1stOncology™: Cancer Intelligence Service – Page 9977 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Evotec SE to announce results for the first nine months 2020 on 12 November 2020

On November 4, 2020 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported that it will announce its financial results for the first nine months of 2020 on Thursday, 12 November 2020 (Press release, Evotec, NOV 4, 2020, View Source;announcements/press-releases/p/evotec-se-to-announce-results-for-the-first-nine-months-2020-on-12-november-2020-5992 [SID1234569998]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

The Company is going to hold a conference call to discuss the results as well as to provide an update on its performance. The conference call will be held in English.

Webcast details

To join the audio webcast and to access the presentation slides you will find a link on our homepage www.evotec.com shortly before the event.

The access code is 315597280#. The on-demand version of the webcast will be available on our website: View Source

Oncternal Announces Third Quarter 2020 Financial Results and Provides Business Update

On November 4, 2020 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported third quarter 2020 financial results (Press release, Oncternal Therapeutics, NOV 4, 2020, View Source [SID1234569997]).

"In the third quarter we continued advancing our oncology pipeline while strengthening our balance sheet," said James Breitmeyer, M.D., Ph.D., President and CEO, Oncternal. "We expect to provide additional data updates on our clinical trials in patients with mantle cell lymphoma (MCL), Ewing sarcoma, and chronic lymphocytic leukemia (CLL) in the fourth quarter."

Recent Highlights

In July 2020, we hosted a virtual scientific presentation on the current treatment landscape of MCL, along with a discussion of our cirmtuzumab MCL clinical data set, with Dr. Michael Wang, professor of Lymphoma & Myeloma at The University of Texas MD Anderson Cancer Center. A data update from our ongoing open-label Phase 1/2 clinical trial of cirmtuzumab in combination with ibrutinib that was presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Annual Meeting in May 2020 showed a 58% complete response (CR) rate and 83% overall best objective response rate (ORR) for patients with relapsed/refractory MCL, as of the April 30, 2020 data cut-off date. Cirmtuzumab is an investigational, potentially first-in-class humanized monoclonal antibody that binds with high affinity to a biologically important epitope on ROR1 (Receptor-tyrosine kinase-like Orphan Receptor 1).
In September 2020, we met with the U.S. Food and Drug Administration (FDA) and are in a dialogue with the FDA regarding potential accelerated approval pathways for cirmtuzumab plus ibrutinib in patients with relapsed/refractory MCL.
In September 2020, a data update from the ongoing open-label Phase 1 clinical trial of TK216 in patients with relapsed or refractory Ewing sarcoma was given as an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020. The presentation included interim data for 15 evaluable patients treated at the recommended Phase 2 dose as of the August 13, 2020 data cut-off date. Two of the 15 patients had achieved complete responses (CR), including one surgical CR. Both CRs were ongoing and the patients remained on treatment. Five patients had stable disease (SD), for a disease control rate (CR, partial response or SD) of 47%. TK216 is an investigational, potentially first-in-class, targeted small-molecule inhibitor of the E26 transformation-specific (ETS) family of oncoproteins.
In October 2020, we announced that the FDA granted Rare Pediatric Disease designation for TK216 for treatment of Ewing sarcoma.
In July and September 2020, we raised an aggregate of $10.1 million in net proceeds from a registered direct offering and an underwritten offering.
Expected Upcoming Milestones

TK216 (ETS inhibitor) program
Clinical data for over 16 patients with Ewing sarcoma treated in the ongoing expansion cohort to be presented at the Connective Tissue Oncology Society (CTOS) 2020 Virtual Annual Meeting on November 11, 2020
Preclinical data in additional ETS-driven tumors in the first half of 2021
Cirmtuzumab (ROR1 antibody) programs
Clinical data update for patients with MCL and CLL treated with cirmtuzumab plus ibrutinib in the ongoing Phase 1/2 study to be presented at the American Society for Hematology (ASH) (Free ASH Whitepaper) 2020 Virtual Annual Meeting on December 7, 2020
Clinical data update for patients with HER2-negative breast cancer in the ongoing Phase 1b study in the first half of 2021
Preclinical data in additional ROR1 expressing tumors in the first half of 2021
ROR1 CAR-T program
First-in-human dosing in China in 2021
Third Quarter 2020 Financial Results
Our grant revenue was $0.6 million for the third quarter ended September 30, 2020. Our grant revenue is derived from a sub-award under a grant from CIRM to UC San Diego, which was awarded to advance our Phase 1/2 clinical trial evaluating cirmtuzumab in combination with ibrutinib for the treatment of patients with MCL or CLL.

Our total operating expenses for the third quarter ended September 30, 2020 were $5.0 million. Research and development expenses for the quarter totaled $3.0 million, and general and administrative expenses for the quarter totaled $1.9 million. Net loss for the third quarter was $4.4 million, or a loss of $0.22 per share, basic and diluted.

As of September 30, 2020, we had $21.3 million in cash and cash equivalents. We believe our current funds will be sufficient to fund our planned operations into the second quarter of 2021. As of September 30, 2020, we had 22.3 million shares of common stock outstanding.

Mirati Therapeutics Reports Third Quarter 2020 Financial Results And Recent Business Highlights

On November 4, 2020 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported financial results for the third quarter ended September 30, 2020 and recent business highlights (Press release, Mirati, NOV 4, 2020, View Source [SID1234569996]).

"The third quarter was notable for significant progress and we have begun the fourth quarter with positive momentum. At the 32nd EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Therapeutics last week, we presented preliminary adagrasib (MRTX849) data across multiple tumors, which highlighted the potential for this exciting and differentiated program. We have completed enrollment in our Phase 2 potentially registration-enabling monotherapy trial in 2nd or 3rd line non-small cell lung cancer patients, which will enable our anticipated NDA filing to the FDA for accelerated approval in the second half of 2021." said Dr. Charles M. Baum, President and Chief Executive Officer at Mirati Therapeutics, Inc. "We presented the first preclinical data for MRTX1133, a potentially first in class, potent, selective and reversible inhibitor of KRAS G12D in both its active and inactive states. MRTX1133 demonstrated significant tumor regression in several preclinical tumor models, and we anticipate filing an IND in the first half of 2021. Our recent public offering provides the resources to accelerate and expand development across our pipeline, including sitravatinib, adagrasib, MRTX1133 and discovery programs, as we continue to build our organization, prepare for commercialization and strive to bring novel therapies to cancer patients and their families."

Recent Corporate Updates:

Adagrasib (MRTX849, KRAS G12C Selective Inhibitor)

Presented preliminary updated data in non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and other solid tumors at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) virtual conference
Completed enrollment in the single-agent Phase 2 registrational arm in 2nd or 3rd line therapy in NSCLC
Announced clinical collaboration with Boehringer Ingelheim to study BI 1701963, a SOS1::pan-KRAS inhibitor, in combination with adagrasib
MRTX1133 (KRAS G12D Selective Inhibitor)

Reported initial preclinical data demonstrating significant tumor regression in several tumor models
Sitravatinib

Presented updated clinical results from Phase 2 clinical trial evaluating sitravatinib in combination with nivolumab (OPDIVO) in patients with advanced or metastatic urothelial carcinoma at the ESMO (Free ESMO Whitepaper) Virtual Congress
Enrollment is on-going in the Phase 3 SAPPHIRE clinical trial in combination with nivolumab (OPDIVO) in 2nd or 3rd line NSCLC patients
Operational Update

Ended the third quarter with $579.1 million in cash, cash equivalents, and short-term investments and, in addition, strengthened our balance sheet by completing a public offering of common stock on October 30, 2020 that provided estimated net proceeds of $879.7 million
Financial Results for the Third Quarter 2020

License and collaboration revenues for the three months ended September 30, 2020, were $11.4 million, and relate to a license agreement with ORIC Pharmaceuticals, Inc. ("ORIC") pursuant to which the Company granted to ORIC an exclusive, worldwide license to develop and commercialize the Company’s allosteric polycomb repressive complex 2 (PRC2) inhibitors for all indications. License and collaboration revenues for the nine months ended September 30, 2020 were $11.7 million and related primarily to the ORIC license transfer described above, as well as $0.3 million related to the manufacturing supply services agreement with BeiGene. License and collaboration revenues for the three and nine months ended September 30, 2019 were $1.0 million and $2.8 million, respectively, and relate to the manufacturing supply services agreement with BeiGene.

Research and development expenses for the third quarter of 2020 were $79.9 million, compared to $47.4 million for the same period in 2019. Research and development expenses for the nine months ended September 30, 2020 were $216.6 million, compared to $119.9 million for the same period in 2019. The increase in research and development expenses is due to an increase in expense associated with the development of adagrasib (MRTX849), MRTX1133, and other preclinical and early discovery activities, as well as an increase in salaries and related expense, including an increase in share-based compensation expense. The Company recognized research and development-related share-based compensation expenses of $12.6 million during the third quarter of 2020, compared to $8.6 million for the same period in 2019, and $35.9 million during the nine months ended September 30, 2020, compared to $20.4 million for the same period in 2019.

General and administrative expenses for the third quarter of 2020 were $20.2 million, compared to $10.7 million for the same period in 2019. General and administrative expenses for the nine months ended September 30, 2020 were $58.1 million, compared to $30.3 million for the same period in 2019. The increase is due primarily to an increase in share-based compensation expense and an increase in employee-related expenses and professional service expense. The Company recognized general and administrative-related share-based compensation expenses of $9.2 million during the third quarter of 2020, compared to $6.5 million for the same period in 2019, and $28.2 million during the nine months ended September 30, 2020, compared to $18.4 million for the same period in 2019.

Net loss for the third quarter of 2020 was $87.3 million, or $1.96 per share basic and diluted, compared to net loss of $54.3 million, or $1.38 per share basic and diluted for the same period in 2019. Net loss for the nine months ended September 30, 2020 was $256.9 million, or $5.87 per share basic and diluted, compared to net loss of $140.9 million, or $3.83 per share basic and diluted for the same period in 2019.

Cash, cash equivalents, and short-term investments were $579.1 million at September 30, 2020.

Checkpoint Therapeutics Reports Third Quarter 2020 Financial Results and Recent Corporate Highlight

On November 4, 2020 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers, reported financial results for the third quarter ended September 30, 2020, and recent corporate highlights (Press release, Checkpoint Therapeutics, NOV 4, 2020, View Source [SID1234569995]).

James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "We are excited to have presented updated positive interim results from the ongoing registration-enabling clinical trial of cosibelimab for the treatment of metastatic cutaneous squamous cell carcinoma ("mCSCC") at the European Society for Medical Oncology ("ESMO") Virtual Congress 2020. These compelling data underscore cosibelimab’s potential to be best-in-class. We expect to complete enrollment of the registration-enabling cohort in mCSCC in early 2021 and anticipate reporting top-line results in the second half of the year. Based on our planned pricing strategy, we believe cosibelimab can be a market-disruptive product in the $25 billion PD-(L)1 class. Importantly, in order to support the continued development of cosibelimab, as well as our broader oncology pipeline, we expanded our cash runway through the successful completion of a $20.5 million financing during the third quarter."

Recent Corporate Highlights:

In September 2020, Checkpoint announced updated positive interim results from the ongoing global, open-label, multicohort, Phase 1 clinical trial of its anti-PD-L1 antibody, cosibelimab, in patients with advanced cancers, including the registration-enabling cohort of patients with mCSCC. Cosibelimab demonstrated a 51.4% objective response rate ("ORR") and 13.5% complete response rate, which is nearly double the complete response rate observed at the time of previous analysis. These interim data were presented at the ESMO (Free ESMO Whitepaper) Virtual Congress 2020.
In September 2020, Checkpoint closed on gross total of approximately $20.5 million in an underwritten public offering of its common stock before deducting underwriting discounts and commissions and other offering-related expenses.
Earlier this month, Checkpoint announced the expansion of a long-term manufacturing partnership for cosibelimab with Samsung Biologics. Building upon an existing contract manufacturing agreement entered into in 2017, Samsung Biologics will provide additional commercial-scale drug substance manufacturing for cosibelimab.
Financial Results:

Cash Position: As of September 30, 2020, Checkpoint’s cash and cash equivalents totaled $42.0 million, compared to $26.1 million as of December 31, 2019, an increase of $15.9 million year-to-date.
R&D Expenses: Research and development expenses for the third quarter of 2020 were $2.5 million, compared to $3.9 million for the third quarter of 2019, a decrease of $1.4 million. Research and development expenses for the third quarters of 2020 and 2019 each included $0.2 million of non-cash stock expenses.
G&A Expenses: General and administrative expenses for the third quarter of 2020 were $2.4 million, compared to $1.6 million for the third quarter of 2019, an increase of $0.8 million. General and administrative expenses for the third quarter of 2020 included $1.3 million of non-cash stock expenses, compared to $0.7 million in stock compensation expense for the third quarter of 2019.
Net Loss: Net loss attributable to common stockholders for the third quarter of 2020 was $4.9 million, or $0.09 per share, compared to a net loss of $5.2 million, or $0.15 per share, in the third quarter of 2019.

Harpoon Therapeutics Reports Third Quarter 2020 Financial Results and Provides Corporate Update

On November 4, 2020 Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, reported financial results for the third quarter ended September 30, 2020 and provided a corporate update (Press release, Harpoon Therapeutics, NOV 4, 2020, View Source [SID1234569994]).

"We continue to be excited by the advancement of our novel TriTAC pipeline, and are planning for our fourth program, HPN328, to enter the clinic this year for the treatment of DLL3-expressing tumors including small cell lung cancer," said Gerald McMahon, Ph.D., President and Chief Executive Officer of Harpoon Therapeutics. "Additionally, we expect to advance our HPN424, HPN536, and HPN217 clinical programs in the fourth quarter and present preclinical data at SITC (Free SITC Whitepaper) for our first ProTriTAC development program, HPN601, for the treatment of solid tumor malignancies."

Third Quarter 2020 Business Highlights and Other Recent Developments

Harpoon remains on track to initiate a Phase 1/2 clinical trial for HPN328 in the fourth quarter, which will be our fourth TriTAC in clinical development. HPN328 targets Delta-like canonical Notch ligand 3 (DLL3) for the treatment of small cell lung cancer (SCLC) and other DLL3-expressing tumors.
Harpoon has nominated its first ProTriTAC product candidate, HPN601, which targets epithelial cell adhesion molecule (EpCAM), and is applicable to a wide array of solid tumors. ProTriTACs have the potential for additional tumor specificity and enhanced safety profiles due to limited interaction with their molecular targets in healthy tissue, which enables targeting tumor-associated antigens that may be more broadly expressed. Furthermore, a HPN601 preclinical data abstract has been selected for an oral presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting on November 12.
Harpoon continues to expand the expertise within its executive team. In August, Harpoon appointed Karin Ann Thacker, M.Sc., as Vice President, Regulatory Affairs and Quality Assurance. In October, Harpoon appointed Omer Siddiqui as Vice President, Development Operations and Program Management. Both Ms. Thacker and Mr. Siddiqui are recognized R&D leaders in oncology across both early and late-stage clinical development.
In July, Harpoon appointed Joanne Viney, Ph.D., to its board of directors as an independent board member. Dr. Viney is an entrepreneurial scientist and experienced biotech executive with deep autoimmune and inflammatory disease expertise and currently serves as President, CSO and Co-founder of Pandion Therapeutics.
Third Quarter 2020 Financial Results

Harpoon ended the third quarter of 2020 with $162.3 million in cash, cash equivalents, and marketable securities compared to $155.1 million as of December 31, 2019. The increase was due primarily to a $50.0 million milestone payment received from AbbVie in the second quarter, partially offset by cash used in operations.
Revenue for the third quarter ended September 30, 2020 was $3.9 million compared to $1.4 million for the third quarter ended September 30, 2019. For the nine months ended September 30, 2020, revenue was $10.0 million compared to $3.5 million for the nine months ended September 30, 2019. During both the three and nine month periods, the increase in revenue was primarily due to revenue recognized from the development and option agreement with AbbVie, signed in November 2019.
Research and development (R&D) expense for the third quarter ended September 30, 2020 was $13.1 million compared to $9.5 million for the third quarter ended September 30, 2019. For the nine months ended September 30, 2020, R&D expense was $37.5 million, compared to $28.9 million for the nine months ended September 30, 2019. The increase for both periods primarily arose from higher clinical development and personnel-related expense, which included conducting preclinical studies and the continuation and preparation of the clinical trials for HPN424, HPN536, HPN217 and HPN328. These higher expenses were offset by a decrease in manufacturing costs due to a scale up of manufacturing activities in 2019 compared to 2020 to support our four TriTAC product candidates in various stages of development.
General and administrative (G&A) expense for the third quarter ended September 30, 2020 was $4.4 million compared to $8.5 million for the third quarter ended September 30, 2019. G&A expense for the nine months ended September 30, 2020 was $12.3 million compared to $18.1 million for the nine months ended September 30, 2019. For the third quarter ended September 30, 2020, the decrease was primarily attributable to a decrease in legal expenses associated with the Maverick litigation, partially offset by an increase in personnel expenses due to an increase in headcount. For the nine months ended September 30, 2020, the decrease was primarily attributable to a decrease in legal expenses associated with Maverick litigation, partially offset by an increase in personnel expenses related to an increase in headcount and other professional services to support our operations as a public company.
Net loss for the third quarter ended September 30, 2020 was $13.3 million compared to $15.9 million for the third quarter ended September 30, 2019. The net loss for the nine months ended September 30, 2020 was $38.6 million compared to $41.3 million in the first nine months of the prior year.
COVID-19 Business Update

In response to the ongoing COVID-19 pandemic, Harpoon has established testing and other protocols for personnel access to its headquarter offices and laboratory although substantially all of the company’s employees continue to telecommute. Harpoon is currently continuing its clinical trials it has underway at sites in the United States, and has not yet experienced any material delays or impacts as a result of the pandemic. In addition, Harpoon’s third-party contract manufacturers continue to operate at or near normal levels. Harpoon continues to assess the potential impact of the COVID-19 pandemic on its business and operations, including its programs, expected timelines, expenses, manufacturing activities and preclinical and clinical trials. The full extent to which the COVID-19 pandemic may have a negative impact on Harpoon’s business, assets, results of operations and financial condition will depend on future developments that are highly uncertain and cannot be accurately predicted.