On November 4, 2021 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics, reported financial results for the quarter ended September 30, 2021 (Press release, Guardant Health, NOV 4, 2021, View Source [SID1234594433]).

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Recent Highlights

Revenue of $94.8 million for the third quarter of 2021, an increase of 27% over the corresponding period of 2020
Reported 22,806 tests to clinical customers and 4,839 tests to biopharmaceutical customers in the third quarter of 2021, representing an increase of 35% and 58%, respectively, over the third quarter of 2020
Initiated ORACLE study to evaluate performance of Guardant Reveal to predict recurrence across eleven early-stage cancers
Presented data at ACG showing LUNAR-2 blood test is highly sensitive in detecting early-stage colorectal cancer
Announced SHIELD study to validate the performance of blood-based assay in lung cancer screening, with enrollment beginning in December of 2021
Added Myrtle Potter, CEO of Sumitovant Biopharma, to Board of Directors
"We delivered solid results this quarter as we continue to build on our strong foundation as the liquid biopsy leader in oncology, despite the continued impact of COVID," said Helmy Eltoukhy, co-founder and co-CEO. "We have continued our strong cadence of data supporting our Guardant360 products and are making solid progress towards our multi-cancer goal for MRD with the initiation of our ORACLE study. We are dedicated to offering healthcare providers a complete portfolio of oncology products that will provide clinically actionable information to guide patient care."

"At Guardant, we are focused on developing a highly accurate blood test to screen for multiple cancers where lives can be saved," said AmirAli Talasaz, co-founder and co-CEO. "Guardant’s differentiated core technology platform has the potential to significantly improve our ability to detect many cancers at their earliest stages. Successful readouts of ECLIPSE and SHIELD, as well as future studies, will unlock the tremendous opportunity for blood-based cancer screening."

Third Quarter 2021 Financial Results

Revenue was $94.8 million for the three months ended September 30, 2021, a 27% increase from $74.6 million for the three months ended September 30, 2020. Precision oncology revenue grew 31% driven predominantly by an increase in clinical testing revenue which grew 27% over the prior year period. There were 22,806 clinical tests and 4,839 biopharmaceutical tests performed during the third quarter of 2021. Development services and other revenue increased 9% primarily due to progression of collaboration projects from biopharmaceutical customers for companion diagnostic development services during the three months ended September 30, 2021.

Gross profit, or total revenue less cost of precision oncology testing and cost of development services and other, was $64.0 million for the third quarter of 2021, an increase of $10.6 million from $53.4 million for the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 67%, as compared to 72% for the corresponding prior year period.

Operating expenses were $171.3 million for the third quarter of 2021, as compared to $127.6 million for the corresponding prior year period, an increase of 34%. Non-GAAP operating expenses were $135.1 million for the third quarter of 2021, as compared to $71.8 million for the corresponding prior year period.

Net loss attributable to Guardant Health, Inc. common stockholders was $107.5 million for the third quarter of 2021, as compared to $77.7 million for the corresponding prior year period. Net loss per share attributable to Guardant Health, Inc. common stockholders was $1.06 for the third quarter of 2021, as compared to $0.78 for the corresponding prior year period. Non-GAAP net loss was $70.5 million for the third quarter of 2021, as compared to $15.4 million for the corresponding prior year period. Non-GAAP net loss per share was $0.70 for the third quarter of 2021, as compared to $0.15 for the corresponding prior year period.

Adjusted EBITDA loss was $65.2 million for the third quarter of 2021, as compared to a $14.1 million loss for the corresponding prior year period.

Cash, cash equivalents and marketable securities were $1.7 billion as of September 30, 2021.

2021 Guidance

Guardant Health expects full year 2021 revenue to be in the range of $360 million to $370 million, representing 26% to 29% growth over full year 2020.

Webcast Information

Guardant Health will host a conference call to discuss the third quarter 2021 financial results after market close on Thursday, November 4, 2021 at 1:30 pm Pacific Time / 4:30 pm Eastern Time. A webcast of the conference call can be accessed at View Source The webcast will be archived and available for replay for at least 90 days after the event.

Non-GAAP Measures

Guardant Health has presented in this release certain financial information in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and also on a non-GAAP basis, including non-GAAP cost of precision oncology testing, non-GAAP research and development expense, non-GAAP sales and marketing expense, non-GAAP general and administrative expense, non-GAAP loss from operations, non-GAAP net loss, non-GAAP net loss attributable to Guardant Health, Inc., common stockholders, non-GAAP net loss per share attributable to Guardant Health, Inc. common stockholders, basic and diluted, and Adjusted EBITDA.

We define our non-GAAP measures as the applicable GAAP measure adjusted for the impacts of stock-based compensation and related employer payroll tax payments; changes in estimated fair value redeemable noncontrolling interest; contingent consideration; acquisition related expenses, amortization of intangible assets, and other non-recurring items.

Adjusted EBITDA is defined as net loss attributable to Guardant Health, Inc. common stockholders adjusted for interest income; interest expense; other income (expense), net, provision for (benefit from) income taxes; depreciation; and amortization expense; stock-based compensation expense and related employer payroll tax payments; adjustments relating to non-controlling interest and contingent consideration and, if applicable in a reporting period, acquisition-related expenses and other non-recurring items.

We believe that the exclusion of certain income and expenses in calculating these non-GAAP financial measures can provide a useful measure for investors when comparing our period-to-period core operating results, and when comparing those same results to that published by our peers. We exclude certain other items because we believe that these income (expenses) do not reflect expected future operating expenses. Additionally, certain items are inconsistent in amounts and frequency, making it difficult to perform a meaningful evaluation of our current or past operating performance. We use these non-GAAP financial measures to evaluate ongoing operations, for internal planning and forecasting purposes, and to manage our business.

These non-GAAP financial measures are not intended to be considered in isolation from, as substitute for, or as superior to, the corresponding financial measures prepared in accordance with GAAP. There are limitations inherent in non-GAAP financial measures because they exclude charges and credits that are required to be included in a GAAP presentation, and do not present the full measure of our recorded costs against its revenue. In addition, our definition of the non-GAAP financial measures may differ from non-GAAP measures used by other companies.

On November 4, 2021 NGM Biopharmaceuticals, Inc. (NGM) (Nasdaq: NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, reported financial results for the quarterly period ended September 30, 2021 (Press release, NGM Biopharmaceuticals, NOV 4, 2021, View Source [SID1234594432]).

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"This quarter we made notable progress advancing NGM’s oncology portfolio, now four assets strong, all generated by our in-house discovery engine and wholly owned by NGM," said David J. Woodhouse, Ph.D., Chief Executive Officer at NGM. "We reported the first preliminary human data from our NGM120 trial at ESMO (Free ESMO Whitepaper) 2021 and also unveiled our third myeloid reprogramming program, NGM831. Over the past 12 months, we have pulled back the curtain on the intensive discovery work in oncology that has been underway at NGM for several years. Leveraging integrated world-class target discovery research and protein engineering, we’ve created multiple oncology product candidates each with the potential to become next-generation treatment options to help patients mobilize their own immune systems to fight cancer more effectively. We strongly believe myeloid cell reprogramming can be an important additional approach to augment anti-tumor immunity and our portfolio of product candidates provide multiple opportunities to harness that biology."

Key Third Quarter and Recent Highlights

Cancer

Presented preliminary findings from ongoing Phase 1a/1b dose escalation study of NGM120, a first-in-class anti-GDNF family receptor alpha like (GFRAL) antagonist antibody, in patients with advanced solid tumors at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress. Preliminary results showed that treatment with the drug was well tolerated with no dose-limiting toxicities. All six evaluable metastatic pancreatic cancer patients in the Phase 1b combination cohort (NGM120 in combination with gemcitabine + Nab-paclitaxel) demonstrated disease control at 16 weeks, with three partial responses (PR) and three stable disease (SD). Four metastatic pancreatic cancer patients in the Phase 1b cohort continued to exhibit PR/SD beyond 36 weeks at the July 26 data cut-off, compared to the historic median progression-free survival in metastatic pancreatic cancer of 22 weeks1. As of September 16, 2021, three of those four patients remained on drug, with two patients exhibiting PR and one patient exhibiting SD beyond 44 weeks.
Continued enrollment in a Phase 2 placebo-controlled component of the ongoing Phase 1/2 PINNACLES study, with the Phase 2 component testing NGM120 as a first-line treatment in combination with gemcitabine and Nab-paclitaxel in patients with metastatic pancreatic cancer. In March 2021, NGM initiated a multi-center, randomized, single-blind (sponsor unblinded), placebo-controlled component of NGM120 in combination with gemcitabine and Nab-paclitaxel as a first-line treatment in patients with metastatic pancreatic cancer as part of the ongoing Phase 1/2 trial. The Phase 2 component of the study is designed to enroll approximately 60 patients and will assess the efficacy, safety and tolerability of NGM120 or placebo in combination with gemcitabine and Nab-paclitaxel against both cancer and cancer-related cachexia endpoints.
Initiated the Phase 1 component of a Phase 1/2 Study of NGM707, a novel dual antagonist antibody that inhibits the Immunoglobulin-like Transcript 2 (ILT2) and Immunoglobulin-like Transcript 4 (ILT4) receptors, for the treatment of patients with advanced solid tumors. The Phase 1 portion (n≅60) of the study includes a monotherapy dose escalation arm (Part 1a) and a dose-finding arm in combination with KEYTRUDA (pembrolizumab) (Part 1b). The Phase 2 portion (n≅120) of the study will employ a basket design that will include expansion cohorts of patients treated with NGM707 monotherapy (Part 2a) or NGM707 in combination with KEYTRUDA (Part 2b) in a variety of selected solid tumor types.
Disclosed fourth oncology development candidate, NGM831, coinciding with a publication on the ILT3-fibronectin pathway in Cancer Immunology Research. In August 2021, NGM disclosed its fourth oncology development candidate, NGM831, an antagonist antibody designed to block the interaction of Immunoglobulin-like transcript 3 (ILT3) with fibronectin, a key component of tumor stroma, as well as with other ligands. ILT3-fibronectin interactions within the tumor microenvironment may form a stromal checkpoint that actively suppresses myeloid cell function and inhibits tumor activity. NGM plans to advance NGM831 into a Phase 1 study in the first half of 2022. NGM831 joins NGM438 to become the second program in the Company’s oncology portfolio being studied for the potential to impact the tumor microenvironment by releasing stromal checkpoints.
Retinal disease

Completed enrollment in the Phase 2 CATALINA study of NGM621 in patients with geographic atrophy. NGM completed enrollment in the Phase 2 CATALINA study, a multi-center, randomized, double-masked, sham-controlled clinical trial to evaluate the safety and efficacy of intravitreal, or IVT, injections of NGM621 every four weeks or every eight weeks in 320 patients with geographic atrophy in one or both eyes secondary to age-related macular degeneration. The primary efficacy endpoint is the rate of change in geographic atrophy lesion area, as measured by fundus autofluorescence imaging over 52 weeks of treatment. NGM anticipates reporting topline data from the CATALINA study in the second half of 2022. Upon completion of a proof-of-concept study in humans, Merck has a one-time option to license NGM621 and its related molecules or to license NGM621 and its related molecules together with all other ophthalmology compounds included within the scope of our ongoing collaboration with Merck.
Liver and metabolic diseases

Continued enrollment in Phase 2b ALPINE 4 study of aldafermin in patients with compensated non-alcoholic steatohepatitis (NASH) cirrhosis (liver fibrosis stage 4, or F4). The 48-week study is designed to assess the efficacy, safety and tolerability of 0.3 mg, 1 mg and 3 mg doses of aldafermin compared to placebo.
Merck continued enrollment in its Phase 2b study of MK-3655 in patients with NASH and liver fibrosis stage 2 or 3 (F2 or F3). In November 2020, Merck initiated a global Phase 2b multicenter study of MK-3655 for the treatment of patients with F2 or F3 NASH. The 52-week randomized, double-blind study is designed to enroll approximately 320 patients and will assess the efficacy, safety and tolerability of 50 mg, 100 mg and 300 mg once monthly doses of MK-3655 compared to placebo. The primary objective of the Phase 2b study is NASH resolution without worsening of fibrosis after 52 weeks. Merck licensed MK-3655 following NGM’s completion of a proof-of-concept study. NGM retains an option, at the initiation of the first Phase 3 clinical trial for MK-3655, to either receive milestone and royalty payments or to co-fund development and participate in a global cost and revenue sharing arrangement of up to 50%.
Third Quarter 2021 Financial Results

NGM reported a net loss of $28.9 million for the quarter ended September 30, 2021, compared to a net loss of $29.8 million for the same period in 2020.
Related party revenue from our collaboration with Merck was $18.6 million for the quarter ended September 30, 2021, compared to $23.5 million for the same period in 2020. Related party revenue decreased $4.9 million in the quarter ended September 30, 2021 as compared to the prior year period, primarily due to a decrease in research and development revenue.
R&D expenses were $38.7 million for the quarter ended September 30, 2021, compared to $47.0 million for the same period in 2020. R&D expenses decreased $8.3 million in the quarter as compared to the prior year period, primarily due to decreases in expenses for our manufacturing activities and our clinical trials of aldafermin.
General and administrative expenses were $8.9 million for the quarter ended September 30, 2021, compared to $6.5 million for the same period in 2020. The $2.4 million increase in general and administrative expenses in 2021 was primarily attributable to increases in personnel-related expenses driven by increased headcount, as well as external expenses to support our operations.
Cash, cash equivalents and short-term marketable securities were $383.4 million as of September 30, 2021, compared to $295.2 million as of December 31, 2020.

On November 4, 2021 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated therapeutics, reported third quarter 2021 financial results and provided a business update (Press release, CytomX Therapeutics, NOV 4, 2021, View Source [SID1234594431]).

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"With intense focus on execution, the CytomX team made significant progress with clinical site initiation and patient enrollment during the past quarter. As a result, we remain on track to announce initial data by year end from our ongoing Phase 2 expansion study evaluating CX-2029 in defined cancer types," said Sean McCarthy, D.Phil., president, chief executive officer and chairman of CytomX Therapeutics. "We also remain on track for initial data from the praluzatamab ravtansine Phase 2 breast cancer clinical program in 2022. In addition, we are expanding the reach of our versatile platform with anticipated fourth quarter IND filing for our first conditionally activated T-cell bispecific antibody, CX-904, and with the presentation at SITC (Free SITC Whitepaper) 2021 of our emerging drug discovery work in the field of conditional cytokines," added Dr. McCarthy.

Third Quarter Business Highlights and Recent Developments

Clinical site activation and patient enrollment for the ongoing Phase 2 study of CytomX’s wholly owned conditional antibody-drug conjugate (ADC), praluzatamab ravtansine (CX-2009), made substantial progress, including opening additional sites in U.S., Europe, and Asia, as well as partnering with patient advocacy groups to encourage enrollment from underrepresented populations. Praluzatamab ravtansine is currently being evaluated in a Phase 2 study as monotherapy in patients with human epidermal growth factor receptor 2-non-amplified breast cancer and, in combination with pacmilimab (CX-072), in patients with triple-negative breast cancer. Initial data from this study is on track for 2022.
Patient enrollment into the expansion cohorts continued for the Phase 2 study of CX-2029, evaluating the CD71-directed conditionally activated ADC co-developed by CytomX and AbbVie in four cancer indications: squamous non-small cell lung cancer, head and neck squamous cell carcinoma, esophageal and gastro-esophageal junction cancers, and diffuse large B-cell lymphoma. Initial data from this study is on track for the fourth quarter of 2021.
BMS-986249, a Probody version of ipilimumab, continued to be studied by Bristol Myers Squibb, CytomX’s collaboration partner, in combination with nivolumab, the anti-PD-1 antibody, across four different advanced malignancies: melanoma, hepatocellular carcinoma, castration-resistant prostate cancer, and triple-negative breast cancer. Bristol Myers Squibb is also evaluating BMS-986288, a Probody version of non-fucosylated ipilimumab, as monotherapy or in combination with nivolumab, in a Phase 1 study.
CytomX expects to submit an investigational new drug application for CX-904 to the U.S. Food and Drug Administration in late 2021. CX-904 is a conditionally activated T-cell-engaging bispecific antibody candidate against the epidermal growth factor receptor on tumor cells and CD3 on T cells and is partnered with Amgen.
A CytomX abstract highlighting company progress in the field of conditionally active cytokines has been accepted for poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting (SITC 2021), which will be held from November 12-14, 2021 at the Walter E. Washington Convention Center, Washington, DC. This presentation will detail the preclinical characterization and improved therapeutic index of a masked interferon alpha-2b (IFN-a2b) leveraging CytomX proprietary conditional activation technologies.
CytomX published a preclinical study in Cancer Immunology Research showing that systemic administration of conditionally activated anti-programmed cell death ligand 1 (anti-PD-L1) and anti-programmed cell death protein 1 (anti-PD-1) antibodies to tumor-bearing mice elicited antitumor activity similar to that of traditional PD-1/PD-L1-targeted antibodies, but with reduced systemic immune-mediated toxicity. These data provide further preclinical rationale to support the ongoing development of pacmilimab (CX-072), currently in a Phase 2 study in combination with praluzatamab ravtansine in patients with TNBC. The preclinical article can be accessed at View Source
CytomX appointed Alan Ashworth, Ph.D., FRS, a world-renowned expert in cancer research and a global leader in cancer therapy development, to its board of directors.
Third Quarter 2021 Financial Results
Cash, cash equivalents, and investments totaled $336 million as of September 30, 2021, compared to $316 million as of December 31, 2020.

Revenue was $18 million for the three months ended September 30, 2021, relatively flat when compared to the corresponding period in 2020.

Research and development expenses increased $5 million during the three months ended September 30, 2021 to $29 million compared to the corresponding period in 2020. The increase was driven mainly by personnel, clinical trial, and consulting and contract service expenses primarily related to praluzatamab ravtansine and CX-2029.

General and administrative expenses increased $2.5 million during the three months ended September 30, 2021 to $11 million compared to the corresponding period in 2020. The increase was attributable to personnel related and recruiting expenses as well as professional services.

Conference Call & Webcast
CytomX management will host a conference call and a simultaneous webcast today at 5:00 p.m. ET (2:00 p.m. PT) to discuss the financial results and provide a business update. To join the conference call, please dial (877) 809-6037 (domestic) or (615) 247-0221 (international) and reference the conference ID 3886792. A live webcast of the call can be accessed at the Events and Presentations page of CytomX’s website at View Source An archived replay of the webcast will be available on the Company’s website until November 11, 2021.

On November 4, 2021 Cardinal Health (NYSE: CAH) reported that its Board of Directors approved a quarterly dividend of $0.4908 per share (Press release, Cardinal Health, NOV 4, 2021, View Source [SID1234594430]). The dividend will be payable on January 15, 2022 to shareholders of record at the close of business on January 3, 2022.

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On November 4, 2021 Aprea Therapeutics, Inc. (NASDAQ: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein p53, reported that investigators will present data from clinical trials evaluating eprenetapopt at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH) (Free ASH Whitepaper) (Press release, Aprea, NOV 4, 2021, View Source [SID1234594429]).

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Oral presentations are as follows:

Title: Long-Term Follow-up and Combined Phase 2 Results of Eprenetapopt (APR-246) and Azacitidine (AZA) in Patients with TP53 Mutant Myelodysplastic Syndromes (MDS) and Oligoblastic Acute Myeloid Leukemia (AML)
Date & Time: Saturday, December 11, 2021 at 3:15 pm ET
Oral Abstract Session: 637. Myelodysplastic Syndromes—Clinical and Epidemiological: Treatment of High Risk Myelodysplastic Syndrome
Abstract: 246
Location: Georgia World Congress Center, B207-B208
Presenter: David Sallman, M.D., H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida

Title: Phase II Trial of Eprenetapopt (APR-246) in Combination with Azacitidine (AZA) As Maintenance Therapy for TP53 Mutated AML or MDS Following Allogeneic Stem Cell Transplantation (SCT)
Date & Time: Sunday, December 12, 2021 at 9:30 am ET
Oral Abstract Session: 723. Allogeneic Transplantation: Long-term Follow-up and Disease Recurrence
Abstract: 409
Location: Georgia World Congress Center, B304-B305
Presenter: Asmita Mishra, M.D., H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida

Poster presentation is as follows:

Title: Phase I and Expansion Study of Eprenetapopt (APR-246) in Combination with Venetoclax (VEN) and Azacitidine (AZA) in TP53-Mutant Acute Myeloid Leukemia (AML)
Date & Time: Monday, December 13, 2021, 6:00 – 8:00 pm ET
Poster Abstract Session: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster III
Abstract: 3409
Location: Georgia World Congress Center, Hall B5
Presenter: Guillermo Garcia-Manero, M.D., The University of Texas MD Anderson Cancer Center, Houston, Texas