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Innovation Pharmaceuticals Provides Corporate Update Highlighting Clinical Pipeline Progress and Business Development Activities

On July 29, 2019 Innovation Pharmaceuticals (OTCQB:IPIX) ("the Company"), a clinical stage biopharmaceutical company, is reported a corporate update highlighting recent accomplishments, clinical pipeline progress, and ongoing business development activities across its first-in-class drug candidates, Brilacidin and Kevetrin (Press release, Innovation Pharmaceuticals, JUL 29, 2019, View Source [SID1234537853]).

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"We are pleased with our accomplishments, thus far, in 2019, and are committed to advancing the clinical development of our pipeline," commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. "A significant milestone was recently achieved with our execution of a global licensing agreement with Alfasigma—an Italy-based multinational pharmaceutical company with robust R&D and manufacturing capabilities, employing 3,000 people and generating 2018 revenues in excess of €1 billion—granting them worldwide rights to develop locally-administered Brilacidin in Ulcerative Proctitis/ Ulcerative Proctosigmoiditis (UP/UPS). We look forward to leveraging this momentum. Brilacidin is a promising Inflammatory Bowel Disease (IBD) drug candidate that appears to address many root causes of chronic gut disorders. Brilacidin also has been shown in other mid-stage clinical trials to be safe and efficacious in Serious Skin Infections and Oral Mucositis, with both of these Brilacidin indications Phase 3-ready."

Bertolino continued: "The Alfasigma licensing agreement, importantly, enables us to access non-dilutive capital immediately and potentially into the future, via structured milestone-based payments and royalties. Equally important, we can now dedicate further internal resources to moving our clinical portfolio ahead—developing novel oral medications for hard-to-treat diseases like IBD, Oral Mucositis and Cancer. Successfully completing additional strategic alliances and licensing deals remains a primary objective, towards which we are making notable progress, with multiple active advanced-stage negotiations ongoing. We are excited about the Company’s prospects heading into the second-half of 2019, and anticipate providing future updates as events unfold."

2019 Announcements

Brilacidin

Inflammatory Bowel Disease

July 22, 2019: Announced the execution of a licensing agreement with Alfasigma, an Italy-based global pharmaceutical company, for worldwide rights to develop Brilacidin for localized treatment of Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS). As specified in the agreement, Alfasigma has assumed full responsibility for Brilacidin for UP/UPS, inclusive of all development, regulatory and commercialization activities and related expenses. In exchange for exclusive global rights, Alfasigma has committed to making an initial cash payment and other future cash payments to the Company upon certain milestones being met, totaling over $24 million. The Company also would receive a 6 percent royalty on net sales, resulting in additional annual recurring revenue. The initial payment will help cover substantially the costs of our upcoming clinical study of oral-dosed Brilacidin currently being developed for treating Ulcerative Colitis (UC). This first clinical trial, evaluating Brilacidin in oral tablet form, is targeted to commence later this year or early thereafter. In addition, the UP/UPS data generated by Alfasigma, to be shared with us, will help inform our internal development efforts in UC and as we explore other larger Gastrointestinal market opportunities.
June 6, 2019: Initiated, in partnership with BDD Pharma, oral development of Brilacidin in tablet form, utilizing BDD Pharma’s patented OralogiK tablet technology, which employs controlled erosion of a time-dependent barrier layer during small intestine transit to provide effective colon targeting. This will enable the testing of Brilacidin in more extensive forms of IBD, initially in UC and then in Crohn’s Disease—both chronic, hard-to-treat GI conditions for which oral therapies are highly sought after by patients and Big Pharma alike.

May 21, 2019: Attended the 2019 Digestive Disease Week (DDW) Conference, the world’s leading educational forum for professionals working in gastroenterology and related fields.

January 14, 2019: Completed early testing evaluating the stability of Brilacidin in simulated gastric fluid—a synthetic form of the fluid found in the stomach. Results showed very minimal degradation of Brilacidin across 4 hours, reinforcing the drug’s potential for oral development.
Oral Mucositis

May 1, 2019: Received End-of-Phase 2 Meeting Minutes from the Food and Drug Administration (FDA) to align our Phase 3 oral rinse Brilacidin program for the prevention of Severe Oral Mucositis (SOM) in Head and Neck Cancer (HNC) patients receiving chemoradiation. Currently, there are no approved drugs for this indication, with an annual global market opportunity estimated to approach $1 billion.

April 9, 2019: Achieved enhancements in manufacture of Brilacidin Phase 3 drug supply. This builds on the earlier contract signed with Evonik to facilitate and refine bulk production of commercial-grade Brilacidin and on the drug product agreement signed with CoreRx to formulate Brilacidin into granular form in unit sachets, providing OM patients with a convenient, portable, quick-mixing "instant" Brilacidin oral rinse therapy.

March 28, 2019: Formed European subsidiary and granted a Scientific Advisory meeting with the European Medicines Agency (EMA) to discuss a briefing package submitted for Scientific Advice regarding the clinical development program of Brilacidin oral rinse to decrease the incidence of SOM in HNC patients receiving chemoradiation.

February 19, 2019: Obtained patent from the U.S. Patent & Trademark Office (USPTO) that covers methods for treating and/or preventing mucositis with one or more compounds, or pharmaceutically acceptable salts.

January 2, 2019: Obtained patent from USPTO for Brilacidin in the form of a composition containing water. The composition can also contain Tris-buffered saline. The patent also covers Brilacidin in combination with other medicaments.
Kevetrin

Oncology

June 2019: Abstract published—"Kevetrin Dampens MYC Expression and Cellular Metabolism in Acute Myeloid Leukemia"—in collaboration with independent cancer researchers; presented at the European Hematological Association (EHA) (Free EHA Whitepaper) 2019 Annual Meeting. Results showed Kevetrin alters cellular metabolism and several key genes, including MYC, which when dysfunctional is implicated in many types of cancers. These results further support Kevetrin’s treatment potential in AML, especially among those patients carrying p53 mutations for whom few therapeutic options exist.

April 16, 2019: Notified by independent cancer researchers that a scientific article on Kevetrin is under review for publication by a leading oncology journal. The paper details Kevetrin’s treatment potential in AML by targeting p53, an important tumor suppressor protein, and several key leukemia-related genes. AML accounts for almost one-third of all leukemias worldwide and has a 5-year survival rate of only 25 percent. Pre-clinical research and academic literature also supports Kevetrin’s potential in combination with cancer immunotherapies.

TRACON Pharmaceuticals To Participate In Wells Fargo Securities 2019 Biotech Corporate Access Day

On July 29, 2019 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age-related macular degeneration through our license to Santen Pharmaceutical Co. Ltd., and utilizing our product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported that Charles Theuer, M.D., Ph.D., President and CEO, will participate in the Wells Fargo Securities 2019 Biotech Corporate Access Day on August 1, 2019 in San Francisco (Press release, Tracon Pharmaceuticals, JUL 29, 2019, View Source [SID1234537852]).

Genomic Health Reports 19% Revenue Growth and Record Profit in Second Quarter 2019, Raises Full-Year Guidance

On July 29, 2019 Genomic Health, Inc. (NASDAQ: GHDX) reported financial results and business progress for the quarter ended June 30, 2019 (Press release, Genomic Health, JUL 29, 2019, View Source [SID1234537851]). The company’s earnings call and webcast previously scheduled for Thursday, August 1 will now occur Monday, July 29 at 8 a.m. eastern time as a joint transaction call with Exact Sciences Corp.

"In the second quarter of 2019 we delivered 19% topline revenue growth and twice the profit compared to last year. These record results were driven by strength across our entire business with first-half revenue growth of 13% in U.S. invasive breast cancer, 44% in U.S. early-stage prostate cancer and 28% outside of the United States," said Kim Popovits, chairman of the board, chief executive officer and president of Genomic Health. "With this record first-half performance, a public reimbursement recommendation in Germany and increasing private coverage for our urology tests, we are raising both our full-year 2019 revenue and net income guidance."

Second Quarter Financial Results

Total revenue for the second quarter of 2019 was $114.1 million compared with $95.6 million for the second quarter of 2018, an increase of 19.4%, and an increase of 20.1% on a non-GAAP constant currency basis. U.S. product revenue was $96.0 million for the second quarter of 2019 compared with $81.4 million for the second quarter of 2019, an increase of 17.9%.

Revenue delivered across key product areas was as follows:

U.S. invasive breast revenue from Oncotype DX Breast Recurrence Score tests was $82.2 million for the second quarter of 2019 compared with $72.5 million for the second quarter of 2019, an increase of 13.4%.
U.S. prostate test revenue from Oncotype DX Genomic Prostate Score (GPS) tests was $9.6 million for the second quarter of 2019 compared with $6.7 million for the second quarter of 2018, an increase of 42.3%.
International product revenue for the second quarter of 2019 was $18.1 million compared with $14.2 million for the second quarter of 2018, an increase of 27.7%, and an increase of 32.7% on a non-GAAP constant currency basis.
Net income was $16.0 million, or $0.43 and $0.42 per share on a basic and diluted basis, respectively, for the second quarter of 2019, an improvement of $7.7 million, compared with net income of $8.3 million, or $0.23 per share on a basic and diluted basis, for the second quarter of 2018. Operating income was $15.5 million for the second quarter of 2019, an improvement of $8.4 million, compared with operating income of $7.1 million for the second quarter of 2018.

More than 38,470 Oncotype test results were delivered in the second quarter of 2019, an increase of 14.5%, compared with more than 33,590 test results delivered in the same period in 2018. Tests delivered across key product areas was as follows:

Breast Recurrence Score tests delivered in the U.S. grew 13.3% in the second quarter of 2019 compared with the same period in 2018.
GPS tests delivered in the U.S. grew 12.3% in the second quarter of 2019 compared with the same period in 2018.
Oncotype DX international tests delivered grew 21.2% in the second quarter of 2019 compared with the same period in 2018 and represented approximately 23.9% of total test volume in the second quarter of 2019.
Six Months Ended June 30, 2019 Financial Results

Total revenue for the six months ended June 30, 2019, was $222.9 million compared with $188.2 million for the same period in 2018, an increase of 18.4%, and an increase of 19.1% on a non-GAAP constant currency basis. U.S. product revenue was $187.0 million for the six months ended June 30, 2019, compared with $160.3 million for the same period in 2018, an increase of 16.7%.

Revenue delivered across key product areas was as follows:

U.S. invasive breast revenue from Breast Recurrence Score tests was $162.0 million for the six months ended June 30, 2019, compared with $143.4 million for the same period in 2018, an increase of 13.0%.
U.S. prostate test revenue from GPS tests was $18.1 million for the six months ended June 30, 2019, compared with $12.5 million for the same period in 2018, an increase of 44.3%.
International product revenue for the six months ended June 30, 2019 was $35.9 million compared with $27.9 million for the same period in 2018, an increase of 28.4%, and an increase of 33.2% on a non-GAAP constant currency basis.
Net income was $29.0 million, an improvement of $24.5 million, compared with net income of $4.5 million, for the same period in 2018. Operating income was $27.0 million for the six months ended June 30, 2019, an improvement of $24.3 million, compared with operating income of $2.7 million for the same period in 2018.

Cash, cash equivalents and short-term marketable securities at June 30, 2019 were $244 million, an increase of $34 million compared with $210 million at December 31, 2018.

Updated 2019 Financial Guidance

Recent Business Highlights

Clinical/Guidelines

Results from a new analysis of TAILORx confirmed the original, definitive conclusions reported in 2018 with additional detail on clinical risk, focusing on patients with early-stage breast cancer age 50 years or younger. These findings, published in The New England Journal of Medicine and presented at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting, showed that stratifying patients by clinical risk alone does not predict chemotherapy benefit.
Updated American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) guidelines established TAILORx-defined cutoffs for determining chemotherapy benefit with the Oncotype DX Breast Recurrence Score test in node-negative breast cancer, increasing the proportion of women who can be spared unnecessary treatment based on the landmark TAILORx and NSABP B-20 randomized clinical trials.
Recently updated ESMO (Free ESMO Whitepaper) guidelines for early-stage breast cancer elevated the Breast Recurrence Score test to the highest 1A level of evidence based on the prospective TAILORx and PlanB studies.
Global Reimbursement

On June 20, the German Federal Joint Committee (G-BA) issued an exclusive nationwide reimbursement decision for the Oncotype DX Breast Recurrence Score test. This decision follows the conclusion of the German Institute for Quality and Efficiency in Health Care (IQWiG) that only the Oncotype DX test has sufficient evidence to guide breast cancer adjuvant chemotherapy decisions based on results from the landmark TAILORx study.
On July 1, a three-year registry program started in Belgium to provide patients with funded access to the Oncotype DX Breast Recurrence Score test in breast cancer reference centers throughout the country.
Additional private insurers established new coverage for the Oncotype DX Genomic Prostate Score test, bringing the total number of U.S. covered lives to more than 116 million, including Medicare.
Multiple private insurers established reimbursement for the Oncotype DX AR-V7 Nucleus Detect test, bringing the total number of U.S. covered lives to more than 75 million, including Medicare.
Additional private insurers established reimbursement for the Oncotype DX Breast Recurrence Score test in patients with 1-3 positive nodes, bringing the total number of U.S. covered lives in this breast cancer population to more than 144 million, including Medicare.
Non-GAAP Disclosure

The company provides adjusted EBITDA and constant currency, which are non-GAAP financial measure, to supplement the financial information provided on a GAAP basis. Non-GAAP adjusted EBITDA excludes items that are included in GAAP income (loss) from operations, and excludes stock-based compensation expense and depreciation and amortization and their related tax effects. Constant currency is calculated by comparing the company’s quarterly average foreign exchange rates for the three and six months ended June 30, 2019 and 2018. The constant currency disclosures take current local currency revenue and translate it into U.S. dollars based upon the foreign currency exchange rates used to translate the local currency revenue for the applicable comparable period in the prior year, rather than the actual exchange rates in effect during the current period. Constant currency does not include any other effect of changes in foreign currency rates on the company’s results or business. The company believes that these non-GAAP measures reflect operating results that are more indicative of the company’s ongoing operating performance while improving comparability to prior periods, and, as such, may provide investors with an enhanced understanding of the company’s past financial performance and prospects for the future. In addition, the company’s management uses such non-GAAP measures internally to evaluate and assess its core operations and to make ongoing operating decisions. Non-GAAP information is not intended to be considered in isolation or as a substitute for comparable information prepared in accordance with GAAP. Investors are encouraged to review the reconciliation of these non-GAAP measure to their most directly comparable GAAP financial measures as detailed in the tables accompanying this press release.

Conference Call Details
To access the live conference call today, July 29, 2019, at 8:00 a.m. Eastern Time via phone, please dial (877) 201-0168 from the United States and Canada, or +1 (647) 788-4901 internationally. The conference call ID is 8288326. Please dial in approximately 10 minutes prior to the start of the call. To access the live and subsequently archived webcast of the conference call, go to the Investor Relations section of the company’s website at View Source Please connect to the website at least 15 minutes prior to the presentation to allow for any software download that may be necessary.

VBI Vaccines Announces Dosing of First Recurrent GBM Patient in Part B of Ongoing Phase 1/2a Study of VBI-1901

On July 29, 2019 VBI Vaccines Inc. (Nasdaq: VBIV) ("VBI"), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported that the first patient has been dosed in Part B of the ongoing Phase 1/2a clinical study of VBI-1901, VBI’s oncology immunotherapeutic, in recurrent glioblastoma (GBM) patients (Press release, VBI Vaccines, JUL 29, 2019, View Source [SID1234537850]).

"We were very encouraged by the results we saw in Part A of the study, notably that three out of the six patients in the high-dose cohort had evidence of stable disease by magnetic resonance imaging," said David Anderson, Ph.D., VBI’s Chief Scientific Officer. "In part B of the study, we are narrowing the enrollment criteria to first-recurrent GBM patients so that we may better assess the potential correlation between immunogenicity and tumor and clinical responses to VBI-1901. GBM is an incredibly aggressive and devastating disease with very few treatment options, and we believe VBI-1901 has the potential to help address this tragic unmet medical need."

The ongoing two-part study is a multi-center, open-label study conducted at The Neurological Institute of New York Columbia University Medical Center, Dana-Farber Cancer Institute, and Massachusetts General Hospital.

About the Phase 1/2a Study Design

VBI’s two-part Phase 1/2a study is a multi-center, open-label, dose-escalation study of VBI-1901 in up to 28 patients with recurrent GBM:

Part A:

Dose-escalation phase that defined the safety, tolerability, and optimal dose level of VBI-1901 in recurrent GBM patients.
This phase enrolled 18 recurrent GBM patients across three dose cohorts of VBI-1901: 0.4 µg, 2.0 µg, and 10.0µg.

Part B:

Subsequent extension of the optimal dose level, 10.0 µg, as defined in the Part A dose escalation phase.
This phase is expected to enroll an expanded cohort of approximately 10 additional first-recurrent GBM patients.

VBI-1901 is administered intradermally and is adjuvanted with granulocyte-macrophage colony-stimulating factor (GM-CSF), a potent adjuvant that mobilizes dendritic cell function. Patients in both phases of the study will receive the vaccine immunotherapeutic every four weeks until tumor progression.

Additional information, including a detailed description of the study design, eligibility criteria, and investigator sites, is available at ClinicalTrials.gov using identifier NCT03382977.

Stemline Therapeutics to Host Conference Call on Second Quarter 2019 Financial Results on August 2, 2019

On July 29, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported that the company will host a conference call and webcast on Friday, August 2, 2019 at 8:00 a.m. ET to report its second quarter 2019 financial results and other business highlights (Press release, Stemline Therapeutics, JUL 29, 2019, https://ir.stemline.com/news-releases/news-release-details/stemline-therapeutics-host-conference-call-second-quarter-2019 [SID1234537848]).

The conference call can be accessed by dialing 1-888-220-8451 (domestic) or 1-323-794-2588 (international) and referring to conference ID 7887580. The webcast can be accessed via the company’s website (www.stemline.com), at the bottom of the "Investors & Media" section in the "News & Events" page, and will be available live and for replay shortly after the event.

About ELZONRIS
ELZONRIS (tagraxofusp-erzs), a CD123-directed cytotoxin, is approved by the U.S. Food and Drug Administration (FDA) and commercially available in the U.S. for the treatment of adult and pediatric patients, two years or older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). For full prescribing information in the U.S., visit www.ELZONRIS.com. In Europe, a marketing authorization application (MAA) is under review by the European Medicines Agency (EMA). ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and acute myeloid leukemia (AML).

About BPDCN
BPDCN is an aggressive hematologic malignancy with historically poor outcomes and an area of unmet medical need. BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56, as well as other markers. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.

About CD123
CD123 is a cell surface target expressed on a wide range of myeloid tumors including blastic plasmacytoid dendritic cell neoplasm (BPDCN), certain myeloproliferative neoplasms (MPNs) including chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF), acute myeloid leukemia (AML) (and potentially enriched in certain AML subsets), myelodysplastic syndrome (MDS), and chronic myeloid leukemia (CML). CD123 has also been reported on certain lymphoid malignancies including multiple myeloma (MM), acute lymphoid leukemia (ALL), hairy cell leukemia (HCL), Hodgkin’s lymphoma (HL), and certain Non-Hodgkin’s lymphomas (NHL). In addition, CD123 has been detected on some solid tumors as well as autoimmune disorders including cutaneous lupus and scleroderma.