On November 7, 2023 Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that Michael A. Metzger, Chief Executive Officer of Syndax, will participate in a fireside chat at the Stifel Healthcare Conference on Tuesday, November 14, 2023, at 4:45 p.m. ET (Press release, Syndax, NOV 7, 2023, View Source [SID1234637164]).

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A live webcast of the fireside chat can be accessed from the Investor section of the Company’s website at www.syndax.com, where a replay of the event will also be available for a limited time.

On November 7, 2023 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that Jack Khattar, President and CEO of Supernus Pharmaceuticals, will participate in a fireside chat at the Jefferies London Healthcare Conference on Wednesday, November 15, 2023, at 9:00 a.m. ET (2:00 p.m. GMT) at the Waldorf Hilton, London, UK (Press release, Supernus, NOV 7, 2023, View Source [SID1234637163]).

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Investors interested in arranging a meeting with company management during the conference should contact the Jefferies conference coordinator. A live audio webcast of the presentation can be accessed here or by visiting Events & Presentations in the Investor Relations section on the Company’s website at www.supernus.com. An archived replay of the webcast will be available for 60 days on the Company’s website following the conference.

On November 7, 2023 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 third quarter ended September 30, 2023, and provided recent business updates (Press release, Sensei Biotherapeutics, NOV 7, 2023, View Source [SID1234637162]).

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"The third quarter of 2023 was marked by significant progress, culminating in the presentation of favorable clinical data supporting our belief that our lead investigational candidate SNS-101 is a potentially transformative treatment in the oncology space with a best-in-class safety and pharmacokinetic profile," said John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics. "Clinical data to-date support our capability to execute on the promise and development of conditionally active antibodies, and we believe we are well-capitalized to advance SNS-101 clinically toward our near-term business and scientific milestones."

Highlights and Milestones

SNS-101

SNS-101 is a conditionally active antibody targeting the immune checkpoint VISTA (V-domain Ig suppressor of T cell activation), which is implicated in numerous cancer indications and whose 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. Recent updates include:

Enrollment as of November 6, 2023:
A total of 17 patients have been treated with SNS-101 across various dose levels, with 14 patients in the monotherapy arm and three patients in the combination arm.
In the monotherapy dose escalation arm, patients are enrolling at a dose level of 15 mg/kg after clearing dose levels of 0.3, 1, 3, and 10 mg/kg.
In the combination dose escalation arm, three patients have been enrolled in the first cohort which has cleared a dose level of 3.0 mg/kg SNS-101 + Libtayo.
On November 3, 2023, Sensei reported initial data from the monotherapy dose-escalation portion of the Phase 1/2 clinical trial for SNS-101 in a late-breaker poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 38th Annual Meeting, showing that SNS-101 has a potential best-in-class safety and pharmacokinetic profile, including, as of the safety cutoff date of October 3, 2023:
Safety, cytokine expression and pharmacokinetic data were presented for seven patients from the first three monotherapy cohorts, all of which have cleared the dose-limiting toxicity assessment period.
A total of 11 adverse events (including one serious adverse event not considered related to SNS-101) were reported in five patients, with no dose-limiting toxicities observed. Only one adverse event (Grade 2 dermatitis acneiform) was considered related to SNS-101.
There were no instances of cytokine release syndrome and no significant changes in key inflammatory cytokines over time, consistent with preclinical studies.
Pharmacokinetic data demonstrate dose-proportional exposure consistent with lack of target mediated drug disposition, no notable accumulation with repeat dosing, and linear elimination kinetics of SNS-101, in concordance with preclinical data.
On October 23, 2023, Sensei presented a trial-in-progress poster from the Phase 1/2 clinical trial for SNS-101 at the European Society for Medical Oncology Congress (ESMO) (Free ESMO Whitepaper) 2023.
On September 21, 2023, Sensei presented new preclinical data reinforcing SNS-101’s pharmacokinetic profile, safety characteristics, and mechanism of action at the Seventh Annual CRI-ENCI-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper): Translating Science into Survival (CICON).
Anticipated milestones for the SNS-101 Phase 1/2 clinical trial include:

Initial safety and pharmacokinetic data for the combination dose escalation arm of SNS-101 and Libtayo in Q1 2024
Topline data for the SNS-101 monotherapy dose escalation arm in Q2 2024
Topline data for the combination dose escalation arm of SNS-101 and Libtayo in 2024
Additional TMAb Pipeline and Platform Updates

Through its Tumor Microenvironment Activated biologics (TMAb) platform, Sensei is advancing several conditionally active antibody programs, including SNS-102 targeting VSIG4 (V-Set and Immunoglobulin Domain Containing 4), SNS-103 targeting ENTPDase1 (ecto-nucleoside triphosphate diphosphohydrolase-1, also known as CD39) and SNS-201, a VISTAxCD28 bispecific antibody.

Recent updates:

Sensei has selected a lead candidate for SNS-201, a conditionally active VISTAxCD28 bispecific antibody, supporting a mechanism focused on conditional activation of CD28 within low pH environments, such as the tumor microenvironment. CD28 is a major costimulatory pathway for T cells. Based on preclinical data of SNS-201 and a prototype molecule, Sensei believes SNS-201 has the potential to conditionally activate CD28 under low pH conditions, such as those found in the tumor microenvironment, leading to stimulation of T cell activation in the tumor while minimizing off-tumor toxicity.
Sensei has selected a lead candidate for SNS-102, a conditionally active antibody that potently blocks the interaction of VSIG4 with its novel counter-receptor and is 585-fold more selective for VSIG4 at low pH conditions. A counter-receptor has been provisionally identified and confirmation is in progress.
Sensei is continuing to evaluate two potential antibodies as potential lead candidates for SNS-103 (targeting CD39).
Upon successful candidate selection, Sensei expects to advance one product candidate toward early manufacturing activities and single-dose toxicology studies.
In August 2023, Sensei published a review article describing its pH-sensitive antibody engineering efforts, entitled "Conditionally Active, pH-Sensitive Immunoregulatory Antibodies Targeting VISTA and CTLA-4 Lead an Emerging Class of Cancer Therapeutics," in Antibodies, an international, peer-reviewed journal.
Corporate Updates

On November 1, 2023, Sensei announced the announced the appointment of Stephanie Krebs, MS, MBA, as Chief Business Officer.
Upcoming Events

Sensei will participate in the Jefferies London Healthcare Conference in London, UK from November 14-16, 2023.
Sensei will present at the Protein & Antibody Engineering Summit (PEGS-EU) in Lisbon, Portugal on Tuesday, November 14, 2023, at 5:00 p.m. CET.
Third Quarter 2023 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $72.0 million as of September 30, 2023, as compared to $107.1 million as of December 31, 2022. The decrease is due to cash used to fund operations and $9.8 million relating to shares repurchased during the nine months ended September 30, 2023. Sensei expects its current cash balance to fund operations into the second half of 2025.

Research and Development (R&D) Expenses: R&D expenses were $3.8 million for the quarter ended September 30, 2023, compared to $9.2 million for the quarter ended September 30, 2022. The decrease in R&D expenses was primarily attributable to lower manufacturing-related expenses, lower personnel costs due to the Company’s December 2022 restructuring and lower expense relating to lab supply purchases, partially offset by higher expense associated with clinical trials.

General and Administrative (G&A) Expenses: G&A expenses were $3.9 million for the quarter ended September 30, 2023, compared to $4.8 million for the quarter ended September 30, 2022. The decrease in G&A expense was primarily attributable to decreased personnel costs due to the Company’s December 2022 restructuring and lower expense related to directors and officers insurance.

Net Loss: Net loss was $7.1 million for the quarter ended September 30, 2023, compared to $13.4 million for the quarter ended September 30, 2022.

On November 7, 2023 Scholar Rock (NASDAQ: SRRK), a Phase 3 clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported financial results and corporate updates for the third quarter ended September 30, 2023 (Press release, Scholar Rock, NOV 7, 2023, View Source [SID1234637161]).

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"We have made significant progress across our pipeline over the last quarter, including completing enrollment of our Phase 3 SAPPHIRE trial of apitegromab, which was designed to build on the positive Phase 2 TOPAZ results. Based on the sustained improvement in motor function that was observed after 36 months of treatment in the TOPAZ trial, the favorable safety and tolerability profile, and the high continued participation rate in our long-term extension study, we believe apitegromab has the potential to be a transformative therapy for SMA patients," said Jay Backstrom, M.D., MPH, President and Chief Executive Officer of Scholar Rock. "Further, we are excited to leverage our expertise in selective myostatin inhibition and expand into cardiometabolic disorders, including obesity. We believe our highly selective myostatin inhibitor SRK-439 has the potential to help patients retain lean muscle mass, which has been a key obstacle for many on GLP-1 receptor agonist therapy, and we plan to file an IND in 2025 to initiate clinical testing of SRK-439 in combination with GLP-1 receptor agonists."

"Additionally, we recently presented new clinical and biomarker data from the Phase 1 DRAGON trial that demonstrated the therapeutic potential of SRK-181 in heavily pretreated patients with anti-PD-1 resistant clear cell renal cell carcinoma. We believe that the DRAGON trial has achieved the objective of establishing proof of concept that our highly selective approach to blocking latent TGFβ1 can restore sensitivity to a checkpoint inhibitor, most notably in those with anti-PD-1 resistant ccRCC and supports further development of SRK-181," he added.

Recent Company Highlights and Upcoming Milestones

Spinal Muscular Atrophy (SMA) Program

Apitegromab is an investigational fully human monoclonal antibody that inhibits myostatin activation by selectively binding the pro- and latent forms of myostatin in skeletal muscle and is being developed as a potential first muscle-targeted therapy for the treatment of SMA.

Completed enrollment of its pivotal Phase 3 SAPPHIRE clinical trial. The Company announced that it completed enrollment in September 2023, with topline data expected in the fourth quarter of 2024. If successful and if approved, the Company expects to initiate a commercial product launch in 2025.
Presented encore 36-month extension data from the Phase 2 TOPAZ trial at the 28th Annual Congress of the World Muscle Society in October. The Company presented encore data from its Phase 2 TOPAZ trial extension period evaluating patient outcomes in SMA after 36 months of treatment of apitegromab, which showed long-term sustained improvements in motor function and in patient-reported outcome measures in patients with nonambulatory Types 2 and 3 SMA receiving survival motor neuron (SMN) therapy.
ONYX long-term extension study for patients from both the TOPAZ and SAPPHIRE studies remains ongoing.
Immuno-Oncology Program

SRK-181 is an investigational selective inhibitor of latent TGFβ1 activation and is being developed with the aim of overcoming resistance to checkpoint therapy in patients with advanced cancer.

Presented clinical and biomarker data from Phase 1 DRAGON proof-of-concept trial at the SITC (Free SITC Whitepaper) 38th Annual Meeting. The Company presented new data from its Phase 1 DRAGON proof-of-concept trial. As of the August 29, 2023 data cutoff, SRK-181 data showed favorable tolerability and promising anti-tumor activity in heavily pretreated patients with clear cell renal cell carcinoma (ccRCC) resistant to anti-PD-1. Of 28 evaluable patients in the ccRCC cohort, six patients had confirmed partial responses and achieved a best tumor reduction of 33% to 93%. The objective response rate (ORR) was 21.4% and the disease control rate was 57%. Circulating granulocytic myeloid-derived suppressor cell (gMDSC) levels correlated with better clinical responsiveness in ccRCC patients treated with SRK-181 in combination with pembrolizumab. The Company believes these data from the Phase 1 DRAGON trial supports proof of concept and that the trial has met its primary objectives. The Company is completing enrollment of the trial in December 2023, while continuing to treat patients who remain on study.
Cardiometabolic Program

SRK-439 is a novel, preclinical investigational myostatin inhibitor that has high in vitro affinity for pro- and latent myostatin, maintenance of myostatin specificity (i.e., no GDF11 or Activin-A binding), and is initially being developed for the treatment of obesity.

Plans to initiate a Phase 2 proof-of-concept trial with apitegromab in combination with a GLP-1 receptor agonist (GLP-1 RA) in obesity in 2024. As part of the Company’s strategy to advance the development of SRK-439, it plans to initiate a Phase 2 proof-of-concept trial with apitegromab in combination with a GLP-1 RA in 2024, subject to IND clearance. Data from the clinical trial are expected in mid-2025 and will be used to inform further clinical development of SRK-439. The Company plans to file an IND for SRK-439 for the treatment of obesity in 2025.
Third Quarter 2023 Financial Results

For the quarter ended September 30, 2023, net loss was $42.4 million compared to a net loss of $43.3 million for the quarter ended September 30, 2022.

The Company did not record any revenue for either the quarter ended September 30, 2023 or September 30, 2022.
Research and development expense was $30.3 million for the quarter ended September 30, 2023, compared to $33.4 million for the quarter ended September 30, 2022.
General and administrative expense was $13.3 million for the quarter ended September 30, 2023, compared to $10.5 million for the quarter ended September 30, 2022.
As of September 30, 2023, Scholar Rock had cash, cash equivalents, and marketable securities of approximately $218.6 million, which in addition to approximately $92.5 million of net proceeds from the October 2023 equity offering, is projected to fund the Company’s anticipated operating and capital expenditure requirements into the second half of 2025.
"Our upsized public offering achieved two key objectives: it enables us to bring our expertise to the cardiometabolic and obesity space with SRK-439, a highly selective myostatin inhibitor, and it extends our cash runway well past our upcoming SAPPHIRE Phase 3 data read out in Q4 2024," said Ted Myles, Chief Operating Officer and Chief Financial Officer of Scholar Rock. "We are executing against our plan and we are well positioned going into 2024."

Conference Call and Webcast
The Company’s earnings conference call for the third quarter will be held at 8:00 a.m. ET on November 7, 2023. To access the conference call by phone, participants may register here to receive the dial-in number and unique PIN. A live webcast of the conference call will be available on the Investors & Media section of the Scholar Rock website at View Source An archived replay of the webcast will be available for approximately 90 days following the call.

About the Phase 3 SAPPHIRE Trial
SAPPHIRE is an ongoing randomized, double-blind, placebo-controlled, Phase 3 clinical trial evaluating the safety and efficacy of apitegromab in nonambulatory patients with Types 2 and 3 SMA who are receiving SMN-targeted therapy (either nusinersen or risdiplam). SAPPHIRE targeted enrolling approximately 156 patients aged 2-12 years old in the main efficacy population. These patients were randomized 1:1:1 to receive for 12 months either apitegromab 10 mg/kg, apitegromab 20 mg/kg, or placebo by intravenous (IV) infusion every 4 weeks. An exploratory population that targeted enrolling up to 48 patients aged 13-21 years old will also separately be evaluated. These patients were randomized 2:1 to receive either apitegromab 20 mg/kg or placebo. For more information about SAPPHIRE, visit www.clinicaltrials.gov. Apitegromab has not been approved for any use by the US FDA or any other health authority, and its safety and efficacy have not been established.

About SRK-181 & the Phase 1 DRAGON Proof-of-Concept Trial
SRK-181 is a selective inhibitor of TGFβ1 activation being developed to overcome primary resistance to checkpoint inhibitor therapy, such as anti-PD-(L)1 antibodies, in advanced cancer. TGFβ1 is the predominant TGFβ isoform expressed in many human tumor types. Based on analyses of various human tumors that are resistant to anti-PD-(L)1 therapy, data suggest that TGFβ1 is a key contributor to the immunosuppressive tumor microenvironment, excluding and preventing entry of cytotoxic T cells into the tumor, thereby inhibiting anti-tumor immunity. 1

SRK-181 specifically targets the latent TGFβ1 isoform in a context-independent manner, designed to enable complete inhibition of TGFβ1 in all compartments within the tumor microenvironment. Scholar Rock believes that SRK-181 has the potential to overcome this immune cell exclusion and induce tumor regression when administered in combination with anti-PD-(L)1 therapy while potentially avoiding toxicities associated with non-selective TGFβ inhibition. The Phase 1 DRAGON proof-of-concept clinical trial (NCT04291079) in patients with locally advanced or metastatic solid tumors is ongoing. The trial is currently enrolling and dosing patients in multiple proof of concept cohorts conducted in parallel, including urothelial carcinoma (UC), cutaneous melanoma (MEL), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and clear cell renal cell carcinoma (ccRCC). SRK-181 is an investigational product candidate, and its efficacy and safety have not been established. SRK-181 has not been approved for any use by the FDA or any other regulatory agency.

On November 7, 2023 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) reported financial results for the third quarter ended September 30, 2023, including sales of TAVALISSE (fostamatinib disodium hexahydrate) tablets for the treatment of adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment and sales of REZLIDHIA (olutasidenib) capsules for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test (Press release, Rigel, NOV 7, 2023, View Source [SID1234637160]).

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"The third quarter of 2023 was marked by strong momentum from our commercial hematology-oncology portfolio driven by record TAVALISSE net product sales and growing REZLIDHIA awareness among leukemia treaters," said Raul Rodriguez, Rigel’s president and CEO. "These strong net sales combined with our expense discipline have allowed us to make substantial progress on our plan to reach financial breakeven."

Business Update

· In the third quarter of 2023, a total of 2,551 bottles of TAVALISSE were sold in the U.S. During the quarter, 2,412 bottles were shipped directly to patients and clinics, representing the highest number of bottles shipped to patients and clinics in a quarter since launch.

· During the third full quarter of launch, a total of 210 bottles of REZLIDHIA were sold in the U.S. During this quarter, 221 bottles were shipped directly to patients and clinics.

· Last week, Rigel announced four poster presentations highlighting data from the Company’s commercial and clinical-stage hematology-oncology portfolio at the upcoming 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition. Included is a poster, Abstract #2888, reporting post hoc analyses in a subset of patients with mIDH1 R/R AML or MDS that were R/R to hematopoietic stem cell transplant (HSCT), ivosidenib (IVO), or venetoclax (VEN). The analyses suggest that olutasidenib alone or in combination with azacitidine may induce complete remissions in these patients. To learn more about Rigel’s clinical and commercial hematology-oncology portfolio visit Booth #2805 during ASH (Free ASH Whitepaper) 2023.

· Rigel continues to advance its open-label, Phase 1b clinical trial of R2891, an investigational, potent, and selective IRAK1/4 inhibitor, in patients with lower-risk myeloid dysplastic syndrome (LR-MDS) who are refractory/resistant to prior therapies. Target enrollment in the second cohort of the trial has been completed and Rigel is currently enrolling patients in the third cohort. Preliminary data results are expected by mid-year 2024.

· In September, the Data and Safety Monitoring Board (DSMB) recommended that the fostamatinib study arm of the ACTIV-4 Host Tissue (NECTAR) platform cease enrollment. No safety concerns were identified. The National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health, concurs with the DSMB’s recommendations and has asked the trial investigators to cease enrollment, complete follow-up for participants already enrolled, and complete study closeout. The full study data will be analyzed and disseminated as previously planned.

Financial Update

For the third quarter of 2023, Rigel reported a net loss of $5.7 million, or $0.03 per basic and diluted share, compared to a net loss of $19.0 million, or $0.11 per basic and diluted share, for the same period of 2022.

For the third quarter of 2023, total revenues were $28.1 million, consisting of $24.5 million in TAVALISSE net product sales, $2.7 million in REZLIDHIA net product sales, and $1.0 million in contract revenues from collaborations. TAVALISSE net product sales of $24.5 million increased by $5.3 million, or 27%, compared to $19.2 million in the same period of 2022. Contract revenues from collaborations for the third quarter of 2023 consisted primarily of royalty revenue from Grifols S.A. (Grifols) of $0.8 million.

For the third quarter of 2023, total costs and expenses were $32.6 million, compared to $40.8 million for the same period of 2022. The decrease in costs and expenses was partly due to decreased research and development costs due to the completion of activities related to the Phase 3 clinical trial of fostamatinib in wAIHA and the Phase 3 clinical trial of fostamatinib in high-risk hospitalized patients with COVID-19. Also contributing to the decrease, were lower facility-related costs and an upfront payment to Forma Therapeutics Inc. (Forma, now Novo Nordisk) recorded as in-process research and development (IPR&D) and included within cost and expenses in the third quarter of 2022. These decreases were partially offset by increased research and development costs due to the timing of activities related to the IRAK 1/4 inhibitor program.

For the nine months ended September 30, 2023, Rigel reported a net loss of $25.8 million, or $0.15 per basic and diluted share, compared to a net loss of $60.0 million, or $0.35 per basic and diluted share, for the same period of 2022.

For the nine months ended September 30, 2023, total revenues were $81.1 million, consisting of $68.1 million in TAVALISSE net product sales, $6.7 million in REZLIDHIA net product sales, $5.3 million in contract revenues from collaborations, and $1.0 million in government contract revenue. TAVALISSE net product sales of $68.1 million increased by $14.1 million, or 26%, compared to $53.9 million in the same period of 2022. Contract revenues from collaborations for the nine months ended September 30, 2023, consisted primarily of revenue from Grifols related to the delivery of drug supplies of $2.8 million and a royalty of $2.3 million. Government contract revenue for the nine months ended September 30, 2023, was related to income recognized in the second quarter of 2023 pursuant to the agreement with the U.S. Department of Defense to support Rigel’s Phase 3 clinical trial of fostamatinib in high-risk hospitalized patients with COVID-19.

For the nine months ended September 30, 2023, total costs and expenses were $103.5 million, compared to $126.6 million for the same period of 2022. The decrease in costs and expenses was partly due to decreased research and development costs due to the completion of trial activities related to the Phase 3 clinical trial of fostamatinib in wAIHA and the Phase 3 clinical trial of fostamatinib in high-risk hospitalized patients with COVID-19, as well as timing of activities related to the IRAK 1/4 inhibitor program. Also contributing to the decrease were lower facility-related costs, and an upfront payment to Forma (now Novo Nordisk) recorded as IPR&D and included within cost and expenses in the third quarter of 2022.

As of September 30, 2023, Rigel had cash, cash equivalents and short-term investments of $62.4 million, compared to $58.2 million as of December 31, 2022.

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.