On November 2, 2021 MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported financial results for the quarter ended September 30, 2021 (Press release, MacroGenics, NOV 2, 2021, View Source [SID1234594120]).

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"In September, we were pleased to present encouraging preliminary results from our ongoing Phase 1 cohort expansion study of MGC018 at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting. We look forward to providing additional clinical data updates on this study next year as well as sharing our future development plans for this molecule in the first quarter of next year, after continued engagement with Key Opinion Leaders and regulatory agencies," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Beyond MGC018, we continue to advance our growing pipeline of investigational product candidates for the potential treatment of cancer. Finally, the recent FDA approval to manufacture MARGENZA drug substance at our GMP manufacturing facility is an important achievement for the Company."

Updates on Proprietary Programs

The recent progress and key events related to MacroGenics’ investigational product candidates in clinical development and its approved product, MARGENZA, are highlighted below:

MGC018 is an antibody-drug conjugate (ADC) that targets B7-H3. At ESMO (Free ESMO Whitepaper), MacroGenics presented encouraging preliminary clinical results from the ongoing Phase 1 study of MGC018 in patients with solid tumors. The Phase 1 study cohort expansions are ongoing for metastatic castrate-resistant prostate cancer (mCRPC), non-small cell lung cancer (NSCLC), melanoma, squamous cell carcinoma of the head and neck (SCCHN) and triple negative breast cancer (TNBC). The Company expects to present additional data from the ongoing Phase 1 study of MGC018 in the first half of next year. In addition, MacroGenics intends to provide details regarding further development plans in mCRPC in the first quarter of 2022. The Company also intends to initiate a study combining MGC018 with one of its proprietary checkpoint inhibitor molecules in the first half of next year.

Enoblituzumab is an Fc‐engineered, monoclonal antibody that targets B7‐H3. MacroGenics continues to recruit patients into its Phase 2 study of enoblituzumab in a chemotherapy-free regimen in combination with retifanlimab in front-line patients with SCCHN who are PD-L1 positive and with tebotelimab in SCCHN patients who are PD-L1 negative. In September, I-Mab Biopharma announced that an IND to initiate a Phase 2 trial of enoblituzumab in combination with pembrolizumab in patients with select solid tumors was accepted in China, triggering a net $4.5 million milestone payment to MacroGenics. I-Mab has development and commercial rights to enoblituzumab in Greater China.

Bispecific CD123 × CD3 DART molecules:

Flotetuzumab is a bispecific CD123 × CD3 DART molecule being evaluated in patients with refractory acute myeloid leukemia (AML). MacroGenics is conducting a single-arm clinical study to evaluate flotetuzumab in up to 200 patients with refractory AML, with complete remission (CR) and CR with partial hematological recovery (CRh) as the composite primary endpoint. The Company anticipates providing further updates on the clinical development of flotetuzumab in 2022.

MGD024 is a next-generation, bispecific CD123 × CD3 DART molecule designed to minimize cytokine-release syndrome, while maintaining anti-tumor cytolytic activity, and has an Fc domain to permit intermittent dosing through a longer half-life. MacroGenics submitted an IND application for MGD024 to the FDA in October. The Company intends to present preclinical MGD024 data at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December.

Tebotelimab is a bispecific, tetravalent DART molecule targeting PD-1 and LAG-3. MacroGenics is evaluating the molecule in patients as monotherapy as well as in combination with other agents. The Company’s partner for this molecule in Greater China, Zai Lab, expanded its Phase 1b/2 study of tebotelimab in combination with the PARP inhibitor niraparib into new indications, including gastric cancer, TNBC and biliary tract cancer. In addition, Zai Lab enrolled the first patient in an endometrial cancer cohort in October 2021.

MGD019 is a bispecific, tetravalent DART molecule targeting PD-1 and CTLA-4. The Company is conducting a Phase 1 dose expansion study in cohorts of patients with microsatellite stable colorectal cancer (MSS CRC), checkpoint-naïve NSCLC, mCRPC and melanoma. The Company anticipates sharing data from its ongoing Phase 1 dose expansion study next year.

IMGC936 is an ADC that targets ADAM9, a cell surface protein over-expressed in several solid tumor types, and is being developed jointly under a 50/50 collaboration with ImmunoGen, Inc. Under the collaboration, ImmunoGen is leading clinical development of IMGC936 in a Phase 1 clinical trial evaluating safety and pharmacokinetics in multiple solid tumors and has indicated they anticipate disclosing initial data in 2022.

Margetuximab is an Fc-engineered, monoclonal antibody (mAb) that targets the HER2 oncoprotein, which is expressed by certain breast, gastroesophageal and other solid tumor cells.

MARGENZA Commercial Launch. In March 2021, MacroGenics and its commercial partner, EVERSANA, launched MARGENZA for the treatment of adult patients with metastatic HER2-positive breast cancer, in combination with chemotherapy, who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. As previously reported, the median overall survival (OS) in the intent-to-treat population was not statistically different between the two arms. A prespecified, non-alpha allocating, exploratory analysis of OS by CD16A genotype in the SOPHIA trial showed a numerical OS advantage in favor of margetuximab in F homozygous patients and a numerical OS advantage in favor of trastuzumab in V homozygous patients. Finally, MacroGenics recently received U.S. FDA approval to manufacture MARGENZA drug substance at its GMP manufacturing facility in Rockville, MD.

MAHOGANY Study. At ESMO (Free ESMO Whitepaper), MacroGenics presented results from Cohort A Part 1 of the Phase 2/3 MAHOGANY study of margetuximab in combination with retifanlimab, an anti-PD-1 molecule the Company licensed to Incyte Corporation, in patients with advanced gastric and gastroesophageal junction cancer. Although the number of confirmed responses by independent review (twenty one of 40 (53%) patients) exceeded the prespecified futility boundary for this chemotherapy-free regimen, MacroGenics has decided to discontinue enrollment of Cohort A based on a number of factors, including the prioritization of its other product candidates given the competition in this indication, and the accelerated approval of combination therapy with pembrolizumab. MacroGenics’ partner for margetuximab in Greater China, Zai Lab, continues to enroll patients in Cohort B.

Zai Lab’s Bridging Study. In October 2021, Zai Lab announced that the bridging study of margetuximab plus chemotherapy in advanced, previously treated HER2-positive breast cancer met its primary endpoint with acceptable safety and tolerability. The study showed that efficacy of the combination in Chinese patients was consistent with that seen in the global population in MacroGenics’ SOPHIA Phase 3 trial. Zai Lab has indicated that it anticipates submitting a BLA in China for pretreated metastatic HER2-positive breast cancer by approximately year-end 2021.
Updates on Partnered Program

Retifanlimab is an investigational anti-PD-1 antibody that MacroGenics licensed to Incyte. Incyte will present clinical results in poster presentations from both a Phase 2 study of retifanlimab in patients with advanced or metastatic Merkel cell carcinoma and a tumor specific expansion cohort study in patients with recurrent MSI-H or deficient mismatch repair (dMMR) recurrent endometrial cancer at the 2021 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (or SITC (Free SITC Whitepaper)) Virtual Meeting taking place November 10 – 14, 2021.
Third Quarter 2021 Financial Results

Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2021, were $298.9 million, compared to $272.5 million as of December 31, 2020.
Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $15.7 million for the quarter ended September 30, 2021, compared to total revenue of $18.3 million for the quarter ended September 30, 2020. Revenue for the quarter ended September 30, 2021 included $3.6 million net sales of MARGENZA.
R&D Expenses: Research and development expenses were $49.8 million for the quarter ended September 30, 2021, compared to $44.7 million for the quarter ended September 30, 2020. The increase was primarily related to increased clinical trial and development costs related to the Company’s product candidates, as well as research costs related to preclinical molecules, partially offset by decreased clinical costs and BLA support for margetuximab and decreased development and manufacturing costs related to flotetuzumab.
SG&A Expenses: Selling, general and administrative expenses were $17.2 million for the quarter ended September 30, 2021, compared to $9.7 million for the quarter ended September 30, 2020. The increase was primarily related to MARGENZA launch, as well as labor-related costs and legal expenses.
Net Loss: Net loss was $52.9 million for the quarter ended September 30, 2021, compared to net loss of $36.0 million for the quarter ended September 30, 2020.
Shares Outstanding: Shares outstanding as of September 30, 2021 were 61,254,693.
Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities as of September 30, 2021, plus anticipated and potential collaboration payments, should enable it to fund its operations through 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 September 30, 2021 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: 6063045.

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 November 2, 2021 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported its participation in the Credit Suisse 30th Annual Healthcare Conference (Press release, Kura Oncology, NOV 2, 2021, View Source [SID1234594137]). Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to participate in a virtual fireside chat at 3:30 p.m. ET / 12:30 p.m. PT on Tuesday, November 9, 2021.

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A live audio webcast of the fireside chat will be available in the Investors section of Kura’s website at www.kuraoncology.com, with a replay available shortly after the live event.

On November 2, 2021 TYME Technologies, Inc. (Nasdaq: TYME) (the Company or TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported that Richie Cunningham, Chief Executive Officer, and Jonathan Eckard, Chief Business Officer, will present at the Jefferies London Healthcare Conference as follows (Press release, TYME, NOV 2, 2021, View Source [SID1234594156]):

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Date: Wednesday, November 17, 2021

Time: 1:40 PM Greenwich Mean Time / 8:40 AM Eastern Standard Time

Webcast: View Source
The webcast will be accessible on the Events & Presentations page of the Investors section of the TYME website, tymeinc.com, and will be archived for 90 days following the events.

On November 2, 2021 Immunetune, a preclinical-stage biotech developing next-generation DNA vaccines against cancer and infectious diseases, reported the upcoming presentations by members of its management team at several industry and scientific conferences during November 2021 (Press release, ImmuneTune, NOV 2, 2021, View Source [SID1234594081]).

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"We are looking forward to presenting our platform of synthetic DNA vaccines to an audience of investors, pharma and biotech companies, and scientists and investigators," said Sijme Zeilemaker, CEO of Immunetune. "With our lead program NeoVAC, a personalized neoantigen cancer vaccine, moving towards the clinic in 2022, it is a great opportunity to showcase our unique differentiation and explore collaborations with leaders in this field."

Upcoming conferences:

Drug Discovery Strategic Summit, November 4 – 5, Amsterdam, the Netherlands

CEO Sijme Zeilemaker will be presenting on November 4th, 9:50 – 10:10 AM, on "Next-generation DNA vaccines targeting cancer and infectious diseases".

LSX Investival Showcase, November 8 – 15, Virtual / London, UK

CEO Sijme Zeilemaker will be participating virtually and in person on November 15th in London. Please reach out to [email protected] if you would like to set up a meeting within our scope of investors and pharma/biotech collaborations.

Festival of Biologics / World Immunotherapy Congress, November 9 – 11, Basel, Switzerland

CEO Sijme Zeilemaker will be presenting on November 9th, 5:50 – 6:10 PM, in the Innate & Adaptive Checkpoint Inhibition track on "Neoantigen cancer vaccines based on synthetic linear DNA with a pyroptotic adjuvant synergize with checkpoint inhibitors".

Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, November 10 – 14, Virtual / Washington, D.C., US

CSO Jeroen van Bergen will be presenting the poster titled "Personalized synthetic polyepitope DNA cancer vaccines encoding a novel pyroptotic adjuvant to generate effective anti-tumor T cell immunity". Abstracts can be accessed on the SITC (Free SITC Whitepaper) website once the conference begins on November 9th; posters will be presented on November 12 and 13.

On November 2, 2021 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) reported financial results for the third quarter ended September 30, 2021 and provided a corporate update (Press release, Deciphera Pharmaceuticals, NOV 2, 2021, View Source [SID1234594098]).

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"In the third quarter, we made tremendous progress expanding the reach of QINLOCK for patients with GIST around the world. In addition to obtaining the approval for this important medicine in Switzerland and Taiwan, we also received a positive CHMP opinion for QINLOCK in the EU, with approval expected before the end of the year. Finally, we remain on track to report top-line results from the Phase 3 INTRIGUE study in second-line GIST later this quarter."

Mr. Hoerter continued, "At the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021, we shared very encouraging data from both the vimseltinib and rebastinib programs demonstrating significant clinical activity in two diseases with high unmet medical needs. We plan to initiate the Phase 3 MOTION study of vimseltinib in tenosynovial giant cell tumor this quarter and expect to initiate a Phase 3 study of rebastinib in combination with paclitaxel in platinum-resistant ovarian cancer next year. The body of scientific evidence continues to build supporting the potential of our first-in-class ULK inhibitor, DCC-3116, to address a broad spectrum of cancers in which autophagy is upregulated and believed to play an important role in tumor growth and survival. The Phase 1/2 study of DCC-3116 is on track and, with the first-in-class program in this field, we are well positioned to explore the full potential of inhibiting autophagy in cancer."

Third Quarter 2021 Highlights and Upcoming Milestones

QINLOCK(ripretinib)
Recorded $21.7 million in QINLOCK net product revenue in the third quarter of 2021, including $20.0 million in U.S. sales of QINLOCK and $1.7 million in ex-U.S. sales of QINLOCK.
Presented data at the ESMO (Free ESMO Whitepaper) Congress 2021:
An exploratory evaluation of primary and secondary endpoints in the Phase 3 INVICTUS study, with a cutoff date of January 15, 2021, an additional 19 months after the primary analysis, demonstrated consistent progression-free survival (PFS) with no change since the primary data cut off, and improved median overall survival (OS) among patients receiving QINLOCK.
Median PFS was 6.3 months with QINLOCK compared to 1.0 month with placebo.
Median OS was 18.2 months with QINLOCK compared to 6.3 months with placebo.
Phase 1 study in patients with KIT-mutated or KIT-amplified melanoma.
Received approvals in Switzerland and Taiwan for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib.
Expects approval from the EMA for QINLOCK in the fourth quarter of 2021.
Expects to announce top-line results from the Phase 3 INTRIGUE study in the fourth quarter of 2021.
Expects to initiate a Phase 1b/2 study of QINLOCK in combination with binimetinib, a commercially available MEK inhibitor, in post-imatinib GIST patients in the fourth quarter of 2021.
Vimseltinib
Presented updated data from the ongoing Phase 1/2 study in patients with TGCT at the ESMO (Free ESMO Whitepaper) Congress 2021, showing an encouraging ORR of 47% across all cohorts and a manageable safety and tolerability profile.
Expects to initiate the pivotal Phase 3 MOTION study of vimseltinib in the fourth quarter of 2021. MOTION is a two-part, randomized, double-blind, placebo-controlled study of vimseltinib to assess the efficacy and safety in patients with symptomatic TGCT who are not amenable to surgery. The primary endpoint of the study is ORR at week 25 as measured by RECIST v1.1 by blinded independent central review.
Granted Fast Track Designation by the FDA for the treatment of patients with symptomatic TGCT who are not amenable to surgery. This designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
Rebastinib
Presented updated data from the ongoing Phase 1b/2 study of rebastinib in combination with paclitaxel in the platinum-resistant ovarian cancer (PROC) cohort at the ESMO (Free ESMO Whitepaper) Congress 2021. Data showed promising results including median PFS of 9.1 months and an ORR of 38% (confirmed and unconfirmed) in heavily pretreated patients with PROC.
Received Orphan Drug Designation in the EU for the treatment of ovarian cancer based on a positive opinion issued by the EMA Committee for Orphan Medicinal Products (COMP).
Announced that the Company has begun planning for a pivotal study in PROC that is anticipated to start in 2022, subject to feedback from regulators.
DCC-3116
Presented preclinical data at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) showing that DCC-3116 inhibits EGFR inhibitor-induced autophagy in multiple EGFR-mutant non-small cell lung cancer cell lines and decreased tumor burden in combination with osimertinib and afatinib in an EGFR mutant xenograft model.
Announced plans to present initial data from the dose escalation phase of the Phase 1 study in 2022.
Third Quarter Financial Results

Revenue: Total revenue for the third quarter of 2021 was $23.2 million, which includes $21.7 million of net product revenue from sales of QINLOCK and $1.5 million of collaboration revenue comprised primarily of QINLOCK supply and royalty revenue under our license agreement with Zai Lab. Total revenue for the third quarter of 2020 was $15.5 million, which included $15.2 million of net product revenue from sales of QINLOCK and $0.3 million of collaboration revenue.
Cost of Sales: Cost of sales was $0.9 million in the third quarter of 2021, which includes $0.2 million in cost of net product revenue for QINLOCK and $0.7 million in cost of collaboration revenue. Cost of sales was $0.1 million for the third quarter of 2020. Deciphera does not expect that the cost of sales as a percentage of net product sales of QINLOCK will increase significantly after the Company has sold all zero cost inventories and commenced the sales of inventories which will reflect the full cost of manufacturing. The Company expects to continue to sell the zero cost inventories of QINLOCK in the U.S. during 2021 and into 2022.
R&D Expenses: Research and development expenses for the third quarter were $66.4 million, compared to $49.2 million for the same period in 2020. The increase was primarily due to personnel and preclinical costs, and a $4.0 million up-front payment to Sprint Bioscience (Sprint) pursuant to the terms of the agreement with Sprint to exclusively in-license worldwide rights to a research-stage program targeting VPS34, and an increase in clinical trial expenses related to start-up activities for the planned Phase 3 MOTION study of vimseltinib and Phase 1b/2 study of QINLOCK in combination with binimetinib. Non-cash, stock-based compensation was $5.4 million and $4.5 million for the third quarters of 2021 and 2020, respectively.
SG&A Expenses: Selling, general, and administrative expenses for the third quarter of 2021 were $35.5 million, compared to $30.1 million for the same period in 2020. The increase was primarily due to personnel costs as well as external spend related to professional fees, including those associated with establishing a targeted commercial infrastructure and commercial preparedness in key European markets to support a launch of QINLOCK in Europe, if approved. Non-cash, stock-based compensation was $6.4 million and $5.3 million for the third quarters of 2021 and 2020, respectively.
Net Loss: For the third quarter of 2021, Deciphera reported a net loss of $79.8 million, or $1.37 per share, compared with a net loss of $63.7 million, or $1.13 per share, for the same period in 2020. The increase in net loss was primarily a result of increased R&D expenses, as described above, partially offset by increased sales volume in the U.S.
Cash Position: As of September 30, 2021, cash, cash equivalents, and marketable securities were $392.2 million, compared to $451.0 million as of June 30, 2021. Based on its current operating plans, Deciphera expects its current cash, cash equivalents, and marketable securities together with anticipated product, royalty, and supply revenues, excluding any potential future milestone payments under the Zai License Agreement, will enable the Company to fund its operating and capital expenditures into the first half of 2023.
Conference Call and Webcast

Deciphera will host a conference call and webcast to discuss this announcement today, November 2, 2021, at 4:30 PM ET. To access the live call by phone please dial (866) 930-5479 (domestic) or (409) 216-0603 (international); the conference ID is 8178994. A live audio webcast of the event may also be accessed through the "Investors" section of Deciphera’s website at www.deciphera.com. A replay of the webcast will be available for 30 days following the event.