On November 2, 2021 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company generated revenue of $456.4 million for the third quarter ended September 30, 2021, compared to $408.4 million for the same period of 2020 (Press release, Exact Sciences, NOV 2, 2021, View Source [SID1234594124]).

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!

"Exact Sciences is entering an exciting period for its pipeline, generating evidence to support innovative tests that will help defeat cancer through earlier detection," said Kevin Conroy, chairman and CEO. "Our powerful commercial engine will help us achieve our mission by getting more people tested with Cologuard, Oncotype DX, and our future tests."

Third quarter 2021 financial results

For the three-month period ended September 30, 2021, as compared to the same period of 2020 (where applicable):

Total revenue was $456.4 million, an increase of 12 percent
Screening revenue was $280.4 million, an increase of 31 percent
Precision Oncology revenue was $145.4 million, an increase of 59 percent
COVID-19 testing revenue was $30.6 million, a decrease of 70 percent
Gross margin including amortization of acquired intangible assets was 70%, and non-GAAP gross margin excluding amortization of acquired intangible assets was 75%
Intangible asset impairment of $20.2 million was related to a supply agreement asset recorded as part of the combination with Genomic Health
Net loss was $166.9 million, or $0.97 per share, compared to a net loss of $202.5 million, or $1.35 per share
EBITDA was $(119.9) million, and adjusted EBITDA was $(16.3) million
Cash, cash equivalents, and marketable securities were $1.22 billion at the end of the quarter
Screening includes laboratory service revenue from Cologuard tests and revenue from Biomatrica products. Precision Oncology includes laboratory service revenue from global Oncotype products and laboratory service revenue from Ashion.

2021 outlook

The company anticipates revenue of $1,722-$1,737 million during 2021, including Screening revenue of $1,050-$1,055 million, Precision Oncology revenue of $547-$552 million, and COVID-19 testing revenue of $125-$130 million.
Updated revenue guidance has been narrowed toward the high end of our previously expected range of $1,705-$1,745 million, which included Screening revenue of $1,100-$1,125 million, Precision Oncology revenue of $530-$540 million, and COVID-19 testing revenue of $75-$80 million.
Screening revenue expectations are lower due to the rapid rise in Delta variant cases starting in late July, causing in-person sales calls to significantly decrease in August and September.
Non-GAAP disclosure
In addition to the company’s financial results determined in accordance with U.S. GAAP, the company provides non-GAAP measures that it determines to be useful in evaluating its operating performance. The company presents EBITDA, adjusted EBITDA, as well as non-GAAP gross margin and non-GAAP gross profit. EBITDA and adjusted EBITDA consist of net loss after adjustment for those items shown in the table below. The company defines non-GAAP gross profit and non-GAAP gross margin as GAAP gross profit and GAAP gross margin, respectively, excluding amortization of acquired intangible assets. The amortization of acquisition-related intangible assets used in the calculation of non-GAAP gross profit and non-GAAP gross margin pertain only to the amortization associated with developed technology acquired and recorded through purchase accounting transactions. The amortization of these intangible assets will recur in future periods until such intangible assets have been fully amortized. The company believes that these non-GAAP measures are useful in evaluating the company’s operating performance. The company uses this non-GAAP financial information to evaluate ongoing operations and for internal planning and forecasting purposes. Non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental information purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with U.S. GAAP. For example, non-GAAP gross margin and non-GAAP gross profit exclude the amortization of acquired intangible assets although such measures include the revenue associated with the acquisitions. For a reconciliation of these non-GAAP measures to GAAP, see below "EBITDA and Adjusted EBITDA Reconciliations" and "Non-GAAP Gross Profit and Non-GAAP Gross Margin Reconciliations."

Third quarter conference call & webcast
Company management will host a conference call and webcast on Tuesday, November 2, 2021, at 5 p.m. ET to discuss third quarter 2021 results. The webcast will be available at www.exactsciences.com. Domestic callers should dial 833-952-1519 and international callers should dial +1-236-714-2125. The access code for both domestic and international callers is 2782364.

An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or +1-416-621-4642 internationally. The access code for the replay of the call is 2782364. The webcast, conference call and replay are open to all interested parties.

About Cologuard
The Cologuard test was approved by the FDA in August 2014, and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. The Cologuard test is included in the American Cancer Society’s (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2021) and National Comprehensive Cancer Network (2016). The Cologuard test is indicated to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use the Cologuard test if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. The Cologuard test is not a replacement for colonoscopy in high risk patients. The Cologuard test performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. Cologuard performance in repeat testing has not been evaluated. The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for diagnostic colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again. Medicare and most major insurers cover the Cologuard test. For more information about the Cologuard test, visit www.cologuardtest.com.

About Oncotype DX
The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. In breast cancer, the Oncotype DX Breast Recurrence Score test is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. In prostate cancer, the Oncotype DX Genomic Prostate Score test predicts disease aggressiveness and further clarifies the current and future risk of the cancer prior to treatment intervention, and the Oncotype DX AR-V7 Nucleus Detect test helps determine which patients with metastatic castration-resistant prostate cancer (mCRPC) are resistant to androgen receptor (AR)-targeted therapies. The Oncotype DX AR-V7 Nucleus Detect test is performed by Epic Sciences at its centralized, CLIA-certified laboratory in San Diego and offered exclusively by Exact Sciences. The Oncotype MAP Pan-Cancer Tissue test is a rapid, comprehensive tumor profiling panel that aids therapy selection for patients with advanced, metastatic, refractory, or recurrent cancer. With more than 1 million patients tested in more than 90 countries, the Oncotype tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype tests, visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or www.MyProstateCancerTreatment.org.

On November 2, 2021 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) ("Infinity" or the "Company") reported its third quarter 2021 financial results and provided a corporate update on eganelisib, its potentially first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic (Press release, Infinity Pharmaceuticals, NOV 2, 2021, View Source [SID1234594123]).

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!

"Infinity had a very successful 3rd quarter reaching major clinical milestones with eganelisib and welcoming two outstanding R&D executives to our management team," said Adelene Perkins, Chief Executive Officer and Chair, Infinity Pharmaceuticals. "In particular, data presented in July from MARIO-3 and MARIO-275 show that eganelisib, with its unique role in reprogramming macrophages, increases the effectiveness of current checkpoint inhibitors and improves patient outcomes across multiple indications and treatment settings. These data show that eganelisib has the potential to drive the next generation of cancer immuno-therapy."

"The data on prolonged progression-free survival in metastatic triple negative breast cancer, increased overall survival in metastatic urothelial cancer, and translational evidence of modulation of the tumor microenvironment highlight the broad potential of eganelisib to improve immune checkpoint inhibitor-based treatments for patients regardless of PD-L1 status. This is particularly meaningful for PD-L1 negative 1L mTNBC patients for whom no checkpoint inhibitors have been approved and for PD-L1 negative mUC patients for whom checkpoint inhibitors are less effective," said Dr. Robert Ilaria, Chief Medical Officer, Infinity Pharmaceuticals. "We look forward to presenting a TNBC update at SABCS in December for which we are especially interested in seeing if the encouraging PFS data presented this summer is maintained in the maturing data set and to providing an update on eganelisib in UC in our January 5th guidance for 2022."

Recent Updates:

MARIO-3: Updated data was presented from 43 patients (43 patients evaluable for safety and 38 patients evaluable for efficacy) were presented on July 27, 2021, from the Company’s ongoing Phase 2 study evaluating eganelisib in a novel triple combination with Tecentriq (atezolizumab) and Abraxane (nab-paclitaxel) in unresectable locally advanced or metastatic triple negative breast cancer (TNBC). Updated safety and efficacy data will be presented at the San Antonio Breast Cancer Symposium (SABCS) Annual Meeting, December 7-10, 2021.

Encouraging efficacy data presented on July 27, 2021, suggest the addition of eganelisib to Tecentriq and Abraxane has the potential to extend progression-free survival regardless of PD-L1 status.
86.8% (33/38) of evaluable patients demonstrated tumor reduction, with the majority of patients still on treatment.
The addition of eganelisib appears to extend progression-free survival (PFS) in both PD-L1(+) and PD-L1(-) patients relative to the Tecentriq and Abraxane combination from the benchmark IMpassion130 study.
In PD-L1(-) patients, median PFS was 7.3 months (3.5, NA) in MARIO-3, compared to median PFS of 5.6 months for Tecentriq and Abraxane in IMpassion130. There are currently no approved checkpoint inhibitor regimens, including the combination of Tecentriq and Abraxane, for PD-L1 (-) 1L mTNBC patients.
In PD-L1(+) patients, median PFS was 11.2 months (5.3, 11.2) in MARIO-3 compared to 7.5 months for Tecentriq and Abraxane in IMpassion130. The Tecentriq and Abraxane combination is approved in PD-L1(+) 1L mTNBC patients in over 70 countries.
Overall safety in MARIO-3 was consistent with the safety profile of eganelisib and the published safety profile of the marketed products Tecentriq and Abraxane, and no new safety signals were observed. The most common ≥GR3 treatment-related adverse events (AEs) were hepatic AEs (18%); neutropenia AEs (16%); skin AEs (12%); fatigue (6%); peripheral sensory neuropathy (6%); and diarrhea (6%).
MARIO-275: Updated data on 49 patients were presented on July 27, 2021, from the Company’s randomized, placebo-controlled Phase 2 study evaluating the efficacy and safety of eganelisib in combination with Opdivo (nivolumab) in platinum-refractory, I/O naïve patients with locally advanced or metastatic urothelial cancer (UC).

Median overall survival (mOS) in the intent to treat population was 15.4 months (6.2, NE) on the eganelisib plus Opdivo arm compared to 7.9 months (2.3, NE) on the Opdivo control arm (hazard ratio of 0.62 (0.28, 1.36)), reflecting a 38% lower probability of death.
Median overall survival was equally strong in PD-L1(-) patients with a hazard ratio of 0.60 (0.21, 1.71), reflecting a 40% lower probability of death.
The most common ≥Grade 3 treatment-related adverse events (AEs) were, across all doses, all causality, anemia (12.1%), and hepatic AEs including hepatotoxicity (15.2%), increased ALT (12.1%) and increased AST (12.1%) with no Hy’s Law. No Grade 5 hepatic AEs were reported.
Corporate:

Appointed Stéphane Peluso, Ph.D., as Chief Scientific Officer, joining Infinity from Ipsen.
Appointed Robert Ilaria, Jr., M.D. as Chief Medical Officer, joining Infinity from Bristol Myers Squibb/Celgene.
Appointed Brian Schwartz, M.D., to Board of Directors, transitioning from consulting Chief Physician to the Board.
Third Quarter 2021 Financial Results:

At September 30, 2021, Infinity had total cash, cash equivalents and available-for-sale securities of $90.1 million, compared to $97.3 million at June 30, 2021.
Research and development expense for the third quarter of 2021 was $7.1 million, compared to $6.1 million in the same period in 2020. The increase is primarily related to an increase in compensation related expenses and clinical development expenses to support continued development of eganelisib.
General and administrative expense was $3.8 million for the third quarter of 2021, compared to $2.9 million for the same period in 2020. The increase in G&A expense is primarily due to an increase in consulting expenses, professional services and stock compensation.
Net loss for the third quarter of 2021 was $10.7 million, or a basic and diluted loss per common share of $0.12, compared to a net loss of $9.5 million, or a basic and diluted loss per common share of $0.16 in the same period in 2020.
Financial Outlook: Infinity’s 2021 financial guidance remains as follows:

Net Loss: Infinity expects net loss for 2021 to range from $40 million to $50 million.
Cash and Investments: Infinity expects to end 2021 with a year-end-cash, cash equivalents and available for sale securities balance ranging from $70 million to $80 million. Infinity’s financial guidance does not include additional funding or business development activities.
Conference Call Information

Infinity will host a conference call today, November 2, 2021, at 4:30 PM ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the "Investors/Media" section of Infinity’s website at www.infi.com. To participate in the conference call, please dial (877) 316-5293 (domestic) and (631) 291-4526 (international) five minutes prior to start time. The conference ID number is 2938945. An archived version of the webcast will be available on Infinity’s website for 30 days.

On November 2, 2021 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision oncology biopharmaceutical company, reported that the Company’s third quarter 2021 financial results will be released on Tuesday, November 9, 2021 (Press release, Calithera Biosciences, NOV 2, 2021, View Source [SID1234594122]). Company management will host a conference call on Tuesday, November 9, 2021 at 2:00 p.m. Pacific Time/ 5:00 p.m. Eastern Time to discuss the financial results and other recent corporate highlights.

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!

The press release and live audio webcast can be accessed via the Investor section of the Company’s website at www.calithera.com. The conference call can be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international) and refer to conference ID 3797324. Please log in approximately 5-10 minutes before the event to ensure a timely connection. The archived webcast will remain available for replay on Calithera’s website for 30 days.

On November 2, 2021 PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, reported financial results for the third quarter ended October 3, 2021 (Press release, PerkinElmer, NOV 2, 2021, View Source [SID1234594121]).

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!

The Company reported GAAP earnings per share from continuing operations of $1.11, as compared to GAAP earnings per share from continuing operations of $1.57 in the third quarter of 2020. GAAP revenue for the quarter was $1.17 billion, as compared to $964 million in the third quarter of 2020. GAAP operating income from continuing operations for the quarter was $222 million, as compared to $248 million for the same period a year ago. GAAP operating profit margin was 19.0% as a percentage of revenue, as compared to 25.7% in the third quarter of 2020.

Adjusted earnings per share from continuing operations for the quarter was $2.31, as compared to $2.09 in the third quarter of 2020. Adjusted revenue for the quarter was $1.17 billion, as compared to $964 million in the third quarter of 2020. Adjusted operating income from continuing operations for the quarter was $359 million, as compared to $304 million for the same period a year ago. Adjusted operating profit margin was 30.8% as a percentage of adjusted revenue, as compared to 31.6% in the third quarter of 2020.

Adjustments for the Company’s non-GAAP financial measures have been noted in the attached reconciliations.

"I am proud of the team’s tireless efforts to proactively respond to and execute for our customers around the world, driving double digit core growth in all major regions during the third quarter," said Prahlad Singh, president and chief executive officer of PerkinElmer. "Just as importantly, we are embracing new opportunities as we welcome the latest additions to the PerkinElmer family and develop innovative solutions to push the boundaries of what’s possible."

Financial Overview by Reporting Segment for the Third Quarter

Discovery & Analytical Solutions

Third quarter 2021 revenue was $513 million, as compared to $424 million for the third quarter of 2020. Reported revenue increased 21% and organic revenue increased 10% as compared to the third quarter of 2020.
Third quarter 2021 operating income from continuing operations was $7 million, as compared to $43 million for the third quarter of 2020.
Third quarter 2021 adjusted operating income was $95 million, as compared to $62 million for the third quarter of 2020.
Diagnostics

Third quarter 2021 revenue was $654 million, as compared to $540 million for the third quarter of 2020. Reported revenue increased 21% and organic revenue increased 13% as compared to the third quarter of 2020.
Third quarter 2021 operating income from continuing operations was $238 million, as compared to $224 million for the third quarter of 2020.
Third quarter 2021 adjusted operating income was $287 million, as compared to $260 million for the third quarter of 2020.
Initiates Fourth Quarter Guidance and Raises Full Year 2021 Guidance

For the fourth quarter of 2021, the Company forecasts adjusted revenue of approximately $1.2 billion and adjusted earnings per share of $2.05.

For the full year 2021, the Company now forecasts adjusted revenue of $4.9 billion and adjusted earnings per share of $10.81.

Guidance for the fourth quarter and full year is provided on a non-GAAP basis and cannot be reconciled to the closest GAAP measures without unreasonable effort due to the unpredictability of the amounts and timing of events affecting the items the Company excludes from these non-GAAP measures. The timing and amounts of such events and items could be material to the Company’s results prepared in accordance with GAAP.

Conference Call and Webcast Information

The Company will discuss its third quarter 2021 results and its outlook for business trends during a conference call on November 2, 2021 at 5:00 p.m. Eastern Time. A live audio webcast of the call will be available on the Investors section of the Company’s website, www.perkinelmer.com.

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]).

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!

"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.