On August 9, 2021 Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs), reported financial results for the second quarter and six months ended June 30, 2021 and highlighted recent corporate progress (Press release, Avidity Biosciences, AUG 9, 2021, View Source [SID1234586123]).

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"The FDA clearance to proceed with our AOC 1001 Phase 1/2 MARINA trial in adults with myotonic dystrophy (DM1) is a huge milestone for Avidity and our AOC platform. AOC 1001 will be the first program based on our novel technology to enter clinical development. This also marks an important step forward for the DM1 community who have no approved therapies and so desperately needs therapeutic options," said Sarah Boyce, president and chief executive officer. "In addition, over the past quarter we made significant advances in our pipeline including nominating AOC 1044 as the clinical development candidate for our lead DMD program. We remain on track for both AOC 1044 and our AOC FSHD program to advance into the clinic in 2022."

"We are well funded with $280 million at the end of Q2’21, along with an additional $155 million in estimated net proceeds from our successful financing in August 2021. Our strong financial position allows us to further progress our late stage programs while continuing to invest in our skeletal muscle pipeline and our AOC platform," said Mike MacLean, chief financial officer.

AOC Platform and Pipeline Highlights

Received FDA clearance to proceed with clinical studies for AOC 1001 in adults with DM1.

Avidity recently received clearance to proceed with the Phase 1/2 MARINA trial of AOC 1001 in adults with DM1, under its Investigational New Drug application (IND). Avidity continues to be on track to initiate the Phase 1/2 MARINA clinical trial this year. In the second half of 2022, the Company plans to conduct a preliminary assessment of safety, tolerability and key biomarkers.

Detailed information on the MARINA study was presented during Volume 2 of Avidity’s virtual investor and analyst event series. Volume 2 featured presentations on AOC 1001, the MARINA study and a presentation on the clinical impact of DM1 by Nicholas E. Johnson, MD, MSCI, FAAN, an associate professor, division chief of neuromuscular, and vice chair of research in the department of neurology at Virginia Commonwealth University. The event also featured a live Q&A session with Avidity’s management team and Dr. Johnson. Volume 2 in the series follows Volume 1 which was focused on the years of engineering underpinning Avidity’s AOC platform and AOC 1001. Replays of Volume 1 and Volume 2 can be found on the events page in the investors section of the Avidity website.

In July, the FDA granted Orphan Drug Designation for AOC 1001 for the treatment of DM1. The FDA grants Orphan Drug Designation to novel drugs that seek to treat a rare disease or condition and, if the drug is approved for the designated orphan indication, provides 7 years of market exclusivity, along with certain financial incentives, including tax credits, opportunities for grant funding towards clinical trial costs and FDA user-fee waivers.

In May, Avidity reported results from its IND-enabling toxicology study of AOC 1001. Results from the study showed the highest dose tested was the maximum feasible dose and was the no-observed adverse effect level (NOAEL). The Company did not observe any treatment-related histopathologic toxicity or any changes in safety pharmacology parameters (cardiac, respiratory and neurological). All dose levels in the study produced a greater than 80% reduction in the expression of dystrophy myotonic protein kinase (DMPK) across multiple skeletal muscles, demonstrating that pharmacology was essentially saturated even at the lowest dose tested.
Progressed Skeletal Muscle Pipeline including nominating AOC 1044 to move into IND-enabling studies.

AOC 1044 was recently nominated as the clinical development candidate for the DMD program targeting Exon 44. AOC 1044 is entering into IND-enabling studies and is on track with plans to advance into the clinic in 2022.

Data from the AOC FSHD program targeting facioscapulohumeral muscular dystrophy (FSHD) was presented at the 28th Annual FSHD Society International Research Congress (IRC) in June. The data demonstrated promising preclinical activity in both in vitro and in vivo experiments in the cells of patients with FSHD.
Second Quarter 2021 Financial Results

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities totaled $279.5 million as of June 30, 2021, compared to $328.1 million as of December 31, 2020.
Collaboration Revenue: Collaboration revenue, including reimbursable expenses, primarily relates to Avidity’s partnership with Eli Lilly and Company and totaled $2.6 million for the second quarter of 2021 compared with $1.5 million for the second quarter of 2020, and $5.3 million for the first six months of 2021 compared with $2.9 million for the first six months of 2020.
Research and Development (R&D) Expenses: R&D expenses include external and internal costs associated with research and development activities. These expenses were $22.7 million for the second quarter of 2021 compared with $9.0 million for the second quarter of 2020, and $43.4 million for the first six months of 2021 compared with $14.5 million for the first six months of 2020. The increases were primarily driven by the advancement of AOC 1001, AOC 1044 and our AOC FSHD program, as well as costs related to the expansion of our overall research capabilities.
General and Administrative (G&A) Expenses: G&A expenses primarily consist of employee-related expenses, professional fees, insurance costs, and patent filing and maintenance fees. These expenses were $6.3 million for the second quarter of 2021 compared with $2.9 million for the second quarter of 2020, and $12.2 million for the first six months of 2021 compared with $4.9 million for the first six months of 2020. The increases were primarily due to higher personnel costs (including noncash stock-based compensation), professional fees and insurance costs related to being a public company.

On August 9, 2021 Nuvo Pharmaceuticals Inc. (TSX: MRV) (OTCQX: MRVFF) d/b/a Miravo Healthcare (Miravo or the Company), a Canadian-focused healthcare company with global reach and a diversified portfolio of commercial products, reported its financial and operational results for the three and six months ended June 30, 2021 (Press release, Nuvo Pharmaceuticals, AUG 9, 2021, View Source [SID1234586139]). For further details on the results, please refer to Miravo’s Management, Discussion and Analysis (MD&A) and Condensed Consolidated Interim Financial Statements for the three and six months ended June 30, 2021, which are available on the Company’s website (www.miravohealthcare.com). All figures are in Canadian dollars, unless otherwise noted.

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Key Developments

Three months ended June 30, 2021 include the following:

Adjusted total revenue(1) was $19.9 million, an increase of 11% compared to $18.0 million for the three months ended June 30, 2020.
Adjusted EBITDA(1) was $7.4 million, a decrease of 3% compared to $7.6 million for the three months ended June 30, 2020.
Revenue related to Blexten and Cambia was $9.2 million, an increase of 46% compared to revenue of $6.3 million for the three months ended June 30, 2020. Total Canadian prescriptions of Blexten and Cambia increased by 26% and 17% respectively compared to the three months ended June 30, 2020.
The Company repaid $3.0 million (US$2.5 million) of the Amortization Loan to Deerfield Management Company, L.P. (Deerfield).
As at June 30, 2021, cash and cash equivalents were $27.3 million.
Six months ended June 30, 2021 include the following:

Adjusted total revenue(1) was $34.5 million, a decrease of 7% compared to $37.0 million for the six months ended June 30, 2020.
Adjusted EBITDA(1) was $11.7 million, a decrease of 25% compared to $15.6 million for the six months ended June 30, 2020.
Revenue related to Blexten and Cambia was $14.8 million, an increase of 21% compared to revenue of $12.2 million for the six months ended June 30, 2020. Canadian prescriptions of Blexten and Cambia increased by 25% and 13% respectively compared to the six months ended June 30, 2020.
The Company repaid $6.6 million (US$5.4 million) of the Amortization Loan to Deerfield.
(1) Non-International Financial Reporting Standards (IFRS) financial measure defined by the Company below.

Business Update

In July 2021, Nuvo Pharmaceuticals (Ireland) DAC trading as Miravo Healthcare (Miravo Ireland) entered into an exclusive license and supply agreement with SK Chemicals Co., Ltd. (SK Chemicals) for the exclusive right to commercialize Suvexx in the Republic of South Korea. Miravo Ireland will receive up to €1.1 million in upfront consideration, regulatory and sales-based milestone payments, as well as royalties on net sales of Suvexx in South Korea and revenue pursuant to the supply of product.
In May 2021, the Company announced the appointment of Mary Ritchie to its Board of Directors. Ms. Ritchie is the President and Chief Executive Officer of Richford Holdings Ltd., an accounting and investment advisory services firm based in Edmonton, Alberta. Ms. Ritchie has over 30 years of experience in both the public, private and not-for-profit sectors and is a Fellow of CPA Alberta. She is a member of the board of directors and audit committees of Alaris Royalty Corp. (TSX) and EnWave Corporation (TSXV). She has been a past director on a number of boards, including the Canada Pension Plan Investment Board, Industrial Alliance Insurance, Financial Services Inc. (TSX), iA Financial Corporation Inc. (TSX) and IPL Plastics Inc. (TSX) and a past member of the RBC Global Asset Management’s independent oversight committee.
In April 2021, the Company filed and obtained a receipt for a final base shelf prospectus with the securities regulatory authorities in each of the provinces of Canada (the Prospectus). The Company has filed the Prospectus to maintain financial flexibility and to have the ability to offer the securities on an accelerated basis pursuant to the filing of prospectus supplements. The Prospectus is valid for a 25-month period, during which time the Company may offer and issue, from time-to-time, common shares, preferred shares, debt securities, warrants and subscription receipts, or any combination thereof, having an aggregate offering value of up to $40 million.
"Our key promoted brands, Blexten and Cambia, continued their solid performance and demonstrated year-over-year gains in prescription and revenue growth. New Blexten prescriptions now represent 1 in 4 new antihistamine prescriptions nationally, and 1 in 3 new antihistamine prescriptions in Ontario, Alberta, and British Columbia. Our recently launched Suvexx and NeoVisc brands are performing according to plan and are steadily growing market share," said Jesse Ledger, Miravo’s President & CEO. "Our international business also continues to expand with our recently announced Suvexx licensing agreement for South Korea. This represents our first Suvexx license partner for Asia and, once approved, will introduce Suvexx as a treatment option in a rapidly growing acute migraine market. This transaction is another example of our team executing on our business development objectives."

Second Quarter 2021 Financial Results
Adjusted total revenue was $19.9 million and $34.5 million for the three and six months ended June 30, 2021 compared to $18.0 million and $37.0 million for the three and six months ended June 30, 2020. The $1.9 million increase in adjusted total revenue in the current quarter was primarily attributable to an increase of $4.3 million in the Commercial Business segment and an increase of $0.7 million of revenue from the Production and Service Business segment, slightly offset by a decrease of $3.1 million of revenue in the Licensing and Royalty Business segment. Adjusted total revenue attributable to the Commercial Business segment increased during the current quarter due to an increase in sales of the Company’s promoted products (Blexten, Cambia, Suvexx and Neovisc), as well as an increase in sales of the Company’s mature products. The Production and Service Business segment adjusted total revenue increased as a result of an increase in the Company’s Pennsaid product sales, slightly offset by the strengthening of the Canadian dollar against the U.S. dollar, which decreased the value of U.S. denominated sales compared to the three months ended June 30, 2020. Adjusted total revenue decrease in the Licensing and Royalty Business segment as a result of a decrease in royalty earned on U.S. net sales of Vimovo due to a competitor launching a generic version of Vimovo in March 2020, as well as a decrease in amounts billed to customers for existing contract assets. In the comparative quarter, the Company received a $2.4 million (US$1.8 million) milestone from Takeda Pharmaceutical Co., Ltd. related to the use of its Yosprala intellectual property in Japan.

Adjusted EBITDA was $7.4 million and $11.7 million for the three and six months ended June 30, 2021 compared to $7.6 million and $15.6 million for the three and six months ended June 30, 2020. During the three months ended June 30, 2021, increases in gross profit from the Company’s Commercial Business and Production and Service Business segments was more than offset by an increase in general and administrative expenses, as well as a decrease in the contribution from the License and Royalty Business segment due to a decline in the U.S. Vimovo royalty and a decrease in amounts billed to customers for existing contract assets.

Non-IFRS Financial Measures
The Company discloses non-IFRS measures (such as adjusted total revenue and adjusted EBITDA) that do not have standardized meanings prescribed by IFRS. The Company believes that shareholders, investment analysts and other readers find such measures helpful in understanding the Company’s financial performance. Non-IFRS financial measures do not have any standardized meaning prescribed by IFRS and may not have been calculated in the same way as similarly named financial measures presented by other companies. These measures should be considered as supplemental in nature and not as a substitute for related financial information prepared in accordance with IFRS.

Adjusted Total Revenue
The Company defines adjusted total revenue as total revenue, plus amounts billed to customers for existing contract assets, less revenue recognized upon recognition of a contract asset. Management believes adjusted total revenue is a useful supplemental measure to determine the Company’s ability to generate cash from its customer contracts used to fund its operations.

Adjusted EBITDA
EBITDA refers to net income (loss) determined in accordance with IFRS, before depreciation and amortization, net interest expense (income) and income tax expense (recovery). The Company defines adjusted EBITDA as EBITDA, plus amounts billed to customers for existing contract assets, inventory step-up expenses, stock-based compensation expense, Other Expenses (Income), less revenue recognized upon recognition of a contract asset and other income. Management believes adjusted EBITDA is a useful supplemental measure to determine the Company’s ability to generate cash available for working capital, capital expenditures, debt repayments, interest expense and income taxes.

The following is a summary of how EBITDA and adjusted EBITDA are calculated:

Management to Host Conference Call/Webcast
Management will host a conference call to discuss the results today (Monday, August 9, 2021) at 11:00 a.m. ET. To participate in the conference call, please dial 416 764 8688 or 1 888 390 0546. Please call in 15 minutes prior to the call to secure a line. You will be put on hold until the conference call begins.

A taped replay of the conference call will be available two hours after the live conference call and will be accessible until midnight on August 16, 2021 by calling 416 764 8677 or 1 888 390 0541 / replay passcode: 457561#.

A live audio webcast of the conference call will be available through www.miravohealthcare.com. Please connect at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to hear the webcast.

On August 9, 2021 Fulgent Genetics, Inc. (NASDAQ: FLGT) ("Fulgent" or the "Company"), a technology-based genetic testing company focused on transforming patient care in oncology, infectious and rare diseases, and reproductive health, reported that it has acquired CSI Laboratories ("CSI") to expand its presence in somatic molecular diagnostics and cancer testing (Press release, CSI Laboratories, AUG 9, 2021, View Source [SID1234586156]).

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CSI was founded in 1997 to provide a client- and patient-focused model of cancer diagnostic testing for pathologists, community hospitals, and their patients. CSI offers more than 400 unique tests with a focus on oncology and capabilities across flow cytometry, cytogenetic analysis, fluorescence in-situ hybridization ("FISH"), immunohistochemistry, and molecular genetics. CSI’s philosophy of providing expert diagnostic testing with speed, precision, and care, is highly complementary with Fulgent’s core value proposition of offering a broad menu of actionable diagnostic tests with quality results and rapid turnaround time.

Strategic Rationale:

– Expansion into somatic genetic testing market, which is expected to grow to $16.8 billion by 2030

– Realize synergies by leveraging Fulgent’s best-in-class technology and Next Generation Sequencing ("NGS") expertise in new oncology markets

– Geographic expansion of CSI’s reach beyond the Southeastern part of the United States

With the acquisition of CSI, Fulgent will significantly expand its capabilities in molecular diagnostics and oncologic testing. Fulgent will leverage its established technology platform, NGS expertise, lab operations, and sales infrastructure in conjunction with CSI’s extensive cancer testing menu to establish a differentiated foothold in oncologic testing in the United States. The combination of CSI’s extensive molecular diagnostics test menu and Fulgent’s NGS expertise, given its proprietary technology platform, will create a novel, comprehensive cancer testing solution for customers across the United States.

Fulgent’s Chief Medical Officer, Dr. Larry Weiss, will oversee the integration of CSI’s capabilities into Fulgent’s platform and the future operations of the company’s oncologic testing efforts. Fulgent expects to bolster the scale of CSI’s offerings with a new state-of-the-art cancer testing laboratory in California, which it believes will complement CSI’s existing operations in Alpharetta, Georgia.

"We are extremely excited to add CSI Laboratories’ expertise and team to the Fulgent family," said Ming Hsieh, Chairman and CEO of Fulgent. "Their high standards for test quality and customer service fit extremely well with our values and culture at Fulgent. We look forward to adding their extensive oncologic and molecular diagnostic testing capabilities to our platform."

"CSI has an outstanding reputation for providing excellent pathology and oncology services in the southeastern United States. We expect CSI will serve as an anchor to Fulgent’s cancer testing capabilities, bringing their expertise and experience to a national oncologic centered client base, and expanding their broad pathology and molecular offerings by leveraging Fulgent’s leadership in Next Generation Sequencing," said Dr. Larry Weiss, Chief Medical Officer at Fulgent. "Our vision is to combine Fulgent’s excellence in NGS with the broad, high-quality oncologic testing menu already existing in CSI and bring it to a national client base. We expect the addition of CSI will deliver customers a superior experience relative to competitors who offer one-dimensional NGS testing or broader menus without NGS expertise."

"This is an exciting day for CSI Laboratories’ team members, clients and patients, and we are excited to join forces with a company that shares our same level of commitment to the cancer community, " said Ron Ghafary, founder of CSI Laboratories. "We look forward to expanding our cancer testing capabilities on Fulgent’s genomic testing platform and continuing to differentiate ourselves through our expertise, high-quality results and high-touch service model that our clinicians and staff deliver on a daily basis."

Advisors

Piper Sandler acted as the exclusive financial advisor and Mintz Levin, Cohn, Ferris, Glovsky and Popeo served as legal counsel to Fulgent Genetics, Inc. in connection with the transaction.

On August 9, 2021 AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) reported that Positive high-level results from the head-to-head DESTINY-Breast03 Phase III trial showed that Enhertu (trastuzumab deruxtecan), the HER2-directed antibody drug conjugate (ADC), demonstrated superiority over trastuzumab emtansine (T-DM1) (Press release, AstraZeneca, AUG 9, 2021, View Source [SID1234586068]).

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At a planned interim analysis, the Independent Data Monitoring Committee (IDMC) concluded that DESTINY-Breast03 met the primary endpoint of progression-free survival (PFS) showing a highly statistically significant and clinically meaningful improvement for patients with HER2-positive, unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane.

In DESTINY-Breast03, Enhertu also showed a strong trend toward improved overall survival (OS) compared to T-DM1 in a key secondary endpoint, although the OS data are still immature. The safety profile of Enhertu was consistent with previous clinical trials, with no new safety concerns identified and no Grade 4 or 5 treatment-related interstitial lung disease events.

Susan Galbraith, Executive Vice President, Oncology R&D, said: "There is a continued need for new options and better outcomes for patients with HER2-positive metastatic breast cancer who often experience disease progression after initial treatment with available standards of care. These transformative progression-free survival results demonstrate the superiority of Enhertu compared to T-DM1, and the encouraging safety data may open future opportunities to bring this benefit to patients in earlier treatment settings."

Ken Takeshita, Global Head, Research and Development, Daiichi Sankyo, said: "DESTINY-Breast03 is the first global Phase III head-to-head trial of Enhertu against an active control and supports the potential of this medicine to become the new standard of care for patients with HER2-positive metastatic breast cancer following initial treatment with trastuzumab and a taxane. We believe this highly sophisticated and specifically engineered ADC is fulfilling its promise to reshape the treatment of HER2-positive metastatic breast cancer, with the goal to move into earlier lines of treatment for HER2-positive breast cancer and many other HER2-expressing tumour types across our broad clinical trial programme."

The data will be presented at an upcoming medical meeting and shared with health authorities.

Enhertu is approved for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting in the US, Japan, the EU and several other countries based on the results from the DESTINY-Breast01 trial.

Enhertu is being further assessed in a comprehensive clinical development programme evaluating efficacy and safety across multiple HER2-targetable cancers, including breast, gastric, lung and colorectal cancers.

HER2-positive breast cancer
Breast cancer remains the most common cancer and is one of the leading causes of cancer-related deaths in women worldwide.1 More than two million patients with breast cancer were diagnosed in 2020, resulting in nearly 685,000 deaths globally.1 Approximately one in five patients with breast cancer are considered HER2-positive.2

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours, including breast, gastric, lung and colorectal cancers.3 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and a poor prognosis in breast cancer.4

Despite initial treatment with trastuzumab and a taxane, patients with HER2-positive metastatic breast cancer will often experience disease progression.5 More effective options are needed to further delay progression and extend survival.5-7

DESTINY-Breast03
DESTINY-Breast03 is a global head-to-head, randomised, open-label, registrational Phase III trial evaluating the safety and efficacy of Enhertu (5.4mg/kg) versus T-DM1 in patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane. The primary efficacy endpoint of DESTINY-Breast03 is PFS based on blinded independent central review. Secondary efficacy endpoints include OS, objective response rate, duration of response, clinical benefit rate, PFS based on investigator assessment and safety.

DESTINY-Breast03 enrolled approximately 500 patients at multiple sites in Asia, Europe, North America, Oceania and South America. For more information about the trial, visit ClinicalTrials.gov.

Enhertu
Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker.

Enhertu (5.4mg/kg) is approved in Canada, the EU, Israel, Japan, the UK and the US for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting based on the results from the DESTINY-Breast01 trial.

Enhertu (6.4mg/kg) is also approved in Israel, Japan and the US for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 trial.

Enhertu development programme
A comprehensive development programme is underway globally, evaluating the efficacy and safety of Enhertu monotherapy across multiple HER2-targetable cancers, including breast, gastric, lung and colorectal cancers. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.

Enhertu was highlighted in the Clinical Cancer Advances 2021 report as one of two significant advancements in the "ASCO Clinical Advance of the Year: Molecular Profiling Driving Progress in GI Cancers," based on data from both the DESTINY-CRC01 and DESTINY-Gastric01 trials, as well as one of the targeted therapy advances of the year in non-small cell lung cancer (NSCLC), based on the interim results of the HER2-mutated cohort of the DESTINY-Lung01 trial.

In May 2020, Enhertu also received Breakthrough Therapy Designation for the treatment of patients with metastatic NSCLC whose tumours have a HER2-mutation and with disease progression on or after platinum-based therapy.

Daiichi Sankyo collaboration
Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialise Enhertu (a HER2-directed ADC) in March 2019, and datopotamab deruxtecan (DS-1062; a TROP2-directed ADC) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for manufacturing and supply of Enhertu and datopotamab deruxtecan.

AstraZeneca in breast cancer
Driven by a growing understanding of breast cancer biology, AstraZeneca is starting to challenge, and redefine, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death.

AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment. AstraZeneca aims to continue to transform outcomes for HR-positive breast cancer with foundational medicines Faslodex (fulvestrant) and Zoladex (goserelin) and the next-generation oral SERD and potential new medicine AZD9833.

PARP inhibitor, Lynparza (olaparib) is a targeted treatment option for metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD (Merck & Co., Inc. in the US and Canada) continue to research Lynparza in metastatic breast cancer patients with an inherited BRCA mutation and are exploring new opportunities to treat these patients earlier in their disease.

Building on the first approval of Enhertu, a HER2-directed ADC, in previously treated HER2-positive metastatic breast cancer, AstraZeneca and Daiichi Sankyo are exploring its potential in earlier lines of treatment and in new breast cancer settings. To bring much needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is testing immunotherapy Imfinzi (durvalumab) in combination with other oncology medicines, including Lynparza and Enhertu, investigating the potential of AKT kinase inhibitor, capivasertib, in combination with chemotherapy, and collaborating with Daiichi Sankyo to explore the potential of TROP2-directed ADC, datopotamab deruxtecan.

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

On August 9, 2021 Allakos Inc. (the "Company") (Nasdaq: ALLK), a biotechnology company developing lirentelimab (AK002) for the treatment of eosinophil and mast cell-related diseases, reported financial results for the second quarter ended June 30, 2021 (Press release, Allakos, AUG 9, 2021, View Source [SID1234586108]).

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Recent Accomplishments

Presented new data at Digestive Disease Week (DDW) 2021 suggesting eosinophilic gastritis and/or eosinophilic duodenitis (EG/EoD) is significantly underdiagnosed and may be a common cause of moderate-to-severe gastrointestinal symptoms. Forty-five percent (45%, 181/405) of patients with chronic functional gastrointestinal symptoms who underwent upper endoscopy with biopsy met the diagnostic criteria for EG/EoD.
Completed patient enrollment in Phase 3 EG/EoD and Phase 2/3 eosinophilic esophagitis (EoE) clinical trials of lirentelimab (AK002).
Upcoming 2021 Milestones

Topline data from a randomized, double-blind, placebo-controlled Phase 3 study of lirentelimab in patients with EG/EoD expected in the fourth quarter of 2021.
Topline data from a randomized, double-blind, placebo-controlled Phase 2/3 study of lirentelimab in patients with EoE expected in the fourth quarter of 2021.
Initiation of a randomized, double-blind, placebo-controlled Phase 2/3 study of subcutaneous lirentelimab in patients with EG and/or EoD expected in the second half of 2021.
Initiation of a Phase 2 study in a non-eosinophilic gastrointestinal disease in the second half of 2021.
Second Quarter 2021 Financial Results

Research and development expenses were $41.0 million in the second quarter of 2021 as compared to $28.3 million in the same period in 2020, an increase of $12.7 million.

General and administrative expenses were $16.2 million in the second quarter of 2021 as compared to $12.1 million in the same period in 2020, an increase of $4.1 million.

Allakos reported a net loss of $57.2 million in the second quarter of 2021 as compared to $39.3 million in the same period in 2020, an increase of $17.9 million. Net loss per basic and diluted share was $1.07 for the second quarter of 2021 compared to $0.80 in the same period in 2020.

Allakos ended the second quarter of 2021 with $559.7 million in cash, cash equivalents and marketable securities.