On July 29, 2021 Labcorp (NYSE: LH), a leading life sciences company, reported results for the second quarter ended June 30, 2021, and raised full-year guidance (Press release, LabCorp, JUL 29, 2021, View Source [SID1234585389]).

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"Our strategy focusing on science, innovation and technology led to strong second quarter results as we continued to advance health care and patient experiences," said Labcorp Chairman and CEO Adam Schechter. "Patients and pharmaceutical clients accelerated their return to normal health care and business activities, which drove 46% revenue growth in our base business. In light of our second quarter performance and improved outlook, we are raising full-year financial guidance."

Labcorp continues to further scientific advancements and make progress on its five-pillar strategy. As an example, in July the company signed an agreement to acquire the outreach laboratory business of Minnesota-based North Memorial Health and provide management services to its inpatient lab. Additionally, the company made significant strides in oncology, introducing capabilities that bring together its leading diagnostic testing and comprehensive drug development services. By doing so, Labcorp can deliver targeted solutions by leveraging breakthrough science and insights from clinical data to aid better treatment decisions and improved patient outcomes. The company also acquired the remaining ownership interest in OmniSeq, a pioneer in solid tumor profiling, after the quarter ended. This addition enhances Labcorp’s growing portfolio of diagnostic tests and clinical trial opportunities for people with cancer.

Separately, the company continued its critical contributions to the ongoing pandemic response, working with state and federal governments to expand testing access and facilitate vaccinations, and supporting the development of COVID-19 vaccines and therapies. To date, the company has performed over 50 million COVID-19 tests.

Consolidated Results

Second Quarter Results

Revenue for the quarter was $3.84 billion, an increase of 38.7% over $2.77 billion in the second quarter of 2020. The increase was due to organic Base Business growth of 35.5%, acquisitions of 1.2%, and favorable foreign currency translation of 2.0%. COVID-19 PCR and antibody testing (COVID-19 Testing) revenue of $444.0 million was flat compared to last year. Base Business includes Labcorp’s operations except for COVID-19 Testing.

Operating income for the quarter was $704.1 million, or 18.3% of revenue, compared to $297.7 million, or 10.8%, in the second quarter of 2020. The company recorded amortization, restructuring charges, and special items, which together totaled $135.8 million in the quarter, compared to $83.0 million during the same period in 2020. Adjusted operating income (excluding amortization, restructuring charges, and special items) for the quarter was $839.9 million, or 21.9% of revenue, compared to $380.7 million, or 13.8%, in the second quarter of 2020. The increase in operating income and margin was primarily due to organic Base Business growth, acquisitions, and LaunchPad savings, partially offset by higher personnel costs.

Net earnings for the quarter were $467.4 million, compared to $231.6 million in the second quarter of 2020. Diluted EPS were $4.76 in the quarter, up from $2.37 in the same period in 2020. Adjusted EPS (excluding amortization, restructuring charges, and special items) were $6.13 in the quarter, up from $2.57 in the second quarter of 2020.

Operating cash flow for the quarter was $487.2 million, compared to $370.7 million in the second quarter of 2020. The increase in operating cash flow was due to favorable working capital, partially offset by lower cash earnings. Capital expenditures totaled $97.2 million, compared to $98.5 million a year ago. As a result, free cash flow (operating cash flow less capital expenditures) was $390.0 million, up from $272.2 million in the second quarter of 2020.

At the end of the quarter, the company’s cash balance and total debt were $2.0 billion and $5.4 billion, respectively. During the quarter, the company repurchased $300.0 million of stock representing approximately 1.1 million shares.

Year-To-Date Results

Revenue was $8.00 billion, an increase of 43.1% from $5.59 billion in the first half of 2020. The increase was due to organic growth of 40.3%, acquisitions of 1.1%, and favorable foreign currency translation of 1.7%. The organic revenue increase includes a 23.8% contribution from the company’s organic Base Business and a 16.6% increase in COVID-19 Testing.

Operating income was $1,762.0 million, or 22.0% of revenue, compared to $105.1 million, or 1.9%, in the first half of 2020. The company recorded amortization, restructuring charges, special items, and impairments, which together totaled $259.8 million in the first half of 2021, compared to $641.5 million during the same period in 2020. This decrease was primarily due to the goodwill impairment recorded in the first quarter of 2020. Adjusted operating income (excluding amortization, restructuring charges, special items, and impairments) was $2,021.8 million, or 25.3% of revenue, compared to $746.6 million, or 13.3%, in the first half of 2020. The increase in operating income and margin was primarily due to organic Base Business growth, acquisitions, and LaunchPad savings, partially offset by higher personnel costs.

Net earnings (losses) in the first half of 2021 were $1,237.0 million, compared to ($85.6) million in the first half of 2020. Diluted EPS were $12.58 in the first half of 2021 compared to ($0.88) in the same period in 2020. Adjusted EPS (excluding amortization, restructuring charges, special items, and impairments) were $14.92 in the first half of 2021 compared to $4.94 in the first half of 2020.

Operating cash flow was $1,644.8 million, compared to $574.5 million in the first half of 2020. The increase in operating cash flow was due to higher cash earnings and favorable working capital. Capital expenditures totaled $192.6 million, compared to $205.1 million during the same period in 2020. As a result, free cash flow (operating cash flow less capital expenditures) was $1,452.2 million, up from $369.4 million in the first half of 2020.

Second Quarter Segment Results

The following segment results exclude amortization, restructuring charges, special items, and unallocated corporate expenses.

Diagnostics

Revenue for the quarter was $2.37 billion, an increase of 39.7% over $1.69 billion in the second quarter of 2020. The increase was due to organic Base Business growth of 37.8%, acquisitions of 1.1%, and favorable foreign currency translation of 0.9%. COVID-19 Testing revenue of $444.0 million was flat versus last year.

Total volume (measured by requisitions) increased by 39.6% as organic volume increased by 38.7% and acquisition volume contributed 0.9%. The organic volume growth was due to a 39.4% increase in Base Business, partially offset by a (0.7%) decrease in COVID-19 Testing. Price / mix increased by 0.1% due to currency of 0.9%, COVID-19 Testing of 0.7%, and acquisitions of 0.2%, partially offset by organic Base Business of (1.7%) due to the volume recovery. Organic Base Business volume was up 48.2% while price was up 3.1%.

Adjusted operating income for the quarter was $663.2 million, or 28.0% of revenue, compared to $308.8 million, or 18.2%, in the second quarter of 2020. The increase in adjusted operating income and adjusted operating margin was primarily due to organic Base Business growth and LaunchPad savings, partially offset by higher personnel costs. The company remains on track to deliver approximately $200 million of net savings from its three-year Diagnostics LaunchPad initiative by the end of 2021.

Drug Development

Revenue for the quarter was $1.50 billion, an increase of 36.7% over $1.09 billion in the second quarter of 2020. The increase was due to organic Base Business growth of 32.1%, acquisitions of 1.3%, and favorable foreign currency translation of 3.7%, partially offset by lower COVID-19 Testing performed through its Central Laboratories business of (0.3%). Drug Development’s Base Business benefited from broad-based demand, including COVID-19 vaccine and therapeutic work.

Adjusted operating income for the quarter was $221.1 million, or 14.8% of revenue, compared to $112.7 million, or 10.3%, in the second quarter of 2020. The increase in adjusted operating income and adjusted operating margin was primarily due to organic Base Business growth and LaunchPad savings, partially offset by higher personnel costs. The company continues to develop and execute LaunchPad programs to support profitable growth in Drug Development.

Net orders and net book-to-bill during the trailing twelve months were $7.86 billion and 1.41, respectively. Backlog at the end of the quarter was $14.28 billion, compared to $13.97 billion last quarter, and the company expects approximately $4.87 billion of its backlog to convert into revenue in the next twelve months.

Outlook for 2021

Labcorp is raising 2021 full year guidance to reflect its strong second quarter performance and improved full year outlook. The following guidance assumes foreign exchange rates effective as of June 30, 2021 for the remainder of the year. Enterprise level guidance includes the estimated impact from currently anticipated capital allocation, including acquisitions and share repurchases.

(1) 2021 Updated Guidance includes a benefit from foreign currency translation of 1.0%, Previous 2021 Guidance was 0.7%

(2) Enterprise level revenue is presented net of intersegment transaction eliminations, including Drug Development COVID-19 Testing revenue

(3) 2021 Updated Guidance includes a benefit from foreign currency translation of 0.4%, Previous 2021 Guidance was 0.3%

(4) 2021 Updated Guidance includes a benefit from foreign currency translation of 2.0%, Previous 2021 Guidance was 1.4%

(5) Free Cash Flow consists of operating cash flow less capital expenditures

Use of Adjusted Measures

The company has provided in this press release and accompanying tables "adjusted" financial information that has not been prepared in accordance with GAAP, including adjusted net income, adjusted EPS (or adjusted net income per share), adjusted operating income, adjusted operating margin, free cash flow, and certain segment information. The company believes these adjusted measures are useful to investors as a supplement to, but not as a substitute for, GAAP measures, in evaluating the company’s operational performance. The company further believes that the use of these non-GAAP financial measures provides an additional tool for investors in evaluating operating results and trends, and growth and shareholder returns, as well as in comparing the company’s financial results with the financial results of other companies. However, the company notes that these adjusted measures may be different from and not directly comparable to the measures presented by other companies. Reconciliations of these non-GAAP measures to the most comparable GAAP measures and an identification of the components that comprise "special items" used for certain adjusted financial information are included in the tables accompanying this press release.

The company today is providing an investor relations presentation with additional information on its business and operations, which is available in the investor relations section of the company’s website at View Source Analysts and investors are directed to the website to review this supplemental information.

A conference call discussing Labcorp’s quarterly results will be held today at 9:00 a.m. ET and is available by dialing 877-898-8036 (720-634-2811 for international callers). The conference ID is 1789612. A telephone replay of the call will be available through August 12, 2021, and can be heard by dialing 855-859-2056 (404-537-3406 for international callers). The conference ID for the replay is 1789612. A live online broadcast of Labcorp’s quarterly conference call on July 29, 2021, will be available at Labcorp Investor Relations website beginning at 9:00 a.m. ET. This webcast will be archived and accessible through July 15, 2022.

On July 29, 2021 Genocea Biosciences, Inc. (Nasdaq: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, reported a business update for the second quarter ended June 30, 2021 (Press release, Genocea Biosciences, JUL 29, 2021, View Source [SID1234585388]).

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"I am pleased with the GEN-011 program progress. We continue to believe that GEN-011 has the potential to represent a major advancement in solid tumor T cell therapies based on the use of optimal T cells and targets. These T cells are derived from easily accessible peripheral blood as opposed to the tumor itself and are activated to pursue the surface-presented neoantigens of anti-tumor CD8+ and CD4+ T cell responses, prioritized by our proprietary ex vivo discovery platform, ATLAS," said Chip Clark, Genocea’s President and Chief Executive Officer.

Clinical updates
GEN-011 (investigational neoantigen-targeted peripheral T cell therapy – or NPT)

Genocea previously announced dosing of the first patient in its GEN-011 TiTAN clinical trial. GEN-011 is a next-generation solid tumor therapy comprised of neoantigen-targeted peripheral T cells ("NPTs") selectively expanded on neoantigens of anti-tumor CD8+ and CD4+ T cell responses identified by ATLAS. The TiTAN trial is an open-label, multi-center Phase1/2a trial evaluating safety, tolerability, T cell persistence and proliferation and clinical efficacy. Preliminary clinical response data from an initial subset of patients is expected in late Q4 2021 or Q1 2022.
GEN-009 (investigational neoantigen vaccine)

At the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") 2021 Annual Meeting in June, the Company presented long-term follow-up clinical and immunogenicity data from its ongoing Phase 1/2a clinical study demonstrating that GEN-009 continues to generate broad immune responses against neoantigens that can lead to sustained clinical responses. In Part B of the clinical trial, of the nine CPI-sensitive patients, the data show four patients experienced novel reduction in tumor volume post-GEN-009 dosing and achieved independent RECIST responses after vaccination, including three partial responses ("PRs") and one complete response ("CR"). This is an increase from the two PRs and one CR previously reported at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s ("SITC") 2020 Annual Meeting. The remaining five CPI-sensitive patients all achieved disease stabilization. Across the CPI-sensitive cohort, the median duration without disease progression after initial GEN-009 vaccination was 15 months. Of the seven CPI-refractory patients, two achieved stable disease after initial GEN-009 vaccination for up to 10 months. Expanded immunogenicity data revealed that vaccine-specific T cell responses were detected ex vivo after the first dose of the vaccine and continued to rise with each subsequent dose. Vaccine-specific T cell responses remained significantly elevated over baseline and post-CPI, pre-vaccine timepoints for at least 6 months, showing persistence of the vaccine response.
Research updates
Strengthened Scientific Advisory Board

Marcela Maus, M.D., Ph.D. joined the Company’s Scientific Advisory Board. Dr. Maus, the Director of the Cellular Immunotherapy Program at Mass General Cancer Center and an Associate Professor of Medicine at Harvard Medical School, is internationally known for her work as a translational physician-scientist in the field of immunology, particularly T cell immunotherapies and cellular therapies in the treatment of cancer.
Upcoming presentations
Bioprocessing Summit – Event Details

Presentation Title: GEN-011 PLANET Process: A Robust and Rapidly Scalable Manufacturing Process to Generate Neoantigen-Targeted Peripheral T Cells (NPTs)
Date/Time: Thursday, August 19 – 12:40 p.m. ET

Financial and other updates
Second quarter 2021 financial results

Cash position: As of June 30, 2021, cash and cash equivalents were $60.4 million compared to $79.8 million as of December 31, 2020.
Net loss: Net loss was $4.3 million or $0.20 diluted net loss per share for the quarter ended June 30, 2021, compared to $11.3 million or $0.39 per share for the same period in 2020. Net loss was $16.3 million or $0.37 diluted net loss per share for the six months ended June 30, 2021, compared to $24.2 million or $0.84 per share for the same period in 2020.
Research and Development ("R&D") expenses: R&D expenses were $10.5 million for the quarter ended June 30, 2021, compared to $8.6 million for the same period in 2020. R&D expenses were $19.3 million for the six months ended June 30, 2021, compared to $18.6 million for the same period in 2020.

The increase in R&D expenses for the three months ended June 30, 2021 is mainly due to growth in our internal research and manufacturing teams and GEN-011 manufacturing and clinical costs.

The increase in R&D expenses for the six months ended June 30, 2021 is mainly due to growth in our internal research and manufacturing teams, partially offset by the timing of GEN-011 engineering and clinical manufacturing costs.
General and Administrative ("G&A") expenses: G&A expenses were $4.0 million for the quarter ended June 30, 2021, compared to $3.5 million for the same period in 2020. G&A expenses were $7.7 million for the six months ended June 30, 2021, compared to $6.9 million for the same period in 2020.

The increase in G&A expenses for both periods is mainly due to growth in our internal G&A team, partially offset by decreased facility costs.
Other income (expense): Other income (expense) was income of $10.2 million for the quarter ended June 30, 2021, compared to expense of $0.2 million for the same period in 2020. Other income (expense) was income of $10.7 million for the six months ended June 30, 2021, compared to income of $0.4 million for the same period in 2020.

The increase in other income (expense) for both periods is mainly due to the non-cash impact of the fair-value adjustment for the 33.6 million liability-classified warrants issued in connection with our July 2020 private placement.
Guidance

Genocea’s operating plan extends its cash runway to the end of 2022.
Conference Call
Genocea will host a conference call and webcast today at 8:30 a.m. E.T. Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 6789021. To join the live webcast, please visit the presentation page of the investor relations section of the Genocea website at View Source A webcast replay of the conference call will be available on the Genocea website beginning approximately two hours after the event and will be archived for 90 days.

On July 29, 2021 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, reported that Chief Executive Officer, Bill Newell, will participate in a panel titled "ADCs – Take Me to Your Tumor" at the 12th Annual Wedbush PacGrow Healthcare Virtual Conference on Wednesday, August 11, at 2:20 p.m. ET / 11:20 a.m. PT (Press release, Sutro Biopharma, JUL 29, 2021, View Source [SID1234585387]).

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A live webcast of the presentation will be accessible through the News and Events page of the Investor Relations section on the company’s website at www.sutrobio.com. Archived replays of the webcasts will be available on the company’s website for approximately 30 days following each live presentation.

On July 29, 2021 Atreca, Inc. (Atreca) (NASDAQ: BCEL), a clinical-stage biotechnology company focused on developing novel therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, reported initial data from the dose escalation portion of its ongoing Phase 1b trial evaluating ATRC-101 in select solid tumor types that displayed greater than 50% target expression in preclinical studies (Press release, Atreca, JUL 29, 2021, View Source [SID1234585386]).

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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

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"We are pleased to present initial summary data from our first-in-human study of ATRC-101," said Jonathan Benjamin, M.D., Ph.D., Sr. Vice President, Clinical Research. "We are very encouraged by the results observed thus far in a relatively small set of heavily pre-treated participants. ATRC-101, which targets a novel tumor antigen and acts via a novel MOA in oncology, was well-tolerated at all doses evaluated in the study with no dose-limiting toxicities observed. Furthermore, disease control is associated with ATRC-101 target expression, and the preliminary biomarker analysis is consistent with the proposed MOA for ATRC-101. We anticipate reporting additional data from monotherapy dose expansion cohorts in the Phase 1b trial and from combination cohorts evaluating ATRC-101 with pembrolizumab in 2022, and initiating additional combination cohorts evaluating ATRC-101 with chemotherapy later this year."

"ATRC-101 represents a new approach in cancer research," said Dr. John Powderly, M.D., Founder and President of the Carolina BioOncology Institute. "While these data are from a limited number of treatment-refractory patients, I was pleased to see that ATRC-101 was well-tolerated and appears to have an informative biomarker. I look forward to continue investigating the potential of ATRC-101 in cancer patients."

ATRC-101 Phase 1b Study Design

The Phase 1b trial is a first-in-human, open-label study of ATRC-101 in patients with select solid tumor cancers, utilizing a 3+3 design for the dose escalation portion. Enrollment is limited to patients with tumor types reactive to ATRC-101 in more than 50% of historical patient samples evaluated preclinically, which includes non-small cell lung, breast, ovarian, and colorectal cancer, as well as acral melanoma. The objectives of the study are to characterize safety, determine a maximum tolerated or recommended dose for expansion, measure initial clinical activity, and characterize potential biomarkers of activity in tumors, plasma, and peripheral blood mononuclear cells (PBMC).

Initial Study Results

A total of 26 participants had been dosed in the trial as of the data cut-off date of July 16th, including 24 participants treated at five once-every-21-day (q21d) dose levels, 0.3 mg/kg (n = 3), 1 mg/kg (n = 3), 3 mg/kg (n = 9), 10 mg/kg (n = 6), and 30 mg/kg (n = 3), and two participants treated at one once-every-14-day (q14d) dose level, 1 mg/kg (n = 2). Tumor types enrolled in the q21d cohorts were colorectal (n = 13), ovarian (n = 5), breast (n = 3), non-small cell lung (n = 2) and acral melanoma (n = 1). Participants enrolled in the study had received a median of five prior lines of treatment. Of the 26 participants dosed, 24 participants treated with any dose of ATRC-101 were evaluable for safety, 19 for PK, 20 for clinical response, and 18 participants for target expression.

Pharmacokinetics (PK)

The peak concentration of ATRC-101 was dose proportional and minimal accumulation was observed following multiple doses. ATRC-101’s half-life was 10.5 days and was relatively consistent across all dose levels.

Safety

ATRC-101 was generally well-tolerated, with no dose-limiting toxicities at doses ≤30 mg/kg. Thirty-three percent of participants (n = 8) had at least one grade ≥ 3 adverse event (AE). Respiratory failure (n = 2) and sepsis (n = 2) were the only grade ≥ 3 AEs observed in more than one participant, and the one grade 4 treatment-emergent AE observed was a case of acute respiratory failure. The most common treatment-related AEs were fatigue (n = 5, 21%), nausea (n = 4, 17%), and tumor pain (n = 4, 17%).

Disease Efficacy Observations

Eight of the 20 participants (40%) evaluable prior to the data cut-off in this analysis experienced stable disease (SD) as their best RECIST response, including four with tumor reduction observed. The remaining 12 participants had progressive disease as their best RECIST response. Disease control observed in the study was associated with target expression, as 3 of 6 (50%) of participants with evaluable response assessments and baseline tumor H-scores ≥50 achieved SD, compared with 1 of 9 (11%) evaluable participants with an H-score <50.

Biomarkers

Preliminary biomarker evaluation supports the proposed MOA of ATRC-101 initially proposed from preclinical studies. Expansion of peripheral blood CD8+ T cells was observed at day 8 following dosing with ATRC-101 among participants with evaluable baseline tumor biopsies and tumor H-scores ≥50. Preliminary observations of serum cytokines appeared consistent with the proposed MOA of innate immune system activation leading to an adaptive immune response against tumor.

Next Steps

Phase 1b monotherapy dose expansion is ongoing at 30 mg/kg, a combination study evaluating ATRC-101 with pembrolizumab is active and another combination study with pegylated liposomal doxorubicin is expected to begin enrolling patients in 4Q21. Atreca expects to report additional monotherapy data by mid-2022, pembrolizumab combination data in mid-2022 and chemotherapy combination data in late 2022. Supported by data from the dose escalation portion of the trial, Atreca is developing a diagnostic to select patients based on target expression.

"We are very pleased with the results of the Phase 1b study presented today and look forward to the continued clinical development of ATRC-101 as both a monotherapy and in combination studies," said John Orwin, Chief Executive Officer of Atreca. "ATRC-101 is the first anti-cancer agent discovered via Atreca’s platform to be tested in humans, and we believe that the activity observed in the trial provides a strong rationale for further investigation. Furthermore, we believe that these data provide validation for the ability of our discovery platform to identify novel, druggable tumor targets shared across groups of patients. We would like to thank all of the patients who enrolled, their families, and their caregivers for participating in this study."

ATRC-101 Conference Call and Webcast Information

Atreca will host a conference call/webcast today at 8:00 a.m. ET. The live webcast, including slides, can be accessed through the Events & Presentations section of the Company’s website at View Source To access the conference call, please dial (800) 373-6606 (United States) or (409) 937-8918 (international) and reference the conference ID 2386207. An archived replay of the webcast will be available on the Company’s website for 90 days following the live event.

About ATRC-101
ATRC-101 is a monoclonal antibody derived from an antibody identified using Atreca’s discovery platform. ATRC-101 is believed to function through Driver Antigen Engagement, a novel mechanism of action in oncology. This mechanism involves systemic delivery of an antibody that, in preclinical models, engages the innate immune system to cause remodeling of the tumor microenvironment and drive T cell-mediated destruction of tumor cells. Atreca has identified the target of ATRC-101 as a tumor-specific ribonucleoprotein (RNP) complex. ATRC-101 has demonstrated robust anti-tumor activity as a single agent in multiple preclinical syngeneic tumor models, including one model in which PD-1 checkpoint inhibitors typically display limited activity. Further, ATRC-101 has been shown to react in vitro with a majority of human ovarian, non-small cell lung, colorectal, breast cancers and acral melanoma samples from multiple patients. Atreca initiated a Phase 1b first-in-human study of ATRC-101 in participants with select solid tumor cancers in early 2020. Clinical trials to evaluate ATRC-101 in combination with a PD-1 inhibitor and in combination with chemotherapy are planned for 2021, as well as in monotherapy dose expansion cohorts in the ongoing Phase 1b trial. (Press release, Atreca, JUL 29, 2021, View Source [SID1234585386])

On July 29, 2021 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat genetically defined diseases, reported business highlights and financial results for the second quarter ended June 30, 2021 (Press release, Agios Pharmaceuticals, JUL 29, 2021, View Source [SID1234585385]).

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"Our first quarter as a company solely focused on genetically defined diseases was marked by several significant milestones, most notably our U.S. and EU regulatory submissions for mitapivat for the treatment of adults with PK deficiency, bringing us one step closer to potentially delivering the first disease-modifying treatment for people with this serious and underserved condition," said Jackie Fouse, Ph.D., chief executive officer at Agios. "We continue to unlock the potential of mitapivat for people with other chronic hemolytic anemias and are gaining momentum on our pivotal programs in thalassemia and sickle cell disease. This year, we look forward to initiating our two registrational Phase 3 trials – ENERGIZE and ENERGIZE-T – in not regularly transfused and regularly transfused adults with thalassemia, as well as our pivotal Phase 2/3 trial of mitapivat in sickle cell disease."

SECOND QUARTER 2021 & RECENT HIGHLIGHTS

Completed two regulatory filings for approval of mitapivat in adults with PK deficiency; submitted new drug application (NDA) in the U.S. and marketing authorization application (MAA) in the EU.
Presented full analysis of data from Phase 3 ACTIVATE and ACTIVATE-T studies of mitapivat in adults with PK deficiency at European Hematology Association (EHA) (Free EHA Whitepaper) Virtual Congress; studies met primary and secondary endpoints, including patient-reported outcome (PRO) measures that address symptom burden and quality-of-life impact in adults.
Presented data from Phase 2, open-label, multicenter study of mitapivat in adults with non-transfusion dependent α- or β-thalassemia at EHA (Free EHA Whitepaper) Virtual Congress; study met its primary endpoint, with 16 of the 20 patients (80%) achieving a hemoglobin increase of ≥1.0 g/dL from baseline at one or more assessments during Weeks 4-12.
Launched myAgios patient support services for people living with PK deficiency and their caregivers, providing tailored support, educational resources and opportunities to connect with other patients and caregivers in the community.
Completed hiring and training of customer-facing and patient support team that will support the U.S. launch of mitapivat in PK deficiency upon product approval.
Announced succession plan for Chris Bowden, M.D., who will transition from his role as chief medical officer to strategic advisor following his retirement on Sept. 1, at which time Sarah Gheuens, M.D., Ph.D., vice president of clinical development, will assume the role.
Repurchased approximately 10.5 million shares of Agios common stock, inclusive of shares acquired from Bristol-Myers Squibb Company (BMS) and its affiliates, at an average price of $50.41 per share. This accounts for $529 million of the up to $1.2 billion of share repurchases authorized by the Board of Directors following the company’s sale of its oncology business to Servier.
KEY UPCOMING MILESTONES

Initiate two Phase 3 studies of mitapivat, ENERGIZE and ENERGIZE-T, in not regularly transfused and regularly transfused adults with thalassemia, by year-end.
Initiate Phase 2/3 study of mitapivat in sickle cell disease by year-end.
Host investor day in fourth quarter to share more information about commercial launch planning for mitapivat in PK deficiency and research and development pipeline.
Data Presentations

Submit data from ongoing collaborator-led clinical studies of mitapivat in sickle cell disease for presentation at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, to be held Dec. 11-14.
Submit data from the Phase 1 healthy volunteer study of AG-946, the company’s next-generation PKR activator, for presentation at the 63rd ASH (Free ASH Whitepaper) Annual Meeting & Exposition.
SECOND QUARTER 2021 FINANCIAL RESULTS

The financial results discussion compares Agios’ continuing operations. All periods have been adjusted to exclude discontinued operations related to the divested oncology business.

Research and Development (R&D) Expenses: R&D expenses for continuing operations were $62.0 million for the second quarter of 2021 compared to $54.1 million for the second quarter of 2020. The year-over-year increase in R&D was driven primarily by start-up costs associated with the Phase 3 studies of mitapivat in thalassemia and sickle cell disease, as well as the NDA and MAA filings for mitapivat in PK deficiency and launch preparation activities.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses for continuing operations were $29.2 million for both the second quarter of 2021 and the second quarter of 2020.

Non-Operating Income: Non-operating income included approximately $2.0 million from TIBSOVO (ivosidenib) royalties for the second quarter of 2021.

Net Loss: Net loss was $86.2 million for the second quarter of 2021 compared to a net loss of $90.5 million for the second quarter of 2020.

Cash Position and Guidance: Cash, cash equivalents and marketable securities as of June 30, 2021, were $1.7 billion compared to $794.4 million as of June 30, 2020. The company expects that its cash, cash equivalents and marketable securities as of June 30, 2021 will enable the company to execute its operating plan through major catalysts and to cash-flow positivity without the need to raise additional equity.

CONFERENCE CALL INFORMATION
Agios will host a conference call and live webcast with slides today at 8:00 a.m. ET to discuss second quarter 2021 financial results and recent business activities. To participate in the conference call, please dial 1-877-377-7098 (domestic) or 1-631-291-4547 (international) and refer to conference ID 2663508. The live webcast can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. The archived webcast will be available on the company’s website beginning approximately two hours after the event.