On April 7, 2020 Kazia Therapeutics Limited (ASX: KZA;NASDAQ: KZIA), an Australian oncology-focused biotechnology company, reported to share positive interim data from its ongoing phase II study of paxalisib (formerly GDC-0084) in glioblastoma, the most common and most aggressive form of primary brain cancer (Press release, Kazia Therapeutics, APR 7, 2020, View Source [SID1234556187]).

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Key Points

Interim analysis of Part A (escalation cohort) (n=9) showed median overall survival (OS) of 17.7 months, representing a clinically meaningful extension of life when compared to the 12.7 months associated with the existing standard of care, temozolomide
Interim analysis of all evaluable patients (Part A = 9; Part B = 21) shows median progression-free survival (PFS) of 8.5 months, broadly in line with previous analysis, and comparing favourably to the 5.3 months associated with temozolomide
The longest-treated patient remains progression-free 19 months after diagnosis
Approximately half the enrolled patients remain on drug and both OS and PFS figures may further improve as the trial progresses toward conclusion
Kazia expects to present further data in 2H CY2020 and final data in 1H CY2021
Summary of Paxalisib Data in Comparison to Temozolomide (existing standard of care)

Temozolomide
(FDA-approved treatment)

Paxalisib

(interim phase II data)

Progression-Free Survival (PFS)

Measures ability of a drug to slow
growth of a tumour

5.3 months

8.5 months

Overall Survival (OS)

Measures ability of a drug to
prolong life

12.7 months

17.7 months

Kazia CEO, Dr James Garner, commented, "This is an excellent result, and we are delighted with the emerging data. The ‘gold standard’ for any new cancer treatment is the ability to extend life – an especially challenging goal in a disease such as glioblastoma – and this data provides our first evidence that paxalisib may achieve this objective in a very challenging patient population."

He continued, "There have not been any new drug treatments for newly-diagnosed glioblastoma patients for over twenty years, and we aspire to change that situation. We believe that paxalisib is rapidly becoming one of the most promising drug candidates in the global pipeline for this very challenging disease and we will be working strenuously to make it available to patients as quickly and efficiently as possible. The study continues to follow a number of patients who remain on treatment, and we currently expect to report a further data read-out in the second half of the year."

Background

The reported overall survival (OS) figure of 17.7 months represents a strong signal of clinical efficacy. The existing, FDA-approved standard of care, temozolomide, is associated with an OS of 12.7 months in this patient population[1]. Comparison between different studies is always imprecise, but the magnitude of the numerical difference provides powerful evidence that treatment with paxalisib may extend life in this patient group.

The reported progression-free survival (PFS) figure of 8.5 months is slightly better than the figure of 8.4 months previously reported in November 2019. Temozolomide is associated with a PFS of 5.3 months in this patient population.

Before losing patent protection, temozolomide achieved peak sales in excess of US$ 1 billion per annum, which provides an indication of the commercial opportunity associated with a new treatment for glioblastoma.

Thirty patients were enrolled to this study, comprising 9 in Part A, and 21 in Part B. Data reported here are provisional figures from Part A (for OS) and from the entire study population (for PFS), but may change as ongoing patients proceed through the study. The study has been conducted at leading centers of excellence in the United States.

The safety of paxalisib remained broadly consistent with prior experience, with hyperglycaemia (raised blood sugar), oral mucositis (mouth ulcers), and low-grade rash among the most common drug-related toxicities.

In addition to this phase II study in glioblastoma, four other studies are underway with paxalisib in different forms of brain cancer, and it is anticipated that several of these will provide initial efficacy data during CY 2020.

This data had been accepted for presentation at the annual meeting of the American Association of Cancer Research (AACR) (Free AACR Whitepaper) in San Diego, CA from 24 -29 April 2020. However, given the cancellation of the AACR (Free AACR Whitepaper) meeting due to the COVID-19 outbreak, Kazia has determined to provide an update to investors via this ASX announcement.

Next Steps

The phase II study remains ongoing, with approximately half of the total enrolled patient population still receiving drug at the time of analysis and a number of additional patients still in follow-up. At this stage, Kazia expects to present further data in 2H CY2020, and final data in 1H CY2021.

On April 7, 2020 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it will report first quarter 2020 results on Wednesday, April 22, 2020, before the market opens (Press release, Quest Diagnostics, APR 7, 2020, View Source [SID1234556186]). It will hold its quarterly conference call to discuss the results beginning at 8:30 a.m. Eastern Time on that day.

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The company also will provide an update on the impact of the COVID-19 pandemic. On March 31, 2020, Quest Diagnostics filed a Current Report on Form 8-K with the Securities and Exchange Commission to outline the impact of the pandemic on its operating results, cash flows and financial condition and withdraw its previously announced guidance for full year 2020.

The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, using the passcode: "Investor." The earnings release and live webcast will be posted on www.QuestDiagnostics.com/investor. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 800-839-1170 for domestic callers or 402-998-0559 for international callers; no passcode is required. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on April 22, 2020 until midnight Eastern Time on May 6, 2020.

Anyone listening to the call is encouraged to read the company’s periodic reports on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

On April 7, 2020 Alpha Tau Medical – the developer of breakthrough alpha-radiation cancer therapy Alpha DaRT, and Medison Canada – a fully owned subsidiary of Medison Pharma, reported that they have entered into an exclusive distribution arrangement (Press release, Alpha Tau Medical, APR 7, 2020, View Source [SID1234556185]). Medison is a specialized pharmaceutical and biotech company purely focused on licensing highly innovative, cutting edge therapeutics for patients in need of life-saving therapies in rest-of-the-world markets. Medison has exclusive commercial distribution rights in Israel, and according to the new arrangement, Medison shall also have the exclusive rights to commercialize and distribute the Alpha DaRT in Canada. The arrangement for Canada is for a 15-year period from Marketing Approval of the product in Canada. The parties have agreed on a split of revenues between both sides, and Alpha Tau will be entitled to receive upfront, regulatory and milestone sales-based fees of up to US$9 million.

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Alpha Tau CEO, Uzi Sofer, commented, "This arrangement meaningfully furthers our important mission to bring our live-saving cancer therapy to thousands of cancer patients in Canada who may not have other treatment options remaining. We are confident that with Medison’s capabilities, their outstanding team on the ground, and their track record of commercial success around the world, we will build together a successful commercial launch for Alpha DaRT in Canada. Even in these challenging times, we continue to push forward our mission to help cancer patients around the world, with active ongoing patient recruitment and treatment, and we appreciate Medison’s vote of confidence in uncertain times."

Raphi Levy, CFO of Alpha Tau, added, "We are very excited to have allied ourselves with such a leading partner in the Canadian therapeutics market. Canada is assuming increased importance for Alpha Tau as a nexus for our pre-clinical and clinical research. We are excited to work with Medison on bringing our therapy to Canadian clinicians, who are already learning about the Alpha DaRT and are eager to deploy it."

Meir Jakobsohn, Founder and CEO of Medison Pharma, commented, "Alpha DaRT is a great addition to our Canadian portfolio, and we believe that Alpha Tau’s breakthrough technology together with Medison’s on-the-ground extensive commercial capabilities can make a real change in patients’ lives in Canada."

Joe O’Neill, General Manager Medison Canada, added: "We are very excited to partner with Alpha Tau to bring this important treatment option to Canadian patients and their healthcare providers. Canada continues to be a leader in providing clinical trial support to innovative R&D companies in the oncology field and Medison Canada is proud that Alpha Tau is working with one of our leading hospitals, CHUM in Montreal, to develop this important treatment."

As part of its extensive global clinical trial plan, Alpha Tau has recently launched a clinical trial for patients with advanced pancreatic cancer in Montreal, conducted at CHUM (Montreal University Hospital Center). The company is also engaged in a research projects on alpha radiation dosing with leading universities and institutions in Montreal and Israel.

About Alpha DaRT
Alpha DaRT(Diffusing Alpha-emitters Radiation Therapy) enables highly potent and conformal alpha-irradiation of solid tumors. The treatment is delivered by intratumoral insertion of radium-224 impregnated seeds. When the radium decays, its short-lived daughters are released from the seed, and disperse while emitting high-energy alpha particles that destroy the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT mainly affects the tumor, sparing the healthy tissue around it.

On April 7, 2020 SIRION Biotech GmbH reported that Beam Therapeutics licensed rights to use SIRION Biotech’s LentiBOOST for use in their CAR-T cell products (Press release, SIRION Biotech, APR 7, 2020, View Source [SID1234556183]).

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CAR-T cell therapy represents a promising and future-defining shift in cancer treatment. Beam Therapeutics is developing a new generation of CAR-T product candidates using its proprietary base editing technology.

Under the terms of this agreement, SIRION agreed to provide Beam with non-exclusive access to its proprietary lentiviral transduction enhancer LentiBOOST for clinical development and commercialization of Beam’s portfolio of CAR-T programs. SIRION will be entitled to undisclosed upfront and milestone payments and is eligible to receive royalties on future product net sales plus license fees tied to commercial success.

Dr. Christian Thirion, CEO and founder of SIRION Biotech GmbH explains: "LentiBOOST was engineered to improve lentiviral transduction of difficult cell types like T-cells and hematopoietic stem cells. This technology enables robust upscaling of the T-cell production process, and helps to reduce manufacturing costs by lowering the amount of lentiviral vectors needed for production of the cell product while at the same time improving clinical efficacy by increasing vector copy numbers (VCN) per cell. We are delighted that the LentiBOOST technology may help Beam further enhance the clinical success of its CAR-T pipeline."

"LentiBOOST is used in an increasing number of clinical trials in the US and in Europe and the technology is more and more considered as a gold standard in manufacturing of cell products. Our non-exclusive licensing strategy makes our technology available to a wide range of companies and research hospitals to boost the efficiency of their various clinical programs," says SVP of Business Development & Licensing, Dr. Sabine Ott.

On April 7, 2020 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported financial results for the third quarter of fiscal year 2020, which ended February 29, 2020 (Press release, AngioDynamics, APR 7, 2020, View Source [SID1234556182]).

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"The health and safety of the team is our top priority, and I want to thank each of our team members for the resiliency they have shown. We are very pleased with our third quarter results, as increases across all three of our businesses drove solid ex-Asclera top-line growth of 9.3%," commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. "Looking ahead, we are operating in a very dynamic macro environment, and the coming months are likely to present further challenges. However, our healthy balance sheet and world-class team leave us well-prepared to weather those challenges. We experienced strong momentum during the third quarter, and we look forward to building on that momentum once the environment begins to normalize, as we believe that the long-term fundamentals and growth drivers of our business remain intact. All of us at AngioDynamics remain steadfastly focused on the health and safety of our employees and patients and ensuring that our physicians and customers have uninterrupted access to our innovative product portfolio in order to deliver the highest quality care possible."

Third Quarter 2020 Financial Results

Net sales for the third quarter of fiscal 2020 were $69.8 million, an increase of 6.5% compared to the prior-year quarter. Excluding the impact of Asclera sales, which were discontinued during fiscal year 2019, net sales grew 9.3% year over year. Foreign currency translation did not have a significant impact on the Company’s sales in the quarter.

Oncology net sales were $14.6 million, an increase of 5.1% from $13.9 million a year ago, led by strong NanoKnife sales.
Vascular Interventions and Therapies ("VIT") net sales were $30.6 million, an increase of 4.3%, compared to $29.3 million a year ago. Excluding last year’s Asclera sales of $1.7 million in the third quarter, VIT grew 10.5%, driven by higher sales of the Company’s AngioVac, Thrombolytic, and core VIT products.
Vascular Access net sales were $24.6 million, an increase of 10.3% from $22.3 million a year ago, due primarily to higher sales of PICCs, Ports, and Midline products.
Excluding Asclera, U.S. net sales in the third quarter of fiscal 2020 were $54.9 million, an increase of 6.1% from $51.7 million a year ago, and International net sales were $14.9 million, an increase of 22.8% from $12.1 million a year ago.

Gross margin for the third quarter of fiscal 2020 was 57.8%, a decrease of 40 basis points compared to the third quarter of fiscal 2019, primarily due to product mix.

The Company recorded a net loss from continuing operations of $5.7 million, or a loss of $0.15 per share, in the third quarter of fiscal 2020. This compares to a net loss from continuing operations of approximately $4.6 million, or a loss of $0.12 per share, a year ago.

Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income for the third quarter of fiscal 2020 was $0.4 million, or $0.01 per share, compared to adjusted net income of $1.9 million, or $0.05 per share, in the third quarter of fiscal 2019.

Adjusted EBITDA in the third quarter of fiscal 2020, excluding the items shown in the reconciliation table below, was $3.8 million, compared to $7.7 million in the third quarter of fiscal 2019.

In the third quarter of fiscal 2020, the Company used $17.8 million in operating cash and had capital expenditures of $1.7 million. As of February 29, 2020, the Company had $27.2 million in cash and cash equivalents and $15.0 million in debt outstanding.

Nine Months Financial Results

For the nine months ended February 29, 2020:

Net sales were $205.8 million, an increase of 3.2%, compared to $199.5 million for the same period a year ago. Excluding the impact of Asclera, sales of which were discontinued during fiscal year 2019, net sales grew 5.7% year over year.
The Company’s net loss from continuing operations was $9.7 million, or a loss of $0.26 per share, compared to a net loss from continuing operations of $13.9 million, or a loss of $0.37 per share, a year ago.
Gross margin improved 80 basis points to 58.3% from 57.5% a year ago.
Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income was $5.7 million, or $0.15 per share, compared to adjusted net income of $5.4 million, or $0.14 per share, a year ago.
Adjusted EBITDA, excluding the items shown in the reconciliation table below, was $17.5 million, compared to $22.0 million for the same period a year ago.
Fiscal Year 2020 Financial Guidance

As a result of the ongoing pandemic, health systems throughout the country, many of which are AngioDynamics customers, are currently prioritizing the care of COVID-19 patients. Consequently, certain of the procedures that the Company supports have been, and will continue to be, impacted. Given the uncertainty surrounding the magnitude and duration of these impacts, management is withdrawing its fiscal year 2020 financial guidance.

Conference Call

The Company’s management will host a conference call today at 8:00 a.m. ET to discuss its fiscal 2020 third 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 13700177.

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 Tuesday, April 7, 2020, until 11:59 p.m. ET on Tuesday, April 14, 2020. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13700177.

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, adjusted earnings per share, free cash flow and net sales excluding Asclera. 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.