, consisting of $0.66 million for the fair value of the commitment shares issued to Lincoln Park and $0.15 million of issuance costs, net of a nominal gain on shares sold to Lincoln Park. There were no financing costs in the three months ended September 30, 2025.

Nine Months Ended September 30, 2026

Cash used in operating activities for the nine months ended September 30, 2026 was $12.4 million.
Net loss and net loss per share for the nine months ended September 30, 2026 were $36.6 million and $2.54, respectively, compared to $22.2 million and $5.71, respectively, for the same period in 2025.
Research and development expenses for the nine months ended September 30, 2026 were $2.1 million, compared to $12.1 million for the same period in 2025. The $9.9 million decrease was primarily due to a decrease in costs incurred as a result of re-prioritizing efforts towards exploring strategic alternatives initiated in April 2025 and resulting in the Asset Acquisition completed in February 2026.
General and administrative expenses for the nine months ended September 30, 2026 were $11.5 million, compared to $10.4 million for the same period in 2025. The $1.0 million increase was primarily due to one-time costs resulting from the Asset Acquisition completed in February 2026.
Acquired in-process research and development expenses for the nine months ended September 30, 2026 were $22.2 million compared to nil for the nine months ended September 30, 2025. Costs incurred prior to or upon closing the Asset Acquisition in the prior three months ended March 31, 2026 were expensed as acquired in-process research and development.
Financing costs related to the Lincoln Park equity line of credit for the nine months ended September 30, 2026 were $0.8 million, all of which were recognized in the third quarter of 2026. There were no financing costs in the nine months ended September 30, 2025.

(Press release, Tempest Therapeutics, NOV 13, 2026, View Source [SID1234674766])