On May 8, 2023 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies and cytokines for the treatment of patients with cancer and autoimmune diseases, reported financial results for the first quarter ended March 31, 2023 and provided a review of recent business and clinical highlights (Press release, Xencor, MAY 8, 2023, View Source [SID1234631184]).

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"In the first quarter, we and our partners continued to enroll patients across multiple Phase 1 and Phase 2 clinical studies of XmAb drug candidates in oncology and autoimmune diseases. Two new programs are planned to advance into clinical development this year, XmAb662, our engineered IL12-Fc cytokine, on track to start a Phase 1 study mid-year, and XmAb541, our CLDN6 x CD3 bispecific antibody for ovarian cancer, for which we anticipate submitting the IND by year end," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "And recently, we added to our team the expertise and talents of Nancy Valente, M.D., who will lead our clinical programs as our new executive vice president and chief development officer."

Program and Corporate Updates

XmAb564 (IL2-Fc): The Company will present updated results from the Phase 1a single-ascending dose study in healthy volunteers at European Alliance of Associations for Rheumatology (EULAR) Congress, being held from May 31 to June 1, in Milan, Italy. The update will include additional biomarker data. Data previously presented demonstrate a single dose, administered subcutaneously in healthy volunteers, was well tolerated and generated durable, dose-dependent and selective expansion of regulatory T cells.
XmAb104 (PD-1 x ICOS): XmAb104 is a bispecific antibody that targets PD-1, an immune checkpoint receptor, and ICOS, an immune co-stimulatory receptor, to selectively activate the tumor microenvironment. Initial dose-escalation data from a Phase 1 study, presented at ASCO (Free ASCO Whitepaper) 2022, indicates that XmAb104 was well tolerated and exhibited a distinct safety profile compared to other clinical-stage ICOS programs. Anti-tumor activity was observed in patients, and biomarker activity was consistent with engagement with T cells. The Company has opened an expansion portion in the study (Part C) to evaluate XmAb104 in combination with ipilimumab in patients with microsatellite stable or proficient mismatch repair colorectal cancer.
Preclinical Data Presentation: Preclinical data generated from engineered CD28 bispecific antibodies targeting the solid tumor antigens CEACAM5, ENPP3, mesothelin, STEAP1 and Trop-2 were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2023.
Corporate Update: Nancy Valente, M.D., was appointed as Xencor’s Executive Vice President, Chief Development Officer, effective May 1, having previously served as an independent member of the Company’s Board of Directors from September 2022 through April 2023. Dr. Valente brings with her more than 20 years of experience in late-stage biopharmaceutical product development. She most recently served as a senior vice president at Genentech, a member of the Roche Group, and as its global head and co-lead of global product development of its oncology and hematology therapeutic area.
Progress Across Partnered Programs

Alexion Pharmaceuticals, Inc.: In April 2023, Ultomiris (ravulizumab-cwvz), which incorporates Xencor’s Xtend Fc domain, was recommended for marketing authorization in the EU for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 antibody positive. In addition, AstraZeneca recently announced that a Phase 3 study of Ultomiris has been initiated in cardiac surgery-associated acute kidney injury. In the first quarter of 2023, Xencor earned $10.5 million of royalty revenue from Alexion on net sales of Ultomiris.
Ultomiris is a registered trademark of Alexion Pharmaceuticals, Inc.

Financial Results for the First Quarter Ended March 31, 2023

Cash, cash equivalents, receivables and marketable debt securities totaled $568.2 million as of March 31, 2023, compared to $613.5 million on December 31, 2022.

Revenues for the first quarter ended March 31, 2023 were $19.0 million, compared to $85.5 million for the same period in 2022. Total revenues earned in the first quarter of 2023 included milestone revenue earned from Xencor’s Janssen collaboration and royalties from the Alexion agreement, compared to revenue earned from the Janssen collaboration, milestone revenue from Astellas, and royalties from the Alexion, MorphoSys and Vir agreements in the first quarter of 2022.

Research and development expenses for the first quarter ended March 31, 2023 were $64.4 million, compared to $47.8 million for the same period in 2022. Increased research and development spending for first quarter of 2023 compared to 2022 reflects increased spending on the Company’s development programs including XmAb541 and XmAb564 and other research and early-stage programs.

General and administrative expenses for the first quarter ended March 31, 2023 were $14.0 million, compared to $11.3 million in the same period in 2022. Increased general and administrative spending for the first quarter of 2023 compared to 2022 reflects increased facility expenses and additional spending on professional fees.

Non-cash, stock-based compensation expense for the first quarter ended March 31, 2023 was $12.6 million, compared to $10.8 million for the same period in 2022.

Net loss for the first quarter ended March 31, 2023 was $60.8 million, or $(1.02) on a fully diluted per share basis, compared to a net income of $23.6 million, or $0.39 on a fully diluted per share basis, for the same period in 2022. Net loss reported for the first quarter of 2023 compared to net income for the same period in 2022 is primarily due to decreased royalties from the Vir agreement.

The total shares outstanding were 60,381,600 as of March 31, 2023, compared to 59,529,192 as of March 31, 2022.

Financial Guidance

Based on current operating plans, Xencor expects to have cash to fund research and development programs and operations through the end of 2025. The Company expects to end 2023 with between $425 million and $475 million in cash, cash equivalents, receivables and marketable debt securities.

Conference Call and Webcast

Xencor will host a conference call today at 4:30 p.m. ET (1:30 p.m. PT) to discuss the first quarter 2023 financial results and provide a corporate update.

The live webcast will be available under "Events & Presentations" in the Investors section of the Company’s website located at investors.xencor.com and will be archived for at least 30 days. Active participants in the conference call may receive credentials for telephone access by registering at the following link: https://register.vevent.com/register/BI0da076297f5f4f3b920845d8b0e7f2d3.

On May 8, 2023 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, reported financial results for the first quarter of 2023 and recent clinical program updates (Press release, Viracta Therapeutics, MAY 8, 2023, View Source [SID1234631183]).

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"With progress from both of our clinical programs accelerating, we have the opportunity to achieve several important milestones this year. NAVAL-1 is enrolling at a rapid pace, and we look forward to readouts across multiple subtypes that could trigger our first advancement into Stage 2 in the months ahead," said Mark Rothera, President and Chief Executive Officer of Viracta. "On the solid tumor front, we are currently seeking to optimize the dose of Nana-val and are pleased to see that its safety profile continues to support further dose escalation into our trial’s fifth dose level. Following the completion of the Phase 1b portion of the trial, we look forward to selecting our recommended Phase 2 dose and advancing our efforts around Nana-val as a potential tumor agnostic therapy for EBV-associated cancers."

Program Highlights and Anticipated Milestones

Pivotal NAVAL-1 trial of Nana-val in relapsed/refractory (R/R) EBV+ lymphoma

NAVAL-1 continues to enroll across each of the trial’s lymphoma subtype cohorts with more than 70 sites open globally.
An update on NAVAL-1’s first lymphoma subtype that may advance from Stage 1 to Stage 2 is anticipated in the second quarter of 2023.
Potential for additional update(s) on other NAVAL-1 lymphoma subtype(s) in the second half of 2023.
Phase 1b/2 trial of Nana-val in patients with recurrent/metastatic (R/M) EBV+ nasopharyngeal carcinoma (NPC) and other advanced EBV+ solid tumors

The trial has advanced into the fifth dose level of the Phase 1b dose escalation portion; no dose-limiting toxicities have been reported to date.
Clinical data previously reported across the first three dose levels (n=10) include one confirmed partial response (PR) at the third dose level and three patients achieving stable disease.
The Company remains on track to report complete Phase 1b dose escalation data and select a recommended Phase 2 dose (RP2D) in the second half of 2023.
Initiation of the trial’s Phase 2 randomized expansion cohort designed to evaluate Nana-val at the RP2D with or without pembrolizumab in patients with R/M EBV+ NPC is expected in the second half of 2023.
Initiation of the trial’s exploratory Phase 1b expansion cohort designed to evaluate Nana-val at the RP2D in patients with other advanced EBV+ solid tumors, including gastric carcinoma, leiomyosarcoma and lymphoepithelioma, is expected in the second half of 2023.
First Quarter 2023 Financial Results

Cash position – Cash, cash equivalents and short-term investments totaled approximately $80.3 million as of March 31, 2023, which Viracta expects will be sufficient to fund its operations into late 2024 excluding any additional borrowing under a $50.0 million credit facility, of which $25.0 million remains available, at the Company’s request, subject to the discretion of the lenders.
Research and development expenses – Research and development expenses were approximately $7.6 million for the three months ended March 31, 2023, compared to approximately $6.1 million for the three months ended March 31, 2022. The increase in research and development expenses was primarily driven by increases in costs incurred to support the advancement and expansion of our clinical development programs, including incremental costs to support NAVAL-1, our pivotal trial in R/R EBV+ lymphoma, and the initiation of our Phase 1b/2 trial for the treatment of EBV+ solid tumors, as well as an increase in personnel-related costs.
General and administrative expenses – General and administrative expenses were approximately $4.6 million for the three months ended March 31, 2023, compared to $4.3 million for the same period in 2022. The increase in general and administrative expenses can be attributed to an increase in personnel-related costs.
Net loss – Net loss was approximately $12.2 million, or $0.32 per share, (basic and diluted) for the quarter ended March 31, 2023, compared to a net loss of $10.5 million, or $0.28 per share (basic and diluted) for the same period in 2022.
About NAVAL-1

NAVAL-1 (NCT05011058) is a global, multicenter trial of Nana-val in R/R EBV+ lymphoma. The trial employs a Simon two-stage design where participants are enrolled into six indication cohorts based on EBV+ lymphoma subtype in Stage 1. If a pre-specified activity threshold is reached within a lymphoma subtype in Stage 1 (n=10), additional patients will be enrolled in Stage 2 for a total of 21 patients. EBV+ lymphoma subtypes demonstrating promising activity in Stage 2 may be further expanded following discussion with regulators to potentially support registration.

About the Phase 1b/2 Trial of Nana-val in R/M EBV+ NPC and Other EBV+ Solid Tumors

This Phase 1b/2 trial (NCT05166577) is an open-label, multinational trial evaluating Nana-val alone and in combination with pembrolizumab. The Phase 1b dose escalation part is designed to evaluate safety and to determine the RP2D of Nana-val in patients with R/M EBV+ NPC. In Phase 2, up to 60 patients with R/M EBV+ NPC will be randomized to receive Nana-val at the RP2D with or without pembrolizumab to evaluate safety, overall response rate, and potential pharmacodynamic markers. Additionally, patients with other advanced EBV+ solid tumors will be enrolled to receive Nana-val at the RP2D in a Phase 1b dose expansion cohort.

About Nana-val (Nanatinostat and Valganciclovir)

Nanatinostat is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which are key to inducing viral genes that are epigenetically silenced in Epstein-Barr virus (EBV)-associated malignancies. Nanatinostat is currently being investigated in combination with the antiviral agent valganciclovir as an all-oral combination therapy, Nana-val, in various subtypes of EBV-associated malignancies. Ongoing trials include a pivotal, global, multicenter, open-label Phase 2 basket trial in multiple subtypes of relapsed/refractory EBV+ lymphoma (NAVAL-1) as well as a multinational Phase 1b/2 trial in patients with EBV+ recurrent or metastatic nasopharyngeal carcinoma and other EBV+ solid tumors.

On May 8, 2023 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel products for rare and ultrarare diseases, reported that clinical, preclinical and manufacturing data from its investigational gene therapy programs will be presented at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 26th Annual Meeting, which will be held May 16-20, 2023 at the Los Angeles Convention Center in Los Angeles, California (Press release, Ultragenyx Pharmaceutical, MAY 8, 2023, View Source [SID1234631182]).

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The company will present additional data supporting its gene therapy portfolio and discuss critical topics during the clinical trials spotlight symposium and at pre-meeting workshops.

Clinical and pre-clinical presentations:

Oral presentation: Efficacy and safety at week 52 and up to four years in adults with glycogen storage disease type Ia (GSDIa): Results from a Phase 1/2 clinical trial and long-term follow-up study of DTX401, an AAV-8-mediated, liver-directed gene therapy (Abstract #4)
Date/Time: Thursday, May 18, 8:00 – 8:15 AM PDT
Location: Concourse Hall 152 and 153
First author: Rebecca Riba-Wolman, M.D., University of Connecticut
Oral presentation: Long-term Safety and Efficacy of DTX301 in Adults with Late-Onset Ornithine Transcarbamylase (OTC) Deficiency: A Phase 1/2 Trial (Abstract #128)
Date/Time: Thursday, May 18, 2:45 PM – 3:00 PM PDT
Location: Room 403 AB
Presenter: Cary Harding, M.D., Oregon Health & Science University
Poster presentation: Immunosuppression to Inhibit Capsid-Specific Humoral Immune Responses in High-dose AAV Gene Therapy in Cynomolgus Macaques (Board No. 1191)
Date/Time: Thursday, May 18, 12:00 PM PDT
Presenter: Deniz Erturk-Hasdemir, Ph.D., Ultragenyx
Additional presentations including the company’s manufacturing capabilities and Pinnacle PCL (AAV vector producer cell line) platform and technology:

Oral presentation: In Vivo and In Vitro Assessment of Residual DNA Impurity-Derived Transcriptions (Abstract #109)
Date/Time: Thursday, May 18, 1:30 – 1:45 PM PDT
Location: Concourse Hall 150 and 151
Presenter: Hsin-I Jen, Ph.D., Ultragenyx
Poster presentation: Early Development of In Vitro Potency Assays for Rare and Ultrarare Disease Gene Therapy Products (Board No. 782)
Date/Time: Wednesday, May 17, 12:00 PM PDT
Presenter: Elena Balkanska-Sinclair, Ultragenyx

Poster presentation: Global Strategy to Improve the Downstream Manufacturing Process of the Adeno-associated Viral Vector for Glycogen Storage Disease Type Ia Treatment (Board No. 412)

Date/Time: Wednesday, May 17, 12:00 PM PDT
Presenter: Chao Huang, Ph.D., Ultragenyx

Poster presentation: Genome-wide analysis of triple-play plasmid integration in Pinnacle PCL producer cell lines across multiple rAAV programs (Board No. 1162)

Date/Time: Thursday, May 18, 12:00 PM PDT
Presenter: Nicholas Richards, M.S., Ultragenyx

Poster presentation: Identification of novel mutations in PCCA and PCCB genes from Propionic Acidemia patient fibroblasts via long-read sequencing (Board No. 972)

Date/Time: Thursday, May 18, 12:00 PM PDT
Presenter: Rea Guertler, M.Sc., Ultragenyx

Poster presentation: Development of innovative, scalable, high productivity manufacturing process to enable Ph1/2 clinical supply of UX810, an investigational AAV gene therapy to treat Duchenne’s Muscular Dystrophy (Board No. 1424)

Date/Time: Friday, May 19, 12:00 PM PDT
Presenter: Wei Xue, Ph.D., Ultragenyx

Poster presentation: Development of UX055 AAV Gene Therapy for Cyclin-dependent Kinase-like 5 (CDKL5) Deficiency Disorder (CDD), a Rare Neurological Disorder (Board No. 1340)

Date/Time: Friday, May 19, 12:00 PM PDT
Presenter: Julie Wei, Ph.D., Ultragenyx

Poster presentation: Rare Disease Patient Advocacy Perspectives on the Promise and Challenges of Gene Therapy (Board No. 1578)

Date/Time: Friday, May 19, 12:00 PM PDT
Presenter: Kristin Voorhees, Ultragenyx
In addition to the data presentations, Ultragenyx will present at one pre-meeting workshop on Tuesday, May 16:

Pre-meeting workshop: How to Become a Site for AAV Gene Therapy Trials
Time: 8:25-8:50 AM PDT
Location: Concourse Hall 152 and 153
Presenter: Sandra Nino-Siddens, Pharm.D., Ultragenyx

On May 8, 2023 Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported its financial results for the quarter ended March 31, 2023 and provided a business update (Press release, Syndax, MAY 8, 2023, View Source [SID1234631181]).

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"Syndax is at an important inflection point with pivotal data readouts and subsequent U.S. registrational filings from each of our two potential first- and best-in-class product candidates expected by year-end," said Michael A. Metzger, Chief Executive Officer. "As we continue to advance our mission to realize a future in which people with cancer live longer and better than ever before, we look forward to reporting topline data from our AGAVE-201 pivotal trial of axatilimab in chronic graft versus host disease (cGVHD) in mid-2023 as well as topline data from our AUGMENT-101 pivotal trial in patients with KMT2A-rearranged (KMT2Ar) acute leukemia in the third quarter of this year."

Recent Pipeline Progress and Anticipated Milestones

Revumenib

The pivotal Phase 2 portion of AUGMENT-101 is enrolling relapsed/refractory (R/R) patients across distinct trial populations: patients with KMT2Ar acute myeloid leukemia (AML), patients with KMT2Ar acute lymphocytic leukemia (ALL) and patients with nucleophosmin mutant (mNPM1) AML. The Company plans to pool data from the AUGMENT-101 cohorts enrolling adult and pediatric patients with R/R KMT2Ar AML and R/R KMT2Ar ALL to file a single New Drug Application (NDA) for the treatment of adult and pediatric KMT2Ar acute leukemia. The Company expects to share topline data from the KMT2Ar pooled analysis in the third quarter of 2023 and submit an NDA filing by the end of 2023. The Company also expects to complete enrollment of the NPM1 AML cohort in the second half of 2023.
The Company has obtained U.S. Food and Drug Administration (FDA) agreement on a recommended Phase 2 dose (RP2D) of 276 mg of revumenib every 12 hours for patients not receiving a strong CYP3A4 inhibitor.
The Company has several Phase 1 trials of revumenib ongoing that will provide data across the treatment landscape in acute leukemia. These include the following:
BEAT-AML: A combination trial of revumenib with venetoclax and azacitidine in front-line AML patients being conducted as part of the Leukemia & Lymphoma Society’s Beat AML master clinical trial. The Company expects to report initial safety data from the trial by year-end 2023.
AUGMENT-102: A combination trial of revumenib with chemotherapy in adult and pediatric patients with R/R mNPM1 or KMT2Ar acute leukemia. The Company expects to report initial safety data along with an RP2D from the trial by year-end 2023.
INTERCEPT: A trial to test the use of revumenib monotherapy as maintenance therapy in AML patients who are minimal residual disease-positive following initial treatment, being conducted by the Australasian Leukaemia and Lymphoma Group as part of the INTERCEPT AML master clinical trial. The trial continues to enroll patients.
A proof-of-concept clinical trial of revumenib in patients with unresectable metastatic microsatellite stable colorectal cancer is enrolling patients and we expect to have preliminary data by year-end 2023.
Axatilimab

The Company and its partner, Incyte, remain on track to report topline data from the pivotal AGAVE-201 trial evaluating axatilimab in patients with cGVHD following two or more prior lines of therapy in mid-2023, with a Biologics License Application (BLA) filing expected by year-end 2023.
The Company plans to present axatilimab data demonstrating encouraging clinical activity in cGVHD-related bronchiolitis obliterans syndrome at the upcoming 2023 American Thoracic Society (ATS) Conference on May 19-24 in Washington, D.C. The abstract is now available on the ATS website.
Syndax and Incyte expect to initiate a Phase 1 trial assessing axatilimab in combination with ruxolitinib in cGVHD in the second half of 2023.
The Company expects to initiate a randomized, double-blind and placebo-controlled Phase 2 trial to assess the efficacy, safety and tolerability of axatilimab in patients with idiopathic pulmonary fibrosis (IPF) in the second half of 2023.
Corporate Updates

In March 2023, the Company announced the appointment of Neil Gallagher, M.D., Ph.D., as President, Head of Research and Development. Dr. Gallagher brings to Syndax over 20 years of experience as a leading oncology drug developer.
Syndax reported the appointment of Kevin McManus as Chief People Officer. Mr. McManus brings to Syndax over 30 years of experience in human resources and an extensive track record in leadership roles growing organizations and attracting great talent.
First Quarter 2023 Financial Results

As of March 31, 2023, Syndax had cash, cash equivalents, short- and long-term investments of $449.0 million and 69.6 million common shares and prefunded warrants outstanding.

First quarter 2023 research and development expenses increased to $34.1 million from $30.0 million for the comparable prior year period. The increase in research and development expenses was primarily due to increased employee-related expenses and professional fees offset by decreased clinical and manufacturing expenses.

First quarter 2023 general and administrative expenses increased to $12.0 million from $6.8 million for the comparable prior year period. The increase is primarily due to employee-related expenses and professional fees.

For the three months ended March 31, 2023, Syndax reported a net loss attributable to common stockholders of $41.1 million, or $0.59 per share, compared to a net loss attributable to common stockholders of $37.2 million, or $0.63 per share, for the comparable prior year period.

Financial Update and Guidance

For the second quarter of 2023, the Company expects research and development expenses to be $38 to $43 million and total operating expenses to be $53 to $58 million. For the full year of 2023, the Company continues to expect research and development expenses to be $160 to $175 million and total operating expenses to be $225 to $240 million.

Conference Call and Webcast

In connection with the earnings release, Syndax’s management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Monday, May 8, 2023.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website. Alternatively, the conference call may be accessed through the following:

Conference ID: SNDX1Q23
Domestic Dial-in Number: 800-579-2543
International Dial-in Number: 785-424-1789
Live webcast: https://www.veracast.com/webcasts/syndax/events/SNDX1Q23.cfm

For those unable to participate in the conference call or webcast, a replay will be available on the Investors section of the Company’s website at www.syndax.com approximately 24 hours after the conference call and will be available for 90 days following the call.

On May 8, 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 that Bill Newell, Chief Executive Officer, will present at the JMP Securities Life Sciences Conference on Monday, May 15th, 2023, at 2:00 p.m. ET / 11:00 a.m. PT in New York City (Press release, Sutro Biopharma, MAY 8, 2023, View Source [SID1234631180]).

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The presentation will be accessible through the News & Events page of the Investor Relations section of the company’s website at www.sutrobio.com. An archived replay will be available for at least 30 days after the event.