On August 6, 2024 FibroGen, Inc. (NASDAQ: FGEN) reported financial results for the second quarter 2024 and provided an update on the company’s recent developments (Press release, FibroGen, AUG 6, 2024, View Source [SID1234645419]).

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"While we are disappointed with the results from the pamrevlumab pancreatic cancer trials, we continue to be very excited about the prospects of FG-3246 and PET46, our CD46 targeted antibody-drug conjugate and companion PET imaging agent. We have released compelling Phase 1 data on FG-3246 as a monotherapy and in combination with enzalutamide in metastatic castration-resistant prostate cancer. In addition, roxadustat continues its strong momentum in China, exceeding $92 million in net sales in the second quarter," said Thane Wettig, Chief Executive Officer, FibroGen. "Looking ahead, we expect topline data from the Phase 2 portion of the FG-3246 + enzalutamide combination study in mCRPC in the first half of 2025 and plan on initiating our Phase 2 monotherapy study in mCRPC in the first quarter of 2025 with a more focused and streamlined organization. I would like to express my deepest gratitude to our FibroGen colleagues who have dedicated so much of their time and energy for the prospect of bringing much needed therapies to some of the most challenging and deadly diseases affecting humanity."

Recent Developments and Key Events of Second Quarter 2024:

Implementing significant cost reduction plan in the U.S.
Headcount in the U.S. will be reduced by approximately 75%.
Focusing R&D investment on FG-3246 and PET46, a first-in-class antibody-drug conjugate and companion PET imaging agent for mCRPC.
Announced positive interim results from the dose escalation portion of the investigator-sponsored Phase 1b/2 study conducted by the University of California San Francisco of FG-3246 (FOR46), a potential first-in-class anti-CD46 antibody drug conjugate (ADC) with a MMAE-containing payload, in combination with enzalutamide in patients with metastatic castration resistant prostate cancer (mCRPC) at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
The presentation included data from 17 biomarker unselected patients in the dose escalation portion of the trial. Over 70% of the patients in the study received at least two prior ARSIs, which included prior enzalutamide treatment.
The primary endpoint was determination of the maximally tolerated dose (MTD) of FG-3246 in combination with enzalutamide. The MTD was established at 2.1 mg/kg ABW, with primary G-CSF prophylaxis, in combination with enzalutamide 160 mg/day. The combination treatment demonstrated an encouraging preliminary estimate of median radiographic progression free survival (rPFS) of 10.2 months with prostate-specific antigen (PSA) declines observed in 71% (12/17) of evaluable patients.
Additional data from a total of 56 biomarker unselected and heavily pre-treated patients in a Phase 1 monotherapy study of FG-3246 in mCRPC reported.
Efficacy analysis (includes adenocarcinoma patients receiving doses ≥ 1.2 mg/kg):
The median radiographic progression free survival (rPFS) in this patient population was 8.7 months.
For RECIST evaluable patients, 20% met the criteria of a partial response, or measurable tumor reduction in size of ≥ 30%, with a median duration of response of 7.5 months.
PSA reductions of ≥ 50% were observed in 36% of PSA evaluable patients.
Safety analysis:
The most frequent adverse events were consistent with other MMAE-based antibody drug conjugates and included infusion-related reactions, fatigue, weight loss, neutropenia, and peripheral neuropathy.
Reported topline results from the pamrevlumab arm of PanCAN Precision Promise Phase 2/3 adaptive platform trial for the treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC), in which the trial did not meet the primary endpoint.
Reported topline results from the LAPIS Phase 3 study of pamrevlumab in patients with locally advanced, unresectable pancreatic cancer (LAPC), in which the trial did not meet the primary endpoint.
Upcoming Milestones:

Roxadustat

Expect approval decision for roxadustat in chemotherapy-induced anemia (CIA) in China in the second half of 2024. If approved, FibroGen will receive a $10 million milestone payment from AstraZeneca.
Oncology Pipeline

Topline results from the Phase 2 portion of the investigator-sponsored Phase 1b/2 study conducted by the University of California San Francisco of FG-3246 in combination with enzalutamide in patients with mCRPC expected in 1H 2025.
Anticipate initiation of Phase 2 monotherapy dose optimization study of FG-3246 in mCRPC in 1Q 2025.
China:

Second quarter FibroGen net product revenue under U.S. GAAP from the sale of roxadustat in China was $49.6 million compared to $23.9 million in the first quarter of 2023, an increase of 108% year over year.
Second quarter total roxadustat net sales in China1 by FibroGen and the distribution entity jointly owned by FibroGen and AstraZeneca (JDE) was $92.3 million, compared to $76.4 million in the second quarter of 2023, an increase of 21% year over year, driven by a 33% increase in volume.
Roxadustat continues to be the number one brand based on value share in the anemia of CKD market in China.
For 2024, FibroGen’s expected full year net product revenue under U.S. GAAP is raised to a range between $135 million to $150 million, representing expected full year roxadustat net sales in China1 by FibroGen and the JDE of $320 million to $350 million, due to continued strong performance in China.
Financial:

Total revenue for the second quarter of 2024 was $50.6 million, as compared to $44.3 million for the second quarter of 2023, an increase of 14% year over year. Total revenue increase was driven by strong performance of roxadustat in China and changes in net product revenue assumptions under U.S. GAAP.
Net loss for the second quarter of 2024 was $15.5 million, or $0.16 net loss per basic and diluted share, compared to a net loss of $87.7 million, or $0.90 net loss per basic and diluted share one year ago.
At June 30, 2024, FibroGen reported $147.1 million in cash, cash equivalents and accounts receivable.
We expect our cash, cash equivalents and accounts receivable to be sufficient to fund our operating plans into 2026.
Conference Call and Webcast Details
FibroGen management will host a conference call and webcast today, Tuesday, August 6, 2024, at 5:00 PM Eastern Time to discuss financial results and provide a business update. Interested parties may access the conference call by dialing 1-877-300-8521 (in the U.S.) or 1-412-317-6026 (outside the U.S.). The call will be available via webcast by clicking here or on the "Events and Presentation" page on the FibroGen website.

About Roxadustat
Roxadustat, an oral medication, is the first in a new class of medicines comprising HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin. Roxadustat is in clinical development for chemotherapy-induced anemia (CIA) and a Supplemental New Drug Application (sNDA) has been accepted by the China Health Authority.

Roxadustat is approved in China, Europe, Japan, and numerous other countries for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). Several other licensing applications for roxadustat have been submitted by partners, Astellas and AstraZeneca, to regulatory authorities across the globe, and are currently under review. Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in territories including Japan, Europe, Turkey, Russia, and the Commonwealth of Independent States, the Middle East, and South Africa. AstraZeneca and FibroGen continue to collaborate on the development and commercialization of roxadustat in China.

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 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and pyruvate kinase (PK) activation pioneering therapies for rare diseases, reported that the Company will receive a total of $1.1 billion in milestone payments following the U.S. Food and Drug Administration (FDA) approval of vorasidenib for adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery, including biopsy, sub-total resection or gross total resection (Press release, Agios Pharmaceuticals, AUG 6, 2024, View Source [SID1234645404]). These payments include a $905 million payment from Royalty Pharma in connection with the vorasidenib royalty purchase agreement Agios announced in May 2024 and a $200 million payment from Servier in connection with Agios’ divestiture of its oncology business in 2021.

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"Today’s FDA approval of vorasidenib is the first approval for a Grade 2 glioma in over 20 years and highlights both the executional excellence of the Servier team and Agios’ expertise in discovering novel therapies for disease areas of high unmet need," said Cecilia Jones, chief financial officer at Agios. "The $1.1 billion in milestone payments triggered by today’s approval further strengthens our cash position, which we expect will provide us with the financial independence to prepare for potential PYRUKYND (mitapivat) launches in thalassemia in 2025 and sickle cell disease in 2026, as well as drive pipeline progress as we aim to build a multi-billion-dollar franchise."

Agios completed the sale of its oncology business to Servier on March 31, 2021. Under the terms of the agreement, Agios received $1.8 billion in upfront cash, an additional $200 million milestone payment upon FDA approval of vorasidenib, and 15% royalties on potential U.S. net sales of vorasidenib from the first commercial sale through loss of exclusivity. Agios had also retained rights to 5% royalties on U.S. net sales of Servier’s TIBSOVO (ivosidenib tablets), which it sold for a one-time payment of $131.8 million in 2022.

On May 28, 2024, Agios announced that the company agreed to sell its rights to its 15% royalty on potential U.S. net sales of vorasidenib to Royalty Pharma. Under the terms of the agreement, Agios receives an upfront payment of $905 million upon FDA approval of vorasidenib, and Royalty Pharma will receive the entirety of the 15% royalty on annual U.S. net sales of vorasidenib up to $1 billion and a 12% royalty on annual U.S. net sales greater than $1 billion. Agios will retain a 3% royalty on annual U.S. net sales greater than $1 billion.

On August 6, 2024 Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, reported financial results for the three and six months ended June 30, 2024, and highlighted recent corporate updates (Press release, Heron Therapeutics, AUG 6, 2024, View Source [SID1234645420]).

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"We have had an exciting start to 2024 with many encouraging milestones that provide the foundation for ongoing commercial success. We are improving the financial efficiency of the business by growing revenues, improving margins, and reducing expenses. Regarding ZYNRELEF, we continue to expand our partnership with CrossLink and progress our regulatory activities in anticipation of a fourth quarter launch of the VAN," said Craig Collard, Chief Executive Officer of Heron.

Business Highlights

The range for adjusted operating expenses guidance for 2024 is being narrowed from $108.0 million to $116.0 million to a revised $107.0 million to $111.0 million. Additionally, the range for adjusted EBITDA guidance is being narrowed from $(22.0) million to $3.0 million to a revised $(10) million to $3.0 million.

The ZYNRELEF VAN PDUFA goal date is set for September 23, 2024. The VAN is designed to allow for easier and more efficient preparation and administration of ZYNRELEF in the operating room, with anticipated launch before year-end.

Our development program for the ZYNRELEF Prefilled Syringe ("PFS"), which will allow for immediate use of ZYNRELEF, continues to progress with an expected U.S. Food and Drug Administration ("FDA") submission for approval in 2026.

ZYNRELEF is included in the proposed 2025 NOPAIN Act under the Medicare hospital Outpatient Prospective Payment System ("OPPS") and the Medicare Ambulatory Surgical Center ("ASC") payment system (the "Proposed Rule") as a qualifying product effective April 1, 2025. The Proposed Rule’s April 1, 2025 effective date for ZYNRELEF is expected to allow ZYNRELEF to maintain separate reimbursement in the HOPD and ASC settings without disruption.

The training and integration of CrossLink sales representatives to promote ZYNRELEF to orthopedic surgeons continues its rapid progress. To date, 561 CrossLink sales representatives have completed training and are building the foundation for increased adoption.
Financial Guidance for 2024

The Company narrows its full-year 2024 guidance for Adjusted Operating Expenses and Adjusted EBITDA:

Product Revenues, Net

$138.0 to $158.0 million

Adjusted Operating Expenses

Original Revised

$108.0 to $116.0 million $107.0 to $111.0 million

Adjusted EBITDA

Original Revised

$(22.0) to $3.0 million $(10.0) to $3.0 million

Acute Care Franchise

Acute Care Franchise Net Product Sales: For the three and six months ended June 30, 2024, acute care franchise Net Product Sales were $6.8 million and $12.3 million, respectively, which increased from $4.5 million and $8.3 million, respectively, for the same period in 2023.

ZYNRELEF Net Product Sales: Net Product Sales of ZYNRELEF (bupivacaine and meloxicam) extended-release solution for the three and six months ended June 30, 2024 were $5.8 million and $10.8 million, respectively, which increased from $4.2 million and $7.7 million, respectively, for the same period in 2023.

APONVIE Net Product Sales: Net Product Sales of APONVIE for the three and six months ended June 30, 2024 were $1.0 million and $1.5 million, respectively, which increased from $0.3 million and $0.6 million, respectively, for the same period in 2023.
Oncology Care Franchise

Oncology Care Franchise Net Product Sales: For the three and six months ended June 30, 2024, oncology care franchise Net Product Sales were $29.2 million and $58.4 million, respectively, which increased from $27.3 million and $53.1 million for the same period in 2023.

CINVANTI Net Product Sales: Net Product Sales of CINVANTI (aprepitant) injectable emulsion for the three and six months ended June 30, 2024 were $24.9 million and $50.5 million, which increased from $24.5 million and $47.3 million for the same period in 2023.

SUSTOL Net Product Sales: Net Product Sales of SUSTOL (granisetron) extended-release injection for the three and six months ended June 30, 2024 were $4.3 million and $7.9 million, respectively, which increased from $2.8 million and $5.8 million, respectively, for the same period in 2023.
Conference Call and Webcast

Heron will host a conference call and webcast on August 6, 2024 at 4:30 p.m. ET. The conference call can be accessed by dialing (646) 307-1963 for domestic callers and (800) 715-9871 for international callers. Please provide the operator with the passcode 1737564 to join the conference call. The conference call will also be available via webcast under the Investor Relations section of Heron’s website at www.herontx.com. An archive of the teleconference and webcast will also be made available on Heron’s website for sixty days following the call.

About ZYNRELEF for Postoperative Pain

ZYNRELEF is the first and only dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF was initially approved by the FDA in May 2021 for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. In December 2021, the FDA approved an expansion of ZYNRELEF’s indication to include foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. On January 23, 2024, the FDA approved ZYNRELEF for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures.

Please see full prescribing information, including Boxed Warning, at www.ZYNRELEF.com.

About APONVIE for Postoperative Nausea and Vomiting (PONV)

APONVIE is a substance NK1 Receptor Antagonist (RA), indicated for the prevention of PONV in adults. Delivered via a 30-second IV push, APONVIE 32 mg was demonstrated to be bioequivalent to oral aprepitant 40 mg with rapid achievement of therapeutic drug levels. APONVIE is the same formulation as Heron’s approved drug product CINVANTI. APONVIE is supplied in a single-dose vial that delivers the full 32 mg dose for PONV. APONVIE was approved by the FDA in September 2022 and became commercially available in the U.S. on March 6, 2023.

Please see full prescribing information at www.APONVIE.com.

About CINVANTI for Chemotherapy Induced Nausea and Vomiting (CINV) Prevention

CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen, delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen, and nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen. CINVANTI is an IV formulation of aprepitant, an NK1 RA. CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND capsules. Aprepitant (including its prodrug, fosaprepitant) is a single-agent NK1 RA to significantly reduce nausea and vomiting in both the acute phase (0–24 hours after chemotherapy) and the delayed phase (24–120 hours after chemotherapy). The FDA-approved dosing administration included in the U.S. prescribing information for CINVANTI include 100 mg or 130 mg administered as a 30-minute IV infusion or a 2-minute IV injection.

Please see full prescribing information at www.CINVANTI.com.

About SUSTOL for CINV Prevention

SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-hydroxytryptamine type 3 RA that utilizes Heron’s Biochronomer drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL’s efficacy and safety in more than 2,000 patients with cancer. SUSTOL’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0–24 hours after chemotherapy) and delayed phase (24–120 hours after chemotherapy).

Please see full prescribing information at www.SUSTOL.com.

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.