On May 10, 2017 Genmab reported interim Report for the First Quarter of 2017 (Press release, Genmab, MAY 10, 2017, View Source [SID1234519031]).

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Highlights
USD 255 million in net sales of DARZALEX (daratumumab); resulting in royalty income of DKK 211 million
DARZALEX received positive opinion from European regulatory authorities for relapsed or refractory multiple myeloma

Judith Klimovsky, MD appointed Chief Development Officer
Phase II study of daratumumab in non-Hodgkin’s lymphoma (CARINA) did not proceed to stage 2 of trial
"In the first quarter of 2017 we received a positive regulatory opinion for DARZALEX in combination with standard therapies for relapsed or refractory multiple myeloma in the EU, and continued to progress our other pipeline projects. As part of our aim to grow into a sustainably profitable company, we also strengthened our executive management team with the appointment of Judith Klimovsky, MD, as Executive Vice President and Chief Development Officer," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Quarter of 2017
Revenue was DKK 251 million in the first quarter of 2017 compared to DKK 170 million in the first quarter of 2016. The increase of DKK 81 million, or 48%, was mainly driven by increased DARZALEX royalties, partly offset by a decrease in milestone income.

Operating expenses were DKK 205 million in the first quarter of 2017 compared to DKK 154 million in the first quarter of 2016. The increase of DKK 51 million, or 33%, was due to the additional investment in our pipeline of products, including the advancement of tisotumab vedotin, HuMax-AXL-ADC, HexaBody-DR5/DR5, DuoBody-CD3xCD20, and the various products in our pre-clinical pipeline.

Operating income was DKK 46 million in the first quarter of 2017 compared to DKK 16 million in the first quarter of 2016. The increase of DKK 30 million, or 188%, was driven by higher revenue which was partly offset by the increased operating expenses in 2017.

On March 31, 2017, Genmab had a cash position of DKK 4,751 million compared to DKK 3,922 million at December 31, 2016. This represented a net increase of DKK 829 million, which was mainly driven by positive working capital adjustments of DKK 665 million related to milestones achieved in the fourth quarter of 2016 that were received in 2017, proceeds from the exercise of warrants of DKK 103 million, and operating income.

Subsequent Event
April: The European Commission granted a marketing authorization for DARZALEX in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. The approval converts the previous conditional marketing authorization for DARZALEX to a full approval. Genmab will receive milestone payments totaling USD 48 million from Janssen in connection with the first commercial sales of DARZALEX under the expanded label. The sales are expected to occur quickly after the approval.

Outlook
Genmab is maintaining its 2017 financial guidance published on February 22, 2017.

On May 10, 2017 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported financial results for the quarter ended March 31, 2017, and provided an overview of recent accomplishments and upcoming milestones for its research and development programs (Press release, CytRx, MAY 10, 2017, View Source [SID1234519029]).

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"To date, 2017 has been marked by several key achievements, but most importantly, by obtaining clarity from the U.S. Food and Drug Administration (FDA) regarding our soft tissue sarcomas (STS) program and the establishment of a definitive regulatory path toward approval for aldoxorubicin as a treatment for patients with this rare, difficult to treat disease," said Steven A. Kriegsman, CytRx’s Chairman and CEO. "Our Phase 3 trial investigating aldoxorubicin in patients with second-line STS concluded and the data will be used to support our filing strategy."

"Finally, we look forward to presenting the more detailed and updated global Phase 3 STS results to the medical community at the upcoming 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. This Phase 3 trial, along with the combination trial of aldoxorubicin with ifosfamide/mesna, continue to build upon the body of clinical data supporting aldoxorubicin’s potential as a new and better treatment for patients with STS," Mr. Kriegsman commented.

First Quarter 2017 and Recent Highlights

Strengthened the Balance Sheet with $15 Million in Financing and $2 Million in Warrant Proceeds. In early May 2017, CytRx completed the sale of approximately 30 million shares of common stock in a public offering at a price of $0.50 per share, resulting in net proceeds to the Company of approximately $13.9 million after deducting placement agent’s fees and other estimated offering expenses. Additionally, the Company received approximately $1.9 million from the exercise of warrants resulting in a total raise of $15.8 million subsequent to March 31, 2017.

Concluded Phase 3 Trial Evaluating Aldoxorubicin in Relapsed or Refractory STS. Based on its goal to submit a rolling NDA, subject to approval from the FDA, the Company has concluded its Phase 3 study evaluating aldoxorubicin compared to investigator’s choice in patients with relapsed or refractory STS.

Aldoxorubicin Clinical Trial Data in Patients with STS Selected for Oral Presentation at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper). In April 2017, CytRx announced that an abstract describing results from its global Phase 3 clinical trial evaluating aldoxorubicin versus investigators’ choice in patients with relapsed and refractory STS was selected for an oral presentation at ASCO (Free ASCO Whitepaper) 2017, taking place June 2-6, 2017 in Chicago. The oral presentation (abstract #11000) will be given by Principal Investigator, Sant Chawla, M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center in Santa Monica, on Friday, June 2, 2017 between 3:00-6:00 pm CT. In addition to the STS presentation, a poster (abstract #11051) highlighting updated data from CytRx’s ongoing Phase 1/2 clinical trial combining aldoxorubicin with ifosfamide/mesna in patients with first-line soft tissue sarcomas will also be presented by Frederick C. Eilber, M.D., Director of the UCLA Sarcoma Translational Research Program within the Jonsson Comprehensive Cancer Center, on Sunday, June 4, 2017 between 8:00-11:00 am CT.

Announced FDA Agreement on Regulatory Pathway to Approval for Aldoxorubicin in STS. In April 2017, CytRx announced that it had reached an agreement with the FDA on the pathway for a NDA submission for aldoxorubicin as a treatment for STS. The Company’s goal is to submit a rolling NDA under section 505(b)(2) to the FDA in the fourth quarter of 2017. The commercial launch of aldoxorubicin is projected for 2018 in the U.S. Aldoxorubicin has received Orphan Drug Designation from the FDA for the treatment of STS, which provides for several benefits including seven years of market exclusivity after approval, certain R&D related tax credits and protocol assistance from the FDA. CytRx also plans to discuss with the European Medicines Agency a path to filing a Marketing Authorization Application. European regulators granted aldoxorubicin Orphan Medicinal Product Designation for STS which confers ten years of market exclusivity among other benefits.

Upcoming Milestones

Present results from the Company’s pivotal Phase 3 clinical trial evaluating aldoxorubicin compared to investigator’s choice in patients with relapsed or refractory STS in an oral presentation at ASCO (Free ASCO Whitepaper) 2017.
Present updated data from the ongoing Phase 1b/2 clinical trial of aldoxorubicin in combination with ifosfamide/mesna in patients with advanced sarcomas in a poster presentation at ASCO (Free ASCO Whitepaper) 2017.
Report top-line results from the global Phase 2b clinical trial evaluating aldoxorubicin versus topotecan in patients with second-line SCLC in the second quarter of 2017.
Obtain FDA’s permission to initiate a rolling NDA during 2017.
Select the first internally developed ultra-high potency drug conjugate candidate from its laboratory in Freiburg, Germany, for future development during 2017.
First Quarter 2017 Financial Results

CytRx reported cash, cash equivalents and short-term investments of $48.0 million as of March 31, 2017.

On May 2, 2017, CytRx completed a public offering of 30 million shares of its common stock at a price of $0.50 per share. The net proceeds to CytRx from the offering, after deducting placement agent’s fees and other estimated offering expenses, were approximately $13.9 million. In addition, CytRx received $1.9 million in proceeds from the exercise of warrants in April and May 2017.

Net loss for the quarter ended March 31, 2017, was $11.0 million, or $(0.10) per share, compared with a net loss of $12.6 million, or $(0.19) per share, for the quarter ended March 31, 2016. During the first quarter of 2017, the Company recognized a non-cash loss of $0.03 million on the fair value adjustment of warrant derivative liability related to warrants issued in 2016, compared to a non-cash loss of $0.2 million during the first quarter of 2016 related to now expired warrants.

Research and development (R&D) expenses were $6.8 million for the first quarter of 2017, and included development expenses of $4.0 million for aldoxorubicin, approximately $0.6 million for pre-clinical development of new albumin-binding, ultra-high potency cancer drugs (German lab), and approximately $2.2 million for general operation of our clinical programs. R&D expenses were $8.2 million for the first quarter of 2016.

General and administrative (G&A) expenses were $3.0 million for the first quarter of 2017, compared with $4.0 million for the first quarter of 2016.

On May 10, 2017 ChemoCentryx, Inc., (Nasdaq:CCXI), a biopharmaceutical company developing new medications targeted at inflammatory and autoimmune diseases and cancer, reported financial results for the first quarter ended March 31, 2017 (Press release, ChemoCentryx, MAY 10, 2017, View Source [SID1234519027]).

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"We end the first quarter of 2017 with a strengthened balance sheet thanks to our expanded kidney health alliance with Vifor Pharma and also with our Phase III trial for avacopan in ANCA Vasculitis (AAV) underway," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "We are pleased to have received a third orphan drug designation for avacopan from the FDA, adding C3 glomerulopathy to the previous orphan designations for AAV and atypical hemolytic uremic syndrome (aHUS). By the end of this year, we plan to have four late stage clinical trials in rare renal indications in progress, each of which, if successful, may support registration; one for each of avacopan’s three orphan indications, and one for CCX140 in the treatment of focal segmental glomulerosclerosis."

Recent Highlights

In April 2017, the Journal of the American Society of Nephrology (JASN) published the clinical results from the Company’s Phase II CLEAR trial, which demonstrated that avacopan provides rapid and effective control of AAV while eliminating the need for chronic high doses of steroids, which are associated with significant safety issues. AAV is an autoimmune disease that destroys blood vessels and can lead to renal failure. The ADVOCATE Phase III trial of avacopan in AAV is now underway, a randomized, double-blind two arm multi-center study enrolling 300 patients.

In March 2017, ChemoCentryx announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation for avacopan for the treatment of patients with C3 glomerulopathy (C3G), a disease in which deposits of proteins from the body’s complement system disrupt kidney function and trigger a destructive inflammation of the kidney. There is currently no approved treatment for C3G and relapse is common even after kidney transplant. This is the third disease area for which avacopan has been granted U.S. orphan-drug designation, highlighting its potential to help patients with rare renal diseases. The Company is in discussion with the FDA and the European Medicines Agency (EMA) on the design of a clinical trial, which could lead to submission for regulatory approvals.

In February 2017, ChemoCentryx announced an expanded agreement with Vifor Pharma that provides Vifor the rights to commercialize avacopan for orphan and rare renal diseases in all international markets except China, while ChemoCentryx retains the rights to commercialize avacopan in the United States. This agreement harmonizes the international rights for avacopan with those in the agreement signed with Vifor in December 2016 for the Company’s late stage drug candidate CCX140 in the treatment of focal segmental glomerulosclerosis (FSGS). FSGS is a disease for which no FDA-approved treatment exists, and which if left untreated leads to end stage renal disease. The $20 million upfront commitment to ChemoCentryx under the latest agreement brings the total of upfront cash payments and commitments from Vifor Pharma to $155 million, as well as milestone payments and tiered double-digit royalties on potential net sales.
First Quarter 2017 Financial Results

Pro forma cash, cash equivalents, investments and remaining upfront commitments totaled $179.7 million at March 31, 2017.

Revenue was $8.2 million for the first quarter, compared to zero for the same period in 2016.

Research and development (R&D) expenses were $10.0 million for the first quarter, compared to $11.2 million for the same period in 2016.

General and administrative (G&A) expenses were $4.6 million for the first quarter, compared to $4.1 million for the same period in 2016.

Net losses for the first quarter were $6.0 million, compared to $15.2 million for the same period in 2016.

Total shares outstanding at March 31, 2017 were approximately 48.2 million shares.

The Company expects to utilize cash and cash equivalents between $50 million and $55 million in 2017.

On May 10, 2017 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported new data on 20 approved and investigational medicines will be presented during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from 2 June to 6 June in Chicago, United States (Press release, Hoffmann-La Roche, MAY 10, 2017, View Source [SID1234519024]). More than 190 abstracts have been accepted, including two "late breakers" and 24 oral presentations.

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"We are making significant advances with personalised medicines and cancer immunotherapies," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development."

With continued research and collaborations, we are striving to develop medicines and combinations, incorporate sophisticated diagnostics and integrate big data in our effort to get closer to the goal of curing cancer."

Key highlights from the Roche oncology portfolio include new results from the APHINITY study in early breast cancer and the ALEX study in lung cancer. Both of these studies will be highlighted as part of ASCO (Free ASCO Whitepaper)’s official press program on Monday 5 June. APHINITY is a randomised phase III study, investigating Perjeta plus Herceptin (trastuzumab) and chemotherapy as an adjuvant (after surgery) treatment for patients with HER2-positive early breast cancer.
The APHINITY study was conducted in collaboration with the Breast International Group (BIG), Breast European Adjuvant Study Team (BrEAST) and Frontier Science Foundation (FS). ALEX is a randomised, multicentre, open-label phase III study that compared Alecensa and crizotinib in people with previously untreated ALK-positive non-small cell lung cancer (NSCLC).

There has been great progress in the area of cancer immunotherapy in recent years and Roche continues to investigate novel ways to harness the immune system in the fight against cancer as part of its vision to bring the next generation of cancer immunotherapies to patients. With more than 20 investigational cancer immunotherapies in development and 12 in clinical trials, Roche will be presenting early results on its first T-cell bispecific antibody (CEA-CD3 TCB: RG7802; RO6958688) for the treatment of CEA-positive cancers, including metastatic colorectal cancer (mCRC). These data have been generated from two ongoing dose-escalation phase I studies in which CEA-CD3 TCB is used alone or in combination with TECENTRIQ (atezolizumab).

Further information on Roche’s contribution to the ASCO (Free ASCO Whitepaper) 2017 scientific program, as well as Roche’s wider progress in cancer care, will be featured during the Roche media briefing from 09:00–10:45 CDT on
Friday, 2 June at the Chicago Marriott Hotel Downtown Magnificent Mile.

On May 10, 2017 Heron Therapeutics, Inc. (Nasdaq:HRTX) (the Company or Heron), a commercial-stage biotechnology company focused on developing novel best-in-class treatments to address some of the biggest unmet patient needs, reported financial results for the three months ended March 31, 2017 and highlighted recent corporate progress (Press release, Heron Therapeutics, MAY 10, 2017, View Source [SID1234519014]).

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Recent Corporate Progress
Pain Franchise
Expanded Phase 2 Program of HTX-011 with Initiation of TKA and Nerve Block Studies. Heron initiated Phase 2 studies of HTX-011 in two new surgical models, total knee arthroplasty (TKA) and breast augmentation (pectoral pocket nerve block), to complement its four successful Phase 2 studies in abdominoplasty, bunionectomy, and hernia repair. Heron anticipates initiating Phase 3 studies of HTX-011 this year and filing a New Drug Application (NDA) in 2018.

CINV Franchise
SUSTOL Sales Increase; Product Added to National Comprehensive Cancer Network (NCCN) Antiemesis Guidelines. Net product sales of SUSTOL (granisetron) extended-release injection for the three months ended March 31, 2017 were $3.6 million, compared to $1.3 million for the three months ended December 31, 2016. In addition, SUSTOL was granted a Category 1 recommendation by the NCCN for use in the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly or moderately emetogenic chemotherapy (HEC or MEC). The NCCN guidelines identify SUSTOL as a "preferred" agent for preventing CINV following MEC and highlight the unique, extended-release formulation of SUSTOL.

Received Notice of CINVANTI (HTX-019) PDUFA Date. The U.S. Food and Drug Administration (FDA) set a Prescription Drug User Fee Act (PDUFA) goal date of November 12, 2017 for a decision on the Company’s NDA for CINVANTI. If approved, CINVANTI will strengthen Heron’s CINV portfolio by adding a second, complementary therapeutic agent in this category.

"The first quarter of 2017 was a productive period for Heron, highlighted by the completion of several highly-successful Phase 2 studies of HTX-011 in multiple post-operative pain models and the inclusion of SUSTOL in the NCCN guidelines," said Barry D. Quart, Pharm.D., Chief Executive Officer of Heron. "Looking ahead, we are focused on the commencement of Phase 3 studies of HTX-011, as well as the approval of CINVANTI by year-end 2017."

Financial Results
In January 2017, Heron completed an underwritten public offering of its common stock for net proceeds of $163.7 million. As of March 31, 2017, the Company had cash, cash equivalents and short-term investments of $165.2 million, compared to $51.1 million as of December 31, 2016. Based on the Company’s current operating plan and projections, it believes that available cash, cash equivalents and short-term investments are sufficient to fund operations for at least one year.

Net product sales of SUSTOL for the three months ended March 31, 2017 were $3.6 million, which represents 184% sequential quarter-over-quarter growth over the $1.3 million of net product sales of SUSTOL for the three months ended December 31, 2016.

Heron’s net loss for the three months ended March 31, 2017 was $50.3 million, or $1.00 per share, compared to $33.4 million, or $0.92 per share for the same period in 2016. Net loss for the three months ended March 31, 2017, included non-cash, stock-based compensation expense of $8.0 million compared to $5.4 million for the same period in 2016.

Heron’s net cash used for operating activities for the three months ended March 31, 2017 was $50.6 million, compared to $32.4 million for the same period in 2016.
The increases in net loss and net cash used for operating activities for the three months ended March 31, 2017 compared to the same period in 2016 were primarily due to increased clinical and manufacturing costs related to the development of HTX-011 and CINVANTI.