On January 11, 2021 NeuBase Therapeutics, Inc. (NASDAQ: NBSE) ("NeuBase" or the "Company"), a biotechnology company accelerating the genetic revolution using a new class of synthetic medicines, reported that Dietrich A. Stephan, Ph.D., Chief Executive Officer of NeuBase, will present a corporate overview during the H.C. Wainwright Virtual BioConnect Conference, which is being held from January 11 – 14, 2021 (Press release, NeuBase Therapeutics, JAN 11, 2021, View Source [SID1234573782]). A webcast of the on-demand presentation will be available beginning today at 6:00 a.m. Eastern Time and archived on the NeuBase website, www.neubasetherapeutics.com.

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On January 11, 2021 Invitae Corporation (NYSE: NVTA), a leading medical genetics company, reported preliminary unaudited full-year 2020 results, reporting strong growth in volume and revenue, signaling continued momentum into 2021 (Press release, Invitae, JAN 11, 2021, View Source [SID1234573781]).

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

"We are very pleased by the acceleration of our business in 2020, particularly in light of the impact of the COVID-19 pandemic on the healthcare system throughout the year," said Sean George, Ph.D., co-founder and chief executive officer of Invitae. "Our results underscore the strength of our customer relationships, our continued ability to execute and the benefits of the investments we’ve made in expanding our menu, services and platform. The growth in testing during this time of unrelenting stress on the healthcare system further demonstrates the expanding value genetic information is providing patients as they and their physicians face health challenges and decisions."

Preliminary, unaudited financial results and other metrics for 2020

Generated revenue of more than $278 million in 2020, an approximate 28% increase from $217 million in 2019
Reported billable volume of more than 655,000 in 2020, an approximate 40% increase from billable volume of 469,000 in 2019
Announced year-end 2020 cash, cash equivalents, restricted cash and marketable securities of more than $360 million as of December 31, 2020
Outlook for 2021
Looking ahead to 2021 and factoring in the continued impact associated with the COVID-19 pandemic, Invitae reiterates its stated outlook for revenue growth targets of 50% – 60% annual growth over the next few years consistent with its view at the time of the announcement of the ArcherDX acquisition. Invitae anticipates generating revenue in excess of $450 million in 2021.

"We are confident we will continue growing rapidly in 2021, even as we navigate the continued pressure the pandemic is placing on clinicians," said Dr. George. "Our momentum coming out of 2020 and the underlying strength and breadth of our platform enable us to recognize and overcome these challenges while continuing to drive the acceleration of the adoption of genetics in mainstream medicine as the new standard of care."

Invitae has not completed preparation of its financial statements for the fourth quarter or full year 2020. The preliminary, unaudited results presented in this press release for the year ended December 31, 2020 are based on current expectations and are subject to adjustment. Actual results may differ materially from those disclosed in this press release. Invitae will report its full financial results and other metrics during its fourth quarter and year-end 2020 conference call in February.

Invitae’s Presentation at 39th Annual J.P. Morgan Healthcare Conference
Invitae will present at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021 at 10:50 a.m. Eastern/7:50 a.m. Pacific. Following the company presentation, management will participate in a breakout session at 11:10 a.m. Eastern/8:10 a.m. Pacific. The 2021 J.P. Morgan Healthcare Conference is being held virtually via webinar. A live webcast of both the presentation and the breakout session may be accessed at the following direct link or by visiting the investors section of the company’s website at ir.invitae.com. Public listeners can access an audio and slide recording of the session, which will be available shortly after the conclusion of the presentation and breakout session on the investors section of the company’s website at ir.invitae.com.

On January 11, 2021 Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) reported that it will provide a company outlook for 2021 at upcoming conferences (Press release, Idera Pharmaceuticals, JAN 11, 2021, View Source [SID1234573780]).

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"2021 represents a pivotal inflection point for Idera, one in which we anticipate that data soon to be available from our ILLUMINATE program will show that tilsotolimod, the most advanced TLR9 agonist therapy in development, can offer meaningful alternatives to patients suffering from advanced anti-PD-1 refractory melanoma and, potentially, colorectal cancer," stated Vincent Milano, Idera’s Chief Executive Officer. "We’re looking forward to sharing topline response data from ILLUMINATE-301 late in this quarter and a data update from ILLUMINATE-206 in the third quarter of the year."

Continued Mr. Milano, "Our entire team is driven by our goal of making a difference for patients and is unified in its persistence to help ensure the quality of our clinical results, NDA and commercial readiness, and a strong financial outlook that includes existing cash that is expected to take us into the first quarter of 2022. We have confidence that this is the year Idera will deliver on its long history of innovative science and begin to turn that history into a business reality."

The Company plans to share further corporate and ILLUMINATE program updates at the following conferences in January:

-39th Annual J.P. Morgan Healthcare Conference, January 11-14, 2021
Presentation on January 13, 2021, 3:40 pm EST

-H.C. Wainwright BioConnect 2021 Conference, January 11-14, 2021
Pre-recorded conversation available January 11, 2021, 6:00 am EST

Live and archived webcasts of the investor conference presentations will be available in the Investor Relations section of the Idera website.

On January 11, 2021 Gilead Sciences, Inc. (Nasdaq: GILD) reported the company has revised certain elements of its full year 2020 guidance (Press release, Gilead Sciences, JAN 11, 2021, View Source [SID1234573779]).

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The following provides additional details on the company’s updated guidance:

Gilead delivered solid performance, despite the global impacts of COVID-19.
Total product sales guidance range is now $24.30 billion to $24.35 billion, reflecting increased Veklury (remdesivir) sales as hospitalization and treatment rates were higher than expected given the most recent COVID-19 surge.
As a reminder, full year 2020 total product sales excluding Veklury reflects the underlying strong Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg) uptake, partially offset by the Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) loss of exclusivity in the United States and the impact of COVID-19 primarily on Gilead’s pre-exposure prophylaxis ("PrEP") franchise and chronic hepatitis C virus ("HCV") franchise.

Guidance for Research and development ("R&D") expense changed to reflect the increase in expense for obligations under the previously disclosed new commercialization and development agreement for Jyseleca (filgotinib) with Galapagos NV. In addition, R&D expense for the full year 2020 reflects growth due to higher clinical trial and manufacturing ramp-up expenses related to Gilead’s COVID-19 treatment remdesivir.

Selling, general and administrative ("SG&A") expense reflects the low-end of Gilead’s previous guidance. As a reminder, SG&A expense grew for the full year 2020 due to a legal accrual related to a previously disclosed legal settlement, expenses associated with the acquisitions of Forty Seven, Inc. and Immunomedics, Inc., and certain remdesivir donations.

GAAP Diluted EPS guidance is ($0.08) to $0.02 and Non-GAAP Diluted EPS guidance is $6.98 to $7.08 for full year 2020.
The updated 2020 guidance range provided in this document is based on Gilead’s preliminary fourth quarter 2020 results, which are subject to change in connection with the completion of the company’s final closing procedures, final adjustments and other developments that may arise in the course of the preparation or audit of its financial statements. Gilead’s management will host a conference call to discuss the company’s fourth quarter and full year 2020 results in the coming weeks.

Webcast of J.P. Morgan Healthcare Conference

Gilead is scheduled to provide an overview of the company, including updated full year 2020 guidance and a review of key events at the 39th Annual J.P. Morgan Healthcare Conference on Monday, January 11, 2021 at 12:40 p.m. Pacific Time. The live webcast for the J.P. Morgan Healthcare Conference can be accessed at the company’s Investors page at View Source

On January 11, 2021 Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancer reported a review of corporate highlights from 2020 and outlined anticipated key clinical program milestones for 2021 (Press release, Forma Therapeutics, JAN 11, 2021, View Source [SID1234573778]).

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"While 2020 was marked by tremendous challenges due to the COVID-19 pandemic, Forma made important strides due to the courage of patients and the dedication of our employees. We reported promising results our from our clinical programs including FT-4202 in sickle cell disease, olutasidenib in both AML and glioma, and FT-7051 in prostate cancer, and also raised approximately $695 million in public equity offerings," said Frank Lee, president and chief executive officer of Forma. "In this coming year, we anticipate continued progress, and look forward to advancing drug candidates that we believe have the potential to significantly impact patients living with rare hematologic diseases and cancers."

Clinical Program Highlights and Milestones

PKR Program in Sickle Cell Disease (SCD):

FT-4202 is a novel investigational selective red blood cell pyruvate kinase R (PKR) activator Forma is actively evaluating in a multi-center, placebo-controlled Phase 1 trial in individuals with sickle cell disease ages 12 years and older.

In June 2020, encouraging ­single dose cohort data were reported at the 25th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress. Initial findings from Forma’s Phase 1 trial of FT-4202 in patients with SCD demonstrated a favorable tolerability profile and biologic effects, with evidence of pharmacodynamic activity.
In December 2020, clinical proof-of-concept data were presented at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition. Forma presented data from a multi-dose cohort of its Phase 1 trial of FT-4202 in patients with SCD, showing that 86% of patients dosed with 300 mg of FT-4202 for 14 days achieved a hemoglobin increase of greater than 1 g/dL from baseline. The observed reduction in hemolysis in conjunction with the biomarker analysis showing improved deformability and hydration of RBCs supports the hypothesis that pyruvate kinase activation may have an impact on vaso-occlusive crises (VOCs).
Additional clinical data anticipated from the ongoing Phase 1 randomized placebo-controlled trial in SCD patients. Data from the MAD2 600 mg cohort of the Phase 1 trial is expected to be reported in the first quarter of 2021, followed by results from the 12-week open-label extension in the second quarter of 2021.
Expanding FT-4202 development program. Forma has initiated a global pivotal Phase 2/3 trial of FT-4202 in SCD patients, with plans to initiate a Phase 2 trial in thalassemia in the second half of 2021, and a pediatric SCD trial in the first half of 2022.
IDH1 Program in AML and Glioma:

Olutasidenib (FT-2102) is a selective inhibitor for cancers with IDH1 mutations Forma is evaluating for the treatment of acute myeloid leukemia (AML) and glioma. Olutasidenib is currently being studied in a registrational Phase 2 trial for relapsed/refractory (R/R) AML and an exploratory Phase 1 trial for glioma.

In May 2020, positive data for olutasidenib in glioma was announced at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). Forma announced positive preliminary Phase 1 data for olutasidenib in refractory, enhancing glioma at ASCO (Free ASCO Whitepaper) 2020, suggesting the potential for response and prolonged disease control in relapsed/refractory IDH1-mutated glioma patients.
In October 2020, positive data for olutasidenib in a registrational trial for R/R AML was announced. Forma announced positive results from the planned interim analysis of the Phase 2 registration trial of olutasidenib in R/R AML patients with IDH1 gene mutations. Olutasidenib as a monotherapy demonstrated a favorable tolerability profile and achieved a composite complete remission (CR/CRh) rate of 33.3% (30% CR and 3% CRh), the primary efficacy endpoint. While a median duration of CR/CRh has not yet been reached, a sensitivity analysis indicated the median duration of CR/CRh to be 13.8 months. Further data analysis indicates an estimated 87% survival rate at 18 months in patients who respond to treatment with olutasidenib. Olutasidenib’s potential transformative treatment profile is based upon three key indicators: durability of response and increased survival for responders, favorable tolerability suggesting ability to combine with other therapies, and properties to support indication expansion to other IDH1 mutated cancers.
Forma has begun preparing for a new drug application for olutasidenib in R/R AML.
CPB/p300 Program in Prostate Cancer:

FT-7051 is a potent and selective CBP/p300 inhibitor Forma is evaluating for the treatment of metastatic prostate cancer resistant to androgen receptor (AR) signaling inhibitor therapy.

In April 2020, preclinical data on FT-6876 (a research compound related to FT-7051) in breast cancer was presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper). Forma presented preclinical data that demonstrated antitumor activity of FT-6876 in AR-dependent breast cancer cell lines, suggesting that FT-6876 could serve as a treatment for patients with other AR-dependent tumors, such as prostate cancer.
Phase 1 underway in 2021. In December 2020, Forma initiated recruitment in a Phase 1 trial of FT-7051 in men with metastatic castration-resistant prostate cancer including those with AR-v7 splice variants. Dosing in this trial is anticipated to begin in early in the first quarter of 2021. Forma plans to disclose initial safety, tolerability and preliminary response data in the second half of 2021.