On November 2, 2016 Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported the enrollment and dosing of the first patient in the efficacy portion of its Phase 2 clinical study of BP1001, a liposomal Grb2 antisense for the treatment of acute myeloid leukemia (AML) (Filing, 8-K, Bio-Path Holdings, NOV 2, 2016, View Source [SID1234516251]). The objective of the Phase 2 study is to further assess the efficacy and safety of BP1001, Bio-Path’s lead development candidate.

The Phase 2 clinical trial is a multicenter study of BP1001 in combination with low dose cytarabine (LDAC) in patients with previously untreated AML who are not otherwise eligible for standard or high-intensity chemotherapy regimens or who have elected a low-intensity regimen.

The trial is a single arm, open label, two-stage design to assess the safety profile, pharmacokinetics, pharmacodynamics, and efficacy of 60 mg/m2 of BP1001 in combination with LDAC compared to historical response rates documented for LDAC alone. Evaluable patients will receive an initial dose intravenous (IV) infusion of BP1001 over 60 minutes and every three days thereafter, as eight doses per 28-day cycle of 60 mg/m2 BP1001, and will be administered LDAC as a subcutaneous (SQ) injection, twice daily for 20 consecutive doses per 28-day cycle.

The primary endpoint of the study is the number of patients who achieve Complete Remission (CR), including CR with incomplete hematologic recovery (CRi) and CR with incomplete platelet recovery (CRip). Secondary endpoints assessing the safety and efficacy of BP1001 include overall survival, time to response, duration of response, and adverse events as evaluated by physical examination findings, vital signs and clinical laboratory tests.

The full trial design includes approximately 54 evaluable patients with an interim analysis performed after 19 patients. In the event the interim results exceed the primary endpoint in a number of patients that meets or exceeds statistically determined thresholds, the Company may seek to convert the trial into a registration trial for accelerated approval.

Among the sites registered to conduct the study are Weill Medical College of Cornell University, Baylor Scott & White Health, The University of Kansas and The University of Texas MD Anderson Cancer Center.

"This is an exciting milestone for Bio-Path as it will be the first study to confirm the efficacy of BP1001 as a treatment for AML and to validate our DNAbilizeTM platform," said Peter H. Nielsen, Chief Executive Officer of Bio-Path Holdings. "We are particularly pleased with the Phase 2 trial design, which has a built-in interim analysis that offers a pathway to an accelerated approval should the efficacy results for the first 19 evaluable patients demonstrate the high response rate seen in the safety segment of our Phase 2 trial. We look forward to the completion of this study and expect its results to replicate these very promising early data," added Mr. Nielsen.

Patients in the safety segment of the trial treated with 60 mg/m2 and 90 mg/m2 of BP1001 twice a week over a four-week period, in combination with a standard regimen of frontline low-dose cytarabine (LDAC), showed BP1001 to be safe and well tolerated, with signs of significant anti-leukemia activity. Of the six evaluable patients included in both cohorts of the safety segment, three achieved complete remissions, while two others achieved partial remission. There were no attributable adverse events reported.

As previously reported, BP1001’s pharmacokinetics at a dose of 60 mg/m2 had a 30-hour half-life, significantly better than the half-life with a dose of 90 mg/m2. The final analysis of these data, along with the demonstrated reductions in bone marrow blasts, suggested that 60 mg/m2 is the appropriate dose for use in the Phase 2 trial. Administratively, this required Bio-Path to reformat documents for the Phase 2 trial with the 60 mg/m2 dose and resubmit for approvals with the U.S. Food and Drug Administration (FDA) and site Institutional Review Boards, requiring additional time prior to starting the Phase 2 trial.

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!

On November 2, 2016 Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) reported updates on EXPAREL (bupivacaine liposome injectable suspension) for postsurgical pain in the United States and announced consolidated financial results for the third quarter ended September 30, 2016 (Press release, Pacira Pharmaceuticals, NOV 2, 2016, View Source;p=RssLanding&cat=news&id=2218447 [SID1234516231]).

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!

"EXPAREL revenues continued to grow year-over-year in the third quarter," said Dave Stack, Chief Executive Officer and Chairman of Pacira. "We believe our steady blocking and tackling of key programs—from developing robust clinical data in support of marketplace use to strategic commercial partnerships that advance opioid minimization protocols for postsurgical pain control—will continue to improve patient lives and contribute to sales growth."

Recent Highlights

EXPAREL Launches in Oral Surgery at AAOMS, with Data Demonstrating Safety and Efficacy for Pain Relief in Third Molar Removal: Pacira officially launched EXPAREL in oral surgery at the American Association of Oral and Maxillofacial Surgeons (AAOMS) annual meeting in September, where the company presented the results from a prospective, randomized, double-blind, placebo-controlled study in third molar (wisdom teeth) extraction. Overall, patients receiving EXPAREL demonstrated a lower mean opioid consumption and significantly lower pain scores at 48 hours in comparison to that of placebo.

Pacira Partners with American College of Surgeons (ACS) in Launching Educational Program for Patients and Surgeons: Opioids and Surgery: Use, Abuse and Alternatives is an initiative designed to support the rapid dissemination of patient education materials regarding opioids and opioid alternatives, as well as to support the surgeon with evidence-based content, including procedure-specific enhanced recovery protocols, managing pain expectations, non-opioid options, screening programs, discharge education and transition management.

Key Executive Appointments Enhance Commercial Team: Pacira recently announced the appointment of Thomas Sluby, Vice President, Sales and Matthew Lehmann, Vice President, Marketing – Emerging Therapies. Mr. Sluby is responsible for overseeing all aspects of sales execution and customer relations, and will work closely with the commercial team on the development and implementation of sales and product strategies for EXPAREL. Mr. Lehmann will be responsible for the development, implementation and execution of market strategies and tactics, initially focusing on the EXPAREL nerve block launch subsequent to approval. Both individuals will report to Robert Weiland, Chief Commercial Officer.
Third Quarter 2016 Financial Results

EXPAREL net product sales were $64.9 million in the third quarter of 2016, a 9% increase over the $59.7 million reported for the third quarter of 2015.

Total revenues were $68.4 million in the third quarter of 2016, a 10% increase over the $62.2 million reported for the third quarter of 2015.

Total operating expenses were $89.2 million in the third quarter of 2016, compared to $57.1 million in the third quarter of 2015. Total operating expenses in the third quarter of 2016 include a $21.9 million charge to cost of goods sold to fully reserve $20.7 million for the cost of EXPAREL batches impacted by a routine stability test that did not meet required specifications and $1.2 million for an estimated number of replacement boxes and other related costs.

GAAP net loss was $22.2 million, or $(0.59) per share (basic and diluted), in the third quarter, compared to GAAP net income of $3.1 million, or $0.08 per share (basic and diluted), in the third quarter of 2015.

Non-GAAP net income was $8.0 million, or $0.22 per share (basic) and $0.20 per share (diluted), in the third quarter of 2016, compared to non-GAAP net income of $12.9 million, or $0.35 per share (basic) and $0.32 per share (diluted), in the third quarter of 2015.

Pacira ended the third quarter of 2016 with cash, cash equivalents and short-term investments ("cash") of $161.1 million.

Pacira had 37.3 million basic weighted average shares of common stock outstanding in the third quarter of 2016.

For non-GAAP measures, Pacira had 40.2 million diluted weighted average shares of common stock outstanding in the third quarter of 2016.
2016 Outlook

Pacira updates its full year 2016 financial guidance as follows:

EXPAREL net product sales of $263 million to $268 million, reflecting management’s revised expectation about when its commercial strategies and creation of opioid-sparing collaborations will accelerate sales growth.

Non-GAAP gross margins of 70% to 73%.

Non-GAAP research and development (R&D) expense of $40 million to $50 million. This reduction in guidance reflects significant cost savings in three randomized clinical trials, along with a change in timing of some costs related to the two nerve block trials that the company expects to complete in the first quarter of 2017.

Non-GAAP selling, general and administrative (SG&A) expense of $125 million to $135 million.

Stock-based compensation of $30 million to $35 million.
See "Non-GAAP Financial Information" and "Reconciliations of GAAP to Non-GAAP 2016 Financial Guidance" below.

Today’s Conference Call and Webcast Reminder

The Pacira management team will host a conference call to discuss the company’s financial results and recent developments today, Wednesday, November 2, 2016, at 9 a.m. ET. The call can be accessed by dialing 1-877-845-0779 (domestic) or 1-720-545-0035 (international) ten minutes prior to the start of the call and providing the Conference ID 12896365.

A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing 1-855-859-2056 (domestic) or 1-404-537-3406 (international) and providing the Conference ID 12896365. The replay of the call will be available for two weeks from the date of the live call.

The live, listen-only webcast of the conference call can also be accessed by visiting the "Investors & Media" section of the company’s website at investor.pacira.com. A replay of the webcast will be archived on the Pacira website for two weeks following the call.

On November 2, 2016 Genmad reported its interim Report for First Nine Months Ended September 30, 2016 (Press release, Genmab, NOV 2, 2016, View Source [SID1234516222]).
Highlights
Net Sales of DARZALEX (daratumumab) by Janssen for the first nine months of 2016 were USD 372 million, resulting in royalty income of USD 45 million (DKK 298 million)
Announced U.S. and European regulatory submissions for daratumumab in relapsed or refractory multiple myeloma, triggering USD 25 million in milestone payments
Daratumumab received second Breakthrough Therapy Designation from U.S. Food and Drug Administration (FDA)
Announced FDA approval of Arzerra (ofatumumab) in combination with fludarabine and cyclophosphamide for relapsed chronic lymphocytic leukemia (CLL)
Entered commercial license agreement with Gilead Sciences for DuoBody Technology
2016 financial guidance improved
"Throughout the third quarter we continued to see excellent progress in our DARZALEX program with Janssen. Regulatory applications to expand the label for daratumumab to include relapsed or refractory multiple myeloma were submitted in the U.S. and Europe, triggering USD 25 million in milestone payments. Daratumumab also received its second Breakthrough Therapy Designation from the FDA. We continued to see progress with Arzerra too, with another CLL indication approved in the U.S., and we made progress with our DuoBody technology, with a new commercial agreement with Gilead Sciences," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Financial Performance First Nine Months of 2016
Revenue was DKK 889 million in the first nine months of 2016 compared to DKK 558 million in the first nine months of 2015. The increase of DKK 331 million, or 59%, was mainly driven by higher royalty and milestone revenue under our daratumumab collaboration with Janssen.
Operating expenses were DKK 544 million in the first nine months of 2016 compared to DKK 380 million in the first nine months of 2015. The increase of DKK 164 million, or 43%, 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 our other pre-clinical programs.
Operating income was DKK 345 million in the first nine months of 2016 compared to DKK 355 million in the first nine months of 2015. The decrease of DKK 10 million, or 3%, was driven by the one-time reversal of the ofatumumab funding liability of DKK 176 million in 2015, combined with increased operating expenses in 2016, which were partly offset by higher revenue in 2016.
On September 30, 2016, Genmab had a cash position of DKK 3,942 million compared to DKK 3,493 million at December 31, 2015. This represented a net increase of DKK 449 million, which was driven primarily by income from operations and the proceeds from the exercise of warrants of DKK 184 million, partially offset by the purchase of treasury shares for DKK 118 million.
Business Progress Third Quarter
Daratumumab
August: Regulatory submission in Europe for daratumumab (DARZALEX) in patients with multiple myeloma who have received at least one prior therapy. In addition, a regulatory application was submitted in the U.S. for the use of daratumumab in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who received at least one prior therapy. The submissions triggered milestone payments of USD 10 million, and USD 15 million, respectively, to Genmab.
July: The FDA granted Breakthrough Therapy Designation for DARZALEX injection in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.
Ofatumumab
August: The FDA approved ofatumumab (Arzerra) in combination with fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed CLL.
DuoBody
August: Entered an agreement to grant Gilead Sciences, Inc. an exclusive license and an option on a second exclusive license, to use the DuoBody technology platform to create and develop bispecific antibody candidates for a therapeutic program targeting HIV. Under the terms of the agreement, Genmab received an upfront payment of USD 5 million from Gilead Sciences.
Subsequent Event
October: The FDA granted Priority Review for the use of daratumumab in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target date of February 17, 2017 to take a decision on daratumumab in this indication. In addition, the FDA granted a Standard Review period for the use of daratumumab in combination with pomalidomide and dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received at least two prior therapies, including a proteasome inhibitor (PI) and an immunomodulatory agent. The PDUFA date for the combination of daratumumab with pomalidomide/dexamethasone is June 17, 2017.
Outlook
Genmab is improving its 2016 financial guidance published on August 9, 2016 due to increased royalty and milestone income related to the sales of DARZALEX resulting in increased operating income and cash position.
MDKK Revised Guidance Previous Guidance
Revenue 1,200 — 1,250 975 — 1,025
Operating expenses (800) — (850) (800) — (850)
Operating income 375 — 425 150 — 200
Cash position at end of year* 3,650 — 3,750 3,550 — 3,650
*Cash, cash equivalents, and marketable securities

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!

On November 2, 2016 Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) reported its financial results for the third quarter ended September 30, 2016 (Press release, Momenta Pharmaceuticals, NOV 2, 2016, View Source [SID1234516200]).

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!

For the third quarter of 2016, the Company reported total revenues of $29.1 million, including $23.3 million in product revenues from Sandoz’s sale of Glatopa (glatiramer acetate injection). For the nine months ended September 30, 2016, the Company reported total revenues of $75.4 million, including $58.8 million of product revenues from Sandoz’s sales of Glatopa. Momenta reported a net loss of $(17.5) million, or $(0.26) per share for the third quarter of 2016 compared to a net loss of $(30.1) million, or $(0.44) per share for the same period in 2015. For the nine months ended September 30, 2016, the Company reported a net loss of $(62.5) million, or $(0.91) per share compared to a net loss of $(54.1) million, or $(0.88) per share for the same period in 2015. At September 30, 2016, the Company had cash, cash equivalents, and marketable securities of $309.0 million compared to $336.9 million at June 30, 2016.

"Our biosimilars collaboration with Mylan continues to advance. Today we announced the initiation of a Phase 1 trial for our lead candidate, M834, a biosimilar version of ORENCIA. We also recently re-gained the rights to M923, our biosimilar HUMIRA candidate, and believe this is a real opportunity for us to generate additional value from this product," said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. "Glatopa 20 mg sales continued to provide us with a healthy revenue stream, and we remain optimistic for the potential launch of our Glatopa 40 mg product candidate early next year."

Third Quarter Highlights and Recent Events

Complex Generics:

In the third quarter of 2016, Momenta recorded $23.3 million in product revenues from Sandoz’s Glatopa sales.
The Abbreviated New Drug Application (ANDA) submitted by Sandoz for a three-times-a-week generic COPAXONE 40 mg (glatiramer acetate injection) is under U.S. Food and Drug Administration (FDA) review. The Company expects to receive tentative regulatory approval in the next few months.
A district court trial challenging four of Teva’s five Orange Book-listed patents for COPAXONE 40 mg (glatiramer acetate injection) concluded on October 6, 2016. The Company expects a decision to be issued in the first quarter of 2017.
Biosimilars:

Momenta and its collaboration partner Mylan reported the initiation of a Phase 1 clinical trial for M834, a biosimilar ORENCIA (abatacept) candidate. Under the Mylan collaboration agreement, Momenta achieved a regulatory milestone thereby earning a $25.0 million payment from Mylan. The companies plan to report top-line data from the trial by the end of 2017.
In September, the U.S. Patent and Trademark Office held a hearing in Inter Partes Review (IPR) proceedings for the Company’s challenge of the validity of Bristol Myers Squibb’s U.S. Patent No. 8,476,239 covering formulations of ORENCIA which is set to expire in 2028. The Patent Office’s decision is due by January 15, 2017.
In September, Momenta regained global development and commercialization rights to M923, a biosimilar HUMIRA (adalimumab) candidate. Shire exercised its right to terminate the collaboration agreement for M923 following its combination with Baxalta. Under the terms of the collaboration, the agreement will terminate twelve months following the notice, and Shire is obligated to fund the M923 program until termination. The Company plans to release top-line results from the Phase 3 clinical trial for M923 in late 2016, and the first regulatory submission for marketing approval is planned for mid-2017. Subject to marketing approval and patent considerations, the Company expects first commercial launch of M923 to be as early as 2018.
Novel Drugs for Autoimmune Indications:

Momenta’s novel autoimmune portfolio includes two recombinant molecules: M230, a Selective Immunomodulator of Fc receptors (SIF3) and M281, an anti-FcRn monoclonal antibody. The Company has initiated a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of M281 in healthy subjects and expects to report data in the second half of 2017. M230 is in pre-clinical development, and the Company expects to initiate a clinical trial for M230 in 2017. Momenta is also developing a hyper-sialylated IVIg (M254) as a potential high potency version of IVIg. The Company continues its efforts to identify potential collaboration opportunities for the further development and commercialization of its novel drug candidates for autoimmune indications.

Corporate:

The Company announced today the appointment of Scott M. Storer as Senior Vice President and Chief Financial Officer effective November 28, 2016. Mr. Storer will replace Momenta’s current Chief Financial Officer, Rick Shea, who will be retiring. Mr. Storer will report directly to Craig Wheeler, Momenta’s President and Chief Executive Officer, and will serve as a member of the Executive Committee. Prior to joining Momenta, Mr. Storer was Senior Vice President, Finance at Baxalta, Inc. following its spin-out from Baxter International in July 2015. He joined Baxter in 1997 and previously held several positions, most recently serving as Vice President of BioScience Finance.

Third Quarter 2016 Financial Results

Total revenues for the third quarter of 2016 were $29.1 million compared to $13.8 million for the same period in 2015. Total revenues for the third quarter of 2016 include $23.3 million in product revenue earned from net sales of Glatopa by Sandoz, compared to $8.7 million in product revenue earned from net sales of Glatopa by Sandoz for the same period in 2015. The increase in product revenue was due to a higher number of Glatopa units sold in the 2016 period.

Collaborative research and development revenue for the third quarter of 2016 was $5.8 million compared to the $5.1 million recorded in the same quarter last year. The increase of $0.7 million, or 14%, from the 2015 period to the 2016 period was primarily due to $1.8 million of revenue recognized in the third quarter of 2016 from the amortization of the $45 million upfront payment under the Mylan collaboration agreement, offset by lower reimbursable expenses for M923. Collaborative reimbursement revenues from Sandoz and Baxalta, now part of Shire, were $1.5 million for the third quarter of 2016, compared to $2.7 million for the same period in 2015.

Research and development expenses for the third quarter of 2016 were $31.6 million, compared to $31.7 million for the same period in 2015. The decrease of $0.1 million from the 2015 period to the 2016 period was due to a decrease of $7.7 million for Mylan’s 50% share of biosimilar collaboration costs, offset primarily by increases of $3.2 million in process development costs for biosimilars under the Company’s collaboration with Mylan, $1.9 million in non-clinical expenses to advance the Company’s novel autoimmune programs and $1.8 million in necuparanib Phase 2 clinical trial costs due in part to the termination of the development program.

General and administrative expenses for the quarter ended September 30, 2016 were $15.8 million, compared with $12.5 million for the same period in 2015. The increase of $3.3 million, or 26%, was primarily due to increases of $1.4 million in personnel-related expenses due to growth in headcount, $1.5 million in legal and professional fees, $0.4 million in stock-based compensation primarily due to performance-based restricted stock awards granted in 2016 and $0.4 million in facilities expenses. These increases were offset by a decrease of $0.4 million for Mylan’s 50% share of biosimilar collaboration costs.

At September 30, 2016, Momenta had $309.0 million in cash, cash equivalents and marketable securities.

Financial Guidance

Momenta provides non-GAAP operating expense guidance, which it believes can enhance an overall understanding of its financial performance when considered together with GAAP figures. Refer to the section of this press release below entitled "Non-GAAP Financial Information and Other Disclosures" for further discussion of this subject.

Today, Momenta reiterated its non-GAAP operating expense guidance of approximately $40 – $45 million for the fourth quarter of 2016. Non-GAAP operating expense is total operating expenses (which is net of Mylan’s share of collaboration expenses), excluding stock-based compensation expense and net of collaborative reimbursement revenues from Sandoz and Baxalta, now part of Shire. The quarterly recognition of collaborative revenues under the Company’s collaboration with Mylan is expected to be $1.8 million per quarter. Under the collaboration with Baxalta, the Company expects to recognize collaborative revenues of approximately $3.7 million per quarter for the next three quarters and approximately $3.5 million in the third quarter of 2017 representing the remaining balance of deferred revenue.

On November 2, 2016 MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases, reported a corporate progress update and reported financial results for the quarter ended September 30, 2016 (Press release, MacroGenics, NOV 2, 2016, View Source [SID1234516198]).

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!

"MacroGenics continues to make progress across its broad pipeline of clinical compounds, including margetuximab, our Fc-optimized anti-HER2 monoclonal antibody, our two clinical programs targeting B7-H3 as well as several bispecific product candidates based on our DART platform," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "During the third quarter, an IND for MGA012 cleared the FDA and we remain on track to submit two DART molecule INDs in 2017, which would result in a total of eight DART molecules in clinical development. We look forward to providing an update on multiple clinical and preclinical programs at our R&D Day on December 13."

Pipeline Update

Margetuximab. Recent highlights related to the Company’s Fc-optimized monoclonal antibody that targets the human epidermal growth factor receptor 2, or HER2, include:

SOPHIA Study: MacroGenics’ Phase 3 pivotal study in patients with HER2-positive metastatic breast cancer is ongoing, as the Company continues to initiate sites and enroll patients. This study is evaluating the efficacy of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in approximately 530 relapsed/refractory patients. Approximately 90% of the anticipated study sites have been activated as of September 30, 2016.
Phase 1b/2 Gastric Cancer Study: MacroGenics continues to recruit and dose patients in a clinical trial of margetuximab in combination with pembrolizumab, an anti-PD-1 therapy, in patients with advanced HER2-positive gastric cancer. Treatment options for these patients are limited and the combination regimen being explored avoids chemotherapy while exploiting the potential for enhancing the antitumor immune response. This trial is being conducted in collaboration with Merck and is currently recruiting patients in North America. We anticipate the start of this study in Asia by year-end.
B7-H3 Franchise. MacroGenics is developing a portfolio of therapeutics that target B7-H3, a member of the B7 family of molecules involved in immune regulation. The Company is advancing multiple programs that target B7-H3 through complementary mechanisms of action and take advantage of this antigen’s broad expression across multiple solid tumor types. Current ongoing clinical-stage development programs include:

Enoblituzumab: The Company continues to recruit patients in three ongoing studies of enoblituzumab, an Fc-optimized monoclonal antibody that targets B7-H3. These studies include one monotherapy study and two combination studies with each of ipilimumab and pembrolizumab. As previously reported, the monotherapy study was expanded to include additional prostate and bladder cancer cohorts. An additional monotherapy study is planned for children with neuroblastoma and other tumors, and we also anticipate an investigator-sponsored monotherapy study in neo-adjuvant prostate cancer.
MGD009: This DART molecule targeting B7-H3 and CD3 is being evaluated in a Phase 1 study across multiple solid tumor types.
DART Product Candidates. There are currently six DART molecules in Phase 1 clinical development, including MGD006 (CD123 x CD3, also known as S80880), MGD007 (gpA33 x CD3), MGD009 (B7-H3 x CD3), MGD010 (CD32B x CD79B), MGD011 (CD19 x CD3, also known as JNJ-64052781 or duvortuxizumab) and PF-06671008 (P-cadherin x CD3).

During the third quarter and as previously reported, MacroGenics and Takeda Pharmaceutical Company Limited announced the conclusion of their License and Option Agreement for MGD010, a bispecific molecule targeting CD32B and CD79B. MacroGenics regained the worldwide rights to MGD010, for which the Company plans to continue to advance development based on the encouraging study results reported to date.

An Investigational New Drug (IND) application for MGA012, a monoclonal antibody, recently cleared the FDA and the Company plans to submit INDs for two DART molecules in 2017. These two DART molecules are:

MGD013: MacroGenics is developing MGD013 to simultaneously block two immune checkpoint molecules, PD-1 and LAG-3.
MGD014: MGD014 is a DART molecule that is being developed to eliminate latent HIV infection.
Beyond MGD013 and MGD014, MacroGenics continues to generate and evaluate multiple other candidates that target a range of immune regulatory and other molecules using its proprietary platforms.

Corporate Update

R&D Day: MacroGenics plans to host an R&D Day in New York on Tuesday, December 13, 2016. At this meeting, the Company plans to both provide an update on its clinical pipeline as well as preview its next set of development candidates.
Universal Shelf Registration Statement Filing: MacroGenics has filed a shelf registration statement with the SEC and believes that this filing provides the Company with the flexibility to access the equity or debt capital markets most efficiently should the need arise. However, the Company has no immediate plan to undertake an offering.
Third Quarter 2016 Financial Results

Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2016, were $314.1 million, compared to $339.0 million as of December 31, 2015.
Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $3.3 million for the quarter ended September 30, 2016, compared to $14.7 million for the quarter ended September 30, 2015. This decrease was primarily due to recognition of a one-time milestone received from Janssen Biotech, Inc. in 2015.
R&D Expenses: Research and development expenses were $30.3 million for the quarter ended September 30, 2016, compared to $24.1 million for the quarter ended September 30, 2015. This increase was due primarily to increased activity in the Company’s preclinical immune checkpoint programs, including MGD013, MGD014 (funded by NIAID/NIH) and the initiation of two Phase 1 clinical trials combining enoblituzumab with other compounds.
G&A Expenses: General and administrative expenses were $7.2 million for the quarter ended September 30, 2016, compared to $6.0 million for the quarter ended September 30, 2015. This increase was primarily due to increased staff, recruiting costs and stock-based compensation expense.
Net Income/Loss: Net loss was $33.9 million for the quarter ended September 30, 2016, compared to net loss of $15.4 million for the quarter ended September 30, 2015.
Shares Outstanding: Shares outstanding as of September 30, 2016 were 34,813,334.