On November 6, 2023 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, 2023 (Press release, Guardant Health, NOV 6, 2023, View Source [SID1234637026]).

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!

Third Quarter 2023 Financial Highlights
•Revenue of $143.0 million for the third quarter of 2023, an increase of 22% over the third quarter of 2022
•Reported 43,900 tests to clinical customers and 7,500 tests to biopharmaceutical customers in the third quarter of 2023, representing increases of 35% and 11%, respectively, over the third quarter of 2022

Recent Operating Highlights

•Presented first results of the PEGASUS MRD de-escalation trial at the European Society for Medical Oncology, ESMO (Free ESMO Whitepaper), with data suggesting Guardant Reveal may help guide adjuvant treatment of colon cancer
•Received coverage for Guardant Reveal from Geisinger Health Plan
•Surpassed 200 million covered lives for TissueNext
•Launched Guardant360 for clinical use in Japan and biopharma use in China
•Received regulatory approval in Japan for Guardant360 CDx as a companion diagnostic to ENHERTU for treatment of non-small cell lung cancer patients with HER2 mutations
•Published the first paper for Shield demonstrating utility of blood-based CRC screening in Annals of Oncology
"We ended the third quarter with revenue growth of 22%, driven by strong year-over-year growth in clinical volume. We are starting to see the impact of coverage decisions on Guardant360, with uplifts in ASPs and additional tailwinds further strengthening the financial profile of our Therapy Selection business," said Helmy Eltoukhy, co-founder and co-CEO. "We recently presented exciting MRD data, further demonstrating the clinical utility of our Reveal blood test. We look forward to a strong finish to the year."
"We are continuing to make steady progress in our screening business with our Shield blood test," said AmirAli Talasaz, co-founder and co-CEO. "At our recent investor day, we shared some promising new clinical validation data on the next generation of our Shield test. We are also advancing our progress in lung and other indications as we develop Shield into a multi-cancer early detection test."
Third Quarter 2023 Financial Results
Revenue was $143.0 million for the three months ended September 30, 2023, a 22% increase from $117.4 million for the three months ended September 30, 2022. Precision oncology revenue grew 31%, driven predominantly by an increase in clinical testing volume and biopharma sample volume, which grew 35% and 11%, respectively, over the prior year period. In addition, our clinical testing revenue for the three months ended September 30, 2023 includes a payment of $3.6 million from Medicare related to a successful appeal for claims dated between 2018 and 2020. Development services and other revenue decreased by 37%, primarily due to the timing and amount of milestones related to our partnership agreements and companion diagnostics collaboration projects with biopharmaceutical customers, as well as a reduction in royalty revenue during the three months ended September 30, 2023.
Gross profit, or total revenue less cost of precision oncology testing and cost of development services and other, was $85.4 million for the third quarter of 2023, an increase of $8.5 million from $76.9 million for the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 60%, as compared to 66% for the corresponding prior year period. Precision oncology gross margin was 60% in the third quarter of 2023, as compared to 61% in the prior year period. The reduction is primarily due to changes in product mix. Development services and other gross margin was 59% in the third quarter of 2023, as compared to 93% in the prior year period. The change is primarily due to the inclusion of the cost of processing Shield LDT samples as part of our screening market development activities, for which we are currently booking minimal revenue.
Operating expenses were $199.0 million for the third quarter of 2023, as compared to $221.5 million for the corresponding prior year period. Non-GAAP operating expenses were $177.3 million for the third quarter of 2023, as compared to $200.5 million for the corresponding prior year period.

Net loss was $86.1 million for the third quarter of 2023, as compared to $162.0 million for the corresponding prior year period. Net loss per share was $0.73 for the third quarter of 2023, as compared to $1.58 for the corresponding prior year period. The year-over-year reduction in net loss is primarily due to a $31.1 million year-over-year improvement in our loss from operations, a $29.9 million positive change in unrealized gains and losses, and a $9.9 million increase in interest income.
Non-GAAP net loss was $79.2 million for the third quarter of 2023, as compared to $120.8 million for the corresponding prior year period. Non-GAAP net loss per share was $0.67 for the third quarter of 2023, as compared to $1.18 for the corresponding prior year period.
Adjusted EBITDA loss was $79.7 million for the third quarter of 2023, as compared to a $112.8 million loss for the corresponding prior year period.
Free cash flow for the third quarter of 2023 was negative $80.2 million. Cash, cash equivalents and marketable debt securities were $1.2 billion as of September 30, 2023.
2023 Guidance
Guardant Health now expects full year 2023 revenue to be in the range of $553 to $556 million, representing growth of 23% to 24% compared to full year 2022. Guardant Health continues to expect full year 2023 operating expenses to be below full year 2022, driven by efficiency measures and continued leverage of its existing infrastructure, and free cash flow to be approximately negative $350 million in 2023.
Webcast Information
Guardant Health will host a conference call to discuss the third quarter and full year 2023 financial results after market close on Monday, November 6, 2023 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.

On November 6, 2023 GT Biopharma, Inc. (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager, TriKE platform, reported positive preclinical data in highlighting GTB-5550’s potential in prostate cancer (Press release, GT Biopharma, NOV 6, 2023, View Source [SID1234637025]). Martin Felices, PhD, Associate Professor of Medicine at the University of Minnesota, presented these data on Saturday, November 4th at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2023, which is being held in San Diego, California November 1-5.

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!

Natural killer (NK) cells are being increasingly explored in clinical trials due to their safety profile and ability to mediate tumor killing without prior priming. However, lack of antigen-specific targeting, decreased numbers, and suppressive signals from the tumor microenvironment (TME) of Prostate Cancer (PCa), can negatively impact NK cell efficacy. GTB-5550 was specifically designed as a novel tri-specific killer engager (TriKE) molecule with three components: an arm that engages with CD16, an activating receptor of NK cells, an arm that binds to tumor antigens expressed in prostate cancer (PSMA or B7H3), and an interleukin (IL)-15 moiety that is essential for NK cell survival, proliferation, priming and motility.

"These preclinical findings provide additional support for our TriKE technology and the specific mechanism of action for this construct in promoting NK-specific proliferation, effective killing of target cells and ability to bypass the myeloid-derived suppressor cells (MDSC)-induced suppression of NK cells," stated Dr. Jeffrey Miller*, MD, GT Biopharma’s Consulting Chief Medical Officer and Consulting Chief Scientific Officer. "All of this bodes well as we progress this specific TriKE towards the clinic with the goal of an eventual indication in prostate cancer."

Key findings demonstrated that normal donor and prostate cancer patient NK cells displayed better, specific, degranulation against prostate cancer cell lines in the presence of PSMA or B7H3 TriKEs. NK cell cytotoxicity was also improved, even in the presence of enzalutamide resistant lines, hypoxia, or MDSCs. The TriKE molecules displayed improved tumor control, compared to IL-15 control or no treatment, in xenogeneic models of prostate cancer.

Society For Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2023 Annual Meeting – November 1-5, 2023

Poster Title: Maximizing NK Cell Immunotherapy in Prostate Cancer vis TriKEs
Abstract: 1180
Date: Saturday, November 4, 2023
Time: 2:55 pm -4:25 pm & 10:00 pm – 11:30 pm ET
Presenter: Martin Felices*, PhD, Associate Professor of Medicine, University of Minnesota
*Drs Jeff Miller (consultant CMO) and Martin Felices are consultants for GT Biopharma and hold equity.

On November 6, 2023 FibroGen, Inc. (NASDAQ: FGEN) reported financial results for the third quarter 2023 and provided an update on the Company’s recent developments (Press release, FibroGen, NOV 6, 2023, View Source [SID1234637024]).

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!

"Today, we reported another quarter of strong roxadustat volume growth in China, achieving the highest ever value share, at 42%, in the anemia of CKD category," said Thane Wettig, Chief Executive Officer, FibroGen. "The continued strength of our China business, sooner than expected realization of our corporate cost reduction efforts and our strong balance sheet provide us a cash runway into 2026. Over the next 12 months, we will obtain data read-outs from our two late-stage pancreatic cancer trials, start a Phase 2 metastatic castrate-resistant prostate cancer trial, and file two immuno-oncology INDs. These unique and exciting programs, combined with the quality of our talented colleagues, provide a strong foundation to create significant value for shareholders relative to our current valuation."

Recent Developments and Key Events of Third Quarter 2023:

•
Appointed Thane Wettig as Chief Executive Officer.
•
Supplemental New Drug Application (sNDA) accepted by the China Health Authority for roxadustat for the treatment of patients with chemotherapy-induced anemia (CIA). Expect approval decision of CIA in China in mid-2024.
•
Successful implementation of cost reduction plan, now resulting in an expected reduction of total annualized expenses of $120 million.
•
Reported negative topline results from the LELANTOS-2 Phase 3 study of pamrevlumab for the treatment of ambulatory patients with Duchenne muscular dystrophy (DMD).
•
Presented Phase 3 data of roxadustat for CIA in patients with non-myeloid malignancies in an oral presentation at the European Society for Medical Oncology Congress 2023.
•
FibroGen and its partners presented five roxadustat abstracts, including four poster presentations and one late-breaker poster presentation, at the recent American Society of Nephrology (ASN) Kidney Week 2023 conference.
•
Presented preclinical data for the FG-3165 anti-Gal9 antibody program at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2023.

China Performance:

•
Achieved third quarter net product revenue under U.S. GAAP from the sale of roxadustat in China of $29.4 million compared to $17.4 million in the third quarter of 2022, an increase of 69% year over year.
•
Achieved third quarter total roxadustat net sales in China1 by FibroGen and the distribution entity (JDE) jointly owned by FibroGen and AstraZeneca of $77.1 million, compared to $59.0 million in the third quarter of 2022, an increase of 31% year over year, driven by 37% growth in volume.
•
Roxadustat continues to be the number one brand based on value share in the anemia of chronic kidney disease market in China. Total roxadustat net sales in China includes sales made by the distribution entity as well as FibroGen China’s direct sales, each to its own distributors. The distribution entity jointly owned by AstraZeneca and FibroGen is not consolidated into FibroGen’s financial statements.

Upcoming Milestones:

Pamrevlumab

•
Topline data from the LAPIS Phase 3 study of pamrevlumab in locally advanced unresectable pancreatic cancer (LAPC) expected in 1Q 2024.
•
Topline data from the PanCAN Precision PromiseSM Phase 2/3 study of pamrevlumab in metastatic pancreatic cancer expected in 1H 2024.
Oncology Pipeline

•
Expect topline clinical trial results from Phase 1 monotherapy trial of FG-3246, a first-in-class antibody-drug conjugate (ADC) targeting a novel epitope on CD46 for metastatic castration-resistant prostate cancer (mCRPC) by 1Q 2024.
•
Anticipate the initiation of a Phase 2 trial of FG-3246 for mCRPC in 2H 2024.
•
Anticipate the filing of two INDs: FG-3165 (anti-Gal9 antibody) in 1Q 2024 and FG-3175 (anti-CCR8 antibody) in 2H 2024.

Financial:

•
Total revenue for the third quarter of 2023 was $40.1 million, as compared to $15.7 million for the third quarter of 2022, an increase of 155% year over year.
•
Net loss for the third quarter of 2023 was $63.6 million, or $0.65 net loss per basic and diluted share, compared to a net loss of $91.7 million, or $0.98 net loss per basic and diluted share one year ago.
•
Restructuring charge for the third quarter of 2023 was $12.6 million, or $0.13 impact to net loss per basic and diluted share, resulting from the reduction in U.S. workforce announced in July 2023.
•
At September 30, 2023, cash – defined as cash, cash equivalents, investments, and accounts receivable – was $283.0 million.
•
We expect our cash, cash equivalents, investments, and accounts receivable to be sufficient to fund our operating plans into 2026.

Conference Call and Webcast Details

FibroGen will host a conference call and webcast today, Monday, November 6, 2023, at 5:00 PM Eastern Time to discuss financial results and provide a business update. Interested parties may access a live audio webcast of the conference call via the "Investor Relations" page of the Company’s website at www.fibrogen.com. To access the call by phone, please go to this link (registration link), and you will be provided with dial in details. To avoid delays, we encourage participants to dial in to the conference call fifteen minutes ahead of the scheduled start time. A replay of the webcast will also be available for a limited time at the following link (webcast replay).

About Pamrevlumab

Pamrevlumab is a potential first-in-class antibody being developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF). Pamrevlumab is in Phase 3 clinical development for the treatment of locally advanced unresectable pancreatic cancer (LAPC) and in Phase 2/3 for the treatment of metastatic pancreatic cancer. The U.S. Food and Drug Administration has granted Orphan Drug Designation, and Fast Track designation to pamrevlumab for the treatment of patients with LAPC. Pamrevlumab has demonstrated a safety and tolerability profile that has supported ongoing clinical investigation in LAPC and metastatic pancreatic cancer. Pamrevlumab is an investigational drug and not approved for marketing by any regulatory authority. For information about our pamrevlumab studies please visit www.clinicaltrials.gov.

About Roxadustat

Roxadustat, an oral medication, is the first in a new class of medicines comprising HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin. Roxadustat is in clinical development for chemotherapy-induced anemia (CIA) and a Supplemental New Drug Application (sNDA) has been accepted by the China Health Authority.

Roxadustat is approved in China, Europe, Japan, and numerous other countries for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). Several other licensing applications for roxadustat have been submitted by partners, Astellas and AstraZeneca, to regulatory authorities across the globe, and are currently under review. Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in territories including Japan, Europe, Turkey, Russia, and the Commonwealth of Independent States, the Middle East, and South Africa. FibroGen and AstraZeneca are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in the U.S., China, and other markets not licensed to Astellas.

On November 6, 2023 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage TechBio company specializing in the development of AI-Immunology powered vaccines, reported that it is hosting an online webinar featuring Key Opinion Leader (KOL) and study’s Principal Investigator (PI), Professor Adnan Khattak (Press release, Evaxion Biotech, NOV 6, 2023, View Source [SID1234637023]). The webinar will take place on November 8 at 11:30 a.m. EST.

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 this 30-minute-long event, Professor Khattak will set the scene by introducing participants to the medical field of malignant melanoma and the need that Evaxion’s personalized cancer vaccines are trying to meet. After summarizing the promising results reported in the EVX-01 Phase 1 clinical trial, Adnan will dive into Evaxion’s latest EVX-01 Phase 2 clinical update and how these appear to confirm the benefits previously observed for this innovative immunotherapy. In the end, a Q&A session will be held for anyone who wants to learn more about this study and its underlying technology.

Evaxion’s Chief Executive Officer, Christian Kanstrup, commented: "‘This latest clinical update stands as a testament to Evaxion’s unwavering dedication to transforming patients’ lives through innovative and targeted immunotherapies. Despite initial skepticism surrounding our pioneering work in personalized cancer vaccines, we are now reaping consistently positive outcomes that we believe hold the promise to change the lives of melanoma patients." Reflecting on how these results may impact the oncology field in the near future, Christian added, "‘We firmly believe that our AI-Immunology platform has the potential to spearhead a revolution in immuno-oncology, extending far beyond melanoma and positively touching the lives of countless individuals."

To learn more about the clinical impact of Evaxion’s innovative EVX-01 vaccine and gain understanding of how personalized cancer vaccines can revolutionize the field of immuno-oncology, please register by following this link.

About EVX-01 Phase 1 Clinical Trial
The open-label, single-arm, single-center Phase 1 study was conducted in collaboration with DTU, SSI, the Center for Genomic Medicine at Rigshospitalet, and CCIT-DK. The study aimed to assess the safety and efficacy of the EVX-01 vaccine in combination with anti-PD1 (pembrolizumab or Nivolumab) in patients with metastatic melanoma. The design consisted of multiple 15-27mer peptides comprising one or more patient-specific neoantigens formulated with the novel liposomal adjuvant CAF09b to potentiate immune responses. The primary objective was to evaluate the safety and tolerability of the combination of EVX-01 and a checkpoint inhibitor. Additional information can be accessed under clinical trial ID NCT03715985.

About EVX-01 Phase 2 Clinical Trial
EVX-01 is Evaxion’s lead clinical asset and constitutes a peptide-based personalized cancer vaccine. The Phase 2 clinical study is a self-sponsored open-label, single-arm, multi-center trial carried out in collaboration with Merck Sharp & Dohme LLC, and together with leading principal investigators and research centers from Italy and Australia aims at evaluating the efficacy and safety of EVX-01 vaccination in combination with anti-PD1 treatment (pembrolizumab) in treatment-naive patients with metastatic or unresectable malignant stage III or IV melanoma. More information can be accessed under clinical trial ID NCT05309421.

On November 6, 2023 Genialis, the RNA-biomarker company, reported new data detailing how RNA sequencing data can help elucidate tumor biologies that may be amenable to immunotherapies and targeted agents (Press release, Debiopharm, NOV 6, 2023, View Source [SID1234637021]). The information was presented in two posters at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 38th Annual Meeting.

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!

Genialis found the Xerna TME Panel, an RNA-based pan-tumor biomarker previously shown to be predictive of responses to multiple immune-targeted cancer therapies and introduced its ResponderID MSI program, demonstrating how a machine learning-based classifier of microsatellite instability (MSI) from RNA sequencing data performs comparably to state of the art IHC- and PCR-based MSI detection methods.