On July 31, 2019 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, provided an update on its corporate progress and reported financial results for the quarter ended June 30, 2019 (Press release, MacroGenics, JUL 31, 2019, View Source [SID1234537943]).

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"We have made significant progress in the first half of the year, during which we reported positive results from the Phase 3 SOPHIA study of margetuximab in metastatic HER2-positive breast cancer and enrolled patients into our Phase 1 studies. We believe this progress positions us favorably to achieve several important milestones for our Company during the remainder of 2019," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Continuing our focus on execution, in the second half of the year, we are planning to submit the BLA for margetuximab, initiate two registration-directed Phase 2/3 clinical trials, and provide clinical updates for several key programs."

Key Pipeline Updates

Margetuximab. MacroGenics is advancing an investigational, Fc-optimized monoclonal antibody (mAb) that targets human epidermal growth factor receptor 2 (HER2). Highlights include:

•SOPHIA Phase 3 Data Presented at ASCO (Free ASCO Whitepaper); Second Interim OS Data Expected in 4Q2019; Plans to Submit BLA in 4Q2019: At the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2019, MacroGenics presented data from SOPHIA, the Phase 3 clinical trial of margetuximab in patients with HER2-positive metastatic breast cancer. The trial met the first sequential primary endpoint of prolongation of progression-free survival (PFS) in patients treated with the combination of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy. The Company expects to present the results from a pre-specified interim OS analysis and submit a Biologics License Application (BLA) to the U.S. FDA in the fourth quarter of 2019.
•MAHOGANY Phase 2/3 Study Advancing in Front-line Gastric Cancer: MacroGenics and Zai Lab, the Company’s partner in Greater China, plan to initiate a Phase 2/3 registration-directed clinical trial of margetuximab in combination with checkpoint inhibitor molecules, including MGA012 (anti-PD-1 mAb) and MGD013 (bispecific PD-1 x LAG-3 DART molecule) in patients with HER2-positive gastric or gastroesophageal junction cancer in the third quarter of 2019.

B7-H3 Franchise. MacroGenics is developing a portfolio of investigational antibody-based therapeutics that target B7-H3 through complementary mechanisms of action taking advantage of this antigen’s broad expression across multiple solid tumor types. Program updates include:

•Advancing Enoblituzumab Study in Head and Neck Cancer: Enoblituzumab is an investigational, Fc-optimized mAb that targets B7-H3. MacroGenics recently met with FDA to discuss its plans regarding a Phase 2/3 registration-directed study of enoblituzumab in combination with MGA012 in patients with squamous cell carcinoma of the head and neck (SCCHN) and anticipates initiating the trial in the fourth quarter of 2019.

Exhibit 99.1
•MGD009 Program Prioritization: MGD009 is an investigational, bispecific DART molecule designed to target B7-H3 expressed on tumor cells and CD3 expressed on normal T cells. The company is prioritizing the development of the combination of MGD009 with MGA012, including plans to add a new dose expansion cohort in patients with melanoma who have previously been treated with a checkpoint inhibitor. MacroGenics has closed patient enrollment in the MGD009 monotherapy study.
•Continued MGC018 Dose Escalation: MGC018 is an investigational, antibody-drug conjugate (ADC) designed to target solid tumors expressing B7-H3 and has advanced through multiple dose levels in the Phase 1 monotherapy dose escalation.

Flotetuzumab. MacroGenics is advancing an investigational, bispecific DART molecule that recognizes both CD123 and CD3. Updates include:

•Completed Enrollment of Monotherapy Study in Acute Myeloid Leukemia (AML); Data Expected 2H2019; Requested End of Phase 1 Meeting with FDA: MacroGenics has completed enrollment of 50 patients at the recommended Phase 2 dose in the Phase 1 monotherapy study, including 30 patients with primary refractory AML. The Company plans to submit updated data from the trial for presentation at the 2019 American Society for Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. MacroGenics plans to meet with the FDA in the third quarter to discuss the flotetuzumab program, and to define a potential registration path for this molecule.
•Plans to Initiate MGA012 Combination Study: MacroGenics plans to initiate a Phase 1 study in combination with MGA012 in relapsed or refractory AML in the third quarter.
•Regaining Full Global Rights: MacroGenics will regain full global rights to develop and commercialize flotetuzumab following Servier’s notification of its intent to terminate the collaboration and license agreement with the Company.
PD-1 Franchise. MacroGenics is advancing multiple investigational PD-1-directed programs to provide differentiation from existing PD-1-based treatment options and enable a broad set of combination opportunities across the Company’s portfolio. Program highlights include:

•MGA012 Registration-directed Studies: MGA012 (INCMGA0012) is an anti-PD-1 mAb exclusively licensed to Incyte Corporation on a worldwide basis. Incyte is pursuing development of MGA012 monotherapy in three ongoing potentially registration-directed trials. Incyte and MacroGenics are each conducting multiple studies of MGA012 in combination with other agents.
•MGD013 Dose Expansion; Data Expected 2H2019: MGD013 is a first-in-class bispecific DART molecule designed to provide co-blockade of PD-1 and LAG-3, two immune checkpoint molecules expressed on T cells. MacroGenics has enrolled approximately 100 patients in the Phase 1 dose expansion study in up to nine tumor types and expects to submit data from this monotherapy trial for presentation at a scientific conference in the second half of 2019.
•MGD019 Dose Escalation: MGD019 is a bispecific DART molecule designed to provide co-blockade of PD-1 and CTLA-4, two immune checkpoint inhibitors expressed on T cells. MGD019 has advanced through multiple dose levels in a Phase 1 dose escalation study.

MGD007. MacroGenics is evaluating an investigational, bispecific DART molecule that recognizes both gpA33 and CD3. MacroGenics completed the enrollment of 26 patients in the Phase 1 expansion cohort of MGD007 in combination with MGA012. The Company expects to provide a clinical update regarding this study in the first quarter of 2020.

Recent Corporate Developments

•Collaboration with I-Mab Biopharma: In July 2019, MacroGenics entered into an exclusive collaboration and license agreement with I-Mab Biopharma (I-Mab) to develop and commercialize enoblituzumab. I-Mab obtains rights in mainland China, Hong Kong, Macau and Taiwan. MacroGenics will receive an upfront payment of $15 million and will also be eligible to receive milestone payments of up to $135 million. In addition, I-Mab will pay tiered royalties ranging from mid-teens to twenty percent based on annual net sales in its territories.

Exhibit 99.1
Second Quarter 2019 Financial Results
•Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2019, were $272.1 million, compared to $232.9 million as of December 31, 2018.
•Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $10.6 million for the quarter ended June 30, 2019, compared to $18.8 million for the quarter ended June 30, 2018. The decrease was primarily due to decreased revenue recognized under the collaboration and license agreement with Incyte, as well as revenue recognized during the three months ended June 30, 2018 under the license agreement and asset purchase agreement with Provention Bio. The decrease was partially offset by the revenue recognized from the deferred upfront payment under the collaboration and license agreement with Zai Lab.
•R&D Expenses: Research and development expenses were $51.4 million for the quarter ended June 30, 2019, compared to $52.0 million for the quarter ended June 30, 2018.
•G&A Expenses: General and administrative expenses were $12.1 million for the quarter ended June 30, 2019, compared to $11.1 million for the quarter ended June 30, 2018. This increase was primarily due to consulting expenses and other professional service fees.
•Net Loss: Net loss was $31.8 million for the quarter ended June 30, 2019, which included Other Income of $19.6 million related to the revaluation of the warrants received from Provention Bio, compared to net loss of $43.2 million for the quarter ended June 30, 2018.
•Shares Outstanding: Shares outstanding as of June 30, 2019 were 48,893,451.

Conference Call Information

MacroGenics will host a conference call today at 4:30 p.m. ET to discuss financial results for the quarter ended June 30, 2019 and provide a corporate update. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and provide the Conference ID: 3046407.

The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

On July 31, 2019 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that it will report second quarter 2019 financial results and provide a corporate update before market open on Wednesday, August 7, 2019 (Press release, Jounce Therapeutics, JUL 31, 2019, View Source [SID1234537942]). Jounce Therapeutics’ management team will host a live conference call and webcast at 8:00 a.m. ET.

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Conference Call and Webcast
To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 4484315. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at www.jouncetx.com. The webcast will be archived and made available for replay on the company’s website approximately two hours after the call and will be available for 30 days thereafter.

On July 31, 2019 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of novel cancer therapies, reported it has achieved two-thirds enrollment in its ongoing Phase 2 clinical study investigating the first-line treatment of VAL-083 with radiation therapy in newly-diagnosed MGMT-unmethylated GBM (Press release, DelMar Pharmaceuticals, JUL 31, 2019, View Source [SID1234537941]). The trial, which is being conducted at the Sun Yat-sen University Cancer Center (SYSUCC) in Guangzhou, China and in collaboration with Guangxi Wuzhou Pharmaceutical Company, is designed to enroll up to 30 patients to determine whether first-line therapy with VAL-083 treatment improves progression free survival (PFS). The current standard of care is first-line temozolomide (TMZ) with radiation.

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"While treating glioblastoma patients with an unmethylated MGMT promoter is particularly challenging, we have been encouraged by the enhanced levels of tumor shrinkage observed to date following treatment with VAL-083 in combination with radiation," commented Professor Zhong-ping Chen, founder chairman of the Department of Neurosurgery/Neuro-oncology at Sun Yat-sen University Cancer Center, and who is also the study’s principal investigator. "Having reached this two-thirds enrollment point, we look forward to seeing further results corroborating the preliminary data we’ve received, which does appear to support the premise that VAL-083 may provide an additional and valuable treatment option for these difficult-to-treat patient conditions."

The Phase 2 trial is a single-arm, open-label study testing VAL-083 in combination with standard radiotherapy in GBM patients who have an unmethylated promoter of the methylguanine DNA-methyltransferase (MGMT) gene. The clinical trial in newly-diagnosed GBM patients is designed to determine if first-line treatment with VAL-083 plus radiotherapy can provide improvements over the historical efficacy of standard of care temozolomide (TMZ) plus radiotherapy. Efficacy will be measured based on tumor response to treatment, progression-free survival, progression-free survival at six months, and overall survival compared to historical results in the target population.

"This first line study continues to enroll at a consistent pace, and we look forward to completing enrollment in this very important patient population. Once complete, we believe that the data from this study may provide additional support for the advancement of the adjuvant setting trial at MD Anderson Cancer Center, as well as to potentially support a future US study for utilization of VAL-083 as a first-line therapy for newly-diagnosed patients with an unmethylated MGMT gene promoter," commented Saiid Zarrabian, DelMar’s Chief Executive Officer. "In the meantime, we are very proud to be advancing all three of our Phase 2 programs for VAL-083, including the two-arm trial being conducted at MD Anderson Cancer Center in Texas for patients with recurrent GBM and those who have undergone surgery and chemoradiation with TMZ but will now receive VAL-083 in place of standard of care TMZ for adjuvant therapy. We look forward to continuing to provide updates on the progress of all three patient populations."

The company recently announced the initiation of an adjuvant arm to the MD Anderson study to provide early disease data on VAL-083. This arm will enroll up to 24 newly-diagnosed patients who have undergone surgery and chemoradiation with TMZ but will now receive VAL-083 in place of standard of care TMZ for adjuvant therapy. This arm is in addition to a trial arm treating patients with recurrent disease, administering VAL-083 in patients who have been heavily pre-treated with TMZ prior to disease recurrence. The recurrent arm will allow a total of 83 patients to be enrolled, and both arms are being conducted at the University of Texas MD Anderson Cancer Center.

About VAL-083

VAL-083 (dianhydrogalactitol) is a "first-in-class", bifunctional DNA-targeting agent that introduces inter-strand DNA cross-links at the N7-position of guanine leading to DNA double-strand breaks and cancer cell death. VAL-083 has demonstrated clinical activity against a range of cancers including GBM and ovarian cancer in historical clinical trials sponsored by the U.S. National Cancer Institute (NCI). DelMar has demonstrated that VAL-083’s anti-tumor activity is unaffected by common mechanisms of chemoresistance, including MGMT, in cancer cell models and animal studies. Further details regarding these studies can be found at:

View Source

On July 31, 2019 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), reported financial results and provided a business update for the three months ended June 30, 2019 (Press release, Lexicon Pharmaceuticals, JUL 31, 2019, View Source;2019.htm [SID1234537937]).

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"We are pleased that recent preliminary results of three Phase 3 clinical trials support the potential benefits Zynquista may bring to people with type 2 diabetes and particularly those with chronic kidney disease," said Lonnel Coats, Lexicon’s president and chief executive officer. "We are disappointed in Sanofi’s announcement of its purported termination of our alliance but are encouraged by the results that we have received thus far. We expect the balance of the core Phase 3 studies will be completed this year. As for our XERMELO business, we saw 24% growth in XERMELO net sales in the U.S. in the second quarter of 2019 versus the same period in 2018 and continue to make good progress on that front while effectively managing our resources and spend."

Second Quarter Product and Pipeline Highlights

XERMELO (telotristat ethyl)

· XERMELO U.S. net sales were $7.4 million in the second quarter of 2019.
· The Telotristat Ethyl for Advanced Biliary Tract Cancer, or TELE-ABC, study, a Phase 2a clinical study of telotristat ethyl in patients with biliary tract cancer, continues to enroll patients.

Zynquista (sotagliflozin)

· In April, the European Commission granted marketing authorization for Zynquista in both a 200-mg and 400-mg dose for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes (T1D) mellitus with a body mass index (BMI) ≥ 27 kg/m2, who have failed to achieve adequate glycemic control despite optimal insulin therapy.

Second Quarter 2019 Financial Highlights

Revenues: Revenues for the three months ended June 30, 2019 decreased to $9.7 million from $13.8 million for the corresponding period in 2018, primarily due to lower revenues recognized from our collaboration and license agreement with Sanofi, partially offset by an increase in net product revenues. Net product revenues for the three months ended June 30, 2019 included $7.4 million from net sales of XERMELO in the U.S. and $1.3 million from the sales of bulk XERMELO tablets to Ipsen, cumulatively up 19% from the prior year quarter.

Cost of Sales: Cost of sales related to sales of XERMELO for the three months ended June 30, 2019 and 2018 was $1.3 million and $0.8 million, respectively.

Research and Development (R&D) Expenses: Research and development expenses for the three months ended June 30, 2019 decreased to $12.6 million from $26.5 million for the corresponding period in 2018, primarily due to lower external clinical development costs relating to Zynquista.

Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the three months ended June 30, 2019 decreased to $14.3 million from $16.8 million for the corresponding period in 2018, primarily due to decreased marketing costs.

Net Loss: Net loss for the three months ended June 30, 2019 was $23.0 million, or $0.22 per share, compared to a net loss of $34.5 million, or $0.33 per share, in the corresponding period in 2018. For the three months ended June 30, 2019 and 2018, net loss included non-cash, stock-based compensation expense of $3.8 million and $2.9 million, respectively.

Cash and Investments: As of June 30, 2019, Lexicon had $106.0 million in cash and investments, as compared to $160.1 million as of December 31, 2018.

Anticipated Near-Term Milestones

· September 2019 – Presentation of new analyses from pivotal studies of Zynquista in type 1 diabetes at the 55th Annual Meeting of the European Association for the Study of Diabetes (EASD)
· 2H 2019 – Topline Phase 1b data for LX9211
· 2H 2019 – Topline results from core Phase 3 studies for Zynquista in type 2 diabetes
· 2H 2019 – Completion of patient enrollment of the initial safety cohort in the Phase 2 study of telotristat ethyl in biliary tract cancer

Conference Call and Webcast Information

Lexicon management will hold a live conference call and webcast today at 8:00 am EDT / 7:00 am CDT to review its financial and operating results and to provide a general business update. The dial-in number for the conference call is 888-645-5785 (U.S./Canada) or 970-300-1531 (international). The conference ID for all callers is 5789855. The live webcast and replay may be accessed by visiting Lexicon’s website at www.lexpharma.com/investors. An archived version of the webcast will be available on the website for 14 days.

About XERMELO (telotristat ethyl)

Discovered using Lexicon’s unique approach to gene science, XERMELO (telotristat ethyl) is the first and only approved oral therapy for carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSAs. XERMELO targets tryptophan hydroxylase, an enzyme that mediates the excess serotonin production within metastatic neuroendocrine tumor (mNET) cells. XERMELO is approved in the United States, the European Union and certain additional countries for the treatment of carcinoid syndrome diarrhea in combination with SSA therapy in adults inadequately controlled by SSA therapy. Carcinoid syndrome is a rare condition that occurs in patients living with metastatic NETs (mNETs) and is characterized by frequent and debilitating diarrhea. XERMELO targets the overproduction of serotonin inside mNET cells, providing an additional treatment option for patients suffering from carcinoid syndrome diarrhea.

Lexicon has granted Ipsen an exclusive royalty-bearing right and license to commercialize XERMELO outside of the United States and Japan. We are commercializing XERMELO in the United States and Ipsen is commercializing XERMELO in multiple countries, including the United Kingdom and Germany.

XERMELO (telotristat ethyl) Important Safety Information

· Warnings and Precautions: XERMELO may cause constipation, which can be serious. Monitor for signs and symptoms of constipation and/or severe, persistent, or worsening abdominal pain in patients taking XERMELO. Discontinue XERMELO if severe constipation or severe, persistent, or worsening abdominal pain develops.
· Adverse Reactions: The most common adverse reactions (≥5%) include nausea, headache, increased gamma-glutamyl-transferase, depression, flatulence, decreased appetite, peripheral edema, and pyrexia.
· Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 substrates, as XERMELO may decrease their systemic exposure. If combination treatment with XERMELO and short-acting octreotide is needed, administer short-acting octreotide at least 30 minutes after administering XERMELO.
For more information about XERMELO, see Full Prescribing Information at www.xermelo.com.

About Zynquista (sotagliflozin)

Discovered using Lexicon’s unique approach to gene science, Zynquista is an oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney. Zynquista is approved in the European Union (EU) for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes with a body mass index ≥ 27 kg/m2, who could not achieve adequate glycemic control despite optimal insulin therapy. Outside of such approval, Zynquista is investigational and has not been approved by any other regulatory authority for type 1 or type 2 diabetes.

Lexicon has granted Sanofi an exclusive worldwide (excluding Japan) license to develop, manufacture and commercialize Zynquista. Lexicon remains responsible for all clinical development activities relating to type 1 diabetes and Sanofi is responsible for all clinical development activities of Zynquista for the treatment of type 2 diabetes. Sanofi has delivered to Lexicon a notice purporting to terminate the alliance. Lexicon has notified Sanofi that it considers the notice invalid and Sanofi to be in breach of contract.

On July 31, 2019 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that it will release its second quarter 2019 financial results on Wednesday, August 7, after the close of the U.S. financial markets (Press release, Syndax, JUL 31, 2019, View Source [SID1234537936]).

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In connection with the earnings release, Syndax’s management team will host a conference call and live audio webcast at 4:30 p.m. ET on Wednesday, August 7, to discuss the Company’s financial results and provide a general business update.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website at www.syndax.com. Alternatively, the conference call may be accessed through the following:

Conference ID: 8959885
Domestic Dial-in Number: (855) 251-6663
International Dial-in Number: (281) 542-4259
Live webcast: View Source

For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors section of the Company’s website, www.syndax.com.