On March 20, 2024 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that it has initiated the dose expansion portion of the Phase II CLINCH study of ATG-022 (Claudin 18.2 antibody-drug conjugate[ADC]) in China and Australia (Press release, Antengene, MAR 20, 2024, View Source [SID1234641301]). Prior to this, the CLINCH trial has already produced promising preliminary clinical results with partial response (PR) and compete response (CR).

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The CLINCH trial, consists of a dose escalation portion and a dose expansion portion, is a multi-center, open-label Phase I/II study of ATG-022 monotherapy in patients with advanced or metastatic solid tumors. The primary objective of the study is to evaluate the safety and tolerability of ATG-022 and to determine important dosing parameters including maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of ATG-022 monotherapy. The secondary objective is to characterize the pharmacology and evaluate the preliminary efficacy of ATG-022.

The dose expansion portion of the study will enroll patients with gastric cancer or other solid tumors. In May 2023, the U.S. Food and Drug Administration (FDA) consecutively granted two Orphan Drug Designations (ODDs) to ATG-022 for the treatment of pancreatic cancer and gastric cancer, separately.

Dr. Amily Zhang, Antengene’s Chief Medical Officer, said, "We are excited that the dose expansion portion of the Phase II study of ATG-022 in China and Australia. The Phase I/II CLINCH trial is supported by strong preclinical data and has already made encouraging early observations with one PR and CR in two patients with metastatic gastric cancer. With the trial entering its next critical phase, we will continue working closely with regulators and investigators to fully explore the clinical potential of ATG-022."

About ATG-022

ATG-022 is an antibody-drug-conjugate targeting Claudin 18.2. Claudins are cell adhesion molecules normally expressed within the tight junctions between cells to form a barrier that regulates cell permeability. In cancer, Claudins are expressed at the cell surface due to changes in cell polarity. The Claudin 18.2 is often overexpressed in various primary malignant tumors including gastric, esophageal, cholangiocarcinoma and pancreatic cancers.

Data from preclinical studies, including results from gastric cancer-patient derived xenograft models presented at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) (2022 AACR (Free AACR Whitepaper)), showed that ATG-022 binds to Claudin 18.2 with low nanomolar affinity and demonstrated potent in vitro and in vivo antitumor effects, including in vivo efficacy demonstrated in Claudin 18.2 low expression models. This could pave the way for broad clinical utility of ATG-022 in gastric cancer patients with a wide range of Claudin 18.2 expression levels. ATG-022 demonstrated an excellent safety profile in Good Laboratory Practice (GLP) toxicology studies.

On March 20, 2024 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported its 2023 annual results and major business updates (Press release, Innovent Biologics, MAR 20, 2024, View Source [SID1234641302]).

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Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated:"2023 marked a transformative year for Innovent with material progress. We delivered strong revenue growth, improved operational efficiency and financial performance, and enhanced ESG management practices that underline our sustainable business model. Concurrently, we have achieved material innovation progress in both late- and early-stage R&D development, advanced pipeline portfolio across oncology and general biomedicine, and broadened our global pipeline development scope, reinforcing our global innovation strategy. These achievements underscore the dedication to our strategic goals in the second decade – sustainable growth and global innovation. We will continue our high-quality business growth and advance global innovation progress, and create sustainable value for patients, employees, shareholders and society."

Solidified business operations with strong revenue performance and improved financials

Strong revenue growth: total revenue RMB6,206.1 million in the year of 2023, an increase of 36.2% compared with the year of 2022; product sales revenue RMB5,728.3 million in the year of 2023, an increase of 38.4% compared with the prior year, reflecting robust demand for our innovative portfolio and the advantage of our sustainable business model.
Enhanced operational efficiency and financial performance : EBITDA Loss was significantly narrowed, whose key drivers include strong revenue growth, enhanced operational efficiency and remarkable financial improvement.
The selling and marketing expenses of total revenue was 49.3%, a year-over-year decrease of 7.3 percentage points
The administration and expenses of total revenue was 8.8%, a year-over-year decrease of 5.3 percentage points
R&D expenses was RMB1974.9 million; cash and short-term financial assets was RMB10969.6 million, or approximately USD1.5 billion, which enables us to focus on the long-term sustainable development
EBITDA loss was RMB600.1 million, a notable year-over-year decrease of 73.0%
Note: The financial numbers mentioned above were based on non-IFRS measure. Detailed disclosure can be found at the Company’s 2023 annual results announcement.

Solidify oncology leadership; build CVM commercialization capability

Expansion of commercial portfolio into new approved products, new indications and broader NRDL coverage[1],[2] and patient access:
Ten approved products: TYVYT, BYVASDA, SULINNO, HALPRYZA, PEMAZYRE, Olverembatinib, CYRAMZA, Retsevmo, FUCASO (new product, for the treatment of RRMM) and SINTBILO (new product, for the treatment of hypercholesterolemia and mixed dyslipidemia).
All seven approved indications of TYVYT (sintilimab injection) were included in the NRDL. It is also the only PD-1 inhibitor in the NRDL for the treatment of GC and EGFR-mutated NSCLC. As for market expansion, TVYVT (sintilimab injection) was newly approved in the Macau market in February 2024.
Olverembatinib’s first indication was included in the NRDL; and its second indication was newly approved to benefit broader CML patients.
All indications of BYVASDA (bevacizumab injection), HALPRYZA (rituximab injection) and SULINNO (adalimumab injection) were also included in the NRDL.
Oncology and general biomedicines as key growth pillars of the company:
Oncology: we have launched eight products including TYVYT (sintilimab injection), established a mature commercial presence of nearly 3,000 employees, nationwide patient access and a well-recognized brand image. We will continue to solidify leadership and expand business in oncology.
General biomedicine: we have made considerable progress in past years advancing and expanding our pipeline in general biomedicine, including cardiovascular and metabolism (CVM), autoimmune, and ophthalmology, which we believe will result in substantially increased commercial opportunities and diversified long-term growth.
Therefore, as part of the strategic plan, we have been steadily establishing our commercialization capability in the CVM field with systematic approaches. We plan to implement a comprehensive structure and form strategies for key factors, such as patient access, distribution channels, and marketing activities, to ensure all capabilities, personnel and strategies are in place to facilitate effective operations of our business, and to foster long-term brand image and competitive advantage in this new area.
Material innovation progress in both late- and early-stage clinical development

8 assets are in NDA review or pivotal registrational clinical trials, and 18 assets are in early Phase 1/2 clinical studies

Oncology: robust leadership spanning all phases of R&D and novel modalities

Deepened synergies of product portfolio with two target therapies for lung cancer under NDA priority review, which are anticipated to launch in 2024:
IBI344 (ROS1, taletrectinib): 1L and 2L ROS1 positive NSCLC
IBI351 (KRAS G12C, fulzerasib): 2L KRAS G12C mutated NSCLC
Encouraging progress in the next wave innovation of "IO+ADC"
TYVYT (sintilimab): multiple clinical trial collaborations to explore potential of combination therapy with various ADCs for solid tumors
IBI310 (CTLA-4)：plan to initiate a Phase 3 clinical trial for IBI310 in combination with sintilimab in treating neoadjuvant colon cancer
IBI343 (CLDN18.2 ADC)：preparing for a MRCT Phase 3 clinical trial for IBI343 in 3L GC, subject to regulatory communications; a PoC trial in PDAC is ongoing
Advancing multiple bi-/tri-specific antibodies and ADCs with global potential in early-stage clinical trials
IBI363 (PD-1/IL-2) : preliminary PoC signals in multiple IO resistant/unresponsive cancer types; plan to initiate a Phase 2 clinical trial in the U.S.
Multiple programs ongoing including IBI389(CLDN18.2/CD3), IBI334 (EGFR/B7H3), IBI3003 (GPRC5D/BCMA/CD3), IBI3001(EGFR/B7H3 ADC), IBI130 (TROP2 ADC), IBI133 (HER3 ADC)
CVM : multiple new-generation product candidates achieved substantial R&D milestones

SINTBILO (tafolecimab injection): the first domestic self-developed anti-PCSK9 monoclonal antibody, approved for the treatment of hypercholesteremia and mixed dyslipidemia
Mazdutide (GLP-1R/GCGR): globally the first GLP-1R/GCGR dual agonist in the NDA stage. First NDA of mazdutide was accepted for chronic weight management. Five Phase 3 registrational trials and more clinical trials are underway.
IBI128 (XOI): potential best-in-class XOI for the treatment of hyperuricemia in gout patients. It is undergoing overseas Phase 3 clinical trials conducted by our partner LG Chem. We plan to initiate Phase 1 and Phase 2 clinical trials in China in pace with the global registrational progress.
IBI3016（AGT siRNA）: a new-generation siRNA drug candidate to address unmet need in hypertension. We will collaborate with SanageneBio and plan to initiate a Phase 1 clinical trial in 2024.
Next-generation projects will enter into IND-enabling stage in 2024, underscoring our dedication to expanding our strategic presence in the CVM field
Autoimmune: address global unmet needs in various autoimmune diseases

IBI112 (IL-23p19) : potential long-lasting efficacy advantage and convenient extended dosing intervals for psoriasis. We anticipate completing the Phase 3 registrational clinical trial in support of an NDA submission in 2024.
IBI353 (PDE4): the multi-regional Phase 2b clinical study (led by UNION) of IBI353 in psoriasis attained positive topline results.
IBI355 (CD40L) , IBI356 (OX40L) and IBI3002 (IL-4Rα/TSLP): innovative autoimmune molecules entered into first-in-human studies to explore other unmet medical needs in various types of autoimmune diseases, such as primary Sjögren’s syndrome (pSS), systemic lupus erythematosus (SLE), atopic dermatitis (AD) and asthma.
Ophthalmology: a long-standing commitment to elevate standard-of-care

IBI302 (VEGF/C): Phase 3 study initiated for the treatment of nAMD, based on the observed stable and robust visual benefit under extended dosing interval and potential inhibition effect in macular atrophy in two Phase 2 studies.
IBI311 (IGF-1R): Phase 3 clinical trial met the primary endpoint, demonstrating favorable safety and excellent efficacy; we plan to submit an NDA in 2024
IBI324 (VEGF-A/ANG-2) and IBI333 (VEGF-C/VEGF-A) : both are in the Phase 1 stage to explore the potential differentiation clinical values versus existing therapy.
Global innovation as unwavering long-term strategic priority

Innovent Academy as the innovation powerhouse:
In 2023, Innovent Academy has successfully delivered eight high quality novel molecules into IND enabling stage.
A significant portion of preclinical programs lies in key non-oncology areas, including CVM, ophthalmology and autoimmune diseases, forming another important growth pillar of global innovation as oncology counterparts.
Research innovation published in high-impact scientific journals and medical conferences, such as:
Preclinical results publication of IBI363 in Nature Cancer
Preclinical results of IBI334 (EGFR/B7H3), IBI343 (CLDN18.2 ADC), IBI3001 (EGFR/B7H3 ADC) are accepted as Late-breaking Researches by the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2024
Manufacturing capacity adhering to high-standard quality:
Suzhou manufacturing site: 60,000L antibody production capacity and ADC production lines in operation
Hangzhou manufacturing site: 170,000L production capacity (first phase of 80,000L completed construction, second phase of 90,000L in plan) to secure global supply
Shanghai R&D center will be operational in 2024
Devoted to responsible business practices and enhancing ESG management practices

Innovent has been upgraded to ‘A’ level in MSCI ESG rating, ranking at the forefront of the biotechnology industry.
In active support of the United Nations’ sustainable development goals (SDGs) and in fulfilling our social responsibilities, we continued to enhance ESG management across several key dimensions, including: "Excellent governance", "Enjoying good health", "High-quality as key", "People first" and "Green ecology".

On March 20, 2024 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, reported that it has initiated the Phase 2a portion of the BGBC016 clinical study of its selective AXL inhibitor bemcentinib in combination with standard of care therapy in first-line Non Small Cell Lung Cancer (NSCLC) patients harboring a STK11 mutation (STK11m) (Press release, BerGenBio, MAR 20, 2024, View Source [SID1234641303]).

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The initiation of Phase 2a follows a positive recommendation by the independent Drug Safety Monitoring Board (DSMB) which evaluated the safety of the combination of bemcentinib with pembrolizumab (Keytruda) and doublet chemotherapy in first-line (1L) NSCLC patients enrolled in the Phase 1b portion of the study.

Patients with STK11m NSCLC have a significantly poorer response to current therapies, including immune checkpoint inhibitors, when compared with patients with wild-type (non-mutated) STK11. AXL plays a significant role in the survival and spread of cancer and STK11m NSCLC patients have a high expression of AXL suggesting that AXL is an important target to prevent disease progression and resistance to existing therapies. Bemcentinib’s selective inhibition of AXL has been shown to improve the response to immune checkpoint inhibition in STK11m patient-derived preclinical models and in early clinical studies. There are currently no targeted therapies available for the STK11m NSCLC patient population, which represents up to 20% of 1L NSCLC patients.

Cristina Oliva, Chief Medical Officer of BerGenBio commented, "We are very pleased that no new safety signals have been identified and are encouraged by the recommendation of the DSMB to continue the study as planned. We have therefore, opened the Ph2a portion of the study with the goal of reporting initial efficacy data as the next step in validating the benefit of bemcentinib in combination with standard therapies in 1L NSCLC."

Martin Olin, Chief Executive Officer of BerGenBio added, "The high unmet medical need in 1L STK11m NSCLC patients is widely recognized. Bemcentinib represents a novel treatment modality which may significantly improve the outcome for patients, and we are pleased to have achieved this important milestone."

On March 19, 2024 Fate Therapeutics, Inc. (the "Company" or "Fate Therapeutics") (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disorders, reported the pricing of an underwritten offering of 14,545,454 shares of its common stock at an offering price of $5.50 per share (Press release, Fate Therapeutics, MAR 19, 2024, View Source [SID1234641263]). The offering includes participation from new and existing institutional investors, including Adage Capital Partners LP., Boxer Capital, Deep Track Capital, OrbiMed, Suvretta Capital and a life-sciences focused investor.

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In addition, the Company announced the pricing of a concurrent private placement of pre-funded warrants to purchase 3,636,364 shares of its common stock at a purchase price of $5.499 per pre-funded warrant, which represents the offering price per share of common stock less the $0.001 exercise price per share of each pre-funded warrant, to certain institutional and other accredited investors affiliated with or managed by Redmile Group, LLC.

The gross proceeds from the underwritten offering and private placement are expected to be approximately $100.0 million before deducting underwriting discounts and commissions and other offering expenses. BofA Securities, Jefferies, and Leerink Partners are acting as the joint bookrunning managers for the underwritten offering.

All of the shares and pre-funded warrants are to be sold by the Company. The financing is expected to close on or about March 21, 2024, subject to customary closing conditions.

The Company intends to use the net proceeds from the underwritten offering and concurrent private placement for funding clinical trials and nonclinical studies of the Company’s product candidates, manufacturing expenses associated with the development of the Company’s product candidates, the conduct of preclinical research and development, and for other working capital and general corporate purposes.

A shelf registration statement on Form S-3 (File No. 333-275402) relating to the underwritten offering of the securities described above was filed with the Securities and Exchange Commission (the "SEC") on November 8, 2023 and became effective on November 27, 2023. A final prospectus supplement relating to and describing the terms of the underwritten offering will be filed with the SEC and will be available on the SEC’s web site at www.sec.gov. When available, copies of the final prospectus supplement may also be obtained from BofA Securities, Inc. NC1-022-02-25, 201 North Tryon Street, Charlotte, NC 28255-0001, Attn: Prospectus Department or by email at [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388 or by email at [email protected]; or Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected].

The pre-funded warrants to be sold in the concurrent private placement have not been registered under the Securities Act or under any state securities laws and, unless so registered may not be offered or sold in the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws. The securities sold in the private placement will be issued in reliance upon the exemption from registration pursuant to Section 4(a)(2) under the Securities Act in a transaction not involving a public offering of such securities.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On March 19, 2024 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported financial results and operational highlights for the fourth quarter and year ended December 31, 2023 (Press release, Adicet Bio, MAR 19, 2024, View Source [SID1234641280]).

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"We are excited to explore the potential of our gamma delta T cell platform in autoimmune diseases following the FDA’s IND clearance of ADI-001 in lupus nephritis," said Chen Schor, President and Chief Executive Officer at Adicet Bio. "We believe ADI-001 is ideally suited for the treatment of autoimmune diseases given its robust B-cell depletion consistent with other autologous CAR T therapies tested in autoimmune diseases, its tissue tropism potential in autoimmune diseases, and the safety and efficacy data observed in our Phase 1 study. In addition, ADI-001’s off-the-shelf availability and safety profile has the potential to make cell therapy for autoimmune diseases available to patients in community setting. We look forward to initiating the Phase 1 study in lupus nephritis in the second quarter of 2024 and are on track to expand the program to additional autoimmune indications."

Mr. Schor continued: "In addition, we are continuing to enroll MCL patients in our ongoing Phase 1 study of ADI-001 in relapsed or refractory non-Hodgkin’s lymphoma. With the completion of the successful capital raise and other net proceeds from stock sales under the at-the-market program in January, extending our cash runway into the second half of 2026, we are well-positioned to continue clinical execution across our pipeline through multiple upcoming milestones."

Fourth Quarter 2023 and Recent Operational Highlights:

Autoimmune diseases

IND clearance for ADI-001 in lupus nephritis. In December 2023, the FDA cleared the Company’s IND application for ADI-001 in lupus nephritis. Adicet plans to initiate a Phase 1 study to evaluate the safety and efficacy of ADI-001 in lupus nephritis during the second quarter of 2024. Preliminary clinical data from the trial are expected in the fourth quarter of 2024 or first quarter of 2025, pending study site activation progression and patient enrollment.
Expansion of ADI-001 development in autoimmune diseases. Adicet expects to expand into additional autoimmune indications in the near future. The Company anticipates providing preliminary clinical data in the fourth quarter of 2024 or first half of 2025, subject to clearance of INDs in those indications as well as successful site initiation and patient enrollment in the relevant clinical protocols.
Hematologic malignancies and solid tumor indications

Continuing to advance ADI-001 in Phase 1 GLEAN study in mantle cell lymphoma (MCL). The Phase 1 study of ADI-001 in relapsed or refractory non-Hodgkin’s lymphoma (NHL) is ongoing, with enrollment focused on the MCL patient population, which demonstrated the greatest clinical benefit in the June 2023 clinical update. Adicet expects to provide a clinical update on safety, efficacy and 6-month complete response data in MCL patients in the second half of 2024.
Advancing ADI-270 preclinical development in solid tumors. ADI-270 is designed to home to solid tumors, with a highly specific targeting moiety for CD70 and an armoring technology of dominant negative TGF beta receptor to address immunosuppressive factors in the tumor microenvironment. Adicet remains on track to file an IND for ADI-270 in renal cell carcinoma in the second quarter of 2024 and expects to provide clinical data from a Phase 1 study in the first half of 2025, following regulatory clearance and subject to study initiation progress.
Presented persistence and pharmacodynamic data from ADI-001 Phase 1 study at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. In December 2023, Adicet presented new pharmacokinetic and pharmacodynamic data from the Phase 1 study of ADI-001 at the ASH (Free ASH Whitepaper) Annual Meeting. The data demonstrated robust dose-dependent expansion and persistence in patients with relapsed or refractory aggressive B-cell NHL. ADI-001’s strong exposure and persistence profile observed in the study to date further validates Adicet’s gamma delta T cell technology.
Corporate updates

Hired Benjamin Hsu, M.D., Ph.D., as Vice President Clinical Development – Autoimmune. In March 2024, Adicet appointed Dr. Benjamin Hsu, M.D., Ph.D., as Vice President Clinical Development. Dr. Hsu brings over 20 years of experience in the biotech and pharmaceutical industry with extensive expertise in immunology and rheumatology clinical development. Dr. Hsu will lead the clinical design and execution of the clinical development plan for Adicet’s gamma delta T cell therapies for autoimmune diseases.
Extended projected cash runway into 2H 2026. In January 2024, Adicet successfully raised $91.8 million in net proceeds through an underwritten public offering and received $19.3 million in net proceeds under its at-the-market (ATM) program.
Financial Results for Fourth Quarter and Full Year 2023:

Three months Ended December 31, 2023

Research and Development (R&D) Expenses: R&D expenses were $24.8 million for the three months ended December 31, 2023, compared to $25.0 million during the same period in 2022. The $0.2 million decrease was primarily driven by a $2.7 million decrease in expenses related to contract development manufacturing organizations (CDMOs), contract research organizations (CROs) and consultant costs related to our lead product candidate ADI-001. This decrease was partially offset by an increase of $1.3 million in payroll and personnel expenses, an increase of $0.7 million in lab expenses and an increase of $0.6 million in facility and other expenses.
General and Administrative (G&A) Expenses: G&A expenses were $6.8 million for the three months ended December 31, 2023, compared to $6.6 million during the same period in 2022. The $0.2 million increase was primarily driven by an increase of $0.9 million in payroll and personnel expenses. This increase was partially offset by a $0.4 million decrease in professional fees and a $0.4 million decrease in facility and other expenses.
Net Loss: Net loss for the three months ended December 31, 2023 was $29.5 million, or a net loss of $0.69 per basic and diluted share, including non-cash stock-based compensation expense of $4.9 million, as compared to a net loss of $29.9 million, or a net loss of $0.72 per basic and diluted share, including non-cash stock-based compensation expense of $4.3 million during the same period in 2022.
Twelve Months Ended December 31, 2023

Research and Development (R&D) Expenses: R&D expenses were $106.0 million for the year ended December 31, 2023, compared to $71.2 million for the year ended December 31, 2022. The $34.8 million increase was primarily driven by an $11.5 million increase in payroll and personnel expenses resulting from an increase in overall headcount, a net $10.7 million increase in expenses related to CDMOs, CROs and consultant costs related to our lead product candidate ADI-001, a $8.5 million increase in facility and other expenses and a $4.1 million increase in lab expenses.
General and Administrative (G&A) Expenses: G&A expenses were $26.5 million for the year ended December 31, 2023, compared to $26.3 million for the year ended December 31, 2022. The $0.2 million increase was primarily driven by a $3.3 million increase in payroll and personnel expenses, which includes an increase in stock-based compensation of $1.2 million, salaries and benefits of $1.0 million and contractor fees of $0.9 million and an increase in recruiting fees of $0.3 million. These increases were primarily due to increased headcount for the period. The overall increase was partially offset by a $2.6 million decrease in facilities and other related expenses.
Goodwill Impairment: Goodwill was impaired by $19.5 million during the year ended December 31, 2023 following the results of an interim impairment test conducted during the period. This represented the entire remaining balance of goodwill.

Net Loss: Net loss for the year ended December 31, 2023 was $142.7 million, or a net loss of $3.31 per basic and diluted share, including non-cash stock-based compensation expense of $20.3 million, as compared to a net loss of $69.8 million, or a net loss of $1.70 per basic and diluted share, including non-cash stock-based compensation expense of $17.1 million during the same period in 2022.

Cash Position: Cash and cash equivalents were $159.7 million as of December 31, 2023, compared to $257.7 million as of December 31, 2022. Subsequent to December 31, 2023, the Company received $91.8 million of net proceeds from an underwritten public offering and $19.3 million of net proceeds under its ATM program. The Company expects that its cash and cash equivalents as of December 31, 2023, together with the proceeds raised subsequent to year end, will be sufficient to fund its operating expenses into the second half of 2026.