On August 2, 2022 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral kinase inhibitors to treat hematologic malignancies, reported financial results for the three months ended June 30, 2022 and provided a corporate update (Press release, Aptose Biosciences, AUG 2, 2022, View Source [SID1234617258]).

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The net loss for the quarter ended June 30, 2022 was $10.6 million ($0.11 per share) compared with $13.5 million ($0.15 per share) for the quarter ended June 30, 2021. The net loss for the six months ended June 30, 2022 was $22.0 million ($0.24 per share) compared with $29.7 million ($0.33 per share) for the six months ended June 30, 2021. Total cash and cash equivalents and investments as of June 30, 2022 were $62.4 million. Based on current operations, Aptose expects that cash on hand and available capital provide the Company with sufficient resources to fund planned Company operations including research and development into the first quarter of 2024.

"Our mandate at Aptose is to develop targeted kinase inhibitors to safely and effectively treat patients with deadly hematologic malignancies and to avoid the rapid emergence of drug resistance," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "Acute myeloid leukemia (AML) is not a single-mutation disease, but rather a highly heterogeneous cancer that can emerge from a different spectrum of genetic and epigenetic alterations in each patient. For this reason, Aptose’s lead clinical agent, HM43239, was designed as a highly targeted myeloid kinase inhibitor to suppress specific pathways operative in AML and to treat the disease in multiple subpopulations of AML, rather that treating a single target and a prescriptive subpopulation that generally leads to rapid mutational escape. The breadth of activity of HM43239 could support sizable markets in FLT3-mutated patients (including those previously treated with FLT3 inhibitors), TP53-mutated patients, NPM1-mutated/MLL-rearrangement patients and the RUNX1/DNMT3A/RAS-mutated populations. Plus, the robust safety profile of HM43239 to date supports potential use as the agent of choice for combination therapy and for use in maintenance therapy."

"Although it is very challenging to achieve complete remissions with a single agent in the relapsed/refractory (R/R) AML patient population, 239 has achieved such activity even in AML patients with highly adverse mutations," said Rafael Bejar, M.D., Ph.D., Senior Vice President and Chief Medical Officer. "Patients with FLT3 mutation who already have been failed by FLT3 inhibitors have a grim prognosis, yet our current data with HM43239, albeit early, reveal a significant response rate of about 43 percent, and this genetically- and phenotypically defined population represents a potential path for accelerated approval."

Key Corporate Highlights

Aptose Appoints Chief Financial Officer – In June, Aptose appointed Fletcher Payne to the position of Senior Vice President, Chief Financial Officer. In this role, Mr. Payne will lead Aptose’s financial operations and serve as a member of the Company’s executive management team. With a healthcare tenure of more than two decades, Mr. Payne brings to Aptose extensive experience in corporate finance, strategy and operations within the biotechnology industry. He most recently served as CFO of Syapse, where he completed several financings and oversaw accounting, finance, corporate development, and legal functions. Prior, he was CFO at Catalyst Bioscience, a publicly traded biotech company. Mr. Payne also served in a CFO capacity and senior financial positions at CytomX Therapeutics, Plexxikon Inc., Rinat Neuroscience Corporation, Dynavax Technologies Corporation, and Cell Genesys, among others.

HM43239 Remissions Across Three Safe Doses in Diverse AML Patient Populations – HM43239 (239), an oral, myeloid kinase inhibitor in an international Phase 1/2 trial in patients with R/R AML, thus far has delivered composite complete remissions (CRc) at three separate dose levels (80 mg, 120 mg and 160mg) and no drug-related discontinuations, DLTs, SAEs, QTc prolongations, or safety concern trends have been observed at these doses. Among patients treated with ≥ 80 mg HM43239, an overall response rate (ORR) of 43% has been observed for R/R AML patients with FLT3 mutations who failed prior therapy with FLT3 inhibitors. Since our KOL event on June 2nd, 2022 that highlighted the safety and efficacy of HM43239, the pace of enrollment has increased markedly and continues to enroll at the 120 mg and 160 mg dose levels, with the goals of understanding the breadth of activity of 239 in patients with diverse mutations, observing signs of additional clinical activity in certain of these patients early in their course of treatment, and identifying the most efficacious and safe doses to treat R/R AML. In addition, Aptose is now further exploring the 40 mg dose level to identify the lowest dose level that can deliver responses and exposures in the therapeutic range. Current plans take HM43239 into an Expansion Trial beginning 2H2022 as a single agent, and then combination therapy, in R/R AML patients as a planned segue into registrational trials for accelerated approval in subpopulations of R/R AML patients with high unmet medical needs.

Rapid Clinical Evaluation of Luxeptinib "G3" Formulation in Patients – Luxeptinib (Lux), a dual lymphoid and myeloid kinase inhibitor, currently is being evaluated in a Phase 1 a/b study in patients with R/R AML and higher risk MDS, and in a separate Phase 1 a/b study in patients with R/R refractory B-cell malignancies. The company is continuing to observe signs of clinical activity with the original Lux formulation, and two R/R B-cell cancer patients still on study at the 900 mg BID level have observed 35% or more in tumor reductions thus far. Aptose is ahead of schedule in the clinical evaluation of a new formulation (G3) of luxeptinib, that may enable greater exposures from a reduced pill burden and lower dosages. In the ongoing studies in AML and B-cell malignancies, a single dose of G3 formulation at four different dose levels has been administered to patients. PK profiles of the G3 formulation have been collected and computational modeling is ongoing to simulate PK parameters if G3 were dosed continuously at different dose levels and on different dosing schedules. Such studies will define how the G3 might be dosed in patients going forward.
RESULTS OF OPERATIONS

A summary of the results of operations for the three and six-month periods ended June 30, 2022 and 2021 is presented below:

The net loss for the three-month period ended June 30, 2022 decreased by $2.9 million to $10.6 million as compared with $13.5 million for the comparable period in 2021. The net loss for the six-month period ended June 30, 2022 decreased by $7.7 million to $22.0 million as compared with $29.7 million for the comparable period in 2021. Components of the net loss are presented below:

Research and Development

Research and development expenses consist primarily of costs incurred related to the research and development of our product candidates. Costs include the following:

External research and development expenses incurred under agreements with third parties, such as CROs, consultants, members of our scientific advisory boards, external labs and CMOs; and
Employee-related expenses, including salaries, benefits, travel, and stock-based compensation for personnel directly supporting our clinical trials and manufacturing, and development activities.
We have ongoing Phase 1 clinical trials for our product candidates HM43239 and luxeptinib. HM43239 was licensed to Aptose in the fourth quarter of 2021 and we have assumed sponsorship, and the related costs, of the HM43239 study effective January 1, 2022. In the fourth quarter of 2021, we discontinued the APTO-253 program and are exploring strategic alternatives for this compound.

We expect our research and development expenses to be higher for the foreseeable future as we continue to advance HM43239 and luxeptinib into larger clinical trials.

The research and development expenses for the three-month and six-month periods ended June 30, 2022, and 2021 were as follows:

Research and development expenses decreased by $2.5 million to $7.3 million for the three-month period ended June 30, 2022 as compared with $9.8 million for the comparative period in 2021. Changes to the components of our research and development expenses presented in the table above are primarily as a result of the following events:

Program costs for HM43239 were $2.3 million for the three-month period ended June 30, 2022. The Company in-licensed the development rights of HM43239 in the fourth quarter of 2021 and assumed sponsorship, and the related costs, of the study effective January 1, 2022.

Program costs for luxeptinib decreased by approximately $3.3 million, primarily due to lower manufacturing costs as a result of the current formulation requiring less API than the prior formulation and also from lower clinical trial costs, mostly related to lower contractor costs required to support the trials.

Program costs for APTO-253 decreased by approximately $931 thousand, due to the Company’s decision on December 20, 2021 to discontinue further clinical development of APTO-253.

Personnel-related expenses decreased by $125 thousand, related to fewer employees in the current three-month period and partially offset by salary increases and certain employees hired during the second half of 2021.

Stock-based compensation decreased by approximately $461 thousand in the three months ended June 30, 2022, compared with the three months ended June 30, 2021, primarily due to stock options granted with lower grant date fair values, in the current period.
Research and development expenses decreased by $3.3 million to $14.7 million for the six-month period ended June 30, 2021 as compared with $18.1 million for the comparative period in 2021. Changes to the components of our research and development expenses presented in the table above are primarily as a result of the following events:

Program costs for HM43239 were approximately $3.5 million for the six-month period ended June 30, 2022. The Company in-licensed the development rights of HM43239 in the fourth quarter of 2021 and assumed sponsorship, and the related costs, of the study effective January 1, 2022.

Program costs for luxeptinib decreased by approximately $4.5 million, primarily due to lower manufacturing costs as a result of the current formulation requiring less API than the prior formulation and also from lower clinical trial costs, mostly related to fewer contractors needed to support the trials.

Program costs for APTO-253 decreased by approximately $1.9 million, due to the Company’s decision on December 20, 2021 to discontinue further clinical development of APTO-253.

Personnel-related expenses increased by $421 thousand, mostly related to certain employees hired in 2021 to support our clinical trials and manufacturing activities, salary plan, and offset by lower personnel in the current three-month period.

Stock-based compensation decreased by approximately $893 thousand in the six months ended June 30, 2022, compared with the three months ended June 30, 2021, primarily due to stock options granted with lower grant date fair values, in the current period.
General and Administrative

General and administrative expenses consist primarily of salaries, benefits and travel, including stock-based compensation for our executive, finance, business development, human resource, and support functions. Other general and administrative expenses are professional fees for auditing and legal services, investor relations and other consultants, insurance and facility related expenses.

We expect that our general and administrative expenses will increase for the foreseeable future as we incur additional costs to support the expansion of our pipeline of activities. We also expect our intellectual property related legal expenses to increase as our intellectual property portfolio expands.

The general and administrative expenses for the three-month and six-month periods ended June 30, 2022, and 2021 were as follows:

General and administrative expenses for the three-month period ended June 30, 2022 were $3.3 million as compared with $3.7 million for the comparative period in 2021, a decrease of approximately $325 thousand. The decrease was primarily as a result of the following:

General and administrative expenses, other than stock-based compensation and depreciation of equipment, increased by approximately $613 thousand in the three months ended June 30, 2022 primarily as a result of higher salaries expenses and higher professional fees.

Stock-based compensation decreased by approximately $924 thousand in the three months ended June 30, 2022, compared with the three months ended June 30, 2021, primarily due to lower grant date fair value of options which were granted in the current period.
General and administrative expenses for the six-month period ended June 30, 2022 were $7.4 million as compared with $11.7 million for the comparative period, a decrease of approximately $4.2 million. The decrease was primarily a result of the following:

General and administrative expenses, other than share-based compensation and depreciation of equipment, increased by approximately $409 thousand in the six months ended June 30, 2021, primarily as a result of higher salaries expense and higher professional fees.

Stock-based compensation decreased by approximately $4.6 million in the six months ended June 30, 2022, compared with the six months ended June 30, 2021, primarily due to lower grant date fair value of options granted in the current period, and additional compensation recognized in the comparative period for modifications made to then vested and unvested stock options for one officer, as part of a separation and release agreement.
Conference Call and Webcast

Aptose will host a conference call today to discuss results for the quarter ended June 30, 2022:

*Please note the change in platform. Analysts interested in participating in the question-and-answer session will pre-register for the event from the participant registration link above to receive the dial-in numbers and a personal PIN, which are required to access the conference call. They also will have the option to take advantage of a new Call Me button and the system will automatically dial out to connect to the Q&A session.

The audio webcast also can be accessed through a link on the Investor Relations section of Aptose’s website here. A replay of the webcast will be available on the Company’s website for 30 days.

The press release, the financial statements and the management’s discussion and analysis for the quarter ended June 30, 2022 will be available on SEDAR at www.sedar.com and EDGAR at www.sec.gov/edgar.shtml.

On August 2, 2022 Leidos Holdings, Inc. (NYSE: LDOS), a FORTUNE 500 science and technology leader, reported financial results for the second quarter of fiscal year 2022 (Press release, Leidos, AUG 2, 2022, View Source [SID1234617274]).

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Roger Krone, Leidos Chairman and Chief Executive Officer, commented, "Leidos remains on track for another year of solid organic growth and core business profitability. The affirmation of our Defense Enclave Services contract award by the Government Accountability Office demonstrates our leadership in digital modernization across the federal government, with strong demand for our technology solutions and services across our diversified business portfolio. We continue to execute on our disciplined and balanced capital allocation strategy to drive shareholder value. And, we are proving our ability to compete successfully for talent with another quarter of robust hiring."

Revenues for the quarter were $3.60 billion, up 4% in total and organically compared to the second quarter of fiscal year 2021. Revenues grew across all reportable segments; the largest contributors were continued growth of the Navy Next Generation Enterprise Network Recompete (NGEN-R) Service Management, Integration and Transport (SMIT) contract and increased deployments on the Defense Healthcare Management System Modernization (DHMSM) program.

Net income was $172 million and diluted EPS was $1.24. Net income and diluted EPS were up 1% and 5% year-over-year, respectively, and net income margin decreased from 4.9% to 4.8% year-over-year. Net interest expense increased to $50 million from $46 million in the second quarter of fiscal year 2021. In addition, the weighted average diluted share count for the quarter was 138 million compared to 143 million in the prior year quarter, which benefited from the retirement of 0.3 million shares as part of the final settlement of the Accelerated Share Repurchase (ASR) agreement implemented in the first quarter of fiscal year 2022.

Adjusted EBITDA was $366 million for the second quarter, up 2% year-over-year. Adjusted EBITDA margin decreased from 10.4% to 10.2% over the same period. Non-GAAP net income was $220 million for the second quarter, which was up slightly year-over-year, and non-GAAP diluted EPS for the quarter was $1.59, which was up 5% compared to the second quarter of fiscal year 2021.

Cash Flow Summary

In the second quarter of fiscal year 2022, Leidos generated $40 million of net cash provided by operating activities, used $8 million in investing activities and generated $6 million in financing activities. After adjusting for payments for property, equipment and software, quarterly free cash flow was $19 million.

In the quarter Leidos entered into a 364-day term loan credit agreement for a senior unsecured term loan facility in an aggregate principal amount of $380 million, and the proceeds were used to repay the $380 million senior unsecured term loan entered into on May 7, 2021. As of July 1, 2022, Leidos had $339 million in cash and cash equivalents and $5.2 billion of debt, including $150 million of Commercial Paper Notes outstanding.

After the close of the quarter, Leidos entered into a definitive agreement with private equity firm Advent International to acquire Cobham Aviation Services Australia’s Special Mission business. The acquired business provides Border Force Airborne Surveillance and Maritime Safety Search and Rescue services to the Australian Federal Government. The acquisition is subject to customary closing conditions, including regulatory approvals.

On July 29, 2022, the Leidos Board of Directors declared that Leidos will pay a cash dividend of $0.36 per share on September 30, 2022 to stockholders of record at the close of business on September 15, 2022.

New Business Awards

Net bookings totaled $2.2 billion in the quarter, representing a book-to-bill ratio of 0.6. As a result, backlog at the end of the quarter was $34.7 billion, of which $7.5 billion was funded. During the quarter Leidos received several particularly important awards:

Defense Information Systems Agency (DISA) Defense Enclave Services (DES). DISA awarded Leidos a single-award, indefinite delivery, indefinite quantity (IDIQ) contract with a total estimated value of $11.5 billion and a four-year base period of performance followed by three two-year option periods. Through the DES contract, Leidos will consolidate enterprise IT services and provide standardized, responsive and cost-effective solutions for more than 370,000 users spanning 22 Department of Defense (DoD) agencies and field activities with over 500 sites both in the U.S. and abroad. This work will focus on mission value and user experience, while improving cybersecurity, network availability and reliability for Fourth Estate agencies.
Program Executive Office (PEO) Integrated Warfare Systems (IWS) Undersea Warfare Combat System and Product Support. Leidos was awarded a follow-on contract to support the Navy’s PEO IWS Directorate. Under the contract, Leidos will perform a range of support services, including shipboard modernization, curriculum development, training conduct, depot support, technical data, maintenance planning and management. The single award, cost-plus-fixed-fee contract holds an approximate value of $291 million and includes a one-year base period of performance with four additional one-year option periods.
Navy Medical Performance Research. Leidos was awarded a new task order by the Naval Medical Readiness Logistics Command, Detachment Fort Detrick, to support research to maximize warfighter performance and survivability in the aviation, underwater and special warfare environments. Under the contract, Leidos will support research on the human cognitive and physiological factors associated with military operations. The research focuses on motion sickness, aeromedical standards, hypoxia, fatigue assessment, aviation safety and both neurocognitive and neurophysiological effects. The contract holds an approximate value of $53 million and includes a one-year base period of performance with four one-year options and one six-month option.
Punta Cana Security Checkpoint Upgrade. Leidos was selected by the Dominican Republic’s Punta Cana International Airport to upgrade their security checkpoints. Punta Cana hosts more than 4 million tourists annually with strong projected growth over the coming years. The Leidos solution will keep passengers and staff safe while enhancing operational efficiencies and increasing passenger throughput. For example, using enhanced screening techniques, passengers will no longer need to remove electronics and liquids from carry-on bags. Implementation will be completed in the first half of 2023.
Forward Guidance

Leidos does not provide a reconciliation of forward-looking adjusted EBITDA margins or non-GAAP diluted EPS to net income due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation. Because certain deductions for non-GAAP exclusions used to calculate projected net income may vary significantly based on actual events, Leidos is not able to forecast on a GAAP basis with reasonable certainty all deductions needed in order to provide a GAAP calculation of projected net income at this time. The amounts of these deductions may be material and, therefore, could result in projected net income and diluted EPS being materially less than what may be implied by projected adjusted EBITDA margins and non-GAAP diluted EPS.

Conference Call Information

Leidos management will discuss operations and financial results in an earnings conference call beginning at 8:00 A.M. eastern time on August 2, 2022. Analysts and institutional investors may participate by dialing +1 (877) 869-3847 (toll-free U.S.) or +1 (201) 689-8261 (international callers).

A live audio broadcast of the conference call along with a supplemental presentation will be available to the public through links on the Leidos Investor Relations website (View Source).

After the call concludes, an audio replay can be accessed on the Leidos Investor Relations website or by dialing +1 (877) 660-6853 (toll-free U.S.) or +1 (201) 612-7415 (international callers) and entering conference ID 13731269.

On August 2, 2022 4SC AG (4SC, FSE Prime Standard: VSC) reported that it will publish its half-year report 2022 on 9 August 2022 (Press release, 4SC, AUG 2, 2022, View Source [SID1234617290]). On this day, the Management of 4SC AG will host a conference call at 2 pm CEDT (8 am EDT) to inform about important developments in the reporting period and beyond .

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Investors, financial analysts, and journalists interested in participating in the conference call can access via the telephone numbers stated below. Please join the event conference 5-10 minutes prior to the start time. You will be asked to provide the confirmation code.

A presentation document supporting the conference call will be available on 9 August 2022, at 4SC’s website. After the event, a replay can be accessed from there as well.

On August 2, 2022 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that it filed a lawsuit against Foresight Diagnostics Inc. for infringement of Personalis’ U.S. Patent Nos. 10,450,611, 11,299,783, and 11,384,394 (Press release, Personalis, AUG 2, 2022, View Source [SID1234617306]). These patents are part of Personalis’ intellectual property portfolio in the field of whole genome-enabled, tumor-informed molecular residual disease (MRD) testing.

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Personalis’ patent portfolio protects its pioneering work in whole genome sequencing to identify mutations that indicate the continued presence or recurrence of cancer with part-per-million sensitivity. Personalis is seeking both injunctive relief and monetary damages based upon Foresight’s infringement of these patents.

"Personalis has been active in whole human genome sequencing from very early on. By 2013, when we first began filing the applications that led to the patents we are asserting against Foresight, Personalis had already received customer orders to sequence and analyze over 1,000 human genomes and had realized the power of utilizing whole genome sequencing alongside our advanced targeted sequencing methods," said Personalis CEO, John West.

Personalis launched its ultra-sensitive MRD solution, NeXT Personal, in late 2021. NeXT Personal leverages many elements of the asserted patents, including the use of whole genome sequencing to identify up to 1,800 variants that are specific to a patient’s cancer, thereby achieving superior signal-to-noise in the detection of ctDNA in plasma samples. NeXT Personal is purpose-built to accurately detect MRD in patient samples with low overall ctDNA, which is particularly important for cancers that have low shedding or low mutational burden, such as breast and prostate cancers, or soon after resection.

"Personalis has invested hundreds of millions of dollars in research and development across a broad array of disciplines for over a decade, and we stand firm in our resolve to protect that investment and our leadership position in the field. NeXT Personal is our most recent product leveraging our pioneering work. We believe that it represents the most sensitive MRD approach for solid tumors and can be transformational in cancer, detecting residual disease and recurrence, and in actively fighting cancer after recurrence has been detected," Mr. West added.

About NeXT Personal

NeXT Personal is a next-generation, tumor-informed liquid biopsy assay designed to detect and quantify MRD and recurrence in patients previously diagnosed with cancer. The assay is designed to deliver industry-leading MRD sensitivity down to the 1 part-per-million range, an approximately 10- to 100-fold improvement over other available technologies. It leverages whole genome sequencing of a patient’s tumor to identify up to 1,800 specially selected somatic variants that are subsequently used to create a personalized liquid biopsy panel for each patient. This may enable earlier detection across a broader variety of cancers and stages, including typically challenging early-stage, low mutational burden, and low-shedding cancers. NeXT Personal is also designed to simultaneously detect and quantify clinically relevant mutations in ctDNA that may be used in the future to help guide therapy when cancer is detected. These include known targetable cancer mutations, drug resistance mutations, and new variants that can emerge and change over time, especially under therapeutic pressure.

On August 2, 2022 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), reported financial results for the three months ended June 30, 2022 and provided an update on key milestones (Press release, Lexicon Pharmaceuticals, AUG 2, 2022, View Source [SID1234617327]).

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"We received acceptance last week of our New Drug Application (NDA) for sotagliflozin for the treatment of heart failure with a standard review assigned by the FDA and a PDUFA action date anticipated in May 2023," said Lonnel Coats, Lexicon’s chief executive officer. "As we mentioned in the announcement of the acceptance, we are seeking a broad heart failure label in the NDA, informed by our regulatory discussions, that encompasses heart failure patients with and without diabetes. We believe that the results of SOLOIST-WHF in patients admitted for recent worsening heart failure will be an important element distinguishing our proposed label."

"In another major accomplishment this quarter, we announced positive top-line results from our Phase 2 RELIEF-DPN-1 study of LX9211 in painful diabetic neuropathy at the end of June, achieving proof-of-concept for LX9211 with its novel mechanism of action in a historically difficult to treat indication," Mr. Coats continued. "We expect to report top-line results in the fourth quarter of this year from a second proof-of-concept study of LX9211 in post-herpetic neuralgia. We believe that our recent achievements for both sotagliflozin and LX9211 have the potential to be transformative for our organization, our stakeholders, and most importantly, patients."

Second Quarter Highlights

Sotagliflozin

A poster was presented at the 6th Annual HEART IN DIABETES Conference evaluating the effect of sotagliflozin on major adverse cardiovascular events (MACE: cardiovascular [CV] death, non-fatal myocardial infarction [MI] and non-fatal stroke) across the sotagliflozin clinical program of over 20,000 patients with type 1 or type 2 diabetes. The results showed that treatment with sotagliflozin was associated with a statistically significant and clinically meaningful reduction in MACE in patients with T1D and T2D.
A new analysis of data from the SCORED Phase 3 clinical trial of sotagliflozin was presented at the 82nd Scientific Sessions of the American Diabetes Association. The analysis showed that treatment with sotagliflozin significantly reduced HbA1c overall and across prespecified subgroups, including those with stage 4 chronic kidney disease with a severe decrease in glomerular filtration rate (eGFR <30mL/min/1.73m2), possibly reflecting the dual SGLT-1/2 mechanism of action of sotagliflozin.
LX9211

Positive top-line results for the Phase 2 proof-of-concept study of LX9211 for the treatment of painful diabetic neuropathy (RELIEF-DPN-1) were achieved at the end of the second quarter of 2022. Full results from the complete RELIEF-DPN-1 study are expected to be presented at a medical meeting in the fourth quarter of 2022.
Patient enrollment continued in the Phase 2 proof-of-concept study of LX9211 for the treatment of post-herpetic neuralgia (RELIEF-PHN-1), from which top-line results are expected in the fourth quarter of 2022.
Second Quarter 2022 Financial Highlights

Research and Development (R&D) Expenses: Research and development expenses for the second quarter of 2022 increased to $13.4 million from $10.3 million for the corresponding period in 2021, primarily due to increases in salaries and benefits and higher professional and consulting costs related to the resubmission of our NDA for sotagliflozin.

Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the second quarter of 2022 increased to $10.7 million from $7.9 million for the corresponding period in 2021, primarily due to increases in salaries and benefits, professional and consulting costs and marketing costs relating to preparations for the commercial launch of sotagliflozin.

Net Loss: Net loss for the second quarter of 2022 was $24.6 million, or $0.16 per share, as compared to a net loss of $18.1 million, or $0.13 per share, in the corresponding period in 2021. For the second quarters of 2022 and 2021, net loss included non-cash, stock-based compensation expense of $2.8 million for both quarters.

Cash and Investments: As of June 30, 2022, Lexicon had $62.0 million in cash and investments, as compared to $86.7 million as of December 31, 2021. This amount does not include $82.2 million in approximate net proceeds received from the company’s July 27, 2022 public offering and concurrent private placement of its common stock.

Conference Call and Webcast Information

Lexicon management will hold a live conference call and webcast today at 5:00 pm ET / 4:00 pm CT to review its financial and operating results and to provide a general business update. The dial-in number for the conference call is 888-886-7786 and the conference ID for all callers is 78319165. The live webcast and replay may be accessed by visiting Lexicon’s website at www.lexpharma.com/events. An archived version of the webcast will be available on the website for 14 days.