Reata Pharmaceuticals, Inc. Announces Third Quarter 2021 Financial Results and Provides an Update on Clinical Development Programs

On November 8, 2021 Reata Pharmaceuticals, Inc. (Nasdaq: RETA) ("Reata," the "Company," "our," "us," or "we"), a clinical-stage biopharmaceutical company, reported financial results for the quarter ended September 30, 2021, and provided an update on the Company’s business operations and clinical development programs (Press release, Reata Pharmaceuticals, NOV 8, 2021, View Sourcenews/news-details/2021/Reata-Pharmaceuticals-Inc.-Announces-Third-Quarter-2021-Financial-Results-and-Provides-an-Update-on-Clinical-Development-Programs/default.aspx" target="_blank" title="View Sourcenews/news-details/2021/Reata-Pharmaceuticals-Inc.-Announces-Third-Quarter-2021-Financial-Results-and-Provides-an-Update-on-Clinical-Development-Programs/default.aspx" rel="nofollow">View Source [SID1234594737]).

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Recent Company Highlights

Bardoxolone in Patients with CKD Caused by Alport Syndrome

The New Drug Application ("NDA") for bardoxolone methyl ("bardoxolone") for the treatment of patients with chronic kidney disease ("CKD") caused by Alport syndrome is currently under review by the U.S. Food and Drug Administration ("FDA"). An Advisory Committee meeting is scheduled for December 8, 2021, and the Prescription Drug User Fee Act ("PDUFA") date, the FDA action date for the application, is scheduled for February 25, 2022.

We are pursuing marketing approvals outside of the United States. On October 28, 2021, we announced the submission of a Marketing Authorization Application ("MAA") with the European Medicines Agency ("EMA") for marketing approval of bardoxolone for the treatment of CKD caused by Alport syndrome in the European Union.

Bardoxolone in Patients with Autosomal Dominant Polycystic Kidney Disease

FALCON is an international, multi-center, randomized, double-blind, placebo-controlled Phase 3 trial studying the safety and efficacy of bardoxolone in patients with autosomal dominant polycystic kidney disease ("ADPKD") randomized one-to-one to active drug or placebo. We are preparing a protocol amendment following the Type B meeting with the FDA as outlined in our Quarterly Report on Form 10-Q for the second quarter of 2021. We will increase the sample size from 550 to 700 patients. The trial will remain blinded until study completion. The primary endpoint will be the off-treatment estimated glomerular filtration rate ("eGFR") change from baseline versus placebo at Week 104. The key secondary endpoint will be the eGFR change from baseline versus placebo at Week 100. More than 450 patients are currently enrolled in the study, and we expect to complete enrollment by the middle of 2022.

Omaveloxolone in Patients with Friedreich’s Ataxia

On September 30, 2021, we announced that we completed our pre-NDA meeting with the FDA for omaveloxolone for the treatment of patients with Friedreich’s ataxia ("FA"). The purpose of the pre-NDA meeting was to discuss the content of Reata’s planned NDA submission. We are not planning to conduct a second pre-approval clinical study prior to the submission. We are planning to finalize the NDA package for submission during the first quarter of 2022.

Recent Presentations

The following abstracts highlighting results from our various programs in CKD and FA were presented at recent international medical conferences:

David Lynch, MD, PhD, Director, Friedreich’s Ataxia Program, Division of Neurology, Children’s Hospital of Philadelphia, Philadelphia, PA, presented the talk Efficacy of Omaveloxolone in Patients with Friedreich’s Ataxia: Delayed-Start Study at the MDS Virtual Congress of the International Parkinson and Movement Disorder Society, which was held virtually from September 17 – 22, 2021.
An oral presentation was made and six posters highlighting clinical data for bardoxolone and disease education data on Alport syndrome were presented at the American Society of Nephrology Kidney Week 2021 from November 4 – 7, 2021.
Third Quarter Financial Highlights

Cash and Cash Equivalents

At September 30, 2021, we had cash and cash equivalents of $713.2 million. We reaffirm our current cash runway to last through mid-2024.

Collaboration Revenue

Collaboration revenue was $7.4 million in the third quarter of 2021, as compared to $1.4 million for the same period of the year prior.

GAAP and Non-GAAP Research and Development ("R&D") Expenses

R&D expenses according to generally accepted accounting principles in the U.S. ("GAAP") were $39.4 million for the third quarter of 2021, as compared to $37.2 million, for the same period of the year prior.

Non-GAAP R&D expenses were $34.0 million for the third quarter of 2021, as compared to $32.9 million, for the same period of the year prior.1

GAAP and Non-GAAP General and Administrative ("G&A") Expenses

GAAP G&A expenses were $25.7 million for the third quarter of 2021, as compared to $18.3 million, for the same period of the year prior.

Non-GAAP G&A expenses were $17.5 million for the third quarter of 2021, as compared to $11.0 million for the same period of the year prior.1

GAAP and Non-GAAP Net Loss

The GAAP net loss for the third quarter of 2021 was $71.8 million, or $1.97 per share, on both a basic and diluted basis, as compared to a GAAP net loss of $65.5 million, or $1.94 per share, on both a basic and diluted basis, for the same period of the year prior.

The non-GAAP net loss for the third quarter of 2021 was $46.2 million, or $1.27 per share on both a basic and diluted basis, as compared to a non-GAAP net loss of $44.3 million, or $1.31 per share, on both a basic and diluted basis, for the same period of the year prior.1

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1 See "Non-GAAP Financial Measures" below for a description of non-GAAP financial measures and a reconciliation between GAAP and non-GAAP R&D expenses, GAAP and non-GAAP G&A expenses, and GAAP and non-GAAP net loss, respectively, appearing later in the press release.

Non-GAAP Financial Measures

This press release contains non-GAAP financial measures, including non-GAAP R&D expenses, non-GAAP G&A expenses, non-GAAP operating expenses, non-GAAP net loss and non-GAAP net loss per common share – basic and diluted. These measures are not in accordance with, or an alternative to, GAAP, and may be different from non-GAAP financial measures used by other companies.

The Company defines non-GAAP R&D expenses as GAAP R&D expenses, excluding stock-based compensation expense; non-GAAP G&A expenses as GAAP G&A expenses, excluding stock-based compensation expense; non-GAAP operating expenses as GAAP operating expenses, excluding stock-based compensation expense; non-GAAP net loss as GAAP net loss, excluding stock-based compensation expense, non-cash interest expense from liability related to sale of future royalties, loss on extinguishment of debt, and gain on lease termination; and non-GAAP net loss per common share – basic and diluted as GAAP net loss per common share – basic and diluted, excluding stock-based compensation expense, non-cash interest expense from liability related to sale of future royalties, loss on extinguishment of debt and gain on lease termination. The Company has excluded the impact of stock-based compensation expense, which may fluctuate from period to period based on factors including the variability associated with performance-based grants for stock options and restricted stock units and changes in the Company’s stock price, which impacts the fair value of these awards. The Company has excluded the impact of accreted non-cash interest expense from liability related to sale of future royalties as it may be calculated differently from, and therefore may not be comparable to, peer companies who also provide non-GAAP disclosures. The Company has excluded the impact of loss on extinguishment of debt and gain on lease termination as they are non-recurring transactions that make it difficult to compare its results to peer companies who also provide non-GAAP disclosures. The Company has excluded the impact of stock-based compensation expense, non-cash interest expense from liability related to sale of future royalties, loss on extinguishment of debt, and gain on lease termination because the Company believes its impact makes it difficult to compare its results to prior periods and anticipated future periods. Because management believes certain items, such as stock-based compensation expense, non-cash interest expense from liability related to sales of future royalties, loss on extinguishment of debt, and gain on lease termination, can distort the trends associated with the Company’s ongoing performance, the following measures are often provided, excluding special items, and utilized by the Company’s management, analysts, and investors to enhance consistency and comparability of year-over-year results, as well as to industry trends, and to provide a basis for evaluating operating results in future periods: non-GAAP net loss; non-GAAP net loss per common share – basic and diluted; non-GAAP R&D expenses; non-GAAP G&A expenses; and non-GAAP operating expenses.

The Company believes the presentation of these non-GAAP financial measures provides useful information to management and investors regarding the Company’s financial condition and results of operations. When GAAP financial measures are viewed in conjunction with these non-GAAP financial measures, investors are provided with a more meaningful understanding of the Company’s ongoing operating performance and are better able to compare the Company’s performance between periods. In addition, these non-GAAP financial measures are among those indicators the Company uses as a basis for evaluating performance, allocating resources and planning and forecasting future periods. These non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. A reconciliation between these non-GAAP measures and the most directly comparable GAAP measures is provided later in this press release.

Conference Call Information

Reata’s management will host a conference call on November 8, 2021, at 8:30 a.m. ET. The conference call will be accessible by dialing (844)200-6205 (toll-free domestic) or (929)526-1599 (international) using the access code: 052919. The webcast link is View Source

Third quarter financial results to be discussed during the call will be included in an earnings press release that will be available on the Company’s website shortly before the call at View Source and will be available for 12 months after the call. The audio recording and webcast will be accessible for at least 90 days after the event at View Source.

Oncoinvent announces completion of enrollment in the RAD-18-002 phase 1 clinical study

On November 8, 2021 Oncoinvent AS, a clinical stage company advancing a pipeline of radiopharmaceutical products across a variety of solid cancers, reported that it has successfully completed recruitment of the Radspherin RAD-18-002 clinical study (Press release, Oncoinvent, NOV 8, 2021, https://www.oncoinvent.com/press-release/oncoinvent-announces-completion-of-enrollment-in-the-rad-18-002-phase-1-clinical-study/?utm_source=mailpoet&utm_medium=email&utm_campaign=oncoinvent-announces-completion-of-enrollment-in-the-rad-18-002-phase-1-clinical-study_45 [SID1234594736]). All patients enrolled in the study will be followed until disease progression in the abdominal cavity, or for 12 months after the administration of Radspherin whichever comes first. The biodistribution and radiation dosimetry after administration of Radspherin were explored in the six patients included in the expansion phase of the RAD-18-002 study. The dosimetry data will be reported later this year.

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"We are pleased that we did not observe any SAE’s related to the Radspherin, nor did we reach a MTD (maximum tolerated dose) in this phase 1 study." stated Jan A. Alfheim, Oncoinvent CEO. "This indicates that the product is safe to use in combination with cytoreductive surgery and HIPEC (Hyperthermic Intraperitoneal Chemotherapy) in this patient population. We are now busy preparing for the next phase of Radspherin development, in which we will turn our focus on measuring the efficacy of Radspherin in the treatment of peritoneal carcinomatosis".

About Radspherin

Radspherin is a novel alpha-emitting radioactive microsphere suspension designed for treatment of metastatic cancers in body cavities. The radium-224 based therapeutic, Radspherin has shown strong and consistent anticancer activity at doses being essentially non-toxic in preclinical studies. It is anticipated that the product can potentially be used to treat several forms of metastatic cancer.

About the RAD-18-002 Study

The phase 1 open-label, dose-escalation clinical trial is designed to assess the dose, safety, and tolerability of Radspherin, an α-emitting radionuclide therapy, administered into the intraperitoneal cavity in subjects with peritoneal carcinomatosis from colorectal carcinoma following complete cytoreductive surgery and HIPEC. Key objectives in the study include determining maximum tolerated dose, abdominal biodistribution, and preliminary anti-tumor activity. Please refer to www.clinicaltrials.gov for additional clinical trial details.

Blackstone Life Sciences to invest up to $250 million in Autolus Therapeutics to develop obe-cel in adult Acute Lymphoblastic Leukemia (ALL) and advance broader platform

On November 8, 2021 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, and Blackstone Life Sciences reported that the two companies have entered into a strategic collaboration and financing agreement under which funds managed by Blackstone (NYSE: BX) will provide up to $250 million in equity and product financing to support Autolus’ advancement of its CD19 CAR T cell investigational therapy product candidate, obecabtagene autoleucel (obe-cel), as well as next generation product therapies of obe-cel in B-cell malignancies (Press release, Blackstone Life Sciences, NOV 8, 2021, View Source [SID1234594735]).

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As part of this $250 million transaction, Blackstone is committing to invest $150 million in product financing to support obe-cel development and commercialization, with $50 million payable upon closing of the transaction and the remainder payable based on certain development and regulatory achievements. Blackstone has also agreed to purchase $100 million of Autolus’ American Depositary Shares (ADS) in a private placement, which is subject to customary closing conditions. In connection with the collaboration, Blackstone received the right to nominate a member to Autolus’ board of directors.

The transaction continues Blackstone’s commitment to the UK economy which has seen the firm invest more than $18 billion across 44 investments headquartered in UK. These investments support more than 27,000 direct jobs and help make Blackstone the UK’s biggest foreign investor over the past 10 years.

"Autolus is a world-class company with an innovative platform and the potential to deliver best-in-class, lifesaving treatments to patients suffering from cancer," said Dr. Nicholas Galakatos, Global Head of Blackstone Life Sciences. "Our investment in these next generation cell therapies exemplify our conviction in the quality and promise of the life sciences sector in the UK. We look forward to building on this investment in the years to come."

"We welcome Blackstone Life Sciences to join our drive to change the outlook for leukemia and lymphoma patients, notably those with acute lymphoblastic leukemia. Blackstone’s investment and expertise will support the development and preparation for commercialization of obe-cel and put the program and the Company on a strong financial footing as we are approaching the read-out from the potentially pivotal FELIX clinical trial during the course of 2022," said Dr. Christian Itin, Chief Executive Officer of Autolus.

"We are excited to collaborate with Autolus in support of their innovative platform pursuing safer, more durable, therapies with the potential to be lifesaving options for patients with ALL and beyond. We see a significant opportunity to improve the outlook for cancer patients who are facing a devastating course of their disease," said Nicholas Simon, Senior Managing Director of Blackstone Life Sciences. "This investment continues to build on our conviction in not just innovative cell and gene therapies, but also supporting innovation in the United Kingdom and Europe broadly."

UK Science Minister George Freeman said: "This is another vote of confidence in the quality of life science in the UK, reinforcing our reputation as a world leader in discovering new cures for currently untreatable diseases like Autolus’ T cell therapy drugs for leukemia. Big investments like these give real hope to those suffering from diseases like leukemia – and create high skill jobs & opportunities in the development and manufacturing of treatments to help develop and boost our life science clusters all around the UK."

Autolus recently announced plans to build a dedicated manufacturing facility in Stevenage, UK to help secure global commercial launch capacity for obe-cel with a 70,000 square foot building. The ground-breaking ceremony for this new facility is due to be held today, with building works commencing imminently.

Moelis & Company LLC acted as financial advisor. Cooley LLP and Cooley (UK) LLP acted as legal advisor to Autolus, and Goodwin Procter LLP acted as legal advisor to Blackstone.

About the Transaction

The strategic financing collaboration by Autolus and Blackstone Life Sciences is expected to support the development and preparation for commercialization of Autolus’ product candidate, obe-cel. As part of this $250 million transaction, Blackstone is committing to invest an aggregate of $150 million in product financing to support Autolus’ development and potential commercialization of obe-cel, with $50 million payable upon closing of the transaction and the remainder (up to $100 million) payable based on certain development and regulatory achievements. In return for this strategic investment, Autolus has agreed to pay Blackstone a capped single digit royalty plus milestone payments based on net sales of obe‐cel. In addition, Blackstone will receive a warrant to purchase up to $24 million worth of Autolus ADSs at an exercise price premium to market. Blackstone has also agreed to make a $100 million equity investment in Autolus which is expected to close on or about November 12, 2021, subject to customary closing conditions. In connection with the collaboration, Blackstone received the right to nominate a member to Autolus’ board of directors.

Rubius Therapeutics Reports Third Quarter 2021 Financial Results and Provides Business Update

On November 8, 2021 Rubius Therapeutics, Inc. (Nasdaq: RUBY), a clinical-stage biopharmaceutical company that is genetically engineering red blood cells to create an entirely new class of cellular medicines called Red Cell Therapeutics (RCT) for the treatment of cancer and autoimmune diseases, reported third quarter 2021 financial results and provided a business update (Press release, Rubius Therapeutics, NOV 8, 2021, View Source [SID1234594734]).

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"With the clearance of our latest IND application for RTX-224, we will have three Red Cell Therapeutic product candidates for the potential treatment of cancer in the clinic, demonstrating continued strong execution across preclinical and clinical development as well as manufacturing," said Larry Turka, M.D., chief scientific officer and head of research and translational medicine. "As shown in our preclinical studies, RTX-224 is designed to activate CD8+ and CD4+ T cells, promote antigen presentation and activate and expand NK cells to produce a broad and potent anti-tumor T cell response in solid tumor cancers with known sensitivity to T cell killing, including tumor types with high mutational burden, PD-L1 expression and prior responsiveness to checkpoint inhibitors."

Dr. Turka has been promoted to chief scientific officer and head of research & translational medicine. Joining Rubius Therapeutics as chief scientific officer in January 2020, Larry is an internationally recognized physician-scientist in autoimmunity and translational immunology with a distinguished career working in academia and, more recently, in the biotechnology industry where he has built a portfolio of novel therapies targeting immune cells.

"Larry’s impressive record of scientific achievement in immunology and ability to foster an environment of innovation has been instrumental in integrating our preclinical and clinical development programs. As Rubius enters a period of potentially significant clinical data generation, we look forward to leveraging Larry’s expertise in translational medicine and building our clinical development strategy," said Pablo J. Cagnoni, M.D., president and chief executive officer.

Along with this leadership change, chief medical officer Christina Coughlin, M.D., Ph.D., will be leaving Rubius Therapeutics to pursue another opportunity as chief executive officer, and she will continue to serve as an advisor to the Company during a transition period following her resignation. The Company thanks her for her contributions to Rubius and wishes her the best in the next chapter of her career.

Third Quarter 2021 and Recent Highlights

Clinical Development in Oncology

Enrollment continues across Rubius’ portfolio of Red Cell Therapeutics for the treatment of cancer:
The Phase 1 arms of single-agent RTX-240 in advanced solid tumors and relapsed/refractory AML.
The Company plans to present comprehensive results by the end of 2021 or during the first quarter of 2022.
The Phase 1 arm of the ongoing Phase 1/2 RTX-240 clinical trial in combination with KEYTRUDA (pembrolizumab) for advanced solid tumors.
To be eligible for the trial, patients must have disease that is relapsed or refractory to an anti-PD-1 or PD-L1 therapy. With its mechanism of action as a broad immune agonist, RTX-240 may have synergy with immune checkpoint inhibition and potentially overcome resistance to PD-1 inhibition.
The Phase 1 clinical trial of RTX-321 in patients with advanced HPV 16-positive cancers, including cervical, head & neck cancers, and anal cancer.
The company plans to present initial clinical results during the first quarter of 2022.
U.S. FDA cleared the IND application for RTX-224, Rubius’ third oncology product candidate.
The company expects to dose its first patient during the first quarter of 2022.
Peer-Reviewed Publications and Poster Presentations at Medical Conferences

The Company plans to present preclinical data for RTX-224 at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting on November 12th at 8:00 a.m. ET.
The data indicates that RTX-224 activates immune cells in the spleen and blood, leading to their trafficking into the tumor microenvironment to deliver an antitumor effect in preclinical models.
In July 2021, the manuscript entitled "Anti-Tumor Effects of RTX-240: an Engineered Red Blood Cell Expressing 4-1BB Ligand and Interleukin-15" was published in the peer-reviewed journal Cancer Immunology, Immunotherapy, highlighting preclinical findings for RTX-240, which demonstrated that RTX-240 activates and expands CD8+ T cells and NK cells in vitro and in vivo generating potent anti-tumor activity in both a colorectal and melanoma model.
Near-Term Catalysts and Operational Objectives

Present additional clinical data from the RTX-240 solid tumor Phase 1 clinical trial at the end of 2021 or during the first quarter of 2022;
Select specific solid tumor types that will be pursued in the Phase 2 expansion cohorts of RTX-240;
Report initial clinical data from the Phase 1 arm of the RTX-240 clinical trial in relapsed/refractory AML at the end of 2021 or during the first quarter of 2022; and
Report initial Phase 1 clinical data from RTX-321 for the treatment of HPV 16-positive cancers by the first quarter of 2022.
Initiate Phase 1 clinical trial for RTX-224 in advanced solid tumors during the first quarter of 2022.
Third Quarter Financial Results

Net loss for the third quarter of 2021 was $49.0 million or $0.55 per common share, compared to $40.9 million or $0.51 per common share in the third quarter of 2020.

In the third quarter of 2021, Rubius invested $38.0 million in research and development (R&D) related to its novel RED PLATFORM and towards expanding and advancing its product pipeline, as compared to $28.2 million in the third quarter of 2020. This year-over-year increase was principally due to a $6.8 million increase in costs incurred for the Company’s lead cancer programs, RTX-240 and RTX-321, primarily from clinical research organization (CRO) and internal manufacturing costs incurred in connection with the three Phase 1 arms of its Phase 1/2 clinical trial of RTX-240 and for its Phase 1 clinical trial of RTX-321 for the treatment of HPV16-positive cancers. Additionally, personnel-related costs increased $1.6 million principally for additions to headcount to support the Company’s expanded operations and stock-based compensation increased by $1.4 million.

General and administrative (G&A) expenses were flat at $12.0 million during the third quarter of 2021, as compared to the third quarter of 2020. While there were increases totaling $1.3 million across professional fees, facility and personnel costs, they were offset by a decline in stock-based compensation expense of $1.2 million following the full vesting of large awards early in the third quarter of 2021.

Nine Month Financial Results

Net loss for the first nine months of 2021 was $141.5 million or $1.62 per common share, compared to $127.2 million or $1.58 per common share in the first nine months of 2020.

In the nine months ended September 30, 2021, Rubius invested $101.8 million in R&D related to its novel RED PLATFORM and towards expanding and advancing its product pipeline, as compared to $90.5 million in the first nine months of 2020. The year-over-year increase was driven primarily by a $17.7 million increase in costs for the Company’s lead cancer programs, including CRO and internal manufacturing costs. These costs were associated with the three arms of its Phase 1/2 clinical trial of RTX-240 as well as costs incurred for its Phase 1 clinical trial of RTX-321 in patients with advanced HPV 16-positive cancers. This increase was partially offset by a $7.0 million reduction in rare disease program costs, following the deprioritization of the Company’s rare disease pipeline in March 2020. Additionally, platform development, early-stage research and other unallocated expenses increased by $0.6 million. This consisted of $2.8 million in additional stock-based compensation and a $1.7 million increase in personnel and facility related costs, which were partially offset by reductions in contract R&D, laboratory supplies and research materials as research activities shifted to support clinical programs.

G&A expenses were $39.1 million during the first nine months of 2021, as compared to $36.2 million for the same period in 2020. The higher costs were driven by a $2.4 million increase in personnel and facility related costs, as well as a $1.6 million increase in professional and consultant fees. These increases were offset by a decrease in stock-based compensation expense of $1.1 million, following the vesting of large awards early in the third quarter of 2021.

Cash Position

As of September 30, 2021, cash and cash equivalents were $264.0 million, compared to $176.3 million in cash, cash equivalents and investments as of December 31, 2020. In connection with its underwritten public offering completed in March 2021, the Company received net proceeds of $187.2 million, after deducting underwriting discounts and commission and other offering costs. In addition, in June 2021, the Company amended its debt facility, postponing principal payments by two and a half years, until mid-2024.

About Red Cell Therapeutics
Red Cell Therapeutics (RCTs) are a new class of allogeneic, off-the-shelf cellular therapeutic candidates for the treatment of cancer and autoimmune diseases. For the treatment of cancer, RCTs are expected to provide advantages over other therapies by potentially generating a broad anti-tumor response with limited side effects and a wide therapeutic window given the biodistribution of RCTs to the vasculature and spleen. Additionally, RCTs do not have the complex supply chain and administration logistics of other cell therapies, as RCTs are designed to be prepared in the pharmacy, administered in an outpatient setting and do not require lymphodepletion prior to administration.

About RTX-240
RTX-240, Rubius Therapeutics’ lead oncology program, is an allogeneic, off-the-shelf cellular therapy product candidate that is engineered to simultaneously present hundreds of thousands of copies of the costimulatory molecule 4-1BB ligand (4-1BBL) and IL-15TP (trans-presentation of IL-15 on IL-15Rα) in their native forms. RTX-240 is designed to broadly stimulate the immune system by activating and expanding both NK and memory T cells to generate a potent anti-tumor response.

About RTX-321
RTX-321, the Company’s second oncology program, is an allogeneic, off-the-shelf aAPC therapy product candidate that is engineered to induce a tumor-specific immune response by expanding antigen-specific T cells. RTX-321 expresses hundreds of thousands of copies of an HPV peptide antigen bound to major histocompatibility complex class I proteins, the costimulatory molecule 4-1BBL and the cytokine IL-12 on the cell surface to mimic human T cell-APC interactions.

About RTX-224
RTX-224 is an allogeneic, off-the-shelf cellular therapy product candidate that is engineered to express hundreds of thousands of copies of 4-1BBL and IL-12 on the cell surface. In contrast to RTX-240, RTX-224 is designed as a broad immune agonist of both adaptive and innate responses, activating CD8+ and CD4+ T cells, promoting antigen presentation and activating and expanding NK cells. It is expected to produce a broad and potent anti-tumor T cell response, an innate immune response and have anti-tumor activity in those tumor types with known sensitivity to T cell killing, including tumor types with high mutational burden, PD-L1 expression and prior activity of checkpoint inhibitors.

Revolution Medicines to Participate in Stifel 2021 Virtual Healthcare Conference

On November 8, 2021 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage precision oncology company focused on developing targeted drugs to inhibit frontier targets that drive and sustain RAS-addicted cancers, reported that the company will participate in the upcoming Stifel 2021 Virtual Healthcare Conference (Press release, Revolution Medicines, NOV 8, 2021, View Source [SID1234594733]). Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines, will be the featured participant in a fireside chat at the event.

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Details of these company’s participation are as follows:

Stifel 2021 Virtual Healthcare Conference
Conference Date: November 15-17, 2021
Fireside Chat Time/Date: 2:40 p.m. Eastern on Monday, November 15, 2021
Format: Virtual conference