On November 8, 2021 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of targeted drugs for the treatment of cancer, reported financial results for the third quarter ended September 30, 2021 and provided a corporate update (Press release, Cellectar Biosciences, NOV 8, 2021, View Source [SID1234594712]).

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Third Quarter and Recent Corporate Highlights

Announced the completion of the Part A portion of a safety and tolerability study of iopofosine I-131 (iopofosine) in combination with external beam radiation (EBRT) in relapsed or refractory head and neck cancer. The investigator-initiated study is being conducted by the University of Wisconsin as part of a Specialized Program of Research Excellence (SPORE) grant awarded by the National Cancer Institute (NCI).
The study objective is to determine if combining iopofosine with EBRT can reduce the amount or fractions (doses) of EBRT required, which has the potential to diminish the number and severity of EBRT associated adverse events.
Preliminary data suggest that iopofosine is safe and tolerated in combination with EBRT for relapsed or refractory head and neck cancer.

Awarded a peer-reviewed National Institutes of Health (NIH) Phase II Small Business Innovation Research (SBIR) grant of approximately $2 Million from the NCI. The grant will support the ongoing global pivotal study and clinical development of iopofosine in Waldenstrom’s macroglobulinemia (WM).

Announced collaboration with BBK Worldwide to provide new concierge services for patients participating in Cellectar’s clinical studies. These services are designed to improve patient’s and their caregiver’s access to high quality care and innovative treatments for their cancer.

Announced commercial manufacturing and supply agreement with Evergreen Theragnostics, a global radiopharmaceutical contract development and manufacturing organization (CDMO), to provide long term commercial supply of iopofosine and clinical study material for the company’s pivotal study in WM, as well as for the ongoing Phase 1 and Phase 2 clinical studies.
"We remain highly focused on driving our pivotal study of iopofosine in Waldenstrom’s and in parallel advancing the ongoing Phase 2b clinical study for late line, hexa-drug refractory multiple myeloma patients along with our two Phase 1 studies in pediatric and head and neck cancers" said James Caruso, president and CEO of Cellectar. "Our collaboration with Evergreen Theragnostics expands our manufacturing capabilities to help reduce the risks inherent in single sourcing of drug supply and provides the capability to scale supply for future studies and potential commercialization. The recent deal with BBK Worldwide will allow us to more efficiently serve our patients and remove barriers to study participation as we continue to develop iopofosine in WM and other oncology indications. With $40.3 million in cash and cash equivalents as of September 30, we are supported by a strong balance sheet that will fund our expected clinical and regulatory milestones into the second half of 2023."

Third Quarter Financial Highlights

Cash and Cash Equivalents: As of September 30, 2021, the company had cash and cash equivalents of $40.3 million compared to $57.2 million at December 31, 2020. Cash used in operating activities was approximately $18.1 million during the nine months ended September 30, 2021 as compared to $10.1 million during the nine months ended September 30, 2020.
Research and Development Expense: R&D expense for the three months ended September 30, 2021 was $3.9 million, compared to $2.7 million for the three months ended September 30, 2020. The cumulative R&D spending for the first nine months of 2021 was $13.2 million as compared to $7.8 million for the first nine months of 2020. The increase in R&D expense year-to-date in 2021 was primarily a result of start-up costs for our WM pivotal study, clinical project costs and general research and development costs offset by a decrease in manufacturing and related costs.
General and Administrative Expense: G&A expense for the three months ended September 30, 2021 was $1.9 million compared to $1.2 million for the three months ended September 30, 2020. The cumulative G&A spending for the first nine months of 2021 were $5.0 million as compared to $3.7 million for the first nine months of 2020. The increase in G&A expense year-to-date in 2021 was primarily a result of an increase in professional fees and insurance, personnel costs and stock-based compensation expense.
Net Loss: The net loss attributable to common stockholders for the three months ended September 30, 2021 was ($5.8) million, or ($0.10) per share, compared to ($3.9) million, or ($0.15) per share, in 2020. Net loss attributable to common stockholders for the nine months ended September 30, 2021 was ($18.2) million, or ($0.34) per share, compared to ($11.5) million, or ($0.69) per share, in 2020.

On November 8, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a company applying innovative diagnostics to inform disease management and improve patient outcomes, reported its financial results for the third quarter and nine months ended Sept. 30, 2021 (Press release, Castle Biosciences, NOV 8, 2021, View Source [SID1234594711]).

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"The Castle team achieved another quarter of strong growth in revenue and test report volume, despite the diagnoses of cutaneous melanoma being down by approximately 16% compared to historical pre-COVID third quarter 2019 levels," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "From the onset of the pandemic, we made the strategic decision to accelerate investments in our growth initiatives, including the expansion of our commercial team and our R&D programs – both for our commercial and pipeline tests. And as a result, we have seen excellent progress across our key priorities. Our body of evidence supporting our tests continues to grow, with consistent data further demonstrating the potential of our tests to provide valuable, clinically actionable information to clinicians and patients. We doubled our dermatology facing commercial team in the second quarter of 2021. They were fully trained as of July 1, 2021, enabling the promotion of all of our skin cancer genomic tests in all U.S. geographies. The team grew their experience and territory knowledge in the third quarter, and we expect them to continue toward optimal productivity, which we believe takes about two quarters.

"Further, we identified two additional areas of strategic growth that we believe complement and diversify our existing business and align with our focus of addressing indications with unmet clinical need to improve patient care. The first was our acquisition of myPath Melanoma, and more recently, the pending acquisition of Cernostics, Inc. (Cernostics). We believe Cernostics’ first-to-market TissueCypher Barrett’s esophagus (BE) test addresses an unmet clinical need in BE, as it is designed to support improved risk-stratification treatment plans by objectively and accurately predicting progression from non-dysplastic, indefinite for dysplasia and low-grade dysplasia BE to high-grade dysplasia or esophageal adenocarcinoma. The TissueCypher platform also has the potential to answer clinical problems in additional gastroenterology areas and other diseases.

"I am proud of the Castle team, the consistent execution they deliver on our initiatives, and the impact their hard work and dedication has on the lives of patients, which remains our focus. We look forward to furthering our position as a leader in the dermatologic diagnostic space and continuing to build the company with innovative technology that has the potential to accelerate our impact on patient care and thus drive value creation for stockholders."

Third Quarter Ended Sept. 30, 2021, Selected Results

Revenues were $23.5 million, a 54% increase compared to $15.2 million during the same period in 2020. Included in revenue for the period were revenue adjustments related to tests delivered in prior periods. These (negative) positive prior period revenue adjustments for the quarter ended Sept. 30, 2021, were $(0.1) million, compared to $1.5 million for the same period in 2020.
Adjusted revenues, which exclude the effects of revenue adjustments related to tests delivered in prior periods, were $23.6 million, a 71% increase, compared to $13.8 million for the same period in 2020.
Total gene expression profile test reports delivered in the third quarter of 2021 were 7,727, compared to 4,779 in the same period of 2020:
DecisionDx-Melanoma test reports delivered in the third quarter of 2021 were 5,505, compared to 4,404, in the third quarter of 2020, an increase of 25%.
DecisionDx-SCC test reports delivered in the third quarter of 2021 were 934, compared to 57 in the third quarter of 2020 (DecisionDx-SCC became commercially available on August 31, 2020).
myPath Melanoma and DecisionDx DiffDx-Melanoma (Castle’s comprehensive diagnostic offering) aggregate test reports delivered in the third quarter of 2021 were 913.
DecisionDx-UM test reports delivered in the third quarter of 2021 were 375, compared to 318 in the third quarter of 2020, an increase of 18%.
Gross margin for the quarter ended Sept. 30, 2021, was 77.9%.
Adjusted gross margin for the quarter ended Sept. 30, 2021, was 80.9%. Adjusted gross margin is calculated as net revenues (GAAP) less the sum of cost of sales (exclusive of amortization of acquired intangible asset) and amortization of acquired intangible asset.
Operating cash flow was $(6.1) million, compared to $(3.0) million for the same period in 2020.
Adjusted operating cash flow was $(3.0) million, excluding the effects of certain COVID-19-related government payments, unchanged from the same period in 2020.
Nine Months Ended Sept. 30, 2021, Selected Results

Revenues were $69.0 million, a 52% increase compared to $45.4 million during the same period in 2020. Included in revenue for the period were positive revenue adjustments related to tests delivered in prior periods. These positive prior period revenue adjustments for the nine months ended Sept. 30, 2021, were $4.1 million, compared to $0.2 million for the same period in 2020.
Adjusted revenues, which exclude the effects of revenue adjustments related to tests delivered in prior periods, were $64.9 million, a 44% increase, compared to $45.1 million for the same period in 2020.
Total gene expression profile test reports delivered in the nine months ended Sept. 30, 2021, were 19,876, compared to 13,028 in the same period of 2020:
DecisionDx-Melanoma test reports delivered in the nine months ended Sept. 30, 2021, were 14,693, compared to 11,986, during the same period in 2020, an increase of 23%.
DecisionDx-SCC test reports delivered in the nine months ended Sept. 30, 2021, were 2,245.
myPath Melanoma and DecisionDx DiffDx-Melanoma (Castle’s comprehensive diagnostic offering) aggregate test reports delivered in the nine months ended Sept. 30, 2021, were 1,758.
DecisionDx-UM test reports delivered in the nine months ended Sept. 30, 2021, were 1,180, compared to 985, during the same period in 2020, an increase of 20%.
Gross margin for the nine months ended Sept. 30, 2021, was 82.4%.
Adjusted gross margin for the nine months ended Sept. 30, 2021, was 82.7%.
Operating cash flow was $(16.2) million, compared to $10.3 million for the same period in 2020.
Adjusted operating cash flow was $(12.7) million, compared to $0.1 million for the same period in 2020.
Cash and Cash Equivalents

As of Sept. 30, 2021, the Company’s cash and cash equivalents totaled $363 million.

2021 Revenue Guidance

In August of 2021, Castle Biosciences raised its guidance for anticipated total revenue in 2021 to $89-93 million. The Company believes it will meet the guided range.

Third Quarter and Recent Business and Clinical Evidence Highlights

In July and August, the Company presented evidence on its family of skin cancer tests at numerous in-person, hybrid and virtual medical conferences, including American Head & Neck Society (AHNS) 2021 International Conference, Society of Dermatology Physician Assistants (SDPA) Annual Summer Dermatology Conference, DERM 2021 and 2021 American Academy of Dermatology Association (AAD) Summer Meeting. See the Company’s news page for more information.
In August, the Company announced that it had been awarded a five-year U.S. Federal Supply Schedule (FSS) contract from the Veterans Health Administration (VHA) for its DecisionDx-Melanoma gene expression profile test. The VHA is a component of and implements the healthcare program for U.S. veterans through the U.S. Department of Veterans Affairs (VA). The contract became effective on Aug. 15, 2021, and provides greater access to DecisionDx-Melanoma for veterans being treated through the VHA, the largest integrated health care system in the U.S., as well as active-duty service members and their families seeking medical treatment through the Military Health System (MHS). See the Company’s news release from Aug. 24, 2021, for more information.
In September, the Company announced that it received approval from the New York State Department of Health for its proprietary DecisionDx DiffDx-Melanoma gene expression profile (GEP) test. DecisionDx DiffDx-Melanoma is designed to provide an objective and comprehensive diagnostic offering to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions. Castle previously received approvals in the state of New York for its other GEP tests, including DecisionDx-Melanoma, DecisionDx-SCC, DecisionDx-UM and DecisionDx-PRAME, as well as its next generation sequencing panels, DecisionDx-CMSeq and DecisionDx-UMSeq. See the Company’s news release from Sept. 16, 2021, for more information.
In October, the Company signed a definitive agreement to acquire Cernostics, an Illumina Ventures company. Cernostics specializes in spatial biology and artificial intelligence-driven image analysis of tissue biopsies. Its TissueCypher Barrett’s Esophagus Assay is the first precision medicine test designed to predict future development of high-grade dysplasia (HGD) and/or esophageal cancer in patients with BE. The acquisition would expand Castle’s estimated U.S. total addressable market by approximately $1 billion. The Company expects the deal to close before year-end 2021. See the Company’s news release from Oct. 19, 2021, for more information.
In October, the Company presented data on its suite of dermatologic cancer gene expression profile (GEP) tests, as well as presented a poster describing the study design for its inflammatory skin disease pipeline initiative at the 2021 Fall Clinical Dermatology Conference. See the Company’s news release from Oct. 22, 2021, for more information.
In October, the Company announced that the DecisionDx-Melanoma integrated test result (ITR) now includes i31-GEP for Risk of Recurrence (i31-ROR). Designed to improve the precision of treatment plans for better patient care, the i31-ROR predicts patient-specific five-year outcomes for melanoma-specific survival (MSS), distant metastasis-free survival (DMFS) and recurrence-free survival (RFS). See the Company’s news release from Oct. 28, 2021, for more information.
In November, the Company announced the publication of a novel algorithm that integrates the DecisionDx-Melanoma test with clinicopathologic features (i31-GEP SLNB) to determine sentinel lymph node biopsy (SLNB) positivity risk in patients with cutaneous melanoma. The article, titled "Integrating 31-Gene Expression Profiling with Clinicopathologic Features to Optimize Cutaneous Melanoma Sentinel Lymph Node Metastasis Prediction," highlights the development and validation of the i31-GEP SLNB algorithm and demonstrates improved prediction for sentinel lymph node (SLN) status compared to clinicopathologic features alone and a very high correlation comparing predicted versus observed SLN positivity rates of 0.999 (1.0 is complete correlation). The study was published in the peer-reviewed journal JCO Precision Oncology. See the Company’s news release from Nov. 5, 2021, for more information.
In November, the Company announced the launch of its inaugural Environmental, Social and Governance (ESG) report, detailing the Company’s related policies and metrics. See the Company’s news release from earlier today, for more information.
Conference Call and Webcast Details

Castle Biosciences will hold a conference call on Monday, Nov. 8, 2021, at 4:30 p.m. Eastern time to discuss its third quarter 2021 results and provide a corporate update.

A live webcast of the conference call can be accessed here: View Source or via the webcast link on the Investor Relations page of the Company’s website, View Source Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company’s website until Nov. 30, 2021.

To access the live conference call via phone, please dial 844 200 6205 from the United States, or +1 929 526 1599 internationally, at least 10 minutes prior to the start of the call, using the conference ID 256168.

There will be a brief Question & Answer session following management commentary.

Use of Non-GAAP Financial Measures (UNAUDITED)

In this release, we use the metrics of Adjusted Revenue, Adjusted Gross Margin and Adjusted Operating Cash Flow, which are non-GAAP financial measures and are not calculated in accordance with generally accepted accounting principles in the United States (GAAP). Adjusted Revenue and Adjusted Gross Margin reflect adjustments to net revenues to exclude changes in variable consideration related to test reports delivered in previous periods. Adjusted Gross Margin further excludes acquisition-related intangible asset amortization. Adjusted Operating Cash Flow excludes the effects of cash activity associated with COVID-19 government relief payments to healthcare providers.

We use Adjusted Revenue, Adjusted Gross Margin and Adjusted Operating Cash Flow internally because we believe these metrics provide useful supplemental information in assessing our revenue and cash flow performance, respectively. We believe Adjusted Revenue and Adjusted Gross Margin are also useful to investors because they provide additional information on current-period performance by removing the effects of revenue adjustments related to tests delivered in previous periods and acquisition-related intangible asset amortization, which we believe may facilitate revenue and gross margin comparisons to historical periods. We believe Adjusted Operating Cash Flow is also useful to investors as a supplement to GAAP measures in the assessment of our cash flow performance by removing the effects of COVID-19 government relief payments, which we believe are not indicative of our ongoing operations. However, these non-GAAP financial measures may be different from non-GAAP financial measures used by other companies, even when the same or similarly titled terms are used to identify such measures, limiting their usefulness for comparative purposes. These non-GAAP financial measures are not meant to be substitutes for net revenues, gross margin or net cash (used in) provided by operating activities reported in accordance with GAAP and should be considered in conjunction with our financial information presented on GAAP basis. Accordingly, investors should not place undue reliance on non-GAAP financial measures. Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures are presented in the tables at the end of this release.

On November 8, 2021 Boston Scientific Corporation (NYSE: BSX) reported that it will participate in two upcoming investor conferences (Press release, Boston Scientific, NOV 8, 2021, View Source [SID1234594710]).

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On November 15, 2021, Dan Brennan, executive vice president and chief financial officer, and Lauren Tengler, vice president, Investor Relations, will participate in a 30-minute question-and-answer session with the host analyst at the virtual 2021 Stifel Healthcare Conference. The session will begin at approximately 8:00 a.m. EST.

On December 1, 2021, Dave Pierce, executive vice president and president, MedSurg & Endoscopy; Dr. Brian Dunkin, chief medical officer, Endoscopy; and Lauren Tengler will participate in a 45-minute question-and-answer session with the host analyst for the 2021 virtual Evercore ISI HealthCONx Conference. The session will begin at approximately 8:00 a.m. EST.

A live webcast and replay of the webcast for each event will be accessible at investors.bostonscientific.com. The replay will be available approximately one hour following the completion of each event.

On November 8, 2021 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, 2021 and provided a corporate update (Press release, Black Diamond Therapeutics, NOV 8, 2021, View Source [SID1234594709]).

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"Black Diamond’s approach remains deeply rooted in our proprietary Mutation-Allostery-Pharmacology (MAP) drug discovery engine, which leverages population-level genetic sequencing that allows for the identification of novel oncogenic mutations. We are well-positioned to advance differentiated MasterKey programs across a range of oncogenic targets for patient populations with unmet need," said David Epstein, Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "We are excited by the continuing progression of our pipeline of MasterKey inhibitor programs, including the BDTX-189 MasterKey-01 study, our BDTX-1535 program with an IND filing anticipated by the first half of 2022, and our BRAF and fibroblast growth factor receptor (FGFR) programs."

Recent Developments

BDTX-189:

Black Diamond remains on-track with preparations for initiating the Phase 2 portion of the MasterKey-01 Phase 1/2 study of BDTX-189 by the end of 2021. The Company completed the Phase 1 dose-escalation portion of the study and has selected the recommended Phase 2 dose for BDTX-189.
BDTX-1535:

Black Diamond continues to advance BDTX-1535 through IND-enabling studies and expects to file an IND application by the first half of 2022.
In October 2021, Black Diamond presented pre-clinical data for BDTX-1535 at the ANE International Conference:
In cell-based assays, BDTX-1535 achieved potent and selective inhibition of a range of EGFR mutations expressed in glioblastoma (GBM) and non-small cell lung cancer (NSCLC), including canonical, non-canonical, and drug-resistance mutations, such as EGFR-C797S that can arise following treatment with osimertinib.
BDTX-1535 demonstrated a favorable brain-penetrant pharmacokinetic (PK) profile in mouse, rat, and dog models.
In a range of tumor models, including intercranial GBM models and lung cancer drug resistance models expressing the targeted EGFR mutations, BDTX-1535 showed dose-dependent tumor growth inhibition and achieved complete regression without notable impact on body weight.
Early-Stage Pipeline:

Black Diamond continues to progress its early-stage pipeline programs designed to target cancers driven by mutations in BRAF and FGFR. The Company anticipates IND filings for both programs in 2022.
In October 2021, Black Diamond presented pre-clinical data for both the BRAF and FGFR programs at the ANE International Conference:
BRAF:
The presentation described pre-clinical data for a lead compound from Black Diamond’s BRAF program, which is designed for potency and selectivity against a spectrum of non-canonical Class II/III mutations, in addition to Class I mutations (V600E).
In cell-based assays, the lead compound demonstrated potent inhibition of a spectrum of Class I/II/III BRAF mutations.
In contrast to current-generation BRAF inhibitors, such as encorafenib and vemurafenib, treatment of cells harboring wild type BRAF (WT-BRAF) with the Black Diamond compound was not observed to lead to an increase in pERK, a signal of paradoxical activation.
In a BRAF-KIAA1549 fusion allograft tumor model, the lead compound exhibited dose-dependent inhibition of pERK and anti-tumor efficacy.
FGFR:
The presentation was illustrative of the Black Diamond approach, centered on a four-pronged optimization strategy with the goal of delivering an inhibitor that has broad coverage of FGFR2 and FGFR3 oncogenes, while sparing inhibition of FGFR1 and retaining activity against resistance mutations.
In cell-based assays, FGFR program compounds demonstrated potent and selective inhibition of a spectrum of FGFR2/3 oncogenic mutations, while sparing FGFR1. Additionally, FGFR program compounds demonstrated improved potency against resistance mutations.
In an in vivo study conducted in a UM-UC-14 (FGFR3-S249C) mouse model, FGFR program compounds demonstrated anti-tumor activity. Additionally, in mouse and rat models, FGFR program compounds did not promote hyperphosphatemia.
Corporate:

In September 2021, Black Diamond entered into a strategic partnership with OpenEye Scientific to incorporate OpenEye’s Orion molecular design platform into Black Diamond’s proprietary Mutation-Allostery-Pharmacology (MAP) drug discovery engine to help advance MasterKey inhibitor cancer therapies. OpenEye’s Orion Software-as-a-Service platform enables Black Diamond to perform rapid simulations and analysis of protein motion.
Financial Highlights

Black Diamond ended the third quarter of 2021 with $235.0 million in cash, cash equivalents, and investments compared to $315.1 million as of December 31, 2020. Net cash used in operations was $26.5 million for the third quarter of 2021 compared to $11.5 million for the third quarter of 2020.
Research and development (R&D) expenses were $27.6 million for the third quarter of 2021 compared to $12.9 million for the third quarter of 2020. The increase in R&D expenses was primarily related to an increase in headcount and increased spend across preclinical and clinical development.
General and administrative (G&A) expenses were $7.7 million for the third quarter of 2021 compared to $5.6 million for the third quarter of 2020. The increase in G&A expenses was primarily due to an increase in personnel and other corporate-related costs.

On November 8, 2021 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of MasterKey therapies, reported that its President and Chief Executive Officer, David M. Epstein, Ph.D., will present an update about the Company’s progress at the following upcoming investor conferences (Press release, Black Diamond Therapeutics, NOV 8, 2021, View Source [SID1234594708]):

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The Stifel 2021 Virtual Healthcare Conference. The corporate presentation will take place on Monday, November 15, 2021 at 4:40 PM ET.
The 2021 Jefferies London Healthcare Conference. The presentation will be available on-demand beginning Thursday, November 18, 2021, starting at 4:00 AM ET.
A webcast of the Stifel presentation can be accessed by visiting the investor relations section of the Company’s website, www.blackdiamondtherapeutics.com. A replay of each presentation will also be available and archived on the site for 30 days.