On August 4, 2022 DURECT Corporation (Nasdaq: DRRX) reported financial results for the three months ended June 30, 2022 and provided a corporate update (Press release, DURECT, AUG 4, 2022, View Source [SID1234617558]).

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"We continue to see enrollment accelerating in the larsucosterol (DUR-928) AHFIRM trial and are pleased to announce that we have enrolled 170 patients to date. The second quarter continued the recent positive enrollment trend, with more patients dosed than in any prior quarter, reflecting the opening of additional clinical trial sites and our ongoing efforts to work with existing sites to recruit more patients with severe alcohol-associated hepatitis (AH) that meet our enrollment criteria," stated James E. Brown, D.V.M., President and CEO of DURECT.

Second Quarter and Recent Business Highlights:

Continued progress in AHFIRM enrollment – DURECT has enrolled 170 patients in the AHFIRM trial to date, which exceeds 50% of the target enrollment for the 300-patient trial. We now have over 60 AHFIRM study sites open at leading hospitals in the U.S., Australia, E.U. and U.K. We continue to expect to enroll the last patient in the AHFIRM trial in mid-2023, which should enable top-line results to be reported in the second half of 2023.
FDA agreement on modified primary endpoint to include liver transplant in addition to mortality – Through a Type C meeting with the U.S. Food and Drug Administration (FDA), FDA has concurred with DURECT’s proposal to amend the primary endpoint of the ongoing AHFIRM trial to be the reduction in mortality or liver transplant at 90 days. A liver transplant represents a serious and expensive medical event for patients and we believe that including transplanted patients as well as mortality in the primary endpoint better reflects the current state of care for AH patients.
Recent Patent Issuance covering POSIMIR – On August 2, 2022, DURECT was issued a new patent by the US Patent Office, extending US patent coverage for POSIMIR to at least 2041. This event triggered an $8 million milestone payment due to DURECT under our license agreement with Innocoll Pharmaceuticals Limited (Innocoll). This payment is in addition to the $4 million upfront license fee received in January 2022, and a $2 million milestone payment to be received upon the first commercial sale of POSIMIR in the United States.
Financial Highlights for Q2 2022:

Total revenues were $2.1 million and net loss was $11.6 million for the three months ended June 30, 2022 compared to total revenues of $2.3 million and net loss of $9.1 million for the three months ended June 30, 2021.
At June 30, 2022, cash and investments were $54.3 million, compared to cash and investments of $70.0 million at December 31, 2021. Total debt at June 30, 2022 was $20.9 million, compared to $20.6 million at December 31, 2021.
Earnings Conference Ca ll
We will host a conference call today at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss second quarter 2022 results and provide a corporate update:

A live audio webcast of the presentation will be also available by accessing DURECT’s homepage at www.durect.com and clicking "Investors." If you are unable to participate during the live webcast, the call will be archived on DURECT’s website under "Event Calendar" in the "Investors" section.

About the AHFIRM Trial
Enrollment is ongoing in our Phase 2b randomized, double-blind, placebo-controlled, international, multi-center study in subjects with severe acute alcohol-associated hepatitis (AH) to evaluate saFety and effIcacy of laRsucosterol (DUR-928) treatMent (AHFIRM). The study is comprised of three arms targeting enrollment of 300 total patients, with approximately 100 patients in each arm: (1) Placebo plus supportive care, with or without methylprednisolone capsules at the investigators’ discretion; (2) larsucosterol (30 mg); and (3) larsucosterol (90 mg). Patients in the larsucosterol arms receive the same supportive care without steroids. In order to maintain blinding, patients in the two active arms receive matching placebo capsules if the investigator prescribes steroids. The primary outcome measure will be the 90-Day incidence of mortality or liver transplantation for patients treated with larsucosterol compared to those treated with placebo. The Company is enrolling patients at more than 60 clinical trial sites across the U.S., EU, U.K., and Australia. Reflecting the life-threatening nature of AH and the lack of therapeutic options, the U.S. Food and Drug Administration (FDA) has granted larsucosterol Fast Track Designation for the treatment of AH. We believe a positive outcome in the AHFIRM trial could support a New Drug Application filing. For more information, refer to ClinicalTrials.gov Identifier: NCT04563026.

About Alcohol-associated Hepatitis (AH)
AH is a life-threatening acute alcohol-associated liver disease (ALD) often caused by chronic heavy alcohol use and a recent period of increased alcohol consumption (i.e., a binge). It is characterized by severe inflammation and destruction of liver tissue (i.e., necrosis), potentially leading to life-threatening complications including liver failure, acute renal injury and multi-organ failure. There are no FDA approved therapies for AH and a retrospective analysis of 77 studies published between 1971 and 2016, which included data from a total of 8,184 patients, showed the overall mortality from AH was 26% at 28 days, 29% at 90 days and 44% at 180 days. A subsequent global study published in December 2021, which included 85 tertiary centers in 11 countries across 3 continents, prospectively enrolled 2,581 AH patients with a median Model of End-Stage Liver Disease (MELD) score of 23.5, reported mortality at 28 and 90 days of 20% and 31%, respectively. Stopping alcohol consumption is not sufficient for recovery in many moderate (defined as MELD scores of 11-20) and severe (defined as MELD scores >20) patients and the use of treatments to reduce liver inflammation, such as corticosteroids, are limited by contraindications and have been shown to provide no survival benefit at 90 days or 1 year. While liver transplantation is becoming more common for ALD patients, including AH patients, the procedure often involves a long waiting period, a burdensome selection process, costs exceeding $875,000 on average, and patients requiring lifelong immunosuppressive therapy to prevent organ rejection.

About Larsucosterol (DUR-928)
Larsucosterol is an endogenous sulfated oxysterol and an epigenetic regulator. Epigenetic regulators are compounds that regulate patterns of gene expression without modifying the DNA sequence. DNA hypermethylation, an example of epigenetic dysregulation, results in transcriptomic reprogramming and cellular dysfunction, and has been found to be associated with many acute (e.g., AH) or chronic diseases (e.g., NASH). As an inhibitor of DNA methyltransferases (DNMT1, DNMT3a and 3b), larsucosterol inhibits DNA methylation, which subsequently regulates expression of genes that are involved in cell signaling pathways associated with stress responses, cell death and survival, and lipid biosynthesis. This may ultimately lead to improved cell survival, reduced inflammation, and decreased lipotoxicity. As an epigenetic regulator, the proposed mechanism of action provides further scientific rationale for developing larsucosterol for the treatment of acute organ injury and certain chronic diseases.

On August 4, 2022 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated oncology therapeutics, reported second quarter 2022 financial results and provided a business update (Press release, CytomX Therapeutics, AUG 4, 2022, View Source [SID1234617557]).

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"Our commitment to destroying cancer differently is stronger than ever at CytomX and we firmly believe that our multi-modality Probody therapeutic platform has the potential to deliver differentiated medicines for the treatment of people with cancer. Our company restructuring announced in July puts CytomX in the strongest possible position to maintain our technological leadership and advance our exciting, emerging pre-clinical and early clinical pipeline, capitalizing on our continued learnings from the clinic," said Sean McCarthy, D.Phil., chief executive officer and chairman at CytomX Therapeutics. "We also continue to work intensively with our partners to advance multiple novel product candidates towards clinical proof of concept," continued Dr. McCarthy.

Second Quarter Business Highlights and Recent Developments

Strategic realignment – CytomX announced restructuring plans to focus on its early-stage pipeline development, including partnered programs, and to realign capital resources, extending cash runway into 2025.
T-cell-engaging bispecific (TCB) EGFRxCD3 program – CX-904 is a conditionally activated TCB designed to target the epidermal growth factor receptor (EGFR) on cancer cells and the CD3 receptor on T cells within the tumor microenvironment, and is partnered with Amgen. The first patient was dosed in a Phase 1 study of CX-904 in patients with advanced solid tumors.
Ipilimumab Probody program – BMS-986249 and BMS-986288 are Probody versions of the CTLA4-targeting antibodies, ipilimumab and non-fucosylated ipilimumab, respectively, and are being developed by Bristol Myers Squibb. BMS-986249 is being evaluated in a randomized Phase 2 study in combination with nivolumab versus ipilimumab plus nivolumab in patients newly diagnosed with advanced melanoma. This novel combination is also being studied in advanced hepatocellular carcinoma, castration-resistant prostate cancer, and triple-negative breast cancer. Bristol Myers Squibb plans to present updated Phase 1 results for BMS-986249 at the ESMO (Free ESMO Whitepaper) Congress 2022 with the poster presentation titled "Anti–Cytotoxic T Lymphocyte Antigen-4 (CTLA 4) Probody BMS-986249 ± Nivolumab (NIVO) in Patients With Advanced Cancers: Updated Phase 1 Results." BMS-986288 is being evaluated as monotherapy and in combination with nivolumab in a Phase 1 study in advanced solid tumors.
CD71-directed antibody-drug conjugate (ADC) program – CX-2029 is a conditionally activated ADC directed toward CD71, the transferrin receptor, that is being co-developed by CytomX and AbbVie. Patient enrollment into the Phase 2 expansion study is now complete in all three solid cancer indications, including the esophageal/gastro-esophageal junction (E/GEJ) cancer cohort. The diffuse large B-cell lymphoma cohort was deprioritized due to strategic and competitive reasons and did not enroll any patients. A data update for the fully enrolled squamous non-small cell lung cancer cohort is expected in the fourth quarter of 2022. Data from the E/GEJ cancer cohort continues to mature.
CD166-directed ADC program – Praluzatamab ravtansine is a conditionally activated ADC directed toward CD166 and is wholly-owned by CytomX. In a three-arm Phase 2 study, praluzatamab ravtansine demonstrated single-agent activity in heavily-pretreated patients with advanced hormone receptor-positive, HER2-non-amplified breast cancer at the starting dose of 7 mg/kg every three weeks, but median progression-free survival data did not support further evaluation at this dose. While the emerging safety profile of the 6 mg/kg dose is encouraging, CytomX is not advancing this program alone and will seek a collaboration partnership.
Interferon (IFN) alpha-2b program – CX-801 is a wholly-owned IFN alpha-2b Probody. In preclinical studies, CX-801 demonstrated a wide therapeutic index with an enhanced tolerability profile versus unmasked IFN, without compromising its potent antitumor effects. CytomX continued to advance this program with the goal of submitting an investigational new drug application (IND) in the second half of 2023. Preclinical data for the program were presented at AACR (Free AACR Whitepaper) 2022.
EpCAM-directed ADC program – CX-2051 is a wholly-owned conditionally activated ADC directed toward the epithelial cell adhesion molecule (EpCAM), with potential applicability across multiple EpCAM-expressing epithelial cancers. CytomX has prioritized the development of CX-2051 and an IND submission is planned in the second half of 2023.
Early-stage programs – CytomX continued to work internally and with existing partners Astellas, AbbVie, Amgen, and Bristol Myers Squibb on the broad application of its multi-modality Probody platform to additional product candidates.
Publication – CytomX continued to publish key results supporting its platform and pipeline, taking the total preclinical and clinical manuscripts published since 2021 to eight. Nonclinical efficacy and safety of CX-2029 was published in the peer-reviewed journal Molecular Cancer Therapeutics. Preclinically, the anti-CD71 conditionally activated ADC exhibited a highly efficacious and acceptable safety profile that demonstrates the utility of the Probody platform to target CD71, an otherwise undruggable target. View Source
Priorities for 2022/2023

Complete company restructuring by end of 2022
Provide a data update for the Phase 2 study of CX-2029 in patients with squamous non-small cell lung cancer in the fourth quarter of 2022
Provide updated data from the Phase 2 study of praluzatamab ravtansine in advanced breast cancer in the fourth quarter of 2022
Continue enrolling patients with advanced solid tumors in the Phase 1 study of CX-904
Submit INDs for CX-801 and CX-2051 in the second half of 2023
Second Quarter 2022 Financial Results
Cash, cash equivalents and investments totaled $228 million as of June 30, 2022, compared to $305 million as of December 31, 2021.

Total revenue was $18 million for the three months ended June 30, 2022 compared to $16 million for the corresponding period in 2021. The increase in total revenue was largely related to the CD71 collaboration with AbbVie.

Research and development expenses increased by $5 million during the three months ended June 30, 2022 to $31 million compared to $26 million for the second quarter of 2021. The increase was primarily due to higher personnel-related expenses and laboratory contract services in support of our pre-clinical and clinical pipeline.

General and administrative expenses increased by $2.4 million during the second quarter of 2022 to $11.7 million. The increase was mainly in personnel and professional expenses.

Conference Call & Webcast Information
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 (800) 715-9871 (domestic) or (646) 307-1963 (international) and reference the conference ID 4032732. A live webcast of the call can be accessed on 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.

On August 4, 2022 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, reported financial results for the second quarter ended June 30, 2022 and provided business highlights (Press release, Akebia, AUG 4, 2022, View Source [SID1234617556]).

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"In May we outlined the pillars of our refined strategic focus in the wake of the unexpected Complete Response Letter (CRL) for vadadustat from the FDA to focus on driving Auryxia revenue while managing our overall spending, supporting the regulatory path for vadadustat, and thoughtfully investing in our pipeline," said John P. Butler, Chief Executive Officer of Akebia. "Today we are reporting 32.4% revenue growth for Auryxia versus the second quarter of 2021 and are increasing our revenue guidance for 2022. Since the beginning of the second quarter, we have regained the rights to vadadustat from Otsuka in the U.S., Europe, and other territories, completed our end of review conference with the FDA, and today we shared data for vadadustat in ARDS that we believe supports further development of the drug for this indication. The progress we’ve made in alignment with our refined focus is a testament to the resilience and tenacity of the Akebia team. We look forward to continuing our progress."

The company had several important business updates since the beginning of the second quarter 2022:

In April, Akebia completed a reduction in force, reducing the employee base by 42% of full-time employees, and further reducing open headcount for a 47% overall reduction.
In June, Akebia and Otsuka Pharmaceuticals Co. Ltd (Otsuka) agreed to terminate their U.S. and international collaboration agreements. As a result, Akebia has regained the rights for vadadustat from Otsuka in the U.S., Europe, China, Russia, Canada, Australia, the Middle East, and certain other territories. Vadadustat is under review by the European Medicines Agency (EMA) for the treatment of anemia associated with chronic kidney disease (CKD) in adults.
In July, Akebia completed an end of review conference with the U.S. Food & Drug Administration (FDA), the first step in the process to determine the path for a potential U.S. approval for vadadustat as a treatment of anemia due to CKD in patients on dialysis. The company received a CRL from the FDA for vadadustat in March 2022.
In July, Akebia repaid $25 million on its $100 million debt facility with Pharmakon. In exchange for the early payment, Pharmakon agreed to amend and waive certain provisions, as described in the Form 8-K filed by the company at the time. The repayment results in savings of approximately 34% of the company’s cash interest on the loan for the remainder of the term.
Today, in a separate press release, Akebia announced initial findings from an investigator-sponsored clinical study with the University of Texas Health Sciences Center, Houston (UTHealth Houston) evaluating vadadustat, Akebia’s investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the prevention and treatment of ARDS in clinical trial subjects with COVID-19 and hypoxemia (O2 saturation ≤94%).
"We clearly outlined our objective to manage the company with existing cash resources and ongoing cash from operations and we are pleased to have made significant progress both in terms of net product revenue growth and cost reduction measures," said David A. Spellman, Chief Financial Officer of Akebia. "Auryxia is delivering on a growth trajectory driven by an increase in net price per pill due to an improved payor mix and improved commercial contract terms. Further, our expenses have already begun to decrease significantly as a result of our refined strategy."

Financial Results

Revenues: Total revenue was $126.8 million for the second quarter of 2022 compared to $52.9 million for the second quarter of 2021.
Net product revenue was $43.7 million for the second quarter of 2022 compared with $33.0 million for the second quarter of 2021, a 32.4% increase; and, compared with $41.4 million for the first quarter of 2022, a 5.4% increase.
Akebia is increasing its net product revenue guidance for Auryxia to $170 – $175 million for fiscal year 2022, raising both the top and bottom end of the guidance range by $5 million. The guidance assumes, among other things, continued stabilization of the phosphate binder market and continued improvement of net realized price per tablet. The company’s gross margin continues to expand due to a reduction in supply chain costs and cost management activities.
License, collaboration and other revenue was $83.1 million for the second quarter of 2022 compared to $20.0 million for the second quarter of 2021. This increase reflects a nonrefundable and non-creditable payment of $55.0 million that Otsuka paid to Akebia in July 2022 under the terms of a termination and settlement agreement between the companies. In addition, the company recognized $15.5 million related to previously deferred revenue as of the date of termination and $9.6 million of non-cash consideration related to Otsuka’s obligations to complete certain agreed upon clinical activities.
COGS: Cost of goods sold was $18.6 million for the second quarter of 2022 compared to $52.5 million in the second quarter of 2021.The decrease compared to the prior year period was primarily due to a $30.3 million non-cash charge in 2021 related to an increase to the liability for excess purchase commitments during the second quarter of 2021.
R&D Expenses: Research and development expenses were $26.0 million for the second quarter of 2022 compared to $37.2 million for the second quarter of 2021. The decrease compared to the prior year period was primarily due to decreased headcount related costs related to the reduction in force and decreased consulting costs.
SG&A Expenses: Selling, general and administrative expenses were $32.8 million for the second quarter of 2022 compared to $41.7 million for the second quarter of 2021. The decrease compared to the same period in the prior year was primarily due to decreased headcount related costs as a result of the reduction in force and lower marketing expenses.
Restructuring: In connection with its previously announced workforce reductions, Akebia incurred $14.5 million in restructuring charges in the second quarter of 2022, primarily related to one-time termination benefits and contractual termination benefits including severance, non-cash stock-based compensation expense, healthcare and related benefits.
Net Income: Net income was $29.3 million for the second quarter of 2022 compared to a $83.0 million net loss for the second quarter of 2021.
Cash Position: Cash and cash equivalents as of June 30, 2022, were $143.9 million, which does not include the $55.0 million cash payment Akebia received from Otsuka in July 2022 and does not reflect Akebia’s approximately $25.0 million prepayment made to Pharmakon in July 2022. Akebia believes that its cash resources will be sufficient to fund its current operating plan for at least the next twelve months. Akebia’s operating plan includes assumptions pertaining to cost avoidance measures and the reduction of overhead costs resulting from the planned amendment of certain contractual arrangements, including with certain supply partners, and the reduction of certain infrastructure costs. The outcome of these assumptions, such as the potential amendment of certain contractual arrangements with supply partners, are outside of Akebia’s control. In addition, future decisions by the FDA or foreign regulatory agencies related to the potential regulatory approval of vadadustat or our ability to generate additional value from vadadustat through partnerships or other transactions may potentially further extend our cash runway, but such future decisions or transactions are not contemplated in our operating plan.
"A focus on our three strategic pillars have guided us to the point where we believe our existing cash resources and revenues from Auryxia will be sufficient to fund our company’s current operating plan for the next several years," said David A. Spellman, Chief Financial Officer of Akebia. "With key inflection points such as a potential European approval and partnering for vadadustat, we look forward to rebuilding in a measured way."

Conference Call

Akebia will host a conference call on Thursday, August 4, 2022, at 4:30 p.m. Eastern Time to discuss its second quarter financial results and provide business updates. To listen to the conference call on August 4th, please dial (833) 630-1955 (domestic) or (412) 317-1836 (international) and ask to join into the Akebia Therapeutics call. The call will also be webcast LIVE and can be accessed via the Investors section of Akebia’s website at View Source

A replay of the conference call will be available two hours after the completion of the call through August 10, 2022. To access the replay, dial (877) 344-7529 (domestic) or (412) 317-0088 (international) and reference replay access code 3608580. An online archive of the conference call can be accessed via the Investors section of Akebia’s website at View Source

On August 4, 2022 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, 2022 (Press release, Guardant Health, AUG 4, 2022, View Source [SID1234617555]).

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Recent Highlights

Revenue of $109.1 million for the second quarter of 2022, an increase of 19% over the corresponding period of 2021
Reported 29,300 tests to clinical customers and 6,000 tests to biopharmaceutical customers in the second quarter of 2022, representing an increase of 40% and 65%, respectively, over the second quarter of 2021
Received Medicare Coverage for Guardant Reveal, the first blood-only liquid biopsy test for molecular residual disease testing now covered for certain fee-for-service Medicare patients in the US with stage II or III colorectal cancer
Completed the purchase of the Guardant Health AMEA Joint Venture, creating a unified organization to expand commercialization of Guardant Health’s industry-leading liquid biopsy technology across the region
Executed a strategic partnership agreement to offer comprehensive genomic profiling tests to biopharmaceutical companies in China with Adicon, a leading independent clinical laboratory company
The Company’s Shield LDT launch was well received by clinicians and patients and with early activity exceeding expectations
Expect both ECLIPSE readout and PMA submission for Shield assay during the second half of the year
"We ended the second quarter with record revenue for Guardant Health with strong volume growth in Clinical Oncology while growing and strengthening our base of biopharma partners. We were pleased to receive Medicare coverage for Guardant Reveal, providing stage II or III colorectal cancer patients and their doctors greater access to an easy to use blood-based test for molecular residual disease testing. We expect this to help fuel continued expansion as we look ahead to future product launches in the second half of the year," said Helmy Eltoukhy, co-founder and co-CEO.

"We have had an exciting second quarter with the recent launch of our Shield LDT screening test. We have observed strong adherence to our blood-based screening test, and better than expected uptake by early clinical adopters," said AmirAli Talasaz, co-founder and co-CEO. "We continue to progress our pivotal ECLIPSE trial. We remain confident in our ambition to develop Shield into the leading non-invasive CRC screening methodology with future expansion into high-sensitivity multi-cancer screening."

Second Quarter 2022 Financial Results

Revenue was $109.1 million for the three months ended June 30, 2022, a 19% increase from $92.1 million for the three months ended June 30, 2021. Precision oncology revenue grew 27%, driven predominantly by an increase in clinical testing volume and biopharma sample volume, which grew 40% and 65%, respectively, over the prior year period. Development services and other revenue decreased 12%, owing to multiple factors. The primary drivers were the change in collaboration projects with biopharmaceutical customers for companion diagnostic development and regulatory approval services, and the discontinuation of our Guardant-19 tests in August 2021. These factors were partially offset by revenues earned from licensing our technologies during the three months ended June 30, 2022.

Gross profit, or total revenue less cost of precision oncology testing and cost of development services and other, was $72.4 million for the second quarter of 2022, an increase of $10.2 million from $62.2 million for the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 66%, as compared to 68% for the corresponding prior year period.

Operating expenses were $202.7 million for the second quarter of 2022, as compared to $159.8 million for the corresponding prior year period, an increase of 27%. Non-GAAP operating expenses were $176.2 million for the second quarter of 2022, as compared to $124.7 million for the corresponding prior year period.

Net loss attributable to Guardant Health, Inc. common stockholders was $229.4 million for the second quarter of 2022, as compared to $97.6 million for the corresponding prior year period. Net loss per share attributable to Guardant Health, Inc. common stockholders was $2.25 for the second quarter of 2022, as compared to $0.96 for the corresponding prior year period. Non-GAAP net loss was $101.8 million for the second quarter of 2022, as compared to $61.4 million for the corresponding prior year period. Non-GAAP net loss per share was $1.00 for the second quarter of 2022, as compared to $0.61 for the corresponding prior year period.

Adjusted EBITDA loss was $94.3 million for the second quarter of 2022, as compared to a $56.4 million loss for the corresponding prior year period.

Cash, cash equivalents and marketable securities were $1.2 billion as of June 30, 2022.

2022 Guidance

Guardant Health continues to expect full year 2022 revenue to be in the range of $460 million to $470 million, representing 23% to 26% growth over full year 2021.

Webcast Information

Guardant Health will host a conference call to discuss the second quarter 2022 financial results after market close on Thursday, August 4, 2022 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 of noncontrolling interest liability, adjustments relating to 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, changes in estimated fair value of noncontrolling interest liability, adjustments relating to redeemable noncontrolling 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 August 4, 2022 NGM Biopharmaceuticals, Inc. (NGM Bio) (Nasdaq: NGM), a clinical-stage biotechnology company focused on discovering and developing transformative therapeutics for patients, reported financial results for the quarterly period ended June 30, 2022 (Press release, NGM Biopharmaceuticals, AUG 4, 2022, View Source [SID1234617554]).

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"With the dosing of our first patient in the NGM438 Phase 1 clinical trial in the second quarter, we now have all three of our myeloid checkpoint inhibition programs in the clinic and a total of seven clinical-stage programs in our pipeline," said David J. Woodhouse, Ph.D., Chief Executive Officer at NGM Bio. "This progress has set the foundation for us to deliver important clinical trial results over the next 18 months. In particular, we look forward to the topline Phase 2 data from the CATALINA trial for NGM621, a monoclonal antibody product candidate engineered to potently inhibit complement C3 for patients with geographic atrophy, and an initial interim monotherapy data readout from the Phase 1a trial of NGM707, both expected in the fourth quarter of this year."

Key Second Quarter and Recent Highlights

Oncology

Initiated the Phase 1/1b clinical trial of NGM438 as a monotherapy and in combination with KEYTRUDA for the treatment of patients with advanced solid tumors.
Initiated the Phase 1b portion of the Phase 1/2 trial of NGM707 in combination with KEYTRUDA for the treatment of patients with advanced solid tumors.
Presented preclinical research for NGM707, NGM438 and NGM831, an ILT3 antagonist antibody product candidate, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting.
Retinal Disease

Remain on track for topline data readout of the Phase 2 CATALINA trial of NGM621 in patients with geographic atrophy in the fourth quarter of 2022, to be followed by a planned presentation of results at a medical conference in the same quarter.
Corporate Highlights

Announced that Siobhan Nolan Mangini, who has served as Chief Financial Officer since July 2020, was appointed to the additional role of President of NGM Bio. David J. Woodhouse, Ph.D. continues to serve as NGM Bio’s Chief Executive Officer. William J. Rieflin, who served as Executive Chairman of NGM Bio’s Board of Directors since September 2018, transitioned to Chairman of the Board effective July 1, 2022.
Hosted the final two sessions of a four-part virtual R&D overview titled the "Explorer Series," which showcased NGM Bio’s lead myeloid checkpoint program, NGM707, and NGM621, respectively. Replays of each webcast will be available under the Investors and Media section of NGM Bio’s website at View Source for one year following the date of the respective webcast.
Second Quarter 2022 Financial Results

NGM Bio reported a net loss of $46.5 million for the quarter ended June 30, 2022, compared to a net loss of $36.7 million for the same period in 2021.
Related party revenue from our collaboration with Merck Sharp & Dohme LLC, or Merck, was $8.3 million for the quarter ended June 30, 2022, compared to $16.8 million for the same period in 2021. In 2021, we entered into an amended and restated research collaboration, product development and license agreement with Merck, or the Amended Collaboration Agreement. Under the Amended Collaboration Agreement, commencing April 1, 2022, our related party revenue from Merck has decreased substantially and is expected to continue to remain at a significantly lower level through March 31, 2024.
R&D expenses were $45.4 million for the quarter ended June 30, 2022, compared to $43.6 million for the same period in 2021. R&D expenses increased $1.9 million in the quarter as compared to the same period in 2021, primarily due to our ongoing clinical trials of NGM707, NGM831, NGM120 and NGM438, and personnel-related expenses partially offset by decreased expenses for our manufacturing activities and our clinical trials of aldafermin.
General and administrative expenses were $9.9 million for the quarter ended June 30, 2022, compared to $9.8 million for the same period in 2021.
Cash, cash equivalents and short-term marketable securities were $297.8 million as of June 30, 2022, compared to $366.3 million as of December 31, 2021.