On August 14, 2019 Henry Ford Cancer Institute is first-in-the-world reported to enroll a patient in the GBM AGILE Trial (Adaptive Global Innovative Learning Environment) – a novel trial design and architecture made possible by an international collaboration of experts in the care of patients with glioblastoma and the design of clinical trials (Press release, The Henry Ford Cancer Institute, AUG 14, 2019, View Source [SID1234538747]). Led by the trial sponsor Global Coalition for Adaptive Research (GCAR), GBM AGILE is a seamless Phase II (Efficacy and Safety) / Phase III (Confirmatory) trial aimed at identifying the most effective therapies for patients with glioblastoma, the most aggressive form of brain cancer.

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A next-generation clinical trial program and the first-ever adaptive platform trial for brain cancer, GBM AGILE is a move away from the traditional, one-size-fits-all approach to clinical trials – a major step forward for Precision Medicine.

"We are launching an era of unprecedented collaboration and advancement in glioblastoma treatment," said Steven Kalkanis, M.D., chairman of the Department of Neurosurgery at Henry Ford Health System and medical director of the Henry Ford Cancer Institute. "Current treatments have been refined – including surgery, radiation and chemotherapy – but in the era of molecular medicine, dramatic leaps in outcomes through immunotherapy or targeted therapies are yet to be fully realized. With GBM AGILE, those dramatic leaps in outcomes will be more attainable, and at a faster pace, than ever before."

Traditional clinical trials take three-to-seven years to produce results, cannot be modified once started, and study only one treatment against the standard of care. GBM AGILE is uniquely designed as a long-standing platform with the ability to test multiple therapies concurrently against a common control (or standard of care). This enables more patients on trial to get access to experimental therapies. Another innovation of GBM AGILE is adaptive randomization, which means it is continuously updated with the latest information. As information accrues, the trial defines subsets of patients more likely to benefit from therapy. Patients are more likely to receive promising therapies at a faster and less costly rate.

"Progress in the treatment of patients with malignant brain tumors has been slow," said Tom Mikkelsen, M.D. of the Henry Ford Cancer Institute and medical director of the Precision Medicine Program and Clinical Trials Office at Henry Ford Health System. "The efficiency, speed and learning of GBM AGILE is intended to allow rapid discovery of better and better treatments for patients with glioblastoma. The era of data-driven innovation has arrived, and it’s being applied to the most difficult problems in cancer therapy."

GBM AGILE was first conceived in 2015 by an international group of more than 130 clinicians, researchers, biostatisticians, imagers, pathologists, patient advocates, and leaders from government and industry known as the "GBM Knowledge Network." It came together in response to a worldwide effort known as The Cancer Genome Atlas (TCGA), which was launched in 2006 by the National Cancer Institute (NCI) and the National Human Genome Research Institute (NHGRI). The organizations led a nationally-coordinated effort to perform a 10-year, deep-dive into the molecular basis of certain kinds of cancers. One of the first types of tumors studied in the landmark precision medicine effort was glioblastoma. Henry Ford was a major TCGA contributor, nearly 25% of all the gliomas studied over the course of the initiative having been donated by Henry Ford’s Hermelin Brain Tumor Center.

Former Vice President Joe Biden has been an outspoken supporter of GBM AGILE and attended the GBM AGILE launch event in November 2015. Biden’s son, Beau Biden, passed away from glioblastoma in May 2015 at the age of 46. Beau had been diagnosed in 2013 and was treated with surgery, chemotherapy, and radiation. He suffered a recurrence in the spring of 2015, at which time his condition deteriorated rapidly. Biden acknowledged the potential of GBM AGILE to offer unparalleled hope for many patients who had previously waited several years to benefit from advances in brain cancer research.

Henry Ford enrolled GBM AGILE’s first patient in collaboration with GCAR, an international partnership that comprises some of the world’s foremost clinical, translational, and basic science investigators. Through this collaboration and open exchange of ideas, the ultimate beneficiary—the patient—is supported in the fight against rare and deadly diseases.

"This is an important milestone for GBM AGILE and all those involved in this effort, most importantly, the patients, who desperately need new treatment options. We value the dedication of Dr. Tom Mikkelsen and the team at Henry Ford Cancer Institute to make this trial available to their patients and are eager to continue to work with our other committed study sites and investigators to make this trial available to patients across the United States this year, and internationally in 2020," said Dr. Meredith Buxton, Chief Operating Officer of GCAR.

Glioblastoma is one of the deadliest diseases on the planet. When treated with surgery, radiation and chemotherapy, patients have a median life expectancy of 11-15 months. The disease most commonly affects men ages 60 or older, although it can develop at any age in both men and women. The NCI estimates that 22,850 adults were diagnosed with brain and other nervous system cancers in 2015. It also estimates that in the same year, more than 15,000 of those diagnoses resulted in death.

On August 14, 2019 Western Oncolytics (WO), a privately held biotechnology company focused on the discovery and development of next generation oncolytic vaccinia virus immunotherapies reported that it has appointed Helena H. Chaye, Ph.D., J.D. to the position of chief executive officer (Press release, Western Oncolytics, AUG 14, 2019, View Source [SID1234538748]). Dr. Chaye most recently served as chief business officer for SillaJen, Inc., an oncolytic virus therapy company, and brings over 20 years of experience in business development, intellectual property management, corporate affairs and operations to Western Oncolytics.

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"Helena is an excellent, key and timely addition to our management team as we continue to build our company’s foundation ahead of moving into clinical development. Her depth of experience on the operations and business side for a company developing cancer immunotherapies will be invaluable," said Stephen H. Thorne, Ph.D., WO’s founder and chief scientific officer. "We also look forward to tapping into the global network that Helena has developed and believe that her contributions will enable us to move our new generation of optimized, multi-mechanistic cancer immunotherapies to the clinic more quickly."

"I am excited for the opportunity to join Western Oncolytics given the tremendous potential of WO’s technology and look forward to contributing to the company’s mission to create the best-in-class immuno-oncology platform," stated Dr. Chaye. "Among other tremendous progress by the WO team, I was pleased to see the SBIR (Small Business Innovation Research) Grant awarded to WO by the U.S. government and believe this to be greatly validating to our technology and therapeutic approach."

Dr. Chaye served in recent years at SillaJen Biotherapeutics, most recently as chief business officer after having been part of the Strategic Planning and Development team at SillaJen. She was one of the early executives of Jennerex, which was acquired by SillaJen in 2014, and made significant contributions to the early development of the company’s oncolytic virus therapy and the growth of Jennerex during the years 2006 to 2012. At the time of her departure in 2012, Dr. Chaye was vice president of corporate affairs and intellectual property after having held many leadership positions that included business development, human resources and technology operations. She has held business development and IP management positions at DNAtrix, MediGene, Canadian Genetic Diseases Network and has worked as a consultant to start-up companies based in the U.S. and in Korea. Dr. Chaye received her Ph.D. in Genetics from the University of British Columbia and her J.D. from Dalhousie University.

On August 14, 2019 Genmab reported that Interim Report for the First Half of 2019(Press release, Genmab, AUG 14, 2019, View Source [SID1234538770])

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Highlights

Registration statement filed with the U.S. Securities and Exchange Commission for the proposed public offering of American Depository Shares and application submitted for listing of the ADSs on the Nasdaq Global Select Market under the symbol "GMAB." The public offering and listing were completed in July.
Agreement signed with Janssen Biotech, Inc. (Janssen) to collaborate exclusively on next-generation CD38 antibody product candidate, HexaBody-CD38.
The U.S. Food and Drug Administration (U.S. FDA) approved DARZALEX (daratumumab) in combination with lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
The U.S. FDA granted Priority Review for daratumumab in combination with bortezomib, thalidomide and dexamethasone as treatment for newly diagnosed patients with multiple myeloma who are candidates for autologous stem cell transplant.
Janssen initiated Phase III study to examine daratumumab plus lenalidomide as maintenance treatment in patients with newly diagnosed multiple myeloma.
DARZALEX net sales increased 49% over H1 2018 to USD 1,403 million, resulting in royalty income of DKK 1,169 million.
Genmab is updating its 2019 financial guidance due to increased royalty income related to the sales of DARZALEX and increased operating expenses as a result of the advancement of our product pipeline, resulting in a small increase in projected operating income.
"The first half of 2019 brought truly transformational change to Genmab as we began the process of becoming a dual-listed company, with the potential to trade shares in both the U.S. (in the form of ADSs) and in Denmark. We also built upon our already successful relationship with Janssen with the signing of an agreement to collaborate exclusively on the next-generation CD38 antibody product candidate, HexaBody-CD38. We have seen encouraging pre-clinical data from HexaBody-CD38 and believe it has the potential to extend the promise of CD38-targeted therapies beyond what is currently available for patients," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "In addition to these key events, the first half of 2019 also saw the highly anticipated U.S. FDA approval for DARZALEX, based on the Phase III MAIA data. Now that this indication has been approved many more patients in the U.S. who are newly diagnosed with multiple myeloma will have a DARZALEX containing regimen as a choice for their initial therapy."

Financial Performance First Half of 2019

Revenue was DKK 1,365 million in the first half of 2019 compared to DKK 1,191 million in the first half of 2018. The increase of DKK 174 million, or 15%, was mainly driven by higher DARZALEX royalties and reimbursement income from our collaborations with Seattle Genetics and BioNTech, partly offset by the one-time payment from Novartis of USD 50 million (DKK 304 million) during the first half of 2018 for lost potential milestones and royalties following announcement of Novartis’ intention to transition Arzerra (ofatumumab) to limited availability via compassionate use programs for chronic lymphocytic leukemia (CLL) in non-U.S. markets.
Net sales of DARZALEX by Janssen were USD 1,403 million in the first half of 2019 compared to USD 943 million in the first half of 2018, an increase of USD 460 million, or 49%. According to Johnson & Johnson, sales in the second quarter of 2019 included a one-time adjustment related to the completion of pricing and reimbursement discussions in certain European countries, which positively impacted this worldwide second quarter operational growth by 16 percentage points.
Operating expenses were DKK 1,254 million in the first half of 2019 compared to DKK 732 million in the first half of 2018. The increase of DKK 522 million, or 71%, was driven by the advancement of enapotamab vedotin and tisotumab vedotin, additional investments in our product pipeline, and the increase in new employees to support the expansion of our product pipeline.
Operating income was DKK 111 million in the first half of 2019 compared to DKK 459 million in the first half of 2018. As anticipated, the decrease of DKK 348 million, or 76%, was driven primarily by increased operating expenses and the one-time payment from Novartis in 2018.
Subsequent Event

July: Completion of public offering and listing of American Depository Shares (ADSs) on Nasdaq Global Select Market under the symbol "GMAB". Gross proceeds from the issuance of new shares amounted to USD 506 million (DKK 3,368 million) with a corresponding increase in share capital of 2,850,000 ordinary shares or 28,500,000 American Depository Shares ("ADSs"). Further, the underwriters’ exercised in full their option to purchase an additional 427,500 ordinary shares or 4,275,000 ADSs bringing the total gross proceeds of the offering to USD 582 million (DKK 3,873 million). The public offering price of $17.75 per ADS, corresponded to a subscription price of DKK 1,181.80 per New Share at the U.S. dollar/DKK exchange rate of DKK 6.6580 per USD 1.00 on July 17, 2019, multiplied by the ADS-to-share ratio of ten-to-one. Underwriting commissions paid were USD 32 million (DKK 213 million). Total share capital following the public offering amounted to DKK 64,967,643.
Outlook
Genmab is updating its 2019 financial guidance published on February 20, 2019 due to increased royalty income related to the sales of DARZALEX and increased operating expenses as a result of the advancement of our product pipeline.

MDKK Revised Guidance Previous
Guidance
Revenue 4,800 4,600
Operating expenses (2,750) (2,600)
Operating income 2,050 2,000
Conference Call
Genmab will hold a conference call in English to discuss the results for the first half of 2019 today, Wednesday, August 14, at 6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT. To join the call dial
+1 631 510 7495 (U.S. participants) or +44 2071 928000 (international participants) and provide conference code 4966139.

A live and archived webcast of the call and relevant slides will be available at www.genmab.com.

Contact:
Marisol Peron, Corporate Vice President, Communications & Investor Relations
T: +1 609 524 0065; E: [email protected]

For Investor Relations:
Andrew Carlsen, Senior Director, Investor Relations
T: +45 3377 9558; E: [email protected]

On August 14, 2019 ESSA Pharma Inc. ("ESSA", or the "Company") (TSX-V: EPI,NASDAQ: EPIX), a pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, provided a corporate update and reported financial results for the fiscal third quarter ended June 30, 2019 (Press release, ESSA, AUG 14, 2019, View Source [SID1234538749]). All references to "$" in this release refer to United States dollars, unless otherwise indicated.

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"The last quarter marked another significant period in our ongoing transformation process for Essa from both corporate and clinical standpoints. During the quarter, we worked diligently on the work required to complete the acquisition of Realm Therapeutics with the transaction closing on July 31st. The acquisition of Realm and its cash balance put Essa in a strong financial position to allow us to commence the Phase 1 clinical study of EPI-7386," stated David Parkinson, MD, President and CEO of ESSA. "We are progressing with IND-enabling studies on EPI-7386 and on track to file an IND with the FDA in the first calendar quarter of 2020. We look forward to presenting further in vitro and in vivo study results of EPI-7386 in the coming months at medical conferences."

Recent Company Highlights

On July 31, 2019, the Company completed the acquisition of Realm Therapeutics plc ("Realm") pursuant to a scheme of arrangement under Part 26 of the U.K. Companies Act 2006 (the "Acquisition"). Under the terms of the Acquisition, ESSA acquired all of the issued and outstanding shares of Realm, and Realm shareholders received a total of 6,718,150 common shares of the Company.
On May 4, 2019 at the 2019 American Urological Association Meeting, an oral poster presentation presented a deeper preclinical characterization of EPI-7386. The poster showed that pre-clinical studies demonstrate that EPI-7386 (i) displays similar in vitro IC50 potency compared to the lutamide class of antiandrogens in an in vitro androgen receptor (AR) inhibition assay; (ii) shows in vitro activity in several enzalutamide-resistant prostate cancer cell models in which enzalutamide is resistant; (iii) exhibits a favorable metabolic profile across three preclinical animal species (which suggests that EPI-7386 will have high exposure and a long half-life in humans) (iv) provides similar antitumor activity to enzalutamide in the enzalutamide-sensitive LNCaP prostate cancer xenograft model, and (v) provides superior antitumor activity to enzalutamide, as a single agent or in combination with enzalutamide, in the enzalutamide emerging-resistant VCaP prostate cancer xenograft model, specifically showing AR inhibition with both an N-terminal domain inhibitor (EPI-7386) and a ligand binding domain inhibitor (enzalutamide), induces deeper and more consistent anti-tumor responses in the enzalutamide emerging-resistant VCaP xenograft model.
EPI-7386 was selected for a poster presentation at the European Society for Medical Oncology ("ESMO") 2019 Congress to be held September 27-October 1, 2019 in Barcelona, Spain.
Summary Financial Results

Net Income (Loss). ESSA recorded a net loss of $3.3 million ($0.52 loss per common share based on 6,383,737 weighted average common shares outstanding) for the quarter ended June 30, 2019, compared to a net loss of $2.9 million ($0.50 loss per common share based on 5,776,098 weighted average common shares outstanding) for the quarter ended June 30, 2018.

Research and Development ("R&D") expenditures. R&D expenditures for the quarter ended June 30, 2019 were $1.95 million compared to $0.99 million for the quarter ended June 30, 2018. The increase in R&D expenditures for the quarter were primarily related to ESSA’s efforts in preparing an Investigational New Drug application for its recently-nominated clinical candidate, EPI-7386. Costs in the comparative period included preclinical research related to the Company’s next-generation aniten compounds.

General and administration ("G&A") expenditures. G&A expenditures for the quarter ended June 30, 2019 were $1.2 million compared to $1.6 million for the quarter ended June 30, 2018. The decrease is the result of a reduction in professional fees, primarily due to Acquisition-related professional fees being recorded as deferred costs for the period, as well as decreases in rent expense and share-based payments.
Liquidity and Outstanding Share Capital
Cash on hand at June 30, 2019, was $4.9 million, with working capital of $0.3 million, reflecting the aggregate gross proceeds of the completed January 2018 financing, which totaled $26 million, less operating expenses in the intervening period.

As of June 30, 2019, the Company had 7,963,628 common shares issued and outstanding.

In addition, as of June 30, 2019 there were 473,688 common shares issuable upon the exercise of warrants and broker warrants at a weighted-average exercise price of $34.36 per ESSA common share and 1,154,711 ESSA common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $4.58 per common share.

On August 14, 2019 Nuvo Pharmaceuticals Inc. (Nuvo or the Company) (TSX:NRI;OTCQX:NRIFF), a Canadian focused, healthcare company with global reach and a diversified portfolio of commercial products, reported its financial and operational results for the three and six months ended June 30, 2019 (Press release, Nuvo Pharmaceuticals, AUG 14, 2019, View Source [SID1234538750]). For further details on the results, please refer to Nuvo’s Management, Discussion and Analysis (MD&A) and Condensed Consolidated Interim Financial Statements which are available on the Company’s website (www.nuvopharmaceuticals.com). All figures are in Canadian dollars, unless otherwise noted.

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"During the second quarter, our operating segments continued to perform in line with our expectations and our second quarter financial results reinforce the increase in scale the Aralez Transaction has made to our business," said Jesse Ledger, Nuvo’s President & CEO. "While the Vimovo news during the quarter was disappointing, we have made cost-saving adjustments to our operations and our underlying business and financial performance is expected to benefit from these changes moving forward."

Second Quarter Financial Summary

Adjusted total revenue(1) was $19.1 million for the three months ended June 30, 2019 compared to $6.0 million for the three months ended June 30, 2018.

Adjusted EBITDA(1) was $5.7 million for the three months ended June 30, 2019 compared to $2.0 million for the three months ended June 30, 2018.

Gross profit on total revenue was $9.6 million or 58% for the three months ended June 30, 2019 compared to a gross profit of $3.5 million or 60% for the three months ended June 30, 2018.

Cash and short-term investments were $14.7 million as at June 30, 2019 compared to $28.1 million as at December 31, 2018. The decrease was primarily related to the settlement of transaction costs and indebtedness acquired by Nuvo upon close of the Aralez Transaction.
(1)

Non-International Financial Reporting Standards (IFRS) financial measure defined by the Company below.

Second Quarter and 2019 Business Update

Canadian prescriptions of Blexten increased 64% to 105,407 for the three months ended June 30, 2019 compared to 64,404 for the three months ended June 30, 2018.

Canadian prescriptions of Cambia increased 30% to 19,500 for the three months ended June 30, 2019 compared to 15,036 for the three months ended June 30, 2018.

On April 2, 2019, the Company announced the Marketing Authorization Application for Pennsaid 2% had been accepted for review by the Austrian Agency for Health and Food Safety (AGES) acting as the reference member state for Austria, Italy, Greece and Portugal. It is anticipated that a review decision will be made in early 2020.

On May 3, 2019, the Suvexx registration dossier passed screening with Health Canada and is now under formal review. The Company anticipates a review decision from Health Canada during the first half of 2020.

On May 15, 2019, the Company announced the United States Court of Appeals for the Federal Circuit (the Court of Appeals) had reversed the decision by the United States District Court for the District of New Jersey (the District Court) that had upheld the validity of U.S. Patent Nos. 6,926,907 (the ‘907 patent) and 8,557,285 (the ‘285 patent). On July 30, 2019, the Court of Appeals rejected the Company’s en banc request to have the Court of Appeals reconsider its decision. On June 26, 2019, the Company amended its financing agreement with Deerfield Management Company, L.P. (Deerfield), to provide, among other things, for a payment deferral of a portion of mandatory minimum quarterly prepayments should Vimovo U.S. market exclusivity be lost due to a generic entry.

On June 17, 2019, the Company announced that in the second half of 2019, it will start to realize on synergies resulting from organizational changes and its acquisition of Aralez Canada that will reduce its operating expenses by approximately $7.0 million annually.
Second Quarter 2019 Financial Results

Total revenue is comprised of product sales, license revenue and contract revenue. Total revenue was $16.6 million for the three months ended June 30, 2019 compared to $5.9 million for the three months ended June 30, 2018. The significant increase in total revenue for the current quarter was the result of the timing of the Aralez Transaction. Total revenue for the six months ended June 30, 2019 was $31.1 million compared to $10.3 million for the comparative six-month period.

Adjusted total revenue increased to $19.1 million for the three months ended June 30, 2019 compared to $6.0 million for the three months ended June 30, 2018. The $13.1 million increase in adjusted total revenue in the current quarter was primarily related to the timing of the Aralez Transaction, which provided an incremental $9.7 million of total revenue contributed from the Commercial Business segment and $4.7 million attributable to the Vimovo royalties related to the U.S. and ex-U.S. territories, partially offset by a $1.2 million decrease in Production and Service revenue. Adjusted total revenue increased to $36.2 million for the six months ended June 30, 2019 compared to $10.6 for the six months ended June 30, 2018.

Adjusted EBITDA increased to $5.7 million for the three months ended June 30, 2019 compared to $2.0 million for the three months ended June 30, 2018. The increase in adjusted EBITDA for the current quarter was primarily attributable to the increase in gross profit as a result of the Aralez Transaction, partially offset by an increase in sales and marketing and general and administrative (G&A) expenses, including $1.0 million of one-time restructuring expenses. Adjusted EBITDA increased to $10.9 million for the six months ended June 30, 2019 compared to $2.7 million for the six months ended June 30, 2018.

Gross profit on total revenue was $9.6 million or 58% for the three months ended June 30, 2019 compared to a gross profit of $3.5 million or 60% for the three months ended June 30, 2018. The increase in gross profit for the current quarter was primarily attributable to an increase in gross margin on product sales and an increase in license revenue due to the timing of the Aralez Transaction. Gross profit on total revenue was $18.7 million or 60% for the six months ended June 30, 2019 compared to a gross profit of $6.1 million or 59% for the six months ended June 30, 2018.

Non-IFRS Financial Measures
The Company discloses non-IFRS measures (such as adjusted total revenue, adjusted EBITDA and adjusted EBITDA per share) that do not have standardized meanings prescribed by IFRS. The Company believes that shareholders, investment analysts and other readers find such measures helpful in understanding the Company’s financial performance and in interpreting the effect of the Aralez Transaction and the Deerfield Financing on the Company. Non-IFRS financial measures do not have any standardized meaning prescribed by IFRS and may not have been calculated in the same way as similarly named financial measures presented by other companies.

Adjusted Total Revenue
The Company defines adjusted total revenue as total revenue, plus amounts billed to customers for existing contract assets, less revenue recognized upon recognition of a contract asset. Management believes adjusted total revenue is a useful supplemental measure from which to determine the Company’s ability to generate cash from its customer contracts that is used to fund its operations.

The following is a summary of how adjusted total revenue is calculated:

Adjusted EBITDA
EBITDA refers to net income (loss) determined in accordance with IFRS, before depreciation and amortization, net interest expense (income) and income tax expense (recovery). The Company defines adjusted EBITDA as net income before net interest expense (income), depreciation and amortization and income tax expense (recovery) (EBITDA), plus amounts billed to customers for existing contract assets, inventory step-up expense, stock-based compensation expense, Other Expenses, less revenue recognized upon recognition of a contract asset and other income. Management believes adjusted EBITDA is a useful supplemental measure from which to determine the Company’s ability to generate cash available for working capital, capital expenditures, debt repayments, interest expense and income taxes.

The following is a summary of how EBITDA and adjusted EBITDA are calculated:

Management to Host Conference Call/Webcast
Management will host a conference call to discuss the results today (Wednesday, August 14, 2019) at 8:30 a.m. ET. To participate in the conference call, please dial 1 888 390 0546 or 416 764 8688. Please call in 15 minutes prior to the call to secure a line. You will be put on hold until the conference call begins.

A taped replay of the conference call will be available two hours after the live conference call and will be accessible until midnight on August 21, 2019 by calling 1 888 390 0541 or 416 764 8677 playback passcode 509912#.

A live audio webcast of the conference call will be available through www.nuvopharmaceuticals.com. Please connect at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to hear the webcast.