On May 4, 2020 Kitov Pharmaceuticals presented the Corporate Presentation (Presentation, Kitov Pharmaceuticals , MAY 4, 2020, View Source [SID1234556964]).

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On May 4, 2020 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported that it will host a conference call and live audio webcast on Monday, May 11, 2020 at 4:30 p.m. Eastern Time to discuss financial results for the first quarter ended March 31, 2020 and to provide a business update (Press release, CymaBay Therapeutics, MAY 4, 2020, View Source [SID1234556963]).

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Conference Call Details
To access the live conference call, please dial 855-327-6837 from the U.S. and Canada, or 631-891-4304 internationally, Conference ID# 10009543. To access the live and subsequently archived webcast of the conference call, go to the Investors section of the company’s website at View Source

On May 4, 2020 Aduro Biotech, Inc. (NASDAQ: ADRO), a clinical-stage biopharmaceutical company focused on developing therapies targeting the Stimulator of Interferon Genes (STING) and A Proliferation Inducing Ligand (APRIL) pathways for the treatment of cancer, autoimmune and inflammatory diseases, reported financial results for the first quarter ended March 31, 2020 (Press release, Aduro Biotech, MAY 4, 2020, View Source [SID1234556962]).

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"We ended the first quarter of 2020 with a cash position of $205.9 million, which enables us to continue supporting the development of our STING and APRIL programs into 2023. We are currently focused on activating clinical trial sites and enrolling patients for Part 3 of our Phase 1 study of BION-1301 in IgA nephropathy and driving enrollment of patients in our Phase 2 study of ADU-S100 in combination with pembrolizumab in squamous cell carcinoma of the head and neck (SCCHN)," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "Despite the challenges associated with the current COVID-19 pandemic, our Board and leadership team remain committed to supporting the safety of our employees while moving our STING and APRIL clinical programs forward."

Recent Highlights

Announced corporate restructuring to reduce operating expenses and extend cash runway into 2023.

Received a $10 million development milestone payment from license partner, Merck & Co., Inc. (known as MSD outside the United States and Canada) (Merck). The payment was received as a result of Merck’s initiation of a Phase 2 clinical trial of MK-5890, the anti-CD27 agonist antibody licensed to Merck in 2014, in patients with advanced squamous or non-squamous non-small cell lung cancer (NSCLC) that have been previously treated with anti-PD-L1 therapy.

Announced an update on clinical trial timelines and business operations in light of the COVID-19 global pandemic.

We expect delays in activating additional sites and enrolling patients into Part 3 of the Phase 1 clinical trial of BION-1301 in IgA nephropathy. As a result, our ability to report data in IgA nephropathy patients will likely be delayed until the first half of 2021.

Despite some delays in additional site activation and patient enrollment and anticipated delays in patient follow-up and data analysis, we expect to present interim data for the ongoing Phase 2 clinical trial evaluating ADU-S100 and pembrolizumab in SCCHN in the second half of 2020.

We are continuing preparations to initiate a Phase 1 clinical trial evaluating ADU-S100 as an intravesical monotherapy for non-muscle invasive bladder cancer in the second half of 2020. However, study start-up activities may be delayed.

Financial Results

Cash Position – Cash, cash equivalents and marketable securities totaled $205.9 million at March 31, 2020, compared to $213.6 million at December 31, 2019.

Revenue – Revenue was $14.0 million for the first quarter of 2020 compared to $3.9 million for the same period in 2019. The increase in revenue for the quarter was primarily due to recognition of the $10.0 million development milestone payment received under our license and research agreement with Merck.

Expenses –

Research and development expenses were $15.8 million for the first quarter of 2020 compared to $17.5 million for the same period in 2019. The quarter to date costs decreased primarily due to lower costs related to our programs that are winding down partially offset by higher costs as a result of focused spending towards our STING and APRIL programs. The decrease was also attributable to lower compensation and related personnel costs as well as stock-based compensation as compared to 2019.

General and administrative expenses were $7.8 million for the first quarter of 2020 compared to $8.2 million for the same period in 2019. The quarter to date costs decreased primarily due to lower personnel and stock-based compensation expense, as compared to 2019.

Restructuring and related expense was $4.3 million for the first quarter of 2020 compared to $3.0 million for the same period in 2019. The 2020 restructuring and related expenses consisted of severance and employee retention costs as well as the impairment of property and equipment associated with the planned closure of the Oss facility as part of the January 2020 restructuring plan. The $3.0 million restructuring and related expense recorded in 2019, which includes employee severance and retention payments, related to the January 2019 strategic reset.

Net Loss – Net loss for the first quarter of 2020 was $7.6 million or $0.09 per share compared to net loss of $23.4 million or $0.29 per share for the same period in 2019. In addition to the factors described above, the net loss was offset by approximately $5.7 million of income tax benefit related to an income tax refund resulting from the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). The income tax refund is expected to be received in the second half of 2020.

On May 4, 2020 Varian (NYSE: VAR) reported its second quarter fiscal year 2020 results (Press release, Varian Medical Systems, MAY 4, 2020, View Source [SID1234556961]).

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"On behalf of everyone at Varian, I want to express our gratitude to all individuals on the frontlines dedicated to fighting this global pandemic. I also want to thank Varian employees worldwide who continue to focus on cancer patients receiving vital care during these turbulent times," said Dow Wilson, Chief Executive Officer of Varian. "While COVID-19 has created some unique challenges, our business has solid liquidity and is well-positioned strategically and organizationally to navigate through this challenging environment, continue to grow our market leadership, and deliver best-in-class solutions to cancer patients globally."

Non-GAAP net earnings and non-GAAP net earnings per diluted share are defined as GAAP net earnings and GAAP net earnings per diluted share adjusted to exclude the amortization of intangible assets and amortization of inventory step-up, acquisition and integration-related expenses or benefits, impairment charges, significant litigation charges or benefits, legal costs, gains and losses on equity investments, and significant non-recurring tax expense or benefits. Reconciliation of GAAP and non-GAAP financial measures can be found at the end of the press release.

The company ended the quarter with $668 million in cash and cash equivalents and $521 million in debt. Net cash provided by operating activities was $22 million. During the quarter, the company invested $40 million to repurchase three hundred and fifteen thousand shares of common stock.

Impact of COVID-19 Pandemic
The impact of the pandemic in the quarter has varied by region based on the stage of containment and government actions. The impact on revenues in the quarter was primarily due to timing delays associated with installations and acceptance of the company’s products and solutions, as well as delays in the delivery of interventional oncology procedures. As shared in the March 9 press release, the preliminary impact from COVID-19 for the fiscal second quarter was limited to the Asia-Pacific geography. Between March 9 and the end of the quarter, the pandemic spread and impacted the company’s operating performance in the Americas and EMEA (Europe, Middle East, India, and Africa) geographies. The company estimates the operational delays after March 9 negatively impacted revenues in those two geographies by approximately $30 million. This was partially offset by better performance across Asia-Pacific during the last three weeks of the quarter as China and South Korea began to recover from the pandemic.

Oncology Systems Segment
Oncology Systems revenues totaled $761 million, up 2%. GAAP operating earnings were $111 million, down 16%. Gross orders were $773 million, up 1%. Gross orders in the Americas were down 3%, including North America down 1%. In EMEA, gross orders rose 11% driven by two large orders, in Russia and the United Kingdom. In Asia-Pacific, gross orders were down 5%. Gross orders globally were impacted by delays related to COVID-19.

Proton Solutions Segment
The company received two new system orders in Asia-Pacific in the quarter. Proton Solutions revenues totaled $22 million, down 32%. Operating earnings benefited from higher service revenues which were offset by project mix.

Other Segment
Revenues for the Other segment were $12 million. The Other segment is comprised of the Interventional Solutions business, including cryoablation, embolic microspheres, and microwave ablation. Additionally, it includes investments in cardiac radioablation.

Non-GAAP Adjustments
GAAP operating earnings and GAAP EPS included a $41 million impairment of loan receivables from California Proton Therapy Center and a $9 million benefit from the reversal of acquisition-related earnouts.

Guidance Withdrawn for Full Fiscal Year 2020
Since the previous update provided by the company on March 9, 2020, the severity of the COVID-19 pandemic has expanded globally and resulted in a shift in the macroeconomic environment. The uncertainty around the severity and duration of COVID-19 has impacted the company’s ability to reliably estimate the financial impact of the pandemic for the balance of the fiscal year. As a result, the company is withdrawing its fiscal year 2020 guidance. Additionally, as a precautionary measure, the company has paused share buybacks to preserve liquidity.

Investor Conference Call
Varian Medical Systems is scheduled to conduct its second quarter fiscal year 2020 conference call at 1:30 p.m. Pacific Time today. To access the live webcast or replay of the call, visit the Investor Relations page on the company’s website at www.varian.com/investors. To access the call via telephone, dial 1-877-869-3847 from inside the U.S. or 1-201-689-8261 from outside the U.S. The replay can be accessed by dialing 1-877-660-6853 from inside the U.S. or 1-201-612-7415 from outside the U.S. and entering conference ID 13700412. The teleconference replay will be available until 5:00 p.m. Pacific Time, Friday, May 8, 2020.

On May 4, 2020 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported first quarter 2020 financial results and provided a corporate update (Press release, Kura Oncology, MAY 4, 2020, View Source [SID1234556960]).

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"We recently completed a strategic review of our portfolio with the goal of prioritizing programs that have the highest potential to create value," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "As a result, we intend to enhance our focus on two major pillars of the company: our farnesyl transferase inhibitor, tipifarnib, for HRAS-dependent head and neck squamous cell carcinoma (HNSCC), including HRAS mutant and HRAS overexpressed HNSCC, as well as our menin inhibitor, KO-539, for NPM1-mutant and KMT2A(MLL)-rearranged acute myeloid leukemia (AML). This sharpened focus will enhance our efforts around each of these important programs and help to ensure that we are in a strong cash position as we navigate the challenges of the COVID-19 pandemic and continue to advance toward potential value inflection points."

Corporate Update

Prioritized development of menin inhibitor, KO-539 – KO-539 is a potent and selective small molecule inhibitor of the menin-KMT2A(MLL) protein-protein interaction with the potential to target approximately 35% of all AML. A Phase 1/2A clinical trial of KO-539 in relapsed/refractory AML, named KOMET-001, continues in dose escalation. Based on its encouraging progress in the clinic and its potential to create significant value, Kura has prioritized the development of KO-539 in NPM1-mutant and KMT2A/MLL-rearranged AML.

Three tipifarnib abstracts accepted for presentation at ASCO (Free ASCO Whitepaper) – Three abstracts highlighting data from tipifarnib in HRAS mutant solid tumors have been accepted for presentation, including an oral presentation featuring matured clinical outcome data from the Phase 2 clinical trial of tipifarnib in HRAS mutant HNSCC, at the upcoming 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program.

Expanding enrollment of AIM-HN registration-directed trial of tipifarnib in HRAS mutant HNSCC – Based on the Phase 2 dataset and feedback from treating physicians, Kura intends to amend its AIM-HN registration-directed trial to enroll all HRAS mutant HNSCC patients regardless of variant allele frequency and in doing so expand the proportion of HRAS mutant HNSCC patients who are being treated and may ultimately benefit from tipifarnib. The AIM-HN trial will continue to enroll patients while the amendment is being implemented, and the Company plans to communicate more specifics regarding the amendment following the data presentation at ASCO (Free ASCO Whitepaper). Given the proposed amendment and the ongoing impact of COVID-19 on screening and enrollment for this trial, the Company is suspending guidance on full enrollment in the AIM-HN trial until it has more clarity on timing.

HRAS overexpressing HNSCC represents a significant expansion opportunity for tipifarnib – In addition to pursuing the first registrational opportunity in recurrent or metastatic HRAS mutant HNSCC, Kura has also generated encouraging preclinical data showing the potential for tipifarnib in patients with HNSCC whose tumors overexpress the HRAS gene. It is estimated that up to 20% of HNSCC patients have tumors that overexpress HRAS, which can drive resistance to other therapies. Based upon the unmet need and its preclinical data, Kura intends to pursue the clinical development of tipifarnib in combination with other therapies as a strategy to treat HRAS overexpressing HNSCC patients.

Orphan drug designation for tipifarnib in T-cell lymphoma – Last month, the U.S. Food and Drug Administration (FDA) granted orphan drug designation to tipifarnib for the treatment of T-cell lymphoma, recognizing its potential to address a high unmet need for these patients. Although Kura continues to believe that CXCL12 pathway biomarkers have potential to unlock the therapeutic value of farnesyl transferase inhibitors across a range of hematologic and solid tumor indications, due to the challenges associated with the COVID-19 global pandemic, the Company is pausing the initiation of both its proposed registration-directed trial of tipifarnib in T-cell lymphoma and its proof-of-concept study of tipifarnib in pancreatic cancer. The Company intends to use this time to explore strategies to further optimize these opportunities for future development.

Terminating development of ERK inhibitor, KO-947 – Earlier this year, Kura’s Phase 1 trial of KO-947 was placed on a partial clinical hold due to a dose-limiting adverse drug reaction in a single patient on study. Although the Company was successful in lifting the partial clinical hold and continues to have an interest in 11q13-amplified solid tumors, Kura has opted to terminate further development of KO-947 in order to focus its resources on programs with the highest potential to benefit patients and create value.
Financial Results

Research and development expenses for the first quarter of 2020 were $12.6 million, compared to $10.4 million for the first quarter of 2019.

General and administrative expenses for the first quarter of 2020 were $7.6 million, compared to $4.6 million for the first quarter of 2019.

Net loss for the first quarter of 2020 was $19.2 million, compared to a net loss of $13.9 million for the first quarter of 2019.

Cash, cash equivalents and short-term investments totaled $216.9 million as of March 31, 2020, compared with $236.9 million as of December 31, 2019.
Conference Call and Webcast

Kura’s management will host a webcast and conference call today at 4:30 p.m. ET / 1:30 p.m. PT today, May 4, 2020, to discuss the financial results for the first quarter 2020 and provide a corporate update. The live call may be accessed by dialing (877) 516-3514 for domestic callers and +1 (281) 973-6129 for international callers and entering the conference code: 2085246. A live webcast of the call will be available from the Investors and Media section of the Company’s website at www.kuraoncology.com, and will be archived there for 30 days.