On November 19, 2021 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, reported the release of 9 abstracts that will be presented at the 2021 San Antonio Breast Cancer Symposium (SABCS), to be held at the Henry B. Gonzalez Convention Center in San Antonio, Texas, from December 7-10, 2021 (Press release, Puma Biotechnology, NOV 19, 2021, View Source [SID1234595856]). Abstracts are available to the public online on the SABCS website at www.sabcs.org.

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Oral Presentation:

Abstract:

GS4-10

Title:

Neratinib + fulvestrant + trastuzumab for hormone receptor-positive, HER2-mutant metastatic breast cancer and neratinib + trastuzumab for triple-negative disease: Latest updates from the SUMMIT trial

Presenter:

Komal Jhaveri, MD, FACP

Session:

Friday, Dec. 10, 11:00-11:15 a.m. CT

Poster Presentations:

Abstract:

P2-10-08

Title:

Assessment of risk factors for HER2+ breast cancer recurrence: A literature review

Presenter:

Joyce O’Shaughnessy, M.D.

Session:

Poster Session 2, Wednesday, Dec. 8, 5:00-6:30 p.m. CT

Abstract:

P2-11-02

Title:

Subsequent breast cancer among women with HER2+ disease in a large integrated healthcare system

Presenter:

Reina Haque, PhD, MPH

Session:

Poster Session 2, Wednesday, Dec. 8, 5:00-6:30 p.m. CT

Abstract:

P2-11-19

Title:

Estimating the long-term risk of recurrence in patients receiving HER2-targeted agents in HER2+ early-stage breast cancer (ESBC)

Presenter:

David Leroy Veenstra, PharmD, PhD

Session:

Poster Session 2, Wednesday, Dec. 8, 5:00-6:30 p.m. CT

Abstract:

P2-13-05

Title:

Central nervous system metastases as a site of first recurrence in adjuvant therapy trials of HER2+ early breast cancer (EBC)

Presenter:

Nancy U. Lin, MD

Session:

Poster Session 2, Wednesday, Dec. 8, 5:00-6:30 p.m. CT

Abstract:

P2-13-21

Title:

Improved central nervous system outcomes in patients with early-stage HER2-positive breast cancer who receive neratinib for the recommended duration: Findings from the phase 3 ExteNET trial

Presenter:

Frankie Ann Homes, MD, FACP

Session:

Poster Session 2, Wednesday, Dec. 8, 5:00-6:30 p.m. CT

Abstract:

P3-12-20

Title:

Outcomes of patients with pathologic complete response following neoadjuvant HER2-targeted therapy in patients with HER2+ early stage breast cancer

Presenter:

Joyce O’Shaughnessy, M.D.

Session:

Poster Session 3, Thursday, Dec. 9, 7:00-8:30 a.m. CT

Abstract:

P3-16-01

Title:

Population effectiveness model of the consequences of recurrence after trastuzumab emtansine (T-DM1) treatment among U.S. patients with high-risk HER2+ early-stage breast cancer (ESBC)

Presenter:

David Leroy Veenstra, PharmD, PhD

Session:

Poster Session 3, Thursday, Dec. 9, 7:00-8:30 a.m. CT

Abstract:

P5-18-02

Title:

Final findings from the CONTROL trial of diarrheal prophylaxis or neratinib dose escalation on neratinib-associated diarrhea and tolerability in patients with HER2+ early-stage breast cancer

Presenter:

Arlene Chan, MBBS, FRACP, MMED

Session:

Poster Session 5, Friday, Dec. 10, 7:00-8:30 a.m. CT

On November 19, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a company applying innovative diagnostics to transform disease management and improve patient outcomes, reported the publication of a study of patients with stage I-III cutaneous melanoma (Press release, Castle Biosciences, NOV 19, 2021, View Source [SID1234595855]). Data demonstrated that DecisionDx-Melanoma is a significant independent predictor of metastatic recurrence.

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DecisionDx-Melanoma is Castle’s gene expression profile (GEP) test that uses an individual patient’s tumor biology to predict the risk of cutaneous melanoma metastasis or recurrence, as well as the risk of sentinel lymph node (SLN) positivity, independent of traditional staging factors. The study, titled "The 31-gene expression profile stratifies recurrence and metastasis risk in patients with cutaneous melanoma," analyzed 438 patients who were tested with DecisionDx-Melanoma as part of their clinical care. The study can be accessed here.

"This study reinforced one of the primary reasons why I order DecisionDx-Melanoma for my patients as soon as they receive a melanoma diagnosis," said first author Abel Jarell, M.D., dermatologist and dermatopathologist at Northeast Dermatology Associates, Portsmouth, N.H. "It’s designed to provide personalized, prognostic information that I use to determine the likelihood that the cancer will spread, which helps inform decisions for treatment to ensure the best possible outcome for each patient’s disease."

Study background and highlights:

The study’s primary purpose was to show risk stratification by DecisionDx-Melanoma in patients with stage I–III cutaneous melanoma. A secondary end point was to demonstrate the added prognostic value of DecisionDx-Melanoma when combined with complete American Joint Committee on Cancer (AJCC) staging (including SLN status) or with SLN status alone, for recurrence detection.
438 patients with stage I–III melanoma consecutively tested with DecisionDx-Melanoma were analyzed and stratified as low risk (Class 1A), intermediate risk (Class 1B/2A) or high risk (Class 2B) of recurrence or metastasis.
DecisionDx-Melanoma significantly stratified five-year melanoma survival prognoses for patients, including recurrence-free survival (RFS) (p<0.001), distant metastasis-free survival (DMFS) (p<0.001) and melanoma-specific survival (MSS) (p<0.001).
Patients with a DecisionDx-Melanoma low-risk result (Class 1A) had higher five-year survival outcomes and were less likely to experience a recurrence than patients with a high-risk result (Class 2B).
Multivariable analysis showed that DecisionDx-Melanoma is a significant, independent predictor of metastatic recurrence (hazard ratio=5.38, p=0.014).
DecisionDx-Melanoma increased prognostic survival accuracy over sentinel lymph node status alone.
Consistent with previous validation and performance studies, the study demonstrated that DecisionDx-Melanoma added independent prognostic value to current staging guidelines for cutaneous melanoma to identify patients with a high and low recurrence or metastasis risk to improve patient management.
About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 5,700 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. To predict risk of recurrence and likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithms, i31-ROR and i31-SLNB, to produce an Integrated Test Result. Through Sept. 30, 2021, DecisionDx-Melanoma has been ordered 84,195 times for use in patients with cutaneous melanoma.

More information about the test and disease can be found at www.CastleTestInfo.com.

On November 19, 2021 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a biopharmaceutical company developing and commercializing specialty products for allergy, opioid overdose, respiratory and inflammatory disease, reported that it will host an investor conference call on Monday, November 22, 2021 at 2 p.m. Pacific Time to discuss its financial and operating results for the first nine months of 2021, as well as provide a business update (Press release, Adamis Pharmaceuticals, NOV 19, 2021, View Source [SID1234595854]). The Company’s press release concerning its financial results will be available after 1 p.m. Pacific Time on November 22, 2021 and on its website at www.adamispharmaceuticals.com, and the company also expects to file its quarterly reports on Form 10-Q for the quarters ended March 31, 2021, June 30, 2021 and September 30, 2021 on that date.

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Dennis J. Carlo, Ph.D., President and CEO of Adamis, will host the call along with other members of the management team. The call is open to the public and will provide an update on recent developments, events that have taken place during the year, and certain goals for future periods. Forward-looking statements concerning expectations regarding future company performance may be made during the conference call.

A live audio webcast of the conference call will also be available via this link – View Source;tp_key=857fdc0361, with a replay available shortly after the live event.

On November 19, 2021 Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company commercializing the CellFX System powered by Nano-Pulse Stimulation (NPS) technology, reported plans to participate in the Stephens Annual Investment Conference in Nashville, Tennessee (Press release, Pulse Biosciences, NOV 19, 2021, View Source [SID1234595853]).

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Management is scheduled to participate in a fireside chat on Thursday, December 2, 2021 at 2:00pm PT / 4:00pm CT. Interested parties may access the live and recorded webcast on the "Investors" section of the Company’s website at www.pulsebiosciences.com.

On November 19, 2021 Exicure, Inc. (NASDAQ: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) technology, reported financial results for the quarter ended September 30, 2021 and provided an update on corporate progress (Press release, Exicure, NOV 19, 2021, View Source [SID1234595851]).

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"I would first like to recognize the amazing work from the high-quality team members at Exicure as we continue to invest into driving value from our SNA platform technology, most notably being recognized in the third quarter through the consummation of another strategic partnership which brought in additional non-dilutive capital," said Exicure CEO Dr. David Giljohann. "It is important to note our SNA platform is grounded in 15 years of intensive and rigorous scientific development across industry and academia. Although a recent claim of improprieties from one researcher, specifically related to our FXN program, are concerning, we are highly confident in our platform technology which delivers DNA and RNA into cells and tissues more effectively. I remain proud of the team members at Exicure who continue to work hard to bring new medicines to patients in need."

Corporate Updates

As previously reported, on November 9, 2021, the Audit Committee of the Board of Directors of the Company was notified of a claim made by a former Company senior researcher regarding alleged improprieties that researcher claims to have committed with respect to the Company’s XCUR-FXN preclinical program for the treatment of Friedreich’s ataxia. The Audit Committee has retained external counsel to conduct an internal investigation of the claim. The Company is currently unable to predict the timing or outcome of the investigation.

Pipeline Highlights & Updates

Neurology

Ipsen Collaboration

On August 2, 2021, Ipsen Biopharm Limited (Ipsen) and Exicure announced an exclusive collaboration agreement to research, develop, and commercialize novel Spherical Nucleic Acids (SNAs) as potential investigational treatments for Huntington’s disease (HD) and Angelman syndrome (AS). Under the terms of the collaboration:
Exicure received a $20 million upfront payment and is eligible to receive up to $1 billion in option exercise fees and milestone payments should Ipsen opt into both programs, as well as tiered royalties.
Collaborative efforts associated with the Ipsen partnership commenced in the third quarter of 2021, and the upfront payment was recorded as deferred revenue on the Company’s balance sheet and will be recognized as revenue on the Company’s income statement related to services as the Company’s performance obligations are satisfied.
XCUR-FXN–Friedreich’s Ataxia

Exicure remains committed to maintaining its development plans and to pursuing its business strategy in the best interests of its stockholders as well as the patients it looks to serve; however, it acknowledges that, at this point in time, it is unable to determine the potential impact of the asserted claim on its research and development activities or the timing of completion of its current research and development of its XCUR-FXN preclinical program for the treatment of FA, as the investigation of the asserted claim remains ongoing.
Immuno-Oncology

Cavrotolimod (AST-008)

The Phase 1b/2 clinical trial of intra-tumoral cavrotolimod in combination with approved checkpoint inhibitors pembrolizumab or cemiplimab, for the treatment of patients with advanced or metastatic Merkel cell carcinoma (MCC) or cutaneous squamous cell carcinoma (CSCC), is open and actively enrolling patients, and as of November 4, 2021:
the Company had 25 clinical trial sites activated and 2 additional sites pending activation of an approximate target of 27 total clinical trial sites; and
37 patients had been dosed with 32 mg of cavrotolimod (AST-008) in the Phase 2 portion of the clinical trial.
As a result of enrollment delays contributed to by COVID-19, the Company now expects to report top-line overall response rates (ORR) results in the second half of 2022 rather than the first half of 2022.
Third Quarter Financial Results and Financial Guidance

Cash Position: Cash, cash equivalents, short-term investments, and restricted cash were $62.0 million as of September 30, 2021 compared to $57.3 million as of June 30, 2021.

Research and Development (R&D) Expenses: R&D expenses were $16.5 million for the quarter ended September 30, 2021, compared to $9.1 million for the quarter ended September 30, 2020. The Company has increased full-time headcount in R&D from 48 as of September 30, 2020 to 65 as of September 30, 2021. The increase in R&D expense reflects this increased headcount and the related increase in R&D activities, in addition to increased clinical trial activities.

General and Administrative Expenses: General and administrative expenses were $2.9 million for the quarter ended September 30, 2021, compared to $2.4 million for the quarter ended September 30, 2020. This increase is primarily due to costs related to new hires needed to grow the Company as it evolves, as well as higher legal costs.

Net Loss: Exicure had a net loss of $23.5 million for the quarter ended September 30, 2021 compared to a net loss of $8.8 million for the quarter ended September 30, 2020. The increase in net loss was primarily driven by higher R&D costs to advance Exicure’s pipeline as discussed above, as well as lower non-cash revenue during the period largely impacted by the reversal of non-cash revenue associated with Exicure’s collaboration with AbbVie Inc. (AbbVie). During the third quarter of 2021, as a result of a change in the workplan for the AbbVie collaboration, we increased the estimated total project hours to complete our research services associated with the AbbVie collaboration, which resulted in less progress occurring to date compared to the increased estimate of total project hours and thus requiring an adjustment to cumulative revenue recognized through September 30, 2021.

Cash Runway Guidance: The Company believes that, based on its current operating plans and estimates of future expenses, as of the date of this press release, it is uncertain whether the Company’s existing cash and cash equivalents is sufficient to fund operations over the next twelve months. As a result, there is substantial doubt about the Company’s ability to continue as a going concern.

For further financial information for the period ending September 30, 2021, please refer to the financial statements appearing at the end of this release.