On November 8, 2022 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing first-in-class1 therapeutics that combine both targeted and immune-mediated mechanisms, reported financial results for the quarter ended September 30, 2022 and provided a corporate update (Press release, Tempest Therapeutics, NOV 8, 2022, View Source [SID1234623376]).

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"The Tempest team remained focused and continued to execute productively throughout the third quarter," said Stephen R. Brady, chief executive officer of Tempest. "We look forward to presenting data from our diversified pipeline of novel preclinical and clinical oncology programs, including at the upcoming SITC (Free SITC Whitepaper) annual meeting and in 2023 from our ongoing first-line randomized study with F. Hoffmann La Roche comparing TPST-1120 plus atezolizumab and bevacizumab in patients with liver cancer against the standard of care doublet of atezolizumab and bevacizumab."

Recent Highlights

TPST-1120 (clinical PPARα antagonist): continued enrollment in a first-line, randomized global Phase 1b/2 study in patients with hepatocellular carcinoma (HCC), under a collaboration with F. Hoffmann La Roche (Roche).
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): continued enrollment in a Phase 1 study evaluating both monotherapy and combination therapy (with anti-PD-1 checkpoint inhibitor, pembrolizumab) dose and schedule optimization arms, towards establishing a recommended Phase 2 dose.
1 If approved by the FDA

Planned Near-Term Milestones

TPST-1120 (clinical PPARα antagonist): (i) late-breaking presentation of TPST-1120 potential patient biomarker data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting; and (ii) early data from the first 40 patients in the first-line randomized global Phase 1b/2 study in patients with HCC under a collaboration with Roche expected in the first half of 2023.
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): (i) presentation of additional TPST-1495 preclinical data at the 37th SITC (Free SITC Whitepaper) Annual Meeting; and (ii) data from Phase 1 monotherapy and combination dose and schedule optimization arms expected by year end or early 2023, with planned presentation of the combined data in 2023.
TREX-1 Inhibitor (preclinical tumor-selective STING pathway activator): planned selection of development candidate in 2023.
Financial Results

Third Quarter

Tempest ended the third quarter of 2022 with $42.8 million in cash and cash equivalents, compared to $51.8 million on December 31, 2021. The decrease was primarily due to cash used in operations of $24.6 million offset by net proceeds from the issuance of common stock of $8.8 million and pre-funded warrants of $7.3 million.
Net loss and net loss per share for the third quarter of 2022 were $8.9 million and $0.66, respectively, compared to $8.1 million and $1.21, respectively, for the third quarter of 2021.
Research and development expenses for the third quarter of 2022 were $6.0 million compared to $4.6 million for the same period in 2021. The $1.4 million increase was primarily attributable to expanded research and development efforts and higher compensation expenses due to an increase in employee headcount.
General and administrative expenses for the third quarter of 2022 were $2.8 million compared to $3.1 million for the same period in 2021. The decrease of $0.3 million was primarily due to lower consulting and professional services.
Year-to-Date

Net cash used in operations for the nine months ended September 30, 2022 was $24.6 million.
Net loss and net loss per share for the nine months ended September 30, 2022 were $26.6 million and $2.46, respectively, compared to $20.5 million and $7.49, respectively, for the same period in 2021.
Research and development expenses for the nine months ended September 30, 2022 were $16.7 million compared to $12.5 million for the same period in 2021. The $4.2 million increase was primarily due to expanded research and development efforts and higher personnel-related costs.
For the nine months ended September 30, 2022, general and administrative expenses were $9.0 million compared to $7.2 million for the same period in 2021. The increase of $1.8 million was primarily due to an increase in professional and consulting fees and higher insurance expense as a result of operating as a publicly-traded company.

On November 8, 2022 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported that members of management will present at the Jefferies London Healthcare Conference on Tuesday, November 15, 2022, at 3:50 p.m. GMT (10:50 a.m. ET) (Press release, Mersana Therapeutics, NOV 8, 2022, View Source [SID1234623375]).

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A live webcast of the presentation will be available on the Investors & Media section of Mersana’s website at www.mersana.com. An archived replay will be available for approximately 90 days following the event.

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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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

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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).