On November 8, 2022 NuCana plc (NASDAQ: NCNA) reported that Hugh Griffith, Chief Executive Officer, and Don Munoz, Chief Financial Officer, will present and host one-on-one meetings at the Jefferies London Healthcare Conference (Press release, Nucana BioPharmaceuticals, NOV 8, 2022, View Source [SID1234623374]).

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The presentation will be webcast live and available for replay under "Events & Presentations" in the Investors section of the Company’s website at www.nucana.com.

On November 8, 2022 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of MasterKey therapies, reported financial results for the third quarter ended September 30, 2022 and provided a corporate update (Press release, Black Diamond Therapeutics, NOV 8, 2022, View Source [SID1234623373]).

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"We continue to focus on advancement of our lead programs while leveraging our Mutation-Allostery-Pharmacology (MAP) Drug Discovery Engine for discovery of new MasterKey therapies. Our differentiated approach to precision cancer medicine research has the potential to address substantial unmet need of patients with genetically defined cancers. Our recent preclinical posters at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium further demonstrate our unique approach to developing groundbreaking therapeutics that can target families of oncogenic mutations by employing protein conformation-based drug design. We are gearing up for several upcoming clinical and preclinical milestones in the year ahead, most importantly our first clinical update on the BDTX-1535 program in patients with resistant EGFR mutations in NSCLC and patients with GBM harboring EGFR alterations expected in 2023. We also look forward to submitting an IND for BDTX-4933, our brain penetrant BRAF MasterKey inhibitor, in the first half of 2023," said David Epstein, Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "With a proprietary drug discovery engine, intelligent trial design and a growing pipeline of novel MasterKey therapies, we believe Black Diamond is well-positioned to execute across our near- and long-term goals."

Recent Developments

BDTX-1535:

BDTX-1535 is designed to be a potent, selective, irreversible (covalent) and brain-penetrant MasterKey inhibitor of epidermal growth factor receptor (EGFR) mutations expressed in glioblastoma multiforme (GBM) and resistance mutations in non-small cell lung cancer (NSCLC), including de novo resistance and acquired resistance to third generation EGFR inhibitors. BDTX-1535 is currently being evaluated in a Phase 1 Study in GBM patients with EGFR alterations and NSCLC patients with EGFR resistance mutations and was designed using Black Diamond’s proprietary MAP Drug Discovery Engine to target the common, activated conformations used by oncogenic EGFR to drive tumor cell growth in GBM and NSCLC.
In October 2022, Black Diamond presented two posters at the 34th European Organisation for Research and Treatment of Cancer—National Cancer Institute—American Association for Cancer Research (EORTC-NCI-AACR) (Free EORTC-NCI-AACR Whitepaper) Symposium in Barcelona, Spain, with new preclinical data:
Showcasing BDTX-1535’s preclinical exposure and anti-tumor activity across patient derived xenograft (PDX) and allograft models of both NSCLC and GBM;
Demonstrating that multiple EGFR extracellular domain alterations, which can form active covalent homodimers and result in paradoxical EGFR activation by reversible inhibitors, are blocked by the irreversible CNS penetrant inhibitor BDTX-1535;
Outlining features of BDTX-1535 that are believed to be essential for an effective EGFR blockade in GBM, including highly potent targeting of the family of oncogenic EGFR alterations in GBM while sparing inhibition of wild type (WT) EGFR, high CNS penetrance, and an avoidance of paradoxical activation through irreversible inhibition of oncogenic EGFR;
Describing the significant unmet clinical need of NSCLC patients with acquired and intrinsic resistance EGFR mutations against 3rd generation EGFR tyrosine kinase inhibitors (TKIs) which is potentially addressed by BDTX-1535 targeting activated conformations of EGFR caused by these alterations; and
Highlighting that BDTX-1535 is designed using Black Diamond’s proprietary MAP Drug Discovery Engine to target common activated EGFR conformations in NSCLC which result from multiple classical, intrinsic, and acquired oncogenic alterations including C797S, L718Q, G724S, and S768I mutations.
The Company remains on track to provide a clinical update on BDTX-1535 in 2023.
BDTX-4933:

BDTX-4933 is designed to be a highly potent brain-penetrant BRAF MasterKey inhibitor against Class I, II, and III BRAF mutations, together with MAPK pathway alterations that promote activated RAF conformations, with the ability to avoid paradoxical activation. BDTX-4933 was designed using Black Diamond’s proprietary MAP Drug Discovery Engine and is currently in Investigational New Drug (IND) enabling studies.
In October 2022, Black Diamond presented a poster at the 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium highlighting preclinical data showing BDTX-4933 to be a CNS penetrant BRAF MasterKey inhibitor active against tumors that are driven by a Class I/II/III BRAF mutation, as well as by other oncogenic MAPK pathway alterations that promote constitutive RAF dimer activation. BDTX-4933 demonstrated potent, on-target inhibition of the RAF-MEK-ERK signaling pathway and anti-tumor activity in multiple preclinical models, including intracranial tumor models.
Black Diamond expects to submit an IND application for BDTX-4933 with the U.S. Food and Drug Administration (FDA) in the first half of 2023.
Discovery-Stage Pipeline and MAP Drug Discovery Engine:

Black Diamond continues to leverage its MAP drug discovery engine to advance its discovery-stage pipeline and anticipates progressing its fibroblast growth factor receptor (FGFR) program towards development candidate nomination in 2022, in addition to disclosing a development candidate against a new target in 2023.
Corporate:

In October 2022, Black Diamond appointed Melanie Morrison as Senior Vice President, Development Operations, who joined the Company with over two decades of experience in clinical operations, program management, product leadership and other key development functions and in driving corporate transitions from early to late-stage development at several biopharmaceutical companies. Prior to joining Black Diamond, Ms. Morrison served as Senior Vice President, Clinical Operations and Program Management at Nuvation Bio Inc.
Financial Highlights

Cash Position: Black Diamond ended the third quarter of 2022 with approximately $144.2 million in cash, cash equivalents, and investments compared to $209.8 million as of December 31, 2021. Net cash used in operations was $16.5 million for the third quarter of 2022 compared to $26.5 million for the third quarter of 2021.
Research and Development Expenses: Research and development (R&D) expenses were $15.8 million for the third quarter of 2022 compared to $27.6 million for the third quarter of 2021. The decrease in R&D expenses was primarily due to reduced activities on the BDTX-189 program and reduced spending on early discovery projects.
General and Administrative Expenses: General and administrative (G&A) expenses were $6.3 million for the third quarter of 2022, compared to $7.7 million for the third quarter of 2021. The decrease in G&A expenses was primarily due to a decrease in personnel and other corporate-related costs.
Net Loss: Net loss for the third quarter of 2022 was $21.7 million, as compared to $35.1 million for the same period in 2021.
Financial Guidance

Following the Company’s pipeline prioritization and workforce realignment announcement in April 2022, Black Diamond has extended its cash runway, which is expected to be sufficient to fund its anticipated operating expenses and expenditure requirements into the third quarter of 2024.

On November 8, 2022 PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, reported financial results for the third quarter ended September 30, 2022 and provided a corporate update (Press release, PMV Pharma, NOV 8, 2022, View Source [SID1234623372]).

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"PMV continues to advance its ongoing PYNNACLE study evaluating PC14586, a first-in-class p53 Y220C reactivator, in patients with advanced solid tumors and plans the next update in the first half of 2023," said David Mack, Ph.D., President, and Chief Executive Officer. "In addition, we look forward to the initiation of our clinical trial of PC14586 in combination with KEYTRUDA. This study builds upon the promising, preliminary tumor-agnostic clinical efficacy observed with PC14586 monotherapy and allows us to explore the potential synergy between the two agents to improve patient outcomes."

Corporate Highlights:

Continued enrollment in the ongoing Phase 1/2 PYNNACLE trial of PC14586 in patients with advanced solid tumors. Initial Phase 1 data presented at the 2022 ASCO (Free ASCO Whitepaper) annual meeting demonstrated responses in patients across multiple solid tumor types with a p53 Y220C mutation.

On track to initiate Phase 1b trial evaluating PC14586 in combination with KEYTRUDA in Q4 2022.

Appointed Carol Gallagher, Pharm.D. to the Board of Directors. Dr. Gallagher brings 30 years of biotech leadership and expertise in drug development and commercialization.
Third Quarter 2022 Financial Results

As of September 30, 2022, PMV Pharma had $258.9 million in cash, cash equivalents, and marketable securities, compared to $314.1 million at December 31, 2021. Net cash used in operations was $48.4 million for the nine months ended September 30, 2022, compared to $34.5 million for the nine months ended September 30, 2021.

Net loss for the nine months ended September 30, 2022, was $54.0 million compared to $39.5 million for the nine months ended September 30, 2021.

Research and development (R&D) expenses were $37.0 million for the nine months ended September 30, 2022, compared to $24.3 million for the nine months ended September 30, 2021. The increase in R&D expenses was primarily due to clinical expenses related to development of PC14586, the Company’s lead drug candidate.

General and administrative (G&A) expenses were $18.9 million for the nine months ended September 30, 2022, compared to $15.5 million for the nine months ended September 30, 2021. The increase in G&A expenses was primarily due to increased headcount expenses including stock-based compensation.

About PC14586

PC14586 is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the crevice present in the p53 Y220C mutant protein, hence, restoring the wild-type, or normal, p53 protein structure and tumor-suppressing function. The U.S. Food and Drug Administration granted Fast Track designation to PC14586 for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation. For more information about the Phase 1/2 PYNNACLE trial (PMV-586-101), refer to www.clinicaltrials.gov (NCT study identifier NCT04585750).

On November 8, 2022 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a broad pipeline targeting cancers and infectious disease, reported financial results for the third quarter of 2022 (Press release, Agenus, NOV 8, 2022, View Source [SID1234623371]).

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"Botensilimab has demonstrated impressive clinical responses in nine cold, treatment-resistant tumor types with strong durability, and we look forward to presenting expanded data in colorectal, ovarian, lung and sarcoma cohorts at a plenary session at SITC (Free SITC Whitepaper) followed by our R&D event this Saturday," said Garo Armen, PhD, Chairman and Chief Executive Officer of Agenus. "In light of these compelling clinical data, we have expanded our leadership team to accelerate the development and seek registration of botensilimab with the aim of delivering this potentially transformative new therapy to patients across multiple tumor types."

Clinical update on botensilimab, Agenus’ innate and adaptive immune stimulator, to be presented in a plenary session of the SITC (Free SITC Whitepaper) Annual Meeting

New data on multiple expansion cohorts from the Phase 1 study of botensilimab in cold (immunotherapy-resistant) tumors will be presented at an oral plenary session on novel immunotherapies on Saturday, November 12th at 10:50am ET.
Two additional SITC (Free SITC Whitepaper) presentations will include new data on the mechanisms underpinning botensilimab’s differentiated and enhanced anti-tumor immunity.
Initiated Phase 2 ACTIVATE trials in advanced MSS colorectal cancer and melanoma

ACTIVATE-Colorectal is a global, randomized, open-label, dose-optimization study evaluating the safety and efficacy of botensilimab as monotherapy and in combination with balstilimab in advanced refractory MSS CRC patients.
ACTIVATE-Melanoma is a global, randomized, open-label, multi-cohort, dose-optimization study evaluating the safety and efficacy of botensilimab as a single agent in advanced refractory melanoma who have failed prior PD-1 +/- CTLA-4 therapy.
An additional Phase 2 study in pancreatic cancer is anticipated to begin later in 2022.
Expanded clinical and regulatory leadership team to accelerate botensilimab development

Patricia Carlos named Chief Regulatory, Quality, and Safety Officer. Patricia brings over 20 years of regulatory affairs leadership experience, directing programs from investigational new drug application to commercialization including prior regulatory and quality leadership roles at Arcus Biosciences, BeiGene, Medivation, Gilead Sciences, and Bayer.
Todd Yancey, MD named Senior Global Clinical Development, Medical Affairs and Commercial Advisor. Todd brings over 40 years of combined clinical and industry experience, including prior global clinical and commercial leadership roles at Beigene, BioMarin, Medivation, Onyx, Genentech, and Amgen.
Continued to advance clinical pipeline through company-led studies and corporate partnerships

Dosed first patient in Phase 1 study of AGEN1571 (ILT2 antagonist) as a monotherapy and in combination with botensilimab and/or balstilimab in participants with advanced solid tumors.
Combination study with AGEN2373 (CD137 agonist) and botensilimab in melanoma patients who have relapsed or are refractory to prior anti-PD-1 therapy continues to enroll.
Update on the Phase 2 trial of AGEN1423, an anti-CD73-TGFβ-trap bifunctional antibody in combination with balstilimab (anti-PD-1) in advanced pancreatic cancer will be presented at SITC (Free SITC Whitepaper).
BMS launched a Phase I/II study of BMS-986442 (a TIGIT bispecific discovered by Agenus, also known as AGEN1777) in combination with nivolumab +/- chemotherapy in patients with advanced solid tumors and non-small cell lung cancer.
Merck has initiated a randomized Phase II study evaluating MK-4830 (a candidate ILT4 antagonist discovered by Agenus) in combination with pembrolizumab and chemotherapy in ovarian cancer; additional Phase II studies are ongoing in NSCLC, small cell lung cancer, esophageal cancer, MSI-H colorectal cancer, renal cell carcinoma, and melanoma.
Incyte has initiated a randomized Phase II study evaluating INCAGN02385 (LAG-3) and INCAGN02390 (TIM-3), both discovered by Agenus, in combination with anti-PD-1 in 1L squamous cell carcinoma of the head and neck; additional Phase II studies are ongoing in melanoma, endometrial cancer, and urothelial carcinoma.
Third Quarter 2022 Financial Results
We ended our third quarter 2022 with a cash, cash equivalent, and short-term investment balance of $218.2 million as compared to $238.3 million and $306.9 million on June 30, 2022, and December 31, 2021, respectively. Cash used in operations was $32.2 million for the quarter ended September 30, 2022, and $128 million for the nine-months then ended.

We recognized revenue of $22.8 million and incurred a net loss of $56.7 million, or $0.19 per share, for the third quarter ended September 30, 2022. For the nine-months ended September 30, 2022, we recognized revenue of $69.6 million and incurred a net loss of $156.6 million, or $0.54 per share.

Non-cash operating expenses for the third quarter and nine-months ended September 30, 2022, were $22.2 million and $62.8 million respectively.

Webcast
A webcast and replay of the conference call will be accessible from the Events & Presentations page of the Company’s website at View Source and via View Source

"The Road Taken" R&D Event
Agenus will host an in-person and virtual R&D event ("The Road Taken") on Saturday, November 12th from 2:00 p.m. to 5:00 p.m. ET at the Prudential Tower in Boston, MA. The event will feature insights from leading cancer immunologists who will share their collective and individual expertise on the current and future state of cancer immunotherapy, including a deep dive into the botensilimab data presented at SITC (Free SITC Whitepaper). Institutional investors, research analysts, and key opinion leaders are invited to attend the event in-person and can RSVP by emailing [email protected]. To register for the live webcast, please click here.

On November 8, 2022 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson’s disease, Parkinson’s-related disorders and other diseases of the Abelson Tyrosine Kinases, reported that it will report financial results for the third quarter ended September 30, 2022 on Monday, November 14, 2022, after the close of U.S. markets (Press release, Inhibikase Therapeutics, NOV 8, 2022, View Source [SID1234623370]). Following the announcement, the Company will host a conference call and webcast at 8:00 a.m. ET on Tuesday, November 15, 2022 to provide a corporate update and review the financial results.

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The conference call can be accessed by dialing 1-844-825-9789 (United States) or 1-412-317-5180 (International) with the conference code 10172407. A live webcast may be accessed using the link here, or by visiting the investors section of the Company’s website at www.inhibikase.com. After the live webcast, the event will be archived on Inhibikase’s website for approximately 90 days after the call.