On May 5, 2022 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported its financial results for the first quarter ended March 31, 2022 and provided business updates (Press release, Curis, MAY 5, 2022, View Source [SID1234613647]).

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"During the first quarter of 2022, we continued to advance the clinical trials of emavusertib, previously referred to as CA-4948, our first-in-class, small molecule IRAK4 inhibitor in nine distinct patient populations across AML, MDS and B cell cancers. In January, we provided additional preliminary data showing early anti-cancer activity of emavusertib in AML/MDS patients with spliceosome or FLT3 mutation. In addition, we presented initial data from the dose escalation study of CI-8993, a monoclonal antibody targeting VISTA, in patients with relapsed/refractory solid tumors. We also would highlight that we have cleared the 0.3mg/kg dose level, which we believe is an important initial safety hurdle," said James Dentzer, President and Chief Executive Officer of Curis.

"Shortly after the close of the first quarter, our two TakeAim studies were put on partial clinical hold by the U.S. Food and Drug Administration ("FDA") as the agency is seeking additional data relating to emavusertib, including data related to rhabdomyolysis and our determination of the Recommended Phase 2 Dose. We are working collaboratively with the FDA and hope to resolve the partial hold on our studies quickly," continued Mr. Dentzer. "As we gain clarity on the timing of this resolution, we will provide updated guidance on our plan to discuss the potential for a rapid registrational path for emavusertib with the FDA."

First Quarter 2022 and Recent Operational Highlights

Precision oncology, emavusertib (IRAK4 Inhibitor; Aurigene collaboration):

In January, the company hosted a conference call detailing updated data from the TakeAim Leukemia study.
The TakeAim Leukemia study is a Phase 1/2 dose escalation, dose expansion study examining emavusertib use as both monotherapy and in combination with azacitidine or venetoclax in patients with relapsed or refractory ("R/R") acute myeloid leukemia ("AML") or R/R high risk myelodysplastic syndrome ("MDS").
In patients with spliceosome-mutated R/R AML, key findings included:
CR/CRh rate of 40% (2 out of 5 patients)
Both patients who achieved CR/CRh have been on study > 6 months and achieved negative MRD (minimal residual disease) status
Consistent tumor burden reduction observed, 3 out of 5 patients with elevated blast counts achieving ≥ 50% reduction in blast counts
In patients with spliceosome-mutated R/R MDS, key findings included:
Objective response rate of 57% (4 out of 7 patients)
One of the patients who achieved a marrow CR ("mCR") proceeded to stem cell transplant after 1 cycle
Consistent tumor burden reduction observed, with 4 out of 6 patients with elevated baseline blast counts achieving ≥ 50% reduction in blast counts
In patients with a FLT3 mutated R/R AML, key findings included:
CR rate of 33% (1 out of 3 patients; this patient’s AML also had a spliceosome mutation)
2 out of 3 patients showed eradication of FLT3 mutation following treatment, indicating potential for disease modification with emavusertib
Consistent tumor burden reduction observed; with 2 out of 3 patients with elevated blast counts achieving ≥ 50% reduction in blast counts
Curis collaborators at the Washington University School of Medicine in St. Louis, published research suggesting the potential use of emavusertib in solid tumors, such as pancreatic cancer, a setting with very limited therapeutic options.
The manuscript titled "IRAK4 signaling drives resistance to checkpoint immunotherapy in pancreatic ductal adenocarcinoma" concluded that tumor IRAK4 drives T-cell exhaustion in pancreatic nonclinical ductal adenocarcinoma models and is a promising therapeutic target when combined with checkpoint immunotherapy.
The manuscript is available online at View Source(22)00201-3/pdf.
Immuno-oncology, CI-8993 (anti-VISTA antibody; ImmuNext collaboration):

Also discussed during the January update call were data from the Phase 1 study of CI-8993, Curis’s first-in-class monoclonal anti-VISTA antibody, in patients with R/R solid tumors.
Dose escalation has proceeded to the 0.6mg/kg dose level, past the 0.15mg/kg dose level where toxicities were seen previously, namely cytokine release syndrome, or CRS. Dose escalation will continue until the Recommended Phase 2 Dose ("RP2D") has been determined
Pharmacodynamic data suggest CI-8993 has multiple anticancer mechanisms that may position it for combination with existing checkpoint inhibitors, in addition to monotherapy
Presentations at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting

Curis Presentations

TakeAim Lymphoma
Abstract Number: 7575
Abstract Title: Open-label, dose-escalation, and expansion trial of CA-4948 in combination with ibrutinib in patients with relapsed or refractory hematologic malignancies.
Session Type/Title: Poster Session/ Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Session Date and Time: Saturday, June 4, 2022, 8:00 AM-11:00 AM CDT
TakeAim Leukemia
Abstract Number: 7016
Abstract Title: Phase 1/2a study of the IRAK4 inhibitor CA-4948 as monotherapy or in combination with azacitidine or venetoclax in patients with relapsed/refractory (R/R) acute myeloid leukemia or myelodysplastic syndrome.
Session Type/Title: Poster Discussion Session/ Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Session Date and Time: Saturday, June 4, 2022, 1:15 PM-2:45 PM; 8:00 AM-11:00 AM CDT
Collaborator Presentations

Gastric and Esophageal Cancer
Abstract Number: TPS4168
Abstract Title: Phase I trial of CA-4948, an IRAK4 inhibitor, in combination with FOLFOX/PD-1 inhibitor +/- trastuzumab for untreated unresectable gastric and esophageal cancer
Session Type/Title: Poster Session/Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date and Time: Saturday, June 4, 2022, 8:00 AM-11:00 AM CDT
Melanoma Brain Metastases
Abstract Number: 2011
Abstract Title: CA-4948 for the treatment of melanoma brain metastasis.
Session Type/Title: Poster Discussion Session/ Central Nervous System Tumors
Session Date and Time: Sunday, June 5, 2022, 11:30 AM-1:00 PM; 8:00 AM-11:00 AM CDT
Upcoming Planned Milestones for 2022

Report data from the TakeAim Lymphoma study
In the first half of 2022, we plan to present new data for approximately 12 patients who have received treatment with the combination of emavusertib and ibrutinib at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") and European Hematology Association (EHA) (Free EHA Whitepaper) ("EHA") meetings in June 2022
Report data from the TakeAim Leukemia study
In the first half of 2022, we plan to present the monotherapy data released on our January update call in a peer-reviewed setting at the ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) conferences
In the second half of 2022, we plan to present an update with additional monotherapy data
In the second half of 2022, we plan to present initial data for the study of emavusertib in combination with azacitadine or venetoclax
Report data from the CI-8993 (VISTA checkpoint inhibitor) study
In the second half of 2022, we plan to present an update with additional monotherapy data
First Quarter 2022 Financial Results

For the first quarter of 2022, Curis reported a net loss of $16.1 million or $0.18 per share on both a basic and diluted basis, as compared to a net loss of $9.9 million, or $0.11 per share on both a basic and diluted basis for the same period in 2021.

Revenues for the first quarter of 2022 and 2021 were $2.1 million and $2.2 million, respectively. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge.

Operating expenses for the first quarter of 2022 were $17.2 million, as compared to $11.0 million for the same period in 2021, and comprised the following:

Cost of Royalty Revenues. Cost of royalty revenues, represents amounts due to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, were $0.1 million for the first quarter of 2022 and 2021.

Research and Development Expenses. Research and development expenses were $11.4 million for the first quarter of 2022 as compared to $6.8 million for the same period in 2021. The increase in direct research and development expenses for the quarter is primarily attributable to increased manufacturing costs for our programs and increased consulting services. Additionally, personnel related costs increased by $2.4 million and stock compensation increased $0.4 million, primarily as a result of additional headcount.

General and Administrative Expenses. General and administrative expenses were $5.7 million for the first quarter of 2022, as compared to $4.1 million for the same period in 2021. The increase in general and administrative expense was driven primarily by higher costs for personnel, stock-based compensation, and insurance costs.

Other Expense, Net. For the third quarter of 2022 and 2021, net other expense was $1.0 million and $1.1 million, respectively. Net other expense primarily consisted of imputed interest expense related to future royalty payments.

As of March 31, 2022, Curis’s cash, cash equivalents and investments totaled $120.7 million, and there were approximately 91.6 million shares of common stock outstanding. Curis expects that its existing cash, cash equivalents and investments should enable it to maintain its planned operations into 2024.

Conference Call Information

Curis management will host a conference call today, May 5, 2022, at 4:30 p.m. ET, to discuss these financial results, as well as provide a corporate update.

To access the live conference call, please dial 1-888-346-6389 from the United States or 1-412-317-5252 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed on the Curis website at www.curis.com in the Investors section.

On May 5, 2022 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated oncology therapeutics, reported first quarter 2022 financial results and provided a business update (Press release, CytomX Therapeutics, MAY 5, 2022, View Source [SID1234613662]).

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"The CytomX team continued to execute across our portfolio during the first quarter of 2022, including significant progress with patient enrollment in our most advanced clinical studies. Initial data readouts for both Arms A and B for praluzatamab ravtansine and a data update for CX-2029 remain on track for the second half of this year. Beyond these important milestones, we are also advancing many new experimental therapeutics, including our conditionally activated version of interferon alpha-2b, which was detailed in a presentation at the recent American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The breadth of our clinical and preclinical pipeline continues to demonstrate the multi-modality potential of our technology platform to deliver important new treatments for cancer," said Sean McCarthy, D.Phil., chief executive officer and chairman at CytomX Therapeutics.

First Quarter Business Highlights and Recent Developments

Praluzatamab ravtansine – Praluzatamab ravtansine is a CD166-directed conditionally activated antibody-drug conjugate (ADC) wholly-owned by CytomX. The three-arm Phase 2 study is evaluating praluzatamab ravtansine as monotherapy in patients with hormone receptor-positive, human epidermal growth factor receptor 2-non-amplified breast cancer (Arm A) and in patients with triple-negative breast cancer (TNBC, Arm B), and in combination with pacmilimab, our PD-L1 directed Probody therapeutic, in patients with TNBC (Arm C). Enrollment to Arm A is complete.
CX-2029 – CX-2029 is a CD71-directed conditionally activated ADC being co-developed by CytomX and AbbVie. In addition to head and neck squamous cell carcinoma, the Phase 2 expansion study has now also completed patient enrollment in the squamous non-small cell lung cancer cohort. The study remained open for enrollment in the esophageal and gastro-esophageal junction cancers cohort, and the diffuse large B-cell lymphoma cohort.
CX-904 – CX-904 is a conditionally activated T-cell-engaging bispecific antibody targeting the epidermal growth factor receptor (EGFR) on tumor cells and the CD3 receptor on T cells, and is partnered with Amgen. The investigational new drug application for a first-in-human Phase 1 study of CX-904 in patients with advanced solid tumors was allowed to proceed by the U.S. Food and Drug Administration and study start-up activities were initiated.
Ipilimumab Probody Program – BMS-986249 and BMS-986288 are Probody versions of the anti-CTLA4 antibody, ipilimumab and non-fucosylated ipilimumab, respectively. BMS-986249 is currently being evaluated by CytomX’s collaboration partner, Bristol Myers Squibb, in a randomized Phase 2 study in combination with nivolumab, the anti-PD-1 antibody, versus ipilimumab plus nivolumab in patients newly diagnosed with advanced melanoma. This novel combination is also being studied in advanced hepatocellular carcinoma, castration-resistant prostate cancer, and TNBC. Bristol Myers Squibb also continued to evaluate BMS-986288, as monotherapy and in combination with nivolumab, in a Phase 1 study in advanced solid tumors.
Preclinical Programs – CytomX continued to work on broadening the potential application of its multi-modality Probody platform to other product candidates, including a broad initiative towards enhancing the therapeutic window of cytokines. At the 2022 AACR (Free AACR Whitepaper) Annual Meeting, CytomX presented encouraging preclinical data that highlighted a conditionally activated interferon alpha-2b therapeutic candidate as a promising addition to current immunotherapy regimens, potentially expanding benefit to patients with typically unresponsive tumors.
Priorities for 2022

Continue enrolling patients with TNBC in Arms B and C in the Phase 2 study of praluzatamab ravtansine and report initial data from Arms A and B in the second half of 2022
Continue advancing the expansion phase of the Phase 2 study of CX-2029 in collaboration with our partner AbbVie and provide a data update in the second half of 2022
Advance the Phase 1 study of CX-904 in solid tumors
First Quarter 2022 Financial Results
Cash, cash equivalents and investments totaled $263 million as of March 31, 2022, compared to $305 million as of December 31, 2021.

Total revenue was $17.1 million for the three months ended March 31, 2022 compared to $16.0 million for the corresponding period in 2021. The increase in total revenue was largely related to the CD71 collaboration with AbbVie.

Research and development expenses increased by $8.2 million during the three months ended March 31, 2022 to $30.6 million compared to $22.4 million for the first quarter of 2021. The increase was primarily driven by contract and service expenses in manufacturing and development activities in support of our pre-clinical and clinical portfolio.

General and administrative expenses increased by $1.3 million during the first quarter of 2022 to $10.5 million compared to $9.2 million in the same period in 2021. The increase was mainly in personnel and professional expenses.

Conference Call & Webcast Information
CytomX management will host a conference call and a simultaneous webcast today at 5:00 p.m. ET (2:00 p.m. PT) to discuss the financial results and provide a business update. To join the conference call, please dial (877) 809-6037 (domestic) or (615) 247-0221 (international) and reference the conference ID 5241057. A live webcast of the call can be accessed on the Events and Presentations page of CytomX’s website at View Source An archived replay of the webcast will be available on the Company’s website until May 12, 2022.

On May 5, 2022 Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases, reported its first quarter 2022 financial results and provides pipeline updates (Press release, Arbutus Biopharma, MAY 5, 2022, View Source [SID1234613678]).

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"In the first quarter of 2022, we continued to advance our efforts to develop a functional cure for hepatitis B and to develop novel treatment options for coronavirus infections, including SARS-CoV-2," said William Collier, Arbutus’ President and Chief Executive Officer. "We are on-track to achieve our goal of reporting data later this year from four clinical trials with chronically infected HBV patients being treated with either AB-729, our RNAi therapeutic, or AB-836, our next generation oral capsid inhibitor. Furthermore, our IND-enabling studies with our oral PD-L1 inhibitor, AB-101, and our oral RNA destabilizer, AB-161, are moving forward and we expect these to be completed in the second half of 2022. Additionally, we have had seven abstracts accepted at the EASL International Liver Congress, which include some of these data."

Mr. Collier continued, "With respect to our research efforts to develop a nsp5 main protease (Mpro) and nsp12 viral polymerase for SARS-CoV-2 and future coronavirus outbreaks, we are on-track to initiate IND-enabling studies for a nsp5 Mpro candidate later this year. Lead optimization activities are continuing for a nsp12 viral polymerase candidate. Financially, we are well-positioned to continue advancing all our current clinical programs through important data milestones with a projected cash runway into the second quarter of 2024."

Anticipated Milestones in 2022:

Dose first patient in the AB-729-202 Phase 2a clinical trial evaluating AB-729, in combination with VTP-300, Vaccitech plc’s (Vaccitech) therapeutic vaccine and nucleos(t)ide analogue therapy (NA), in cHBV patients in the first half of 2022.
Present new on-treatment data as well as long-term off-treatment data for cHBV patients in the AB-729-001 clinical trial at a medical conference later this year.
Report initial data from the AB-729-201 Phase 2a clinical trial evaluating AB-729 in combination with ongoing NA therapy and short courses of PEG-IFNα-2a in cHBV patients in the second half of 2022.
Report initial data from the Phase 2a clinical trial evaluating AB-729 in combination with vebicorvir (VBR), Assembly Biosciences, Inc.’s (Assembly) lead HBV core inhibitor (capsid inhibitor), and an NA in cHBV patients in the second half of 2022.
Report data set from the AB-836-001 clinical trial evaluating multiple doses of AB-836 in cHBV patients in the first half of 2022.
Complete IND-enabling studies for two oral compounds (PD-L1 inhibitor, AB-101 and RNA destabilizer, AB-161) to treat HBV in the second half of 2022.
Advance an oral compound that inhibits the SARS-CoV-2 nsp5 main protease into IND enabling studies in the second half of 2022.
Continue to explore a potential oncology indication with our oral PD-L1 program.
Financial Results

Cash, Cash Equivalents and Investments

As of March 31, 2022, the Company had cash, cash equivalents and investments in marketable securities of $221.8 million, as compared to $191.0 million as of December 31, 2021.

During the three months ended March 31, 2022, the Company received a $40.0 million (net of withholding taxes) upfront payment from Qilu Pharmaceutical Co., Ltd. ("Qilu") related to a technology transfer and license agreement for AB-729 in greater China, $15.0 million of gross proceeds from Qilu’s equity investment and $0.3 million of net proceeds from the issuance of common shares under Arbutus’s "at-the-market" offering program. These cash inflows were partially offset by $23.4 million of cash used in operations. The Company expects a net cash burn between $90 to $95 million in 2022, not including the $55 million of proceeds received from Qilu, and believes its cash runway will be sufficient to fund operations into the second quarter of 2024.

Revenue

Revenues were $12.6 million for the three months ended March 31, 2022 compared to $2.1 million for the same period in 2021. The increase of $10.5 million was due primarily to $9.6 million of revenue recognition from the Company’s license agreement with Qilu based on employee labor hours expended by the Company during the first quarter of 2022 to perform its manufacturing obligations under the license agreement.

Net Loss

For the three months ended March 31, 2022, the Company’s net loss attributable to common shares was $15.8 million, or a loss of $0.11 per basic and diluted common share, as compared to a net loss attributable to common shares of $19.6 million, or a loss of $0.21 per basic and diluted common share, for the three months ended March 31, 2021. Net loss attributable to common shares for the three months ended March 31, 2021 included $3.2 million of non-cash expense for the accrual coupon on the Company’s convertible preferred shares, which converted into 22.8 million common shares in October 2021.

Operating Expenses

Research and development expenses were $18.5 million for the three months ended March 31, 2022 compared to $13.8 million for the same period in 2021. The increase of $4.7 million was due primarily to an increase in expenses related to the Company’s multiple, ongoing AB-729 Phase 2a clinical trials, including its collaborations with Assembly and Vaccitech, an increase in expenses for its ongoing AB-836-001 clinical trial, and an increase in expenses for its early stage development programs, including AB-101 and AB-161. General and administrative expenses were $4.9 million for the three months ended March 31, 2022 compared to $3.9 million for the same period in 2021. This increase was due primarily to increases in professional fees, employee compensation and non-cash stock-based compensation expense.

Outstanding Shares

As of March 31, 2022, the Company had approximately 148.7 million common shares issued and outstanding, as well as approximately 15.7 million stock options outstanding. Roivant Sciences Ltd. owned approximately 26% of the Company’s outstanding common shares as of March 31, 2022.

COVID-19 Impact

The COVID-19 pandemic has resulted in and will likely continue to result in significant disruptions to businesses. Measures implemented around the world in attempts to slow the spread of COVID-19 have had, and will likely continue to have, a major impact on clinical development, at least in the near-term, including shortages and delays in the supply chain and prohibitions in certain countries on enrolling subjects and patients in new clinical trials. While we have been able to progress with our clinical and pre-clinical activities to date, it is not possible to predict if the COVID-19 pandemic will materially impact our plans and timelines in the future.

On May 5, 2022 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported that it will report its first quarter 2022 financial results on Thursday, May 12, 2022 and will provide a business update (Press release, Altimmune, MAY 5, 2022, View Source [SID1234613694]).

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Altimmune management will host a conference call at 8:30 am E.T. on May 12 to discuss financial results and provide a business update.

On May 5, 2022 -SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, reported that the company will host a live R&D investor event with optional virtual participation on Thursday, May 19, 2022, from 4:05 – 5:30 p.m. ET (Press release, SQZ Biotech, MAY 5, 2022, View Source [SID1234613710]).

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The event will feature presentations on the company’s point-of-care (POC) manufacturing system, currently in internal testing, and its potential impact on cell therapy development. The company will also discuss its first anticipated clinical use in the SQZ TAC clinical development program for celiac disease, which has an FDA investigational new drug application submission planned for the first half of 2023.

Company leadership will also discuss the collaboration with STEMCELL Technologies and the development of a research-use-only Cell Squeeze system.

The event will include a special fireside chat on the present and future state of cell engineering. Speakers include:

Robert S. Langer, Sc.D., Scientific Advisory Board Member and Founder of SQZ Biotechnologies, and David H. Koch Institute Professor at the Massachusetts Institute of Technology
Klavs F. Jensen, Ph.D., Board Member and Founder of SQZ Biotechnologies, and Warren K. Lewis Professor of Chemical Engineering at the Massachusetts Institute of Technology
Armon Sharei, Ph.D., Chief Executive Officer and Founder of SQZ Biotechnologies
Moderated by Mike Huckman, Global Practice Leader, Executive Communications at Real Chemistry, and former CNBC Pharmaceuticals Reporter
Event Details
The company will host a live R&D Investor event with optional virtual participation on Thursday, May 19, 2022, beginning at 4:05 p.m. ET. Onsite and virtual participants can register in advance by completing the registration form on the event website: View Source Following the event, a webcast replay will be made available on the company’s investor website: investors.sqzbiotech.com.