On Juy 30, 2020 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel products for serious rare and ultra-rare genetic diseases, reported its financial results for the quarter ended June 30, 2020 and maintained its full year 2020 financial guidance for Crysvita in Ultragenyx territories (Press release, Ultragenyx Pharmaceutical, JUL 30, 2020, View Source [SID1234562566]).

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"In the second quarter we made significant progress expanding the commercial reach of Crysvita and Mepsevii despite the COVID environment. We also expanded our commercial portfolio with two FDA approvals in a two-week period as Dojolvi for LC-FAOD and Crysvita for TIO became the third and fourth approvals for Ultragenyx," said Emil D. Kakkis, M.D., Ph.D., Chief Executive Officer and President of Ultragenyx. "We also presented positive updates at ASGCT (Free ASGCT Whitepaper) on both of our clinical gene therapy programs, DTX401 for GSDIa and DTX301 for OTC deficiency, and we are heading towards Phase 3 studies for each of them."

Second Quarter 2020 Financial Results

Net Revenues
For the second quarter of 2020, Ultragenyx reported $61.7 million in total revenue. Ultragenyx recognized $32.4 million in total Crysvita revenue in the Ultragenyx territories, which includes $29.8 million in collaboration revenue in the North American profit share territory and net product sales in other regions of $2.5 million. Total royalty revenue related to European Crysvita sales were $5.0 million, which includes $1.5 million recognized on sales that occurred prior to January 1, 2020. Mepsevii (vestronidase alfa) product revenue for the second quarter of 2020 was $4.2 million, and UX007 named patient revenue was $1.3 million. Revenue for the second quarter also includes $18.9 million of revenue related to the collaboration and license agreement with Daiichi Sankyo that was executed in March 2020.

Revenue for the six months ended June 30, 2020 was $98.0 million, including $61.2 million in total Crysvita revenue in the Ultragenyx territories. Crysvita collaboration revenue in the North American profit share territory was $57.0 million and net Crysvita product sales in other regions were $4.2 million. Total royalty revenue related to European Crysvita royalties was $7.6 million in the first half of 2020, which includes $1.5 million recognized on sales that occurred prior to January 1, 2020. Mepsevii product revenue for the six months ended June 30, 2020 was $7.6 million and UX007 named patient revenue was $2.8 million. The technology transfer services with Daiichi Sankyo were initiated during the second quarter of 2020 and Ultragenyx began recognizing revenue during the period related to the collaboration and license agreement. For the three and six months ended June 30, 2020, revenue related to this agreement was $18.9 million.

Operating Expenses
Total operating expenses for the second quarter of 2020 were $124.8 million, including non-cash stock-based compensation of $22.4 million. Total operating expenses for the second quarter of 2019 were $136.6 million, including a $15.6 million research and development expense from the Arcturus collaboration amendment, and non-cash stock-based compensation of $22.2 million.

Total operating expenses for the six months ended June 30, 2020 were $281.7 million, which includes $25.0 million to maintain the option to acquire GeneTx, $7.0 million to license certain vectors from REGENXBIO, and non-cash stock-based compensation of $42.6 million. This is compared with $254.0 million for the same period in 2019, which includes a $15.6 million research and development expense from the Arcturus collaboration amendment and non-cash stock-based compensation $42.4 million. The increase in total operating expenses is due to the increase in commercial, development, and general and administrative costs as the company commercializes, grows, and advances its portfolio.

For the second quarter of 2020, Ultragenyx reported net income of $25.3 million, or $0.42 per basic share and $0.41 per diluted share, compared with a net loss for the second quarter of 2019 of $99.2 million, or $1.72 per share, basic and diluted. For the six months ended June 30, 2020, net loss was $93.7 million, or $1.59 per share, basic and diluted, compared with a net loss for the same period in 2019 of $195.9 million, or $3.54 per share, basic and diluted. The net income for the second quarter of 2020 and the net loss for the six months ended June 30, 2020 includes a $95.2 million unrealized gain and a $102.9 million unrealized gain for the three and six months ended June 30, 2020, respectively, from the fair value adjustment on the investment in Arcturus equity. Net cash used in operations for the first six months of 2020 was $7.8 million, which includes $134.9 million of operating cash received from Daiichi Sankyo related to the collaboration and license agreement, compared to net cash used of $184.8 million for the same period in 2019.

Cash, Cash Equivalents and Investments
Cash, cash equivalents, and investments were $817.5 million as of June 30, 2020.

2020 Guidance

Crysvita Guidance in Ultragenyx Territories
The company continues to maintain its guidance range for 2020 Crysvita revenue in the Ultragenyx territories between $125.0 million and $140.0 million, but will continue to monitor the COVID-19 pandemic situation. Ultragenyx territories include the collaboration revenue from the North American profit share territory (U.S. and Canada) and other regions where revenue from product sales are recognized by Ultragenyx (Latin America, Turkey). This excludes the European territory revenue, which is recognized as non-cash royalty revenue since the rights were sold to Royalty Pharma in December 2019.

Corporate Update

Arcturus Collaboration

In May 2020, Ultragenyx exercised its option to purchase 600,000 shares of Arcturus common stock at $16.00 per share. Upon completion of the new equity purchase, Ultragenyx owned 3,000,000 shares of Arcturus common stock and continued to be its largest shareholder.
COVID-19 Update

Despite the ongoing pandemic, the company has been able to maintain an uninterrupted supply of medicine to patients around the world as no significant disruptions to manufacturing or distribution activities have been experienced. There has been some impact to preclinical manufacturing, clinical study site conduct, and regulatory interactions. The company is adapting clinical and commercial strategies to ensure continuity of clinical and commercial programs during this unprecedented time.
Program Updates and Upcoming Milestones

Dojolvi for Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD): Approved by FDA on June 30, 2020

The U.S. FDA approved Dojolvi for the treatment of pediatric and adult patients for all forms of LC-FAOD with a molecularly-confirmed diagnosis. Dojolvi is the first FDA-approved therapy for these lifelong and life-threatening genetic disorders and is now available to patients in the U.S.

Dojolvi has been submitted for approval with ANVISA in Brazil and has been submitted to Health Canada after being granted priority review.
Crysvita for Tumor-Induced Osteomalacia (TIO): Approved by FDA on June 18, 2020

The U.S. FDA approved Crysvita for the treatment of fibroblast growth factor 23 (FGF23)-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adults and pediatric patients 2 years of age and older. This is the second FDA approval for Crysvita, which was first approved in April 2018 for the treatment of X-linked hypophosphatemia (XLH).
DTX401 for Glycogen Storage Disease Type Ia (GSDIa): Positive data from confirmatory cohort in Phase 1/2 study presented at American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting

As presented at ASGCT (Free ASGCT Whitepaper), all three patients in the third, confirmatory dose cohort (6.0 x 10^12 GC/kg) demonstrated increased time to hypoglycemia and substantial reductions in cornstarch usage. Prolonged periods of hyperglycemia were observed in Cohort 3 with the implementation of continuous glucose monitoring (CGM), which is indicative of early transgene expression and glucose release from the liver. The early transgene expression resulted in faster cornstarch reductions in Cohort 3, with a mean reduction of 57% at week 12 compared with 38% and 14% in the first and second cohorts, respectively. Across all three cohorts in the study, 100 percent of patients have demonstrated meaningful and sustained cornstarch regimens over time and significant increases in time to hypoglycemia. After longer-term follow-up, four of six patients in the first two cohorts have discontinued daytime cornstarch.

Barring delays related to COVID-19, the company expects to release additional data on Cohort 3 in the second half of 2020, intends to hold an end-of-Phase 2 meeting with the U.S. FDA, and potentially initiate a Phase 3 study in early 2021.
DTX301 for Ornithine Transcarbamylase (OTC) Deficiency: Updated positive data from Phase 1/2 study presented at ASGCT (Free ASGCT Whitepaper)

Updated data presented at ASGCT (Free ASGCT Whitepaper) confirmed that all three patients in the third dose cohort (1.0 x 10^13 GC/kg) are responders to DTX301 as shown by sustained meaningful increases in the rate of ureagenesis or reductions in ammonia levels. Six of nine patients across all three cohorts have now responded to the gene therapy, including three females and three males. All three complete responders, those who have discontinued all ammonia scavengers and liberalized their diets, remain clinically and metabolically stable after longer-term follow-up.

A fourth cohort of three patients at the same Cohort 3 dose is planned using prophylactic steroids. Dosing is still on hold due to COVID-19 but data are expected by the end of 2020. Ultragenyx intends to hold an end-of-phase 2 meeting with the FDA based on the first three cohorts, with Phase 3 study initiation currently expected in the first half of 2021.
DTX201 / BAY 2599023 Partnered with Bayer for Hemophilia A: Cohort 3 data from Phase 1/2 study presented at International Society on Thrombosis and Haemostasis (ISTH) 2020 Congress

Three cohorts with two patients each have been dosed with AAVhu37 (DTX201 / BAY 2599023), using material from Ultragenyx’s proprietary HeLa manufacturing platform. Initial data from the third dose cohort (2.0 x 10^13 GC/kg) and longer-term data from the lower dose cohorts were presented at ISTH. The data demonstrated a dose response with FVIII expression of 72.1% and 12.9% at weeks 29 and 26 in the two Cohort 3 patients. No spontaneous bleeds were reported after Cohort 3 patients reached peak expression despite prophylaxis discontinuation. One traumatic bleed occurred with no need for Factor VIII treatment. No adverse events related to DTX201 were observed, and ALT elevations in both patients were successfully treated with corticosteroids. Longer-term data from the two earlier cohorts showed sustained FVIII expression up to 16 months with no loss of expression.
GTX-102 for Angelman Syndrome Conducted by Partner, GeneTx: First two cohorts have been fully enrolled

The first two cohorts of two patients each have been fully enrolled with all patients receiving multiples doses in the Phase 1/2 study of GTX-102 in Angelman Syndrome. Safety and efficacy data from the first two dose escalating cohorts are currently being evaluated and enrollment and dosing at the next dose levels are expected to resume shortly. Preliminary data from the study are expected in the first half of 2021.
Crysvita for X-Linked Hypophosphatemia (XLH): Positive opinion from Committee for Medicinal Products for Human Use (CHMP)

In Europe, Crysvita received a positive opinion from the CHMP, for the use of Crysvita for the treatment of XLH in adolescents and adults. This could lead to an expansion of the current market authorization beyond the current approval for children 1 year of age and older and adolescents with growing skeletons. A formal decision from the European Commission (EC) is expected in the second half of 2020.
Mepsevii for Mucopolysaccharidosis Type VII (MPS VII): Positive opinion from CHMP to expand the Summary of Product Characteristics in Europe

The CHMP provided a positive opinion on a type II variation that would expand the EMA approval to include long-term effects of Mepsevii on the reduction of urinary glycosaminoglycans (uGAGs) and improvements in the multi-domain clinical responder index (MDRI) and 6-minute walk test (6MWT). A formal decision from the EC is expected in the second half of 2020.
Other Gene Therapy Platform Updates

An IND application for UX701 in Wilson disease, a larger rare metabolic disease, is expected by the end of 2020 barring any delays in nonclinical or manufacturing activities.

Ultragenyx and Daiichi Sankyo initiated technology transfer activities related to the non-exclusive license agreement executed in the first quarter of 2020 with respect to Ultragenyx’s HeLa PCL and HEK293 transient transfection manufacturing technology platforms for AAV-based gene therapy products. Daiichi Sankyo will pay $25.0 million upon completion of transfer of both platforms, as well as single-digit royalties on net sales of products manufactured in either system.
Conference Call and Webcast Information

Ultragenyx will host a conference call today, Thursday, July 30, 2020, at 2 p.m. PT/ 5 p.m. ET to discuss the second quarter 2020 financial results and provide a corporate update. The live and replayed webcast of the call will be available through the company’s website at View Source To participate in the live call by phone, dial (855) 797-6910 (USA) or (262) 912-6260 (international) and enter the passcode 1808389. The replay of the call will be available for one year.

On July 30, 2020 MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) reported that it will publish its results for the second quarter and first half of 2020 on August 5, 2020 at 10:00pm CEST (9:00pm BST; 4:00pm EDT) (Press release, MorphoSys, JUL 30, 2020, View Source [SID1234562565]).

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MorphoSys’ Management team will host a conference call and webcast on August 6, 2020 at 2:00pm CEST (1:00pm BST; 8:00am EDT) to present the second quarter and first half financial results 2020 and the further outlook for 2020.

Date of the conference call: Thursday, August 6, 2020
Time: 2:00pm CEST (1:00pm BST, 8:00am EDT)
Dial-in numbers:
Germany: +49 69 201 744 220
United Kingdom: +44 203 009 2470
USA: +1 877 423 0830
(all numbers reachable from any geography)
Participant PIN: 43014391#
Please dial in 10 minutes before the beginning of the conference.

A live webcast and slides will be made available at www.morphosys.com.

Approximately two hours after the call, a slide-synchronized audio replay of the conference and a transcript of the prepared remarks will be available on www.morphosys.com.

On July 30, 2020 NeuBase Therapeutics, Inc. (NASDAQ: NBSE) ("NeuBase" or the "Company"), a biotechnology company developing next-generation antisense oligonucleotide (ASO) therapies using its scalable PATrOL platform to address genetic diseases, reported that Dietrich Stephan, Chief Executive Officer of NeuBase, will participate in a virtual fireside chat at the BTIG Virtual Biotechnology Conference 2020, being held on August 10 – 11 (Press release, NeuBase Therapeutics, JUL 30, 2020, View Source [SID1234562564]).

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BTIG Virtual Biotechnology Conference 2020:
Date: Tuesday, August 11th
Time: 9:30 a.m. ET
Location: Webcast Link – or at the company’s website (click here)

On July 30, 2020 Piramal Pharma Solutions a contract development and manufacturing organization (CDMO) and San Francisco-based biotech Bolt Bioterapeutics reported that have signed a production agreement in which Piramal will be handling the manufacturing of Bolt’s Boltbody Immune-Stimulating Antibody Conjugate (ISAC), BDC-1001 (Press release, Bolt Biotherapeutics, JUL 30, 2020, View Source [SID1234562560]).

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Bolt Biotherapeutics’ Platform Technology, exclusively licensed from Stanford University, is applicable to a broad spectrum of antibodies targeting tumor antigens expressed on all types of cancer and consists of Immune-Stimulating Antibody Conjugates (ISAC), a new class of immuno-oncology therapeutics, that harnesses the ability of innate immune stimulants to convert cold tumors into immunologically hot tumors, thereby illuminating tumors to the immune system and allowing them to be invaded by tumor-killing cells.[1] The promise of Immunological memory. Bolt Biotherapeutics’ Immune-Stimulating Antibody Conjugate (ISAC) selectively target tumors for destruction by the immune system. Tumor-associated myeloid cells engulf ISAC-bound tumors, become armed with tumor neoantigens, and migrate to the lymph nodes where they mediate the activation and expansion of tumor-reactive T-cells. In preclinical tumor models, ISAC therapy leads to the regression of established tumors and generation of immunological memory, which guards against the recurrence of tumors that express tumor neoantigens even if they no longer express the ISAC target antigen. Image courtesy: © 2020 Bolt Biotherapeutics. Used with permission.

BDC-1001 In preclinical studies, researchers at Bolt demonstrated profound antitumor efficacy for BDC-1001, the company’s lead HER2-targeted ISAC therapeutic program when administered as a monotherapy. Treatment results in activation of the innate immune system that subsequently generates an adaptive immune response leading to complete and durable T-cell mediated clearance of large tumors. These Piramal Pharma Solutions and Bolt Biotherapeutics Sign Production Agreement By ADC Review | Editorial Team-July 29, 2020  preclinical studies also showed that BDC-1001 produces an immunologic memory – the immune system retained the ability to attack tumors even after the Boltbody was no longer present in the body, even protecting against tumors that had lost HER2 expression.[1]

BDC-1001, Bolt’s first Boltbody has entered clinical development and is currently being evaluated a first-in-human phase I/II study in patients with human epidermal growth factor receptor (HER2-) expressing solid tumors.

Agreement
Under the terms of the agreement, Piramal manufactures Bolt’s BDC-1001 ISAC for the ongoing Phase I/II clinical study in cancer patients.

Piramal will apply its integrated drug development model to Bolt’s BDC-1001. The program includes formulation development and ISAC development and manufacturing at Piramal’s Grangemouth, UK site. Following the manufacturing phase, the materials are further processed into lyophilized, sterile fill-finish vials at Piramal’s Lexington, Kentucky (USA) site.

This seamless integration across two of Piramal’s manufacturing facilities, which is expected to shorten delivery timelines and expedites distribution to the clinic, is part of the company’s patientcentric philosophy.

"Bolt’s technology platform has demonstrated significant, positive data in preclinical models, including the development of immunological memory against tumors, and is now in a human clinical trial. The manufacturing of ISACs utilizes essentially the same process as antibody-drug conjugate (ADC) manufacturing, enabling us to capitalize on our deep expertise in this space," said Peter DeYoung, Chief Executive Officer, Piramal Pharma Solutions.

"Our ability to produce these novel ISACs and package them for clinical trials in one efficient, integrated process compresses the timeline of the development of Bolt’s drug. We remain committed to our patient-centric approach and are proud to partner with an industry-leader like Bolt to help reduce the burden of disease on patients," he added.

Reliable partner "We’re a leader in ISAC technology, and our partnership with Piramal Pharma Solutions is important to bring our technology to the clinic. Piramal’s experience in the manufacture of commercial ADCs provides Bolt with a reliable partner for the development of BDC-1001," noted Nathan Ihle, Vice President CMC & Quality for Bolt Biotherapeutics.

A spokesperson for Piramal confirmed that the first cycle of trial drugs manufacturing has been successfully completed through Piramal’s integrated program. Additional cycles are in progress, as are further developments that will benefit future indications and new clinical programs.

Both Biotherpeutics was founded by Edgar G. Engleman, M.D., Director, Immunology & Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Programs, Stanford Cancer Institute and Bolt Biotherapeutics founder and board member.

Clinical trials A First-in-human Study Using BDC-1001 in Advanced and HER2-Expressing Solid Tumors – NCT04278144

Reference
Gingrich J.How the Next Generation Antibody Drug Conjugates Expands Beyond Cytotoxic Payloads for Cancer Therapy. JADC 4.7.2020 [Article] Featured Image: Piramal’s Piramal’s Lexington, Kentuky (USA) site (formerly Coldstream Laboratories) Photo Courtesy: © 2014 – 2020 Piramal Pharma Solutions. Used with permission.

On July 30, 2020 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, 2020 (Press release, MacroGenics, JUL 30, 2020, View Source [SID1234562563]).

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"We are excited about the momentum we have built to date in 2020. We have presented promising initial clinical data at ASCO (Free ASCO Whitepaper) from the MGD013 and MGC018 programs. We have defined a potential registration path for flotetuzumab and we have received FDA clearance to initiate clinical testing of our novel antibody-drug conjugate targeting ADAM9 being co-developed with ImmunoGen. Furthermore, we were able to extend our cash runway into 2023," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "In the coming months, we anticipate presentation of clinical data from other investigational product candidates in our pipeline, including MGD019, a PD-1 × CTLA-4 DART molecule, and retifanlimab, an anti-PD-1 antibody. Additionally, the PDUFA goal date for the margetuximab BLA is in December."

Key Highlights from Investigational Product Candidates

MGC018 (B7-H3 antibody-drug conjugate): At the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Annual Meeting in May, data were presented from the ongoing Phase 1/2 dose escalation study of MGC018 that suggested manageable safety and preliminary activity in patients with metastatic castration-resistant prostate cancer (mCRPC). The Company expects to commence the enrollment of an expansion cohort of patients with mCRPC as part of the Phase 1/2 study in the third quarter of 2020.

Flotetuzumab (bispecific CD123 × CD3 DART molecule): In May, MacroGenics announced that the trial of flotetuzumab designed to support registration in the U.S. will be a single arm study in up to 200 patients with AML whose disease is refractory to induction treatment (primary induction failure) or has relapsed after a remission of less than six months (early relapse). The trial will be conducted as an expansion of the ongoing Phase 1/2 study. The primary endpoint is a response rate comprised of complete remission (CR) and CR with partial hematological recovery (CRh). The Company plans to submit updated data for presentation at a scientific conference in the fourth quarter of 2020.

Margetuximab (Fc-engineered, anti-HER2 mAb): The Food and Drug Administration (FDA) notified MacroGenics in May that it no longer plans to hold an Oncologic Drugs Advisory Committee (ODAC) meeting to discuss the Biologics License Application (BLA) for margetuximab in combination with chemotherapy as a treatment for patients with metastatic HER2-positive breast cancer. The Prescription Drug User Fee Act (PDUFA) target action date is December 18, 2020.

In July, The Lancet Oncology published results from a Phase 2 study of margetuximab and pembrolizumab in second-line patients with advanced HER2-positive gastric or gastroesophageal junction cancer. These data formed the basis for conducting the ongoing Phase 2/3 MAHOGANY study of margetuximab plus checkpoint blockade in front-line patients.
MGD013 (bispecific PD-1 × LAG-3 DART molecule): At the ASCO (Free ASCO Whitepaper) Virtual Annual Meeting, results were presented from dose escalation and select expansion cohorts from the ongoing Phase 1 study of MGD013 in advanced solid tumors as well as the combination of MGD013 and margetuximab in a cohort of patients with advanced HER2-positive tumors. MacroGenics is expanding enrollment of the combination cohort.

MGD019 (bispecific PD-1 × CTLA-4 DART molecule): Data from the Phase 1 dose escalation study of MGD019 are scheduled to be presented during an oral session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 to be held September 19-21.

IMGC936 (ADAM9 antibody-drug conjugate): In July, MacroGenics received FDA clearance of the Investigational New Drug (IND) application for IMGC936 that is being advanced under a co-development agreement with ImmunoGen, Inc. ADAM9 is a cell surface protein over-expressed in several solid tumor types. ImmunoGen expects to initiate a Phase 1 dose escalation study in patients with select advanced solid tumors in the fourth quarter of 2020.

Enoblituzumab (Fc-engineered, anti-B7-H3 mAb): MacroGenics expects to initiate a Phase 2 study of enoblituzumab in combination with retifanlimab as a chemo-free regimen in front-line patients with advanced head and neck cancer in the first quarter of 2021.

Retifanlimab (anti-PD-1 mAb also known as MGA012 or INCMGA0012): Data from POD1UM-201, the ongoing study of retifanlimab monotherapy in patients with Merkel cell carcinoma, are scheduled to be presented during a poster session at the ESMO (Free ESMO Whitepaper) Virtual Congress 2020. In addition, data from POD1UM-202, the fully-enrolled, potentially registration-enabling monotherapy study in patients with squamous cell carcinoma of the anal canal, are expected to be presented at a medical congress in the second half of 2020. Retifanlimab was invented by MacroGenics and licensed to Incyte.
Corporate Highlights

Stephen Eck, M.D., Ph.D. joined the senior leadership team at MacroGenics as Senior Vice President, Clinical Development and Chief Medical Officer.
Second Quarter 2020 Financial Results

Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2020, were $232.8 million, compared to $215.8 million as of December 31, 2019. During the quarter ended June 30, 2020, $96.5 million in net proceeds were received from the sale of 4,060,482 shares of the Company’s common stock pursuant to its at-the-market (ATM) offering. Subsequent to June 30, 2020, an additional $21.3 million net proceeds were received from the sale of 726,380 shares pursuant to the Company’s ATM offering and $12.0 million was received from Boehringer Ingelheim GmbH under a 2010 license and collaboration agreement.

Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $20.3 million for the quarter ended June 30, 2020, compared to $10.6 million for the quarter ended June 30, 2019. This increase was primarily due to $12.0 million recognized from the agreement with Boehringer Ingelheim.

R&D Expenses: Research and development expenses were $57.4 million for the quarter ended June 30, 2020, compared to $51.4 million for the quarter ended June 30, 2019. This increase was primarily due to an increase in development and clinical trial costs for multiple programs.

G&A Expenses: General and administrative expenses were $10.2 million for the quarter ended June 30, 2020, compared to $12.1 million for the quarter ended June 30, 2019. This decrease is primarily due to a decrease in consulting costs, with a smaller decrease in travel-related costs due to COVID-19.

Net Loss: Net loss was $46.9 million for the quarter ended June 30, 2020, compared to net loss of $31.8 million for the quarter ended June 30, 2019.

Shares Outstanding: Shares outstanding as of June 30, 2020 were 53,365,003.

Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities as of June 30, 2020, plus the additional proceeds referred to above which were subsequently received, combined with anticipated and potential collaboration payments, should enable it to fund its operations into 2023, assuming the Company’s programs and collaborations advance as currently contemplated.
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, 2020 and provide a corporate update. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) ten minutes prior to the start of the call and provide the Conference ID: 3236629.

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.