On March 2, 2023 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), reported financial results for the three months and full-year ended December 31, 2022 and provided an update on key corporate milestones (Press release, Lexicon Pharmaceuticals, MAR 2, 2023, View Source [SID1234628057]).

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"We are on track for the PDUFA action date in May of this year for our NDA for sotagliflozin for the treatment of heart failure, as confirmed during this week’s FDA late-cycle review meeting," said Lonnel Coats, Lexicon’s chief executive officer. "We believe the uniqueness of our data from the SOLOIST-WHF trial provides a point of clinical differentiation and provides a strong opportunity to launch into a growing market with recently adopted medical treatment guidelines recommending the use of SGLT inhibitors as a key pillar of heart failure treatment."

"We continue to advance the science across our portfolio with the upcoming presentation of sotagliflozin-related analyses at the American College of Cardiology’s 72nd Annual Scientific Session Together With World Heart Federation’s World Congress of Cardiology in New Orleans, Louisiana, including a featured presentation on the time to clinical benefit of sotagliflozin in people with worsening heart failure. In parallel, we are equally excited about the clinical progress of our AAK1-inhibitor, LX9211. We plan to advance LX9211 into late-stage development in neuropathic pain, supported by data from Phase 2 proof-of-concept studies in painful diabetic neuropathy (PDN) and postherpetic neuralgia (PHN), both completed in 2022."

Fourth Quarter Highlights

Sotagliflozin

•On November 6, a new analysis of results from the SOLOIST-WHF Phase 3 outcomes study of sotagliflozin was presented at the American Heart Association Scientific Sessions 2022 in Chicago, Illinois. The oral presentation was titled "The effect of the dual SGLT1 and 2 inhibitor sotagliflozin on cardiovascular mortality and hospital readmission rates for heart failure at 30- and 90-days post discharge in patients with type 2 diabetes hospitalized for worsening heart failure in the SOLOIST-WHF trial" and showed that treatment with sotagliflozin resulted in a significant relative risk reduction versus placebo of approximately 50% for readmission for non-fatal heart failure events and for the composite of cardiovascular death and readmission for heart failure at both 30 and 90 days following hospital discharge.

•A poster was presented at the American Society of Nephrology Kidney Week 2022 annual scientific meeting in Orlando, Florida on November 5. The poster was titled "Effect of sotagliflozin on albuminuria in patients with type 2 diabetes and chronic kidney disease" and described the results of a post hoc analysis of clinical data from the SCORED trial that showed sotagliflozin significantly reduced urine albumin-to-creatinine ratio (UACR) and had favorable effects on albuminuria progression and regression from a higher UACR category

LX9211

•An oral presentation, titled "A Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of LX9211 in the Treatment of Diabetic Peripheral Neuropathic Pain (RELIEF-DPN-1)," was given at the 16th Annual Pain Therapeutics Summit in Washington, D.C. on November 14. The presentation of full data from the entire 11-week evaluation period of the study, which included a 5-week placebo run-off period following the initial 6-week treatment period, showed consistent and statistically significant treatment-period benefits in measures of particular importance in diabetic peripheral neuropathic pain for both dose arms compared to placebo, such as reductions in burning pain (p<0.001 and p=0.017, respectively) and interference of pain on sleep (p=0.005 and p=0.002, respectively).

•On December 21, we announced topline results of our RELIEF-PHN-1 Phase 2 proof-of-concept study of LX9211 in postherpetic neuralgia. LX9211 achieved a reduction in average daily pain score (ADPS) of 2.42 points from baseline at week 6 compared to a reduction of 1.62 points in the placebo arm, with a placebo adjusted difference of 0.80 points (p=0.12). Although these results did not reach statistical significance on the primary endpoint of the study, overall study results demonstrated clear evidence of effect. Separation of LX9211 from placebo on ADPS was seen at week 1 and maintained consistently thereafter, with an average placebo-adjusted reduction over the 6-week dosing period of 0.80 points (p=0.03).

Fourth Quarter 2022 Financial Highlights

Unless otherwise stated, all comparisons are for the fourth quarter and full year of 2022 compared to the fourth quarter and full year of 2021.

Research and Development (R&D) Expenses: Research and development expenses for the fourth quarter of 2022 decreased to $14.0 million from $16.5 million for the corresponding period in 2021, and for the full-year decreased to $52.8 million from $55.0 million in 2021, primarily due to lower professional and consulting fees in 2022 related to the preparations for the submission of our application for regulatory approval to market sotagliflozin for heart failure.

Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the fourth quarter of 2022 increased to $16.3 million from $8.8 million for the corresponding period in 2021, and for the full-year increased to $48.1 million from $32.3 million 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 in heart failure.

Net Loss: Net loss for the fourth quarter of 2022 was $30.5 million, or $0.16 per share, as compared to a net loss of $25.6 million, or $0.17 per share, in the corresponding period in 2021. For the fourth quarters of 2022 and 2021, net loss included non-cash, stock-based compensation expense of $3.3 million and $2.2 million, respectively. Net loss for the full-year 2022 was $101.9 million, or $0.62 per share, as compared to a net loss of $87.8 million, or $0.60 per share in 2021. For the full years of 2022 and 2021, net loss included non-cash, stock-based compensation expense of $11.5 million and $10.6 million, respectively.

Cash and Investments: As of December 31, 2022, Lexicon had $138.4 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 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 70766912. 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.

On March 2, 2023 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, reported its fourth quarter and full year 2022 financial results and provide a corporate update following market close on Thursday, March 9, 2023 (Press release, Gritstone Bio, MAR 2, 2023, View Source [SID1234628056]). The announcement will be followed by a conference call and audio webcast, which will begin at 4:30pm ET.

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To access by webcast, visit: View Source
To access by phone, dial: 1-877-407-4018
Conference ID: 13734754

While not required, it is recommended you join five minutes prior to the event’s start. An archived replay will be accessible at View Source for 30 days following the event.

On March 2, 2023 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that the Company will release its fourth quarter 2022 financial results on Thursday, March 9, 2023, after the close of U.S. markets. Management will host a conference call on the same day at 4:30 p.m. ET (Press release, Curis, MAR 2, 2023, View Source,-2023 [SID1234628055]).

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To access the live conference call, please dial (888)-346-6389 from the United States or (412)-317-5252 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed on the Curis website at www.curis.com in the ‘Investors’ section. A replay of the financial results conference call will be available on the Curis website shortly after completion of the call.

On March 2, 2023 Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported that the U.S. Food and Drug Administration ("FDA") has accepted for filing the Biologics License Application ("BLA") for cosibelimab, Checkpoint’s investigational anti-PD-L1 antibody, as a treatment for patients with metastatic cutaneous squamous cell carcinoma ("cSCC") or locally advanced cSCC who are not candidates for curative surgery or radiation (Press release, Checkpoint Therapeutics, MAR 2, 2023, View Source [SID1234628054]). The FDA has set a Prescription Drug User Fee Act ("PDUFA") goal date of January 3, 2024. In its BLA filing acceptance letter, the FDA indicated that no potential filing review issues have been identified, and that an advisory committee meeting to discuss the application is not currently planned

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The filing acceptance of our BLA is a major milestone for Checkpoint and our promising cosibelimab development program," said James Oliviero, President and Chief Executive Officer of Checkpoint. "We look forward to continuing to work closely with the FDA as we endeavor to bring cosibelimab to patients in need as quickly as possible. I would like to thank the patients and physicians who participated in the cosibelimab clinical studies, as well as our team for their hard work and dedication in achieving this important milestone

Mr. Oliviero continued, "According to U.S. prescription claims data, in 2021, approximately 11,000 cSCC patients were treated with systemic therapies. As PD-1 inhibitors comprised less than half of patient prescriptions, cSCC remains a disease with a high need for more effective and tolerable treatment options, particularly for the significant number of cSCC patients with immunosuppressive conditions or autoimmune diseases. With its unique mechanism of action and compelling safety profile, we believe cosibelimab, if approved, would be uniquely positioned to provide an important new treatment option for cSCC patients that are currently underserved by available therapies

The BLA submission is supported by the positive results from Checkpoint’s registration-enabling clinical trial evaluating cosibelimab in patients with metastatic and locally advanced cSCC. In January 2022, Checkpoint announced that the metastatic cSCC cohort met its primary endpoint, with cosibelimab demonstrating a confirmed objective response rate ("ORR") of 47.4% (95% CI: 36.0, 59.1) based on independent central review of 78 patients enrolled in the cohort using Response Evaluation Criteria in Solid Tumors version 1.1 ("RECIST 1.1") criteria. The pivotal results were subsequently presented at the June 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting. Also in June 2022, Checkpoint announced positive interim results from its locally advanced cSCC cohort, with cosibelimab demonstrating a confirmed ORR of 54.8% (95% CI: 36.0, 72.7) based on independent central review of 31 patients enrolled in the cohort. Based upon subsequent interactions with the FDA, the BLA under review includes both the metastatic and locally advanced cSCC indications

About Cutaneous Squamous Cell Carcinoma (cSCC)

cSCC is the second most common type of skin cancer in the United States, with an estimated annual incidence of approximately 1.8 million cases according to the Skin Cancer Foundation. Important risk factors for cSCC include chronic ultraviolet exposure and immunosuppressive conditions. While most cases are localized tumors amenable to curative resection, approximately 40,000 cases will become advanced, and an estimated 15,000 people will die from this disease each year. In addition to being a life-threatening disease, cSCC causes significant functional morbidities and cosmetic deformities based on tumors commonly arising in the head and neck region and invading blood vessels, nerves and vital organs such as the eye or ear. The immune-suppressed population represents a challenging target in the treatment of advanced cSCC, as they present with a more aggressive disease and with a higher risk of developing immune-related toxicities from checkpoint inhibitor treatment

About Cosibelimab

Cosibelimab is a potential best-in-class, high affinity, fully-human monoclonal antibody of IgG1 subtype that directly binds to programmed death ligand-1 ("PD-L1") and blocks the PD-L1 interaction with the programmed death receptor-1 ("PD-1") and B7.1 receptors. Cosibelimab’s primary mechanism of action is based on the inhibition of the interaction between PD-L1 and its receptors PD-1 and B7.1, which removes the suppressive effects of PD-L1 on anti-tumor CD8+ T-cells to restore the cytotoxic T cell response. Cosibelimab is potentially differentiated from the currently marketed PD-1 and PD-L1 antibodies through sustained >99% target tumor occupancy to reactivate an antitumor immune response and the additional benefit of a functional Fc domain capable of inducing antibody-dependent cell-mediated cytotoxicity ("ADCC") for potential enhanced efficacy in certain tumor types.

On March 2, 2023 Cancer Advances, Inc., a clinical stage biopharmaceutical company developing therapeutics for gastrointestinal (GI) cancers, reported that the U.S. Patent and Trademark Office has issued new patent No. 11,583,576, enhancing the Company’s intellectual property position for lead asset Polyclonal Antibody Stimulator (PAS) vaccine (Press release, Cancer Advances, MAR 2, 2023, View Source [SID1234628053]). The new patent titled "Compositions and Methods for Inducing Humoral and Cellular Immunities against Tumors and Cancer" covers a method for treating and/or preventing and/or inhibiting development of a tumor and/or a cancer associated with gastrin signaling in a subject. Gastrin mediated tumors include, but are not limited to, gastrointestinal cancers.

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The novel IP further covers methods for treatment of GI cancer by administering PAS followed by an immune checkpoint inhibitor. A related claim covers reduction in fibrosis associated with pancreatic cancer via the administration of this combination.

"After more than six years of research, we are excited to have this patent issued. We have known that PAS can induce the development of antibodies to Gastrin, bringing Gastrin levels down and increasing survival times by 50% in GI clinical trials. With our research now demonstrating that PAS is able to alter the tumor microenvironment, it opens the door to many new opportunities to improve current treatment for GI cancer patients," commented Lynda Sutton, President of Cancer Advances.

The issued patent adds to the over one hundred granted global patents for PAS. Cancer Advances plans to seek approval for PAS in the treatment of gastric and pancreatic cancers.