On August 11, 2022 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported financial results for the three-month period ended June 30, 2022 and provided a corporate update (Press release, Spectrum Pharmaceuticals, AUG 11, 2022, View Source [SID1234618092]).

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"The completion of the FDA re-inspection of the drug substance facility for eflapegrastim is a critical step in the regulatory review process. With this hurdle behind us, we have turned our focus to our potential approval and commercialization," said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals. "Additionally, our team is engaged in extensive preparations ahead of poziotinib’s ODAC review in September, and we look forward to moving a step closer to bringing this therapy to patients."

Pipeline Updates

Eflapegrastim, a novel long-acting G-CSF

The Biologics License Application (BLA) for eflapegrastim is under active review at the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) date of September 9, 2022. The pre-approval inspection of the drug substance manufacturing facility has been completed by the FDA. The company anticipates an FDA decision by the PDUFA date and is actively preparing for the potential commercial launch.
Poziotinib, a Pan ErbB inhibitor targeting HER2 exon 20 mutations

The New Drug Application (NDA) for poziotinib is under active review at the FDA with Fast Track designation and a PDUFA date of November 24, 2022. The NDA is based on the positive results of Cohort 2 from the ZENITH20 clinical trial in patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2 exon 20 insertion mutations. There is currently no FDA approved therapy for patients with NSCLC harboring HER2 exon 20 insertion mutations.
An abstract showing a high level of activity for poziotinib in patients with a G778_P780dup mutation, the second most prevalent mutation in HER2 exon 20 NSCLC, has been accepted for presentation at ESMO (Free ESMO Whitepaper) 2022 being held September 9-13 in Paris. The data comes from Cohorts 2 and 4 of the ZENITH20 clinical trial.
A study for poziotinib is in progress to confirm the clinical benefit seen in Cohort 2, as required for an accelerated approval. The trial, Study SPI-POZ-301 (PINNACLE), is designed to enroll 268 patients with previously treated NSCLC harboring HER2 exon 20 mutations. Patients are being randomized 2-to-1 into one of two treatment arms using 8mg of poziotinib orally administered BID (twice daily) versus 75mg/m2 of docetaxel administered intravenously every three weeks. The primary endpoint is progression free survival.
The FDA’s Oncologic Drugs Advisory Committee (ODAC) is scheduled to review poziotinib for the treatment of patients with previously treated locally advanced or metastatic NSCLC harboring HER2 exon 20 insertion mutations. The poziotinib ODAC review is scheduled for September 22, 2022 at 9 a.m. ET. ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational products for use in the treatment of cancer and makes non-binding recommendations to the FDA. The final decision regarding the approval of the product is made solely by the FDA.
The company presented data on the predictive ability of circulating tumor DNA (ctDNA) in poziotinib treated patients with NSCLC harboring HER2 exon 20 insertion mutations at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June. Preliminary results suggest that decreases in plasma ctDNA during poziotinib therapy correlate with clinical response in patients with advanced NSCLC with HER2 exon 20 insertion mutations.
Three-Month Period Ended June 30, 2022 (All numbers are from Continuing Operations)

Spectrum recorded a net loss of $29.0 million, or a $0.17 loss per basic and diluted share, in the three-month period ended June 30, 2022, compared to a net loss of $49.9 million, or a $0.32 loss per basic and diluted share, in the comparable period in 2021. Total research and development expenses were $16.0 million in the quarter, as compared to $29.1 million in the same period in 2021. Selling, general and administrative expenses were $9.4 million in the quarter, compared to $15.0 million in the same period in 2021.

Cash Position and Guidance

The company’s cash, cash equivalents and marketable securities balance was approximately $68 million at June 30, 2022, which provides for a cash runway into 2023.

Conference Call

Thursday, August 11, 2022 @ 8:30 a.m. Eastern/5:30 a.m. Pacific

To access the live call by phone, please go to this link (registration link), and you will be provided with dial in details. To avoid delays, participants are encouraged to dial into the conference call fifteen minutes ahead of the scheduled start time.

This conference call will also be webcast. Listeners may access the webcast, which will be available on the investor relations page of Spectrum Pharmaceuticals’ website: View Source on August 11, 2022 at 8:30 a.m. Eastern/5:30 a.m. Pacific.

On August 11, 2022 NeuBase Therapeutics, Inc. (Nasdaq: NBSE) ("NeuBase" or the "Company"), a biotechnology platform company Drugging the Genome to address disease at the base level using a new class of precision genetic medicines, reported its financial results for the three-month period ended June 30, 2022, and other recent developments (Press release, NeuBase Therapeutics, AUG 11, 2022, View Source [SID1234618091]).

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"Thus far in 2022, we have generated new data that strengthens application of the PATrOLTM platform and its potential to output novel genetic medicines that are broadly biodistributed after systemic routes of administration and engage double-stranded nucleic acid targets in the nucleus to resolve gene dysfunction. This includes new PK and biodistribution data for our DM1 development candidate, which were presented at the ASGCT (Free ASGCT Whitepaper) 25th Annual Meeting, that support a differentiated whole-body solution for DM1 patients," said Dietrich A. Stephan, Ph.D., Founder, Chief Executive Officer, and Chairman of NeuBase. "The data in each tissue we evaluated also displayed an extended elimination phase with tissue concentrations measurable for at least four weeks following a single intravenous (IV) dose administration and consistent with the durable pharmacology in the transgenic animal models. With these data in hand, we decided to perform additional IND-enabling studies to further characterize our development candidate and confirm our expectations of safety and efficacy. While conducting these additional studies will require us to push our guidance on the timing for our DM1 IND filing to mid-CY2023, patient safety and benefit are of utmost importance to us. We also believe the information that will be generated by these studies will benefit not only our DM1 program but all of our programs and better prepare us to enter the clinic and fulfill our mission of delivering new medicines to patients who currently have no therapeutic options."

Dr. Stephan continued, "We continue to generate positive data from other programs in our pipeline, including in HD, that support the ability of the PATrOLTM platform to develop differentiated genetic medicines. We are confident in the ability of our platform and team to advance these drug candidates to clinical trials, and we look forward to providing further updates on our progress."

Third Quarter of Fiscal Year 2022 and Recent Operating Highlights

Myotonic Dystrophy Type 1 (DM1) Program: NeuBase is making steady progress advancing IND-enabling studies for its development candidate in the DM1 program, which includes PK, absorption, distribution, metabolism, and excretion (ADME), and bioavailability via IV and subcutaneous routes of administration, exploratory and IND-enabling Good Laboratory Practice (GLP) toxicology, and mechanism of action studies. In addition, Good Manufacturing Practice (GMP) of NeuBase’s development candidate to support Phase 1/2 clinical trials has been successfully implemented via contract manufacturing organizations.
In May 2022, the Company presented preclinical PK and biodistribution data at the ASGCT (Free ASGCT Whitepaper) 25th Annual Meeting for its lead development candidate, NT-0231.F, supporting a differentiated whole body treatment solution for DM1. Following a single IV injection of 30 mg/kg in wild-type BALB/c mice, NT-0231.F was cleared rapidly from the systemic compartment and demonstrated rapid and wide distribution into tibialis anterior muscle, heart muscle, and brain tissues. NT-0231.F rapidly cleared the plasma, and each tissue evaluated displayed an extended elimination phase with tissue concentrations measurable for at least four weeks following a single IV dose administration.
Completed exploratory toxicology work in non-human primates and rats.
Initiated a collaboration with Inserm to further study NT-0231.F using the DMSXL mouse model to measure central nervous system and heart pharmacology and to refine the human equivalent dose.
Committed to support the Myotonic Dystrophy Clinical Research Network, the world’s largest patient organization focused solely on myotonic dystrophy.
The Company expects to submit an IND application to the FDA for NT-0231.F in mid-CY2023.
Huntington’s Disease (HD) Program: Preclinical development activities in the Company’s HD program progressed during the second quarter of CY2022. During the second half of CY2022, NeuBase expects to present new preclinical data at upcoming scientific conferences describing the pharmacology of a candidate compound in the brain after systemic administration, nominate a development candidate, and initiate scale-up and toxicology activities.
KRAS Oncology Program: The Company continued in vitro mechanistic studies and in vivo pharmacology studies for the KRAS program (KRAS G12V and G12D mutations) to support the development of an allele-selective approach to engaging mutant KRAS at the DNA and RNA levels.
Management Update: William (Bill) Mann, Ph.D. was promoted to President of the Company. Dr. Mann continues to serve as NeuBase’s Chief Operating Officer.
Financial Results for the Third Fiscal Quarter Ended June 30, 2022

As of June 30, 2022, the Company had cash and cash equivalents of approximately $29.8 million, compared with approximately $52.9 million as of September 30, 2021.
For the fiscal quarter ended June 30, 2022, the Company reported a net loss of approximately $8.5 million, or a net loss of $0.26 per share, compared with a net loss of approximately $8.7 million, or a net loss of $0.29 per share, for the same period last year.
For the fiscal quarter ended June 30, 2022, total operating expenses were approximately $8.4 million, consisting of approximately $3.6 million in general and administrative expenses and $4.8 million of research and development expenses. This compares with total operating expenses of approximately $8.8 million for the same period last year, consisting of approximately $3.5 million in general and administrative expenses and $5.3 million in research and development expenses.
Financial Results for the Nine-Month Period Ended June 30, 2022

For the nine-month period ended June 30, 2022, the Company reported a net loss of approximately $26.1 million, or a net loss of $0.80 per share, compared with a net loss of approximately $18.3 million, or a net loss of $0.72 per share, for the same period last year.
For the nine-month period ended June 30, 2022, total operating expenses were approximately $25.6 million, consisting of approximately $9.6 million in general and administrative expenses and $16.0 million of research and development expenses. This compares with total operating expenses of approximately $19.4 million for the same period last year, consisting of approximately $8.8 million in general and administrative expenses and $10.6 million in research and development expenses.

On August 11, 2022 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapies based on its proprietary arenavirus platform, reported financial results for the second quarter of 2022 and Company updates (Press release, Hookipa Biotech, AUG 11, 2022, View Source [SID1234618090]).

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"We continued to observe validation of our novel arenaviral platform in the second quarter with key Phase 1 data presented at ASCO (Free ASCO Whitepaper) for HB-200 in head and neck cancer and our plans to move forward with the Phase 2 program," said Joern Aldag, Chief Executive Officer at HOOKIPA. "We have expanded our clinical portfolio with the concurrent FDA acceptance of our investigational new drug application for HB-300 in prostate cancer and our Drug Master File. The Drug Master File is significant as it supports the implementation of our platform approach, facilitating reduced cycle time between preclinical studies and clinical entry of our pipeline projects across various cancer types."

HOOKIPA Portfolio Highlights

In July, HOOKIPA announced that the US FDA accepted HOOKIPA’s Investigational New Drug Application for HB-300 for the treatment of metastatic castration-resistant prostate cancer. A Drug Master File was also accepted, facilitating reduced cycle time between completion of preclinical studies and clinical entry of HOOKIPA’s pipeline projects.

In June, HOOKIPA announced positive Phase 1 data and Phase 2 plans for HB-200 for the treatment of advanced head and neck cancers at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Alternating 2-vector therapy showed superior antigen-specific T cell responses, more robust anti-tumor activity and similar tolerability vs. single-vector therapy. The Phase 2 trial will proceed with alternating 2-vector therapy alone and in combination with pembrolizumab, which will help inform the randomized Phase 2 trial planned to start in the first half of 2023.

In June, HOOKIPA presented preclinical data on its novel arenaviral HIV therapeutic vaccines. The data were presented at the Keystone Symposium and highlighted robust and high-quality immune responses following administration of arenaviral therapeutic vaccines in a preclinical setting. Alternating 2-vector therapy induced greater immune response than single-vector therapy, translating to a significant reduction in viral load.

In April, new data were announced at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting showing HOOKIPA’s arenaviral immunotherapies induced potent T cell responses in novel combinations and against tumor self-antigens. Preclinical data also expanded evidence on arenaviral immunotherapy targeting self-antigens, reinforcing the scientific approach for the HB-300 program in prostate cancer.
HOOKIPA Leadership Updates

In May, HOOKIPA announced the promotion of Christine D. Baker to Chief Operating Officer. Baker was previously Chief Business Officer for HOOKIPA.

In June, HOOKIPA announced several executive leadership changes. Igor Matushansky, Chief Medical Officer and Global Head of Research and Development transitioned to Chair of HOOKIPA’s Scientific Advisory Board. Katia Schlienger, Senior Vice President and Head of Immuno-oncology was promoted to Executive Vice President, Clinical Development. Roman Necina, Chief Technology Officer, was appointed to the newly created role of Chief Development Officer.
Upcoming Anticipated Milestones

Phase 2 HB-200 data in combination with pembrolizumab in HPV16+ head and neck cancer:
First-line initial data expected in the second half of 2022
Second-line initial data expected in the second half of 2022

Randomized Phase 2 HB-200 study in combination with pembrolizumab in first-line for HPV16+ HNSCC: First half of 2023 (Fast Track designation)

Hepatitis B therapeutic IND: 2022 (Gilead-led)

Prostate cancer First Patient Enrolled expected in first quarter of 2023
Second Quarter 2022 Financial Results

Cash Position: HOOKIPA’s cash, cash equivalents and restricted cash as of June 30, 2022 was $118.9 million compared to $66.9 million as of December 31, 2021. The increase was primarily attributable to funds resulting from the amended and restated Gilead collaboration agreement and the follow-on financing in March 2022, partly offset by cash used in operating activities.

Revenue was $2.7 million for the three months ended June 30, 2022, compared to $5.4 million for the three months ended June 30, 2021. The decrease was primarily due to lower cost reimbursements received under the Collaboration Agreement with Gilead. The $4.0 million milestone payment and the $15.0 million initiation fee received in the three months ended March 31, 2022 largely remained recorded as deferred revenue to be recognized in future accounting periods.

Research and Development Expenses: HOOKIPA’s research and development expenses were $16.1 million for the three months ended June 30, 2022, compared to $19.6 million for the three months ended June 30, 2021. The decrease for the three months ended June 30, 2022 compared to the three months ended June 30, 2021 was primarily driven by lower manufacturing expenses for our HB-200 and Gilead partnered programs, a decrease in personnel-related expenses including stock-based compensation, and a decrease in laboratory consumables that was partially offset by an increase in professional and consulting fees and an increase in training and recruitment expenses.

General and Administrative Expenses: General and administrative expenses for the three months ended June 30, 2022 were $5.0 million, compared to $5.1 million for the three months ended June 30, 2021. The decrease was primarily due to a decrease in personnel-related expenses and a decrease in other expenses that was partially offset by an increase in professional and consulting fees. The decrease in personnel-related expenses resulted from decreased stock compensation expenses and the conversion of a portion of the base salaries of the Company’s executive team for the six months ended June 30, 2022 into common stock with a fair value below the conversion rate, that was partially offset by a growth in headcount along with increased salaries in our general and administrative functions.

Net Loss: HOOKIPA’s net loss was $16.4 million for the three months ended June 30, 2022 compared to a net loss of $17.2 million for the three months ended June 30, 2021. This decrease was primarily due to a decrease in research and development expenses.

On August 11, 2022 Cardinal Health (NYSE: CAH) reported that its Board of Directors has elected Jason Hollar as the company’s next Chief Executive Officer, effective September 1, 2022 (Press release, Cardinal Health, AUG 11, 2022, View Source [SID1234618089]). Hollar will also join the Board of Directors effective August 11, 2022. Hollar will succeed current Chief Executive Officer, Mike Kaufmann.

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Hollar, an experienced financial and operating executive, has served as Cardinal Health’s Chief Financial Officer since May 2020, leading financial activities across the enterprise, including financial strategy, capital deployment, treasury, tax, investor relations, risk management, accounting and reporting. During his tenure, he has helped Cardinal Health prioritize investments in growth businesses, strengthened the balance sheet, and returned capital to shareholders. Prior to joining Cardinal Health, Hollar served as Chief Financial Officer and Executive Vice President for Tenneco. Before that, Hollar served as Chief Financial Officer and Senior Vice President of finance for Sears Holdings Corporation.

In addition, Patricia English will serve as Cardinal Health’s interim Chief Financial Officer, working with Hollar to ensure a smooth transition. English currently serves as Chief Accounting Officer and Senior Vice President of Cardinal Health and previously served as Vice President of accounting in both the pharmaceutical and medical segments. Cardinal Health’s Board will engage an executive search firm to evaluate candidates for the permanent Chief Financial Officer position.

"Mike has been a tremendous leader during his tenure at Cardinal Health, helping the company navigate a period of unprecedented challenges, directing strategic investments for growth and innovation, and cultivating an inclusive and vibrant workforce culture. We are grateful for Mike’s many contributions over his more than 30 years of service and wish him the best in his future endeavors," said Gregory Kenny, Cardinal Health’s Independent Chairman of the Board. "We look forward to leveraging Jason’s broad executive experience and are confident in his ability to lead Cardinal Health on a path to long-term growth."

Kaufmann said, "I am grateful for the privilege of serving alongside such a dedicated, purpose-driven, and talented team over the past three decades. It was truly the honor of a lifetime to serve as CEO of Cardinal Health these last five years. The Board and I are confident that Jason is the right person to lead Cardinal Health in the years to come."

Hollar said, "I sincerely appreciate the confidence the Board has placed in me to help position the company for future growth. This is a transformational period at Cardinal Health and I am humbled to have the opportunity to lead a business that plays such a vital role in the healthcare ecosystem. I look forward to working closely with Cardinal Health’s talented employees, management team, and Board as we continue to build upon our strong foundation and deliver value to our customers, communities and shareholders."

Hollar continued, "I also look forward to continuing to work alongside Trish, who has been a valuable member of the Cardinal Health family for over sixteen years. She brings a strong combination of financial expertise and leadership experience to the role as interim Chief Financial Officer."

About Jason Hollar
Jason Hollar has been Chief Financial Officer of Cardinal Health since May 2020, leading financial activities across the enterprise including financial strategy, capital deployment, treasury, tax, investor relations, accounting and reporting. Hollar has deep executive experience as well as expertise leading in dynamic environments, most recently serving as the Chief Financial Officer of Tenneco Inc., a global automotive products and services company. As Tenneco’s Executive Vice President and Chief Financial Officer, Hollar was responsible for financial planning and analysis, accounting and reporting, tax, treasury and investor relations for the company. Hollar joined Tenneco in June 2017 from Sears Holdings Corporation, where he served as Chief Financial Officer and Senior Vice president finance. Prior to Sears, Hollar worked with both Delphi Automotive and Navistar International in a number of senior finance roles. He served as Delphi’s corporate controller and as Vice President of finance for the company’s powertrain systems division, which also included oversight of the Europe, Middle East and Africa regions. At Navistar, he held finance positions of increasing responsibility in the company’s engine group, South America operations and corporate financial planning and analysis. Hollar received his Master of Business Administration from The University of Chicago and his bachelor’s degree in business from Indiana University.

About Patricia English
Patricia English has served as Chief Accounting Officer and Senior Vice President of Cardinal Health since September 2020. She previously served as Vice President, pharmaceutical segment accounting at Cardinal Health from January 2019 to August 2020. She also served as Vice President, medical segment accounting from March 2015 to December 2018 and as director, pharmaceutical distribution accounting from June 2011 to March 2015. English holds a bachelor’s degree in accounting from The Ohio State University.

Webcast
Cardinal Health will host a webcast today at 8:30 a.m. Eastern to discuss fourth quarter and full year results. To access the webcast and corresponding slide presentation, go to the Investor Relations page at ir.cardinalhealth.com. No access code is required. Presentation slides and a webcast replay will be available until August 10, 2023.

On August 11, 2022 Targovax ASA (OSE: TRVX) reported that it will announce its second quarter and first half 2022 results on Thursday 18 August 2022 (Press release, Targovax, AUG 11, 2022, View Source [SID1234618084]). Targovax’s management will present the results at a live streamed webcast at 10:00 am CET to investors, analysts and the press.

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The results report and the presentation will be available at www.targovax.com in the Investors section from 07:00 am CET, on 18 August 2022.

Presentation

There will be a virtual presentation of the results with a live webcast 18 August at 10.00 am CET. You can join the webcast here. It will be possible to ask questions during the presentation.