On January 5, 2023 -Novocure (NASDAQ: NVCR) reported the LUNAR study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in overall survival over standard therapies alone (Press release, NovoCure, JAN 5, 2023, View Source [SID1234625945]). The LUNAR study is a pivotal, open-label, randomized study evaluating the safety and efficacy of Tumor Treating Fields (TTFields) together with standard therapies for stage 4 non-small cell lung cancer (NSCLC) following progression while on or after treatment with platinum-based therapy.

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The LUNAR study also showed a statistically significant and clinically meaningful improvement in overall survival when patients were treated with TTFields and immune checkpoint inhibitors (ICI), as compared to those treated with immune checkpoint inhibitors alone, and a positive trend in overall survival when patients were treated with TTFields and docetaxel versus docetaxel alone. Patient enrollment was well balanced between the ICI and docetaxel cohorts of the experimental and control arms, and control arms performed in line with prior studies. TTFields therapy was well tolerated by patients enrolled in the experimental arm of the study.

"We are pleased with the positive readout of the LUNAR study. Prior to LUNAR, the last phase 3 trial to lead to significant improvement in overall survival in late-stage, platinum-resistant non-small cell lung cancer was six years ago, underlining the difficulty in treating this disease," said William Doyle, Novocure’s Executive Chairman. "We are also pleased by the profound performance of the TTFields together with immunotherapy, which has the potential to meaningfully extend patient survival beyond what was previously possible. I would like to thank our patients and investigators for their courage and dedication in completing LUNAR. And, I would like to thank Novocure’s employees for their unrelenting commitment to patients and their perseverance in propelling Novocure to this major milestone."

Novocure plans to release the full results of the LUNAR study at a future medical conference. Novocure expects to file a Premarket Approval application with the U.S. Food and Drug Administration (FDA) in the second half of 2023. Novocure also expects to file for a CE Mark in the European Union concurrently with the FDA submission.

On January 5, 2023 AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving quality of life for patients, reported financial results for the second quarter of fiscal year 2023, which ended November 30, 2022 (Press release, AngioDynamics, JAN 5, 2023, View Source [SID1234625944]).

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"We drove strong performance during the second quarter, and we believe our results through the first half of the year position us well to achieve our full-year targets," commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. "I am pleased with the way the team has managed through the current macro environment as we continue to execute on our strategy of pursuing attractive markets where our med tech platforms possess a differentiated technology advantage. In addition, I am thrilled that we have surpassed the mid-point of our enrollment target on our Preserve study during the quarter, as we continue to progress toward our goal of offering treatment options aimed at improving quality of life for prostate cancer patients."

Second Quarter 2023 Financial Results

Net sales for the second quarter of fiscal 2023 were $85.4 million, an increase of 9.1% compared to the prior-year quarter. Foreign currency translation did not have a significant impact on the Company’s net sales in the quarter.

Med Tech net sales were $24.5 million, a 29.7% increase from the prior-year period. Med Tech includes the Auryon peripheral atherectomy platform, the thrombus management platform and the NanoKnife irreversible electroporation platform. Growth was driven by Auryon sales during the quarter of $10.1 million, which increased 60.6%, and NanoKnife sales of $5.5 million, which increased 49.5% compared to the second quarter of fiscal 2022. NanoKnife disposable sales were $4.2 million, which increased 45.4% compared to the second quarter of fiscal 2022.

Med Device net sales were $60.9 million, an increase of 2.6% compared to the prior-year period.

U.S. net sales in the second quarter of fiscal 2023 were $71.6 million, an increase of 9.6% from $65.4 million a year ago. International net sales were $13.8 million, an increase of 6.7% compared to a year ago.

Gross margin for the second quarter of fiscal 2023 was 52.8%, an increase of 100 basis points compared to the second quarter of fiscal 2022. Gross margin for the Med Tech business was 63.7%, a decline of 290 basis points from the second quarter of fiscal 2022. Gross margin for the Med Device business was 48.4%, an increase of 130 basis points compared to the second quarter of fiscal 2022. Gross margin was negatively impacted by macro forces including labor shortages and increased costs for labor, raw materials and freight.

The Company recorded a net loss of $8.5 million, or a loss per share of $0.21, in the second quarter of fiscal 2023. This compares to a net loss of $8.4 million, or a loss per share of $0.21, a year ago.

Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income for the second quarter of fiscal 2023 was $0.4 million, and adjusted earnings per share was $0.01, compared to adjusted net loss of $0.9 million and adjusted loss per share of $0.02 in the prior-year period.

Adjusted EBITDA in the second quarter of fiscal 2023, excluding the items shown in the reconciliation table below, was $7.5 million, compared to adjusted EBITDA of $4.4 million in the second quarter of fiscal 2022.

In the second quarter of fiscal 2023, the Company generated $7.5 million in operating cash, had capital expenditures of $1.3 million and had additions to Auryon placement and evaluation units of $1.2 million.

On November 30, 2022, the Company had $29.9 million in cash and cash equivalents, compared to $28.8 million in cash and cash equivalents on May 31, 2022. The Company had $25.0 million outstanding on the delayed-draw term loan and $25.0 million outstanding under its revolving credit facility at November 30, 2022.

Six Months Financial Results

For the six months ended November 30, 2022:

Net sales were $167.0 million, an increase of 7.5%, compared to $155.3 million for the same period a year ago.

Med Tech net sales were $47.3 million, a 29.7% increase from the prior year period. Med Device net sales were $119.6 million, an increase of 0.7% from the prior year period.

Gross margin increased 30 basis points to 52.3% from 52.0% a year ago.

The Company’s net loss was $21.5 million, or a loss of $0.55 per share, compared to a net loss of $15.3 million, or a loss of $0.39 per share, a year ago.

Excluding the items shown in the non-GAAP reconciliation table, below, adjusted net loss was $2.1 million, with adjusted loss per share of $0.05, compared to adjusted net loss and adjusted loss per share of $1.7 million, and $0.04, respectively, a year ago.

Adjusted EBITDA, excluding the items shown in the reconciliation table below, was $10.4 million, compared to $8.0 million for the same period a year ago.

Fiscal Year 2023 Financial Guidance

Management is reaffirming its previously issued fiscal year 2023 guidance. Management expects net sales to be in the range of $342 to $348 million, gross margin to be approximately 52.5% to 54.5% and adjusted earnings per share in the range of $0.01 to $0.06 as it continues to invest in new product launches to drive future growth.

Conference Call

The Company’s management will host a conference call today at 8:00 a.m. ET to discuss its second quarter results.

To participate in the conference call, dial 1-877-407-0784 (domestic) or +1-201-689-8560 (international) and refer to the passcode 13734978.

This conference call will also be webcast and can be accessed from the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Thursday, January 5, 2023, until 11:59 p.m. ET on Thursday, January 12, 2023. To listen to this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13734978.

Use of Non-GAAP Measures

Management uses non-GAAP measures to establish operational goals and believes that non-GAAP measures may assist investors in analyzing the underlying trends in AngioDynamics’ business over time. Investors should consider these non-GAAP measures in addition to, not as a substitute for or as superior to, financial reporting measures prepared in accordance with GAAP. In this news release, AngioDynamics has reported adjusted EBITDA, adjusted net income and adjusted earnings per share. Management uses these measures in its internal analysis and review of operational performance. Management believes that these measures provide investors with useful information in comparing AngioDynamics’ performance over different periods. By using these non-GAAP measures, management believes that investors get a better picture of the performance of AngioDynamics’ underlying business. Management encourages investors to review AngioDynamics’ financial results prepared in accordance with GAAP to understand AngioDynamics’ performance taking into account all relevant factors, including those that may only occur from time to time but have a material impact on AngioDynamics’ financial results. Please see the tables that follow for a reconciliation of non-GAAP measures to measures prepared in accordance with GAAP.

On January 5, 2023 Inspirna, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule cancer therapeutics, reported interim data from its ongoing Phase 1b/2 clinical trial of abequolixron in patients with non-small cell lung cancer (NSCLC) and small-cell lung cancer (SCLC) (Press release, Inspirna, JAN 5, 2023, View Source [SID1234625943]).

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Abequolixron (RGX-104) is a first-in-class, small molecule liver X receptor (LXR) agonist designed to target APOE dysregulation and enhance anti-tumor immunity by inhibiting tumor angiogenesis, depleting myeloid derived suppressor cells (MDSC), and activating cytotoxic T lymphocytes (CTL). Abequolixron is currently being evaluated in a Phase 1b/2 clinical trial in combination with docetaxel in second- or third-line (2/3L) NSCLC as well as second-line (2L) SCLC. The primary objectives of the study include characterizing the safety profile and the antitumor activity of the abequolixron and docetaxel combination.

"The data thus far demonstrate that abequolixron is well tolerated in combination with full dose docetaxel, while showing encouraging clinical activity suggesting that this drug candidate could be a valuable addition to a current standard of care chemotherapy in heavily-pretreated patients with lung cancer," said Hossein Borghaei, D.O., M.S., Chief of the Division of Thoracic Medical Oncology at Fox Chase Cancer Center and Principal Investigator on the study. "I am very encouraged by the overall response rate, disease control rate, and time to progression so far seen in the study and I look forward to further evaluation of this unique compound as the clinical trial progresses."

"These data, while early, clearly show the potential that abequolixron may have in driving deep responses in patients with heavily-pretreated lung cancer," said Masoud Tavazoie, M.D., Ph.D., Chief Executive Officer of Inspirna. "We are excited to begin the new year by announcing these promising data for abequolixron and look forward to sharing more updates as we continue advancing our novel pipeline in difficult-to-treat cancers."

Key findings from the data

As of December 2, 2022, 17 patients were treated at the Recommended Phase 2 Dose (RP2D) as determined in the dose escalation stage, with 120mg abequolixron twice daily (BID), 5 days on/2 days off, plus docetaxel. Thirteen patients were evaluable for response per RECIST v1.1, including five patients with 2/3L NSCLC and eight patients with 2L SCLC.
The ORR across all evaluable patients was 38% (n=13), with a disease control rate (DCR) of 77%, including five patients who achieved partial response (PR).
In the 2/3L NSCLC cohort, of five evaluable patients, four patients achieved PRs with two patients achieving confirmed partial responses. Four of the five patients were on study treatment for > 19 weeks, including one patient for 25 weeks, one patient for 28 weeks and one ongoing patient at 37 weeks.
In the 2L SCLC cohort, of eight evaluable patients, one patient achieved a PR and five patients had a best overall response (BoR) of stable disease (SD). Four patients (50%) were on study drug progression free for > 24 weeks. One of the patients with a BoR of SD, although experiencing CNS progression at week 12, stayed on therapy for clinical benefit for 30 weeks without experiencing systemic PD.
Across the two cohorts (N=17), the most common TEAEs were fatigue in 12 patients, diarrhea and nausea in 9 patients, decreased appetite in 8 patients and neutropenia and weight loss in 7 patients. Of the most common TEAEs, Grade 4 events were neutropenia (2 patients) and Grade 3 events were fatigue (2 patients), diarrhea (1 patient), nausea (1 patient), decreased appetite (1 patient) and the others were Grade < 2.
The expansion stage of the study is ongoing and continues to enroll patients with 2/3L NSCLC. In addition, this Phase 1b/2 study includes an ongoing expansion arm of abequolixron in combination with Yervoy (ipilimumab) in second- or third-line endometrial cancer as part of a clinical collaboration with Bristol Myers Squibb.

About Abequolixron (RGX-104)

Abequolixron is an orally administered small molecule agonist of the Liver X Receptor (LXR) which activates expression of the APOE tumor suppressor protein. APOE expression becomes dysregulated (silenced) in the tumors of select patients with solid cancers. APOE dysregulation results in increased tumor angiogenesis (tumor blood vessel growth) as well as a shifting of the tumor myeloid cell population from immune-stimulatory to immune-suppressive, which are both counteracted by abequolixron. Abequolixron is currently being tested in a Phase 1b/2 clinical trial in combination with standard-of-care regimens in several lung cancer indications that are enriched for APOE dysregulation, including SCLC and NSCLC.

On January 5, 2023 Arsenal Biosciences, Inc. (ArsenalBio), a privately held, clinical stage, programmable cell therapy company engineering advanced CAR T cell therapies for solid tumors, repored that the first patient has been dosed with AB-1015 in a Phase 1, first-in-human clinical trial for patients with ovarian cancer that is resistant to platinum-based regimens (Press release, Arsenal Bio, JAN 5, 2023, View Source [SID1234625942]). AB-1015 is ArsenalBio’s first internally discovered T cell medicine to enter clinical development and uses synthetic DNA programming to overcome tumor defenses, increase potency, and target ovarian cancer cells without harming normal tissues.

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"The initiation of this first-in-platform trial marks the beginning of a new chapter in the story of cell therapy and will enable ArsenalBio to validate our Integrated Circuit T (ICT) cell technology in humans," said Ken Drazan, M.D., ArsenalBio’s co-founder and Chief Executive Officer. "To date, first generation T cell-based technologies have failed to drive deep and durable responses in solid tumors, leaving a large unmet need for effective immunotherapies across many types of solid tumor cancers. We hope this study succeeds in identifying a safe and therapeutic dose to further study in larger patient cohorts; thereby demonstrating the utility of our technology platform and the benefit of our pipeline of potential medicines."

Dr. Drazan will provide a business overview and update inclusive of information about the clinical trial during the company’s upcoming presentation on January 10th at the 41st Annual J.P. Morgan Healthcare Conference.

On January 5, 2023 RenovoRx, Inc. (Nasdaq: RNXT), a biopharmaceutical company focused on the localized treatment of difficult-to-treat solid tumors, reported that on January 3, 2023 the United States Patent and Trademark Office issued US patent number 11,541,211 broadly covering methods for treating cholangiocarcinoma (bile duct cancer) by selectively delivering one or more therapeutic agents into targeted regions of the bile duct (Press release, Renovorx, JAN 5, 2023, View Source [SID1234625941]). This is RenovoRx’s eighth US patent.

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Our newest patent builds upon our strong IP portfolio, which now consists of eight US method and device patents, one EU delivery system patent, and eight additional pending patents in the US, EU, and Asia," said Shaun Bagai, CEO of RenovoRx. "Additionally, this additional patent bolsters the seven years of post-approval market exclusivity that we currently have with our lead oncology product candidate, RenovoGem, through the Orphan Drug designation granted by the FDA for our first two indications."