On May 12, 2022 TCR² Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage cell therapy company with a pipeline of novel T cell therapies for cancer patients suffering from solid tumors, reported financial results for the first quarter ended March 31, 2022 and provided a corporate update (Press release, TCR2 Therapeutics, MAY 12, 2022, View Source [SID1234614383]).

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"We are very pleased with the momentum generated in the last quarter as we initiated the next phases on two clinical programs and expect to present in July an expanded dataset on 30 patients treated with gavo-cel," said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR² Therapeutics. "The consistent tumor regression observed with gavo-cel in Phase 1 establishes a baseline efficacy and safety profile upon which we can build in Phase 2. With the initiation of the TC-510 Phase 1 clinical trial, which includes the treatment of pancreatic cancer, colorectal cancer and triple negative breast cancer, we have an opportunity to expand the number of indications potentially addressable with our TRuC-T cell therapies. We look forward to a busy second half of execution as we scale these clinical trials as well as build out our preclinical pipeline targeting CD70 with enhancements and allogeneic strategies."

Recent Developments

Gavo-cel:

TCR² initiated the Phase 2 expansion portion of the ongoing Phase 1/2 clinical trial of gavo-cel, its first-in-class TRuC-T cell targeting mesothelin-expressing solid tumors. Enrollment is ongoing and the Company expects to report on progress from the Phase 2 portion of the clinical trial in the second half of 2022.
TCR² announced the Company plans to present the expanded Phase 1 dataset for gavo-cel from the dose escalation portion of the Phase 1/2 clinical trial of gavo-cel in patients with treatment refractory mesothelin-expressing solid tumors in July 2022. The presentation will focus on safety, efficacy and translational data and include 30 patients from the Phase 1 dose escalation, with data from additional malignant pleural/peritoneal mesothelioma (MPM) and ovarian patients.
TC-510:

TCR² announced the U.S. Food and Drug Administration (FDA) cleared the investigational new drug (IND) application for TC-510, a TRuC-T cell targeting mesothelin that co-expresses a PD-1:CD28 chimeric switch receptor. The Phase 1/2 clinical trial is evaluating the safety and efficacy of TC-510 in patients with mesothelin-expressing MPM, ovarian cancer, pancreatic cancer, colorectal cancer and triple negative breast cancer. The Company expects to report on progress from the Phase 1 portion of the clinical trial in the second half of 2022.
Anticipated Milestones

Gavo-cel:

Present the expanded Phase 1 dataset for gavo-cel in July 2022.
Provide an update from the Phase 2 portion of the ongoing gavo-cel Phase 1/2 clinical trial in the second half of 2022.
TC-510:

Report initial safety, efficacy and translational data from at least one of the Phase 1 dose escalation cohorts of the TC-510 Phase 1/2 clinical trial in the second half of 2022.
Pipeline:

Initiate IND-enabling studies for TC-520, an enhanced CD70 targeting TRuC-T cell program, in 2022.
Select a lead candidate for its allogeneic program in 2022.
Manufacturing:

Production of clinical trial material to commence at ElevateBio BaseCamp as capacity is increased in anticipation of demand from the Phase 2 expansion trial of gavo-cel in 2022.
Financial Highlights

Cash Position: TCR² ended the first quarter of 2022 with $232.2 million in cash, cash equivalents, and investments compared to $265.6 million as of December 31, 2021. Net cash used in operations was $31.1 million for the first quarter of 2022 compared to $23.9 million for the first quarter of 2021. TCR² projects net cash use of $115-125 million for 2022, the lower end of the range previously provided. We expect cash on hand to support operations into 2024.
R&D Expenses: Research and development expenses were $22.9 million for the first quarter of 2022 compared to $15.9 million for the first quarter of 2021. The increase in R&D expenses was primarily due to an increase in headcount, clinical trial expenses associated with patient treatment and manufacturing, and manufacturing facilities expenses.
G&A Expenses: General and administrative expenses were $6.3 million for the first quarter of 2022 compared to $5.7 million for the first quarter of 2021. The increase in general and administrative expenses was due to an increase in personnel costs and other professional fees.
Net Loss: Net loss was $29.1 million for the first quarter of 2022 compared to $21.5 million for the first quarter of 2021.
Upcoming Events

TCR² Therapeutics management is scheduled to participate at the following upcoming conferences.

H.C. Wainwright Global Investment Conference: Garry Menzel, President and Chief Executive Officer of TCR² Therapeutics, will present an update on Company progress on Tuesday, May 24, 2022 at 7:00am ET

On May 12, 2022 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") and machine learning (ML) platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that it will host a virtual key opinion leader (KOL) webinar on May 26th, 2022 at 12:00 p.m. ET (Press release, Lantern Pharma, MAY 12, 2022, View Source [SID1234614382]). The webinar will focus on glioblastoma multiforme (GBM) and the potential of Lantern’s drug candidate LP-184 for GBM as well as other brain cancers.

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The webcast will feature discussions by two leading experts in GBM and brain cancer treatment and research: John Laterra, M.D., Ph.D. and Matthias Holdhoff, M.D., Ph.D. They will be accompanied by Lantern’s Chief Scientific Officer, Kishor Bhatia, Ph.D. who will describe the clinical development plans for LP-184 as well as the mechanisms targeted by LP-184 in GBM and other brain cancers. Following their discussion, there will be a live question and answer session with Dr. Bhatia.

Virtual KOL Webinar Details:

Thursday, May 26th, 2022 at 12:00 p.m. – 1:00 p.m. ET
To register for the webinar, please use the link below:
View Source
A replay of the webinar will be available on Lantern’s website beginning on May 27th: www.lanternpharma.com
About Brain Cancer Awareness Month:
This KOL webinar will be hosted during Brain Tumor Awareness Month, which is also known as "Gray May". This month is meant to bring support and awareness to the estimated 700,000 people in the US living with primary brain tumors and to their families and caregivers. Patients with primary brain tumors have a low 5-year survival rate of only 35.6% and have limited treatment options due to the lack of effective drugs that can cross the blood brain barrier. For more information, please visit the Brain Tumor Awareness month website.

GBM is one of the most common types of primary brain tumors with an estimated 13,000 people in the US diagnosed each year. Patients with GBM have a very poor prognosis with a median overall survival of 24 months. The low survival rate of patients with GBM is in part due to the lack of effective new therapies that can cross the blood brain barrier (BBB) and there is an urgent and unmet clinical need for new therapies. In preclinical studies, Lantern’s drug candidate, LP-184, has shown potency against unmethylated and methylated types of GBM as well as the ability to cross the BBB.

About Dr. John Laterra
Dr. Laterra is an internationally recognized researcher in neurology, oncology, and neuroscience. He serves as the Director of the Brain Cancer Program and the Director of the Division of Neuro-Oncology at Johns Hopkins School of Medicine where he specializes in investigating mechanisms of brain tumor malignancy, tumor vascular biology, and identification of new therapeutic targets in gliomas. Dr. Laterra received his Ph.D. in microbiology and M.D. from Case Western Reserve University. He served as a resident and chief resident in neurology at the University of Michigan at Ann Arbor. Dr. Latera joined Johns Hopkins and the Kennedy Krieger Institute in 1988.

About Dr. Mattias Holdhoff:
Dr. Holdhoff is a medical neuro-oncologist in the Brain Cancer Program at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, as well as an associate professor of oncology and neurological surgery at Johns Hopkins University School of Medicine. Dr. Holdhoff’s clinical and research expertise is in primary brain cancers, malignant gliomas, and central nervous system lymphomas. He received his Ph.D. at Charité University Medicine Berlin and his M.D. from Freie Universität Berlin. Dr. Holdhoff completed his residency in internal medicine at Johns Hopkins Bayview Medical Center, followed by a fellowship in medical oncology at Johns Hopkins Hospital.

On May 12, 2022 Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, reported financial results for the quarter ended March 31, 2022 and provided recent business highlights (Press release, Shattuck Labs, MAY 12, 2022, View Source [SID1234614381]).

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"We are now completing the monotherapy dose-escalation study for SL-172154 in ovarian cancer patients and are focused on the initiation and rapid clinical execution of multiple combination studies in both hematologic and solid tumors. This expansion is a critical step in establishing SL-172154 as both a first- and best-in-class CD47 inhibitor and CD40 agonist, and we continue to expect SL-172154 to differentiate from other CD47 inhibitors and CD40 agonists in terms of safety, pharmacodynamic activity, and efficacy in combinations. The next 18 months are shaping up to be a defining period for establishing CD47 inhibition as a key macrophage checkpoint in multiple indications, and we look forward to providing initial combination data from SL-172154 in the first half of 2023," said Taylor Schreiber, M.D., Ph.D., and Chief Executive Officer of Shattuck.

First Quarter 2022 Recent Business Highlights and Other Recent Developments

ARC Clinical-Stage Pipeline and Preclinical Pipeline

SL-172154 (SIRPα-Fc-CD40L)

Continued Enrollment of SL-172154 Phase 1A Dose-Escalation Clinical Trial in Platinum-Resistant Ovarian Cancer: This open-label, multi-center, dose-escalation clinical trial is evaluating the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of SL-172154 administered intravenously in patients with platinum resistant ovarian cancer. Full dose-escalation data from the trial are expected in the first half of 2023.
Phase 1B Clinical Trial of SL-172154 in Combination with Liposomal Doxorubicin Expected to Begin in the Second Half of 2022: This clinical trial will evaluate the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamics effects of SL-172154 in combination with liposomal doxorubicin in patients with advanced, platinum-resistant ovarian cancer and is anticipated to begin enrollment in the second half of 2022. Initial combination data from the trial are expected in the first half of 2023. Additional combination trials with SL-172154 in ovarian cancer and novel agents are currently being planned.
Enrollment Continues in SL-172154 Phase 1A/B Clinical Trial in Acute Myeloid Leukemia (AML) and Higher-Risk Myelodysplastic Syndromes (HR-MDS): The trial is evaluating the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of SL-172154, as both monotherapy and in combination. In both HR-MDS and TP53 mutant AML, SL-172154 will be combined with azacitidine. In AML, SL-172154 will be evaluated in combination with both azacitidine and venetoclax. Initial data from the monotherapy and combination dose escalation portions of the trial are expected in the first half of 2023.
Data for Intratumorally Administered SL-172154 Phase 1 Clinical Trial in Squamous Cell Carcinoma of the Head and Neck or Skin to be Presented in the Second Half of 2022: Shattuck anticipates presenting data from the clinical trial in the second half of 2022. Shattuck may continue further development of SL-172154 in squamous cell carcinoma of the head and neck (HNSCC) or skin (CSCC) via intravenous administration following selection of a recommended Phase 2 dose in ovarian cancer.
SL-279252 (PD1-Fc-OX40L)

Continued Enrollment of SL-279252 Phase 1 Dose-Escalation Clinical Trial in Advanced Solid Tumors: Enrollment of patients with primarily PD-L1 selected tumors continues in the Phase 1 open-label, multi-center, dose-escalation clinical trial to evaluate the safety, tolerability, pharmacokinetics, anti-tumor activity and pharmacodynamic effects of SL-279252 in patients with advanced solid tumors and lymphoma. Top-line data from all treated subjects across the full dose range are anticipated in the second half of 2022.
Preclinical

Presented Preclinical Data on SL-9258 at AACR (Free AACR Whitepaper) in April: Preclinical data for SL-9258 (TIGIT-Fc-LIGHT), a dual TIGIT inhibitor and HVEM/LTβR agonist, were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (AACR) (Free AACR Whitepaper) in April 2022. These data, from studies in a mouse model, provided preclinical evidence for anti-tumor activity of the murine equivalent of SL-9258 in PD-1 acquired resistant tumors and increased tumor rejection in comparison to TIGIT blocking antibodies. In these preclinical models, TIGIT-Fc-LIGHT outperformed TIGIT blocking antibodies independent of PD-L1 or DNAM-1 (CD226) expression. TIGIT-Fc-LIGHT was also evaluated and well tolerated in non-human primates and observed similar on-target pharmacodynamic activity to what was characterized in the mouse model. Together, these results suggest that TIGIT-Fc-LIGHT may provide clinical benefit to patients that are refractory to conventional checkpoint blockade therapy.
Presented Preclinical Data at AACR (Free AACR Whitepaper) on GADLEN Platform: Shattuck also presented preclinical data highlighting the potential of GADLENs to direct gamma delta T cells to kill tumor cells and, in the process, further elucidate tumor cell markers which are important for the therapeutic activity of gamma delta T cell-based therapies. Butyrophilin heterodimeric fusion proteins from Shattuck’s GADLEN platform showed enhanced tumor cell killing targeting CD19 and CD20 and demonstrated preclinical proof of concept in the treatment of cancer.
Clinical Pipeline Product Candidate to be Selected in 2022: As Shattuck looks to advance its preclinical pipeline, a new product candidate from the ARC or GADLEN platform is anticipated to be selected in the second half of 2022.
Upcoming Events

H.C. Wainwright 2022 Global Investment Conference

Management will participate in investor one-on-one meetings and give a corporate presentation during the H.C. Wainwright 2022 Global Investment Conference from May 24-26, 2022. A live and archived audio webcast of the presentation will be available by visiting the Events & Presentations section of the Company’s website.

First Quarter 2022 Financial Results

Cash Position: As of March 31, 2022, cash and cash equivalents and short-term investments were $239.2 million, as compared to $321.2 million as of March 31, 2021.
Research and Development (R&D) Expenses: R&D expenses were $19.2 million for the quarter ended March 31, 2022, as compared to $10.3 million for the quarter ended March 31, 2021. This increase was primarily driven by increases in process development costs and manufacturing of trial materials and personnel-related costs.
General and Administrative (G&A) Expenses: G&A expenses were $5.0 million for the quarter ended March 31, 2022, as compared to $4.4 million for the quarter ended March 31, 2021. This increase was primarily driven by increases in compensation related and other operating costs.
Net Income/Loss: Net loss was $24.5 million for the quarter ended March 31, 2022, or $0.58 per basic and diluted share, as compared to a net loss of $11.8 million for the quarter ended March 31, 2021, or $0.28 per basic and diluted share.
2022 Financial Guidance

Shattuck believes its cash and cash equivalents and short-term investments will be sufficient to fund its operations into the second half of 2024, beyond results from its Phase 1 clinical trials of SL-172154 and SL-279252. This cash runway guidance is based on the Company’s current operational plans and excludes any additional funding that may be received or business development or additional clinical development activities that may be undertaken.

About SL-172154

SL-172154 (SIRPα-Fc-CD40L) is an investigational ARC fusion protein designed to simultaneously inhibit the CD47/SIRPα checkpoint interaction and activate the CD40 costimulatory receptor to bolster an anti-tumor immune response in patients with advanced cancer. Two Phase 1 clinical trials are ongoing, the first for patients with advanced and platinum resistant ovarian cancer (NCT04406623) and the second for patients with AML and HR-MDS (NCT05275439).

About SL-279252

SL-279252 (PD1-Fc-OX40L) is an investigational ARC fusion protein designed to simultaneously inhibit the PD-1/PD-L1 interaction and activate the OX40 receptor in patients with advanced cancers. A Phase 1 trial in patients with solid tumors and lymphoma is ongoing (NCT03894618).

On May 12, 2022 Bio-Techne Corporation (NASDAQ: TECH) and Nonagen Bioscience reported an agreement for R&D Systems, a Bio-Techne brand, to exclusively manufacture Nonagen Bioscience’s Oncuria bladder cancer diagnostic panel using xMAP Luminex technology (Press release, Bio-Techne, MAY 12, 2022, View Source [SID1234614380]).

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Oncuria is the first-of-its-kind multiplex protein-based urine test to provide early and accurate detection, therapy choice, and disease monitoring of bladder cancer. The Luminex-based multiplex assay panel combines Bio-Techne’s high-quality reagents and over 40 years of industry-leading immunoassay experience with Nonagen’s diagnostic expertise to create a powerful solution to advance bladder cancer treatment strategies. The partnership demonstrates Bio-Techne’s commitment to supporting laboratory developed tests (LDTs) to bring clinical diagnostic tools to the market.

Nonagen Bioscience and Bio-Techne are targeting the last quarter of calendar 2022 to make Oncuria available as an LDT.

The US Food and Drug Administration (FDA) granted Oncuria a Breakthrough Device Designation in September 2021, for predicting response to Bacillus Calmette-Guérin (BCG) therapy, a first-line treatment for bladder cancer. The designation enables close collaboration with, and expedited review of the assay by the FDA. It also provides formal acknowledgement of Oncuria’s utility and potential clinical benefit.

"We’re excited to partner with Bio-Techne to make Oncuria available as a laboratory developed test (LDT), given their extensive biomarker discovery expertise," said Nonagen Bioscience CEO Charles Joel Rosser, MD, MBA. "Bio-Techne also shares our passion for translating research discoveries into innovative diagnostics, to improve the detection and management of cancer."

"We look forward to working with Nonagen to develop this game-changing immunoassay in the fight against bladder cancer," said Will Geist, President of Bio-Techne’s Protein Sciences division. "Nonagen’s deep experience in diagnostic and testing research is complementary to Bio-Techne’s extensive immunoassay expertise and world-class manufacturing capabilities, creating an ideal partnership for this important bladder cancer detection assay."

About Bladder Cancer
As the 6th most common cancer in the United States1 and a highly recurrent disease, bladder cancer is a major health concern that places an immense burden on healthcare systems. Up to 77% of early-stage bladder tumors that are treated with current approaches (tumor resection and/or intravesical BCG or chemotherapy) will recur.2 More than half of patients who receive BCG therapy as the first-line treatment for bladder cancer will fail to respond. In addition, in 20% of patients, the disease grows and extends during or after BCG therapy.3,4

This is where the exceptional sensitivity and rapid biomarker quantification capabilities of the Oncuria diagnostic assay are poised to play a vital role. The ability to quickly and accurately detect the presence of bladder cancer and monitor disease activity can help improve patient outcomes.

On May 12, 2022 Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company developing medicines for metabolic and immunological diseases through its proprietary approach to synthetic biology, reported financial results for the first quarter ended March 31, 2022 and provided an update on pipeline programs (Press release, Synlogic, MAY 12, 2022, View Source [SID1234614379]).

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"We are pleased to share this progress as we seek to advance our novel phenylketonuria (PKU) program towards Phase 3 initiation," said Synlogic President and Chief Executive Officer Aoife Brennan, M.B. Ch.B. "We believe that we have a unique opportunity to advance a potential treatment for the 55,000 people around the globe with PKU, of whom more than 75% remain in need of additional treatment options – either monotherapy or adjunctive. We are pleased with the progress across our additional programs with expected milestones in 2022, including our homocystinuria (HCU) and enteric hyperoxaluria programs, as well as research progress including our ongoing collaborations with Ginkgo Bioworks and Roche."

Anticipated Upcoming Milestones

Report additional Phase 2 data and final candidate selection for PKU program in H2 2022

Initiate the Phase 3 trial for the PKU program in H1 2023 with Phase 3 readiness activities currently underway

Share data from the Phase 1 trial in healthy volunteers for SYNB1353 in H2 2022

Share proof of concept data for SYNB8802 for enteric hyperoxaluria in H2 2022
Recent Business Highlights

Michael Jensen joined Synlogic as CFO in March 2022

Participation and data presentations at scientific congresses described below:

PKU and HCU program data were presented at inborn errors of metabolism congresses including the Society for Inherited Metabolic Disorders (SIMD) Annual Meeting, the Genetic Metabolic Dietitians International (GMDI) 2022 Conference, and the Garrod Symposium 2022

From Synlogic’s Research team, five different programs were represented at the 2022 Synthetic Biology: Engineering, Evolution & Design (SEED) Conference covering preclinical and clinical work in PKU, HCU, enteric hyperoxaluria, inflammatory bowel disease (IBD), and gout

From Process Development & Manufacturing Sciences (PDMS) at Synlogic, a presentation at the 2022 18th Annual Protein Engineering & Cell Therapy Summit (PEGS) Boston Conference & Expo
First Quarter 2022 Financial Results

As of March 31, 2022, Synlogic had cash, cash equivalents and short-term investments of $120.5 million.

Revenue was $0.2 million for the three months ended March 31, 2022. Revenue in 2022 was associated with the ongoing research collaboration with Roche for the discovery of a novel Synthetic Biotic for the treatment of IBD. There was no revenue for the three months ended March 31, 2021.

For the three months ended March 31, 2022, Synlogic reported a consolidated net loss of $15.7 million, or $0.22 per share, compared to a consolidated net loss of $15.0 million, or $0.36 per share, for the corresponding period in 2021.

Research and development expenses were $11.7 million for the three months ended March 31, 2022 compared to $11.2 million for the corresponding period in 2021.

General and administrative expenses were $4.3 million for the three months ended March 31, 2022 compared to $3.9 million for the corresponding period in 2021.

Financial Outlook

Based upon its current operating plan and balance sheet as of March 31, 2022, Synlogic expects to have sufficient cash to be able to fund operations into 2024.

Investor & Industry Conference Participation

Synlogic will participate in the following upcoming investor and industry conferences:

RBC Capital Markets Global Healthcare Conference. Dr. Brennan will provide a Company presentation on Wednesday, May 18, 2022 at 8:30 am ET during the RBC Capital Markets Global Healthcare Conference to be held in New York City from May 17-18, 2022.

The H.C. Wainwright Global Investment Conference. Chief Financial Officer Michael Jensen and Chief Business Officer Molly Harper will provide a company presentation on Wednesday, May 25, 2022 at 10:30 am ET during the H.C. Wainwright Global Investment Conference taking place from May 23- 26, 2022 in Miami, Florida.

BIO International Convention. Synlogic will participate in the BIO International Convention taking place from June 13-16, 2022 in San Diego, California, including a company presentation by Ms. Harper.
Live webcasts of the presentations, if available, will be accessible under the "Event Calendar" in the Investors & Media section of the Synlogic website. Archived versions will be available afterwards at the same location.

Conference Call & Webcast Information

Synlogic will host a conference call and live webcast at 8:30 a.m. ET today, May 12, 2022. To access the live webcast, please visit the "Event Calendar" page within the Investors and Media section of the Synlogic website. Investors may listen to the call by dialing +1 (844) 815-2882 from locations in the United States or (213) 660-0926 from outside the United States. The conference ID number is 5149412. A replay will be available for 30 days on the Investors and Media section of the Synlogic website.