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Legend Biotech Reports Full-Year 2022 Results and Recent Highlights

On March 30, 2023 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, reported its full year 2022 audited financial results (Press release, Legend Biotech, MAR 30, 2023, View Source [SID1234629681]).

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"2022 was a year of significant milestones for Legend Biotech, marked by the regulatory approvals of CARVYKTI in the U.S., Europe, and Japan. In addition to launching our first commercial product, we advanced our clinical development program for cilta-cel, obtained FDA clearances on two investigational new drug applications targeting solid tumors, and critically, expanded our commercial infrastructure and manufacturing capabilities to support future growth" said Ying Huang, Chief Executive Officer of Legend Biotech.

"Our teams across the entire business delivered exceptionally during an incredibly busy year. Looking forward, we remain focused on the continued expansion of our manufacturing footprint and advancing our clinical program in order to bring CARVYKTI to more eligible patients."

Second Half 2022 Highlights and Recent Events

On January 27, 2023, Legend Biotech announced that CARTITUDE-4, the Phase 3 study evaluating CARVYKTI (ciltacabtagene autoleucel) for the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma, met its primary endpoint of showing a statistically significant improvement in progression-free survival (PFS) compared to standard therapy at the study’s first pre-specified interim analysis

On January 2, 2023, Legend Biotech announced that China’s National Medical Products Administration (NMPA) has formally accepted the New Drug Application (NDA) for ciltacabtagene autoleucel (cilta-cel)

On November 21, 2022, Legend Biotech announced that the U.S. Food and Drug Administration (FDA) cleared Legend Biotech’s Investigational New Drug (IND) application to proceed with the clinical development of LB2102, an investigational, autologous chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of adult patients with extensive stage small cell lung cancer (SCLC)

On September 27, 2022, Legend Biotech announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) approved CARVYKTI (ciltacabtagene autoleucel) for the treatment of adults with relapsed or refractory multiple myeloma, limited to cases meeting both of the following conditions: patients have no history of CAR-positive T cell infusion therapy targeting BCMA; and patients have received three or more lines of therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody, and in whom multiple myeloma has not responded to or has relapsed following the most recent therapy
Financial Results for Year Ended December 31, 2022

Cash and Cash Equivalents, Time Deposits, and Short-Term Investments

As of December 31, 2022, Legend Biotech had approximately $1.0 billion of cash and cash equivalents, time deposits, and short-term investments.

Revenue

Revenue for the year ended December 31, 2022 was $117.0 million compared to $68.8 million for the year ended December 31, 2021. The increase of $48.2 million was due to product sales for the commercial launch of CARVYKTI in the U.S. in connection with Legend Biotech’s collaboration agreement with Janssen Biotech, Inc. (the "Janssen Agreement").

Research and Development Expenses

Research and development expenses for the year ended December 31, 2022 were $335.6 million compared to $313.3 million for the year ended December 31, 2021. This increase of $22.3 million was primarily due to continued investment in cilta-cel for earlier lines of therapies and increase in Legend Biotech’s pipeline expenditures as it filed two Investigational New Drug applications and began preparation for Phase 1 clinical development in the U.S. in the year ended December 31, 2022.

Administrative Expenses

Administrative expenses for the year ended December 31, 2022 were $80.6 million compared to $47.0 million for the year ended December 31, 2021. The increase of $33.7 million was primarily due to the final phase of separation of certain information technology services from GenScript Biotech Corporation, required enhancements for cybersecurity and privacy, along with the required information technology infrastructure build to support manufacturing facilities.

Selling and Distribution Expenses

Selling and distribution expenses for the year ended December 31, 2022 were $93.4 million compared to $102.5 million for the year ended December 31, 2021. This increase of $9.1 million was primarily due to costs associated with the commercialization of CARVYKTI.

Other Income and Gains

Other income and gains for the year ended December 31, 2022 were $12.0 million compared to $3.1 million for the year ended December 31, 2021. The increase of $8.9 million was primarily due to increase in interest income, government grants and fair value gain from financial assets.

Other Expenses

Other expenses for the year ended December 31, 2022 were $9.8 million compared to $9.1 million for the year ended December 31, 2021. The increase was primarily due to foreign currency exchange loss in the year.

Finance Costs

Finance costs for the year ended December 31, 2022 were $10.8 million compared to $0.9 million for the year ended December 31, 2021. The increase was primarily due to interest on advance funding, which is interest-bearing borrowings funded by Janssen under the Janssen Agreement and constituted by principal and applicable interests upon such principal. Legend Biotech elected to borrow an incremental $130.3 million as of December 31, 2022 in accordance with the terms of the Janssen Agreement.

Fair Value Gain of Warrant Liability

Fair value gain of warrant liability for the year ended December 31, 2022 was $20.9 million caused by changes in the fair value of a warrant that Legend Biotech issued to an institutional investor through a private placement transaction in May 2021 with an initial fair value of $81.7 million at the issuance date. The warrant was assessed as a financial liability with a fair value of $67.0 million as of December 31, 2022.

Loss for the Period

For the year ended December 31, 2022, net loss was $446.3 million, or $1.40 per share, compared to a net loss of $403.6 million, or $1.43 per share, for the year ended December 31, 2021.

OmniAb Reports Fourth Quarter and Full Year 2022 Financial Results and Business Highlights

On March 30, 2023 OmniAb, Inc. (NASDAQ: OABI) reported financial results for the three and 12 months ended December 31, 2022, and provided operating and partner program updates (Press release, OmniAb, MAR 30, 2023, View Source [SID1234629680]).

"Following the closing of the spin-off and business combination transactions last November, OmniAb is well-positioned for continued growth by offering cutting-edge antibody discovery platforms and complementary technologies," said Matt Foehr, Chief Executive Officer of OmniAb. "Leveraging a rich heritage of innovations designed to facilitate the discovery of novel therapeutics including those targeting ion channels and transporters, OmniAb is at the forefront of antibody discovery with the industry’s only four-species platform facilitating fully human and bispecific antibody discovery, supported by a highly dedicated staff and world-class scientific and business advisors.

"2022 was another terrific year for the business as we added a record-high 13 new partnerships and our partners continued to increase their number of programs. We are excited about the future as we leverage our highly scalable business model and invest in our technologies," he added. "We are planning to introduce new technologies and innovations later this year as we serve current partners and add new ones, while enhancing our best-in-class technology stack."

On November 1, 2022, OmniAb completed a spin-off from Ligand Pharmaceuticals Incorporated (NASDAQ: LGND), resulting in OmniAb becoming an independent publicly traded company. Financial results prior to November 1, 2022, are presented on a carve-out basis derived from Ligand’s historical accounting records, as if OmniAb were an independent company.

Fourth Quarter 2022 Financial Results

Revenue for the fourth quarter of 2022 was $35.3 million, compared with $15.3 million for the same period in 2021, with the increase primarily attributable to the recognition of a $25.0 million milestone payment related to the first commercial sale of TECVAYLI (teclistamab) in the U.S. OmniAb expects to recognize a $10.0 million milestone payment related to the first commercial sale in the European Union (EU) in 2023.

Research and development expense was $12.9 million for the fourth quarter of 2022, compared with $11.0 million for the same period in 2021, with the increase primarily due to investments in facilities, headcount and technology innovation. General and administrative expense was $10.2 million for the fourth quarter of 2022, compared with $4.3 million for the same period in 2021, with the increase primarily due to higher headcount related to becoming an independent publicly traded company.

Net income for the fourth quarter of 2022 was $6.8 million, or $0.07 per diluted share, compared with a net loss of $3.1 million, or $0.04 per share, for the same period in 2021.

Full Year 2022 Financial Results

Revenue for 2022 was $59.1 million, compared with $34.7 million for 2021, with the increase attributable to the recognition of the $25.0 million TECVAYLI (teclistamab) milestone payment following the first commercial sale in the U.S. and royalty revenue from our partners’ sales of zimberelimab and sugemalimab.

Research and development expense for 2022 was $48.4 million, compared with $39.2 million for 2021, with the increase primarily due to continued investments in facilities, headcount and technology innovation. General and administrative expense for 2022 was $24.9 million, compared with $16.9 million for 2021, with the increase primarily due to expenses associated with the spin-off and business combination, as well as headcount-related expenditures as we prepared to become an independent public company.

Net loss for 2022 was $22.3 million, or $0.26 per share, compared with a net loss of $27.0 million, or $0.33 per share, for 2021. Cash used to fund operating activities was $3.6 million for 2022.

As of December 31, 2022, OmniAb had cash, cash equivalents and short-term investments of $88.3 million. Subsequent to the close of the year, in January 2023 OmniAb received $35.0 million in milestone payments from Janssen related to TECVAYLI (teclistamab). The current cash, cash equivalents and short-term investments balance, along with the cash the Company generates from operations are expected to be sufficient to fund operations for the foreseeable future. The Company expects its 2023 year-end cash, cash equivalents and short-term investments balance to be slightly higher than year-end 2022.

Fourth Quarter 2022 and Recent Business Highlights

In 2022, the company signed 13 new licenses, including one in the fourth quarter with the Wistar Institute. In addition, during the quarter three new programs entered the clinic: M9140 (Merck KGaA), an antibody-drug conjugate anti-CEACAM5 in advanced solid tumors; GEN1053 (Genmab/BioNTech), a hexabody anti-CD27 in malignant solid tumors; and JNJ-79635322 (Janssen), a trispecific in relapsed or refractory multiple myeloma. As of December 31, 2022, the company had 69 active partners with 26 OmniAb-derived programs in clinical development or being commercialized, and a total of 291 programs being pursued or commercialized.

During the quarter, OmniAb entered into an agreement with mAbsolve Ltd. for STR, mAbsolve’s Fc-silencing platform technology. The agreement provides OmniAb with exclusive, sublicensable right to incorporate the STR technology with antibodies that have been generated using OmniAb’s antibody discovery platform.

Fourth quarter 2022 and recent partner highlights include the following:

TECVAYLI (teclistamab)

Janssen Biotech, Inc. received approval from the U.S. Food and Drug Administration for TECVAYLI (teclistamab) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.
Batoclimab

Immunovant announced initiation of a Phase 3 clinical trial of batoclimab in thyroid eye disease and a Phase 2b clinical trial in chronic inflammatory demyelinating polyneuropathy.
Sugemalimab

EQRx announced the Marketing Authorization Applications for sugemalimab in combination with chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) were accepted for review by both the Medicines and Healthcare products Regulatory Agency in the United Kingdom and the European Medicines Agency for the EU.
CStone announced the National Medical Products Administration of China accepted the supplemental new drug application (sNDA) for sugemalimab in combination with chemotherapy as a first-line treatment of unresectable locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma. The sNDA is based on the GEMSTONE-303 study, in which sugemalimab in combination with chemotherapy as a first-line treatment for unresectable locally advanced or metastatic gastric adenocarcinoma/gastro-esophageal junction adenocarcinoma with PD-L1 expression ≥5% met one of its primary endpoints, progression-free survival. CStone also announced topline results from the GEMSTONE-304 study, in which sugemalimab in combination with chemotherapy as a first-line treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma met its primary endpoints.
Zimberelimab

Gilead Sciences and Arcus Biosciences announced positive results from the fourth interim analysis of the ARC-7 study in patients with first-line, metastatic NSCLC with PD-L1 tumor proportion score ≥50% without epidermal growth factor receptor or anaplastic lymphoma kinase mutations. ARC-7 is a Phase 2 multicenter, three-arm, randomized, open-label study evaluating the combinations of Fc-silent anti-TIGIT monoclonal antibody domvanalimab plus anti-PD-1 monoclonal antibody zimberelimab (doublet) and domvanalimab plus zimberelimab and etrumadenant, an A2a/b adenosine receptor antagonist (triplet), versus zimberelimab monotherapy.

Entry into a Material Definitive Agreement

On March 29, 2023, XOMA (US) LLC ("XOMA"), a wholly-owned subsidiary of XOMA Corporation (the "Company"), entered into a Payment Interest Purchase Agreement (the "Agreement") with Aptevo Therapeutics Inc., a Delaware corporation ("Aptevo") (Filing, 8-K, , MAR 30, 2023, View Source [SID1234629674]). Pursuant to the Agreement, XOMA has acquired all right, title, and interest to 100% of deferred payments based on net sales of IXINITY, which is marketed by Medexus Pharma, Inc. ("Medexus") for the control and prevention of bleeding episodes and postoperative management in people with Hemophilia B, 25% of a certain milestone payment, and 50% of certain other milestone payments otherwise payable by Medexus to Aptevo (the "Purchased Receivables") pursuant to a certain sale agreement dated February 28, 2020, by and between Aptevo and Medexus. In exchange for the Purchased Receivables, XOMA paid Aptevo $9.6 million, and if XOMA receives more than $500,000 of deferred payments attributable to net sales of IXINITY that occur during the first quarter of 2023, XOMA will make a one-time payment of $50,000 to Aptevo.

The Agreement contains certain covenants and representations and warranties regarding the parties’ rights and obligations with respect to the Agreement, indemnification provisions, and customary covenants and representations for a transaction of this nature.

The description of the Agreement contained herein does not purport to be complete and is qualified in its entirety by reference to such Agreement, a copy of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2023.

Sutro Biopharma Reports Full Year 2022 Financial Results, Business Highlights and Select Anticipated Milestones

On March 30, 2023 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported its financial results for the full year 2022, its recent business highlights, and a preview of select anticipated milestones (Press release, Sutro Biopharma, MAR 30, 2023, View Source [SID1234629672]).

"In 2022, we achieved significant milestones in both our internal pipeline and strategic collaborations, while strengthening our management team with the appointment of Anne Borgman, M.D., as Chief Medical Officer," said Bill Newell, Sutro’s Chief Executive Officer. "We are delighted with the recent data updates for our lead candidate, luvelta, in advanced ovarian cancer and rare pediatric AML, and are excited to progress it into a planned registration-directed study in ovarian cancer in the second quarter of this year. As we look to the future, we remain confident in our ability to drive value and deliver on our mission to develop next-generation therapies that have the potential to transform the lives of cancer patients."

Recent Business Highlights and Select Anticipated Milestones

STRO-002, International Nonproprietary Name, "luveltamab tazevibulin" or abbreviated as "luvelta", FolRα-Targeting ADC: Luvelta is being studied in the clinic, in the U.S. and Europe, for patients with ovarian and endometrial cancers.

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Sutro plans to initiate REFRaME, a Phase 2/3 registration-directed study for patients with platinum-resistant ovarian cancer, in the second quarter of 2023, as discussed with the U.S. Food and Drug Administration (FDA). Once results are collected on approximately 110 patients in the selected dose of the luvelta arm, Sutro plans to apply for accelerated approval based on overall response rate (ORR) as the primary endpoint. At the end of the trial, full approval can be sought based on progression free survival (PFS) as the primary endpoint, comparing the luvelta arm and the standard of care arm.
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In January 2023, the company announced results from the luvelta Phase 1 dose-expansion study demonstrating that FolRα-selected patients–-defined as patients with TPS >25%–-experienced meaningful clinical benefit, with 43.8% ORR, median duration of response (DOR) of 5.4 months, and median PFS of 6.6 months for those receiving the higher starting dose of 5.2 mg/kg. The safety profile is generally consistent with prior data; asymptomatic neutropenia was the primary adverse event and no new safety signals were observed. Interim data from an exploratory cohort, with 5.2 mg/kg doses of luvelta together with prophylactic pegfilgrastim, appear to demonstrate reduced dose delays and lower incidences of Grade 3+ neutropenia.

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Patients with CBFA2T3::GLIS2 (CBF/GLIS) AML, a highly refractory and uniformly fatal subtype of acute megakaryoblastic leukemia found exclusively in infants and young children, were treated with luvelta under compassionate use. During the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (ASH 2022), an oral presentation was given by the investigator who aggregated the experiences of patients who were treated.
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Additional ongoing clinical studies for luvelta include a combination study with bevacizumab for patients with advanced ovarian cancer and a dose-expansion study for patients with endometrial cancer. Translational work is ongoing to support an Investigational New Drug (IND) for the initiation of a non-small cell lung cancer (NSCLC) study, for which submission is planned in 2023.
STRO-001, CD74-Targeting ADC: The Phase 1 study for patients with B‑cell malignancies has been completed in the global sites ex-Greater China and clinical studies in Greater China have been initiated.

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Sutro has completed the Phase 1 dose-escalation study in patients with non-Hodgkin’s lymphoma (NHL) and multiple myeloma (MM), after reaching a maximum tolerated dose (MTD). Sutro plans to leverage the clinical data produced by its partner BioNova Pharma (BioNova) in Greater China to make decisions regarding further clinical development, based on a prioritization assessment.
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BioNova is advancing clinical development of BN301 (STRO-001) for patients with hematological malignancies in Greater China. In February 2023, BioNova announced that the first patient had been dosed in the Phase 1 clinical study of BN301 (STRO-001) for the treatment of advanced B-cell Non-Hodgkin’s Lymphoma (NHL).
Additional Pipeline Programs: A Sutro Research Forum, held in 2022, highlighted STRO-003 and Sutro’s emerging research portfolio.

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STRO-003 is an advanced ADC that has been designed to target ROR1, takes advantage of innovative linker-warhead technology and features eight precisely placed β-Glucuronidase-cleavable linkers attached to next-generation exatecan warheads, known for their ability to inhibit topoisomerase-1 (TOPO-1) and cause DNA disruption.
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STRO-003 has demonstrated in NSCLC and breast cancer patient-derived xenograft models strong cell-killing activity in low and heterogeneous expressing tumors. STRO-003 has exhibited promising tolerability in preclinical studies involving rodents and non-human primates, potentially reducing lung toxicity, a concern that is commonly associated with TOPO-1 class payload ADCs. Preparations are underway for IND enabling studies for STRO-003, which we expect will be completed in the first quarter of 2024.
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Sutro provided details on its product and process design, which enables its emerging portfolio including novel therapeutic modalities—for example, a single antibody which can be conjugated site-specifically to deliver two different payloads with synergistic mechanisms.
Collaboration Updates: Sutro continues to seek to maximize the value of its proprietary cell-free platform by working with partners on programs in multiple disease spaces and geographies and has generated from collaborators an aggregate of approximately $621 million in payments through December 31, 2022, including equity investments.

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In December 2022, Sutro and Vaxcyte expanded upon a nearly decade-long relationship through a new agreement, under which Vaxcyte acquired an option to access expanded rights to develop and manufacture cell-free extract, among other rights, and includes a $22.5 million upfront payment and, upon exercise of the option, up to an additional $135 million in option exercise and contingent payments. In October 2022, Vaxcyte reported positive topline data from the Phase 1/2 proof-of-concept study of its 24-valent pneumococcal conjugate vaccine candidate (VAX-24) under investigation for the prevention of invasive pneumococcal disease in adults aged 18-64. Under an existing license agreement with Vaxcyte, Sutro is eligible to receive four percent (4%) royalties on worldwide net sales of any licensed vaccine candidates for human health use, including VAX-24.
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Sutro’s collaboration with Astellas on the discovery of immunostimulatory antibody-drug conjugates (iADCs) for three targets is ongoing, for which Sutro receives financial support for its research efforts, potential milestone payments and royalties, and has an option to co-develop and co-commercialize product candidates in the U.S.
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Sutro is manufacturing initial drug supply for the clinical development of Merck’s MK-1484, currently in a Phase 1; and clinical trial materials for Bristol Myers Squibb’s (BMS) CC-99712, a BCMA‑targeting ADC for treatment of multiple myeloma, currently in Phase 1.
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Sutro is providing clinical drug supply to BioNova for clinical studies for BN301 (STRO-001) in Greater China. Sutro is currently supporting Tasly Biopharmaceuticals (Tasly) for initiation of clinical development activities and an IND filing in Greater China for STRO-002 and will provide initial clinical drug supply.
Corporate Updates: Sutro strengthened and continues to build a world-class leadership team through the appointment of a new Chief Medical Officer and internal promotions.

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Anne Borgman, M.D., joined Sutro as Chief Medical Officer in February 2023 overseeing the Clinical Development & Regulatory teams, with focus on the development of luvelta and clinical strategy for Sutro’s proprietary pipeline, in addition to being a member of Sutro’s Senior Management Team.
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Sutro bolstered the Senior Management Team with the promotion of Brunilda Shtylla to Chief Business Officer, who leads Business Development. Devendra Luhar was promoted to SVP, Manufacturing & San Carlos Facility, and Carlos Lugo Ponce was promoted to SVP, Quality Control & Quality Assurance.
Full Year 2022 Financial Highlights

Cash, Cash Equivalents and Marketable Securities

As of December 31, 2022, Sutro had cash, cash equivalents and marketable securities of $302.3 million, as compared to $287.3 million as of September 30, 2022, and approximately 0.7 million shares of Vaxcyte common stock with a fair value of $32.0 million, which together provide a projected cash runway into the second half of 2024, based on current business plans and assumptions.

Unrealized Gain from Increase in Value of Vaxcyte Common Stock

The non-operating, unrealized gain of $12.1 million for the year 2022 was due to the increase since December 31, 2021 in the estimated fair value of Sutro’s holdings of Vaxcyte common stock. Vaxcyte common stock held by Sutro will be remeasured at fair value based on the closing price of Vaxcyte’s common stock on the last trading day of each reporting period, with any non-operating, unrealized gains and losses recorded in Sutro’s statements of operations. Sutro sold approximately 1.1 million shares of Vaxcyte common stock during 2022.

Revenue

Revenue was $67.8 million for the year ended December 31, 2022, as compared to $61.9 million for the same period in 2021, with the 2022 amount related principally to recognition of the upfront payment from Tasly, the milestone payment from Merck, and the Astellas, BMS, and EMD Serono collaborations and BioNova agreement. Future collaboration and license revenue under existing agreements and from any additional collaboration and license partners, will fluctuate as a result of the amount and timing of revenue recognition of upfront, milestones, and other agreement payments.

Operating Expenses

Total operating expenses for the year ended December 31, 2022 were $196.7 million, as compared to $160.4 million for the same period in 2021. The year 2022 includes non-cash expenses for stock-based compensation of $26.3 million and depreciation and amortization of $5.7 million, as compared to $23.2 million and $4.8 million, respectively, in the comparable 2021 period. Total operating expenses for the year ended December 31, 2022 were comprised of research and development expenses of $137.2 million and general and administrative expenses of $59.5 million, which are expected to increase in 2023 as Sutro’s internal product candidates advance in clinical development and additional general and administrative expenses are incurred as a public company.

Sensei Biotherapeutics to Participate in Cantor Fitzgerald’s Future of Oncology Virtual Symposium

On March 30, 2023 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), an immuno-oncology company focused on the discovery and development of next generation therapeutics for cancer patients, reported that John Celebi, president and chief executive officer, will participate in a panel titled ‘Novel Approaches in Immunotherapy’ at Cantor Fitzgerald’s Future of Oncology Virtual Symposium on Monday, April 3rd at 10:00 a.m. ET (Press release, Sensei Biotherapeutics, MAR 30, 2023, View Source [SID1234629671]).