On November 4, 2021 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company primarily focused on targeting virus-associated malignancies, reported the acceptance of two abstracts for oral presentation and one for a poster presentation at the upcoming 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which will be held from December 11-14, 2021, both in Atlanta, Georgia and virtually (Press release, Viracta Therapeutics, NOV 4, 2021, View Source [SID1234594355]).

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!

"We are thrilled that the final results from our Phase 1b/2 trial in relapsed/refractory EBV positive lymphoma have been selected for an oral presentation at ASH (Free ASH Whitepaper), and we are pleased to see our presence expand this year to include an additional asset from our portfolio," said Ivor Royston, M.D., President and Chief Executive Officer of Viracta. "Having three abstracts accepted at ASH (Free ASH Whitepaper) is an honor that we believe speaks to the innovative nature of our growing pipeline. We look forward to the meeting in December and are excited to share more about these programs following the presentations."

Details on the abstracts, which have been published on the ASH (Free ASH Whitepaper) website, are shown below:

Nanatinostat (Nstat) and Valganciclovir (VGCV) in Relapsed/Refractory (R/R) Epstein-Barr Virus-Positive (EBV+) Lymphomas: Final Results from the Phase 1b/2 VT3996-201 Study (Publication #623)
Session Name: 624. Hodgkin Lymphomas and T/NK cell Lymphomas: T/NK Cell Lymphoma Relapsed Therapy
Session Date: Monday, December 13, 2021
Session Time: 10:30 AM – 12:00 PM ET
Presentation Time: 11:30 AM ET
Presentation Type: Oral
Room: Georgia World Congress Center, Hall A1

Final results from Viracta’s Phase 1b/2 trial evaluating Nana-val in R/R EBV+ lymphoma will be presented. Data from the trial indicate that Nana-val was well tolerated and showed promising efficacy.

Enhanced CAR T cell activity with non-covalent BTK/ITK inhibition (Publication #906)
Session Name: 703. Cellular Immunotherapies: Basic and Translational IV
Session Date: Monday, December 13, 2021
Session Time: 6:15 PM – 7:45 PM ET
Presentation Time: 7:30 PM ET
Presentation Type: Oral
Room: Georgia World Congress Center, Hall A1

Data to be featured in the oral presentation relate to vecabrutinib, a selective, reversible, non-covalent inhibitor of Burton’s tyrosine kinase (BTK) and interleukin-2-inducible kinase (ITK). These data demonstrate that using vecabrutinib is a novel strategy to modulate CD19-targeted chimeric antigen receptor (CAR) T cell functions by increasing their efficacy, and decreasing their toxicity, while maintaining their proliferative potential.

Efficacy of Vecabrutinib Treatment in a Murine Model of Sclerodermatous Graft-Versus-Host-Disease (Publication #1685)
Session Name: 701. Experimental Transplantation: Basic and Translational: Poster I
Session Date: Saturday, December 11, 2021
Presentation Time: 5:30 – 7:30 PM ET
Presentation Type: Poster
Location: Georgia World Congress Center, Hall B5

The poster presentation will feature data showing that vecabrutinib treatment demonstrated efficacy and beneficially regulated B cell and T cell immune subsets in a preclinical murine model of sclerodermatous chronic graft-versus-host disease.

Copies of the poster and oral presentations will be available on the "Events and Webcasts" section of the Viracta website at View Source following their presentation at the meeting.

About Nanatinostat

Nanatinostat (VRx-3996) is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which is key to inducing viral genes that are epigenetically silenced in EBV-associated malignancies. Nana-val (nanatinostat and valganciclovir) is being investigated in multiple subtypes of relapsed/refractory EBV+ lymphoma and in advanced EBV+ solid tumors in three ongoing trials, one of which is a registration-enabling global, multicenter, open-label Phase 2 basket trial in relapsed/refractory EBV+ lymphoma (NAVAL-1).

About Vecabrutinib

Vecabrutinib is a selective, reversible, non-covalent inhibitor of Burton’s tyrosine kinase (BTK) and interleukin-2-inducible kinase (ITK). Vecabrutinib is being studied as a potential enhancer of efficacy and safety of CAR T cell therapy.

On November 4, 2021 Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, reported third quarter financial results and provided business and clinical highlights (Press release, Sangamo Therapeutics, NOV 4, 2021, View Source [SID1234594372]).

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!

"We are delighted to share clinical data and business updates across several programs demonstrating that Sangamo has three important assets progressing toward late-stage development. Our gene therapy portfolio is advancing with accumulating safety and efficacy data in our Fabry and hemophilia A programs, and preliminary proof-of-concept data demonstrate the clinical potential of our zinc finger genome engineering technology in sickle cell disease. These data readouts show the progression of our first-generation genomic medicine pipeline and potentially pave the way for new treatments. Our next generation programs focus on genome regulation and allogeneic CAR-Treg cell therapy, where we have a robust preclinical pipeline in neurological and autoimmune diseases. We are energized by this momentum and look forward to continued execution of our corporate strategy," said Sandy Macrae, Chief Executive Officer of Sangamo.

Recent Clinical and Business Highlights

Fabry Disease – First four patients dosed exhibited above normal α-Gal A activity; Phase 3 planning initiated

Earlier today, we announced preliminary clinical data from the first four patients treated in our Phase 1/2 STAAR study evaluating isaralgagene civaparvovec, or ST-920, our wholly owned Fabry disease gene therapy product candidate. Data as of the September 17, 2021 cutoff date from the four patients in the first two dose cohorts showed that isaralgagene civaparvovec was generally well tolerated. All four patients exhibited above normal alpha-galactosidase A (α-Gal A) activity, which was maintained for up to one year for the first patient treated and through 14 weeks for the most recently treated patient. Activity of 2-fold to 15-fold above mean normal was observed at last measurement as of the cutoff date. Withdrawal from enzyme replacement therapy (ERT) has taken place for one patient and is planned for the other patient on ERT, based on the stability of their α-Gal A activity following treatment.
The fifth patient in the STAAR study, who is the first patient in the third cohort (3e13vg/kg), was dosed after the cutoff date. The sixth patient is currently in screening also for the third dose cohort. We expect to provide updated data throughout 2022 and present these results at a medical meeting.
Based on the STAAR study results to date, we have initiated planning for a Phase 3 Fabry disease clinical trial.
Sickle Cell Disease – Preliminary-proof-of-concept data will be presented at ASH (Free ASH Whitepaper) as clinical program advances

Preliminary proof-of-concept results from the Phase 1/2 PRECIZN-1 study investigating SAR445136, formerly BIVV003, an investigational zinc finger nuclease gene edited cell therapy, in patients with severe sickle cell disease (SCD) will be presented at the 63rd Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) on December 12, 2021. Results as of the June 25, 2021 cutoff date show that all four treated patients did not require blood transfusions post engraftment and had no adverse or serious adverse events related to SAR445136 through 65 weeks of follow-up for the longest treated patient. The four treated patients all experienced increases in total hemoglobin, fetal hemoglobin and percent F cells.
We and Sanofi continue to advance the sickle cell disease program. We recently obtained manufacturing requirements guidance from FDA in preparation for further potential clinical studies. Separately, we and Sanofi made the business decision to cease development of the beta thalassemia indication in order to focus resources on the sickle cell disease program. ST-400 for beta thalassemia was developed with the support of a grant from the California Institute for Regenerative Medicine (CIRM).
Hemophilia A – Four patients at highest dose experienced mean FVIII activity of 30.9% at week 104

Updated follow-up results from the Phase 1/2 Alta study of giroctocogene fitelparvovec gene therapy in patients with severe hemophilia A will be presented at ASH (Free ASH Whitepaper) on December 12, 2021. For the four patients in the highest dose 3e13vg/kg cohort who have reached 104 weeks of follow-up as of the May 19, 2021 cutoff date, mean Factor VIII (FVIII) activity was 30.9% at week 104 as measured by chromogenic assay. In this cohort, the annualized bleeding rate was zero for the first year after treatment and 0.9 throughout total duration of follow-up. Giroctocogene fitelparvovec was generally well tolerated.
We and Pfizer also announced that some of the patients treated in the Phase 3 AFFINE trial of giroctocogene fitelparvovec experienced FVIII activity greater than 150% following treatment. None of these patients have experienced thrombotic events and some have been treated with direct oral anticoagulants to reduce thrombotic risk. Pfizer voluntarily paused screening and dosing of additional patients in the trial to implement a protocol amendment intending to provide guidance regarding the management of patients with FVIII levels that exceed 150%. On November 3, 2021, Pfizer was informed that the FDA has put this trial on clinical hold. The next step is to share the proposed protocol amendment with health authorities and respond to the clinical hold, after which the Companies will be able to provide updated timing for the trial.
Renal Transplant – First patient enrolled, expect two patients to be dosed by mid-2022

The first patient has been enrolled in our Phase 1/2 STEADFAST study evaluating TX200, our wholly owned autologous HLA-A2 CAR Treg cell therapy product candidate treating patients receiving an HLA-A2 mismatched kidney from a living donor. We expect the first two patients in this study to be dosed by the middle of 2022 following kidney transplantation. We continue to open study sites and screen patients.
Research, Manufacturing, and Corporate Updates

Biogen announced type 1 myotonic dystrophy (DM1) as the previously undisclosed neuromuscular preclinical target in our collaboration.
We recently completed and brought online our in-house cell therapy manufacturing facility in our Brisbane, California headquarters and remain on track to complete our in-house cell therapy manufacturing facility in Valbonne, France by year-end.
We appointed D. Mark McClung as Chief Operating Officer, an important organizational step to support the multiple advancing wholly owned and partnered programs.
Third Quarter 2021 Financial Results

Consolidated net loss attributable to Sangamo for the third quarter ended September 30, 2021 was $47.7 million, or $0.33 per share, compared to a net loss attributable to Sangamo of $1.6 million, or $0.01 per share, for the same period in 2020.

Revenues

Revenues for the third quarter ended September 30, 2021, were $28.6 million, compared to $57.8 million for the same period in 2020, a decrease of $29.2 million.

The reduction in revenue was primarily due to a $39.3 million decrease related to our giroctocogene fitelparvovec and C9ORF72 collaboration agreements with Pfizer, resulting from the completion of our activities in 2020, and a $2.3 million decrease related to our collaboration agreement with Sanofi. These decreases were partially offset by higher revenues of $11.5 million and $1.3 million related to our collaboration agreements with Novartis and Biogen, respectively.

GAAP and Non-GAAP operating expenses

Total operating expenses on a GAAP basis for the third quarter ended September 30, 2021 were $77.0 million compared to $61.5 million for the same period in 2020. Non-GAAP operating expenses, which exclude stock-based compensation expense, for the third quarter ended September 30, 2021 were $69.1 million compared to $54.8 million for the same period in 2020.

The increase in total operating expenses on a GAAP basis was primarily driven by our higher clinical and manufacturing supply expenses along with our increased headcount to support the advancement of our clinical trials and our ongoing collaborations.

Cash, cash equivalents and marketable securities

Cash, cash equivalents and marketable securities as of September 30, 2021 were $519.0 million compared to $692.0 million as of December 31, 2020.

Revised Financial Guidance for 2021

We are revising our full-year operating expense guidance initially provided on February 24, 2021 and reiterated most recently on August 5, 2021 as follows:

Conference Call

Sangamo will host a conference call today, November 4, 2021, at 9:15 a.m. Eastern Time, which will be open to the public. The call and live Q&A will be webcast.

The conference call dial-in numbers are (877) 377-7553 for domestic callers and (678) 894-3968 for international callers. The conference ID number for the call is 5178059. Participants may access the live webcast via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. Call replay will be available for one week following the conference call. The conference call replay numbers for domestic and international callers are (855) 859-2056 and (404) 537-3406, respectively. The conference ID number for the replay is 5178059.

On November 4, 2021 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that Lantern Pharma’s abstract on the effectiveness of LP-284 in hematologic cancers has been accepted as a poster at the upcoming 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which is being held in-person and virtually from December 11 – 14, 2021 (Press release, Lantern Pharma, NOV 4, 2021, View Source [SID1234594400]). The abstract is available online on the ASH (Free ASH Whitepaper) website.

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!

Abstract Title: The Positive Enantiomer of a Novel Chiral DNA Alkylating Agent Exhibits Nanomolar Potency in Hematologic Cancers
Session Name: 802. Chemical Biology and Experimental Therapeutics: Poster III
Abstract Number: 3991
Poster Session Date & Time: Monday, December 13, 2021, 6:00 PM – 8:00 PM
Presenter: Jianli Zhou, Ph.D., Lantern Pharma

LP-284 is a fully synthetic molecule belonging to the new generation of acylfulvenes, a family of naturally derived anti-cancer drug candidates. While LP-184 shows potency in solid cancer, LP-284 was primarily developed as an analogue which shows selective efficacy against hematologic cancer. LP-284 is currently being evaluated for activity in a wide spectrum of hematological cancers.

Together with the work of collaborators, the roadmap to advancement of LP-284 to the clinic includes identification and validation of target indications, response gene signature development leading to IND-enabling pharmacokinetic profiling, and tolerability and dose range finding studies followed by clinical protocol development.

On November 4, 2021 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage oncology company, developing new precision medicine treatment options for cancer patients in indications with the greatest unmet medical need including KRAS-mutated colorectal cancer, pancreatic cancer, and castrate-resistant prostate cancer, reported recent company highlights and financial results for the third quarter ended September 30, 2021 (Press release, Cardiff Oncology, NOV 4, 2021, View Source [SID1234594416]).

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!

"During the third quarter, the data we released from our Phase 1b/2 KRAS-mutated metastatic colorectal cancer trial showed meaningful improvements in treatment response and durability relative to historical controls," said Mark Erlander, Ph.D., chief executive officer of Cardiff Oncology. "With radiographic responses achieved across multiple KRAS mutation variants, we believe these findings differentiate onvansertib from agents targeting individual KRAS mutations such as G12C."

Dr. Erlander added, "Beyond our KRAS-focused programs, we also continue to leverage onvansertib’s broadly applicable mechanism of action to advance its development as a platform molecule. By targeting PLK1, onvansertib inhibits DNA repair and processes that promote mitosis, positioning it to combine synergistically with a range of anti-cancer agents and potentially improve outcomes across a broad array of difficult-to-treat indications."

Program highlights for the quarter ended September 30, 2021, include:

KRAS-mutated Metastatic Colorectal Cancer (mCRC) Program:

Announced new data from Phase 1b/2 trial evaluating onvansertib plus FOLFIRI/bevacizumab continuing to show robust objective response rate and progression-free survival

The data were presented as part of a key opinion leader webinar and showed that trial participants treated with onvansertib plus standard-of-care FOLFIRI/bevacizumab had an objective response rate (ORR) and median progression-free survival (mPFS) that substantially exceeded those previously achieved with FOLFIRI/bevacizumab alone. Highlights from the webinar include:

Efficacy data in patients evaluable for disease response as of data cutoff date (July 2, 2021):

Patients treated per protocol at the recommended Phase 2 dose (RP2D; 15 mg/m2) across Phase 1b and Phase 2
7 of 19 (37%) achieved a confirmed partial response (PR; based on further follow-up of patients with an initial PR as of data cutoff date)
ORRs observed in historical control trials in similar patient populations treated with standard-of-care are 5-13%1-4
Patients evaluable for response treated at all dose levels (12 mg/m2, 15 mg/m2, 18 mg/m2) across Phase 1b and Phase 2
10 of 32 (31%) have achieved a confirmed PR (based on further follow-up of patients with an initial PR as of data cutoff date)
mPFS biomarker, and safety data as of cutoff date

mPFS across all response-evaluable patients (n = 32) is 9.4 months (95% confidence interval: 7.8 – not yet reached); which favorably compares to ~4.5-5.7 months reported in historical control trials in similar patient populations treated with standard-of-care1-4
PRs were observed across different KRAS mutation variants, including the 3 most common observed in colorectal cancer (G12D, G12V, G13D)
The combination of onvansertib and FOLFIRI/bevacizumab was shown to be well-tolerated with only 10% (49/490) of reported treatment-emergent adverse events being G3/G4
A replay of the key opinion leader webinar, which featured the clinical trial principal investigator, Heinz-Josef Lenz, M.D., FACP, USC Norris Comprehensive Cancer Center, key clinical advisor Afsaneh Barzi, M.D., Ph.D., City of Hope Comprehensive Cancer Center, and members of the Cardiff Oncology management team, can be viewed here.

Corporate Highlights:

Strengthened management team with the appointments of Katherine L. Ruffner, M.D., as chief medical officer and James E. Levine as chief financial officer

Dr. Ruffner is a US-trained hematologist/oncologist with over 25 years of clinical care, oncology, biotechnology and pharmaceutical drug development experience, most recently serving as vice president, clinical development for ALX Oncology. Mr. Levine was most recently the CFO of Cidara Therapeutics and has over two decades of corporate and investment banking experience in the biotechnology and pharmaceutical sectors.

Third Quarter 2021 Financial Results:

As of September 30, 2021, Cardiff Oncology had approximately $134 million in cash, cash equivalents, and short-term investments.

Total operating expenses were approximately $7.1 million for the three months ended September 30, 2021, an increase of $2.6 million from $4.5 million for the same period in 2020. The increase in operating expenses is attributed to advancing ongoing and new onvansertib clinical development programs and preclinical activities, additional outside services for legal fees mainly related to the expansion of our patent portfolio, recruiting fees and stock compensation expense.

Research and development expenses increased by approximately $1.3 million to $4.2 million for the three months ended September 30, 2021, from $2.9 million for the same period in 2020. The increase in research and development expenses was primarily due to advancing the onvansertib clinical and preclinical programs and recruitment fees to fill critical medical and clinical operations positions.

Selling, general and administrative expenses increased by approximately $1.3 million to $2.9 million for the three months ended September 30, 2021, from $1.6 million for the same period in 2020. The increase is attributed to increased outside services for legal fees related to the expansion of our patent portfolio, recruitment fees, and stock compensation expense.

Net cash used in operating activities for the third quarter of 2021 was approximately $5.5 million, an increase of approximately $2.0 million from $3.5 million for the same period in 2020.

References

Giessen et al., Acta Oncologica 2015, 54: 187-193
Cremolini et al., Lancet Oncol 2020, 21: 497–507
Antoniotti et al., Correspondence Lancet Oncol June 2020
Bennouna et al., Lancet Oncol 2013; 14: 29–37

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]).

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!

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.