On August 3, 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 June 30, 2023 (Press release, Guardant Health, AUG 3, 2023, View Source [SID1234633798]).

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"We are continuing to make advancements in our screening business as we spearhead a new patient-preferred category with our Shield blood test"

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Second Quarter 2023 Financial Highlights

Revenue of $137.2 million for the second quarter of 2023, an increase of 26% over the second quarter of 2022
Reported 43,500 tests to clinical customers and 6,700 tests to biopharmaceutical customers in the second quarter of 2023, representing increases of 49% and 12%, respectively, over the second quarter of 2022
Recent Operating Highlights

Received new commercial plan coverage from Anthem Blue Cross and Blue Shield, Aetna, and Humana, resulting in Guardant360 now being covered by all major U.S. commercial health insurers and exceeding 300 million covered lives
Announced reimbursement approval of Guardant360 CDx liquid biopsy test in Japan for patients with advanced solid tumor cancers
Received first commercial plan coverage for Guardant Reveal
Strengthened financial position with an underwritten public offering raising $381 million in net proceeds, ending the quarter with $1.2 billion of cash, cash equivalents and marketable securities
"We had another very strong quarter with revenue growing 26% year over year, driven by strength across precision oncology where we reached 50,000 combined tests during the quarter," said Helmy Eltoukhy, co-founder and co-CEO. "Our clinical volumes were driven by growth in lung and breast cancer for Guardant360 and by rapid year-over-year growth for Reveal and TissueNext. With this strong momentum, we are on track to achieve cash flow breakeven in Therapy Selection within the next 3-6 months."

"We are continuing to make advancements in our screening business as we spearhead a new patient-preferred category with our Shield blood test," said AmirAli Talasaz, co-founder and co-CEO. "In the near-term, we remain focused on obtaining FDA approval for the Shield test in colorectal cancer, preparing for the commercial launch of Shield IVD in 2024 and delivering on our plans to develop Shield into a multi-cancer test."

Second Quarter 2023 Financial Results

Revenue was $137.2 million for the three months ended June 30, 2023, a 26% increase from $109.1 million for the three months ended June 30, 2022. Precision oncology revenue grew 36%, driven predominantly by an increase in clinical testing volume and biopharma sample volume, which grew 49% and 12%, respectively, over the prior year period. Development services and other revenue decreased by 30%, primarily due to the timing and amount of milestones related to our partnership agreements and the change in companion diagnostics collaboration projects with biopharma customers.

Gross profit, or total revenue less cost of precision oncology testing and cost of development services and other, was $83.3 million for the second quarter of 2023, an increase of $10.9 million from $72.4 million for the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 61%, as compared to 66% for the corresponding prior year period. Precision oncology gross margin was 61% in the second quarter of 2023, as compared to 63% in the prior year period. The reduction is due to the change in mix between clinical and biopharma revenue, as well as the year over year change in blended clinical ASP due to the increased proportion of volume coming from Reveal, TissueNext and Response. Development services and other gross margin was 62% in the second quarter of 2023, as compared to 86% 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.

Operating expenses were $202.9 million for the second quarter of 2023, as compared to $202.7 million for the corresponding prior year period. Non-GAAP operating expenses were $180.5 million for the second quarter of 2023, as compared to $176.2 million for the corresponding prior year period.

Net loss was $72.8 million for the second quarter of 2023, as compared to $229.4 million for the corresponding prior year period. Net loss per share was $0.67 for the second quarter of 2023, as compared to $2.25 for the corresponding prior year period. The year over year reduction in net loss is primarily due to a charge of $99.8 million recorded in the second quarter of 2022 to reflect an increase in the fair value of the outstanding shares in our AMEA joint venture which we acquired in June 2022, and other income of $64.0 million reflecting an unrealized gain related to our strategic equity investment in Lunit, Inc., our AI partner for TissueNext, which has seen a substantial increase in its share price over the last few months.

Non-GAAP net loss was $88.7 million for the second quarter of 2023, as compared to $101.8 million for the corresponding prior year period. Non-GAAP net loss per share was $0.82 for the second quarter of 2023, as compared to $1.00 for the corresponding prior year period.

Adjusted EBITDA loss was $85.2 million for the second quarter of 2023, as compared to a $94.3 million loss for the corresponding prior year period.

Free cash flow for the second quarter of 2023 was negative $100.5 million. Cash, cash equivalents and marketable debt securities were $1.2 billion as of June 30, 2023.

2023 Guidance

Guardant Health now expects full year 2023 revenue to be in the range of $545 to $550 million, representing growth of 21% to 22% compared to full year 2022. This compares to its previous guidance range of $535 to $545 million. 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 second quarter and full year 2023 financial results after market close on Thursday, August 3, 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 August 3, 2023 Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, reported its financial results for the second quarter ended June 30, 2023, and provided a business update (Press release, Nuvation Bio, AUG 3, 2023, View Source [SID1234633797]).

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"We continue to enroll patients in the Phase 1 and Phase 1b studies of NUV-868 where dose escalation is ongoing. We also look forward to expanding our pipeline as we progress our first nominated DDC clinical candidate toward an IND filing, which we expect by the end of 2023," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "Lastly, we announced the formation of our Scientific Advisory Board, composed of leading experts in oncology drug and clinical development. We are excited to work alongside them to bring innovative new therapies to cancer patients."

Recent Business Updates

NUV-868, BD2-Selective BETi: Advanced solid tumors

Dosing underway in both regimens of the Phase 1b combination study. Nuvation Bio continues to enroll the Phase 1b study of NUV-868 in combination with olaparib in patients with ovarian cancer, pancreatic cancer, metastatic castration-resistant prostate cancer (mCRPC), triple negative breast cancer and other solid tumors, and in combination with enzalutamide in patients with mCRPC.
Dosing underway in the Phase 1 monotherapy study. Nuvation Bio continues to enroll the Phase 1 monotherapy study in advanced solid tumors.
Drug-Drug Conjugate Platform: Solid tumors

Nominated first clinical candidate. Nuvation Bio remains on track to submit an Investigational New Drug (IND) application for an undisclosed DDC candidate with the U.S. Food and Drug Administration by year end 2023.
Corporate Updates

Announced formation of oncology-focused Scientific Advisory Board. The Scientific Advisory Board will work alongside the Nuvation Bio management team to advance its pipeline of therapeutic candidates for some of the most difficult-to-treat cancers.
Second Quarter 2023 Financial Results

As of June 30, 2023, Nuvation Bio had cash, cash equivalents and marketable securities of $630.9 million. For the three months ended June 30, 2023, research and development expenses were $18.6 million, compared to $28.9 million for the three months ended June 30, 2022. The decrease was primarily due to a $0.7 million decrease in personnel-related costs driven by a headcount reduction as well as a $9.6 million decrease in third-party costs related to research services and manufacturing primarily due to the termination of the NUV-422 program.

For the three months ended June 30, 2023, general and administrative expenses were $7.5 million, compared to $8.9 million for the three months ended June 30, 2022. The decrease was primarily due to a $0.6 million decrease in insurance, a $0.6 million decrease in recruiting and computer expenses, a $0.6 million decrease in legal fees and a $0.2 million decrease in other professional fees offset by a $0.6 million increase in personnel-related costs driven by stock-based compensation and other benefits.

For the three months ended June 30, 2023, Nuvation Bio reported a net loss of $20.6 million, or $(0.09) per share. This compares to a net loss of $34.9 million, or $(0.16) per share, for the comparable period in 2022.

On August 3, 2023 Kyverna Therapeutics ("Kyverna"), a clinical-stage cell therapy company with the mission of engineering a new class of therapies for autoimmune diseases, reported the close of an oversubscribed $60 million Series B financing round extension, bringing the total Series B financing round to $145 million (Press release, Kyverna Therapeutics, AUG 3, 2023, View Source [SID1234633796]). New investors, Bain Capital Life Sciences and GordonMD Global Investments LP, join existing investors Gilead Sciences, Westlake Village BioPartners, Vida Ventures, Northpond Ventures, RTW Investments, Insight Partners, CAM Capital, LYFE Capital, jVen Capital, and others.

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"We are pleased by the increasing investor confidence in the promise of Kyverna’s anti-CD19 CAR T-cell therapy for autoimmune diseases," said Ryan Jones, chief financial officer of Kyverna. "This Series B extension will fund Kyverna’s clinical studies in the U.S. and Europe, enabling us to move more quickly toward bringing potentially transformative and life-saving therapies to patients. We continue to treat autoimmune patients in multiple indications and multiple geographies, and we look forward to sharing clinical data in the second half of 2023."

"I have supported anti-CD19 CAR T-cell therapy for cancer since the early clinical trials. It is exciting to see Kyverna break into new frontiers by advancing cell therapies for autoimmune diseases. I am looking forward to future developments from Kyverna," said Craig Gordon, M.D., founder, chief executive officer, and chief investment officer of Gordon MD Global Investments LP.

Chimeric antigen receptor (CAR) T-cell therapy involves modifying a patient’s immune T cells to recognize and remove B cells in the patient’s body. Kyverna’s anti-CD19 CAR T-cell therapies, KYV-101 and KYV-201, specifically target CD19, a protein expressed on the surface of B cells which is involved in various types of autoimmune diseases including lupus nephritis. These novel therapies have the potential to offer new hope to patients who have exhausted current treatment options. Kyverna continues to explore additional indications for its anti-CD19 CAR T-cell therapies, as well as develop a robust pipeline of promising immunotherapies aimed at addressing unmet medical needs.

About KYV-101
KYV-101 is an autologous version of a novel, fully human clinical-stage anti-CD19 chimeric antigen receptor (CAR) T-cell construct with properties well suited for use in B cell-driven autoimmune diseases such as lupus nephritis and other B cell-driven autoimmune diseases. In a 20-patient Phase 1/2 study in oncology, expected anti-lymphoma activity was associated with a significant reduction of cytokines released that translated into a strong reduction of cytokine-driven side effects, such as the rate of immune effector cells-associated neurotoxicity syndrome (ICANS)1. The fully human anti-CD19 CAR also translated into reduced immunogenicity that favorably impacted cell persistence at one month. Kyverna recognized that these properties singled out KYV-101 as a product ideally poised for use in autoimmune disease patients, and the company obtained exclusive, worldwide licenses from the National Institutes of Health (NIH) to use this anti-CD19 construct in both autologous and allogeneic CAR T-cell therapies. KYV-101 has initiated a Phase 1 clinical trial in lupus nephritis in the U.S. and a Phase 1/2 trial in Germany.

About KYV-201
KYV-201 is an allogeneic version of Kyverna’s novel, fully human clinical-stage anti-CD19 chimeric antigen receptor (CAR) T-cell construct with properties well suited for use in B cell-driven autoimmune diseases such as lupus nephritis and other B cell-driven autoimmune diseases. KYV-201 leverages the power of genome editing through a proprietary ex vivo CRISPR/Cas9-based allogeneic platform for use in B cell-mediated autoimmune diseases.

On August 3, 2023 Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Oncology, Inc., reported the launch of the REZILIENT3 trial (NCT05973773, Researching Zipalertinib In EGFR Non-Small Cell Lung Cancer Tumors), a global Phase 3 clinical trial evaluating the combination of zipalertinib and chemotherapy as a potential first-line treatment for adult patients with previously untreated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the epidermal growth factor receptor (EGFR) exon 20 insertion mutation and who meet additional criteria (Press release, Taiho, AUG 3, 2023, View Source [SID1234633795]).

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NSCLC is a common form of lung cancer and up to 4% of all cases have EGFR exon 20 insertions, which makes them the third most common EGFR mutation subtype.1 In the United States, approximately 16% of patients with NSCLC harbor EGFR mutations, with insertions at exon 20 accounting for up to 12% of these mutations.1

"Patients with NSCLC who have EGFR exon 20 insertion mutations are known to have poorer outcomes than those with more common EGFR mutations,1" said Volker Wacheck, MD, PhD, Senior Vice President, Clinical Development, Taiho Oncology, Inc. "Advancing care for this subset of patients with NSCLC is essential to advancing care in NSCLC overall."

The launch of the REZILIENT3 trial follows a Phase 1 / 2a clinical trial (NCT04036682) of zipalertinib in patients with NSCLC harboring EGFR exon 20 insertion mutations. Results demonstrated the therapeutic potential of zipalertinib in heavily pretreated patients and were presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.2 Updated data from this trial were recently published in the Journal of Clinical Oncology.3

"The initiation of the Phase 3 trial for zipalertinib in the first-line setting is an important step forward for this clinical research program, as it represents an opportunity for zipalertinib to help more patients with EGFR exon 20 insertion mutation NSCLC," said Jeffrey Jones, MD, MPH, MBA, Chief Medical Officer, Cullinan Oncology, Inc. "We look forward to working with our partners at Taiho to rapidly assess zipalertinib in the front line, while in parallel continuing to advance our pivotal Phase 2b trial in patients who have received prior systemic treatment for locally advanced or metastatic disease."

About the REZILIENT3 Trial
This multicenter, randomized, controlled, open-label global trial is currently enrolling adults with previously untreated, locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations.

The primary objective of this trial is to assess progression-free survival in the zipalertinib plus chemotherapy arm versus the chemotherapy arm. Approximately 312 patients will ultimately be enrolled in this trial from around the world.

About Zipalertinib
Zipalertinib (development code: CLN-081/TAS6417) is an orally available small molecule designed to target activating mutations in EGFR. The molecule was engineered to inhibit EGFR variants with exon 20 insertion mutations, while sparing wild-type EGFR. Zipalertinib is designed as a next generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer. Zipalertinib has received Breakthrough Therapy Designation from the FDA.

Zipalertinib is being developed by Taiho Oncology, Inc., its parent company, Taiho Pharmaceutical Co., Ltd., and Cullinan Oncology, Inc. Cullinan Pearl Corp., which Taiho Pharmaceutical Co., Ltd., acquired from Cullinan Oncology, Inc. in 2022, previously licensed the rights to zipalertinib in Greater China to Zai Lab Limited in 2020.

On August 3, 2023 Harpoon Therapeutics, Inc. (NASDAQ: HARP), a clinical-stage immunotherapy company developing novel T cell engagers, reported that management will participate in two upcoming investor conferences (Press release, Harpoon Therapeutics, AUG 3, 2023, View Source [SID1234633794]):

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A corporate presentation at the Canaccord Genuity 43rd Annual Growth Conference in Boston, at 9:30 a.m. ET (6:30 a.m. PT) on Thursday, August 10, 2023.

A fireside chat at the H.C. Wainwright Immune Cell Engager Virtual Conference at 10:30 a.m. ET (7:30 a.m. PT) on Thursday, August 17, 2023.

A live audio webcast of the presentations will be available in the Investors section of the Harpoon Therapeutics website at www.harpoontx.com with an archived replay available following the event.