On November 12, 2024 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, reported an upcoming plenary oral presentation at the 29th Annual Meeting and Education Day of the Society for Neuro-Oncology (SNO), being hosted November 21 – 24, 2024 in Houston, TX (Press release, In8bio, NOV 12, 2024, View Source [SID1234648176]). IN8bio will provide longer-term follow-up and additional data demonstrating the activity of its DRI gamma-delta T cell approach in solid tumors from the Phase 1 trial of INB-200. In June 2024, preliminary clinical data were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, demonstrating that 92% of evaluable patients treated in the investigator-initiated trial exceeded the median progression-free survival of 7 months typically observed using standard-of-care therapy with concomitant temozolomide (TMZ).

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Details for the SNO oral presentation are as follows:

Title: INB-200: Fully Enrolled Phase 1 Study of Gene-Modified Autologous Gamma-Delta (γδ) T Cells in Newly Diagnosed Glioblastoma Multiforme (GBM) Patients Receiving Maintenance Temozolomide (TMZ)

Presenter: Mina Lobbous, MD, MSPH, Assistant Professor, Cleveland Clinic Lerner College of Medicine
Abstract #: CTIM-09
Session Name: Abstract Session – Clinical Trials
Date and Time: Saturday, November 23, 2024, 11:25 AM – 11:35 AM CST

The abstract will be available online and can be accessed via the conference website at SNO 29th Annual Meeting & Education Day.

On November 12, 2024 IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies for cancer, reported financial results for the third quarter ended September 30, 2024, and recent corporate highlights (Press release, In8bio, NOV 12, 2024, View Source [SID1234648175]).

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"This past quarter marked a critical moment for IN8bio. We streamlined our operations and refined our pipeline to focus our resources. This strategic realignment enhances our capacity to deliver on the potential of gamma-delta T cell therapies, which are increasingly gaining recognition for their significant contributions to immunity." said William Ho, CEO and co-founder of IN8bio. "INB-100 is our allogeneic therapy in development for the treatment of patients with leukemias. The FDA’s guidance received in a Type B meeting over the summer provides a clear path forward for a potential registrational trial. We’ve secured additional funding to advance INB-100 through the ongoing expansion cohort in the Phase 1 study that will provide additional data to further de-risk the program. With a leaner, more focused organization, we are advancing INB-100 and seeking opportunities to potentially partner assets in our pipeline."

Corporate Highlights and Recent Developments

IN8bio will present updated clinical trial results from INB-200 in a Plenary Oral Presentation at the Society for Neuro-Oncology (SNO) in November 2024.
A poster presentation updating patient data from the INB-100 trial will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) in December 2024.
Secured net proceeds of $11.6 million from a private placement that is expected to provide cash runway into the first quarter of 2026.
Funding is expected to be used to continue to advance development of INB-100, future product candidates and for working capital and other general corporate purposes.
Focusing on continued enrollment in the Phase 1 expansion cohort of up to approximately 25 patients at the RP2D of INB-100, with plans to potentially add additional centers and include a parallel observational arm to provide control data.
Received FDA guidance in a Type B meeting, on the registrational path for INB-100 in AML, an allogeneic gamma-delta T cell therapy demonstrating early signs of activity in high-risk leukemia patients.
All AML patients treated with INB-100 have remained in CR as of August 31, 2024.
Older, high-risk leukemia patients receiving non-myeloablative, reduced intensity conditioning (RIC), have exceeded the expected one-year progression-free survival (PFS) rate of approximately 40-50% post-haploidentical transplantation.
These data continue to demonstrate the broad clinical potential of gamma-delta T cells for difficult-to-treat cancers and provides support for the advancement of these therapies into pivotal trials.
Significant dose-dependent in vivo expansion and long-term persistence of circulating gamma-delta T cells has been observed up to 365 days.
IN8bio implemented a plan to optimize resource allocation through pipeline prioritization and a strategic workforce reduction that was completed in the third quarter of 2024. IN8bio also suspended enrollment in its Phase 2 clinical trial of INB-400 for newly diagnosed glioblastoma (GBM) but will continue monitoring previously treated GBM patients in both the Phase 2 INB-400 and the Phase 1 INB-200 clinical trials to assess progression-free and overall survival. Updated data to be presented at future medical meetings.
Third Quarter 2024 Financial Highlights

Research and Development (R&D) expenses: R&D expenses were $3.3 million, compared to $3.8 million for the comparable prior year period. The decrease of $0.5 million was primarily due to a decrease of $0.6 million in personnel expenses, including salaries and stock-based compensation (SBC) as a result of our workforce reduction and a decrease of $0.1 million in facility-related and other expenses primarily due to decreases in R&D activities in connection with our pipeline prioritization, partially offset by an increase of $0.2 million in direct costs related to our clinical trials, primarily related to the INB-400 program. As part of the Company’s pipeline prioritization announced in September 2024, further clinical development on INB-400 has been suspended.

General and Administrative (G&A) expenses: G&A expenses were $2.7 million, compared to $3.4 million for the comparable prior year period. The decrease of $0.7 million was primarily due to a decrease in salaries and bonus expense in connection with our workforce reduction and cost savings related to directors’ and officers’ insurance premiums, partially offset by an increase in professional services.

Severance and related charges: Severance and related charges were $1.1 million for the three months ended September 30, 2024, compared to zero for the comparable prior year period. The increase of $1.1 million was due to one-time costs related to the September 2024 workforce reduction, including SBC expense of $0.8 million resulting from acceleration in full of outstanding unvested stock options at the separation date for the impacted employees, and $0.3 million related to severance payments.

Net loss: Net loss was $7.1 million, or $0.15 per basic and diluted common share, compared to a net loss of $7.2 million, or $0.23 per basic and diluted common share, for the comparable prior year period.

Cash position: As of September 30, 2024, the Company had cash of $4.0 million, compared to $10.2 million, as of June 30, 2024. Subsequently in October 2024 closed a Private Placement of $11.6 Million in net proceeds.

On November 12, 2024 ImmunityBio, Inc. (NASDAQ: IBRX) reported its financial results for the third-quarter ended September 30, 2024 (Press release, ImmunityBio, NOV 12, 2024, View Source [SID1234648173]).

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ANKTIVA received a J-code (HCPCS Level II Code) in October 2024, effective January 1, 2025.
ANKTIVA (FDA-approved and commercially available in the U.S. since May 2024) is now widely accessible to patients through commercial and government insurance programs (VA, DoD, Medicare). ImmunityBio has secured coverage for over 200 million medical lives through medical reimbursement policies.
ImmunityBio achieved a net product revenue of approximately $6.0 million during the three months ended September 30, 2024, surpassing net product revenue of $1.0 million in the prior quarter and analyst estimates.
ImmunityBio has extended the shelf life of ANKTIVA from two years to three years, with over 125,000 doses, providing ample product for the market and for clinical trials.
ImmunityBio submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) a Marketing Authorization Application (MAA) for ANKTIVA in the United Kingdom on November 1, 2024.
ImmunityBio intends to submit to the European Medicines Agency (EMA) an MAA for ANKTIVA in the European Union (EU) in Q4 2024, covering 30 countries, including 27 in the EU and 3 in the European Economic Area (Iceland, Norway, Liechtenstein).
"The U.S. launch of ANKTIVA for NMIBC CIS continues to gain momentum, and we are pleased to see the clinical impact for patients," said Richard Adcock, President and CEO of ImmunityBio. "Our permanent J-code has been issued by Centers for Medicare and Medicaid Services and will be effective January 1, 2025. Our submission of ANKTIVA for NMIBC CIS to the MHRA in the UK for potential approval demonstrates our plans for global expansion. Further, we anticipate an EU submission this quarter."

"The response from the urologists and clinical practices with regard to the utility of ANKTIVA in NMIBC CIS has been gratifying. ImmunityBio’s clinical trial in BCG naïve NMIBC is enrolling well, and clinical sites have been expanded from the U.S. to multiple global locations. In the urology space, initial clinical trials of ANKTIVA are being designed for high-risk prostate cancer," said Dr. Patrick Soon-Shiong, Executive Chairman, Global Chief Scientific & Medical Officer of ImmunityBio. "With the approval of ANKTIVA and the label of activating NK cells, CD4+ CD8+ T cells with memory T cells, ImmunityBio is focusing the regulatory development of ANKTIVA in BCG naïve bladder cancer and non-small cell lung cancer (NSCLC) patients who have failed checkpoint inhibitors."

Third-Quarter Ended September 30, 2024 Financial Summary

Cash and Marketable Securities Position

As of September 30, 2024, the Company had consolidated cash and cash equivalents, and marketable securities of $130.4 million.

Research and Development Expenses

Research and development (R&D) expenses increased $2.0 million to $50.4 million during the three months ended September 30, 2024, as compared to $48.4 million during the three months ended September 30, 2023. The increase was primarily driven by personnel-related and other R&D costs, partially offset by a decrease in external R&D expense driven by lower CMO fees and material purchases.

Selling, General and Administrative Expenses

Selling, general and administrative expenses increased $4.1 million to $35.9 million during the three months ended September 30, 2024, as compared to $31.8 million during the three months ended September 30, 2023. The increase was primarily driven by higher salaries and benefits expense as a result of a reversal of discretionary compensation not paid in the prior period and an increase in consulting costs associated with commercial activities.

Net Loss Attributable to ImmunityBio Common Stockholders

Net loss attributable to ImmunityBio common stockholders was $85.7 million during the three months ended September 30, 2024, compared to $95.6 million during the three months ended September 30, 2023.

About ANKTIVA

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response.

ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and drives the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. The proliferation of the trifecta of these immune killing cells and the activation of trained immune memory results in immunogenic cell death, inducing a state of equilibrium with durable complete responses. ANKTIVA has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in-vivo.

On November 12, 2024 Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, reported financial results for the three and nine months ended September 30, 2024, and highlighted recent corporate updates (Press release, Heron Therapeutics, NOV 12, 2024, View Source [SID1234648172]).

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"We are pleased to report that with our prudent financial management and continued revenue growth we were able to achieve positive Adjusted EBITDA for the quarter," said Craig Collard, Chief Executive Officer. "The future looks bright as we continue to grow all product revenue. The CrossLink partnership roll out, FDA approval of the VAN in September, and inclusion in the CMS Final Rule Non-Opioid Policy for Pain Relief, positions ZYNRELEF for significant growth within the surgical setting."

"We continue to deliver on our commitment to financial efficiency while growing revenue. The team has made great strides in the transformation of Heron over the past year. We are looking forward to a strong fourth quarter which is off to a great start. As such, we are narrowing guidance for full-year 2024."

On November 12, 2024 FibroGen, Inc. (NASDAQ: FGEN) reported financial results for the third quarter 2024 and provided an update on the company’s recent developments (Press release, FibroGen, NOV 12, 2024, View Source [SID1234648171]).

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"This past quarter we transformed into a lean and more focused organization, resulting in significant cost savings that will extend into the future. Moreover, roxadustat continued its impressive performance, generating $96.6 million in net sales in China during the quarter," said Thane Wettig, Chief Executive Officer, FibroGen. "Having implemented our cost reduction plan, we are well positioned to advance FG-3246, with topline results from the Phase 2 portion of the investigator-sponsored study of FG-3246 in combination with enzalutamide at the University of California San Francisco (UCSF) on track for the first half of 2025, and the anticipated start of our Phase 2 monotherapy trial in the first quarter of 2025. We continue to be optimistic about our future prospects."

Recent Developments and Key Events of Third Quarter 2024:

•Meaningful progress on U.S. cost reduction plan.
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Expected to be substantially complete by year-end 2024
•Reported topline results from the pamrevlumab arm of PanCAN Precision Promise Phase 2/3 adaptive platform trial for the treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC), in which the trial did not meet the primary endpoint.
•Reported topline results from the LAPIS Phase 3 study of pamrevlumab in patients with locally advanced, unresectable pancreatic cancer (LAPC), in which the trial did not meet the primary endpoint.

Upcoming Milestones:

Roxadustat

•Expect approval decision for roxadustat in chemotherapy-induced anemia (CIA) in China in early 2025. If approved, FibroGen will receive a $10 million milestone payment from AstraZeneca.
FG-3246 and FG-3180 (PET Imaging Agent)

•Topline results from the Phase 2 portion of the investigator-sponsored Phase 1b/2 study conducted by UCSF of FG-3246 in combination with enzalutamide in patients with mCRPC expected in 1H 2025.
•Anticipate initiation of Phase 2 monotherapy dose optimization study of FG-3246 in mCRPC in 1Q 2025. This trial will include a sub-study of FG-3180 to enable assessment of CD46 expression and response to FG-3246.