On August 6, 2020 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing that enables in vitro diagnostics, pre-clinical nucleic acid-based therapeutic drug candidates, supply chain security, anti-counterfeiting and anti-theft technology, reported consolidated financial results for the fiscal third quarter and the nine months ended June 30, 2020 (Press release, Applied DNA Sciences, AUG 6, 2020, View Source [SID1234563050]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We continued during the quarter to position the Company to serve the unmet and evolving needs for COVID-19 testing solutions and vaccine development," said Dr. James A. Hayward, president and CEO of Applied DNA Sciences. "Upon the receipt of FDA Emergency Use Authorization ("EUA") for our Linea COVID-19 diagnostic assay kit (for use with nasopharyngeal (NP) swab and anterior nasal swab (ANS) sample collections), we put into place the foundation of our COVID-19 diagnostics business: we established the requisite supply chains and inventory to support anticipated growth in assay kit demand; we formed a clinical lab subsidiary (Applied DNA Clinical Labs) that, once certified by the State of New York, will offer testing as a service ("TaaS") whose potential economics to us is more favorable than that of standalone kit sales; and we applied for amendments to our EUA to expand the addressable market for our kits and improve customer testing turnaround time and throughput. We are in the marketplace today with what we believe to be a highly sensitive and purpose-designed platform for the high-throughput workflows found at clinical diagnostic laboratories nationally. We are currently pursuing diagnostic kit contracts and, upon State certification, commercial testing contracts."

Continued Dr. Hayward, "The U.S. is facing bottlenecks in testing capacity with supply shortages and testing backlogs at laboratories that, together with the spike in infection numbers in the southern and western parts of the country, suggests greater and long-term demand for testing. We believe we are well-positioned to deliver greater patient access to testing and increased market penetration in the coming quarters. The recent amendments to our EUA advance our go-to-market strategy significantly: they greatly enhance our opportunity for commercial kit sales by increasing the size of the installed base of RT-PCR systems upon which our kit can run and they enable the use of automated RNA extraction robotics at third-party labs and at Applied DNA Clinical Labs LLC, when licensed, to increase testing throughput.

"We have also recruited our first research sponsors who have funded the development of pooling models for the testing of asymptomatic patients (screening testing), which we will be presenting to FDA. We believe that our ability to sample for the virus using the less-invasive ANS will enhance compliance among students and asymptomatic individuals who may require multiple rounds of testing. Several academic institutions are contemplating COVID-19 safety programs based upon the use of our diagnostic kit to enhance the safety of students, faculty, and staff. We have recruited both internal and external sales infrastructures to drive demand for our diagnostic kit."

Commenting on the development of the Company’s vaccine candidates co-developed with Takis S.R.L. and Evvivax S.R.L. (collectively, "Takis Biotech"), Dr. Hayward stated, "Tests on the linear DNA forms of our COVID-19 vaccine candidates provoked seroconversion in mouse models that are consistent with prior data from the plasmid forms of the vaccine candidates by Takis Biotech. Our results suggest that a low-dose vaccine could be potentially effective in providing protection while the T cell response suggests potential long-term persistence. We believe our results in animal models echo the effectiveness announced by some of the COVID-19 vaccines already in human trials. We have attracted the attention of ‘Big Pharma’ and are presently negotiating rights to novel delivery systems and funding for sophisticated toxicology screens done in collaboration with our partner Takis Biotech and their network of service partners."

With regard to the Company’s non-biological business segment, Dr. Hayward said, "Our supply chain security segment felt the full brunt of COVID-19 in the fiscal third quarter that resulted in a further weakening of demand for tagging and related services across the global supply chain chains we serve. We remain focused on business-building in key industrial and regulated markets, including textiles, cannabis, personal care, nutraceuticals, and pharmaceuticals, ahead of the return of increased demand patterns."

Concluded Dr. Hayward, "Looking ahead, we are focused on advancing our COVID-19 diagnostic kit and TaaS market strategy and progressing the development of the linear DNA forms of our vaccine candidates. To drive broader adoption of our kit by laboratories and to increase TaaS opportunities, we plan additional EUA amendments to further expand the base of RT-PCR systems relevant to our kit and to secure the ability to conduct asymptomatic screening testing, which we believe would confer onto us a potentially significant commercial advantage in the marketplace. We also await New York State certification of Applied DNA Clinical Labs LLC that would initiate commercial testing revenues.

"In the development of our vaccine candidates, we expect to launch toxicology screens once funding is secured followed by higher animal studies before initiating human trials. We are recruiting industry partners to lead on the regulatory process and distribution with Applied DNA serving as the sole-source manufacturer globally. With our linear DNATM manufacturing platform, we are differentiated not only for our ability to manufacture any linear DNA form of a COVID-19 vaccine at extremely large scale, but also for our ability to react to any new variants of the virus with unrivaled speed."

Recent Business Highlights:

COVID-19

LineaTM COVID-19 SARS-CoV-2 Assay Kit

On July 31, 2020, the Company announced that the U.S. Food and Drug Administration (FDA) had granted its second EUA amendment that increases the size of the installed base of RT-PCR systems upon which the Company’s diagnostic assay kit can run as well as the speed and throughput of the laboratory process, including RNA extraction, via a robotic platform. The EUA was granted to Applied DNA on May 13, 2020, and the first amendment to the EUA was granted on July 8, 2020.

The second amendment to the EUA: 1) extends the RT-PCR platform from the Applied Biosystems (ThermoFisher Scientific) QuantStudio Dx to include Applied Biosystems’ QuantStudio 5 Real-Time PCR system to analyze patient samples on the company’s Linea COVID-19 assay kit; and 2) authorized the use of the Hamilton STARlet robotic automation in conjunction with the Omega Bio-tek MagBind viral RNA Express kit to speed the process of extracting viral RNA from specimens and drive greater testing throughput.

The scope of the EUA, as amended, is expressly limited to use consistent with the Instructions for Use by authorized laboratories, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests. The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 is terminated or until the EUA’s prior termination or revocation. The diagnostic kit has not been FDA cleared or approved, and the EUA’s limited authorization is only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.

Vaccine Candidates

On July 17, 2020, Applied DNA and its vaccine development partner, Takis Biotech, announced that linear DNA forms of COVID-19 vaccine candidates under development by Takis Biotech and manufactured by the Company yielded strong antibody and T-cell responses even at very low doses of linear DNA.

The Company believes that linear DNA vaccines offer a broad array of potential advantages: stability during storage and shipment, the capacity to manufacture both centrally and locally across the globe, vaccine expression without apparent integration into the patient’s genome, the avoidance of antibiotics, no risk of transference of antibiotic-resistance genes, the avoidance of bacterial vectors, high purity and simplicity of production, and apparent high efficacy. Given the mutational proclivity of SARS-CoV-2, and the synthetic genomic design skills of Takis Biotech, the Company believes it could manufacture an improved linear DNA vaccine within weeks of obtaining the sequence of a mutant variant that dodged any future vaccines targeting then dominant variants.

Applied DNA Clinical Labs LLC ("ADCL")

On July 9, 2020, the Company announced the formation of ADCL as a wholly-owned subsidiary dedicated to the commercial development of its tests in virology (for the detection of COVID-19) and in oncology (for the detection and enumeration of invasive Circulating Tumor Cells (iCTCs) in patients with cancer).

In forming ADCL, Applied DNA is executing on a strategy to expand its market reach through value-added services complementary to a growing portfolio of diagnostic assays attractive to a broader number of qualified labs.

Corporate
On June 26, 2020, the Company announced that it had joined the Russell Microcap Index (the "Index") following the conclusion of the 2020 Russell indexes annual reconstitution.

Fiscal Third Quarter 2020 Financial Results:

Revenues decreased 79% for the third quarter of fiscal 2020 to $432 thousand, compared with $2.1 million reported in the third quarter of fiscal 2019, and decreased 22% from the $552 thousand reported in the second fiscal quarter ended March 31, 2020. The decrease in year-over-year revenues was due primarily to a decrease in revenue from a licensing agreement in the cannabis industry of $1.0 million, as well as cannabis feasibility pilots of $137 thousand during the three months ended June 30, 2019. The decrease also relates to a decline in revenues of approximately $213 thousand from the government development contract award that expired during the second half of fiscal 2019. The remaining decrease related to a decline in product revenue as a result of lower textile and biopharmaceutical revenue.
Total operating expenses increased to $3.5 million for the third fiscal quarter of 2020, compared with $3.2 million in the prior fiscal year’s third quarter. This increase is primarily attributable to an increase in selling, general and administrative expenses of $182 thousand. This increase was the result of stock-based compensation expense. There was also an increase of approximately $95 thousand in research and development expenses, specifically as it relates to the development of our Linea COVID-19 diagnostic assay kit.
Net loss for the quarter ended June 30, 2020 was $3.3 million, or $0.72 per share, compared with a net loss of $1.5 million, or $1.55 per share, for the quarter ended June 30, 2019, and a net loss of $3.0 million, or $0.79 per share, for the quarter ended March 31, 2020.
Excluding non-cash expenses, Adjusted EBITDA was negative $2.8 million and a negative $1.2 million for the quarters ended June 30, 2020 and 2019, respectively. See below for information regarding non-GAAP measures.
Nine-Month Financial Highlights:

Revenues for the first nine months of fiscal 2020 totaled $1.6 million, a decrease of 56% from $3.7 million from the same period in the prior fiscal year. The decrease in revenues was due to a decline in revenue of approximately $613 thousand associated with the completion of a government contract award, which was completed during the second half of fiscal 2019, as well as decreases of approximately $1.2 million in cannabis due to a decline in licensing and feasibility projects year over year.
Operating expenses for the nine months ended June 30, 2020 decreased by $886 thousand or 9% for the same period last fiscal year. The decrease is primarily attributable to a decrease in stock-based compensation, consulting, travel and legal and professional fees, as well as a decrease in payroll of $273 thousand.
Net loss for the nine months ended June 30, 2020 was $8.9 million or $2.54 per share, compared with a net loss of $7.4 million or $8.46 per share for the nine months ended June 30, 2019.
Excluding non-cash expenses and interest, Adjusted EBITDA for the nine months ended June 30, 2020 was a negative $7.8 million as compared to a negative $6.1 million for the same period in the prior fiscal year. See below for information regarding non-GAAP measures.
Fiscal Third Quarter 2020 Conference Call Information
The Company will hold a conference call and webcast to discuss its fiscal third quarter-end 2020 results on Thursday, August 6, 2020 at 4:30 PM ET. To participate on the conference call, please follow the instructions below. While every attempt will be made to answer investors’ questions on the Q&A portion of the call, due to the large number of expected participants, not all questions may be answered.

For those investors unable to attend the live call, a copy of management’s PowerPoint presentation will be available for review under ‘IR Calendar’ portion of the Company’s Investors web site: View Source

Information about Non-GAAP Financial Measures

As used herein, "GAAP" refers to accounting principles generally accepted in the United States of America. To supplement our condensed consolidated financial statements prepared and presented in accordance with GAAP, this earnings release includes Adjusted EBITDA, which is a non-GAAP financial measure as defined in Rule 101 of Regulation G promulgated by the Securities and Exchange Commission. Generally, a non-GAAP financial measure is a numerical measure of a company’s historical or future performance, financial position, or cash flows that either excludes or includes amounts that are not normally excluded or included in the most directly comparable measure calculated and presented in accordance with GAAP. The presentation of this non-GAAP financial information is not intended to be considered in isolation or as a substitute for, or superior to, the financial information presented in accordance with GAAP. We use this non-GAAP financial measure for internal financial and operational decision-making purposes and as a means to evaluate period-to-period comparisons of the performance and results of operations of our core business. Our management believes that these non-GAAP financial measures provide meaningful supplemental information regarding the performance of our business by excluding non-cash expenses that may not be indicative of our recurring operating results. We believe this non-GAAP financial measure is useful to investors as they allow for greater transparency with respect to key metrics used by management in its financial and operational decision making.

"EBITDA"- is defined as earnings (loss) before interest expense, income tax expense and depreciation and amortization expense.

"Adjusted EBITDA"- is defined as EBITDA adjusted to exclude (i) stock-based compensation and (ii) other non-cash expenses.

On August 6, 2020Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, reported financial and operating results for the second quarter ended June 30, 2020 (Press release, Lineage Cell Therapeutics, AUG 6, 2020, View Source [SID1234563049]). Lineage management will host a conference call today at 5:30 p.m. Eastern Time/2:30 p.m. Pacific Time to discuss its second quarter 2020 financial and operating results and to provide a business update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Lineage has continued to make significant progress across our entire cell therapy pipeline, with positive milestones on each of our three programs announced this quarter," stated Brian M. Culley, Lineage CEO. "Most importantly, after moving into a cohort of patients with less advanced disease, we reported the first known finding of retinal tissue restoration, which we believe could become a landmark discovery in the treatment of dry AMD. Specifically, Lineage reported evidence of substantial anatomical restoration of retinal tissue within an area of geographic atrophy, or GA. The area of GA was approximately 25% smaller when assessed at 9 months, compared to the patient’s pre-treatment baseline. These findings were initially discovered by an independent external advisor using multiple imaging technologies and were subsequently confirmed by the reading center and additional experts in the field of retinal imaging. In light of the significance of this finding, our objective is to treat and monitor the final three patients in Cohort 4 of our dry AMD study and seek to demonstrate additional evidence of this exciting finding. These data also will direct our clinical, regulatory, and ongoing partnership discussions.

We also recently exercised an option with Cancer Research UK, which allowed us to assume responsibility for advancing our dendritic cell vaccine program, strengthening our pipeline and moving Lineage more prominently into the field of cancer immunotherapy. The VAC platform will permit us to expand not only our oncology pipeline, but also enter infectious diseases, with steps being taken to identify external funding to develop a SARS-CoV-2 vaccine, based on VAC platform data showing strong induction of cellular immunity via T cells.

Lastly, we have made significant progress developing and implementing manufacturing improvements for our OPC1 program to treat spinal cord injuries. We now are working to develop a "thaw-and-inject" formulation and are evaluating a superior delivery system to enable an easier and faster surgical procedure and facilitate enrollment in a late-stage clinical study.

Our aim is to provide safe and sustained benefits of targeted cell-based therapies, alongside commercially relevant solutions with competitive advantages in areas of scale-up, production costs, and delivery techniques. We believe our holistic approach to designing new therapeutic solutions will allow us to position ourselves as the clear leader in the emerging field of cell therapy transplant medicine."

Lineage has the following plans and objectives for the second half of 2020:

– Meet with Biomedical Advanced Research and Development Authority (BARDA) in August to discuss our proposal for non-dilutive support for a coronavirus vaccine candidate.

– Report initial VAC2 clinical data from patients treated in the ongoing Phase 1 trial in NSCLC (non-small cell lung cancer) run by Cancer Research UK.

– Complete patient enrollment in the U.S. with the Gyroscope Orbit SDS and new thaw-and-inject formulation in the ongoing Phase 1/2a clinical trial of OpRegen for the treatment of dry AMD.

– Present new and accumulated OpRegen data from the ongoing Phase 1/2a clinical trial at the American Academy of Ophthalmology (AAO) Annual 2020 Meeting the second week of November.

– Meet with the U.S. Food and Drug Administration (FDA) to discuss further development of the OPC1 program.

Balance Sheet and Cash Flow Highlights

Cash, cash equivalents, and marketable securities totaled $20.3 million as of June 30, 2020. Marketable securities include our remaining ownership of unrestricted securities in OncoCyte Corporation (OncoCyte), AgeX Therapeutics, Inc. (AgeX) and Hadasit Bio-Holdings Ltd (Hadasit).

We have continued to fund our operations primarily by selling a portion of our marketable securities. In the six months ended June 30, 2020, we sold approximately 4.8 million shares of OncoCyte common stock for net proceeds of $10.9 million. We continue to hold approximately 3.6 million shares of OncoCyte stock that are valued at $6.8 million as of August 4, 2020, based on the closing price of its common stock on that date. All of our marketable securities are now in companies in which we hold less than 10% of the outstanding shares.

In conjunction with the sale of AgeX shares to Juvenescence Limited (Juvenescence) in 2018, we also hold a $21.6 million promissory note bearing 7% annual interest that matures later this month, on August 30, 2020. As of June 30, 2020, the outstanding principal and accrued interest on the note was $24.4 million. If, prior to August 30, 2020, Juvenescence completes an initial public offering resulting in gross proceeds of at least $50.0 million, the promissory note automatically converts into the Juvenescence securities.

Net cash used in operating activities for the six months ended June 30, 2020 was approximately $9.3 million, a decrease of $9.7 million as compared to $19.0 million in the same period of 2019. Additionally, net cash used in the three months ended June 30, 2020 of $4.3 million is $0.7 million lower than net cash used in the three months ended March 31, 2020 of $5.0 million.

Second Quarter Operating Results

Revenues: Lineage’s revenue is generated primarily from research grants, royalties and licensing fees. Total revenues for the three months ended June 30, 2020 were $0.4 million, a decrease of $0.4 million as compared to $0.8 million for the same period in 2019. The decrease was primarily related to a $0.2 million decrease in grant revenue due to the timing of grant related activities for OpRegen and other ophthalmic applications and a $0.1 million decrease in the sale of research products and services due to the cessation of such sales.

Operating Expenses: Operating expenses are comprised of research and development (R&D) expenses and general and administrative (G&A) expenses. Total operating expenses for the three months ended June 30, 2020 were approximately $6.7 million, a decrease of $4.8 million as compared to $11.5 million for the same period in 2019.

R&D Expenses: R&D expenses for the three months ended June 30, 2020 were $2.8 million, an approximate decrease of $2.4 million as compared to $5.2 million for the same period in 2019. The overall decrease was primarily related to decreases of $1.7 million in OpRegen and other ophthalmic application expenses, attributable primarily to a decrease in manufacturing activities in 2020 as compared to 2019, and $0.7 million in OPC1 expenses, primarily related to a decrease in development activities in 2020 as compared to 2019 when technology transfer was a focus to support OPC1 coming in-house with the acquisition of Asterias.

G&A Expenses: G&A expenses for the three months ended June 30, 2020 were $3.9 million, a decrease of $2.4 million as compared to approximately $6.3 million for the same period in 2019. The decrease was primarily attributable to a $1.6 million reduction in expenses related to our merger with Asterias Biotherapeutics, Inc. (Asterias), a $0.2 million reduction in compensation expenses, a $0.2 million reduction in investor and public relations expenses, a $0.2 million reduction in accounting expenses, a $0.1 million reduction in travel expenses, a $0.1 million reduction in rent expenses and a $0.1 million reduction in consulting expenses, offset by a $0.2 million increase related to the cessation of shared services reimbursements.

Loss from Operations: Loss from operations for the three months ended June 30, 2020 was $6.4 million, a decrease of $4.4 million as compared to $10.8 million for the same period in 2019.

Other (Expense) Income, Net: Other income/(expenses), net for the three months ended June 30, 2020 reflected other expense, net of ($0.1) million, compared to other expense, net of ($20.5) million for the same period in 2019. The variance was primarily related to changes in the value of equity method investments and marketable equity securities for the applicable periods, as well as foreign currency translation adjustments related to Lineage’s international subsidiaries. The value of Lineage’s OncoCyte shares decreased by $21.4 million in the three months ended June 30, 2019, which contributed greatly to the overall balance in other expense, net for that period.

Net loss attributable to Lineage: The net loss attributable to Lineage for the three months ended June 30, 2020 was $6.5 million, or $0.04 per share (basic and diluted), compared to a net loss attributable to Lineage of $30.0 million, or $0.20 per share (basic and diluted), for the same period in 2019.

Conference Call and Webcast

Lineage will host a conference call and webcast today, at 2:30 pm PT/5:30 pm ET to discuss its second quarter 2020 financial results and to provide a business update. Interested parties may access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through August 14, 2020, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and Canada and entering conference ID number 6649516.

On August 6, 2020 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported its financial results for the second quarter ended June 30, 2020. In addition, the Company provided a clinical and business update (Press release, Syndax, AUG 6, 2020, View Source [SID1234563048]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are very pleased that the FDA has agreed to several proposed changes to the Phase 1 portion of AUGMENT-101 which build on emerging clinical data and help us maximize SNDX-5613’s potential in as many appropriate patients as possible," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "This includes focusing enrollment exclusively on patients with MLL-r and NPM1 mutant acute leukemias, the ability to expand dose cohorts that demonstrate efficacy, and the inclusion of pediatric patients, which has long been a key component of our overall strategy for SNDX-5613. We remain on track to identify a recommended Phase 2 dose by the end of this year, with full Phase 1 data anticipated in early 2021."

Dr. Morrison added, "Progress also continues with the Phase 1/2 trial of axatilimab, our anti-CSF-1R monoclonal antibody, in patients with cGVHD, with Phase 1 results expected in the fourth quarter. We are actively committed to helping people with cancer live longer and better than ever before and look forward to further advancing this mission throughout the balance of the year."

Pipeline Updates

SNDX-5613

Syndax reported that the U.S. Food and Drug Administration (FDA) has agreed to several enhancements to the Phase 1 portion of the AUGMENT-101 protocol. AUGMENT-101 is the Company’s Phase 1/2 open-label trial designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of orally administered SNDX-5613, its potent, highly selective oral menin inhibitor, in patients with acute leukemias. As recently reported, the Phase 1 dose escalation portion of AUGMENT-101 was separated into two cohorts based on concomitant treatment with a strong CYP3A4 inhibitor. Arm A will enroll patients not receiving a strong CYP3A4 inhibitor, while Arm B will enroll patients receiving a strong CYP3A4 inhibitor.
Supported by initial clinical data, as well as new insights from emerging data in the pediatric compassionate use setting, the Company will enact the following enhancements to the Phase 1 portion of the trial: focusing enrollment exclusively on patients with mixed lineage leukemia rearranged (MLL-r) and nucleophosmin (NPM1) mutant acute leukemias; backfilling any dose escalation cohort up to a total of 12 patients in either Arm A or Arm B if efficacy has been observed at that dose level; and expansion of enrollment to include pediatric patients over 30 days old. The Company continues to anticipate identifying a recommended Phase 2 dose by the end of 2020, with full data from the amended Phase 1 portion expected in early 2021. SNDX-5613 was recently granted Orphan Drug Designation for the treatment of adult and pediatric AML by the FDA.

The Company recently participated in the U.S. FDA’s June 2020 meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (pedsODAC) to discuss the clinical development plan for SNDX-5613 in pediatric patients. A replay of the pedsODAC meeting, which was intended to improve and encourage the development of oncology and hematology drugs for pediatric use, as well as a copy of the Company’s briefing package, can be found here.
At the 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting I in April, Syndax announced initial clinical data from the AUGMENT-101 trial. Data presented serve as the first clinical evidence that inhibition of the menin-MLL1 interaction can induce response in patients with MLL-r acute leukemias. The presentation also highlighted preclinical findings, including data published in Cancer Cell and Science magazine, supporting the potential of single-agent menin-MLL inhibition to serve as an effective intervention for both MLL-r acute leukemias and NPM1 mutant AML. A copy of the presentation is available on Syndax’s website under Publications, Menin-MLL-r Inhibitors.
Axatilimab

Enrollment continues across the Company’s Phase 1/2 trial evaluating axatilimab, its anti-CSF-1R monoclonal antibody, for the treatment of chronic graft versus host disease (cGVHD). The Phase 1 portion continues to explore alternate dose and schedules, while the Phase 2 expansion is evaluating the benefit of treatment at 1 mg/kg every two weeks. The Company expects to present additional results from the Phase 1 trial in the fourth quarter of 2020.
Data from the Phase 1 trials exploring axatilimab, both as a monotherapy and in combination with IMFINZI (durvalumab) in patients with locally-advanced or metastatic solid tumors, were summarized in two oral presentations at the AACR (Free AACR Whitepaper) Virtual Annual Meeting I. The data indicate that axatilimab is tolerated well in solid tumor patients and provide evidence of its ability to deplete circulating pro-inflammatory monocytes. A recommended Phase 2 dose of axatilimab for the treatment of patients with solid tumors was determined as monotherapy and in combination with IMFINZI (durvalumab). A copy of each presentation is available on Syndax’s website under Publications, Axatilimab.
Entinostat

In May 2020, the Company reported final results of E2112, the Phase 3 clinical trial conducted by ECOG-ACRIN Cancer Research Group and sponsored by the National Cancer Institute, that evaluated the investigational compound entinostat, Syndax’s class I HDAC inhibitor, plus exemestane in patients with advanced hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer. The trial did not achieve the primary endpoint of demonstrating a statistically significant overall survival benefit over hormone therapy alone. The Company has decided to deprioritize the entinostat program to focus resources on advancing the remainder of its pipeline.
Financial Update and Guidance

As of June 30, 2020, Syndax had cash, cash equivalents and short-term investments of $186.8 million and 44.1 million shares and share equivalents issued and outstanding which included 38.5 million shares of common stock and pre-funded warrants to purchase 5.6 million shares of common stock.

In May 2020, Syndax closed an underwritten public offering whereby the Company sold 6.4 million shares of common stock at a price of $18.00 per share. The aggregate net proceeds received by the Company were $107.9 million, net of underwriting discounts and commissions and estimated offering expenses payable by the Company.

Second quarter 2020 research and development expenses decreased to $10.9 million from $12.3 million for the prior year period. The second quarter decrease was primarily due to the impact of a $4.0 million expense for achievement of a clinical milestone associated with SNDX-5613 which was recognized and recorded in the second quarter of 2019. Excluding this milestone, research and development expenses in the second quarter of 2020 increased compared to the prior year period primarily due to an increase in clinical activities related to SNDX-5613 and axatilimab, and professional fees, partially offset by a decrease in clinical activities related to entinostat.

General and administrative expenses for the second quarter 2020 increased to $6.0 million from $3.5 million for the prior year period. The increase was primarily due to increased pre-commercialization activities in advance of the Phase 3 breast cancer results for entinostat and employee related expenses.

For the three months ended June 30, 2020, Syndax reported a net loss attributable to common stockholders of $17.1 million or $0.42 per share compared to $14.9 million or $0.47 per share for the prior year period.

Financial Guidance

Today the Company provided operating expense guidance for the third quarter and second half of 2020. For the third quarter and second half of 2020, research and development expenses are expected to be $14 to $16 million and $30 to $35 million, respectively, and total operating expenses are expected to be $19 to $21 million and $40 to $45 million, respectively.

Conference Call and Webcast

In connection with the earnings release, Syndax’s management team will host a conference call and live audio webcast at 4:30 p.m. ET today, August 6, 2020.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website at www.syndax.com. Alternatively, the conference call may be accessed through the following:

Conference ID: 8998873
Domestic Dial-in Number: (855) 251-6663
International Dial-in Number: (281) 542-4259
Live webcast: View Source

For those unable to participate in the conference call or webcast, a replay will be available on the Investors section of the Company’s website, www.syndax.com.

On August 6, 2020 Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results for the quarter ended June 30, 2020, and provided an update on the Company’s clinical development programs and regulatory and commercial outlook for the rest of the year (Press release, Clovis Oncology, AUG 6, 2020, View Source [SID1234563047]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are pleased with our U.S. approval in advanced prostate cancer and continued sales growth for Rubraca year over year in the U.S. and Europe, particularly in the face of evident headwinds from COVID-19. Second-quarter revenues were negatively affected, largely due to fewer new patient starts, as oncology practices and patients adjusted to the impact of the virus in the U.S. and Europe," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We continue to believe that Rubraca has significant advantages as a maintenance option in ovarian cancer and a treatment option for prostate cancer in an environment in which physicians are trying to reduce patient visits to their clinics, and will continue our efforts to engage with clinicians during this period, which is ongoing as resurgences of the virus continue in large U.S. markets. I am pleased that we successfully completed target enrollment in the 1000 patient Phase 3 ATHENA study in front-line, newly diagnosed advanced ovarian cancer maintenance in June in less than two years. We are also particularly enthusiastic to be moving FAP-2286 into the clinic with planned imaging and therapeutic INDs in the fourth quarter."

Second Quarter 2020 Financial Results

Clovis reported net product revenue for Rubraca of $39.9 million for the second quarter of 2020, which included U.S. product revenue of $36.7 million and ex-U.S. product revenue of $3.2 million, compared to net product revenue for Q2 2019 of $33.0 million, which included U.S. net product revenue of $32.7 million and ex-U.S. net product revenue of $0.3 million. U.S. product revenues increased 12 percent in Q2 2020 compared to Q2 2019 and ex-U.S. product revenue increased meaningfully from the first reported ex-U.S. sales in Q2 2019.

Clovis reported net product revenue for Rubraca of $82.5 million for the six months ended June 30, 2020, which included U.S. product revenue of $76.0 million and ex-U.S. product revenue of $6.5 million, compared to net product revenue for same period in 2019 of $66.1 million, which included U.S. net product revenue of $64.6 million and ex-U.S. net product revenue of $1.5 million.

Net product revenue decreased six percent sequentially from Q1 2020 to Q2 2020 principally due to reduced new patient starts which we believe is the result of the effects of COVID-19 in the U.S. and Europe during the quarter. The effects of COVID-19 on future sales are difficult to predict, especially with the increase in COVID-19 cases in the U.S. and Europe.

Clovis had $261.4 million in cash and cash equivalents as of June 30, 2020, including $82.8 million in net proceeds in an equity offering of 11.1 million shares of common stock in May 2020.

The Company has reduced its total outstanding convertible debt by $145.1 million in outstanding principal amount from December 31, 2019 through June 30, 2020.

As of June 30, 2020, the Company had drawn approximately $68 million under the TPG ATHENA clinical trial financing and had up to $107 million available to draw under the agreement to fund the expenses of the ATHENA trial through Q3 2022.

Based on the Company’s anticipated revenues, spending, available financing sources and existing cash and cash equivalents, the Company believes it has sufficient cash and cash equivalents to fund its operating plan into early 2022, after taking into account any cash repayment (unless refinanced earlier) of the remaining $64.42 million aggregate principal amount of the 2.50% convertible notes, at their maturity in September 2021.

Net cash used in operating activities was significantly lower at $59.9 million for the second quarter of 2020, compared with $98.0 million for the second quarter of 2019. Similarly, net cash used in operating activities for the first half of 2020 was $142.4 million, compared with $196.5 million for the first half of 2019.

Borrowings under the TPG ATHENA financing provided $17.7 million in cash in Q2 2020, and we paid a milestone payment to Pfizer of $8.0 million for the U.S. mCRPC approval. Cash burn in Q2 2020 was $50.1 million, which represents a 25 percent decline from the Q1 2020 cash burn of $66.9 million. Cash burn in the first half of 2020 was $117.0 million.

Clovis reported a net loss for the second quarter of 2020 of $92.2 million, or ($1.15) per share, and a net loss of $191.6 million, or ($2.52) per share, for the first half of 2020. Net loss for Q2 2019 was $120.4 million, or ($2.27) per share, and $206.9 million, or a net loss of ($3.91) per share, for the first half of 2019. Net loss for Q2 and the first half of 2020 included share-based compensation expense of $13.3 million and $26.3 million, compared to $14.1 million and $27.8 million for the comparable periods of 2019.

Research and development expenses totaled $69.9 million for Q2 2020 and $138.1 million for the first half of 2020, compared to $70.7 million and $132.8 million for the comparable periods in 2019. Research and development expenses remained relatively flat for the second quarter and increased slightly for the first half of 2020 compared to the same period in the prior year. We expect research and development expenses to be lower in the full year 2021 compared to full year 2020.

Selling, general and administrative expenses totaled $41.9 million for Q2 2020 and $84.5 million for the first half of 2020, compared to $48.0 million and $95.8 million for the comparable periods in 2019. Selling, general and administrative expenses decreased during the second quarter and first half of 2020 compared to the same period in the prior year with savings due to the COVID-19 situation globally and overall cost reduction efforts.

U.S. Approval and Label Expansion for Rubraca now includes BRCA1/2-mutant mCRPC

On May 15, 2020, the U.S. FDA approved Rubraca for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castrate-resistant prostate cancer who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. The FDA approved this indication under accelerated approval based on objective response rate and duration of response data from the multi-center, single arm TRITON2 clinical trial.

In late May, the National Comprehensive Cancer Network (NCCN) updated its Clinical Practice Guidelines in Oncology for Prostate Cancer to include new recommendations for Rubraca. In addition to its ovarian cancer recommendations, Rubraca is now recommended in the NCCN Guidelines for the treatment of patients with BRCA-mutant tumors with mCRPC under second-line treatment and subsequent therapy as a Category 2A recommendation inclusive of the following:

Rucaparib is a treatment option for patients with mCRPC and a pathogenic BRCA1 or BRCA2 mutation (germline and/or somatic) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. If the patient is not fit for chemotherapy, rucaparib can be considered even if taxane-based therapy has not been given.

Target Enrollment Completed in the Phase 3 ATHENA Study

In June, the Company announced the completion of target enrollment of 1000 patients in the Clovis-sponsored Phase 3 ATHENA trial evaluating Rubraca as monotherapy and the combination of Rubraca and Opdivo as front-line maintenance treatment of newly-diagnosed advanced ovarian cancer. ATHENA is the first front-line switch maintenance study designed to evaluate PARP monotherapy and PARP/PD-1 combination therapy in one study design. Target enrollment of 1000 patients in the ATHENA study was achieved in less than two years with the support and involvement of the Gynecologic Oncology Group (GOG) and the European Network for Gynecological Oncological Trials (ENGOT), two of the largest cooperative groups in the U.S. and Europe dedicated to the treatment of gynecological cancers.

In addition, three abstracts describing data from rucaparib monotherapy or combination clinical trials were accepted for e-poster presentation at the 2020 ESMO (Free ESMO Whitepaper) Virtual Congress in September.

Lucitanib Combination Studies Underway

Two Clovis-sponsored early Phase 1b/2 lucitanib combination studies are currently underway: LIO-1, evaluating lucitanib and Opdivo in combination in advanced solid tumors (Phase 1b) and gynecologic cancers (Phase 2); and lucitanib in combination with rucaparib in advanced solid tumors (Phase 1b) and ovarian cancer (Phase 2) as an arm of the SEASTAR study. An abstract describing the initial Phase 1b clinical experience of lucitanib in combination with Opdivo (LIO-1) has been accepted as an e-poster for the 2020 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress to be held in September. In addition, the Phase 2 portion of LIO-1 recently opened for enrollment and treated the first patient in the trial, and a Trials-In-Progress e-poster describing the trial design was also accepted for the 2020 ESMO (Free ESMO Whitepaper) Virtual Congress.

FAP-2286 and Peptide-Targeted Radiotherapy Development Program

The Company’s peptide-targeted radiopharmaceutical therapy development program includes lead compound FAP-2286 and three additional unnamed preclinical targets. An abstract describing the first presentation of FAP-2286 preclinical data in animal models has been accepted for the 2020 ESMO (Free ESMO Whitepaper) Virtual Congress, and during Q4 2020, Clovis intends to submit two Investigational New Drug (IND) applications for FAP-2286 for use as imaging and treatment agents respectively. Upon activation of the INDs by the U.S. FDA, Clovis will initiate a Phase 1 study to determine the dose and tolerability of the FAP-targeting therapeutic agent, with expansion cohorts planned in multiple tumor types. The FAP-targeting imaging agent will be utilized to identify tumors that contain FAP for treatment in the Phase 1 study.

Conference Call Details

Clovis will hold a conference call to discuss Q2 2020 results this afternoon, August 6, at 4:30pm ET. The conference call will be simultaneously webcast on the Clovis Oncology web site www.clovisoncology.com, and archived for future review. Dial-in numbers for the conference call are as follows: US participants (877) 698-7048, International participants (647) 689-5448, conference ID: 7155799.

About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed multiple tumor types, including ovarian and prostate cancers, as monotherapy and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway. Clovis holds worldwide rights for Rubraca.

In the United States, Rubraca is approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Rubraca is also approved in the United States for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. Additionally, Rubraca is approved in the U.S. for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Patients should be selected for treatment with Rubraca based on the presence of a deleterious BRCA mutation (germline and/or somatic). This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The TRITON3 clinical trial is expected to serve as the confirmatory study for the Rubraca accelerated approval in mCRPC.

In Europe, Rubraca is approved for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. Rubraca is also approved in Europe for the treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

Rubraca is an unlicensed medical product outside of the U.S. and Europe.

About Lucitanib

Lucitanib is an oral, potent inhibitor of the tyrosine kinase activity of vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDGFRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR1-3). Emerging clinical data support the combination of angiogenesis inhibitors and immunotherapy to increase effectiveness in multiple cancer indications. Angiogenic factors, such as vascular endothelial growth factor (VEGF), are frequently up-regulated in tumors and create an immunosuppressive tumor microenvironment. Use of antiangiogenic drugs may reverse this immunosuppression and augment response to immunotherapy.

Lucitanib is an unlicensed medical product.

About FAP-2286

FAP-2286 is a preclinical candidate discovered by 3B Pharmaceuticals under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein alpha (FAP). FAP is highly expressed in many epithelial cancers, including more than 90 percent of breast, lung, colorectal and pancreatic carcinomas. Clovis is planning to submit an investigational new drug application (IND) for FAP-2286 in the second half of 2020. Clovis will conduct the global clinical trials and holds U.S. and global rights, excluding Europe.

FAP-2286 is an unlicensed medical product.

On August 6, 2020 NantHealth, Inc. (NASDAQ-GS: NH), a next-generation, evidence-based, personalized healthcare company, reported financial results for its second quarter ended June 30, 2020 (Press release, NantHealth, AUG 6, 2020, View Source [SID1234563045]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In July, we completed the strategic acquisition of the OpenNMS Group, Inc., a company with the world’s premier open source network management software platform," said Ron Louks, Chief Operating Officer, NantHealth. "This is an exciting transaction for NantHealth because it expands and diversifies our software portfolio and service offerings, enhances our AI, Cloud and SaaS capabilities, and opens market opportunities beyond healthcare.

"In response to the COVID-19 crisis, we supported the healthcare community by launching the NantHealth Cares initiative. As part of this initiative, we made our NaviNet AllPayer platform available to providers for free during the month of May. We believe it is important to do our part during the pandemic to help reduce the financial and capacity strain on hard-hit providers, even if it temporarily impacted our revenue.

"In addition, NantHealth CEO, Dr. Patrick Soon-Shiong, presented a video series exploring the science behind COVID-19. The educational series was made accessible on the NantHealth.com website and our NaviNet and Eviti platforms, which garnered more than 10,000 views – over 1,300 hours watched. In addition, NantHealth medical experts hosted two webinars designed to educate our payers, providers and partners on COVID-19. Both webinars generated considerable interest with over 900 registrants each."

Software and Services Highlights:

Clinical Decision Support (Eviti):
Implemented, through a channel partnership, Eviti Advisor clinical decision support platform with a leading non-profit medical center in New York City
In July, significantly expanded Eviti Connect across the Medicaid population of a leading U.S. health insurance company with the addition of two states
Leveraged the Eviti platform to educate users on the implications of COVID-19 for cancer care and the science behind emerging treatments through videos and instruction. Also, added a feature enabling payers to gain insights to COVID-19 testing relative to oncology treatment plans
Released enhancements to the Eviti platform, including:
Return-on-Investment (ROI) reporting: implemented cost savings dashboard enabling more robust and expedited validation of ROI for our customers
White blood cell growth factor deviation messaging: added messaging to communicate unexpected use of white blood cell growth factor when a treatment plan is entered, allowing users to make real-time corrections for faster review and approval
Payer Engagement (NaviNet):
Leveraged the NaviNet platform to enable payers to post updates to their medical policies and other key information – assisting the provider community directly impacted by the COVID-19 pandemic
Launched workflow enhancements that enable providers to update prior authorizations already on file with our payer customers. Payers that enable this option as part of their NaviNet Open services can expect to receive more prior authorization requests electronically, while streamlining the process of managing prior authorizations for their providers

Precision Medicine and Artificial Intelligence – Highlights:

In May, received notice from Molecular Diagnostic Services (MolDx) of a limited coverage determination for Omics CoreSM
In June, announced the publication of four abstracts in the developmental therapeutics session of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program. In collaboration with ImmunityBio, LLC, the company presented data, gathered from its database, which was used to advance findings in molecularly targeted agents and tumor biology
In June, announced the publication of a study in JCI Insight, a peer reviewed journal dedicated to biomedical research. The study, "Transcriptomic silencing as a potential mechanism of treatment resistance," explained the importance of using both transcriptomics and genomics for patient tumor interrogation to gain actionable insights into reducing the risk of tumor treatment resistance
Business and Financial Highlights

For the 2020 second quarter:

Total net revenue was $17.6 million, which included $17.5 million of SaaS revenue. This compares with 2019 second quarter total net revenue of $20.1 million, which included $18.3 million of SaaS revenue and $1.3 million of home health care services revenue, a business the Company divested on June 7, 2019
Gross profit increased to $10.3 million, or 58% of total net revenue, compared with $11.3 million, or 56% of total net revenue, for the prior year period
Selling, general and administrative (SG&A) expenses declined to $12.0 million from $13.8 million in 2019 second quarter
Research and development (R&D) expenses increased to $4.2 million from $3.4 million, primarily due to investments in product portfolio expansion and growth in data science, machine learning and AI capabilities
Net loss from continuing operations, net of tax, was $48.3 million, or $0.44 per share, which included a non-cash loss from related party equity method investment of $29.9 million and a $6.9 million expense from our fair value bookings commitment liability. This compares with the prior-year second quarter net loss from continuing operations, net of tax, of $17.1 million, or $0.15 per share, which included loss from related party equity method investment of $2.2 million
Non-GAAP net loss from continuing operations was $7.5 million, or $0.07 per share, compared with $6.9 million, or $0.06 per share, for the second quarter of last year
At June 30, 2020, cash and cash equivalents totaled $37.5 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, 2020. The conference call will be available to interested parties by dialing 800-708-4540 from the U.S. or Canada, or 847-619-6397 from international locations, passcode 49876109. 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.