On February 14, 2019 Medicenna Therapeutics Corp. ("Medicenna" or the "Company") (TSX: MDNA; OTCQB: MDNAF), a clinical stage immuno-oncology company, reported financial results for the three and nine months ended December 31, 2018 (Press release, Medicenna Therapeutics, FEB 14, 2019, View Source [SID1234533326]).

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 following are the achievements and highlights for the quarter ending December 31, 2018 through to the date hereof:

Presented promising survival data from the ongoing MDNA55 Phase 2b clinical trial for the treatment of recurrent glioblastoma ("rGBM") the most common and uniformly fatal form of brain cancer showing a median overall survival of 15.2 months in the IL4 receptor positive patients who have a more aggressive form of rGBM. Whereas the current standard of care for all rGBM patients provide a median overall survival of only 8.0 months.
Strengthened the balance sheet with a $4.0 million financing in December 2018 and received an additional US$1.2 million in non-dilutive funding in the same month.
Provided an update on MDNA109 demonstrating that it has best-in-class potency toward cancer killing effector T cell and that it potently synergizes with anti-PD-1 or anti-CTLA-4 checkpoint inhibitors to eliminate tumors in the majority of tumor-bearing mice.
Upcoming milestones include:

Completion of patient enrolment in the MDNA55 Phase 2b rGBM is anticipated by the end of Q1 2019
Top line interim results announced in the MDNA55 Phase 2b clinical trial mid-2019
Initiation of Phase 2 clinical trial with MDNA55 for the treatment of newly diagnosed GBM in Q2 2019
Selection of lead MDNA109 candidate in Q1 2019
"2019 is off to an excellent start with compelling median overall survival data in the MDNA55 Phase 2b clinical trial for the treatment of recurrent glioblastoma reported in February as well as the impressive pre-clinical package we are assembling for MDNA109," said Dr. Fahar Merchant, President and CEO of Medicenna. He added that "the clinical and scientific progress we have made in addition to the capital raised and non-dilutive funds received in December has placed Medicenna on an excellent footing to hit key value inflection milestones for 2019."

MDNA55 update
On February 7, 2019 Dr. John H. Sampson, MD, PhD, (Robert H. and Gloria Wilkins Distinguished Professor and Chair of Neurosurgery at Duke University in Durham, NC) presented new clinical study results on MDNA55 for the treatment of rGBM at the 5th Annual Immuno-Oncology 360o Conference held in New York, NY. In a podium presentation entitled, "The IL4 Receptor as a Biomarker and Immunotherapeutic Target for Glioblastoma: Preliminary Evidence with MDNA55, a Locally Administered IL-4 Guided Toxin", Dr. Sampson outlined that following a single treatment with MDNA55 at the low dose, (a) the IL4R positive group showed a remarkable increase in median overall survival ("mOS") of 15.2 months when compared to 8.5 months in the IL4R negative group and (b) irrespective of IL4R expression, mOS was 11.8 months in all patients, substantially exceeding landmark mOS reported for approved drugs for rGBM (mOS is 8 months for Avastin and Lomustine).

On October 22, 2018, the Company presented results and participated in a poster discussion session at the European Society for Medical Oncology Congress held in Munich on October 20, 2018. Based on interim data from patients treated at low doses implemented during the first half of the Phase 2b study of MDNA55, the presentation highlighted the benefits of using of advanced imaging modalities in order to help tumor response evaluation and identify pseudo-progression in some patients which ultimately translates into tumor shrinkage, and potential treatment benefit.

On November 16, 2018, Medicenna presented an update on intratumoral delivery of MDNA55 using MRI-guided convective delivery at the 23rd Annual Meeting of the Society for Neuro-Oncology

MDNA109 update
On February 6, 2019 Dr. Moutih Rafei, PhD, (Associate Professor, Department of Pharmacology and Physiology, Université de Montreal) presented new results on MDNA109 and its long acting variants at the 5th Annual Immuno-Oncology 360o Meeting held in New York, NY. In a podium presentation entitled, "Putting Pedal to the Metal: Combining IL-2 Superkine (MDNA109) with Checkpoint Inhibitors." The presentation outlined that MDNA109, an engineered IL-2 superkine exhibited a 1000-fold enhanced affinity toward the CD122 receptor, has best-in-class potency toward cancer killing effector T cells, was not immunogenic in-vivo and potently synergized with anti-PD-1 or anti-CTLA-4 checkpoint inhibitors to eliminate tumors in the majority of tumor-bearing mice.

On November 9, 2018, Medicenna presented an update on preliminary pre-clinical results on MDNA109 at the 33rd Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) held in Washington, DC.

Operational update
On December 21, 2018, the Company completed a public offering and issued 4,000,000 units of the Company for gross proceeds of CDN$4,000,000.

On December 5, 2018, Medicenna received a US$1.2 million reimbursement of past expenses from the Cancer Prevention and Research Institute of Texas ("CPRIT").

Financial Results
For the three months ended December 31, 2018, Medicenna reported a net loss of $1,723,081 or $0.07 per share compared to a loss of $2,181,022 or $0.09 per share for the three months ended December 31, 2017. For the nine months ended December 31, 2018, Medicenna reported a net loss of $3,658,957 or $0.15 per share compared to a loss of $6,154,946 or $0.25 per share for the nine months ended December 31, 2017.

Research and Development Expenses
Research and development ("R&D") expenses of $2,356,683 were incurred during the nine months ended December 31, 2018, compared with $4,226,141 incurred in the nine months ended December 31, 2017 and were $1,275,896 during the three months ended December 31, 2018, compared with $1,351,703 incurred in the three months ended December 31, 2017. The decrease in the expenses in the current year periods can be primarily attributed to reduced discovery and pre-clinical expenses due to work ongoing and completed in the prior year related to the development of MDNA57as well as lower clinical trial costs due to reduced consulting costs, clinical supplies and CRO fees due to nearing the end of the clinical study and general cost containment. Finally, the variance in recoveries from CPRIT contributed to the changes in net loss of $905,585 in the three months and $3,824,293 in the nine months ended December 31, 2018 compared with $1,884,820 in the three months and $3,334,424 in the nine months ended December 31, 2017

General and Administrative Expenses
General and administrative ("G&A") expenses of $437,218 were incurred in the three months and $1,295,132 in the nine months ended December 31, 2018, compared with $824,007 in the three months and $1,894,230 in the nine months ended December 31, 2017. The decrease in G&A expenses period over period is attributed primarily to lower stock based compensation costs due to timing of grants as well as a lower number of option grants in the current year periods, reduced legal expenses in the current year periods due to expenses related to the graduation from the TSXV to TSX as well as the OTC listing incurred in the prior year periods and lower salary and benefit costs due to headcount reductions and a bonus accrual in the prior year and no comparable accrual in the current year periods

On February 14, 2019 Ohr Pharmaceutical, Inc. (Nasdaq: OHRP) (the "Company" or "Ohr") reported financial results for the three months ended December 31, 2018 (Press release, Ohr Pharmaceutical, FEB 14, 2019, View Source [SID1234533348]).

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!

"Since we announced the signing of a definitive agreement to merge with NeuBase Therapeutics, Inc., a privately-held biotechnology company, we have been working diligently to bring the proposed merger with NeuBase to our stockholders for a vote. We expect to hold a special stockholder meeting in the second calendar quarter of 2019," said Jason Slakter, M.D., chief executive officer of Ohr Pharmaceutical. "After reviewing various strategic alternatives for our business in 2018, we identified a merger with NeuBase as the best opportunity to generate value for our stockholders, based on their ongoing work to change the paradigm for treating rare genetic diseases with next generation, highly specific antisense oligonucleotide therapies. We look forward to working with NeuBase to create a successful company focused on bringing transformative new therapies to patients around the world suffering from rare genetic diseases."

Proposed NeuBase Merger and NASDAQ Listing Update:

On January 3, 2019, Ohr announced a definitive merger agreement with NeuBase Therapeutics, Inc. ("NeuBase")
The proposed merger has been approved by the board of directors of both Ohr and NeuBase
Ohr anticipates it will file the proxy materials for its proposed merger with NeuBase with the Securities and Exchange Commission (SEC) in the first calendar quarter of 2019
Ohr expects to hold a special meeting of stockholders in the second calendar quarter of 2019 to vote on the proposed merger with NeuBase
Ohr completed a 1-for-20 reverse stock split that was effective February 4, 2019, which Ohr believes will allow it to maintain its Nasdaq listing
Financial Results for the First Quarter of FY 2019 ended December 31, 2018:

For the three months ended December 31, 2018, the Company reported a net loss of approximately $0.9 million, or ($0.32) per share, compared to a net loss of approximately $4.2 million, or ($1.48) per share, in the three months ended December 31, 2017. Loss per share amounts have been retroactively adjusted for the reverse stock split effected on February 4, 2019.
For the three months ended December 31, 2018, total operating expenses were approximately $0.9 million, consisting of approximately $0.7 million in general and administrative expenses, approximately $0.1 million of research and development expenses, and approximately $0.2 million in depreciation and amortization. This compares to total operating expenses of $4.2 million in the three months ended December 31, 2017, comprised of approximately $1.5 million in general and administrative expenses, approximately $2.4 million in research and development expenses, and approximately $0.3 million in depreciation and amortization.
At December 31, 2018, the Company had cash and cash equivalents of approximately $3.1 million, compared to cash and equivalents of approximately $3.8 million at September 30, 2018.
Merger Agreement with NeuBase
On January 3, 2019, Ohr announced entering into a definitive merger agreement with NeuBase under which the stockholders of NeuBase would become the majority holders of the combined company. The proposed merger will create a public company focused on advancing NeuBase’s peptide-nucleic acid (PNA) antisense oligonucleotide (PATrOL) technology platform for the development of therapies to address severe and currently untreatable diseases caused by genetic mutations. The proposed merger has been approved by the board of directors of both companies.

On a pro forma basis and based upon the number of shares of Ohr common stock to be issued in the merger, current Ohr stockholders will own approximately 20% of the combined company and NeuBase stockholders will own approximately 80% of the combined company, after accounting for the additional NeuBase financing transaction. The actual allocation will be subject to adjustment based on Ohr’s and NeuBase’s cash balance at the time of closing and the amount of the additional financing consummated by NeuBase at or before the closing of the proposed merger. Certain members and affiliates of the board of directors and management of Ohr and NeuBase have indicated an intent to invest in the additional NeuBase financing.

The proposed merger is subject to the approval of Ohr’s stockholders and the satisfaction or waiver of other customary conditions.

On February 14, 2019 Alkermes plc (Nasdaq: ALKS) reported financial results for the year ended Dec. 31, 2018 and provided financial expectations for 2019 (Press release, Alkermes, FEB 14, 2019, View Source [SID1234533306]).

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!

"Our strong financial results in 2018 were driven by the growth of our proprietary commercial products and the continued strength and diversity of our royalty and manufacturing business," commented James Frates, Chief Financial Officer of Alkermes. "As we enter 2019, our financial expectations reflect the continued growth of our proprietary products, VIVITROL and ARISTADA, as well as important investments in the future growth drivers of the company including our advancing development pipeline and commercial capabilities to support our expanding presence in schizophrenia."

Quarter Ended Sept. 30, 2018 Financial Highlights

Total revenues for the quarter were $315.8 million. This compared to $275.4 million for the same period in the prior year, representing an increase of 15%. Proprietary product net sales for VIVITROL and ARISTADAi were $132.7 million for the quarter, reflecting a 28% increase compared to the same period in the prior year.

Net loss according to generally accepted accounting principles in the U.S. (GAAP) was $9.7 million for the quarter, or a basic and diluted GAAP net loss per share of $0.06. This compared to GAAP net loss of $9.8 million, or a basic and diluted GAAP net loss per share of $0.06, for the same period in the prior year.

Non-GAAP net income was $54.8 million for the quarter, or a non-GAAP basic earnings per share of $0.35 and non-GAAP diluted earnings per share of $0.34. This compared to non-GAAP net income of $50.3 million, or a non-GAAP basic earnings per share of $0.33 and non-GAAP diluted earnings per share of $0.31, for the same period in the prior year.

The launch of ARISTADA INITIOii continues to gain traction as payers and providers recognize the value proposition of this important new offering, particularly in combination with the ARISTADA two-month dose which provides the unique ability to fully dose a patient on day one for up to two monthsiii. With this offering, we are supporting continuity of care which is critically important for this patient population. We also continue to build the customized commercial capabilities necessary to navigate this complex treatment environment, including recent expansions of our field- and hospital-based teams," stated Jim Robinson, President and Chief Operating Officer of Alkermes. "VIVITROL results for 2018 were in-line with our expectations and we are encouraged by solid growth trends across many states. As we enter 2019, we remain committed to increasing access to VIVITROL and driving increased adoption in order to meet the needs of patients with opioid and alcohol dependence."

Quarter Ended Dec. 31, 2018 Financial Results

Revenues

Net sales of VIVITROL were $83.8 million, compared to $75.6 million for the same period in the prior year, representing an increase of approximately 11%.

Net sales of ARISTADA were $48.8 million, compared to $28.3 million for the same period in the prior year, representing an increase of approximately 72%.

Manufacturing and royalty revenues from RISPERDAL CONSTA, INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA were $81.4 million, compared to $78.2 million for the same period in the prior year.

Manufacturing and royalty revenues from AMPYRA/FAMPYRAiv were $38.8 million, compared to $38.1 million for the same period in the prior year, which was above our expectations given generic entry into the market in 2018.

Manufacturing and royalty revenues included $26.7 million from Alkermes’ share of proceeds from the sale of certain royalty streams by Zealand Pharma A/S, related to products using Alkermes’ technology, to Royalty Pharma.

Research and development revenues were $15.6 million, of which $14.4 million related to R&D reimbursement from the company’s collaboration with Biogen for diroximel fumarate, or BIIB098.

Costs and Expenses

Operating expenses were $315.7 million, compared to $269.5 million for the same period in the prior year, primarily reflecting increased investment in the commercialization of ARISTADA and VIVITROL.

Calendar Year 2018 Financial Highlights

Total revenues increased 21% to $1.09 billion in 2018, which included VIVITROL net sales of $302.6 million and ARISTADA net sales of $147.7 million. This compared to total revenues of $903.4 million for 2017, which included VIVITROL net sales of $269.3 million and ARISTADA net sales of $93.5 million. Please see the tables at the end of this press release for a detailed breakdown of the revenues from our key commercial products.

GAAP net loss was $139.3 million, or a basic and diluted GAAP loss per share of $0.90, for 2018. This compared to a GAAP net loss of $157.9 million, or a basic and diluted GAAP loss per share of $1.03, for 2017.

Non-GAAP net income was $97.8 million, or a non-GAAP basic earnings per share of $0.63 and non-GAAP diluted earnings per share of $0.61, for 2018. This compared to non-GAAP net income of $27.8 million, or a non-GAAP basic earnings per share of $0.18 and non-GAAP diluted earnings per share of $0.17, for 2017.

At Dec. 31, 2018, Alkermes recorded cash, cash equivalents and total investments of $620.0 million, compared to $590.7 million at Dec. 31, 2017. At Dec. 31, 2018, the company’s total debt outstanding was $279.3 million, compared to $281.4 million at Dec. 31, 2017.

"Alkermes is defined by our commitment to making medicines that help address critical public health challenges, using our scientific insights to develop medicines that are designed with the real-world needs of patients in mind. Following the positive results of the ALKS 3831 ENLIGHTEN-2 pivotal study and the increasing traction of ARISTADA in the market, we continue to establish our emerging leadership position in the treatment of schizophrenia," said Richard Pops, Chief Executive Officer of Alkermes. "2019 will be an important year for our late-stage pipeline highlighted by the planned submission of the

ALKS 3831 New Drug Application and the regulatory review of the recently submitted New Drug Application for diroximel fumarate for multiple sclerosis, with expected action in the fourth quarter. As development activities surrounding our ALKS 4230 immuno-oncology program gain momentum, we expect to have our first indications of ALKS 4230’s anti-tumor response activity this year, and we look forward to updating you on our progress."

Recent Events:

ALKS 3831

In November 2018, Alkermes announced positive topline results from ENLIGHTEN-2, a pivotal phase 3 study of ALKS 3831 compared to olanzapine in patients with stable schizophrenia. In the study, ALKS 3831 met the pre-specified co-primary endpoints, demonstrating both a lower mean percent weight gain from baseline at six months compared to the olanzapine group and a lower proportion of patients who gained 10% or more of their baseline body weight at six months compared to the olanzapine group.

Diroximel fumarate (BIIB098)

In December 2018, Alkermes and Biogen announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for diroximel fumarate, a novel oral fumarate in development for the treatment of relapsing forms of multiple sclerosis. If approved, Biogen intends to market diroximel fumarate under the brand name VUMERITYTM. This name has been conditionally accepted by the FDA and will be confirmed upon approval.

ALKS 4230

In November 2018, Alkermes presented initial clinical data from the ongoing dose-escalation stage of the phase 1 study for ALKS 4230 at the 2018 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting.

ALKS 5461

In January 2019, Alkermes received a Complete Response Letter from the FDA regarding the NDA for ALKS 5461 for the adjunctive treatment of major depressive disorder.

Financial Expectations for 2019

The following outlines the company’s financial expectations for 2019, which include planned investments in the company’s pipeline of development candidates and commercial infrastructure to support the company’s expanding presence in schizophrenia.

Revenues: The company expects total revenues to range from $1.14 billion to $1.19 billion, driven by expected growth of our proprietary products and an expected $150 million milestone payment from Biogen in the fourth quarter related to the potential FDA approval of diroximel fumarate. Included in this total revenue expectation, Alkermes expects VIVITROL net sales to range from $330 million to $350 million, and ARISTADA net sales to range from $210 million to $230 million.

Cost of Goods Manufactured and Sold: The company expects cost of goods manufactured and sold to range from $180 million to $190 million.

Research and Development (R&D) Expenses: The company expects R&D expenses to range from $450 million to $480 million.

Selling, General and Administrative (SG&A) Expenses: The company expects SG&A expenses to range from $590 million to $620 million.

Amortization of Intangible Assets: The company expects amortization of intangibles to be approximately $40 million.

Net Interest Expense: The company expects net interest expense to range from $5 million to $10 million.

Income Tax Expense: The company expects income tax expense to range from $10 million to $15 million.

GAAP Net Loss: The company expects GAAP net loss to range from $135 million to $165 million, or a basic and diluted loss per share of $0.87 to $1.06, based on a weighted average basic and diluted share count of approximately 156 million shares outstanding.

Non-GAAP Net Income: The company expects non-GAAP net income to range from $40 million to $70 million, or a non-GAAP basic earnings per share of $0.26 to $0.45, based on a weighted average basic share count of approximately 156 million shares outstanding and a non-GAAP diluted earnings per share of $0.25 to $0.43, based on a weighted average diluted share count of approximately 161 million shares outstanding.

Share-Based Compensation: The company expects share-based compensation of approximately $120 million.

Capital Expenditures: The company expects capital expenditures to range from $90 million to $100 million.

Conference Call

Alkermes will host a conference call and webcast presentation with accompanying slides at 8:30 a.m. ET (1:30 p.m. BST) on Thursday, Feb. 14, 2019, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call will be available from 11:00 a.m. ET (4:00 p.m. BST) on Thursday, Feb. 14, 2019, through Thursday, Feb. 21, 2019, and may be accessed by visiting Alkermes’ website or by dialing +1 877 660 6853 for U.S. callers and +1 201 612 7415 for international callers. The replay conference ID is 13687392.

On February 14, 2019 Bayer reported Results from the pivotal Phase III ARAMIS trial in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) showed a statistically significant improvement in metastasis-free survival (MFS) with the investigational drug darolutamide plus androgen deprivation therapy (ADT) compared to placebo plus ADT (HR=0.41, 95% CI 0.34-0.50; P<0.001) (Press release, Bayer, FEB 14, 2019, View Source [SID1234533327]).2 This translates to a 59 percent reduction in the risk of metastasis or death.1 The median MFS was 40.4 months in the darolutamide arm compared with 18.4 months for the placebo arm – an overall difference in median MFS of 22 months.1

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 incidence of adverse events (AEs) was generally similar in the darolutamide and placebo arms; only fatigue occurred in more than 10 percent of patients (15.8 percent with darolutamide plus ADT versus 11.4 percent with placebo plus ADT).2 The most common grade 3-4 AEs for darolutamide and placebo were 24.7 percent and 19.5 percent, respectively.2 Grade 3-4 AEs occurring in greater than or equal to 2 percent of patients were hypertension (3.1 percent versus 2.2 percent) and urinary retention (1.6 percent versus 2.0 percent) for darolutamide and placebo, respectively.2

These data were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU) in San Francisco and published simultaneously in The New England Journal of Medicine.

"These data are exciting for the prostate cancer community, as they show darolutamide’s potential to treat asymptomatic nmCRPC patients and delay spread of the disease," said Karim Fizazi, M.D., Ph.D., Professor of Medicine at the Institut Gustave Roussy, University of Paris Sud, France.

"These data demonstrate that darolutamide may be an option for men with nmCRPC and can potentially fulfill an unmet need for these patients," said Matthew Smith, M.D., Ph.D., Director of the Genitourinary Malignancies Program, Massachusetts General Hospital Cancer Center.

"Bayer is working diligently to bring treatments to patients in need," said Scott Z. Fields, M.D., senior vice president and head of Oncology Development at Bayer’s Pharmaceutical Division. "With the positive results of the ARAMIS trial, we are one step closer to our goal of bringing darolutamide to patients and physicians."

Bayer plans to discuss the data from the ARAMIS trial with health authorities regarding the submission of new drug applications. Bayer has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for darolutamide in men with nmCRPC. Darolutamide is being developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

Detailed study results
The ARAMIS trial also included several key secondary endpoints.2 At the time of the first interim analysis, median OS had not yet been reached in either treatment arm.1 However, these interim results demonstrated a trend in favor of darolutamide plus ADT (HR=0.71, 95% CI 0.50-0.99; P=0.045).1 Median time to pain progression was 40.3 months in the darolutamide arm compared to 25.4 months in the placebo arm (HR=0.65, 95% CI 0.53-0.79; P<0.001).1 Median time to cytotoxic chemotherapy was not reached yet in the darolutamide arm compared to 38.2 months in the placebo arm (HR=0.43, 95% CI 0.31-0.60; P<0.001).1 Median time to first symptomatic skeletal event (SSE) was also not reached yet in either treatment arm; however, these interim results demonstrated a trend in favor of darolutamide plus ADT (HR=0.43, 95% CI 0.22-0.84; P<0.001).1 SSE was defined as external beam radiation therapy (EBRT) to relieve skeletal symptoms, new symptomatic pathologic bone fracture, or occurrence of spinal cord compression or tumor-related orthopedic surgical intervention, whichever occurs first.2

Time-to-event exploratory endpoints included progression-free survival (PFS) and time to prostate-specific antigen (PSA) progression.2 Median PFS was 36.8 months in the darolutamide arm compared to 14.8 months in the placebo arm (HR=0.38, 95% CI 0.32-0.45; P<0.001).1 Time to PSA progression was 33.2 months in the darolutamide arm versus 7.3 months in the placebo arm (HR=0.13, 95% CI 0.11-0.16; P<0.001).2

Exploratory PRO-based endpoints (based on the Functional Assessment of Cancer Therapy-Prostate; FACT-P, European Organisation for Research and Treatment of Cancer quality of life; EORTC-QLQ-PR25, and EQ-5D-3L questionnaires) were also evaluated in the ARAMIS trial.1

About the ARAMIS trial design
The ARAMIS trial is a randomized, Phase III, multi-center, double-blind, placebo-controlled trial evaluating the safety and efficacy of oral darolutamide in patients with nmCRPC who are currently being treated with ADT as standard of care and are at high risk for developing metastatic disease. 1,509 patients were randomized in a 2:1 ratio to receive 600 mg of darolutamide twice a day or placebo along with ADT.

The primary endpoint of this trial is MFS defined as time between randomization and evidence of metastasis or death. The secondary endpoints of this trial are OS, time to pain progression, time to initiation of first cytotoxic chemotherapy, time to first SSE, and characterization of the safety and tolerability of darolutamide.

About castration-resistant prostate cancer (CRPC)
Prostate cancer is the second most commonly diagnosed malignancy in men worldwide.3 In 2018, an estimated 1.2 million men were diagnosed with prostate cancer, and about 358,000 died from the disease worldwide.3 Prostate cancer is the fifth leading cause of death from cancer in men.3 Prostate cancer results from the abnormal proliferation of cells within the prostate gland, which is part of a man’s reproductive system.4 It mainly affects men over the age of 50, and the risk increases with age.5 Treatment options range from surgery to radiation treatment to therapy using hormone-receptor antagonists, i.e. substances that stop the formation of testosterone or prevent its effect at the target location.6 However, in nearly all cases, the cancer eventually becomes resistant to conventional hormone therapy.7
CRPC is an advanced form of the disease where the cancer keeps progressing even when the amount of testosterone is reduced to very low levels in the body. The field of treatment options for castration-resistant patients is evolving rapidly, but until recently, there have been no effective treatment options for CRPC patients who have rising PSA levels while on ADT and no detectable metastases. In men with progressive nmCRPC, a short PSA doubling time has been consistently associated with reduced time to first metastasis and death.8

About darolutamide
Darolutamide is an investigational, non-steroidal androgen receptor antagonist with a chemical structure that binds to the receptor and exhibits antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells. In addition to the Phase III trial ARAMIS in men with nmCRPC, darolutamide is also being investigated in a Phase III study in metastatic hormone-sensitive prostate cancer (ARASENS). Information about these trials can be found at www.clinicaltrials.gov.

On February 14, 2019 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, repored full-year 2018 financial results on Wednesday, February 27, 2019, after the close of U.S. markets (Press release, CytomX Therapeutics, FEB 14, 2019, View Sourcenews-releases/news-release-details/cytomx-therapeutics-announce-full-year-2018-financial-results" target="_blank" title="View Sourcenews-releases/news-release-details/cytomx-therapeutics-announce-full-year-2018-financial-results" rel="nofollow">View Source [SID1234533349]). Following the announcement, the company will host a conference call beginning at 5:00 p.m. ET to discuss its results.

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!

Participants may access the live audio webcast of the teleconference from the "Investors & News" section of CytomX’s website at View Source . Please access the website 15 minutes prior to the start of the call to download and install any necessary audio software.

Audio Conference Call:
U.S. Dial-in Number: (877) 809-6037
International Dial-in Number: (615) 247-0221
Conference ID: 3748238
An archived webcast replay will be available on the Company’s website from February 27, 2019, until March 6, 2019.

CytomX Therapeutics’ 2019 Research and Development Day

CytomX plans to host a Research and Development Day on February 26, 2019 from 8:00 a.m. – 11:30 a.m. ET in New York City.

The event will be webcast live under the "Investors & News" section of CytomX’s website at View Sourceevents-and-presentations. Please connect to the webcast several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary. An archived webcast replay will be available on the Company’s website for 90 days following the event.

Institutional investors and equity analysts seeking information on or registration for the live event in New York City please contact Chris Keenan at [email protected].