On May 5, 2022 Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies for autoimmune diseases, enhance gene therapies and mitigate unwanted immune responses to biologics, reported financial results for the first quarter ended March 31, 2022 and provided a business update (Press release, Selecta Biosciences, MAY 5, 2022, View Source [SID1234613636]).

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"In the first quarter of 2022, we executed across our pipeline and proactively took measures to extend our cash runway into mid-2024," said Carsten Brunn, Ph.D., president and chief executive officer of Selecta. "In early April, we successfully completed an underwritten offering, raising an additional $38.7 million in gross proceeds, further strengthening our financial resources which we believe will carry us through key value-driving milestones and help Selecta realize the full potential of our leading precision immune tolerance platform. The synergistic effects of ImmTOR in combination with a Treg-selective IL-2 (ImmTOR-IL) has the potential to be a first-in-class, antigen-specific immunotherapy, with broad applications across all three pillars of our pipeline. Furthermore, we believe we are well-positioned to deliver on our clinical development strategy across our wholly owned pipeline while continuing to pursue strategic partnerships in gene therapy and biologics. We remain on track to deliver on multiple upcoming catalysts in 2022, including the initiation of a Phase 1 trial of SEL-302, our wholly owned gene therapy in combination with ImmTOR for the treatment MMA, the completion of the Phase 3 DISSOLVE clinical program in chronic refractory gout and several IND-enabling studies that collectively advance our strategy for re-imagining immunotherapy for autoimmune disease, unlocking the potential of AAV gene therapy and amplifying the efficacy of biologics."

Recent Highlights and Anticipated Upcoming Milestones:

Tolerogenic Therapies for Autoimmune Disease

ImmTOR with proprietary IL-2 protein agonist (ImmTOR-IL): Pre-clinically, Selecta has observed synergistic activity when ImmTOR is combined with engineered IL-2 molecules that are selective for Tregs. When ImmTOR-IL was co-administered with an antigen of interest in a preclinical study, the resulting preclinical data suggest that ImmTOR may have profound synergistic effects in further expanding antigen-specific Tregs when compared to ImmTOR alone, positioning it to be a potential first-in-class antigen-specific therapy for the treatment of autoimmune disease.
Selecta is working with its partner, Cyrus Biotechnology, to develop a next generation IL-2 molecule to combine with ImmTOR.
Selecta continues work toward identifying suitable target indications and accelerating the development of ImmTOR-IL to the clinic.
Primary biliary cholangitis (PBC): Selecta continues IND-enabling work on an ImmTOR platform approach to treating PBC.
Gene Therapies:

SEL-302 for methylmalonic acidemia (MMA): On March 9, 2022, the FDA removed the clinical hold on SEL-302 for the treatment of patients with MMA.
Selecta expects initiation of the Phase 1 clinical trial of SEL-302 in the second half of 2022.
SEL-018 IgG Protease (Xork): In collaboration with Genovis, Selecta continues to advance Xork, a next-generation IgG protease, to help address disease in those patients who are ineligible for gene therapies due to pre-existing anti-AAV antibodies. Selecta believes the novel combination of Xork and ImmTOR has the potential to simultaneously address two of the key hurdles in gene therapy today: pre-existing immunity and the inability to re-dose AAV gene therapies.
IND-enabling studies are expected to commence in 2022.
Biologic Therapies:

SEL-212 for chronic refractory gout: Selecta continues to advance DISSOLVE, the Phase 3 development program of SEL-212, which has been licensed to Swedish Orphan Biovitrum AB (publ.) ("Sobi").
On December 1, 2021, Selecta announced complete enrollment for DISSOLVE I, currently being run in the United States.
DISSOLVE II continues to enroll, with trial sites in the United States and four Eastern European countries. Screening and randomization in both Russia and Ukraine have been temporarily closed to preserve study supplies in these countries for those already enrolled. Moreover, 11 additional sites in the United States have been activated to speed enrollment and help mitigate any potential disruptions from the closure of screening and randomization in Russia and Ukraine, and DISSOLVE II enrollment has been increased to approximately 140 study participants.
DISSOLVE I & II studies are on track for completion in Q4 2022 with joint topline readout expected in Q1 2023.
ImmTOR with IgA1 protease for IgA nephropathy: Selecta is working with both Ginkgo Bioworks and IGAN Biosciences to identify and develop a next generation IgA protease to combine with ImmTOR.
Selecta anticipates enzyme candidate selection to be completed in 2022.
Corporate Updates:

Completed underwritten offering of common stock and warrants, raising approximately $38.7 million in gross proceeds.
Amended outstanding term loan to defer principal amortization period to April 1, 2023.
Performed strategic review and portfolio prioritization, pausing SEL-313, OTC-D gene therapy development and increasing focus on providing modality-enabling solutions to AAV gene therapy companies.
First Quarter 2022 Financial Results

Cash Position: Selecta had $118.8 million in cash, cash equivalents, marketable securities, and restricted cash as of March 31, 2022, as compared to cash, cash equivalents, marketable securities, and restricted cash of $129.4 million as of December 31, 2021. With the approximately $36.0 million in net proceeds raised from the April underwritten offering, Selecta believes its available cash, cash equivalents, restricted cash, and marketable securities will be sufficient to meet its operating requirements into mid-2024. Net cash used in operating activities was $11.9 million for the quarter ended March 31, 2022, as compared to $12.1 million of cash used in operating activities for the same period in 2021.

Collaboration and License Revenue: Collaboration and license revenue for the first quarter of 2022 was $34.0 million, as compared to $11.1 million for the same period in 2021. Revenue was primarily driven by the shipment of clinical supply and the reimbursement of costs incurred for the Phase 3 DISSOLVE clinical program under the license agreement with Sobi.

Research and Development Expenses: Research and development expenses for the first quarter of 2022 were $17.7 million, as compared to $13.0 million for the same period in 2021. The increase in cost was primarily the result of expenses incurred for the preclinical programs, salaries and contract license and milestone payments.

General and Administrative Expenses: General and administrative expenses for the first quarter of 2022 were $5.5 million, as compared to $5.2 million for the same period in 2021. The increase in costs was primarily the result of stock compensation expenses.

Net Income (loss): For the first quarter of 2022, Selecta reported net income of $28.8 million, or basic net income per share of $0.23, compared to net loss of $(24.6) million, or $(0.22) per share, for the same period in 2021.

Conference Call and Webcast Reminder
Selecta management will host a conference call at 8:30 AM ET today to provide a corporate update and review the company’s first quarter 2022 financial results. Individuals may participate in the live call via telephone by dialing (844) 845-4170 (domestic) or (412) 717-9621 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10157872. Investors and the public can access the live and archived webcast of this call and a copy of the presentation via the Investors & Media section of the company’s website, www.selectabio.com.

On May 5, 2022 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, reported financial results for its first quarter 2022 (Press release, Myriad Genetics, MAY 5, 2022, View Source [SID1234613635]). The company also reiterated long-term and 2022 financial guidance and provided an update on business performance, recent product launches and strategic growth initiatives.

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"We continue to execute on our transformation and growth plan with strong commercial demand for new offerings like our recently launched suite of Precise Oncology Solutions. In Mental Health, the GeneSight Psychotropic test reached one of its highest quarterly volume levels ever while our Women’s Health products generated double digit year-over-year revenue growth in the first quarter of 2022. Fast Company also named Myriad Genetics among its 2022 list of the world’s most innovative companies. Throughout the COVID-19 pandemic, we continued to invest in innovation to meet the needs of patients and healthcare providers, digital engagement to drive increased demand, tech-enabled commercial tools to improve customer experience, and our Lab of the Future to improve productivity. We are pleased to see the results of these efforts across multiple lines of business, and I want to thank my teammates and our provider partners for their continued efforts to serve our patients during the pandemic in what continues to be a very difficult operating environment," said Paul J. Diaz, president and CEO, Myriad Genetics.

Financial and Operational Highlights:

Diagnostic test volumes of 241,000 in the first quarter of 2022 increased 10% year-over-year and 2% sequentially from the fourth quarter of 2021, excluding divested businesses. Sequential volumes were impacted during the first six weeks of 2022 by access constraints and staffing challenges due to COVID-19 and its variants, particularly in the hereditary cancer testing business.
Hereditary cancer test volumes for the quarter decreased 12% year-over-year and 10% sequentially. Excluding the impact of COVID-19 and its variants in the first six weeks of the quarter, the company estimates hereditary cancer test volumes for the quarter would have decreased 3% year-over-year and 1% sequentially in-line with typically weaker first quarter seasonal trends.
Prenatal test volumes in Women’s Health for the quarter decreased 1% year-over-year and increased 3% sequentially.
Tumor profiling test volumes in Oncology for the quarter increased 12% year-over-year and 17% sequentially.
Pharmacogenomics test volumes in Mental Health for the quarter increased 49% year-over-year and 7% sequentially.
Overall, average selling price (ASP)1 in the first quarter of 2022 increased 1% year-over-year and sequentially, excluding divested businesses. Positive ASP trends are primarily due to benefits realized from operational efficiencies and improved revenue cycle management.
Total revenue in the first quarter of 2022 was $164.9 million, an increase of 11% year-over-year and 2% sequentially, excluding the divested business revenue from Myriad RBM, Autoimmune and myPath Melanoma.
Sequential 2% revenue improvement came in spite of an estimated $7-9 million negative revenue impact due to access restraints and staffing challenges from new COVID-19 variants and typical weaker first quarter seasonality trends.
The following table summarizes year-over-year quarterly revenue changes in the company’s core businesses by product category:

GAAP gross margin in the first quarter of 2022 was 70.9%; adjusted gross margin in the quarter was 71.1%, which decreased 40 basis points year-over-year.
GAAP total operating expenses in the first quarter of 2022 were $142.5 million, decreasing $27.0 million year-over-year; adjusted operating expenses in the quarter decreased $7.0 million year-over-year to $120.0 million.
GAAP operating loss in the first quarter of 2022 was $25.6 million, improving $21.1 million year-over-year; adjusted operating loss was $2.8 million, improving $0.5 million year-over year.
Diluted GAAP EPS in the first quarter of 2022 were $(0.26), improving $0.26 year-over-year; adjusted EPS were $(0.03), improving $0.03 year-over-year.
Ended the first quarter of 2022 with $339.2 million in cash, cash equivalents and investments and no debt outstanding.
Business Performance and Highlights:

Oncology
The Myriad Genetics Oncology business provides hereditary cancer testing, including MyRiskTM hereditary cancer test with RiskScore, for patients who have cancer. It also provides tumor profiling products such as the EndoPredict breast cancer prognostic test, the Precise Tumor molecular tumor profiling test, the Prolaris prostate cancer test, and the myChoiceCDx companion diagnostic test for predicting response to PARP inhibitors. The Oncology business delivered revenue of $69.8 million in the first quarter of 2022, a decrease of 8% year-over-year and an increase of 4% sequentially from the fourth quarter of 2021.

In March of 2022, Myriad Genetics launched Precise Tumor for molecular tumor profiling – part of a suite of Precise Oncology Solutions that combines the company’s MyRisk germline hereditary cancer testing technology and its myChoiceCDx companion diagnostic test with a Myriad Genetics tumor profiling test powered by Illumina, Inc.’s TruSightTM Oncology 500 (TSO500) assay and processed by Intermountain Precision Genomics.
In April of 2022, Myriad Genetics announced an expansion of its partnership with Intermountain Precision Genomics to add a new liquid biopsy therapy selection test to its suite of Precise Oncology Solutions. The Myriad Genetics liquid biopsy test will use Illumina’s TSO500 ctDNA assay and be processed by Intermountain Precision Genomics.
In March of 2022, Myriad Genetics received U.S. Food and Drug Administration (FDA) approval for BRACAnalysis CDx as a companion diagnostic test for use with Lynparza in early-stage breast cancer treatment. BRACAnalysis CDx is now the only germline test approved by the FDA as a companion diagnostic for treatment of HER2 negative high-risk early-stage breast cancer.
Prolaris is a prostate cancer prognostic test designed to assess prostate cancer aggressiveness. It is the only test that measures how fast prostate cancer tumors are growing. In the first quarter of 2022, Prolaris saw continued volume growth with a record-breaking number of tests ordered in a month during March of 2022, beating its previous monthly volume record by 8%.
Women’s Health
The Myriad Genetics Women’s Health business serves women of all ancestries by assessing their risk of cancer and offers prenatal testing solutions for those who are pregnant or planning a family. Women’s Health delivered revenue of $65.5 million in the first quarter of 2022, an increase of 19% year-over-year and 2% sequentially from the fourth quarter of 2021.

Hereditary Cancer
Myriad Genetics continues to address the health inequities and accessibility challenges that exist within the hereditary cancer testing market. Myriad Genetics’ MyRisk hereditary cancer test with RiskScore for all ancestries offers the first and only personalized 5-year and lifetime breast cancer risk assessment for all women, including those of non-European ancestry. RiskScore is available at no additional cost to women who take the MyRisk test.
In March of 2022, Myriad Genetics expanded its MyRisk hereditary cancer test to include thirteen additional actionable gene markers and four new indications: including indications for renal, lung, endocrine and gastric cancers.
Prenatal
Myriad Genetics saw continued growth in the first quarter of 2022 from its Prequel noninvasive prenatal screening (NIPS) test, including proprietary AMPLIFY technology, which significantly enhances the test’s performance and works to reduce test failure rates so that patients may avoid unnecessary invasive procedures. Prequel continues to provide future parents with critical genetic insights for family planning.
Mental Health
The Myriad Genetics Mental Health business consists of the GeneSight psychotropic test that covers 64 medications commonly prescribed for depression, anxiety, attention deficit hyperactivity disorder, and other psychiatric conditions. GeneSight helps physicians understand how genetic alterations impact patient response to antidepressants and other drugs. In the pharmacogenomics category, GeneSight delivered revenue of $29.3 million in the first quarter of 2022, an increase of 66% year-over-year and flat sequentially from the fourth quarter of 2021.

For the first quarter of 2022, the Mental Health business reported one of its highest GeneSight volumes ever, overcoming industry-wide challenges presented in the first six weeks of 2022 by new COVID-19 variants, which the company believes demonstrates the effectiveness of the company’s new commercial capabilities, marketing strategies, and customer-centric sales initiatives implemented during the past year.
Myriad Genetics recently launched GeneSight Psychotropic 4.1 in March of 2022 – an update to the GeneSight test featuring improved clinical considerations, drug categorization, additional medications, and revised phenotype language for certain genes.
Key Accomplishments in the Quarter
In the first quarter of 2022, Myriad Genetics unveiled a number of new technological capabilities with the launch of several new digital enhancement tools and partnerships.

In February of 2022:
The company launched its Unified Provider Ordering Portal in February of 2022 to create a new digital engagement experience for oncologists and their patients – offering a streamlined, tech enabled portal that simplifies ordering and reporting processes. The portal will be rolled out in the Women’s Health business unit in the third quarter of 2022 and for all other Myriad Genetics products by the second quarter of 2023.
Myriad Genetics partnered with Genome Medical, Inc. to launch a virtual care solution that guides patients through the end-to-end hereditary cancer testing process from ordering a MyRisk test to receiving and reviewing results with a Genome Medical expert. This service is designed to expand awareness and access to genetic insights while providing professional guidance and support to those in need.
The new MyGeneHistoryTM 3.0 platform also launched in February of 2022. This new technology provides a customizable assessment service that was created to meet the needs of clinicians with a modern user experience that easily integrates with Myriad Genetics’ Unified Provider Ordering Portal and Genome Medical, Inc.’s systems.
In March of 2022, the company put in place new solutions to address patient and provider expectations on price transparency and affordability for its prenatal and hereditary cancer tests. Myriad Genetics has a wide breadth of coverage for prenatal and hereditary cancer testing and has taken steps to equip providers and patients with more accurate pricing information at the point of service and enhanced affordability programs to enable them to make the best decisions for the health and well-being of every patient.
As part of Myriad Genetics’ $50+ million technology investment to drive volume and improve productivity, the company is in the process of implementing new sequencing capabilities, powered by advanced robotics and data analytics, in its Lab of the Future. Construction of the company’s new advanced molecular diagnostics lab in Salt Lake City began in April 2022, and construction of the company’s new research and innovation center in South San Francisco is expected to begin in August of 2022.
"We are confident that these new technological capabilities, together with the product enhancements and new products rolled-out this quarter, significantly improve the company’s competitive position, and will accelerate growth in the second half of 2022 and 2023," said Paul J. Diaz.

Myriad Genetics’ fiscal year 2022 non-GAAP guidance begins with the comparable GAAP financial measure and excludes the impact of stock-based compensation expense ($36.5 million), non-cash amortization associated with acquisitions ($41.0 million) and special items such as costs related to transformation initiatives ($8.5 million). In addition to fiscal 2022 non-GAAP guidance, Myriad Genetics reiterates its long-term financial guidance of 9-12% estimated organic revenue growth through 2024. These projections are forward-looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release. The company will provide further details on its business outlook during the conference call today and discuss first quarter 2022 financial results. Myriad Genetics plans on hosting its 2022 Investor Day in New York City on August 11, 2022.

Conference Call and Webcast
A conference call will be held today, Thursday, May 5, 2022, at 4:30 p.m. EDT to discuss Myriad Genetics’ financial results and business developments for the first quarter 2022. The dial-in number for domestic callers is 1-800-954-0620. International callers may dial 1-212-231-2920. All callers will be asked to reference reservation number 22018216. An archived replay of the call will be available for seven days by dialing 1-800-633-8284 and entering the reservation number above. The conference call and slide presentation will be available through a live webcast at www.myriad.com.

On May 5, 2022 XOMA Corporation (Nasdaq: XOMA), a biotech royalty aggregator playing a distinctive role in helping biotech companies achieve their goal of advancing novel therapeutic candidates aimed at improving human health, reported its first quarter 2022 financial results and provided a recent operations update (Press release, Xoma, MAY 5, 2022, View Source [SID1234613621]).

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"Our team’s ability to identify and acquire the economic interests in potential therapeutic assets that have significant potential has been further validated with two events in the first months of 2022. First, since enacting of the milestone and royalty monetization strategy, an asset in our royalty portfolio became the first to achieve regulatory and commercialization approvals, leading off with the FDA in January and Japan’s MHLW at the end of the quarter. Second, we are encouraged by Regeneron’s recently announced acquisition of Checkmate and vidutolimod (CMP-001)1," stated Jim Neal, Chairman and Chief Executive Officer of XOMA. "We congratulate our partners on their recent achievements."

"Several other partners announced milestones in their development programs. In January 2022, Rezolute dosed the final patient with RZ358 in its Phase 2 congenital hyperinsulinism (CHI) study, which triggered a $2 million milestone payment to XOMA. We congratulate Rezolute on the RIZE Study data presented at Pediatric Endocrine Society Annual Meeting, which took place on May 12,3 and its $130 million registered direct offering and private placement4. We are pleased Rezolute and its shareholders are committed to

moving RZ358 into Phase 3 clinical development. Additionally, Janssen expanded its cetrelimab clinical program to investigate the compound in patients with chronic hepatitis B virus. Furthermore, Palobiofarma launched a Phase 2 study with PBF-6880 in COPD patients. Each of these advancements reflect the dedication and desire of the scientists and clinicians to give patients and their families much needed hope."

Faricimab, Affitech, and Roche Update

In October 2021, XOMA acquired an economic interest Roche’s novel bispecific antibody from Affitech SA. During the first quarter of 2022, XOMA paid $5 million in milestones to Affitech based upon the January 2022 commercialization approval from the U.S. Food and Drug Administration (FDA)5. XOMA does not owe Affitech a milestone based upon the Japan’s Ministry of Health, Labour and Welfare (MHLW) commercialization approval6, which was granted in March 2022. On April 25, 2022, Roche reported first quarter 2022 financial results, which included initial faricimab sales7.

Financial Results

XOMA recorded total revenues of $3.1 million for the first quarter of 2022, compared with $0.4 million in the first quarter of 2021. The increase for the three months ended March 31, 2022, as compared to the corresponding period of 2021, was primarily due to the $2.0 million milestone earned under the Company’s development and commercialization agreement with Rezolute and a $0.8 million milestone earned under the Takeda Collaboration Agreement.

Research and development ("R&D") expenses were $56,000 and $61,000, respectively, for the first quarters of 2022 and 2021.

General and administrative ("G&A") expenses were $5.1 million for the first quarter of 2022, compared to $6.7 million for the first quarter of 2021. The decrease of $1.6 million for the three months ended March 31, 2022, as compared to the corresponding period of 2021, was due primarily to a $1.9 million decrease in stock-based compensation expense for stock options and a $0.2 million decrease in consulting and deal costs, partially offset by a $0.5 million increase in personnel related expenses.

In the first quarter of 2022, G&A expenses included $1.0 million in non-cash stock-based compensation expense, compared with $2.9 million in the first quarter of 2021. XOMA’s net cash used in operations in the first quarter of 2022 was $1.0 million, as compared with $0.9 million during the first quarter of 2021.

Other expense, net was $0.2 million for the first quarter of 2022, compared to other expense, net of $0.7 million in the corresponding quarter of 2021. The fluctuation in other (expense) income, net between the quarters ended March 31, 2022 and 2021, is primarily due to the change in the fair value of equity securities XOMA holds in Rezolute, Inc.

Net loss for the first quarter of 2022 was $2.3 million, compared to net loss of $7.4 million for the first quarter of 2021.

On March 31, 2022, XOMA had cash, cash equivalents and restricted cash of $88.6 million. On January 18, 2022, the Company paid cash dividends on the 8.625% Series A Cumulative Perpetual Preferred Stock (Nasdaq: XOMAP) equal to $0.53906 per share and cash dividends on the 8.375% Series B Cumulative Perpetual Preferred Stock (Nasdaq: XOMAO) equal to $0.52344 per depositary share. The Company ended December 31, 2021, with cash and restricted cash of $95.4 million. After paying its remaining debt obligations in the second quarter of 2021, XOMA has no debt on its balance sheet. The Company continues to believe its current cash position will be sufficient to fund XOMA’s operations for multiple years.

On May 5, 2022 Perrigo Company plc (NYSE: PRGO), a leading global provider of Consumer Self-Care Products, reported that its Board of Directors declared a quarterly dividend of $0.26 per share, payable on June 21, 2022, to shareholders of record on June 3, 2022 (Press release, Perrigo Company, MAY 5, 2022, View Source [SID1234613620]).

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On May 5, 2022 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), reported financial results for the three months ended March 31, 2022 and provided an update on key milestones (Press release, Lexicon Pharmaceuticals, MAY 5, 2022, View Source [SID1234613619]).

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"We plan to resubmit our New Drug Application (NDA) for sotagliflozin for the treatment of heart failure this month having received confirmation from the FDA in late April that it is aligned with our resubmission plans. With the recently announced loan facility, we have committed access to sufficient resources to support our commercial preparations for launch in the first half of 2023," said Lonnel Coats, Lexicon’s chief executive officer. "In addition, we are looking forward to completing and announcing top-line results by the end of this quarter for our proof-of-concept Phase 2 study of LX9211 in diabetic peripheral neuropathic pain."

First Quarter Highlights

Sotagliflozin

A new analysis of data from the SCORED Phase 3 clinical trial of sotagliflozin was presented at the American College of Cardiology’s 71st Annual Scientific Session. The analysis showed that treatment with sotagliflozin resulted in a significant reduction in major adverse cardiovascular events (MACE) of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke in the entire cohort as compared to placebo, with consistent results in patients with and without prior cardiovascular disease.
New guidelines for the management of heart failure were issued jointly by the American Heart Association, the American College of Cardiology and the Heart Failure Society of America, recommending the use of SGLT2 inhibitors in the prevention and treatment of heart failure with the highest-level recommendations among classes of therapy in each category.
Lexicon entered into a loan facility with Oxford Finance LLC that provides up to $150 million in borrowing capacity designed primarily to support commercial preparations and the potential launch of sotagliflozin in heart failure. An initial $25 million tranche was funded at closing.
LX9211

Top-line results for the ongoing Phase 2 proof-of-concept studies of LX9211 are expected by the end of the second quarter of 2022 for the treatment of diabetic peripheral neuropathic pain (RELIEF-DPN-1) and the third quarter of 2022 for the treatment of post-herpetic neuralgia (RELIEF-PHN-1).
First Quarter 2022 Financial Highlights

Research and Development (R&D) Expenses: Research and development expenses for the first quarter of 2022 increased to $14.9 million from $12.6 million for the corresponding period in 2021, primarily due to increases in professional and consulting costs related to the company’s NDA for sotagliflozin.

Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the first quarter of 2022 increased to $8.5 million from $8.3 million for the corresponding period in 2021, primarily due to increases in personnel and external expenses relating to preparations for the commercial launch of sotagliflozin.

Net Loss: Net loss for the first quarter of 2022 was $23.5 million, or $0.16 per share, as compared to a net loss of $21.0 million, or $0.15 per share, in the corresponding period in 2021. For the first quarters of 2022 and 2021, net loss included non-cash, stock-based compensation expense of $2.8 million and $2.9 million, respectively.

Cash and Investments: As of March 31, 2022, Lexicon had $86.5 million in cash and investments, as compared to $86.7 million as of December 31, 2021.

Conference Call and Webcast Information

Lexicon management will hold a live conference call and webcast today at 8:00 am ET / 7:00 am CT to review its financial and operating results and to provide a general business update. The dial-in number for the conference call is 888-645-5785 (U.S./Canada) or 970-300-1531 (international). The conference ID for all callers is 3334447. 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.