On August 13, 2019 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported financial results for the second quarter ended June 30, 2019 (Press release, Personalis, AUG 13, 2019, View Source [SID1234538657]).

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!

Second Quarter 2019 Highlights

Record revenues of $15.8 million in the second quarter of 2019, versus $8.8 million in the second quarter of 2018, an increase of 80%
In June, completed initial public offering of 9.1 million shares, raising $140.0 million in net proceeds, after deducting underwriting discounts, and fees and other expenses
Announced several important customer and partner relationships including agreements with the Parker Institute for Cancer Immunotherapy and RAPT Therapeutics
Initial customer pilots of ImmunoID NeXT, the company’s universal cancer immunogenomics platform
"The Personalis team has made solid progress over the last few months. With our raising of $140 million and very encouraging traction with our Million Veteran Program and biopharmaceutical customers, I believe we are well-positioned for continued growth ahead," said John West, Chief Executive Officer. "With the proceeds from our offering, we are driving the build out of our commercial infrastructure and accelerating our new product programs to capitalize on the approximately $5 billion total addressable market for comprehensive tissue and liquid biopsy testing, and investing in our operational capabilities and infrastructure so we can scale quickly in response to customer demands."

Second Quarter 2019 Financial Results

Revenues were $15.8 million in the three months ended June 30, 2019, up 80% from $8.8 million in the same period of the prior year. Second quarter revenue growth was driven by an increase in volume for testing and analytical services provided to pharmaceutical, biotech, the U.S. Department of Veterans Affairs "Million Veteran Program" ("VA-MVP"), universities, and research laboratory customers. The VA-MVP accounted for 54% of our revenues in the three months ended June 30, 2019, and the remaining 46% was primarily from pharmaceutical and biotech customers.

Gross margin for the three months ended June 30, 2019 was 37.3% and increased 10.1% from 27.2% in the same period of the prior year.

Operating expenses totaled $10.0 million for the three months ended June 30, 2019, compared with $6.1 million for the same period of the prior year.

Net loss for the three months ended June 30, 2019 was $5.9 million and net loss per share was $0.89 based on a weighted-average basic and diluted share count of 6.6 million, compared with a net loss of $7.3 million and a net loss per share of $2.39 on a weighted-average basic and diluted share count of 3.1 million last year.

Cash and cash equivalents were $163.3 million as of June 30, 2019. Personalis received net proceeds of $140.0 million in its initial public offering, net of underwriting discounts, fees and expenses payable by the company, and issued 9.1 million shares of common stock.

2019 Outlook

Personalis expects full year 2019 revenues to be in the range of $60 million to $62 million, representing 59% to 64% growth over full year 2018.

Webcast and Conference Call Information

Personalis will host a conference call to discuss the second quarter financial results after market close on Tuesday, August 13, 2019 at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live over the phone (866) 220-8061 for U.S. callers or (470) 495-9168 for international callers, using conference ID: 5981178. The live webinar can be accessed at View Source

On August 13, 2019 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported the commencement of a registered underwritten public offering of $200.0 million in shares of its common stock (Press release, Deciphera Pharmaceuticals, AUG 13, 2019, View Source [SID1234538656]). In addition, Deciphera intends to grant the underwriters a 30-day option to purchase up to $30.0 million in shares of its common stock.

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!

J.P. Morgan, Piper Jaffray and Jefferies are acting as joint book-running managers for the offering.

Deciphera intends to use the net proceeds of the offering to fund: clinical trials for ripretinib, including the expansion stage of its current Phase 1 clinical trial, its ongoing pivotal Phase 3 clinical trials, and additional clinical trials, as well as clinical research outsourcing and manufacturing of clinical trial material, and pre-commercialization manufacturing process development and validation; clinical trials for DCC-3014, including the expansion stage of its current Phase 1 clinical trial, as well as clinical research outsourcing and manufacturing of clinical trial material; clinical trials for rebastinib, including its current Phase 1b/2 clinical trial, as well as clinical research outsourcing and manufacturing of clinical trial material; Investigational New Drug-enabling studies and the potential development of DCC-3116; new and ongoing research activities for future drug candidates using its proprietary kinase switch control inhibitor platform; continued growth of its commercial and medical affairs capabilities to support its transition from a development-stage company toward a commercial-stage company; and working capital purposes, including general operating expenses.

A shelf registration statement relating to the shares of common stock offered in the public offering described above was filed with the Securities and Exchange Commission (SEC) and was declared effective by the SEC on October 12, 2018. The securities may be offered only by means of a written prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from J.P. Morgan Securities LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Piper Jaffray & Co., 800 Nicollet Mall, J12S03, Minneapolis, Minnesota, 55402, Attention: Prospectus Department, by telephone at (800) 747-3924 or by email at [email protected]; and Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On August 13, 2019 KIYATEC, Inc. reported that Capital Health has joined its U.S. clinical trial, 3D-PREDICT, to validate the company’s test as a patient-specific predictor of response to cancer therapies in glioblastoma (GBM) and anaplastic astrocytoma (AA) patients (Press release, KIYATEC, AUG 13, 2019, View Source [SID1234538655]). Capital Health is currently the only healthcare system in New Jersey, Pennsylvania and the New York City region enrolling GBM patients in the study.

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!

"Capital Health is committed to improving the health and well-being of our patients, while making the care we provide as personalized as possible. Taking part in this clinical trial underscores our mission to provide the best care, for each individual patient, at the earliest possible time," said Dr. Navid Redjal, director of Neurosurgical Oncology at Capital Health, and lead investigator of the study. "In oncology treatment, and especially for our patients with glioblastoma, being able to predict if a treatment will be successful has the potential to truly change patient care, particularly when time is of the essence."

3D-PREDICT is a prospective, open-label, multi-institutional, non-interventional study to validate KIYATEC’s EV3D platform for clinical use and to investigate the impact on outcomes for cancer patients with both newly diagnosed and recurrent epithelial ovarian cancer and recurrent high-grade gliomas. KIYATEC’s EV3D cell culture platform utilizes live cancer cells derived from surgical or biopsy tissue to create a patient specific in vivo-like tumor and immune microenvironment. The tumor and immune microenvironment are used to accurately model and assess responses from both investigational and approved cancer therapies. The study is anticipated to continue through 2020. Details on the trial can be found on View Source

"The continued growth of patient enrollment with the addition of Capital Health is a true testament to the value that oncology clinical teams realize in being able to better determine a viable treatment path for their patients at the earliest possible time," said Matthew Gevaert, CEO of KIYATEC. "We are realizing tremendous momentum, both with our ongoing clinical trial as well as recent publication of the positive results of our ovarian cancer study in the Nature journal Scientific Reports. This is a truly exciting time in the company’s growth as we continue on our path to provide a more personalized cancer treatment experience for patients."

On August 13, 2019 Genprex, Inc. (NASDAQ: GNPX), a clinical-stage gene therapy company, reported recent achievements the company has completed as a part of the company’s overall strategy to expand its clinical development programs and bring its lead drug candidate, Oncoprex immunogene therapy, to commercialization (Press release, Genprex, AUG 13, 2019, View Source [SID1234538654]).

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!

These recent achievements are outlined in the company’s newly launched, interactive corporate timeline, which can be found on Genprex’s website.

"Since Genprex’s IPO last year, we have made significant progress in many areas of the company, including progress toward expansion of our clinical programs and sponsored research, our manufacturing process development and scalability, and the growth of our team to support these initatives," said Rodney Varner, Chairman and Chief Executive Officer of Genprex. "These accomplishments have set the stage for us to continue on our path of growth and expansion, enabling our efforts to bring our drug candidate to market for lung cancer patients who cannot benefit from today’s therapies."

Genprex’s updates to ongoing activities, include:

Q2 2019

Announced positive pre-clinical findings from MD Anderson Cancer Center Sponsored Research Agreement studying the effects of TUSC2 with pembrolizumab at American Association of Cancer Research meeting
Developed Oncoprex and immunotherapy combination clinical trial design
Collaborated with Addison Whitney for drug nomenclature branding program and submission of non-proprietary drug name selections
Initiated manufacturing process development with key manufacturing partners to support clinical expansion and manufacturing scale-up processes
Completed manufacturing of TUSC2 DNA plasmid to support clinical trial ramp-up
Q1 2019

Appointed Key Staff: Senior Director of Pharmaceutical Sciences and Manufacturing and Senior Manager of Communications and Marketing
USPTO issued two additional patents to add to our intellectual property portfolio
Identified potential new clinical sites for expansion of Oncoprex and erlotinib combination clinical trial
Q4 2018

Appointed Key Staff: VP of Clinical Operations
Completion of clinical data reconciliation within a CDISC/SDTM-compliant database
Q3 2018

Initiated clinical site selection and expansion program with CRO partner
Initialization of sponsored pre-clinical research with MD Anderson Cancer Center to evaluate TUSC2 with immunotherapies including immune checkpoint inhibitors anti-PD1 and CTLA-4
Q2 2018

Continued execution and enhancement of strategy for manufacturing technology transfer and scale-up initiatives
Genprex’s new interactive timeline on its website shares additional historical achievements, where visitors can follow the company’s success since its inception.

On August 13, 2019 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that the European Commission (EC) has approved variations to broaden the use of Imbruvica (ibrutinib) in two indications (Press release, Johnson & Johnson, AUG 13, 2019, View Source [SID1234538653]). This includes the use of ibrutinib in combination with obinutuzumab in adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and the use of ibrutinib plus rituximab for the treatment of adult patients with Waldenström’s macroglobulinemia (WM). The approval follows the Positive Opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on 28 June 2019.

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!

"The data supporting both the CLL and WM approvals show significant improvements in progression free survival with the use of ibrutinib-based therapy versus the standard of care study comparators respectively," said Dr Alessandra Tedeschi, Medical Director, Department of Hematology, Niguarda Hospital, Milan, Italy, and investigator in both the iNNOVATE and iLLUMINATE studies. "These approvals therefore provide healthcare professionals with new chemotherapy-free options for patients with these complex blood cancers."

The approval in CLL was based on results from the Phase 3 iLLUMINATE (PCYC-1130) study, published in The Lancet Oncology, which investigated ibrutinib in combination with obinutuzumab versus chlorambucil plus obinutuzumab in patients with previously untreated CLL.1

In WM, the decision was based on data from the Phase 3 iNNOVATE (PCYC-1127) study, published in the New England Journal of Medicine.2 The study evaluated the efficacy and safety of ibrutinib in combination with rituximab, versus rituximab with placebo, in patients with previously untreated and relapsed/refractory WM.3

Additional information about both studies can be found at www.ClinicalTrials.gov (NCT02264574 and NCT02165397).4,5

"With five European Commission approvals in five years, this latest EC decision further extends the potential reach and impact ibrutinib can have for patients," said Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC. "We remain committed to a comprehensive clinical development programme for ibrutinib, including exploring its use in other combinations, to address the needs of more and more patients with B-cell malignancies."

Ibrutinib, a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, is jointly developed and commercialised by Janssen Biotech, Inc., and Pharmacyclics LLC, an AbbVie company.

Dr Alessandra Tedeschi is co-investigator in both the iNNOVATE and iLLUMINATE studies. She was not compensated for any media work.

#ENDS#

About ibrutinib
Ibrutinib is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, which works by forming a strong covalent bond with BTK to block the transmission of cell survival signals within the malignant B-cells.6 By blocking this BTK protein, ibrutinib decreases survival and migration of B lymphocytes, thereby delaying progression of the cancer.7

Ibrutinib is currently approved in Europe for:8

Chronic lymphocytic leukaemia (CLL): As a single agent or in combination with obinutuzumab for the treatment of adult patients with previously untreated CLL, and as a single agent or in combination with bendamustine and rituximab (BR) for the treatment of adult patients with CLL who have received at least one prior therapy
Mantle cell lymphoma (MCL): As a single agent for the treatment of adult patients with relapsed or refractory MCL
Waldenström’s macroglobulinemia (WM): As a single agent for the treatment of adult patients who have received at least one prior therapy or in first-line treatment for patients unsuitable for chemo-immunotherapy, and in combination with rituximab for the treatment of adult patients
Ibrutinib is approved in more than 95 countries, and, to date, has been used to treat more than 158,000 patients worldwide across its approved indications.

The most common adverse reactions seen with ibrutinib include diarrhoea, neutropenia, haemorrhage (e.g., bruising), musculoskeletal pain, nausea, rash, and pyrexia.8

For a full list of side effects and information on dosage and administration, contraindications and other precautions when using ibrutinib please refer to the Summary of Product Characteristics for further information.

About chronic lymphocytic leukaemia
Chronic lymphocytic leukaemia (CLL) is typically a slow-growing blood cancer of the white blood cells.9 The overall incidence of CLL in Europe is approximately 4.92 cases per 100,000 persons per year and is about 1.5 times more common in men than in women.10 CLL is predominantly a disease of the elderly, with a median age of 72 years at diagnosis.11

The disease eventually progresses in the majority of patients, and they are faced with fewer treatment options with each relapse. Patients are often prescribed multiple lines of therapy as they relapse or become resistant to treatments.

About Waldenström’s macroglobulinemia
Waldenström’s macroglobulinemia (WM) is a rare form of non-Hodgkin’s lymphoma (NHL).12 It causes overproduction of a protein called monoclonal immunoglobulin M (IgM) antibody, which causes a thickening of the blood.13 Incidence rates among men and women in Europe are approximately 7.3 and 4.2 per million persons, respectively.14 The causes of WM are unknown, with it typically affecting older adults and being slightly more common in men than women.12,14