On November 9, 2022 IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer therapies based on its T-win technology platform, reported financial results for the quarter ending September 30, 2022 (Press release, IO Biotech, NOV 9, 2022, View Source [SID1234623551]).

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"During the last three months, we have made significant progress with the activation of clinical sites participating in our global Phase 3 combination trial of IOB102-IO103 with pembrolizumab as a potential first-line treatment in advanced melanoma," said Mai-Britt Zocca, Ph.D., President and Chief Executive Officer of IO Biotech. "We ended October with 55 sites actively enrolling in study, compared to 19 actively enrolling sites at the end of July. We view the pace of site activation as a leading indicator of patient enrollment, and we are very pleased with our progress."

Dr. Zocca continued, "Additionally, enrollment in our second ongoing clinical study, the Phase 2 basket trial of IO102-IO103 in combination with pembrolizumab, is progressing nicely and we continue to expect to receive preliminary data in one indication this quarter with additional data in 2023. We believe that our T-win platform—and its novel approach to activate naturally occurring T cells to target immunosuppressive mechanisms—has the potential to benefit patients in need of more treatment options and look forward to reporting our progress in the coming months."

Highlights for Third Quarter 2022 and Recent Weeks

An oral presentation and two poster presentations related to the company’s programs are being presented at the 2022 SITC (Free SITC Whitepaper) Meeting this week. See the following press release for more information, "IO Biotech ApS—IO Biotech Announces Invited Oral Presentation and Two Poster Presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 37th Annual Meeting."

Consistent with the earlier reported data, with an additional 12 months of patient follow-up, results from a new October 2022 data cut for the MM1636 Phase 1/2 study with IO102-IO103 in combination with nivolumab for metastatic melanoma continue to be encouraging. As of that data cut-off, 30 PD-1 naïve patients were enrolled with a median follow-up time of 31.7 months. Median overall survival (mOS) was reached at 46.8 months post first trial treatment, median progression free survival (mPFS) was 22.5 months, and 50% of patients (15/30) achieved a complete response (CR), or complete disappearance of their tumors. The overall response rate for the study was 73.3% as previously reported. Patients who were PD-1 refractory and enrolled in cohort B in this study had no response to therapy, which we believe shows that our vaccine works best in front-line metastatic melanoma patients, as we expected in this setting.

In the past three months, the company has accelerated the rate of clinical trial site activation in the global Phase 3 trial of IO102-IO103 in combination with pembrolizumab for front-line treatment of PD-1 naïve metastatic melanoma patients.

In October 2022, the company named Amy Sullivan as Chief Financial Officer. Ms. Sullivan brings 30 years of experience building biotech companies to IO Biotech.

In November 2022, the company entered into a fourth clinical trial collaboration and supply agreement with Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside the United States and Canada), through a subsidiary. See the following press release for more information, "IO Biotech ApS—IO Biotech Announces New Clinical Collaboration with Merck to Evaluate Neoadjuvant and Adjuvant IO102-IO103 in Combination With KEYTRUDA (pembrolizumab) in a Phase 2, Multi-cohort Trial in Patients with Resectable Tumors."

Third Quarter Financial Results

Net loss for the three months ended September 30, 2022 was $15.7 million, compared to $4.5 million for the three months ended September 30, 2021.

Research and development expenses were $10.0 million for the three months ended September 30, 2022, compared to $4.1 million for the three months ended September 30, 2021. The increase of $5.9 million was primarily related to an increase in preclinical studies and clinical trial-related activities for our IO102-IO103 product candidate, including the continued execution of our Phase 3 clinical trial, of $2.9 million and an increase in personnel costs of $2.8 million primarily related to an increase in headcount and related recruiting costs.

General and administrative expenses were $5.8 million for the three months ended September 30, 2022, compared to $2.9 million for the three months ended September 30, 2021. The increase of $2.9 million was primarily related to costs associated with being a public company.

Other income, net was $0.3 million for the three months ended September 30, 2022, compared to $2.6 million for the three months ended September 30, 2021. The decrease of $2.3 million was primarily due to the decrease in the fair value adjustments on the Company’s preferred stock tranche obligations.

Cash and cash equivalents as of September 30, 2022 were $151.2 million, compared to $211.5 million at December 31, 2021. During the third quarter 2022, the Company used cash, cash equivalents and restricted cash of $13.5 million from operating, investing and financing activities with an additional decrease of $5.5 million in cash due to the effects of foreign currency exchange rates. Cash on hand is expected to support operations through anticipated data readouts into mid-2024.

About the IOB-013/KN-D18 Clinical Trial

IOB-013/KN-D18 (Clinical Trials.gov: NCT05155254) is an open label, randomized Phase 3 clinical trial being conducted in collaboration with Merck of IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma. Target enrollment will be 300 patients from centers spread across Europe, Australia, and the United States. Biomarker analyses will also be conducted. IO Biotech will sponsor the Phase 3 trial and Merck will supply pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103.

About IOB-022/KN-D38

IOB-022/KN-D38 is a non-comparative, open label Phase 2 trial to investigate the safety and efficacy of IO102-IO103 in combination with pembrolizumab in each of the following first-line indications: non-small cell lung cancer, squamous cell carcinoma of the head and neck, and metastatic urothelial bladder cancer. The clinical trial will be sponsored by IO Biotech and conducted in collaboration with Merck. IO Biotech maintains global commercial rights to IO102-IO103.

About IO102-IO103

IO102-IO103 is an investigational cancer immunotherapy designed to target the immunosuppressive mechanisms mediated by the key immunosuppressive proteins indoleamine 2,3-dioxygenase (IDO) and PD-L1.

On November 9, 2022 Imago BioSciences, Inc. ("Imago") (Nasdaq: IMGO), a clinical stage biopharmaceutical company discovering and developing new medicines for the treatment of myeloproliferative neoplasms (MPNs) and other bone marrow diseases, reported financial results for the third quarter ended September 30, 2022 and provided a corporate update (Press release, Imago BioSciences, NOV 9, 2022, View Source [SID1234623550]).

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"Imago continues to make progress in the clinical development of Bomedemstat for the treatment of MPNs including essential thrombocythemia (ET), polycythemia vera (PV) and myelofibrosis (MF). Enrollment in the ongoing Phase 2 ET study is complete and all patients remaining on study will have been treated for 24 weeks by year end. Imago has announced positive data for Bomedemstat in the treatment of ET and MF and will present additional data in an oral presentation for ET and a poster for MF at the ASH (Free ASH Whitepaper) Annual Meeting on December 12, 2022," said Hugh Young Rienhoff, Jr., M.D., Chief Executive Officer of Imago. "In addition, start-up activities continue to progress nicely for our planned Bomedemstat pivotal Phase 3 ET and Phase 2 PV trials, and we expect the investigator-sponsored study of Bomedemstat in combination with ruxolitinib for the treatment of MF to begin enrolling patients in the coming weeks."

Third Quarter 2022 and Subsequent Highlights

Announced Oral and Poster Presentations at the Upcoming 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. On November 3, Imago announced that an abstract entitled "A Phase 2 Study of the LSD1 Inhibitor Bomedemstat (IMG-7289) for the Treatment of Essential Thrombocythemia (ET)" had been accepted for an oral presentation on December 12, 2022 at the ASH (Free ASH Whitepaper) Annual Meeting. A second abstract entitled "A Phase 2 Study of the LSD1 Inhibitor Bomedemstat (IMG-7289) for the Treatment of Advanced Myelofibrosis (MF): Updated Results and Genomic Analyses" will be presented as a poster.
Study Start-up Activities. During the quarter, Imago advanced important study start-up activities for both the Bomedemstat pivotal Phase 3 ET and Phase 2 PV trials, including submission of both protocols to the U.S. Food and Drug Administration (FDA) for review. The Company anticipates initiation of both studies in early 2023.
Third Quarter 2022 Financial Results

Cash, Cash Equivalents, and Short-Term Investments: As of September 30, 2022, Imago had cash, cash equivalents, and short-term investments of $178.4 million compared to $217.4 million as of December 31, 2021. Based on current operating plans and financing arrangements, management believes its cash runway extends into 2025.
Research & Development (R&D) Expenses: R&D expenses for the quarter ended September 30, 2022 were $13.5 million (including stock-based compensation expense of $0.5 million), compared to $8.7 million for the same period in 2021. The overall increase in R&D expenses was primarily related to the start-up activities related to preparations for the planned Phase 3 clinical trial for ET and Phase 2 clinical trial for PV, continued development of commercial material and material to support the ongoing and new clinical trials, and salaries and non-cash stock-based compensation expense related to R&D employees, as we ramped up our operations.
General and Administrative (G&A) Expenses: G&A expenses for the quarter ended September 30, 2022 were $4.1 million (including stock-based compensation expense of $1.2 million), compared to $3.0 million for the same period in 2021. The increase of $1.1 million was primarily due to an increase of $0.7 million in stock-based compensation expense, as a result of increased headcount, and $0.3 million in professional fees attributable to accounting, legal, audit costs, and other public company expenses.
Net Loss: Net loss for the quarter ended September 30, 2022 was $16.8 million, compared to $11.7 million for the same period in 2021.

On November 9, 2022 Omeros Corporation (Nasdaq: OMER), a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation and immunologic diseases, including complement-mediated diseases and cancers, reported recent highlights and developments as well as financial results for the third quarter ended September 30, 2022, which include (Press release, Omeros, NOV 9, 2022, View Source [SID1234623549]):

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For the quarter ended September 30, 2022, we earned royalties of $16.5 million on net sales of our former ophthalmology product OMIDRIA. Royalties earned in the quarter represent 50 percent of net sales of OMIDRIA by Rayner Surgical, Inc. (Rayner), which purchased our ophthalmology assets in December 2021. Rayner’s U.S. net sales of OMIDRIA were $33.0 million for the third quarter of 2022.
Net loss in 3Q 2022 was $17.5 million, or $0.28 per share, which included $4.6 million of non-cash expenses, or $0.07 per share. This compares to a net loss of $22.7 million, or $0.36 per share for the prior year quarter, which included $6.4 million of non-cash expenses, or $0.10 per share.
On September 30, 2022, we sold to DRI Healthcare Acquisitions LP (DRI) an interest in a portion of our future OMIDRIA royalty receivables for a cash purchase price of $125.0 million. The purchased royalty interest entitles DRI to receive royalty payments on OMIDRIA net sales between September 1, 2022 and December 31, 2030, up to the amount of maximum caps established for each annual period. The maximum aggregate payout DRI is entitled to receive is $188.4 million.
At September 30, 2022, we had $221.0 million of cash, cash equivalents and short-term investments.
As announced yesterday, we received the decision by FDA’s Office of New Drugs (OND) denying our appeal of the complete response letter (CRL) issued earlier by FDA concerning the biologics license application (BLA) for narsoplimab in hematopoietic stem cell transplant-associated microangiopathy (TA-TMA). Although our request for immediate resubmission and labeling discussions was denied, the decision proposes a path forward for resubmission of the BLA based on survival data from the completed pivotal trial versus a historical control group, with or without an independent literature analysis.
In November 2022, the Centers for Medicare and Medicaid Services (CMS) issued its final Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems rule for calendar year 2023. The rule confirms that for calendar year 2023 CMS will continue to pay separately for OMIDRIA when used in ambulatory surgical centers.
"FDA’s decision on our CRL appeal request provides paths forward that are based on a comparison of patient survival in our pivotal trial to historical survival data in TA-TMA and to response data in the literature. Together with our regulatory and legal advisors, we are assessing potential next steps and look forward to working with the Agency to approve narsoplimab as quickly as possible," said Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer. "Also heading into 2023, we have established financial flexibility with our royalty monetization transaction, which could be further strengthened by our receipt of the $200-million OMIDRIA-related milestone payment. From our clinical trials, throughout the coming year we anticipate data from our MASP-3 inhibitor OMS906 in PNH and C3 glomerulopathy beginning in the first quarter, from our Phase 1 program for our long-acting MASP-2 inhibitor in the second quarter and, in mid-year, from our narsoplimab Phase 3 trial in IgA nephropathy. We also expect news from our OMS527 PDE7 inhibitor and immuno-oncology programs. All of these assets are rapidly advancing – collectively representing significant opportunities and substantial enterprise value."

Third Quarter and Recent Clinical Developments

Recent developments regarding narsoplimab, our lead monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2) in advanced clinical programs for the treatment of TA-TMA, immunoglobulin A (IgA) nephropathy, atypical hemolytic uremic syndrome (aHUS) and severely ill COVID-19 patients, include the following:
On October 18, 2021, we announced the receipt of a CRL from FDA indicating that the BLA for narsoplimab in TA-TMA could not be approved as submitted. Following additional interactions with FDA regarding the BLA we submitted a Formal Dispute Resolution Request, in June 2022, appealing the issuance of the CRL to a higher level within FDA, in this case OND, and requesting that OND direct the review division to accept a Class 1 resubmission of the BLA and to commence labeling discussions immediately thereafter. In November 2022, we received OND’s decision denying our appeal. Although our request for immediate resubmission and labeling discussions was denied, the decision proposes a path forward for the resubmission of the BLA based on survival data from the completed pivotal trial versus a historical control group. Specifically, the decision proposes the resubmission of the narsoplimab BLA including a comparison of the existing response data from the completed pivotal trial to a threshold derived from an independent literature analysis and evidence of increased survival from patients in the pivotal trial compared to an appropriate historical control group. It also notes that persuasive evidence of superior survival versus a well-matched historical control group could be sufficient even in the absence of the independent literature analysis. The specific approach to any resubmission and its details would be determined through discussion with the review division.
Enrollment in our Phase 3 ARTEMIS-IGAN trial continues to progress toward an anticipated readout of 9-month data on proteinuria by mid-next year.
A case report describing the successful treatment of an adult patient with recurrent IgA nephropathy under compassionate use was presented at the American Society of Nephrology’s kidney week congress held last week in Orlando, Florida. The poster presentation is entitled Narsoplimab Treatment for Recurrent IgA Nephropathy Stabilized eGFR and Proteinuria.
A poster presentation describing the design of our open-label Phase 2 study evaluating efficacy and safety of narsoplimab in pediatric patients with high-risk TA-TMA will be presented at the annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) to be held in December 2022 in New Orleans, Louisiana.
In September 2022, results of the narsoplimab treatment arm of the I-SPY COVID-19 adaptive platform trial sponsored by Quantum Leap Healthcare Collaborative were announced. Although the narsoplimab treatment arm was terminated prior to accrual of the maximum of 125 patients, analysis in the randomized patient population showed that the addition of narsoplimab to treatment of critically ill patients with COVID-19 reduces the mortality risk (hazard ratio [HR]=0.81, with probability [HR <1] equal to 0.77). In approximately half of the patients who died in the narsoplimab group, narsoplimab was not given or was prematurely stopped, with those patients dying 9 to 35 days later. Neither the trial’s futility nor graduation criteria had been met in the analysis of the randomized population at the time the narsoplimab arm was terminated; however, Quantum Leap’s data monitoring committee terminated the narsoplimab treatment arm on the basis of analysis in a population of pre-consented patients in which substantial imbalance was detected, resulting in a marked bias against the narsoplimab arm.
Recent developments regarding OMS906, our lead monoclonal antibody targeting MASP-3, the key activator of the alternative pathway, and OMS1029, the company’s long-acting, next-generation MASP-2 inhibitor, include the following:
We expect soon to begin enrolling patients in a Phase 1b clinical trial evaluating OMS906 in patients with paroxysmal nocturnal hemoglobinuria (PNH) who have had an unsatisfactory response to the C5 inhibitor ravulizumab. Regulatory submissions and site selection are also progressing on a planned expansion of clinical programs designed to evaluate OMS906 in treatment-naïve PNH patients, patients with complement 3 (C3) glomerulopathy and, potentially, patients with one or more related indications. Initial efficacy data from these open-label studies are targeted for availability in early 2023.
A poster presentation describing the results of a Phase 1 single-ascending-dose clinical trial of OMS906 in normal human volunteers will be featured at the annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) to be held in December 2022 in New Orleans, Louisiana.
A Phase 1 clinical trial assessing safety, tolerability and pharmacokinetics/pharmacodynamics (PK/PD) of OMS1029 in healthy subjects is underway, with dosing of the first three of six cohorts in the single-ascending-dose study now complete. Dosing of OMS1029 is expected to be once-monthly to once-quarterly by subcutaneous or intravenous administration. This next-generation MASP-2 inhibitor is intended as complementary to narsoplimab, enabling us to pursue both acute and chronic indications and to provide a significant benefit of dosing convenience to patients.
Financial Results

On September 30, 2022, we sold to DRI an interest in a portion of our future OMIDRIA royalty receivables in exchange for $125.0 million in cash consideration. DRI is entitled to receive royalties on OMIDRIA net sales between September 1, 2022 and December 31, 2030, up to the amount of a fixed annual cap. DRI receives payment of royalties monthly, as received from Rayner, up to the amount of a prorated monthly cap amount before we receive any royalty proceeds. DRI is not entitled to carry-forward nor recoup any shortfall if the royalties paid by Rayner for an annual period are less than the cap amount for the applicable calendar year. Additionally, DRI has no recourse to or security interest in our assets other than our OMIDRIA royalty receivables. We retain all royalty receipts in excess of the respective cap in any given year. The maximum aggregate payout DRI is entitled to receive is $188.4 million which, if fully paid, is an effective interest rate of 9.4%. The maximum amount payable for the remainder of 2022 is $1.7 million. The maximum amount payable in 2023 is $13.0 million. Assuming the maximum amount is paid each year, DRI will recoup the $125 million purchase price in August 2028.

During the third quarter of 2022, we earned royalties of $16.5 million on sales of OMIDRIA, which were recorded as a reduction from the OMIDRIA contract royalty asset. We also recorded $37.3 million of income in discontinued operations, primarily representing interest income and remeasurement adjustments to the OMIDRIA contract royalty asset.

Total costs and expenses for the third quarter of 2022 were $50.8 million compared to $39.8 million for the third quarter of 2021. The increase was primarily due to the manufacturing of narsoplimab drug substance in the third quarter of 2022 for future commercial and clinical use.

Net loss was $17.5 million in the third quarter of 2022, or $0.28 per share, which included $4.6 million of non-cash expenses, or $0.07 per share. This compares to a net loss of $22.7 million, or $0.36 per share, including $6.4 million of non-cash expenses, or $0.10 per share, in 3Q 2021.

As of September 30, 2022, we had $221.0 million of cash, cash equivalents and short-term investments.

Conference Call Details

To access the live conference call via phone, participants must register at the following link to receive a unique PIN: https://register.vevent.com/register/BI4363ad5bbf154eef81c3be16f4e47738. Once registered, you will have two options: (1) Dial in to the conference line provided at the registration site using the PIN provided to you, or (2) choose the "Call Me" option, which will instantly dial the phone number you provide. Should you lose your PIN or registration confirmation email, simply re-register to receive a new PIN.

For online access to the live or subsequently archived webcast of the conference call, go to Omeros’ website at View Source

On November 9, 2022 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), reported financial results for the three months ended September 30, 2022 and provided an update on key corporate milestones (Press release, Lexicon Pharmaceuticals, NOV 9, 2022, View Source [SID1234623548]).

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"Our mid-cycle review meeting with the FDA was held this week for our NDA for sotagliflozin for the treatment of heart failure, which remains on track for its PDUFA action date in May 2023," said Lonnel Coats, Lexicon’s chief executive officer. "This past weekend, important data for sotagliflozin were presented at two major medical conferences, notably including an oral presentation at the American Heart Association Scientific Sessions 2022 on reduced cardiovascular mortality and hospital readmissions for heart failure at 30- and 90-days post discharge in patients hospitalized for worsening heart failure in the SOLOIST-WHF trial."

"This coming Monday, final data from our successful RELIEF-DPN-1 study of LX9211 in painful diabetic neuropathy will be presented at the 16th Annual Pain Therapeutics Summit in Washington, D.C., which we will follow with a conference call discussing the results and their importance in an area of significant unmet need," Mr. Coats continued. "Finally, we completed enrollment earlier this quarter in our RELIEF-PHN-1 study of LX9211 in post-herpetic neuralgia, from which we expect to report top-line data before year-end."

Third Quarter Highlights

Sotagliflozin

•The U.S. Food and Drug Administration (FDA) accepted for review and filed Lexicon’s New Drug Application (NDA) for sotagliflozin for the treatment of heart failure. The FDA assigned a standard review for the NDA filing with a Prescription Drug User Fee Act (PDUFA) target action date in May 2023.
•Two posters were presented at the 70th annual European Society of Cardiology Congress, highlighting protein expression analyses comparing sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, with a selective SGLT2 inhibitor in cell-based models relative to inflammation and thrombosis.
◦The first poster, "Sotagliflozin, a Dual SGLT1/2 Inhibitor, Reduced Expression of Neutrophil Degranulation Proteins During Endothelial Dysfunction Compared with a Selective SGLT2 Inhibitor," concluded that the favorable effects of sotagliflozin on mechanisms of inflammation have implications for ischemic disease, including myocardial infarction and stroke.
◦The second poster, "Sotagliflozin, a Dual SGLT1/2 Inhibitor, Reduced Expression of Platelet Activators During Endothelial Dysfunction Compared to Empagliflozin," concluded that the effects of dual SGLT1 and SGLT2 inhibition on platelet activity may have implications for reduced atherothrombotic risk.
•A manuscript entitled "Metabolic, Intestinal, and Cardiovascular Effects of Sotagliflozin Compared with Empagliflozin in Patients with Type 2 Diabetes: A Randomized, Double-Blind Study" was published in the September issue of the journal Diabetes Care. Results from the study showed significant differences between the agents with respect to certain incremental incretin levels following meals, particularly at breakfast. Sotagliflozin significantly reduced postprandial glucose, insulin, and glucose-dependent insulinotropic polypeptide (GIP) and significantly increased glucagon-

like peptide 1 (GLP-1), in each case relative to empagliflozin and consistent with sotagliflozin’s inhibition of intestinal SGLT-1. The favorable changes in these measures were noted in the manuscript as having potential implications for cardiovascular disease.

LX9211

•A poster was presented and an oral presentation was given at the PAINWeek 2022 National Conference on Pain Management. The poster and presentation, each titled "LX9211, a Novel Therapeutic Approach to Treatment of Neuropathic Pain," described the mechanism of action of LX9211’s novel target, adaptor-associated protein kinase 1 (AAK1), as well as results from multiple preclinical models of neuropathic pain after treatment with LX9211.
•A poster was presented at the IASP World Congress on Pain, titled "Efficacy, Safety, and Pharmacokinetics of LX9211 in the Treatment of Diabetic Peripheral Neuropathic Pain (RELIEF-DPN-1)," outlining the study design, baseline patient characteristics, and positive results of the primary endpoint of the study.

Public Offering and Concurrent Private Placement

•Lexicon completed a public offering and concurrent private placement of common stock, with net proceeds to the company of $94.3 million.

Third Quarter 2022 Financial Highlights

Research and Development (R&D) Expenses: Research and development expenses for the third quarter of 2022 decreased to $10.6 million from $15.7 million for the corresponding period in 2021, primarily due to lower clinical external research expenses and professional and consulting costs.

Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the third quarter of 2022 increased to $12.6 million from $7.3 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 third quarter of 2022 was $23.4 million, or $0.13 per share, as compared to a net loss of $23.1 million, or $0.16 per share, in the corresponding period in 2021. For the third quarters of 2022 and 2021, net loss included non-cash, stock-based compensation expense of $2.6 million and $2.7 million, respectively.

Cash and Investments: As of September 30, 2022, Lexicon had $136.2 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 November 9, 2022 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported financial results for the third quarter ended September 30, 2022 (Press release, Repare Therapeutics, NOV 9, 2022, View Source [SID1234623547]).

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"Our focus in the third quarter has remained on execution of our pipeline of programs including RP-6306, our first-in-class, oral PKMYT1 inhibitor currently being evaluated in the Phase 1 MYTHIC, MAGNETIC, and MINOTAUR studies. We look forward to reporting data for RP-6306 in the first half of 2023 as we continue to execute on this novel program," said Lloyd M. Segal, President and Chief Executive Officer of Repare. "Based on promising preclinical data released at the 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium in October 2022, Repare is working with clinical investigators to initiate clinical testing of a new carboplatin combination with RP-6306 in 2023."

"This quarter, after HSR clearance, we closed our worldwide license and collaboration agreement with Roche for the development and commercialization of camonsertib (also known as RP-3500). We recognize the significant collaborative efforts by Roche and our team in completing a swift and efficient regulatory and operational transfer of this program, while we continue to provide ongoing support for the TRESR and ATTACC trials into 2023. In connection with this agreement, Repare received a $125 million upfront payment in July 2022 and may expect to receive up to $55 million in potential near-term payments."

"We also made important progress in advancing RP-2119, our polymerase theta inhibitor, with ongoing IND-enabling studies and we expect to initiate clinical trials next summer. We are also preparing to conduct further IND-enabling studies for an additional small molecule in the first half of 2023 as we look to another substantial year ahead."

Third Quarter 2022 Review and Operational Updates:

Evaluating RP-6306, a first-in-class, oral PKMYT1 inhibitor as a monotherapy and in combinations in multiple Phase 1 studies.
Repare continues to advance Phase 1 clinical trials evaluating RP-6306 as a monotherapy (MYTHIC), as well as in combinations with gemcitabine (MAGNETIC), FOLFIRI (MINOTAUR), and camonsertib (MYTHIC), each for the treatment of molecularly selected advanced solid tumors.
Initial Phase 1 clinical data readout for RP-6306 is expected in the first half of 2023.
Based on promising preclinical data released at the 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium in October 2022, Repare is working with clinical investigators to initiate clinical testing of a new carboplatin combination with RP-6306 in 2023. Repare demonstrated that the PKMYT1 inhibitor RP-6306 synergized with carboplatin in multiple CCNE1 high/amplified cellular models to induce an increase in DNA damage, which led to increased cell death compared to either agent alone. The combination of RP-6306 and carboplatin induced profound tumor regression in the OVCAR3 xenograft model and was well tolerated with no additional suppression of red blood cells or neutrophils.
Preclinical data from RP-6306 was published in Journal of Medicinal Chemistry in July 2022. The article, entitled "Discovery of an Orally Bioavailable and Selective PKMYT1 Inhibitor, RP-6306", is available on the Company website under Scientific References.
Advancing camonsertib, a potent and selective oral small molecule inhibitor of ATR (Ataxia-Telangiectasia and Rad3-related protein kinase) for the treatment of tumors with specific synthetic lethal genomic alterations, in partnership with Roche.
Under the agreement with Roche, Roche assumed the development of camonsertib with the potential to expand development into additional tumor indications and multiple combination studies.
Repare will continue to provide ongoing support for the TRESR and ATTACC trials into 2023.
In connection with this agreement, Repare received a $125 million upfront payment in July 2022. Repare is eligible to receive up to an additional $1.172 billion in potential development, regulatory, commercial and sales milestones, including up to $55 million in potential near-term payments, and royalties on global net sales ranging from high-single-digits to high-teens.
Advancing IND-enabling studies for RP-2119, Repare’s Polθ inhibitor, and plan to initiate clinical trials in the summer of 2023.
Repare also expects to initiate IND-enabling studies in the first half of 2023 for an additional small molecule against an undisclosed target.
Third Quarter 2022 Financial Results:

Cash and cash equivalents and marketable securities: Cash and cash equivalents and marketable securities as of September 30, 2022 were $370.4 million, which Repare believes will be sufficient to fund planned operations into 2026.
Research and development expenses, net of tax credits (Net R&D): Net R&D expenses were $31.2 million and $89.2 million for the three and nine months ended September 30, 2022, respectively, as compared to $25.4 million and $62.1 million for the three and nine months ended September 30, 2021. The increase in R&D expenses for the three- and nine-month periods were primarily due to an increase in development activities related to the advancement of the RP-6306 program and the RP-2119 IND-enabling studies; an increase of personnel-related costs, including share-based compensation, for increased headcount in support of discovery and development activities; and other research and development costs. Camonsertib costs increased year over year as a result of higher development costs in relation to the advancement of the program, but decreased quarter over quarter following the transfer of CMC related activities to Roche pursuant to the collaboration agreement.
General and administrative (G&A) expenses: G&A expenses were $8.0 million and $24.6 million for the three and nine months ended September 30, 2022, respectively, as compared to $6.6 million and $18.6 million for the three and nine months ended September 30, 2021. The increase in G&A expenses for the three- and nine-month periods were primarily due to an increase in personnel related costs, including share-based compensation; an increase in professional fees associated with the Roche collaboration agreement and the establishment of our at-the-market (ATM) offering, as well as timing of audit and SOX compliance efforts, partially offset by a decrease in our D&O insurance premium.
Net income (loss): Net income was $75.5 million, or $1.71 diluted earnings per share, or EPS, and $2.6 million, or $0.06 diluted EPS, for the three and nine months ended September 30, 2022, respectively, and net loss was $30.9 million, or $0.83 diluted loss per share, and $78.6 million, or $2.12 diluted loss per share, for the three and nine months ended September 30, 2021, respectively.
About Repare Therapeutics’ SNIPRx Platform

Repare’s SNIPRx platform is a genome-wide CRISPR-based screening approach that utilizes proprietary isogenic cell lines to identify novel and known synthetic lethal gene pairs and the corresponding patients who are most likely to benefit from the Company’s therapies based on the genetic profile of their tumors. Repare’s platform enables the development of precision therapeutics in patients whose tumors contain one or more genomic alterations identified by SNIPRx screening, in order to selectively target those tumors in patients most likely to achieve clinical benefit from resulting product candidates.