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ORIC Pharmaceuticals Provides Corporate Update and Highlights Key 2021 Milestones

On January 11, 2021 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported program updates and announced key milestones for 2021, which are expected to substantially expand and advance the company’s clinical pipeline (Press release, ORIC Pharmaceuticals, JAN 11, 2021, View Source [SID1234573783]).

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"2020 was a transformational year for ORIC during which we significantly broadened the pipeline via internal discovery and business development efforts, expanded the team, and strengthened the balance sheet with the completion of an IPO and follow-on financing," said Jacob Chacko, M.D., president and chief executive officer. "These efforts have positioned us for a dynamic 2021, with our first data from two ongoing trials of our lead program ORIC-101 and three INDs/CTAs for our other product candidates, which represents a tremendous amount of development activity for a company at our stage."

Program Updates and 2021 Milestones

ORIC-101: Glucocorticoid Receptor (GR) Antagonist
ORIC-101 is a potent and selective GR antagonist, with two distinct mechanisms of action being evaluated in two Phase 1b trials in combination with: (1) Xtandi (enzalutamide) in metastatic prostate cancer and (2) Abraxane (nab-paclitaxel) in advanced or metastatic solid tumors.

The company announced today the completion of the Part I dose escalation portion of the Phase 1b trial of ORIC-101 in combination with enzalutamide in metastatic prostate cancer, by identifying the provisional recommended Phase 2 dose (RP2D) that will be used in the Part II expansion portion of the trial. The selection of the provisional RP2D was based upon the totality of safety, pharmacokinetic, and pharmacodynamic data demonstrating a well-tolerated regimen that achieved ORIC-101 exposures leading to demonstrable target engagement and GR inhibition. In the Part I dose escalation portion of the trial, patients were enrolled to evaluate daily dosing of ORIC-101 with doses ranging from 80 to 240 mg, in combination with daily dosing of 160 mg of enzalutamide. In the Part II dose expansion portion of the trial, up to 48 patients are expected to be enrolled and treated at the RP2D of 240 mg of ORIC-101 and 160 mg of enzalutamide on a continuous daily dosing schedule. Patients will be enrolled independent of GR status, with retrospective analysis of GR expression and other potentially predictive biomarkers. The company expects to report interim safety, efficacy, and translational data from this trial in the second half of 2021.
The Phase 1b trial of ORIC-101 in combination with nab-paclitaxel is now enrolling patients in the Part II dose expansion portion. In December 2020, the company announced the completion of the Part I dose escalation portion of ORIC-101 in combination with nab-paclitaxel in solid tumors, the selection of the RP2D, and the initiation of the dose expansion portion of the trial. For the Part II dose expansion portion of the trial, up to 132 patients are expected to be enrolled across four cohorts, including pancreatic ductal adenocarcinoma, ovarian cancer, triple negative breast cancer, and other advanced solid tumors. Patients in Part II of the trial will be treated at the RP2D of 160 mg of ORIC-101 continuous once daily dosing and 75 mg/m2 of nab-paclitaxel on days 1, 8, and 15 of a 28-day cycle, without requirement for prophylactic granulocyte colony-stimulating factor. Eligible patients must have previously progressed on a taxane-containing regimen and will be enrolled independent of baseline GR status, with retrospective analysis of GR expression and other potentially predictive biomarkers. The company expects to report interim safety, efficacy, and translational data from this trial in the first half of 2021.
ORIC-533: CD73 Inhibitor
ORIC-533 was designed to be a highly potent, orally bioavailable CD73 inhibitor and has demonstrated more potent adenosine inhibition in preclinical studies compared to an antibody approach and other small molecule CD73 inhibitors. ORIC-533 continues to progress in Investigational New Drug (IND) enabling studies and the company expects to file an IND with the Food and Drug Administration (FDA) in the first half of 2021. Having conducted a preclinical collaboration with an academic key opinion leader that generated compelling single agent activity in patient derived model systems in an undisclosed tumor type, the company plans to pursue a single agent clinical development path in this indication.

ORIC-944: PRC2 Inhibitor
ORIC-944, in-licensed in August 2020, is a potent and selective allosteric inhibitor of polycomb repressive complex 2 (PRC2), that targets its regulatory embryonic ectoderm development (EED) subunit and has demonstrated single agent efficacy in multiple enzalutamide-resistant prostate cancer models in preclinical studies. The company plans to conduct IND enabling studies and then file an IND with the FDA in the second half of 2021, with initial clinical development as a single agent in treatment-resistant prostate cancer.

ORIC-114: EGFR/HER2 Inhibitor
ORIC-114, in-licensed in October 2020, is a brain penetrant, orally bioavailable, irreversible inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations. ORIC-114 has demonstrated greater brain exposure in preclinical studies compared to other compounds being developed against exon 20 mutations and has shown strong antitumor activity in an EGFR-driven intracranial lung cancer model. The company plans to conduct IND enabling studies and then file a Clinical Trial Application (CTA) in South Korea in the second half of 2021.

Discovery Pipeline
In addition to the four product candidates, the company is leveraging its resistance platform in pursuit of multiple discovery research programs that focus on its expertise in precision oncology, hormone-dependent cancers, and key tumor dependencies. These programs highlight the company’s medicinal chemistry and structure-based drug design proficiency to target drivers of resistance in solid tumors like prostate, breast, and lung cancer that relapse with innate, acquired or bypass mechanisms of resistance. The company recently advanced one of these programs into lead optimization.

Anticipated 2021 Milestones

ORIC anticipates the following milestones in 2021:

ORIC-101: Report interim safety, efficacy, and translational data from ongoing combination trial with nab-paclitaxel in the first half of 2021
ORIC-101: Report interim safety, efficacy, and translational data from ongoing combination trial with enzalutamide in the second half of 2021
ORIC-533: File an IND in the first half of 2021
ORIC-944: File an IND in the second half of 2021
ORIC-114: File a CTA in the second half of 2021
Present additional preclinical and translational research data on ORIC-101, ORIC-533, ORIC-944, and ORIC-114 at scientific conferences in 2021
Financial Guidance

Cash, cash equivalents and marketable securities totaled $293.6 million as of December 31, 2020, which included gross proceeds of $133.3 million from the follow-on financing completed in November 2020. The company expects its cash, cash equivalents and marketable securities will be sufficient to fund its current operating plan into the second half of 2023.

Presentation and Webcast

Jacob Chacko, M.D., president and chief executive officer, will present a corporate overview at the 39th J.P. Morgan Healthcare Conference beginning at 12:40 p.m. PT on Tuesday, January 12, 2021. A live webcast will be available through the investor section of the company’s website at View Source A replay of the webcast will be available for 90 days following the event.

NeuBase Therapeutics to Present at the H.C. Wainwright Virtual BioConnect Conference

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.

Invitae Reports Preliminary 2020 Financial Results of More Than $278 Million in Revenue and More Than 655,000 in Billable Volume

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]).

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.

Idera Pharmaceuticals to Present at Upcoming Conferences

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]).

"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.

Gilead Sciences Announces Updated 2020 Guidance

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]).

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