On August 6, 2024 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients, reported financial results for the second quarter ended June 30, 2024, and provided corporate updates (Press release, Sensei Biotherapeutics, AUG 6, 2024, View Source [SID1234645436]).

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"Collectively, the clinical data presented on SNS-101 over the past six months demonstrated early signs of clinical activity in a patient population generally resistant to immunotherapy, a well-tolerated safety profile, and the avoidance of a pharmacokinetic sink that hindered first-generation approaches to targeting VISTA," said John Celebi, President and Chief Executive Officer. "We believe these data validate that a pH-selective approach can overcome the previous hurdles associated with targeting VISTA, and we look forward to advancing patient enrollment in dose expansion cohorts to inform our Phase 2 trial design. With cash runway into the fourth quarter of 2025, we believe we are well positioned to substantially progress SNS-101 as we seek to create value for Sensei’s stockholders by developing innovative new treatment options for patients."

Clinical Highlights and Milestones

SNS-101

SNS-101 is a conditionally active antibody harnessing the acidic tumor microenvironment to selectively target the immune checkpoint VISTA (V-domain Ig suppressor of T cell activation). VISTA is implicated in numerous cancer indications and its expression correlates with low survival rates.

Sensei is conducting a multi-center Phase 1/2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SNS-101 as both a monotherapy and in combination with Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) in patients with advanced solid tumors.

In May 2024, Sensei presented promising clinical data from the dose escalation portion of its Phase 1/2 trial of SNS-101 at the 2024 American Society of Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. As of the April 30, 2024 data cutoff, SNS-101 demonstrated preliminary evidence of promising clinical activity in multiple tumor types, a potentially best-in-class pharmacokinetic (PK) profile and was well tolerated alone and in combination with cemiplimab, with no dose-limiting toxicities observed.
Patient enrollment is advancing in the dose expansion portion of the Phase 1/2 study. The Company is on track to report initial data from the dose expansion cohorts and hold an end-of-Phase 1 meeting with the FDA by the end of 2024.
In April 2024, Sensei published a peer-reviewed research paper in Nature Communications describing the mechanism of action of SNS-101 selectively targeting the active form of VISTA within the tumor microenvironment.
Corporate Updates

Sensei announces the appointment of Josiah Craver effective as of July 22, 2024, as Senior Vice President of Finance. Mr. Craver brings extensive experience in finance and accounting. Prior to joining Sensei in July 2024, he was the SVP of finance and corporate controller at KALA BIO and held senior finance positions at Solid Biosciences, including VP of finance and corporate controller after starting his career at PricewaterhouseCoopers in the health industries audit practice primarily serving life science and biotech companies of all sizes. Mr. Craver holds a M.S. in Accountancy and is a Certified Public Accountant.
Second Quarter 2024 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $52.3 million as of June 30, 2024. Sensei expects its current cash balance to fund operations into the fourth quarter of 2025.

Research and Development (R&D) Expenses: R&D expenses were $4.6 million for the quarter ended June 30, 2024, compared to $4.8 million for the quarter ended June 30, 2023. The decrease in R&D expenses was primarily attributable to lower outside research fees and lower costs related to preclinical research, primarily offset by higher expenses associated with clinical trials.

General and Administrative (G&A) Expenses: G&A expenses were $3.2 million for the quarter ended June 30, 2024, compared to $5.4 million for the quarter ended June 30, 2023. The decrease in G&A expense was primarily attributable to decreased cost for external professional services.

Net Loss: Net loss was $7.1 million for the quarter ended June 30, 2024, compared to $9.4million for the quarter ended June 30, 2023.

On August 6, 2024 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) for SLS009, a novel, and highly selective CDK9 inhibitor, for the treatment of relapsed/refractory (r/r) peripheral T-cell lymphomas (PTCL) (Press release, Sellas Life Sciences, AUG 6, 2024, View Source [SID1234645435]).

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"We are pleased to announce the EMA’s granting of ODD for SLS009, highlighting another important milestone following recent FDA’s Orphan Drug and Fast Track Designations for SLS009 in PTCL," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "PTCL is an aggressive form of lymphoma with limited treatment options, underscoring the urgent need for new and effective therapies. We are delighted that the potential of SLS009 has been recognized by both regulatory agencies and across multiple indications including acute myeloid leukemia (AML), pediatric AML, and pediatric acute lymphoblastic leukemia (ALL). This additional orphan drug designation also highlights our strong internal regulatory expertise, and we look forward to advancing the SLS009 development and our overall clinical programs to deliver its potential benefits to cancer patients."

In the completed dose-escalation portion of the Phase 1 trial in relapsed/refractory hematological malignancies, SLS009 demonstrated favorable safety/tolerability and promising clinical efficacy. Complete or partial responses were observed in AML and lymphoma patients, with a 36.4% response rate achieved specifically in the PTCL patient group, including one patient who remained in continuous treatment for over 56 weeks. The current standard of care for r/r PTCL, belinostat, showed in its pivotal Phase 2 study a 25.8% response rate in a similar patient population to that in the SLS009 Phase 1 clinical trial.

Orphan Designation is granted to therapies aimed at the treatment, prevention, or diagnosis of life-threatening or chronically debilitating diseases that affect no more than five in 10,000 persons in the European Union (EU) and for which no satisfactory therapy is available. The treatment must also provide significant benefit to those affected by the condition.

On August 6, 2024 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, reported financial results for the second quarter ended June 30, 2024, including sales of TAVALISSE (fostamatinib disodium hexahydrate) for the treatment of chronic immune thrombocytopenia (ITP); REZLIDHIA (olutasidenib) for the treatment of relapsed or refractory (R/R) mutated isocitrate dehydrogenase-1 (mIDH1) acute myeloid leukemia (AML); and GAVRETO (pralsetinib) for the treatment of metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) and advanced or metastatic thyroid cancer, and recent business progress (Press release, Rigel, AUG 6, 2024, View Source [SID1234645434]).

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"In the second quarter, we advanced key strategic initiatives including the successful transfer of GAVRETO to our commercial portfolio, enabling us to bring this important treatment option to current and newly prescribed patients without interruption," said Raul Rodriguez, Rigel’s president and CEO. "The addition of GAVRETO, combined with record revenues from TAVALISSE and REZLIDHIA, has allowed us to approach net income break even. We look to maintain our financial discipline as we expand our commercial reach and advance our development programs."

Second Quarter 2024 Business Update
Commercial Update

Commercial strength continues with record TAVALISSE and REZLIDHIA bottles shipped to patients and clinics and total bottles sold.
In June 2024, Rigel announced the completion of the transfer of the New Drug Application (NDA) for the U.S. rights to GAVRETO. GAVRETO became commercially available from Rigel in the U.S. beginning June 27, 2024, ahead of the company’s July 1 target for commercial availability.
The following table summarizes total bottles shipped for the second quarter:

TAVALISSE

REZLIDHIA

GAVRETO*

Bottles shipped to patients and clinics

2,672

424

–

Change in bottles remaining in distribution channel

50

(23)

228

Total bottles shipped

2,722

401

228

*GAVRETO bottle count represents 60-count bottle equivalent

Clinical and Development Update

Rigel continues to advance its Phase 1b clinical trial evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of R2891, a novel and selective IRAK1/4 inhibitor, in patients with relapsed/refractory lower-risk myelodysplastic syndrome (LR-MDS). Enrollment in the fourth dose level (250 mg twice daily) of the trial is underway. Preliminary data are expected by the end of 2024.
In early August, The University of Texas MD Anderson Cancer Center, with Rigel’s support, opened enrollment for a Phase 1b/2 trial of decitabine and venetoclax in combination with olutasidenib in patients with IDH1-mutated AML (NCT06445959). This is the first trial in Rigel’s multi-year strategic development collaboration with MD Anderson. The Phase 1b part of the trial seeks to determine the safety and tolerability and recommended Phase 2 dose of decitabine and venetoclax in combination with olutasidenib. The primary objective of the Phase 2 part of the trial is to determine the complete remission rate in both newly diagnosed and relapsed/refractory patients.
In late July, City of Hope National Medical Center opened enrollment for a pilot trial of olutasidenib as maintenance therapy following allogeneic hematopoietic cell transplantation (HCT). The primary objective of the trial is to evaluate the safety and tolerability of olutasidenib as post-HCT maintenance therapy in patients with mIDH1 AML, myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML).
Rigel presented the final long-term efficacy data from the registrational Phase 2 trial of REZLIDHIA in heavily pretreated patients with R/R mIDH1 AML, including those receiving prior venetoclax, in an oral presentation and 4 posters at the EHA (Free EHA Whitepaper)2024 Hybrid Congress. In addition, the company presented 3 posters at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting, which included safety and efficacy of olutasidenib treatment in elderly patients with R/R mIDH1 AML and an overview of the Phase 1b trial of R289 in patients with LR-MDS.
Dr. Jorge E. Cortes, Director, Georgia Cancer Center, Cecil F. Whitaker Jr., GRA Eminent Scholar Chair in Cancer, and Phase 2 trial investigator, was published in the Expert Review of Hematology in May outlining the drug profile and summarizing key safety and efficacy data for olutasidenib, including in patients previously treated with venetoclax or ivosidenib.
Second Quarter 2024 and Year-To-Date Financial Update
For the second quarter ended June 30, 2024, total revenues were $36.8 million, consisting of $26.4 million in TAVALISSE net product sales, $5.2 million in REZLIDHIA net product sales, $1.9 million in GAVRETO net product sales, and $3.4 million in contract revenue from collaborations. TAVALISSE net product sales grew 24% compared to $21.3 million in the same period of 2023. REZLIDHIA net product sales grew 102% compared to $2.6 million in the same period of 2023. GAVRETO became commercially available from Rigel on June 27, 2024. Contract revenue from collaborations consisted of $2.2 million from Kissei Pharmaceutical Co., Ltd. (Kissei) related to delivery of drug supplies, $1.1 million from Grifols S.A. (Grifols) related to earned royalties, and $0.1 million from Medison Pharma Trading AG (Medison) related to delivery of drug supplies and earned royalties.

Total costs and expenses were $36.4 million compared to $32.2 million for the same period of 2023. The increase in costs and expenses was partly due to higher cost of product sales, driven primarily by higher amortization of intangibles and royalties, increased personnel-related costs, and increased research and development costs due to the progress of clinical activities, including R289, the company’s IRAK 1/4 inhibitor program.

Rigel reported a net loss of $1.0 million, or $0.06 per basic and diluted share, compared to a net loss of $6.6 million, or $0.38 per basic and diluted share, for the same period of 2023. The basic and diluted share and per share amounts have been restated to reflect the 1-for-10 reverse stock split effected on June 27, 2024 on a retroactive basis for all periods presented.

For the six months ended June 30, 2024, total revenues were $66.4 million, consisting of $47.5 million in TAVALISSE net product sales, $10.0 million in REZLIDHIA net product sales, $1.9 million in GAVRETO net product sales, and $6.9 million in contract revenue from collaborations. TAVALISSE net product sales grew 9% compared to $43.6 million in the same period of 2023. REZLIDHIA net product sales grew 150% compared to $4.0 million in the same period of 2023. As mentioned above, GAVRETO became commercially available from Rigel on June 27, 2024. Contract revenue from collaborations consisted of $4.5 million from Kissei related to delivery of drug supplies, $2.2 million from Grifols related to earned royalties, and $0.2 million from Medison related to delivery of drug supplies and earned royalties.

Total costs and expenses were $72.9 million compared to $70.9 million for the same period of 2023. The increase in costs and expenses was partly due to higher cost of product sales, driven primarily by higher amortization of intangibles and royalties, increased personnel-related costs and higher stock-based compensation expenses mainly from performance awards. These increases were partially offset by decreased research and development costs due to the timing of clinical trial activities related to R289, the company’s IRAK 1/4 inhibitor program, as well as reduced trial activities related to the completed Phase 3 clinical trials of fostamatinib in patients with COVID-19 and warm antibody hemolytic anemia (wAIHA).

Rigel reported a net loss of $9.3 million, or $0.53 per basic and diluted share, compared to a net loss of $20.1 million, or $1.16 per basic and diluted share, for the same period of 2023. As discussed above, the share and per share amounts have been restated to reflect the 1-for-10 reverse stock split on a retroactive basis for all periods presented.

Cash, cash equivalents and short-term investments as of June 30, 2024 was $49.1 million, compared to $49.6 million as of March 31, 2024, and $56.9 million as of December 31, 2023.

Conference Call and Webcast with Slides Today at 4:30pm Eastern Time
Rigel will hold a live conference call and webcast today at 4:30pm Eastern Time (1:30pm Pacific Time).

Participants can access the live conference call by dialing (877) 407-3088 (domestic) or (201) 389-0927 (international). The conference call will also be webcast live and can be accessed from the Investor Relations section of the company’s website at www.rigel.com. The webcast will be archived and available for replay after the call via the Rigel website.

About ITP
In patients with ITP (immune thrombocytopenia), the immune system attacks and destroys the body’s own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs), and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

About AML
Acute myeloid leukemia (AML) is a rapidly progressing cancer of the blood and bone marrow that affects myeloid cells, which normally develop into various types of mature blood cells. AML occurs primarily in adults and accounts for about 1 percent of all adult cancers. The American Cancer Society estimates that there will be about 20,800 new cases in the United States, most in adults, in 2024.2

Relapsed AML affects about half of all patients who, following treatment and remission, experience a return of leukemia cells in the bone marrow.3 Refractory AML, which affects between 10 and 40 percent of newly diagnosed patients, occurs when a patient fails to achieve remission even after intensive treatment.4 Quality of life declines for patients with each successive line of treatment for AML, and well-tolerated treatments in relapsed or refractory disease remain an unmet need.

About NSCLC
It is estimated that over 230,000 adults in the U.S. will be diagnosed with lung cancer in 2024. Lung cancer is the leading cause of cancer death in the U.S, with NSCLC being the most common type accounting for 80-85% of all lung cancer diagnoses.5 RET fusions are implicated in approximately 1-2% of patients with NSCLC.6

About TAVALISSE
TAVALISSE (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

Please click here for Important Safety Information and Full Prescribing Information for TAVALISSE.

About REZLIDHIA
REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

Please click here for Important Safety Information and Full Prescribing Information, including Boxed WARNING, for REZLIDHIA.

About GAVRETO
GAVRETO is indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test and adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).*

*Thyroid indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Please click here for Important Safety Information and Full Prescribing Information for GAVRETO.

To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

TAVALISSE, REZLIDHIA and GAVRETO are registered trademarks of Rigel Pharmaceuticals, Inc.

On August 6, 2024 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported financial results for the second quarter ended June 30, 2024 (Press release, Repare Therapeutics, AUG 6, 2024, View Source [SID1234645433]).

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"We continued to make meaningful progress across our clinical programs in the second quarter and we look forward to a catalyst-rich second half of 2024 that includes the release of data from our ongoing MYTHIC dose expansion clinical trial evaluating the promising combination of lunresertib and camonsertib at the recommended Phase 2 dose. This combination therapy has the potential to be a new treatment paradigm in genomically-defined platinum-resistant ovarian cancer and second-line endometrial cancer. We remain on track to deliver this data in the fourth quarter of this year, with the potential to begin a registrational trial in 2025," said Lloyd M. Segal, President and CEO of Repare. "As we prepare for potential near-term registrational clinical programs, we are thrilled that Dr. Steven H. Stein has joined Repare’s Board of Directors. He brings extensive experience in global pivotal trial development and will chair our Science and Technology Committee. He replaces Dr. Briggs Morrison, who has been instrumental in building Repare into a leading, precision oncology company. We are grateful for Dr. Morrison’s seven years of service, his substantial contributions to our company, and for his longstanding and ongoing support."

Second Quarter 2024 and Recent Portfolio Highlights:

▪
Lunresertib (RP-6306)
▪
Currently evaluating lunresertib in combination with camonsertib in Repare’s MYTHIC dose expansion clinical trial at the recommended Phase 2 dose (RP2D) in patients with platinum-resistant ovarian and endometrial cancers harboring CCNE1 amplification or FBXW7 or PPP2R1A mutations, which are predictive of poor prognosis. Repare expects to report data from approximately 20-30 patients in each cohort in the fourth quarter of 2024.
▪
In preparation for a potential registrational clinical trial start in 2025, Repare formed a collaboration with Foundation Medicine, Inc. to provide prospective genomic profiling for patients in the ongoing MYTHIC clinical trial. Additionally, Repare and Foundation Medicine are exploring opportunities to

develop FoundationOneCDx, a tissue-based comprehensive genomic profiling test, as a companion diagnostic for the lunresertib program.
▪
Granted Fast-Track designation by the U.S. Food and Drug Administration (FDA) in June 2024 for lunresertib in combination with camonsertib for the treatment of adult patients with CCNE1 amplified, or FBXW7 or PPP2R1A-mutated platinum-resistant ovarian cancer.
▪
Dosed the first patient in Module 4 of the ongoing MYTHIC clinical trial investigating lunresertib in combination with Debio 0123, an oral, brain-penetrant, highly selective WEE1 kinase inhibitor. Repare expects to report initial data from this module in 2025.
▪
Announced positive initial data from the ongoing Phase 1 MINOTAUR clinical trial evaluating lunresertib (RP-6306) in combination with FOLFIRI in patients with advanced solid tumors at the ESMO (Free ESMO Whitepaper) GI Cancers Congress in June 2024. The data showed the lunresertib combination therapy was well tolerated without excess toxicity above expected rates for lunresertib or standard FOLFIRI alone.
▪
Camonsertib (RP-3500)
▪
Dosed the first patient in the camonsertib monotherapy non-small cell lung cancer (NSCLC) expansion of the TRESR clinical trial. The NSCLC expansion is expected to enroll up to 20 patients with ATR-inhibitor sensitizing mutations in NSCLC to study the efficacy of camonsertib at the RP2D. Repare expects to report initial data from the TRESR trial in 2025.
▪
RP-1664
▪
Actively enrolling patients into the Phase 1 LIONS trial evaluating RP-1664, a potential first-in-class selective PLK4 inhibitor, in adult and adolescent patients with TRIM37-high advanced solid tumors and other biomarkers. The Company expects to rapidly advance RP-1664 into a Phase 1/2 clinical trial in pediatric patients with high risk, recurrent neuroblastoma, where the patients have a high prevalence of TRIM37-altered tumors, after evaluating the safety profile in the LIONS trial.
▪
RP-3467
▪
Initiation of a Phase 1 dose finding trial of RP-3467, a potential best-in-class Polθ ATPase inhibitor, is expected in the fourth quarter of 2024.
▪
Corporate
▪
Welcomed Steven H. Stein, M.D., Chief Medical Officer of Incyte Corporation, to Repare’s Board of Directors, effective as of June 17, 2024, the date of the Company’s annual meeting of shareholders. Effective today, Briggs Morrison, M.D. is stepping down from the Board after seven years of service.

Second Quarter 2024 Financial Results:

▪
Cash, cash equivalents and marketable securities: Cash, cash equivalents and marketable securities as of June 30, 2024 were $208.1 million. The Company believes that its cash, cash equivalents, and marketable securities are sufficient to fund its current operational plans at least into mid-2026.
▪
Revenue from collaboration agreements: Revenue from collaboration agreements were $1.1 million and $53.5 million for the three months and six months ended June 30, 2024, respectively, as compared to $30.2 million and $35.9 million for the three and six months ended June 30, 2023.

▪
Research and development expenses, net of tax credits (Net R&D): Net R&D expenses were $30.1 million and $63.0 million for the three and six months ended June 30, 2024, respectively, as compared to $33.8 million and $65.6 million for the three and six months ended June 30, 2023.
▪
General and administrative (G&A) expenses: G&A expenses were $8.3 million and $16.9 million for the three and six months ended June 30, 2024, respectively, compared to $8.7 million and $17.2 million for the three and six months ended June 30, 2023.
▪
Net loss: Net loss was $34.8 million, or $0.82 per share, and $21.6 million, or $0.51 per share, in the three and six months ended June 30, 2024, respectively, compared to $11.9 million, or $0.28 per share, and $46.9 million, or $1.11 per share, in the three and six months ended June 30, 2023, respectively.

On August 6, 2024 Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, reported second quarter 2024 financial results and corporate highlights (Press release, Relay Therapeutics, AUG 6, 2024, View Source [SID1234645432]).

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"In the second quarter, we made important progress continuing to advance our clinical programs, which we believe has positioned us well for multiple data readouts later this year. Additionally, we look forward to expanding the RLY-2608 development program, with the initiation of a new triplet combination with Pfizer’s novel investigative selective-CDK4 inhibitor atirmociclib by the end of the year," said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics. "Looking further ahead, we are very excited by the pre-clinical programs we unveiled in June, including our first two genetic disease programs, which will be important in driving our continued growth and diversification."

Recent Corporate Highlights

RLY-2608 (ReDiscover study)

• RLY-2608 doublet: continued to enroll patients with PI3Kα-mutant, HR+, HER2- locally advanced or metastatic breast cancer in dose expansion cohorts of RLY-2608 400mg BID and 600mg BID in combination with fulvestrant

o
The next data update is expected in the fourth quarter of 2024 and will include approximately 100 patients across doses in the safety database and approximately 60 patients at the 600mg BID dose, including about 40 who have had the opportunity to be on RLY-2608 for at least 6 months
• RLY-2608 triplet:

o
CDK4/6: continued enrollment of RLY-2608 + fulvestrant + ribociclib triplet combination in patients with PI3Kα-mutant, HR+, HER2- locally advanced or metastatic breast cancer
o
CDK4: announced a clinical trial collaboration to evaluate atirmociclib, Pfizer’s investigative selective-CDK4 inhibitor, in combination with RLY-2608 and fulvestrant in patients with PI3Kα-mutant, HR+, HER2- metastatic breast cancer. The RLY-2608 + atirmociclib + fulvestrant triplet combination is planned to begin by the end of 2024

• RLY-2608 monotherapy: continued to enroll patients with unresectable or metastatic solid tumors with a PI3Kα mutation in dose escalation portion of RLY-2608 monotherapy arm and reported partial responses in multiple tumor types

Migoprotafib (GDC-1971)​

• As previously disclosed, Genentech has terminated the collaboration agreement for the development and commercialization of migoprotafib

• The company will not continue development of migoprotafib

Pre-Clinical Programs

• Disclosed three new pre-clinical programs: vascular malformations, Fabry disease and NRAS

• Vascular Malformations

o
PI3Kα is the most common driver mutation among specific types of vascular malformations, which are a series of rare syndromes that occur due to atypical development of lymphatic and/or blood vessels and can become life-threatening, depending on what vessel(s) are involved
o
In the U.S., an estimated 170,000 people have one of the sub-types driven by a PI3Kα mutation, which include PIK3CA-related overgrowth spectrum, lymphatic malformations, venous malformations and cerebral cavernous malformations
o
A mutant selective PI3Kα inhibitor provides the opportunity for greater target coverage, leading to the potential for improved efficacy and better chronic tolerability
o
Relay Therapeutics plans to initiate clinical development of RLY-2608 in vascular malformations in the first quarter of 2025
• Fabry Disease

o
In Fabry disease, harmful levels of Gb3 accumulate in blood cells and tissues throughout the body, due to insufficient αGal enzyme activity, which can lead to a range of symptoms, including potentially life-threatening ones such as kidney failure, heart failure and stroke. In the U.S., approximately 8,000 people have Fabry disease
o
Relay Therapeutics has created the first investigational non-inhibitory chaperone for Fabry disease, which is designed to stabilize the αGal protein without inhibiting its activity, thus enabling greater Gb3 clearance across organs
o
The company expects its non-inhibitory chaperone to enter the clinic in the second half of 2025
• NRAS

o
In the U.S., an estimated 28,000 people are diagnosed annually with mutated NRAS solid tumors, which are a known oncogene driver in the RAS family and can lead to a number of cancers, including melanoma, colorectal and non-small-cell lung
o
Relay Therapeutics has created the first NRAS-selective inhibitor, which has been designed to address the liabilities of current pan-RAS inhibitors by only binding to NRAS, while sparing KRAS and HRAS
o
The company expects to initiate clinical development of its NRAS-selective inhibitor in the second half of 2025

Anticipated Upcoming Milestones

• Breast Cancer

o
RLY-2608 + fulvestrant data update in the fourth quarter of 2024
o
RLY-2608 + fulvestrant + ribociclib initial safety data in the fourth quarter of 2024
o
RLY-2608 + fulvestrant + atirmociclib clinical trial initiation by the end of 2024
o
RLY-2608 + fulvestrant potential Phase 3 trial initiation in 2025
• Lirafugratinib: tumor agnostic data and regulatory update in the second half of 2024

• Pre-clinical

o
Vascular malformations: RLY-2608 clinical trial initiation in the first quarter of 2025
o
Fabry disease: clinical start in the second half of 2025
o
NRAS: clinical start in the second half of 2025
Second Quarter 2024 Financial Results

Cash, Cash Equivalents and Investments: As of June 30, 2024, cash, cash equivalents and investments totaled $688.4 million compared to $750.1 million as of December 31, 2023. The company expects its current cash, cash equivalents and investments will be sufficient to fund its current operating plan into the second half of 2026.

R&D Expenses: Research and development expenses were $92.0 million for the second quarter of 2024, as compared to $88.2 million for the second quarter of 2023. The increase was primarily due to additional external costs in connection with the ReDiscover trial for RLY-2608.

G&A Expenses: General and administrative expenses were $20.1 million for the second quarter of 2024, as well as for the second quarter of 2023.

Net Loss: Net loss was $92.2 million for the second quarter of 2024, or a net loss per share of $0.69, as compared to a net loss of $98.5 million for the second quarter of 2023, or a net loss per share of $0.81.