On August 5, 2021 NantHealth, Inc. (NASDAQ-GS: NH), a provider of enterprise solutions that help businesses transform complex data into actionable insights, reported financial results for its second quarter ended June 30, 2021 (Press release, NantHealth, AUG 5, 2021, View Source [SID1234585878]).

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"Our 2021 second-quarter financial results were in-line with our expectations and remained steady compared with the previous quarter," said Ron Louks, Chief Operating Officer, NantHealth. "We are focused on investing in our business through the development of enhancements and additional capabilities for our product and service lines. To that end, during the second quarter we expanded Eviti Connect beyond oncology to cover a new disease state, autoimmune, and we expect to launch a tailored pilot program with a key customer during the second half of this year. We are also continuing our research and development initiatives to build out our data services and cloud capabilities to complement our existing portfolio of products.

As a result of the $137.5 million financing transaction completed in April, the Company’s cash increased to $52 million at June 30, 2021 after paying off substantially all of its 2016 Notes.

Software and Services Highlights:

Clinical Decision Support (Eviti):
Continued the development of Eviti Connect for autoimmune diseases, including the creation of a completely new CMS library application, which allows multiple dosing and scheduling per treatment plan and sharing justifications across multiple regimens. This design allows for new autoimmune drug policy and modifications at scale and in near real time
Launched a new payer reporting application making it easier for customers to view a broad range of data analytics and reporting, enabling insights into network utilization for better informed, real-time business decisions
Achieved Eviti Connect milestone: 10 years of helping oncology practices and health plans prescribe and reimburse high-quality, high-value patient care:
Over 345,000 members have received evidence-based cancer treatment protocols that enable access to the highest standards of care available
6,900+ medical practices across the U.S. have used Eviti Connect to submit treatment plans for validation
Significant platform investments have driven 80+ major product releases, including continual updates to the regimen library and clinical trials database
Payer Engagement (NaviNet and Population Health Management):
AllPayer, the Company’s direct-to-provider solution, recorded its eighth consecutive quarter of growth and introduced enhancements to drive revenue:
Consolidated AllPayer pricing tiers into one simplified plan, AllPayer Advantage, giving customers an upgraded option that provides higher value, resulting in improved average revenue per customer
Released a new Medicare Eligibility and Benefits API, enabling providers to connect directly to Medicare, improving speed and accuracy of billing and collections
Network Monitoring and Management (The OpenNMS Group, Inc.):
Debuted an updated visual identity, including a new logo and website, to reflect the evolution of OpenNMS as a market leader in open source network monitoring and management
Announced a new reseller, Software Information Resource Corporation (SIRC), securing a five-year renewal from a major government agency
Delivered hardware appliances for secure distributed monitoring for beta testing with a Fortune 500 consumer electronics company
Released Meridian 2021, introducing Application Performance Monitoring (APM)/Digital Experience Monitoring (DEM) functionalities to enterprise OpenNMS users
Released Horizon 28, which now enables users to visualize and filter traffic flows by quality of service (QoS). Users can create congestion reports and make changes as needed to ensure optimal service performance
Business and Financial Highlights

For the 2021 second quarter:

Total net revenue was $16.1 million compared with $17.6 million in Q2 of 2020.
Gross profit was $9.1 million, or 56% of total net revenue, compared with $10.3 million, or 58% of total net revenue, for the prior-year period.
Selling, general and administrative (SG&A) expenses decreased to $11.8 million from $12.0 million in the 2020 second quarter.
Research and development (R&D) expenses increased to $4.8 million from $4.2 million.
Net loss from continuing operations attributable to NantHealth, net of tax, was $15.3 million, or $0.13 per share, compared with $48.3 million, or $0.44 per share, in the 2020 second quarter.
Non-GAAP net loss from continuing operations attributable to NantHealth was $8.8 million, or $0.08 per share, compared with $7.5 million, or $0.07 per share, for the second quarter of 2020.
At June 30, 2021, cash and cash equivalents totaled $52.0 million.
Conference Call Information and Forward-Looking Statements

Later today, the Company will host a conference call at 1:30 p.m. PT (4:30 p.m. ET) to review its results of operations for the second quarter ended June 30, 2021. The conference call will be available to interested parties by dialing 800-582-4096 from the U.S. or Canada, or 212-231-2918 from international locations. The call will be broadcast via the Internet at www.nanthealth.com. Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register, download and install any necessary audio software. A playback of the call will be archived and accessible on the same website for at least three months.

Discussion during the conference call may include forward-looking statements regarding topics such as the Company’s financial status and performance, regulatory and operational developments, and other comments the Company may make about its future plans or prospects in response to questions from participants on the conference call.

Use of Non-GAAP Financial Measures

This news release contains references to Non-GAAP financial measures, including adjusted net loss and adjusted net loss per share, which are financial measures that are not prepared in conformity with United States generally accepted accounting principles (U.S. GAAP). The Company’s management believes that the presentation of Non-GAAP financial measures provides useful supplementary information regarding operational performance, because it enhances an investor’s overall understanding of the financial results for the Company’s core business. Additionally, it provides a basis for the comparison of the financial results for the Company’s core business between current, past and future periods. Other companies may define these measures in different ways. Non-GAAP financial measures should be considered only as a supplement to, and not as a substitute for or as a superior measure to, financial measures prepared in accordance with U.S. GAAP. Non-GAAP per share numbers are calculated based on one class of common stock and do not incorporate the effects, if any, of using the two-class method.

On August 5, 2021 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported second quarter 2021 financial results and provided a corporate update (Press release, Kura Oncology, AUG 5, 2021, View Source [SID1234585877]).

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"I am extremely proud of the progress our team has made over the past several months, underscoring our focus on operational execution," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "We continue to have strong conviction in KO-539 and its potential to be both a first-in-class and a best-in-class menin inhibitor. This confidence is supported by clinical data from KOMET-001, our Phase 1/2 trial of KO-539 in patients with relapsed or refractory acute myeloid leukemia (AML). Given the wide therapeutic window KO-539 demonstrated in the Phase 1a dose escalation portion of the trial, we have now advanced into the Phase 1b expansion cohorts in patients with NPM1-mutant and KMT2A-rearranged relapsed/refractory AML. The Phase 1b enables us to refine the selection of a recommended Phase 2 dose while maintaining an aggressive development timeline for the program."

"Although it is early and the results are still preliminary," continued Dr. Wilson, "we are encouraged by observations of early signs of clinical activity in the Phase 1b expansion cohorts. We are also encouraged by the rate of patient screening and enrollment, an indication of the enthusiasm of the investigators as well as the strong execution of our clinical operations team. We intend to provide an update on both the Phase 1a and the Phase 1b at a future medical meeting, pending determination of the recommended Phase 2 dose. In the meantime, we look forward to providing qualitative updates on the progress of the Phase 1b in the months ahead."

Recent Highlights

First patients dosed in Phase 1b expansion cohorts with KO-539 – In late June, Kura announced that the first patient was dosed in the Phase 1b portion of KOMET-001. Patients are now enrolled in each of the two expansion cohorts – a lower dose of 200 mg and a higher dose of 600 mg – each comprising NPM1-mutant and KMT2A-rearranged relapsed/refractory AML patients. The Company expects to complete enrollment of 12 evaluable patients in each cohort by the first quarter of 2022, then will assess those patients for safety and tolerability, pharmacokinetics and efficacy in order to determine the recommended Phase 2 dose.
Multiple expansion opportunities in acute leukemias – Pending determination of a recommended Phase 2 dose, Kura is preparing to conduct a comprehensive clinical development plan for KO-539, aimed at broadening the opportunity in acute leukemias. Additional development opportunities include combination studies, other genetic subtypes, a pediatric development strategy and other indications, such as acute lymphocytic leukemia and myelodysplastic syndrome.
Clinical collaboration to evaluate tipifarnib and alpelisib in HNSCC – In July, Kura announced a clinical collaboration with Novartis to evaluate the combination of tipifarnib and the PI3Kα inhibitor alpelisib in patients with head and neck squamous cell carcinoma (HNSCC). The Company is now preparing for a Phase 1/2 clinical trial (KURRENT) of tipifarnib in combination with alpelisib in patients who have HRAS- and/or PIK3CA-dependent HNSCC. The initial cohort will include patients who have PIK3CA-dependent HNSCC and the trial is expected to initiate in the fourth quarter of 2021.
Nomination of KO-2806 as lead development candidate – Kura has nominated KO-2806 as its lead development candidate in the Company’s next-generation farnesyl transferase inhibitor program. KO-2806 was nominated based on its improved potency, pharmacokinetic and physicochemical properties relative to tipifarnib, and is designed to target innovative biology and address large oncology indications of high unmet need through rational combinations. The Company is now conducting investigational new drug (IND)-enabling studies and expects to submit an IND application for KO-2806 by the end of 2022.
Addition of industry veterans to board of directors – Kura recently appointed Carol Schafer and Helen Collins, M.D. to its board of directors. Ms. Schafer brings more than 25 years of experience as a strategic and financial advisor to the leadership teams of growing biopharmaceutical companies, most recently as Vice Chair of Equity Capital Markets at Wells Fargo Securities. Dr. Collins joins with more than 25 years of medical experience, most recently as Chief Medical Officer at Five Prime Therapeutics, where she was responsible for the strategy and execution of the company’s clinical development plans until its acquisition by Amgen in April 2021.
Financial Results and Guidance

Research and development expenses for the second quarter of 2021 were $21.1 million, compared to $13.7 million for the second quarter of 2020.
General and administrative expenses for the second quarter of 2021 were $12.6 million, compared to $7.5 million for the second quarter of 2020.
Net loss for the second quarter of 2021 was $33.7 million, compared to a net loss of $20.5 million for the second quarter of 2020. This included non-cash share-based compensation expense for the second quarter of 2021 of $6.0 million, compared to $2.6 million for the same period in 2020.
Cash, cash equivalents and short-term investments totaled $567.5 million as of June 30, 2021, compared with $633.3 million as of December 31, 2020. The cash balance as of June 30 reflects the full repayment of the Company’s debt facility.
Operating expenses for the full year 2021 are expected to be in the range of $130 million to $140 million.
Net cash used in operating activities for the full year 2021 is expected to be $105 million to $115 million.
Management expects that current cash, cash equivalents and short-term investments will be sufficient to fund current operations into 2024.
Upcoming Milestones

Initiate the KURRENT Phase 1/2 study of tipifarnib in combination with alpelisib in the fourth quarter of 2021.
Complete enrollment of 24 evaluable patients in the KOMET-001 Phase 1b expansion cohorts by the first quarter of 2022.
Determine the recommended Phase 2 dose of KO-539 by the first quarter of 2022.
Submit an IND application for KO-2806 by the end of 2022.
Conference Call and Webcast

Kura’s management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT today, August 5, 2021, to discuss the financial results for the second quarter 2021 and provide a corporate update. The live call may be accessed by dialing (877) 516-3514 for domestic callers and (281) 973-6129 for international callers and entering the conference code: 3171857. A live webcast and archive of the call will be available online from the investor relations section of the company website at www.kuraoncology.com.

On August 5, 2021 Illumina, Inc. (NASDAQ: ILMN) reported its financial results for the second quarter of fiscal year 2021 (Press release, Illumina, AUG 5, 2021, View Source [SID1234585876]).

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Second quarter results reflect record revenue:

Revenue of $1,126 million, a 78% increase compared to the prior year period
GAAP net income for the quarter of $185 million, or $1.26 per diluted share, compared to $47 million, or $0.32 per diluted share, for the prior year period
Non-GAAP net income for the quarter of $276 million, or $1.87 per diluted share, compared to $92 million, or $0.62 per diluted share, for the prior year period. Non-GAAP net income excludes acquisition-related expenses, primarily the Continuation Payments paid to GRAIL (see the "Reconciliation Between GAAP and Non-GAAP Net Income" table for a reconciliation of these GAAP and non-GAAP financial measures)
Cash flow from operations of $253 million compared to $240 million in the prior year period
Free cash flow (cash flow from operations less capital expenditures) of $209 million for the quarter compared to $202 million in the prior year period
"Illumina’s record second quarter revenue exceeded expectations across all regions," said Francis deSouza, Chief Executive Officer. "This demonstrates the strength of our business led by clinical applications, including oncology and genetic disease testing, as well as research. Additionally, we are proud of the critical role that NGS plays in identifying and monitoring COVID-19 variants to inform strategies to combat the pandemic. As a result of the enduring strength of the core business, we are again raising our 2021 financial guidance."

Gross margin in the second quarter of 2021 was 71.2% compared to 67.7% in the prior year period. Excluding amortization of acquired intangible assets, non-GAAP gross margin was 71.8% for the second quarter of 2021 compared to 68.6% in the prior year period.

Research and development (R&D) expenses for the second quarter of 2021 were $202 million compared to $155 million in the prior year period. Non-GAAP R&D expenses as a percentage of revenue were 18.0% compared to 24.7% in the prior year period.

Selling, general and administrative (SG&A) expenses for the second quarter of 2021 were $413 million compared to $177 million in the prior year period. Excluding acquisition-related expenses, gain on litigation, and expenses related to COVID-19, non-GAAP SG&A expenses as a percentage of revenue were 23.8% compared to 28.1% in the prior year period.

Depreciation and amortization expenses were $48 million and capital expenditures for free cash flow purposes were $44 million during the second quarter of 2021. At the close of the quarter, the company held $4.3 billion in cash, cash equivalents and short-term investments, compared to $3.5 billion as of January 3, 2021.

Updates since our last earnings release:

Established a global pathogen genomics initiative in partnership with the Bill & Melinda Gates Foundation to help make NGS technology and expertise accessible in areas of need, building critical public health capabilities and revolutionizing the way public health entities manage biological threats
Received Emergency Use Authorization from the U.S. FDA for COVIDSeq on NextSeq 2000, expanding COVID-19 diagnostic testing and surveillance capabilities for mid- and high-throughput laboratories
Launched the CE-IVD VeriSeq NIPT Solution v2 in Thailand, broadening access to accurate and reliable testing for expectant parents, in partnership with Next Generation Genomic Co., Ltd.
Received the 2021 Red Dot Design Award for the NextSeq 1000/2000, exemplifying the platform’s high design quality
Hosted our first NGS summit in Shanghai, bringing together more than 300 genomic scientists, venture capitalists, and hospital executives to discuss the future of oncology and healthcare
Appointed Susan Tousi as Chief Commercial Officer and Dr. Alex Aravanis as Chief Technology Officer, Head of Research and Product Development
Financial outlook and guidance

The non-GAAP financial guidance discussed below reflects certain pro forma adjustments to assist in analyzing and assessing our core operational performance. Please see our Reconciliation of Non-GAAP Financial Guidance included in this release for a reconciliation of the GAAP and non-GAAP financial measures.

For fiscal 2021, the company now expects year-over-year revenue growth in the range of 32% to 34%, GAAP earnings per diluted share of $4.69 to $4.89, and non-GAAP earnings per diluted share of $6.30 to $6.50. The company’s financial guidance excludes any potential impact of consolidating the financial results of GRAIL.

Conference call information

The conference call will begin at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time) on Thursday, August 5, 2021. Interested parties may access the live teleconference through the Investor Info section of Illumina’s website under the "Company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing 1 (866) 211-4597 or 1 (647) 689-6853 outside North America, both using conference ID 2850779.

A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.

Statement regarding use of non-GAAP financial measures

The company reports non-GAAP results for diluted net income per share, net income, gross margins, operating expenses, operating margins, other income, and free cash flow in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The company’s financial measures under GAAP include substantial charges such as amortization of acquired intangible assets, non-cash interest expense associated with the company’s convertible debt instruments that may be settled in cash, and others that are listed in the itemized reconciliations between GAAP and non-GAAP financial measures included in this press release. Management has excluded the effects of these items in non-GAAP measures to assist investors in analyzing and assessing past and future operating performance. Additionally, non-GAAP net income and diluted earnings per share are key components of the financial metrics utilized by the company’s board of directors to measure, in part, management’s performance and determine significant elements of management’s compensation.

The company encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP information and the reconciliation between these presentations, to more fully understand its business. Reconciliations between GAAP and non-GAAP results are presented in the tables of this release.

On August 5, 2021 Sierra Oncology, Inc. (SRRA), a late-stage biopharmaceutical company with a mission to deliver targeted therapies that treat rare forms of cancer, reported its financial and operating results for the second quarter ended June 30, 2021 (Press release, Sierra Oncology, AUG 5, 2021, View Source [SID1234585875]).

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"We are extremely excited by the progress that has been made in the second quarter with the completion of enrollment for our MOMENTUM study," said Stephen Dilly, MBBS, PhD, President and Chief Executive Officer at Sierra Oncology. "Importantly, we exceeded our target enrollment for our registration-enabling Phase 3 trial, which supports our hypothesis that physicians want new treatment options for patients suffering from myelofibrosis. We believe the forthcoming data from the MOMENTUM study, when combined with the Phase 3 SIMPLIFY data sets, will provide a robust picture of how momelotinib may help myelofibrosis patients and provide an option for those who are not well served by currently available therapies."

Key Business Highlights

Georgia Erbez and Christy Oliger joined the company’s Board of Directors. Together, they bring over three decades of strategic, financial and commercial experience to Sierra in advance of momelotinib commercialization. Ms. Erbez is presently Chief Financial Officer at Harpoon Therapeutics. Ms. Oliger currently serves on the Board of Directors at Karyopharm Therapeutics and Reata Pharmaceuticals, and most recently was Senior Vice President of the Oncology Business Unit at Genentech.
The Company received an oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) annual meeting suggesting that myelofibrosis patients receiving momelotinib who achieve or maintain transfusion independence at Week 24 have favorable overall survival compared to non-responders, including patients with anemia at baseline. In a separate presentation, transfusion independence was achieved in patients treated with momelotinib irrespective of baseline degree of anemia, platelet count or transfusion status. Combined, these data suggest the goal of achieving transfusion independence should become an important driver of treatment decisions in myelofibrosis.
In June, the company announced the MOMENTUM study—a global, randomized, double-blind, Phase 3 study for intermediate and high-risk myelofibrosis patients previously treated with a JAK inhibitor—had completed enrollment. The study enrolled 195 of a planned 180 patients across 21 countries. Topline data are anticipated in Q1 2022. Assuming MOMENTUM data are positive, Sierra plans to file for regulatory approval of momelotinib with the US Food & Drug Administration (FDA) in mid-2022. The FDA has granted Fast Track designation for momelotinib.
On August 3, the company entered into an agreement with AstraZeneca to in-license AZD5153, a potent and selective BRD4 BET inhibitor with a novel bivalent binding mode. Sierra plans to initiate a Phase 2 study examining momelotinib in combination with AZD5153 for the treatment of myelofibrosis in the first half of 2022.
Second Quarter 2021 Financial Results (all amounts reported in U.S. currency)

Research and development expenses were $14.1 million for the three months ended June 30, 2021 compared with $10.2 million for the three months ended June 30, 2020. The increase was due to costs for momelotinib including a $1.3 million increase in clinical trial and development costs and a $0.7 million increase in manufacturing costs. Also attributing to the increase was a $2.0 million increase in personnel-related and allocated overhead costs of which $0.8 million pertained to an increase in non-cash stock-based compensation. Research and development expenses included non-cash stock-based compensation of $1.8 million and $0.9 million for the three months ended June 30, 2021 and 2020, respectively.

Research and development expenses were $28.1 million for the six months ended June 30, 2021, compared with $21.8 million for the six months ended June 30, 2020. The increase was due to costs for momelotinib including a $3.0 million increase in clinical trial and development costs and a $1.4 million increase in third-party manufacturing costs. Also attributing to the increase was a $3.7 million increase in personnel-related and allocated overhead costs of which $2.0 million pertained to an increase in non-cash stock-based compensation. These increases were partially offset by a $1.5 million non-cash charge incurred in 2020 to recognize the change in fair value of an obligation to issue securities to Gilead until the issuance of the securities in January 2020, and a $0.3 million decrease in costs for SRA737. Research and development expenses included non-cash stock-based compensation of $3.4 million and $1.5 million for the six months ended June 30, 2021 and 2020, respectively.

General and administrative expenses were $6.4 million for the three months ended June 30, 2021, compared to $6.3 million for the three months ended June 30, 2020. The increase was due to a $0.4 million increase in professional fees, primarily relating to pre-commercial costs for momelotinib, which was offset by a decrease of $0.2 million in personnel-related and allocated overhead costs. General and administrative expenses included non-cash stock-based compensation of $1.5 million and $2.7 million for the three months ended June 30, 2021 and 2020, respectively.

General and administrative expenses were $12.3 million for the six months ended June 30, 2021, compared to $10.8 million for the six months ended June 30, 2020. The increase was due to a $1.0 million increase in personnel-related and allocated overhead costs and an increase of $0.5 million in professional fees primarily relating to pre-commercial costs for momelotinib. General and administrative expenses included non-cash stock-based compensation of $2.7 million and $3.1 million six months ended June 30, 2021 and 2020, respectively.

Total other expense (income), net was $0.1 million of total other expense, net for the six months ended June 30, 2021, compared to $15.7 million of total other expense, net for the six months ended June 30, 2020. The difference was primarily attributable to a non-cash charge of $16.2 million incurred during the six months ended June 30, 2020 related to the change in fair value of warrant liabilities until the reclassification to equity in January 2020.

For the three months ended June 30, 2021, Sierra incurred a Generally Accepted Accounting Principles (GAAP) net loss of $20.6 million compared to a GAAP net loss of $16.5 million for the three months ended June 30, 2020. For the six months ended June 30, 2021 Sierra incurred a GAAP net loss of $40.5 million compared to a GAAP net loss of $48.4 million for the six months ended June 30, 2020. The GAAP net loss for the six months ended June 30, 2020 includes a non-cash charge of $16.2 million related to the change in fair value of warrant liabilities included in total other expense (income), net and a $1.5 million non-cash charge pertaining to the obligation to issue securities to Gilead included in research and development expenses as mentioned above.

Non-GAAP adjusted net loss was $17.4 million for the three months ended June 30, 2021, compared with a non-GAAP adjusted net loss of $12.8 million for the three months ended June 30, 2020. Non-GAAP adjusted net loss for the three months ended June 30, 2021 and 2020 excludes expenses related to stock-based compensation. For the six months ended June 30, 2021, Sierra incurred a non-GAAP adjusted net loss of $34.4 million compared to a non-GAAP adjusted net loss of $26.1 million for the six months ended June 30, 2020. Non-GAAP adjusted net loss for the six months ended June 30, 2021 excludes expenses related to stock-based compensation. Non-GAAP adjusted net loss for the six months ended June 30, 2020 excludes expenses related to the change in fair value of warrant liabilities, the change in fair value of the securities issuance obligation, and stock-based compensation. See "Non-GAAP Financial Measures" and "Reconciliation of GAAP to Non-GAAP Financial Measures" below for a reconciliation of this GAAP measure to non-GAAP financial measure.

Cash and cash equivalents totaled $90.7 million as of June 30, 2021, compared to $104.1 million as of December 31, 2020.

As of June 30, 2021, there were 12,358,517 total shares of common stock outstanding and warrants to purchase 11,052,256 shares of common stock, with an exercise price equal to $13.20 per share. There were 4,786,469 shares issuable upon exercise of stock options and an additional warrant to purchase 1,839 shares.

On August 5, 2021 Neoleukin Therapeutics, Inc., "Neoleukin" (NASDAQ:NLTX), a biopharmaceutical company utilizing sophisticated computational methods to design de novo protein therapeutics, reported financial results for the second quarter ended June 30, 2021 and provided a midyear corporate update (Press release, Neoleukin Therapeutics, AUG 5, 2021, View Source [SID1234585874]).

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"Our progression to a clinical stage company is a significant milestone, and we remain focused on execution of our clinical development strategy and pipeline expansion as we advance and explore the potential of our de novo protein technology platform," said Jonathan Drachman, M.D., Chief Executive Officer of Neoleukin.

Recent Updates
NL-201
NL-201 is Neoleukin’s lead de novo protein therapeutic candidate, designed to mimic the therapeutic activity of natural cytokines IL-2 and IL-15, while potentially reducing the toxicities associated with high-dose IL-2.

In May 2021, Neoleukin announced dosing of the first patient in a Phase 1 trial of NL-201. The Phase 1 study, underway at clinical sites in the U.S. and Australia, is enrolling patients with advanced, relapsed, or refractory solid tumors. Patients will receive NL-201 as intravenous monotherapy to assess safety, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity. While certain factors, including COVID-19, have had an impact on site activation for our Phase 1 trial of NL-201, we are accelerating site start-up activities to increase the pace of enrollment. Interim data from the ongoing systemic Phase 1 trial of NL-201 is currently anticipated in 2022.

In addition, Neoleukin is assessing plans for a local administration study of NL-201 while prioritizing the NL-201 systemic trial. Management will update timing for future trials as appropriate.

NL-CVX1
NL-CVX1 is a de novo protein that binds to the spike protein of SARS-CoV-2, the virus that causes COVID-19 and blocks infection of human cells. The design and characterization of NL-CVX1 in under three months underscores the speed and versatility of Neoleukin’s de novo protein platform.
In June 2021, in response to the evolving COVID-19 therapeutic landscape, including the widespread availability of effective vaccines, Neoleukin suspended plans to advance this research program into clinical trials.
Other Research Updates
Neoleukin has multiple research projects underway evaluating the applications of de novo protein technology to develop agonists and antagonists of immune pathways. Neoleukin currently plans to discuss its de novo protein pipeline during the second half of 2021.
Summary of Financial Results
Cash Position: Cash and cash equivalents totaled $164.2 million as of June 30, 2021, compared to $192.6 million as of December 31, 2020.
Based upon current internal infrastructure and pipeline initiatives, Neoleukin believes it has sufficient cash to fund operations into 2023.
R&D Expenses: Research and development expenses for the second quarter of 2021 increased to $9.8 million from $4.8 million for the second quarter of 2020. The increase was primarily due to increased expenses incurred from IND-enabling and clinical trial activities related to Neoleukin’s lead product candidate, NL-201, and in connection with the advancement of other Neoleukin technologies.
G&A Expenses: General and administrative expenses for the second quarter of 2021 increased to $5.3 million from $4.9 million for the second quarter of 2020. The increase in general and administrative expenses was primarily due to increases in personnel-related costs as Neoleukin continues to grow its operations. The increase was partially offset by higher costs incurred in the second quarter of 2020 associated with the termination of its Vancouver, Canada office lease.
Net Loss: Net loss for the second quarter of 2021 was $15.1 million compared to a net loss of $9.7 million in the second quarter of 2020.