On November 5, 2026 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported financial results and business highlights for the third quarter 2026.

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"We continue to make meaningful progress toward initiating clinical studies of SC451 later this year and SG293 in 1Q 2027," said Steve Harr, Sana’s President and Chief Executive Officer. "We aim to share data from both of these programs in 2027 and anticipate both have the potential for relatively rapid proof of concept. In particular, SC451 in type 1 diabetes may provide a rapid signal, similar to what was seen with UP421, on whether the therapy can evade immune detection and function in patients."

Corporate Highlights

Continued progress toward beginning clinical trials for SC451 and SG293

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SC451, an O-negative, hypoimmune (HIP)-modified, iPSC-derived pancreatic islet cell therapy which uses the same HIP gene modifications as UP421, is being developed as a one-time treatment for patients with type 1 diabetes with a goal of long-term normal blood glucose without the need for any insulin therapy or immunosuppression. Sana expects to file an investigational new drug application (IND) and begin a Phase 1/2 clinical trial for SC451 as early as this year.
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SG293 is a CD8-targeted fusosome that delivers the genetic material to make CD19-directed CAR T cells. SG293 has been designed to minimize potential toxicities related to in vivo CAR T cells, including peri-infusion reactions and off-target delivery to tissues such as the liver. Preclinical data presented at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2026 Annual Meeting demonstrate that a SG293 surrogate, which is active in non-human primates, achieves cell-specific delivery and deep B cell depletion – as measured by depletion in circulating and lymph node B cells as well as a phenotypic reset when B cells return – in non-human primates without the use of any lymphodepleting chemotherapy. Sana has the potential to share first-in-human data for SG293 in non-Hodgkin lymphoma as early as the first half of 2027. If successful, the company intends to expand clinical development into B cell-mediated autoimmune diseases as well.

Shared updated, positive results from an investigator-sponsored, first-in-human study transplanting UP421, an allogeneic primary islet cell therapy engineered with HIP technology, into a patient with type 1 diabetes without the use of any immunosuppression.

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UP421 is a primary human HIP-modified pancreatic islet cell therapy for patients with type 1 diabetes. The goal of this investigator-sponsored trial (IST) is to understand safety, immune evasion, islet cell survival, and beta cell function, as measured by C-peptide production, of HIP-modified pancreatic islet cells transplanted into a type 1 diabetes patient without the use of any immunosuppression. The trial is being conducted under a clinical trial authorization at Uppsala University Hospital with Dr. Per-Ola Carlsson as the principal investigator.

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Results of the study through 14 months after cell transplantation demonstrated the survival and function of pancreatic beta cells in a patient as measured by the presence of circulating C-peptide, a biomarker indicating that transplanted beta cells are producing insulin. C-peptide levels also increased with mixed meal tolerance tests (MMTT) performed over the course of the study, consistent with insulin secretion in response to a meal. Fasting and MMTT-stimulated C-peptide levels at month 14 were comparable to those observed in the first six months of the study. PET-MRI scanning performed at week 12 and again at week 52 demonstrated islet cells at the transplant site in the forearm. The study has identified no safety issues, and the HIP-modified islet cells have evaded immune detection.
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Announced that The New England Journal of Medicine published a peer-reviewed Letter to the Editor titled "Long-Term Survival of Hypoimmune Allogeneic Islets without Immunosuppression" (DOI: 10.1056/NEJMc2604408), which discusses 14-month results from this study.
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14-month data from the study were presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2026.

Advanced strategic collaboration with Mayo Clinic for the development of SC451, a HIP-modified, induced pluripotent stem cell (iPSC)-derived pancreatic islet cell therapy for type 1 diabetes.

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The purpose of the collaboration is to draw on Mayo Clinic’s multidisciplinary expertise to accelerate the development, validation, and standardization of protocols and processes for SC451, supporting safe, scalable, and consistent delivery across diverse clinical environments.

Advanced preclinical pipeline

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SG227, a CD8-targeted fusosome that delivers the genetic material to make BCMA-directed CAR T cells, is being developed as a potential treatment for patients with multiple myeloma. SG227 delivers a BCMA CAR that has been validated in the autologous CAR T setting for patients with multiple myeloma in a product that is currently approved in China. Sana is preparing to begin clinical testing as early as 2027, contingent upon the early clinical profile of SG293.

Third Quarter 2026 Financial Results

GAAP Results

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Cash Position: Cash, cash equivalents, and marketable securities as of September 30, 2026 were $121.7 million compared to $138.4 million as of December 31, 2025. The decrease of $16.7 million was primarily due to cash used in operations of $108.9 million and cash used for the purchase of property and equipment of $2.7 million, partially offset by net proceeds from equity financings of $93.3 million.
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Research and Development Expenses: For the three and nine months ended September 30, 2026, research and development expenses, inclusive of non-cash expenses, were $33.9 million and $93.4 million, respectively, compared to $30.1 million and $97.1 million for the same periods in 2025. The $3.8 million increase for the three months ended September 30, 2026 compared to the same period in 2025 was primarily due to higher third-party manufacturing costs at contract development and manufacturing organizations (CDMOs) for our SC451 and SG293 programs and higher laboratory costs related to our SC451 program. These increases were partially offset by third-party manufacturing costs at CDMOs and clinical trial costs associated with the suspended allogeneic CAR T programs incurred in the prior-year period that did not recur in 2026. The $3.7 million decrease for the nine months ended September 30, 2026 compared to the same period in 2025 was primarily due to lower personnel-related expenses, including non-cash stock-based compensation, lower facility and other allocated costs, and third-party manufacturing costs at CDMOs associated with the suspended allogeneic CAR T programs incurred in the prior-year period that did not recur in 2026. These decreases were partially offset by higher laboratory costs related to our SC451 program and higher third-party manufacturing costs at CDMOs for our SC451 and SG293 programs. Research and development expenses include non-cash stock-based compensation of $3.0 million and $9.3 million for the three and nine months ended September 30, 2026, respectively, compared to $3.2 million and $12.0 million for the same periods in 2025.

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Research and Development Related Success Payments and Contingent Consideration: For the three and nine months ended September 30, 2026, Sana recognized non-cash gains of $63.4 million and $31.0 million, respectively, compared to non-cash expenses of $3.1 million and $15.3 million for the same periods in 2025, related to changes in the estimated fair value of the success payment liabilities and contingent consideration in aggregate. Of the gains recognized during the three and nine months ended September 30, 2026, $55.5 million and $28.4 million, respectively, related to changes in the estimated fair value of the Cobalt contingent consideration (Cobalt Contingent Consideration), primarily reflecting the impact of the August 2026 amendment to the Cobalt acquisition agreement. The fair value of these potential liabilities may fluctuate significantly based on changes in the timing and probability of achieving specified development milestones, the estimated amount, timing, and probability of potential payments to Sana from business development transactions involving the fusogen technology, and Sana’s market capitalization and stock price.
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General and Administrative Expenses: General and administrative expenses for the three and nine months ended September 30, 2026, inclusive of non-cash expenses, were $10.9 million and $33.2 million, respectively, compared to $10.3 million and $32.1 million for the same periods in 2025. The increases for each of the three and nine months ended September 30, 2026 compared to the same periods in 2025 were primarily due to higher facility and other allocated costs. General and administrative expenses include non-cash stock-based compensation of $2.3 million and $7.0 million for the three and nine months ended September 30, 2026, respectively, compared to $2.3 million and $7.1 million for the same periods in 2025.
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Impairment of Long-Lived Assets: For the nine months ended September 30, 2025, non-cash impairment of long-lived assets was $44.6 million. There was no impairment of long-lived assets for the three and nine months ended September 30, 2026. The non-cash impairment in 2025 was primarily related to Sana’s manufacturing facility in Bothell, Washington and certain laboratory and office space in Seattle, Washington. In the second quarter of 2025, because of increased availability of manufacturing capacity at third-party CDMOs for cell and gene therapy products, together with progress in understanding our near-term manufacturing needs, we determined that CDMOs could meet our manufacturing requirements. Accordingly, we suspended further build-out of our internal manufacturing capabilities and continue to rely on CDMOs to meet our manufacturing needs at present.
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Net Income (Loss): Net income for the three months ended September 30, 2026 was $20.4 million, or $0.07 per share, and net loss for the nine months ended September 30, 2026 was $90.4 million, or $0.31 per share, compared to net losses of $42.2 million, or $0.16 per share, and $185.3 million, or $0.75 per share, for the same periods in 2025.

(Press release, Sana Biotechnology, NOV 5, 2026, View Source [SID1234674327])

On November 5, 2026 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, reported financial results for the third quarter ended September 30, 2026, including sales of TAVALISSE (fostamatinib disodium hexahydrate), REZLIDHIA (olutasidenib), GAVRETO (pralsetinib) and VEPPANU (vepdegestrant).

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"VEPPANU’s launch marks an exciting and transformational milestone for Rigel and we are very pleased with the initial uptake. In the first six weeks of launch we shipped VEPPANU to more than 100 patients and clinics and have already seen many refills," said Raul Rodriguez, Rigel’s president and CEO. "Our priorities are to build on the VEPPANU launch and advance R289 in lower-risk MDS, with updated Phase 1b data to be presented at ASH (Free ASH Whitepaper) in December. We believe VEPPANU and R289 have significant commercial potential to further transform Rigel and drive long-term shareholder value."

Third Quarter 2026 Business Update

Commercial

Third quarter net product sales were $72.3 million, an increase of 13% from the same period of 2025.
Year-to-date net product sales were $194.2 million, an increase of 17% from the same period of 2025.
Rigel announced that VEPPANU (vepdegestrant) became commercially available in the U.S. on August 13, 2026, generating $6.6 million in net product sales in the third quarter. VEPPANU is the first and only PRoteolysis TArgeting Chimera (PROTAC) approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer (mBC), as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.
Rigel’s partner Knight Therapeutics Inc. (Knight) received regulatory approval from Colombia’s Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) in September for TAVALISSE for the treatment of adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response, loss of response, or intolerance to prior treatment with corticosteroids and intravenous immunoglobulin.
Knight announced it commercially launched TAVALISSE in Brazil in October.
Clinical Development

Rigel continues to advance its Phase 1b clinical study of R2891, a potent and selective dual inhibitor of interleukin receptor-associated kinases 1 and 4 (IRAK1/4), in patients with relapsed or refractory (R/R) lower-risk myelodysplastic syndrome (MDS) and the company expects to complete enrollment and select the recommended Phase 2 dose for future development by the end of 2026.
Rigel announced that data from the ongoing Phase 1b study of R289 in patients with lower-risk MDS, including initial efficacy data from the dose expansion phase of the study, will be presented in an oral session at the 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in December. In addition, three poster presentations will include data for fostamatinib in patients with immune thrombocytopenia (ITP) and warm autoimmune hemolytic anemia (wAIHA).
The European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026 featured data from the ARROW and TAPISTRY clinical trials of pralsetinib in patients with rearranged during transfection (RET) fusion-positive solid tumors in a rapid oral session. In addition, two poster presentations and an ePoster included clinical and health-related quality of life (HR-QoL) data from the TAPISTRY clinical trial in patients with RET fusion-positive thyroid cancer and ARROW trial in patients with RET fusion-positive non-small cell lung cancer (NSCLC).
At the 2026 American Thyroid Association (ATA) Annual Meeting, HR-QOL among patients with medullary thyroid cancer and RET fusion-positive thyroid cancer from the ARROW clinical trial of pralsetinib was presented in an oral session, demonstrating that treatment with pralsetinib resulted in clinically meaningful improvements in several measures of HR-QoL for patients, including diarrhea, a common symptom of patients with medullary thyroid cancer and RET fusion-positive thyroid cancer. In addition, data from the ARROW and TAPISTRY clinical trials of pralsetinib in patients with RET fusion-positive thyroid cancer showed robust and durable clinical activity, with an overall response rate of 83.7% and a median progression-free survival of 30.3 months. The safety profile was consistent with previous experience and monitoring for infections is warranted.
Third Quarter and Year-to-Date 2026 Financial Update

For the third quarter ended September 30, 2026, total revenues were $80.9 million, consisting of $72.3 million in net product sales and $8.6 million in contract revenues from collaborations. Net product sales increased 13% compared to $64.1 million in the same period of 2025. TAVALISSE net product sales were $46.0 million, an increase of 3% compared to $44.7 million in the same period of 2025. REZLIDHIA net product sales were $9.9 million, an increase of 20% compared to $8.3 million in the same period of 2025. GAVRETO net product sales were $9.8 million, a decrease of 11% compared to $11.1 million in the same period of 2025. VEPPANU became commercially available from Rigel in August 2026 and generated initial net product sales of $6.6 million. Contract revenues from collaborations primarily consisted of $3.8 million from Grifols S.A. (Grifols) related to earned royalties and delivery of drug supplies, $3.2 million from Kissei Pharmaceutical Co., Ltd. (Kissei) related to delivery of drug supplies, and $0.3 million from Medison Pharma (Medison) and a total of $1.3 million from other parties related to earned royalties and delivery of drug supplies.

Total costs and expenses were $63.8 million, compared to $41.0 million for the same period of 2025. The increase in costs and expenses was primarily driven by higher research and development costs related to the R289 and vepdegestrant clinical programs, cost of product sales, commercial-related expenses due to the commercial launch of vepdegestrant, and personnel-related costs.

Income before income taxes was $17.4 million, compared to $27.6 million for the same period of 2025.

Rigel reported net income of $13.2 million, or $0.70 basic and $0.65 diluted per share, compared to $27.9 million, or $1.55 basic and $1.46 diluted per share, for the same period of 2025.

For the nine months ended September 30, 2026, total revenues were $218.4 million, consisting of $194.2 million in net product sales and $24.2 million in contract revenues from collaborations. Net product sales increased 17% compared to $166.6 million in the same period of 2025. TAVALISSE net product sales were $130.6 million, an increase of 15% compared to $113.3 million in the same period of 2025. GAVRETO net product sales were $30.1 million, a decrease of 6% compared to $31.9 million in the same period of 2025. REZLIDHIA net product sales were $26.9 million, an increase of 25% compared to $21.4 million in the same period of 2025. VEPPANU became commercially available from Rigel in August 2026, and net product sales were $6.6 million. Contract revenues from collaborations primarily consisted of $10.8 million from Kissei, including a $4.0 million regulatory milestone and delivery of drug supplies; $10.5 million from Grifols related to earned royalties and delivery of drug supplies; and $0.9 million from Medison and a total of $2.0 million from other parties related to earned royalties and delivery of drug supplies. Contract revenues from collaborations in the prior year period included $40.0 million in non-cash revenue resulting from the release of the remaining cost share liability from Rigel’s collaboration agreement with Eli Lilly and Company (Lilly) and a $3.0 million regulatory milestone in connection with the approval of TAVALISSE in the Republic of Korea.

Total costs and expenses were $165.8 million, compared to $122.2 million for the same period of 2025. The increase in costs and expenses was primarily driven by higher research and development costs related to the R289 and vepdegestrant clinical programs, cost of product sales, personnel-related costs and commercial-related expenses due to the commercial launch of vepdegestrant.

Income before income taxes was $52.7 million, compared to $99.1 million for the same period of 2025.

Rigel reported net income of $39.1 million, or $2.11 basic and $1.97 diluted per share, compared to $99.0 million, or $5.52 basic and $5.38 diluted per share, for the same period of 2025. As noted above, the prior year period included $40.0 million in non-cash revenue related to Rigel’s collaboration agreement with Lilly.

Cash, cash equivalents and short-term investments as of September 30, 2026 was $99.3 million, compared to $155.0 million as of December 31, 2025.

2026 Outlook

Rigel has updated its 2026 total revenues guidance to approximately $290 to $295 million, from the previous range of approximately $285 to $295 million, which includes:

Net product sales of approximately $255 to $260 million, from the previous range of approximately $255 to $265 million.
Contract revenues of approximately $35 million, from the previous guidance of approximately $30 million.
The above revenue guidance excludes VEPPANU.

The company also continues to anticipate it will report positive net income for the full year 2026, while funding existing and new clinical development programs.

Conference Call and Webcast with Slides Today at 4:30 p.m. Eastern Time
Rigel will hold a live conference call and webcast today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time).

Participants can access the live conference call by dialing (877) 407-3088 (domestic) or (201) 389-0927 (international). The conference call will also be webcast live and will be accessible from the Investor Relations section of the company’s website at www.rigel.com. The webcast will be archived and available for replay after the call via the Rigel website.

About ITP
In patients with immune thrombocytopenia (ITP), the immune system attacks and destroys the body’s own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. Patients suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs), and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

About AML

Acute myeloid leukemia (AML) is a rapidly progressing cancer of the blood and bone marrow that affects myeloid cells, which normally develop into various types of mature blood cells. AML occurs primarily in adults and accounts for about 1 percent of all adult cancers. The American Cancer Society estimates that there will be about 22,720 new cases in the United States, most in adults, in 2026.2

Relapsed AML affects about half of all patients who, following treatment and remission, experience a return of leukemia cells in the bone marrow.3,4 Refractory AML, which affects between 10 and 40 percent of newly diagnosed patients, occurs when a patient fails to achieve remission even after intensive treatment.5 Quality of life declines for patients with each successive line of treatment for AML, and well-tolerated treatments in relapsed or refractory disease remain an unmet need.

About NSCLC

It is estimated that over 229,000 adults in the U.S. will be diagnosed with lung cancer in 2026. Lung cancer is the leading cause of cancer death in the U.S., with non-small cell lung cancer (NSCLC) being the most common type accounting for 77% of all lung cancer diagnoses.6 RET fusions are implicated in approximately 1-2% of patients with NSCLC.7

About ER+/HER2-, ESR1-mutated Metastatic Breast Cancer
Breast cancer is the most common cancer in women in the United States, except for skin cancers.8 The estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER+/HER2-) patient population represents the majority (70%) of breast cancer, where treatment with endocrine therapies (aromatase inhibitors) is the standard of care. While endocrine therapy remains a cornerstone of metastatic ER+/HER2- breast cancer treatment, up to 50% of patients treated with endocrine therapy and a CDK4/6 inhibitor acquire estrogen receptor 1 gene (ESR1) mutations, resulting in endocrine resistance and poor prognosis. Treatment options in second-line and later ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer setting include chemotherapy, selective estrogen receptor degraders (SERDs), and as of May 2026, vepdegestrant, the first and only FDA-approved oral PROteolysis TArgeting Chimera (PROTAC).

About TAVALISSE
TAVALISSE (fostamatinib disodium hexahydrate) is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

Please click here for Important Safety Information and Full Prescribing Information for TAVALISSE.

About REZLIDHIA
REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

Please click here for Important Safety Information and Full Prescribing Information, including Boxed WARNING, for REZLIDHIA.

About GAVRETO
GAVRETO is indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test and adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).*

*Thyroid indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Please click here for Important Safety Information and Full Prescribing Information, including Boxed WARNING, for GAVRETO.

About VEPPANU
VEPPANU is indicated for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.

Please click here for Important Safety Information and Full Prescribing Information for VEPPANU.

To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

TAVALISSE, GAVRETO and REZLIDHIA are registered trademarks and VEPPANU is a trademark of Rigel Pharmaceuticals, Inc.

(Press release, Rigel, NOV 5, 2026, View Source [SID1234674326])

On November 5, 2026 Rezolute, Inc. (Nasdaq: RZLT) (Rezolute or the Company), a late-stage ultra-rare, metabolic disease company focused on treating refractory hypoglycemia caused by any form of hyperinsulinism (HI), reported financial results and provided a business update for the first quarter ended September 30, 2026.

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Tumor HI

· upLIFT, a Phase 3, single-arm, open label study in up to 16 hospitalized participants for the treatment of tumor HI, is ongoing.
· Enrollment is complete and topline results are expected by mid-December 2026.
· Earlier this year, the Company announced that 7 of the 8 participants enrolled in the first half of the study met the responder criterion for the study’s primary endpoint.
· Each of these participants also achieved complete discontinuation of intravenous glucose with the administration of ersodetug.
· Ersodetug has been well-tolerated in the study thus far, with no drug-related safety findings reported.
· The eighth participant in the first half of the study discontinued study drug shortly after enrollment in favor of pursuing hospice care at home, where they died one week later due to cancer progression. The Company considers this participant as a non-responder, for purposes of the primary endpoint.

Congenital HI

· In October 2026, the Company provided an update that the U.S. Food and Drug Administration (FDA or the Agency) has reviewed additional study data provided by the Company at the Agency’s request.
· The Agency recommended the Company file for review under a Biologics License Agreement (BLA) for congenital HI after holding a pre-BLA meeting.
· As previously reported, sunRIZE, a Phase 3, multicenter, double-blind, randomized, placebo-controlled safety and efficacy study of ersodetug for the treatment of congenital HI, demonstrated glycemic improvements, but did not meet the primary endpoint because the reductions in hypoglycemia events by finger-stick self-monitored blood glucose (SMBG) were not statistically significant compared to placebo. However, consistent and clinically relevant improvements in hypoglycemia were observed across multiple CGM-based hypoglycemia endpoints in both treatment arms.
· The open-label extension (OLE) phase of the sunRIZE study is ongoing, with a high participation rate and several indicators of improved glycemic control, including a notable reduction in the use of background standard of care therapies.

Business Update

· On October 29, 2026, the Company participated in a virtual Q&A as part of Guggenheim’s Healthcare Spotlight Series. The discussion focused on commercial outlook and launch strategy for ersodetug. Key highlights include:

· Potential $5 billion combined market opportunity.
· Plan to submit a BLA for ersodetug for one or potentially both indications in 2027.

First Quarter Fiscal 2027 Financial Results

Cash, cash equivalents and investments in marketable securities were $90.0 million as of September 30, 2026, compared with $107.8 million as of June 30, 2026.

Research and development (R&D) expenses were $12.8 million for the first quarter of fiscal 2027, compared with $13.1 million for the same period a year ago. The decrease was primarily due to decreased manufacturing costs for ersodetug and patient affairs costs, partially offset by increased employee-related stock-based compensation expense. R&D expenses include $1.5 million of share-based compensation expense for the first quarter of fiscal 2027, compared with $1.2 million for the same period a year ago.

General and administrative (G&A) expenses were $6.6 million for the first quarter of fiscal 2027, compared with $6.7 million for the same period a year ago. The decrease was primarily attributable to a decrease in professional fees, partially offset by increased employee-related stock-based compensation expense. G&A expenses include $1.8 million of share-based compensation expense for the first quarter of fiscal 2027, compared with $1.4 million for the same period a year ago.

Net loss was $18.5 million for the first quarter of fiscal 2027 compared with a net loss of $18.2 million for the same period a year ago.

About Ersodetug

Ersodetug is a fully human monoclonal antibody that binds allosterically to the insulin receptor to decrease receptor over-activation by insulin and related substances (such as IGF-2) in the setting of hyperinsulinism (HI), thereby improving hypoglycemia. Because ersodetug acts downstream from pancreatic insulin or paraneoplastic IGF-2 secretion, and from entero-incretin pathways, it has the potential to be universally effective at treating refractory hypoglycemia due to any form of hyperinsulinism (HI), including congenital HI, tumor HI (insulinoma, non-islet cell tumors) or bariatric/non-bariatric gastrointestinal surgery hypoglycemia. Ersodetug for the treatment of HI is investigational. Statements about safety and efficacy have not been approved by any health authority.

(Press release, Rezolute, NOV 5, 2026, View Source [SID1234674325])

On November 5, 2026 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life sciences company commercializing RenovoCath, a patented, FDA-cleared drug-delivery device, and evaluating a novel targeted oncology drug-device product candidate, reported its financial results for the third quarter ended September 30, 2026 and provided shareholders with a business update highlighting continued commercial momentum and clinical progress.

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"We generated record results in the third quarter as revenue exceeded the million-dollar threshold and we continued to deliver on all three of our core priorities," said Shaun Bagai, Chief Executive Officer of RenovoRx. "First, revenue increased four-fold year-over-year. Second, we ended the quarter with 26 active commercial cancer center customers, compared to 21 at the end of the second quarter 2026. Third, we are seeing physician-driven expansion of our TAMP platform, enabled by our FDA-cleared RenovoCath device, into applications beyond locally advanced pancreatic cancer, highlighting the potential for broader clinical adoption."

Mr. Bagai continued, "Driving much of our growth is our fully staffed sales team that continues to gain traction and accelerate customer engagement and adoption of TAMP. The sales team, comprised of a Vice President of Sales and Market Development, and five Regional Market Development Managers, is strategically deployed to cover major U.S. cancer centers. Our focused and regionally deployed sales team is sufficiently sized to address the market and effectively penetrate cancer centers that treat solid tumors, such as pancreatic cancer."

Mr. Bagai concluded, "Looking ahead, given the strong momentum, we continue to expect full-year 2026 revenue for RenovoCath in the range of $3.75 million to $4.25 million, which would more than triple 2025 revenue at the midpoint."

RenovoCath Commercialization Update

Every newly activated commercial cancer center customer drives more procedures and revenue, accelerating growth. RenovoRx ended the third quarter of 2026 with 26 active commercial cancer center customers, compared to 21 at the end of the second quarter of 2026. RenovoRx remains confident in its ability to meet the year-end 2026 target of 36 active commercial cancer centers as RenovoRx continues to activate centers in the commercial funnel and convert sites from its fully enrolled Phase III TIGeR-PaC trial to active centers.

RenovoRx continues to observe strong repeat ordering from the majority of existing customers, which the Company believes signals physician satisfaction and clinical utility in interventional oncology.

The Trans-Arterial Micro-Perfusion (TAMP), enabled by RenovoCath, is a collaborative, localized drug-delivery platform, with two ways emerging cancer therapies can strengthen the Company’s commercial opportunity: (i) TAMP can deliver established drugs locally, and sequentially to or concurrently with novel therapies, creating the potential for improved patient outcomes, concentrating therapy where it is needed, and (ii) as new drugs come to market, the Company believes many of these drugs can be delivered directly via RenovoCath. In both cases, the Company believes that novel improved therapies could make the TAMP targeted drug-delivery platform even more valuable.

In light of these trends, the Company believes that as physicians incorporate RenovoCath into routine clinical practice, repeat utilization is expected to drive sustained revenue growth.

Expansion of RenovoCath Beyond Locally Advanced Pancreatic Cancer

In the third quarter of 2026, RenovoRx continued to support building the evidence base for TAMP through a multi-center post-marketing registry study to generate real-world safety and efficacy data, as well as supporting Investigator Initiated Trials (IITs) in borderline resectable and metastatic pancreatic cancer and cholangiocarcinoma (bile duct cancer). These studies are designed to achieve cost neutrality while broadening the platform’s evidence base.

In October 2026, the first patient was treated in PRISM-TAMP, an IIT led by researchers at the University of Vermont (UVM). The trial is evaluating gemcitabine delivered through the TAMP platform, enabled by RenovoCath, prior to surgery in patients with planned surgical resection for the first time in the neoadjuvant setting. It is the first IIT supported by RenovoRx to begin patient enrollment and takes TAMP upstream of locally advanced disease, where physicians have asked about its potential. UVM plans to enroll approximately 10 patients in this trial. IITs are capital-efficient for the Company and allow independent investigators to generate safety and tolerability data for new applications of TAMP.

In August 2026, TAMP enabled by RenovoCath was deployed in the first commercial clinical use in a solid tumor beyond pancreatic cancer as an existing commercial cancer center customer utilized the device to treat a patient with sarcoma. The Company views this physician-driven expansion as an encouraging indicator of the potential for broader adoption of RenovoCath within its FDA-cleared fields of use.

Phase III TIGeR-PaC Trial

In August 2026, RenovoRx achieved full enrollment in its Phase III TIGeR-PaC trial evaluating intra-arterial delivery of intra-arterial gemcitabine (IAG) via the RenovoCath device for the treatment of locally advanced pancreatic cancer (LAPC). This significant milestone reflects successful patient recruitment, clinical execution, and collaboration among investigators and study teams evaluating IAG for LAPC, a difficult-to-treat cancer. The primary endpoint of the study is overall survival. TIGeR-PaC is designed to evaluate whether RenovoRx’s patented method of targeted delivery of the chemotherapy gemcitabine improves patient survival, safety, and tolerability compared to the standard of care systemic (intravenous) chemotherapy gemcitabine + Abraxane.

RenovoRx anticipates initial top-line data in the second half of 2027 and expects the data readout to support and potentially expand current clinical adoption of TAMP by providing more rigorous evidence on tolerability and reduced side effects. The trial may also show whether TAMP can improve survival in this setting.

Third Quarter 2026 and Subsequent Key Highlights

During the third quarter and the subsequent period, RenovoRx added clinical evidence supporting its TAMP platform, including two peer-reviewed publications.

In August 2026, the pharmacokinetic and pharmacodynamic (PK-PD) data from a sub-study of the ongoing Phase III TIGeR-PaC trial was published in Cancer Chemotherapy and Pharmacology. The findings from this PK-PD study provided additional meaningful mechanistic support for RenovoRx’s TAMP platform’s targeted drug-delivery approach and provided direct PK evidence supporting TAMP’s potential to deliver chemotherapy directly near the tumor while limiting systemic exposure. These findings provide further support for TAMP as a differentiated therapeutic approach designed to potentially improve the therapeutic index of chemotherapy in patients with LAPC.

In October 2026, a peer-reviewed case series from Hackensack Meridian Health’s Jersey Shore University Medical Center was published in Case Reports in Oncology. In the publication, physicians shared their experiences using TAMP for drug-delivery to treat patients diagnosed with LAPC, whose tumors were not surgically removable due to significant complex blood vessel involvement despite receiving extensive prior therapy. RenovoRx is encouraged that physicians are independently documenting and sharing their experiences with TAMP and its potential to provide clinical benefit for patients.

RenovoRx also continued to strengthen its intellectual property position in the third quarter of 2026. In August 2026, the U.S. Patent and Trademark Office issued a Notice of Allowance for a new patent covering RenovoCath dual-occlusion catheter system, bringing the Company’s portfolio to 10 issued or allowed (1 allowed) U.S. patents, 10 issued OUS patents, 6 pending U.S. cases, 7 pending OUS cases and 2 pending Patent Cooperation Treaty (PCT) applications.

Financial Highlights for the Third Quarter Ended September 30, 2026

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Revenue was $1.07 million, compared to $266,000 for the three months ended September 30, 2025. The nearly 300% year-over-year and 17% sequential quarterly increases were driven by the continued commercialization of RenovoCath and expanding adoption across U.S. cancer centers.

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Gross profit was $878,000, representing a gross margin of approximately 82%, compared to approximately 80% for the three months ended September 30, 2025. Margin performance in third quarter 2026 reflected the conversion of three devices from one clinical site in the TIGeR-PaC trial to a commercial cancer center customer at no gross margin, in accordance with generally accepted accounting principles.

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Research and development expenses were approximately $1.2 million, compared to approximately $1.7 million for the three months ended September 30, 2025.

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Selling, general, and administrative expenses were approximately $2.9 million, compared to approximately $1.7 million for the three months ended September 30, 2025, reflecting the investment made to build and support the Company’s commercial infrastructure.

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Loss from operations was approximately $3.2 million, compared to approximately $3.2 million for the three months ended September 30, 2025. Net loss per share was $0.08 for the three months ended September 30, 2026, compared to a net loss of $0.08 for the three months ended September 30, 2025.

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Cash and cash equivalents were approximately $10.4 million as of September 30, 2026, compared to approximately $9.5 million as of June 30, 2026. The increase was driven by $3.5 million received from the exercise of outstanding common stock warrants, which offset cash used in operations. The Company believes its current cash resources are sufficient to fund operations into the second half of 2027.

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Shares outstanding: As of September 30, 2026, common shares outstanding totaled 48,190,073.

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Guidance: RenovoRx is maintaining its full-year 2026 revenue guidance of $3.75 million to $4.25 million, which implies year-over-year revenue growth of approximately 241% to 286% compared to full-year 2025 revenue of $1.1 million.

Conference Call Details

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Access ID: 10212350

(Press release, Renovorx, NOV 5, 2026, View Source [SID1234674324])

On November 5, 2026 Rakovina Therapeutics Inc. (TSX-V: RKV) (FSE: 7JO0) (OTCMKTS: RKVTF), a biopharmaceutical company advancing innovative cancer therapies through AI-powered drug discovery, reported that new preclinical data from its kt-5000AI ATR inhibitor program will be presented in a poster at the 31st Society for Neuro-Oncology (SNO) Annual Meeting & Education Day, taking place November 12-15, 2026, in Philadelphia, Pennsylvania.

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The poster describes brain-penetrant inhibitors of ataxia telangiectasia and Rad3-related protein kinase (ATR) developed with Variational AI Inc. ("Variational AI") using its Enki generative AI platform. The compounds were designed for tumours that have lost the tumour-suppressor gene PTEN, a vulnerability found in gliomas and in cancers that commonly spread to the brain.

The program initially explored dual ATR and mTOR inhibition, as reflected in the abstract title. Lead optimization has since converged on ATR-selective compounds, and kt-5000AI is now focused on brain-penetrant ATR inhibition.

Presentation Details

Title: Brain-penetrant dual ATR-mTOR inhibitors for PTEN-deficient cancers

Abstract Code: DNAR-04

Format: Poster Presentation

Date and Time: Friday, November 13, 2026, 7:30 to 9:30 p.m. EST

Location: Exhibit Hall D & E, Pennsylvania Convention Center, Philadelphia, Pennsylvania

As announced on October 22, 2026, the kt-5000AI program has advanced from target specification to an advanced lead-optimization stage in approximately two years using the Enki platform. Optimized compounds have demonstrated potent and selective ATR inhibition, improved metabolic stability, and permeability and efflux characteristics associated with brain penetration. Studies to characterize CNS exposure in the optimized series are ongoing.

"The Society for Neuro-Oncology provides an important opportunity to present our research to leading clinicians and scientists focused on advancing treatments for brain cancers," said Dr. Mads Daugaard, President and Chief Scientific Officer of Rakovina Therapeutics. "PTEN-deficient tumours may be particularly vulnerable to ATR inhibition, presenting a compelling opportunity for targeted therapeutic development. Our kt-5000AI program was designed specifically to address this limitation, combining potent and selective ATR inhibition with the potential to reach tumours within the central nervous system."

Webinar Today

Rakovina will host a joint webinar with Variational AI today, November 5, 2026, at 9:30 a.m. Vancouver time (11:30 a.m. Toronto time), to discuss the kt-5000AI program and its progress to date, including the results described in the recently published case study. The webinar will feature Kim Oishi, Chief Executive Officer, and Dr. Mads Daugaard, President and Chief Scientific Officer, of Rakovina Therapeutics, and Handol Kim, Co-Founder and Chief Executive Officer of Variational AI. Registration is available at View Source

About the Society for Neuro-Oncology

The Society for Neuro-Oncology (SNO) is a multidisciplinary organization dedicated to advancing brain tumour research, education and collaboration to drive discovery and improve patient care. The 31st SNO Annual Meeting & Education Day, themed "Crossing the Translational Divide: From Neurons to Novel Therapies," focuses on the research, diagnosis and treatment of central nervous system malignancies. More information is available at www.soc-neuro-onc.org.

(Press release, Rakovina Therapeutics, NOV 5, 2026, View Source;utm_medium=rss&utm_campaign=rakovina-therapeutics-to-present-brain-penetrant-atr-inhibitor-data [SID1234674323])