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.

On August 5, 2021 CTI BioPharma Corp. (Nasdaq: CTIC) reported its financial results for the second quarter ended June 30, 2021 (Press release, CTI BioPharma, AUG 5, 2021, View Source [SID1234585873]).

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"This past quarter, we continued to advance pacritinib towards a potential U.S. approval and commercial launch this year. The U.S. Food and Drug Administration’s acceptance with priority review of our NDA submission for the use of pacritinib in myelofibrosis patients with severe thrombocytopenia underscores the unmet need in this area," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI Biopharma. "With a PDUFA target action date of November 30, 2021, and commercial preparations already well underway, we will be well positioned for a potential U.S. launch later this year. We are working closely with the FDA during the review of our application and we continue to advance our commercial launch activities."

Expected Milestones

PDUFA action date – November 30, 2021
Expected U.S. commercial launch of pacritinib – by the end of 2021
Reporting of interim analysis from the Phase 3 PRE-VENT trial in hospitalized patients with severe COVID-19 – Q3 2021
Second Quarter Financial Results
Operating loss was $19.5 million and $36.6 million for the three and six months ended June 30, 2021, respectively, compared to operating loss of $10.0 million and $21.9 million for the corresponding periods in 2020. The increase in operating loss for the three and six months ended June 30, 2021 as compared to the comparable periods in 2020 resulted primarily from increases in research and development and general and administrative activities associated with continued development and preparation for the potential commercialization of pacritinib.

Net loss for the three months ended June 30, 2021 was $19.7 million, or $0.21 for basic and diluted loss per share, compared to net loss of $14.0 million, or $0.19 for basic and diluted loss per share, for the same period in 2020. Net loss for the six months ended June 30, 2021 was $36.9 million, or $0.44 for basic and diluted loss per share, compared to net loss of $26.2 million, or $0.38 for basic and diluted loss per share, for the same period in 2020.

As of June 30, 2021, cash, cash equivalents and short-term investments totaled $71.9 million, as compared to $52.5 million as of December 31, 2020. We expect our current cash and cash equivalents will enable us to fund our operations into the fourth quarter of 2021.

Conference Call and Webcast
CTI will host a conference call and webcast to review its second quarter 2021 financial results and provide an update on business activities today, August 5 at 4:30 PM ET. To access the live call by phone please dial (877) 735-2860 (domestic) or (602) 563-8791 (international); the conference ID is 6891246. A live audio webcast of the event may also be accessed through the "Investors" section of CTI’s website at www.ctibiopharma.com. A replay of the webcast will be available for 30 days following the event.

About Myelofibrosis and Severe Thrombocytopenia
Myelofibrosis is bone marrow cancer that results in formation of fibrous scar tissue and can lead to severe thrombocytopenia and anemia, weakness, fatigue and enlarged spleen and liver. Patients with severe thrombocytopenia are estimated to make up more than one-third of patients treated for myelofibrosis, or approximately 17,000 people in the United States and Europe. Severe thrombocytopenia, defined as blood platelet counts of less than 50,000 per microliter, has been shown to result in overall survival rates of just 15 months. Thrombocytopenia in patients with myelofibrosis is associated with the underlying disease but has also been shown to correlate with treatment with ruxolitinib, which can lead to dose reductions, and as a result, may potentially reduce clinical benefit. Survival in patients who have discontinued ruxolitinib therapy is further compromised, with an average overall survival of seven to 14 months. Myelofibrosis patients with severe thrombocytopenia have limited treatment options, creating a significant area of unmet medical need.

On August 5, 2021 Caladrius Biosciences, Inc. (Nasdaq: CLBS) ("Caladrius" or the "Company"), a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse disease, reported financial results for the three and six months ended June 30, 2021 (Press release, Caladrius Biosciences, AUG 5, 2021, View Source [SID1234585872]).

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"The second quarter and first six months of 2021 have proven to be operationally and financially positive for Caladrius. Despite the continuing challenges presented by the COVID-19 pandemic, we continued to advance and expand our clinical pipeline while also adding a large amount of additional capital to our balance sheet," stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius. "Most notably, we are seeing steady progress with site activation for our Phase 2b FREEDOM Trial of CLBS16 for the treatment of coronary microvascular dysfunction, as we continue to increase outreach activities to potential subjects in order to accelerate enrollment. In addition, a Phase 2 proof-of-concept clinical trial of CLBS201, designed to assess the safety and efficacy of CD34+ cell therapy as a treatment for patients with pre-dialysis diabetic kidney disease, is on track for a planned initiation in the second half of 2021. Lastly, even though our registration-eligible study of HONEDRA in critical limb ischemia and Buerger’s disease continues to be greatly impacted by the Japanese government-issued states of emergency tied to the COVID-19 pandemic, we have managed to treat patients and remain optimistic that the few remaining patients needed to complete enrollment will be treated by year end."

Product Development and Financing Highlights

CLBS16 for the treatment of coronary microvascular dysfunction

Caladrius reported in May 2020 the compelling results of its ESCaPE-CMD Phase 2a study of CLBS16 for the treatment of coronary microvascular dysfunction ("CMD"), a disease that continues to be underdiagnosed and potentially afflicts millions annually – a vast majority of whom are female – with no current treatment options. The Company is committed to raising awareness of this growing women’s health crisis and finding an effective treatment. To this end, we have partnered with the American Heart Association on a number of activities designed to educate people about CMD and to encourage them to discuss the condition with their physician. Caladrius recently initiated, and is currently treating patients in, a rigorous 105-subject Phase 2b clinical trial (the FREEDOM Trial) which, to our knowledge, is the first controlled regenerative medicine trial in CMD.

Investigator and subject response to the FREEDOM Trial has been favorable and early enrollment proceeded according to plan. However, the continued impact of the COVID-19 pandemic, including the resurgence of cases occurring in select areas throughout the United States, has contributed to a general slowing of enrollment. In addition, further work with investigators and prospective subject feedback led the Company to propose to the FDA amendments to the FREEDOM Trial protocol to enhance the breadth and speed of subject enrollment. These changes included expanding the techniques that are acceptable for diagnosing CMD. Nevertheless, given the uncertainty that persists surrounding the future impact of the COVID-19 pandemic on potential patient recruitment and the accessibility of investigator sites, the Company now projects enrollment completion for the FREEDOM Trial to occur in the third quarter of 2022 with final data (based on the 6 month assessment of all subjects) expected by the second quarter of 2023.

HONEDRA (CLBS12) for the treatment of critical limb ischemia

The Company’s open-label, registration-eligible study of SAKIGAKE-designated HONEDRA in Japan for the treatment of critical limb ischemia ("CLI") and Buerger’s disease (an orphan-sized subset of CLI) has shown strong results to date. The initial responses observed in the subjects who have reached an endpoint in this study are consistent with a positive therapeutic effect and safety profile reported by previously published clinical trials in Japan and the U.S. The study’s enrollment continues to be almost stopped by the pandemic’s impact in Japan, however, the Company is encouraged that less than a handful of patients are needed to reach study completion, the exact date of which is impossible to predict given the continuing impact of COVID-19 on clinical trials in Japan. While the final outcome of the trial will depend on all data from all subjects, the data to date is encouraging (~60% of subjects in the completed Buerger’s disease cohort have reached a positive "CLI-free" endpoint despite a natural history of such patients that predicts continuing disease progression to amputation). In the U.S., the Company was pleased to report that the U.S. Food and Drug Administration ("FDA") granted orphan designation to CLBS12 as a treatment for Buerger’s disease, however, any decisions regarding potential development in the U.S. will be made after further discussion with FDA on the requirements for registration.

CLBS201 for the treatment of diabetic kidney disease

The Company has prepared an initial development plan for the clinical study of CLBS201, a CD34+ investigational product for administration via the renal arteries to slow the deterioration, or, ideally, reverse the decline of renal function in patients with diabetic kidney disease ("DKD") who, although still pre-dialysis, exhibit rapidly progressing stage 3b disease. Progressive kidney failure is associated with attrition of the microcirculation of the kidney. Pre-clinical studies in kidney disease and injury models have demonstrated that protection or replenishment of the microcirculation results in improved kidney function. A Phase 2 proof of concept, randomized, placebo-controlled study for the stage 3b chronic kidney disease patient population is planned to initiate in the second half of 2021. The protocol, pending final central institutional review board approval, calls for a six-subject open-label treatment run-in arm in which patients will be treated sequentially, to be completed, evaluated and cleared for continuation by the study’s data safety monitoring board prior to initiating the 40-patient randomized, placebo-controlled, double blinded portion of the trial. The Company is projecting that safety data from the six-subject run-in arm will be completed by the end of the second quarter of 2022.

OLOGO for the treatment of no option refractory disabling angina

Caladrius acquired the rights to data and regulatory filings for a CD34+ cell therapy program for no option refractory disabling angina ("NORDA") that had been advanced to Phase 3 by a previous sponsor. Based on the clinical evidence from the completed studies that a single administration of OLOGO reduces mortality, improves angina, and increases exercise capacity in patients with otherwise untreatable angina, this product received Regenerative Medicine Advanced Therapy ("RMAT") designation from the FDA. Discussions with the FDA have resulted in a rejection of the Company’s efforts to reduce the FDA requirement of a 400-patient Phase 3 study for registration (including an arm of 50 standard of care patients and an arm of 150 placebo patients), despite data showing that the NORDA population is orphan in size. Because enrollment of a study of this magnitude and design is projected to take many years, if executable at all, the Company has decided not to pursue a Phase 3 program for OLOGO on its own, but will continue to seek a partner to execute the study and advance the program.

Sufficient capital to fund operations beyond multiple key data readouts anticipated in 2023

As previously disclosed, in January 2021, Caladrius raised $25.0 million in a private placement priced at-the-market under Nasdaq rules. In February 2021, the Company announced that it closed a $65.0 million capital raise through the sale of its common stock and warrants to several institutional and accredited investors in two registered direct offerings priced at-the-market under Nasdaq rules. In addition, in May 2021, the Company received $1.4 million in non-dilutive funding as an approved participant of the Technology Business Tax Certificate Transfer Program (the "Program") sponsored by the New Jersey Economic Development Authority (NJEDA). The Program enables qualifying New Jersey-based biotechnology or technology companies to sell a percentage of their New Jersey net operating losses ("NOLs") and research and development tax credits to unrelated qualifying corporations.

Second Quarter 2021 Financial Summary

Research and development expenses were approximately $4.3 million for the three months ended June 30, 2021, compared to $1.8 million for the three months ended June 30, 2020, representing an increase of 138%. Research and development in both periods focused on the advancement of our ischemic repair platform and related to:

Expenses associated with efforts to advance the FREEDOM Trial where the first patient was dosed in the first quarter of 2021;

Expenses associated with the planning and preparation of an IND and Phase 2 proof-of-concept protocol for CLBS201 as a treatment for diabetic kidney disease; and

Ongoing expenses for HONEDRA in critical limb ischemia and Buerger’s disease in Japan for which we continue to focus spending on patient enrollment and Japanese NDA preparation.
General and administrative expenses were approximately $2.8 million for the three months ended June 30, 2021, compared to $2.5 million for the three months ended June 30, 2020, representing an increase of 14%.

Overall, net losses were $5.7 million for the three months ended June 30, 2021, compared to net income of $6.6 million for the three months ended June 30, 2020.

Balance Sheet Highlights

As of June 30, 2021, we had cash, cash equivalents and marketable securities of approximately $106.1 million. Based on existing programs and projections, the Company remains confident that its current cash balances will fund its operations for the next several years, notably through study completion for the FREEDOM Trial, through the registration-eligible study completion for HONEDRA and through the Phase 2 proof-of-concept study for CLBS201, while still potentially providing capital to explore additional pipeline expansion opportunities.

Conference Call

Caladrius will hold a live conference call today, August 5, 2021, at 4:30 p.m. (ET) to discuss financial results, provide a business update and answer questions. To join the conference call, please refer to the dial-in information provided below. A live webcast of the call will also be available under the Investors & News section of the Caladrius website, View Source, and will be available for replay for 90 days after the conclusion of the call.