OPKO Health to Report First Quarter 2020 Financial Results on May 6, 2020

On April 30, 2020 OPKO Health, Inc. (NASDAQ: OPK) reported that operating and financial results for the three months ended March 31, 2020, as well as discuss financial guidance, after the close of the U.S. financial markets on Wednesday, May 6, 2020 (Press release, Opko Health, APR 30, 2020, View Source [SID1234556916]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

CONFERENCE CALL & WEBCAST INFORMATION

OPKO’s senior management will provide a business update and discuss results in greater detail in a conference call and live audio webcast at 4:30 p.m. Eastern time on Wednesday, May 6, 2020. The conference call dial-in and webcast information is as follows:

DOMESTIC DIAL-IN:
INTERNATIONAL DIAL-IN:
PASSCODE:
WEBCAST:
(877) 783-8475
(614) 999-1827
9095275
OPKO 1Q20 Results Conference Call

For those unable to participate in the live conference call or webcast, a replay will be available beginning approximately two hours after the close of the conference call. To access the replay, dial 855-859-2056 or 404-537-3406. The replay passcode is 9095275. The replay can be accessed for a period of time on OPKO’s website at OPKO 1Q20 Results Conference Call.

Gilead Sciences Announces Second Quarter 2020 Dividend

On April 30, 2020 Gilead Sciences, Inc. (Nasdaq: GILD) reported that the company’s Board of Directors has declared a cash dividend of $0.68 per share of common stock for the second quarter of 2020 (Press release, Gilead Sciences, APR 30, 2020, View Source [SID1234556915]). The dividend is payable on June 29, 2020, to stockholders of record at the close of business on June 12, 2020. Future dividends will be subject to Board approval.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!


Idera Pharmaceuticals Reports First Quarter Financial Results and Provides Corporate Update

On April 30, 2020 Idera Pharmaceuticals, Inc. ("Idera" or the "Company") (Nasdaq: IDRA) reported its financial and operational results for the first quarter ended March 31, 2020 (Press release, Idera Pharmaceuticals, APR 30, 2020, View Source [SID1234556900]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"I’m proud of what Idera has accomplished since the beginning of the year, despite the worldwide impact of the COVID-19 pandemic. We have completed and reported encouraging data from ILLUMINATE-204, secured additional financing to help execute our key objectives, and, to date, are on track with timelines for both ILLUMINATE-301 and ILLUMINATE-206," stated Vincent Milano, Idera’s Chief Executive Officer. "The level of dedication and determination from our employees, our partners, and our investigators is incredibly inspiring."

Corporate Update

Since December 31, 2019, the Company entered into a private placement financing of up to $20.7 million, with $5 million received in April 2020. The Company anticipates that its current cash, cash equivalents, and short-term investments will fund our operations into the second quarter of 2021.

ILLUMINATE (tilsotolimod) Clinical Development Updates

ILLUMINATE-204: Phase 1/2 trial of tilsotolimod in combination with Yervoy* or Keytruda± (pembrolizumab) in patients with anti-PD-1 refractory advanced melanoma:

·Final topline results released in April 2020 from the recommended phase 2 dose (RP2D) of 8 mg of tilsotolimod in combination with Yervoy, which is the treatment regimen being evaluated in the Company’s registrational trial, ILLUINATE-301.
oMedian overall survival (OS) was 21.0 months (95% confidence interval (CI): 9.8 months-not reached (NR));
oThe overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) was 22.4%, including 2 complete responses (95% CI: 11.8-36.6%);
oThe disease control rate (stable disease or better) was 71.4% (95% CI: 56.7%-83.4%);
oMedian duration of response was 11.4 months (95% CI: 3.3 months-NR); and
oThe combination regimen was generally well tolerated.
·Final data from the trial to be submitted for presentation at a medical conference in the second half of 2020.

ILLUMINATE-301: Randomized phase 3 trial of tilsotolimod in combination with Yervoy (ipilimumab) versus Yervoy alone in patients with anti-PD-1 refractory advanced melanoma:

·Primary endpoint family of overall response rate (ORR) per RECIST v1.1 and overall survival (OS);
·Trial initiated in March 2018;
·Enrollment completed in March 2020; and
·ORR and other preliminary data expected in the first quarter of 2021.

ILLUMINATE-206: Phase 2, open-label, multicohort, multicenter study to test the safety and effectiveness of tilsotolimod in combination with Yervoy and Opdivo* (nivolumab) for the treatment of solid tumors:

·Trial initiated in September 2019 with the microsatellite stable colorectal cancer (MSS-CRC) cohort;
·Initial safety run-in cohort of 10 patients with MSS-CRC fully enrolled; and
·Preliminary data from this cohort expected in the second quarter of 2020.

First Quarter Financial Results

Research and development expenses for the three months ended March 31, 2020 totaled $9.5 million compared to $8.1 million for the same period in 2019. General and administrative expense for the three months ended March 31, 2020 totaled $3.6 million compared to $3.1 million for the same period in 2019. Additionally, during the three months ended March 31, 2020 we recorded $1.1 million and $20.7 million of non-cash warrant revaluation income and non-cash future tranche right revaluation income, respectively, related to securities issued in connection with our December 2019 private placement transaction.

As a result of the factors above, net income applicable to common stockholders for the three months ended March 31, 2020 was $8.8 million, or $0.27 per basic share and $0.22 per diluted share, compared to net loss applicable to common stockholders of $11.0 million, or $0.40 per basic and diluted share, for the same period in 2019. Excluding the non-cash income of approximately $21.8 million for the three months ended March 31, 2020 related to the securities issued in connection with the December 2019 private placement transaction, net loss applicable to common stockholders was $13.0 million, or $0.43 per basic and diluted share (calculated based upon the basic weighted-average number of common shares, due to the antidilutive effect of net loss).

As of March 31, 2020, our cash, cash equivalents, and short-term investments totaled $33.5 million, which includes a $6.2 million contingently refundable option fee received in connection with the December 2019 private placement transaction. Based on our current operating plan, we anticipate that our current cash, cash equivalents, and short-term investments, including the $6.2 million contingently refundable option fee and the $5.0 million gross proceeds in cash received in April 2020 pursuant to the April 2020 Securities Purchase Agreement, will fund our operations into the second quarter of 2021.

Intellia Therapeutics Names David Lebwohl, M.D., Chief Medical Officer

On April 30, 2020 Intellia Therapeutics, Inc. (NASDAQ:NTLA) reported that has named David Lebwohl, M.D., as its new executive vice president and chief medical officer (Press release, Intellia Therapeutics, APR 30, 2020, View Source [SID1234556893]). Dr. Lebwohl brings decades of biopharmaceutial leadership and drug development experience, and joins Intellia to lead its clinical development and regulatory organizations.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"Dr. Lebwohl joins Intellia during an exciting time for the company, as we continue to rapidly progess our first systemic CRISPR/Cas9-based therapy to the clinic. David’s vast experience in rare diseases, engineered cell therapy and clinical development complement our R&D capabilities and leadership team strength," said Intellia President and Chief Executive Officer John Leonard, M.D. "He has been at the helm of premier development organizations that launched breakthrough oncology therapies to patients, most notably the recent CAR-T therapy, Kymriah, and the multi-indication blockbuster, Afinitor. Under his leadership, we look forward to the impact he can make in delivering Intellia’s CRISPR/Cas9-based treatments to patients."

Dr. Lebwohl’s Professional and Academic Credentials

Dr. Lebwohl’s career spans three decades in the biopharmaceutical industry, successfully bringing novel medicines through all phases of clinical trials and global regulatory approvals. During his career, he has overseen multiple full-scale development programs with more than 200 clinical studies across myriad indications. He joins Intellia from Semma Therapeutics, Inc., where he was chief medical officer and led the company’s regenerative medicine efforts using stem-cell-derived pancreatic islets to cure type I diabetes starting in November 2018. Semma was acquired by Vertex Pharmaceuticals Inc., in October 2019. Prior to his role at Semma, Dr. Lebwohl held numerous senior-level drug development leadership positions at the global healthcare company, Novartis Pharmaceuticals Inc. (Novartis), where most recently he was senior vice president and franchise global program head, CAR-T, Promacta and SEG101 Global Program Teams, responsible for the development of the breakthrough therapy Kymriah (tisagenlecleucel), approved for the treatment of B-cell acute lymphoblastic leukemia. Dr. Lebwohl also was responsible for numerous other Novartis oncology drug development programs, and led the company’s Cell and Gene Therapies Unit. Under his leadership, the blockbuster drug, Afinitor (everolimus), was approved for five indications including metastatic breast, kidney, brain and lung cancers. Prior to working at Novartis, Dr. Lebwohl spent five years at Bristol Myers Squibb, Inc., where he worked in the Oncology Clinical Development group at the company’s Pharmaceutical Research Institute. He is a well-recognized medical oncologist, with certifications in hematology and internal medicine.

Dr. Lebwohl received an undergraduate degree in Biochemical Sciences from Harvard College, and an M.D. from the Yale University School of Medicine. He completed his fellowship training at Memorial Sloan Kettering Cancer Center, and his residency in Internal Medicine at Brigham and Women’s Hospital in Boston. He has authored more than 50 peer-reviewed publications.

"I am thrilled to join Intellia’s leadership team as we propel the first systemic CRISPR/Cas9 genome editing treatment to the clinic this year," said Dr. Lebwohl. "I am passionate about working on the next generation of treatments, like genome editing therapies, that are both game-changing for medical practice and can address the unmet needs of patients. I look forward to leading the Development organization and building on the company’s clinical capabilities."

Immutep Announces First INSIGHT-004 Data and New TACTI-002 Data to be
Included in Poster Presentations During the ASCO 2020 Annual Meeting

On April 30, 2020 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company") reported new data are scheduled to be presented in two poster presentations during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) Annual Meeting, a leading global scientific meeting for oncology professionals, taking place from 29 May – 31 May 2020 (Press release, Immutep, APR 30, 2020, View Source [SID1234556892]). This year ASCO (Free ASCO Whitepaper) is being held in a virtual format due to restrictions resulting from the COVID-19 pandemic. Abstracts and poster presentations will be published on the ASCO (Free ASCO Whitepaper) website (click here) at 8 a.m. ET on Friday, May 29, 2020. In addition, Immutep will make the data available on its website following its publication at ASCO (Free ASCO Whitepaper), at www.immutep.com.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Poster Presentations at ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program:

Title: Initial results from a phase II study (TACTI-002) in metastatic non-small cell lung or head and neck carcinoma patients receiving eftilagimod alpha (soluble LAG-3 protein) and pembrolizumab
Date: Available from 8 a.m. ET on Friday, MAY 29, 2020
Presenter: Dr. Enriqueta Felip, investigator
Abstract: 3100
Poster: 164
Title: Open-label, phase I study evaluating feasibility and safety of subcutaneous IMP321 (LAG-3Ig fusion protein, eftilagimod alpha) combined with avelumab in advanced stage solid tumor entities: results from stratum D of the INSIGHT platform trial
Date: Available from 8 a.m. ET on Friday, MAY 29, 2020
Presenter: PD. Dr. Thorsten O. Goetze, investigator
Abstract: 3099
Poster: 163
About TACTI-002

TACTI-002 is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada). It is evaluating the combination of efti with MSD’s KEYTRUDA (or pembrolizumab, an anti-PD-1 therapy) in up to 109 patients.

Immutep Limited, Level 12, 95 Pitt Street, Sydney NSW 2000

ABN: 90 009 237 889

About INSIGHT-004

INSIGHT-004 is the fourth arm of the investigator-initiated INSIGHT trial which is being conducted by Institute of Clinical Cancer Research, Krankenhaus Nordwest GmbH in Frankfurt, Germany (IKF). It is being conducted under Immutep’s collaboration with Merck KGaA, Darmstadt, Germany, and Pfizer Inc., and is evaluating the safety, tolerability and recommended Phase II dose of Immutep’s lead immunotherapy product candidate efti when given in combination with avelumab in 12 patients with advanced solid malignancies.