On November 8, 2024 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported financial results and business highlights for the third quarter 2024 (Press release, Sana Biotechnology, NOV 8, 2024, View Source [SID1234648033]).

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

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

                  Schedule Your 30 min Free Demo!

"Early clinical data with our hypoimmune technology suggest HIP-modified cells evade immune detection, and we look forward to sharing data in 2024 and 2025 across multiple clinical settings, including type 1 diabetes, B-cell mediated autoimmune diseases, and oncology," said Steve Harr, Sana’s President and Chief Executive Officer. "This past quarter was an important one for the company, as we enhanced our leadership team with the addition of Dhaval Patel as our new Chief Scientific Officer, made progress with our clinical programs, and focused our pipeline. We are optimistic that our recent strategic repositioning to increase focus on immunologic diseases, particularly type 1 diabetes and B-cell mediated autoimmune diseases, will help accelerate development and prolong the capital runway for the company. We look forward to multiple clinical data readouts with our current balance sheet with our cash runway into 2026."

Payments related to ongoing activities combined with the strategic repositioning may increase the 2024 operating cash burn above prior guidance of less than $200 million.

Recent Corporate Highlights

Advancing three clinical programs across five indications, including a gene-modified primary islet cell therapy in type 1 diabetes, an allogeneic CAR T program for B-cell mediated autoimmune diseases, and an allogeneic CAR T program for cancer patients that have failed a CD19-targeted therapy:

Type 1 Diabetes – UP421 is a primary human HIP-modified pancreatic islet cell therapy for patients with type 1 diabetes. The goal of this investigator-sponsored trial (IST) is to understand immune evasion, islet cell survival, and beta cell function, as measured by C-peptide production, of HIP-modified pancreatic islet cells in type 1 diabetics without any immunosuppression. Sana expects to share initial data in 2024 and/or 2025. Sana is also making progress with the pre-clinical development of SC451, a HIP-modified, stem cell-derived pancreatic islet cell program.
B-cell Mediated Autoimmune Diseases – The GLEAM trial evaluates SC291, a HIP-modified CD19-directed allogeneic CAR T therapy, in patients with B-cell mediated autoimmune diseases including lupus nephritis, extrarenal lupus, and antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. Sana is enrolling patients in this study and expects to share initial data in 2024 and/or 2025.
Oncology – The VIVID trial evaluates SC262, a HIP-modified CD22-directed allogeneic CAR T therapy, in patients with relapsed or refractory B-cell malignancies who have received prior CD19-directed CAR T therapy. Sana is enrolling patients and expects to share data in 2025.
Strengthened Research and Development leadership with the appointment of new Chief Scientific Officer

Appointed Dhaval Patel, M.D., Ph.D., as Executive Vice President and Chief Scientific Officer. Dr. Patel has decades of experience in research, drug discovery, drug development, and clinical care – including roles at UCB, Novartis, University of North Carolina, and the Duke University School of Medicine – and over the course of his career has participated in the development of 10 approved drugs in multiple indications.
Third Quarter 2024 Financial Results

GAAP Results

Cash Position: Cash, cash equivalents, and marketable securities as of September 30, 2024 were $199.0 million compared to $205.2 million as of December 31, 2023. The decrease of $6.2 million was primarily driven by cash used in operations of $176.0 million and cash used for the purchase of property and equipment of $33.0 million, partially offset by net proceeds from equity financings of $181.0 million, proceeds from stock option exercises and the employee stock purchase plan of $10.3 million, and net proceeds of $7.8 million from a loan to fund tenant improvements for our manufacturing facility in Bothell, Washington during the nine months ended September 30, 2024.

Research and Development Expenses: For the three and nine months ended September 30, 2024, research and development expenses, inclusive of non-cash expenses, were $53.2 million and $170.5 million, respectively, compared to $65.6 million and $205.8 million for the same periods in 2023. The decreases of $12.4 million and $35.3 million for the three and nine months ended September 30, 2024, respectively, compared to the same periods in 2023 were primarily due to lower personnel-related and laboratory costs due to a decrease in headcount and decreased research costs related to the strategic repositioning in the fourth quarter of 2023, lower costs for third-party manufacturing at contract development and manufacturing organizations, and a decline in facility and other allocated costs. These decreases were partially offset by increased clinical development costs. Research and development expenses include non-cash stock-based compensation of $6.5 million and $19.5 million, respectively, for the three and nine months ended September 30, 2024 and $5.7 million and $18.4 million, for the same periods in 2023.

Research and Development Related Success Payments and Contingent Consideration: For the three and nine months ended September 30, 2024, Sana recognized a non-cash gain of $5.5 million and a non-cash expense of $4.6 million, respectively, in connection with the change in the estimated fair value of the success payment liabilities and contingent consideration in aggregate, compared to non-cash gains of $82.6 million and $55.8 million for the same periods in 2023. The value of these potential liabilities fluctuate significantly with changes in Sana’s market capitalization and stock price.
General and Administrative Expenses: General and administrative expenses for the three and nine months ended September 30, 2024, inclusive of non-cash expenses, were $14.1 million and $46.8 million, respectively, compared to $19.2 million and $52.5 million for the same periods in 2023. The decreases of $5.1 million and $5.8 million for the three and nine months ended September 30, 2024, respectively, compared to the same periods in 2023 were primarily due to a decrease in costs related to Sana’s previously planned manufacturing facility in Fremont, California, a decrease in legal and consulting fees, and lower personnel-related costs due to a decrease in headcount. These decreases were partially offset by an increase in non-cash stock-based compensation.

Net Loss: Net loss for the three and nine months ended September 30, 2024 was $59.9 million, or $0.25 per share, and $217.7 million, or $0.95 per share, respectively. Net income for the three months ended September 30, 2023 was $1.0 million, or $0.00 per share, and net loss for the nine months ended September 30, 2023 was $195.1 million, or $1.01 per share.

Non-GAAP Measures

Non-GAAP Operating Cash Burn: Non-GAAP operating cash burn for the nine months ended September 30, 2024 was $153.1 million compared to $187.2 million for the same period in 2023. Non-GAAP operating cash burn is the decrease in cash, cash equivalents, and marketable securities, excluding cash inflows from financing activities, cash outflows from business development, non-recurring items, and the purchase of property and equipment.
Non-GAAP General and Administrative Expenses: Non-GAAP general and administrative expenses for the three and nine months ended September 30, 2024 were $14.1 million and $46.8 million, respectively, compared to $16.5 million and $49.8 million for the same periods in 2023. Non-GAAP general and administrative expenses for the three and nine months ended September 30, 2023 excludes the loss on termination of the Fremont lease.
Non-GAAP Net Loss: Non-GAAP net loss for the three and nine months ended September 30, 2024 was $64.7 million, or $0.27 per share, and $208.3 million, or $0.91 per share, respectively, compared to $79.0 million, or $0.41 per share, and $248.3 million, or $1.28 per share, for the same periods in 2023. Non-GAAP net loss excludes non-cash expenses and gains related to the change in the estimated fair value of contingent consideration and success payment liabilities, the impairment of other assets, and, for the three and nine months ended September 30, 2023, the loss on termination of the Fremont lease.

On November 8, 2024 NanoCell Therapeutics, Inc. ("NanoCell"), a company developing a non-viral, DNA-based in vivo gene therapy platform, reported animal proof of concept data from its lead program utilizing targeted lipid nanoparticle (tLNP) technology for in vivo CAR-T cell generation (Press release, NanoCell Therapeutics, NOV 8, 2024, View Source [SID1234648032]).

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

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

                  Schedule Your 30 min Free Demo!

"The studies demonstrated successful targeting and stable CAR expression in a human PBMC engrafted mouse model evaluating the company’s tLNP technology. These findings were initially shared at the 31st Annual Congress of the European Society of Gene & Cell Therapy (ESGCT) in Rome last month. Additional data are being presented at the SITC (Free SITC Whitepaper) 39th Annual Meeting in Houston (Abstract #284)]"

These preclinical data demonstrate the potential of our cell-directed, lipid-enabled delivery platform," said Maurits Geerlings, CEO of NanoCell. "As we progress from platform validation, we are advancing our lead clinical construct, a dual-CAR CD19/CD22 targeting B cell malignancies and autoimmune diseases."

"Our proof of concept studies demonstrate that our cell-directed, lipid-enabled delivery system can achieve stable CAR expression in T cells in vivo," said Dr. Jacek Lubelski, Chief Technology Officer of NanoCell. "These results prove the mechanism of action for our non-viral vector technology approach."

Click here to view Abstract #284

To learn more about our work and stay updated about our latest developments, please visit our website at View Source

On November 8, 2024 Monopar Therapeutics Inc. ("Monopar" or the "Company") (Nasdaq: MNPR), a clinical-stage biotechnology company focused on developing innovative treatments for patients with unmet medical needs, reported third quarter 2024 financial results and summarized recent developments (Press release, Monopar Therapeutics, NOV 8, 2024, View Source [SID1234648031]).

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

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

                  Schedule Your 30 min Free Demo!

Recent Developments

ALXN-1840 for Wilson disease – Late Stage

●

On October 23, 2024, the Company entered into an exclusive license with Alexion, AstraZeneca Rare Disease whereby the Company gained worldwide rights to develop and commercialize ALXN-1840 (bis-choline tetrathiomolybdate). ALXN-1840 is a drug candidate for Wilson disease that is in late-stage development, having already completed a Phase 3 clinical trial. Monopar will be assembling a regulatory package and initiating discussions with the FDA, with an initial focus on Wilson disease patients with more severe symptoms. More details on this transaction can be found here (link).

MNPR‐-101 for Radiopharmaceutical Use – Phase 1

●

In August 2024, the Company received regulatory clearance in Australia to commence a first-in-human Phase 1a therapeutic clinical trial of its novel urokinase plasminogen activator receptor (uPAR)-targeted radiopharmaceutical therapy MNPR-101-Lu (MNPR-101 conjugated to lutetium-177) in patients with advanced solid cancers. The Company activated its first clinical trial site and launched the study in October 2024; the trial is currently active and recruiting patients.

●

In September 2024, the Company announced positive early clinical data from its ongoing open-label Phase 1 imaging and dosimetry clinical trial of MNPR-101-Zr that validate the tumor-targeting ability of MNPR-101-Zr. In October, the Company presented additional clinical data at the European Association of Nuclear Medicine Annual Congress 2024. The data demonstrate clear and durable tumor uptake of MNPR-101-Zr in a patient with advanced ovarian cancer and show favorable biodistribution with low off-target binding.

●

The Company is also actively exploring opportunities to expand its radiopharmaceutical pipeline primarily through internal development efforts. In October 2024, the Company announced the filing of a provisional patent application for new radiopharmaceutical compounds and a family of linkers used to connect radioisotopes with targeting agents, including its uPAR-targeting antibody MNPR-101. This provisional patent could enable the Company to use these linkers to create new proprietary radiopharmaceuticals to pursue well-established, high-value cancer targets of interest.

Capital Raise

●

On October 30, 2024, the Company completed a registered public offering of 1,181,540 shares of the Company’s common stock at $16.25 per share, generating net proceeds of approximately $17.7 million, after deducting placement agent fees and other estimated offering expenses.

Results for the Third Quarter Ended September 30, 2024 Compared to the Third Quarter Ended September 30, 2023

Cash and Net Loss

Cash and cash equivalents as of September 30, 2024, were $6.0 million. As noted above, the Company completed a registered public offering on October 30, 2024 that yielded net proceeds to the Company of approximately $17.7 million, after deducting placement agent fees and other estimated offering expenses.

Monopar projects that its current funds will be sufficient to continue operations at least into the first half of 2026, including to: (1) assemble a regulatory package and initiate discussions with the FDA on ALXN-1840 for Wilson disease; (2) continue to conduct and conclude its first-in-human imaging and dosimetry Phase 1 clinical trial with MNPR-101-Zr; (3) continue to conduct its first-in-human therapeutic radiopharma clinical trial with MNPR-101-Lu; (4) advance its preclinical MNPR-101-Ac program into the clinic, and (5) invest in internal R&D projects to expand its radiopharma pipeline.

Net loss for the third quarter of 2024 was $1.3 million, or $0.37 per share, compared to net loss of $2.0 million, or $0.69 per share, for the third quarter of 2023.

Research and Development (R&D) Expenses

R&D expenses for the three months ended September 30, 2024 were $984,000, compared to $1,317,000 for the three months ended September 30, 2023. This represents a decrease of $333,000 attributed to (1) a decrease in camsirubicin manufacturing costs of $301,000 due to the Company’s decision to wind down that program, and (2) a decrease of $218,000 in Validive clinical trial related expenses due to the closure of the trial in March 2023. These decreases were partially offset by a net increase of $186,000 due to other R&D expenses attributable to MNPR-101 for radiopharmaceutical use.

General and Administrative (G&A) Expenses

G&A expenses for the three months ended September 30, 2024 were $591,000, compared to $749,000 for the three months ended September 30, 2023. This represents a decrease of $158,000 primarily attributed to (1) a reduction of stock based compensation expenses of $146,000 due to the full vesting of the 2020 grants in the fourth quarter of 2023, and (2) a decrease in stock-based compensation to the CEO and the board of directors of $64,000 as no equity awards have been issued to the CEO and the board of directors to date in 2024, partially offset by a net increase in consulting and other G&A expenses of $52,000.

On November 8, 2024 Kineta, Inc. (OTC Pink: KANT), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, reported at the Society for Immunotherapy in Cancer (SITC) (Free SITC Whitepaper) in Houston, TX an update on its ongoing VISTA-101 Phase 1/2 clinical trial evaluating KVA12123, an anti-VISTA monoclonal antibody, as monotherapy and in combination with Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with advanced solid tumors (Press release, Kineta, NOV 8, 2024, View Source;utm_medium=rss&utm_campaign=kineta-updates-kva12123-clinical-results-from-ongoing-phase-1-2-vista101-study-at-society-for-immunotherapy-of-cancer-2024 [SID1234648030]).

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

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

                  Schedule Your 30 min Free Demo!

KVA12123 cleared all six monotherapy dose levels and the second of four cohorts in combination with pembrolizumab. KVA12123 was well tolerated with no dose limiting toxicities (DLT) and a favorable safety profile at all dose levels in both arms of the study.

The poster presentation (SITC #625): "A phase 1/2 clinical trial of antiVISTA – KVA12123 alone and in combination with pembrolizumab in patients with advanced solid tumors" was presented by Dr. Jason Henry, M.D., Sarah Cannon Research Institute at HealthONE, Denver, CO, on Friday November 8, 2024 at 9 a.m. CST. The update included the following findings (with a data cutoff date of October 18, 2024):

Monotherapy Dose Escalation (3-1000 mg KVA12123 Q2W)

Of the 24 patients enrolled in the six monotherapy dose cohorts, 19 patients had at least one follow-up scan and 13 of these patients experienced stable disease (iRECIST).
Durable clinical outcomes have been observed in a number of monotherapy patients with one patient with non-small cell lung cancer that failed six prior lines of therapy, including checkpoint inhibitor (CPI) therapy, experiencing stable disease lasting 60 weeks.
Nine of 24 monotherapy patients had prior CPI exposure.
Combination Therapy Dose Escalation (30-100 mg KVA12123 Q2W, 400 mg pembrolizumab Q6W)

Nine patients have been enrolled in the two combination cohorts with at least one follow-up scan:
iCR and iPR responses have been observed and the combination has been well tolerated.
Confirmed Partial Response in one mucoepidermoid carcinoma patient with a 54% reduction in target lesions and a confirmed complete response (CR) in non-target lesions.
Stable disease in one renal cell carcinoma patient that had progressed on prior CPI therapy with a 24% reduction in target lesions.
Two remaining combination cohorts are expected to be fully enrolled by year-end.
Safety

No DLTs observed in any patient at any dose level in either study arm.
A very clean safety profile with few adverse events.
"We are pleased to present our progress on the VISTA-101 clinical trial at SITC (Free SITC Whitepaper) this year, with the initial clinical response data emerging from the study. We have observed promising clinical responses in this advanced cancer patient population. KVA12123 has the potential to be a new alternative for patients with hard-to-treat cancers," said Jason Henry, M.D. "The safety profile of KVA12123 to date has been remarkable in the monotherapy as well as in combination cohorts. Initial read-outs demonstrated that KVA12123 is not only safe but exhibits potential clinical benefit for some patients as either monotherapy or combination and may offer patients a novel approach to address immunosuppression in the tumor microenvironment and better manage solid tumor cancers," added Thierry Guillaudeux, Ph.D., Chief Scientific Officer of Kineta.

On July 8, 2024, Kineta announced that it had entered into an exclusivity and right of first offer agreement (the "Agreement") with TuHURA Biosciences, Inc. ("TuHURA"), a Phase 3 registration-stage immuno-oncology company developing novel technologies to overcome resistance to cancer immunotherapy. As part of the Agreement, Kineta received a $5 million nonrefundable payment from TuHURA in July 2024. In August 2024, Kineta announced that in collaboration with TuHURA, it reopened enrollment in the VISTA-101 clinical trial. Kineta and TuHURA continue to collaborate on the ongoing Phase 1 clinical program in patients with advanced solid tumor cancer. On October 2, 2024, Kineta announced that TuHURA was exercising its right to extend their exclusivity and right of first offer pursuant to the terms of the Agreement.

KVA12123 is a VISTA blocking immunotherapy in development as a twice weekly monoclonal antibody infusion drug being evaluated in a Phase 1/2 clinical trial for patients with advanced solid tumors. Competitive therapies targeting VISTA have demonstrated either poor monotherapy anti-tumor activity in preclinical models or induction of cytokine release syndrome (CRS) in human clinical trials. Through the combination of unique epitope binding and an optimized IgG1 Fc region, KVA12123 demonstrates strong monotherapy tumor growth inhibition in preclinical models without evidence of CRS in clinical trial participants. KVA12123 has been shown to de-risk the VISTA target and provides a novel approach to address immune suppression in the TME with a mechanism of action that is differentiated and complementary with T cell focused therapies. KVA12123 may be an effective immunotherapy for many types of cancer including non-small cell lung (NSCLC), colorectal, renal cell carcinoma, head and neck, and ovarian cancer.

VISTA (V-domain Ig suppressor of T cell activation) is a negative immune checkpoint that suppresses T cell function in a variety of solid tumors. High VISTA expression in tumor correlates with poor survival in cancer patients and has been associated with a lack of response to other immune checkpoint inhibitors. Blocking VISTA induces an efficient polyfunctional immune response to address immunosuppression and drives anti-tumor responses.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

On November 8, 2024 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company creating and developing engineered IgM antibodies, reported its financial results for the fiscal quarter ended September 30, 2024 and provided an update on recent developments (Press release, IGM Biosciences, NOV 8, 2024, View Source [SID1234648025]).

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

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

                  Schedule Your 30 min Free Demo!

"The third quarter was transformative for IGM, punctuated by the announcement of our strategic pivot to focus exclusively on autoimmunity," said Mary Beth Harler, M.D., Chief Executive Officer of IGM Biosciences. "Our near-term focus for imvotamab remains generating robust initial data sets in rheumatoid arthritis, systemic lupus erythematosus and myositis. Based on enrollment timing, we expect to have sufficient information by the middle of 2025 to present initial imvotamab data at an appropriate venue as well as determine next steps to advance imvotamab in autoimmune indications."

Pipeline Updates

Imvotamab (CD20 x CD3 T cell engager)

•Clinical development of imvotamab in autoimmune diseases advances, with initial clinical data disclosure expected by mid-2025.
•
hird dose cohort in rheumatoid arthritis successfully completed. The Company has cleared the third dose cohort of its placebo-controlled clinical study testing imvotamab in severe rheumatoid arthritis.
•Enrollment in second dose cohort in systemic lupus erythematosus ongoing. The Company has cleared the first dose cohort of its open-label clinical study testing imvotamab in severe systemic lupus erythematosus (SLE) and is currently enrolling patients in a second dose cohort.
•First patient dosed in myositis. The Company has dosed the first patient in its single arm, open-label clinical study testing imvotamab in moderate-severe idiopathic inflammatory myopathies (myositis). Enrollment is ongoing in this study, which is being conducted in collaboration with Stanford University.
•Imvotamab preclinical data selected for poster presentation at ACR Convergence 2024. The Company will present a poster titled "Imvotamab, a CD20-Targeted Bispecific IgM T Cell Engager, Effectively Depletes Low-Expressing CD20+ B Cells in Preclinical Models of Autoimmune Disease" at the American College of Rheumatology’s annual meeting, ACR Convergence 2024, taking place in Washington, D.C., on November 17, 2024.
IGM-2644 (CD38 x CD3 T cell engager)

•Clinical development of IGM-2644 in autoimmune diseases to be initiated. The Company continues to make significant progress towards initiating clinical development of IGM-2644, a CD38 x CD3 T cell engager antibody, in the
treatment of autoimmune diseases. The Company expects to enter IGM-2644 into a single arm, open-label clinical study for generalized myasthenia gravis (gMG) by the end of 2024.
Corporate Updates

•Peer-reviewed article titled "Cutting-edge Approaches to B-cell Depletion in Autoimmune Diseases" published in Frontiers in Immunology. IGM co-authored this article with Bill Robinson, M.D., Ph.D., et al. and the article can be found online here. Dr. Robinson is Chief of the Division of Immunology and Rheumatology at Stanford University.
•Eric Humke, M.D., Ph.D., Senior Vice President, appointed as Head of Clinical Research and Development. Dr. Humke joined IGM in 2019 as Vice President, Clinical Development. Prior to IGM, he spent eight years at Genentech, most recently serving as Senior Medical Director, where he led the early clinical development of multiple first-in-human therapeutics. Prior to joining Genentech, he was an Instructor of Medicine at the Stanford University School of Medicine, where he conducted basic science research and cared for patients.
Third Quarter 2024 Financial Results

•Cash and Investments: Cash and investments as of September 30, 2024 were $218.8 million, compared to $337.7 million as of December 31, 2023.
•Collaboration Revenue: For the third quarter of 2024, collaboration revenues were $0.5 million, compared to $0.5 million for the third quarter of 2023.
•Research and Development (R&D) Expenses: For the third quarter of 2024, R&D expenses were $46.1 million, compared to $54.8 million for the third quarter of 2023. R&D expenses for the third quarter of 2024 included $5.5 million in one-time expenses related to the strategic pivot to focus exclusively on autoimmunity.
•General and Administrative (G&A) Expenses: For the third quarter of 2024, G&A expenses were $18.8 million, compared to $12.5 million for the third quarter of 2023. G&A expenses for the third quarter of 2024 included $8.5 million in one-time expenses related to the strategic pivot to focus exclusively on autoimmunity.
•Net Loss: For the third quarter of 2024, net loss was $61.4 million, or a loss of $1.01 per share, compared to a net loss of $62.0 million, or a loss of $1.04 per share, for the third quarter of 2023.

2024 Financial Guidance

The Company expects full year 2024 GAAP operating expenses of $215 million to $225 million including estimated non-cash stock-based compensation expense of approximately $40 million, and full year collaboration revenue of approximately $2 million related to the Sanofi agreement. The Company expects to end 2024 with a balance of approximately $180 million in cash and investments and for the balance to enable it to fund its operating expenses and capital expenditure requirements into 2027.