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Gritstone bio Reports Third Quarter 2023 Financial Results and Provides Corporate Updates

On November 8, 2023 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, reported financial results for the third quarter ended September 30, 2023 and provided recent corporate and clinical updates (Press release, Gritstone Bio, NOV 8, 2023, View Source [SID1234637258]).

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"As cancer and infectious diseases continue to challenge human health across the globe, we at Gritstone continue advancing our vision to deliver more potent and durable vaccines," said Andrew Allen, M.D., Ph.D., Co-founder, President, and Chief Executive Officer of Gritstone bio. "The ongoing advancement of our CORAL program positions our infectious disease approach, which combines self-amplifying mRNA (samRNA) with novel B and T cell targets, as a leading potential next-generation vaccine platform for COVID-19 and beyond. We believe the data recently shared at IDWeek underscore the promise of this novel approach to drive broad and long-lasting clinical protection against COVID-19 with vaccine-elicited neutralizing antibodies against the virus persisting at high concentrations for at least 12 months, unlike current approved vaccines. In oncology, preliminary findings from the randomized Phase 2/3 study of our personalized cancer vaccine, GRANITE, in MSS-CRC are rapidly approaching. This is important data not only for Gritstone but for the field, as GRANITE represents an opportunity to bring a new class of therapy to patients with ‘cold’ solid tumors, for whom the benefits of today’s immunotherapies are minimal. The scientific bedrock of GRANITE extends to SLATE, where our collaboration with Steven A. Rosenberg and the NCI is now advancing. With GRANITE and CORAL now in or entering randomized Phase 2 studies, Gritstone stands at the precipice of unlocking the full potential of our novel vaccine platforms in both oncology and infectious diseases."

Corporate Update

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In August 2023, Gritstone and Genevant Sciences entered into a multi-year option and license agreement that provides Gritstone with nonexclusive access to Genevant’s leading LNP technology, on a pathogen-by-pathogen basis, for development and commercialization of Gritstone’s samRNA infectious disease vaccines.

Clinical Program Updates

Tumor-Specific Neoantigen Oncology Programs (GRANITE and SLATE)

GRANITE – Personalized neoantigen vaccine program
SLATE – "Off-the-shelf" neoantigen vaccine program

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The Phase 2 portion of the Phase 2/3 study evaluating GRANITE as a maintenance therapy in first-line MSS-CRC remains ongoing, and preliminary efficacy data from the Phase 2 portion remain expected in the first quarter of 2024. Gritstone met its enrollment target of 100 patients randomized in August 2023.
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The clinical trial collaboration with the National Cancer Institute (NCI) to evaluate an autologous T cell therapy in combination with Gritstone’s KRAS-directed "off the shelf" vaccine candidate, SLATE-KRAS, is ongoing. An IND to run a Phase 1 study was cleared by the U.S. Food and Drug Administration (FDA) in October 2023. The study is led by Steven A. Rosenberg, M.D., Ph.D., Chief of the Surgery Branch at the NCI’s Center for Cancer Research. Under the terms of the collaboration, Gritstone will provide the SLATE-KRAS vaccine as requested by NCI. NCI will be responsible for conducting the study at the NIH Clinical Center.
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Gritstone intends to initiate a randomized Phase 2 clinical trial within SLATE ("off-the-shelf" neoantigen vaccine program) in 2024.

Infectious Disease Programs

CORAL – Next-generation SARS-CoV-2 vaccine program that serves as proof-of-concept for Gritstone’s samRNA platform and novel approach in infectious diseases

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In September 2023, Gritstone was awarded a contract by BARDA (the Biomedical Advanced Research and Development Authority), part of the Administration for Strategic Preparedness and Response in the U.S. Department of Health and Human Services, to conduct a Phase 2b comparative study evaluating its next-generation vaccine candidate against COVID-19(a). Per the contract, which is valued at up to $433.0 million, Gritstone is currently preparing to conduct a 10,000 participant, randomized Phase 2b double-blinded study to compare the efficacy, safety, and immunogenicity of Gritstone’s samRNA vaccine candidate against an approved COVID-19 vaccine. Preparations for the study are covered under the initial base period of the contract. Gritstone expects the study to be initiated in the first quarter of 2024.
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In October 2023, new data was presented from Gritstone’s three Phase 1 CORAL studies. Results across these studies highlighted the potential of Gritstone’s next-generation samRNA-based approach, which incorporates Spike plus other viral targets ("Spike plus"), to drive broad and long-lasting clinical protection against COVID-19. Highlights from the data, which were presented at IDWeek 2023, include:
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High neutralizing antibody (nAb) responses were sustained through the latest evaluable timepoints across all three studies, highlighting potential for durable clinical protection.
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High nAb levels were demonstrated through at least 12 months in the CORAL-CEPI and CORAL-BOOST studies and at least 6 months in the CORAL-NIH study.
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T cell responses to Spike plus other viral targets observed in all Phase 1 studies, demonstrating broad and potentially variant-proof immune response.
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Vaccine candidates were generally well tolerated in all Phase 1 studies; over 300 subjects dosed to date. See all poster presentations here: CORAL-CEPI, CORAL-BOOST, CORAL-NIH

HIV – Collaboration with Gilead under Gilead’s HIV Cure Program to research and develop vaccine-based HIV immunotherapy treatment

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The collaboration with Gilead to research and develop a vaccine-based HIV immunotherapy treatment remains active and ongoing.

Third Quarter 2023 Financial Results

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Cash, cash equivalents, marketable securities and restricted cash were $90.5 million as of September 30, 2023, compared to $185.2 million as of December 31, 2022.

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Research and development expenses were $32.8 million for the three months ended September 30, 2023, compared to $26.4 million for the three months ended September 30, 2022. The increase of $6.3 million was primarily due increases of $2.5 million in milestone and license payments, $1.0 million in personnel-related expenses, $2.0 million in facilities-related costs, and $0.9 million in outside services, consisting primarily of clinical trial and other chemistry, manufacturing and controls-related expenses, offset by decreases of $0.1 million in laboratory supplies.

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General and administrative expenses were $7.4 million for the three months ended September 30, 2023, compared to $6.5 million for the three months ended September 30, 2022. The increase of $0.9 million was primarily due to increases of $0.5 million in outside services, $0.2 million in personnel-related expenses, and $0.2 million in facilities-related costs.

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Collaboration, license, and grant revenues were $1.6 million for the three months ended September 30, 2023, compared to $3.0 million for the three months ended September 30, 2022. During the three months ended September 30, 2023, we recorded $0.1 million in collaboration revenue related to the Gilead collaboration agreement, $0.3 million in collaboration revenue related to the 2seventy agreement, $0.8 million in grant revenue from the CEPI funding agreement, and $0.4 million in grant revenue pursuant to the Gates grant agreement.

Fate Therapeutics Reports Third Quarter 2023 Financial Results and Business Updates

On November 8, 2023 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disorders, reported business highlights and financial results for the third quarter ended September 30, 2023 (Press release, Fate Therapeutics, NOV 8, 2023, View Source [SID1234637257]).

"We achieved several key milestones for our iPSC product platform in oncology and autoimmunity, creating additional opportunities to generate new clinical data across multiple programs during 2024," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "We have initiated patient enrollment in our Phase 1 study of FT522, our ADR-armed, CD19-targeted CAR NK cell program, where we intend to assess FT522 with and without conditioning chemotherapy in patients with B-cell lymphoma. In addition, our IND application was cleared by the FDA for FT825/ONO-8250 in solid tumors under our collaboration with ONO Pharmaceutical, which multiplexed-engineered CAR T-cell program incorporates seven synthetic controls of cell function including a novel cancer-specific binding domain targeting HER2. Finally, I am pleased to announce the expansion of our iPSC product platform into autoimmunity with the clearance by the FDA of our IND application for FT819, our off-the-shelf, CD19-targeted CAR T-cell program, in systemic lupus erythematosus."

FT522 iPSC-derived CAR NK Cell Program in B-cell Lymphoma

Phase 1 Study of ADR-armed, CD19-targeted CAR NK Cell Program Open for Enrollment. FT522 is the Company’s off-the-shelf, multiplexed-engineered natural killer (NK) cell product candidate that incorporates five synthetic controls of cell function. It is the Company’s first product candidate armed with its proprietary alloimmune defense receptor (ADR) technology, which is comprised of a synthetic engineered receptor targeting 4-1BB expressed on alloreactive immune cells. In preclinical studies, engagement of ADR-armed CAR NK cells with alloreactive immune cells mitigated rejection, promoted cellular proliferation, and increased anti-tumor activity, indicating that ADR-armed CAR NK cells may be effective without requiring administration of intensive conditioning chemotherapy to patients. The Phase 1 study of FT522 in combination with rituximab for relapsed / refractory B-cell lymphoma (BCL) is designed to assess safety, pharmacokinetics, and activity with and without administration of a standard three-day preconditioning regimen to patients. Enrollment into the first three-dose cohort at 300 million cells per dose has been initiated. The Company is also assessing in preclinical studies the potential of FT522 to induce benefit across a range of autoimmune diseases.

FT825/ONO-8250 iPSC-derived CAR T-cell Program in Solid Tumors

IND Application Cleared by FDA for Multiplexed-engineered, CAR T-cell Program Incorporating Seven Novel Synthetic Controls of Cell Function. Under the Company’s collaboration with ONO Pharmaceutical Co., Ltd. (ONO), the companies are co-developing FT825/ONO-8250, an iPSC-derived CAR T-cell product candidate that incorporates a novel cancer-specific H2CasMab-2 CAR targeting HER2 and is designed to overcome unique challenges in treating solid tumors. The Company’s Investigational New Drug (IND) application for FT825/ONO-8250 was cleared by the U.S. Food and Drug Administration (FDA) in October for conduct of a Phase 1 study in patients with advanced solid tumors. The dose-escalation schema includes two treatment regimens: single-dose FT825/ONO-8250 as monotherapy; and FT825/ONO-8250 in combination with cetuximab. Novel synthetic controls incorporated into the multiplexed-engineered CAR T-cell product candidate include a CXCR2 receptor to promote cell trafficking, a chimeric TGFβ receptor to redirect immunosuppressive signals in the tumor microenvironment, and a high-affinity, non-cleavable CD16a receptor to promote antibody-dependent cellular cytotoxicity. Preclinical data of FT825/ONO-8250, which was presented at the 2023 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, demonstrated that the antigen binding profile of H2CasMab-2 is unique and differentiated from that of trastuzumab, exhibiting similar potency with greater specificity for malignant HER2-expressing cells.

FT819 iPSC-derived CAR T-cell Program in Systemic Lupus Erythematosus and B-cell Malignancies

Expansion into Autoimmunity with Phase 1 Study Start-up Ongoing in SLE. In July, the Company’s IND application was cleared by the FDA for clinical investigation of FT819 in patients with systemic lupus erythematosus (SLE), including those with active lupus nephritis (LN) or active SLE without renal involvement. FT819 is the Company’s off-the-shelf, iPSC-derived CAR T-cell product candidate that incorporates several novel synthetic controls of cell function including the integration of a novel CD19-targeted 1XX CAR construct into the T-cell receptor alpha constant (TRAC) locus, which is intended to promote uniform CAR expression, enhance T-cell potency, and prevent graft-versus-host disease. The clinical trial is designed to evaluate the safety, pharmacokinetics, anti-B-cell activity of a single dose of FT819 administered following a standard three-day preconditioning regimen. The FT819 Phase 1 protocol received a favorable review by clinical experts of the Protocol Design Committee of Lupus Therapeutics, an affiliate of the Lupus Research Alliance.

Phase 1 Study Advancing in Single-dose Escalation Cohorts for B-cell Malignancies. The Company’s landmark Phase 1 clinical trial of FT819 is the first-ever clinical investigation of a T-cell product candidate manufactured from a clonal master iPSC line. The Company is currently enrolling patients in single-dose treatment cohorts at 540 million cells in BCL and at 360 million cells in chronic lymphocytic leukemia using a standard three-day preconditioning regimen. Clinical data previously presented by the Company from the first 11 patients with relapsed / refractory BCL treated with a single dose of FT819 at up to 360 million cells showed anti-tumor activity including three complete responses and one partial response, CAR T-cell expansion that peaked in the peripheral blood between Days 8 and 11, and a favorable safety profile with no immune effector-cell associated neurotoxicity syndrome (ICANS) and mild cytokine release syndrome (CRS).

FT576 iPSC-derived CAR NK Cell Program in Multiple Myeloma

Phase 1 Study Accruing Patients in Three-dose Treatment Cohorts. The Company’s Phase 1 study of FT576, its multiplexed-engineered BCMA-targeted CAR NK cell product candidate for relapsed / refractory multiple myeloma, is currently enrolling patients in two, three-dose treatment cohorts at 1 billion cells per dose. The Company has treated three patients as monotherapy as well as two patients in combination with CD38-targeted monoclonal antibody therapy to assess the therapeutic potential of dual-antigen targeting of myeloma cells, with no dose-limiting toxicities reported by investigators in either cohort.

Third Quarter 2023 Financial Results

Cash & Investment Position: Cash, cash equivalents and investments as of September 30, 2023 were $349.7 million. In addition, as of September 30, 2023, cash receivables from the Company’s collaboration with ONO were $1.5 million.
Total Revenue: Revenue was $1.9 million for the third quarter of 2023, which was derived from the Company’s conduct of preclinical development activities for a second collaboration candidate targeting an undisclosed solid tumor antigen under its collaboration with ONO.
Total Operating Expenses: For the third quarter of 2023, GAAP operating expenses were $53.2 million, including research and development expenses of $34.3 million and general and administrative expenses of $18.9 million. Such amounts included $10.1 million of non-cash stock-based compensation expense.
Shares Outstanding: Common shares outstanding were 98.6 million, and preferred shares outstanding were 2.8 million, as of September 30, 2023. Each preferred share is convertible into five common shares.

Today’s Conference Call and Webcast

The Company will conduct a conference call today, Wednesday, November 8, 2023 at 5:00 p.m. ET to review financial and operating results for the quarter ended September 30, 2023. In order to participate in the conference call, please register using the conference link here. The live webcast can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.

Evotec SE reports results for the first nine months 2023 and provides corporate update

On November 8, 2023 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported the financial results and corporate updates for the first nine months 2023 (Press release, Evotec, NOV 8, 2023, View Source [SID1234637256]).

HIGHLIGHTS

EVOTEC’S TOPLINE SUCCESS REFLECTS STRONG DEMAND

Group revenues increased by 14% (19% excluding fx-effects) to € 580.1 m (9M 2022: € 510.8 m); excluding a lower contribution from milestones, upfronts and license payments, Base business at € 575.3 m (9M 2022: € 502.8 m) continued to show comparable growth of 14%.
Costs of € 43.9 m were incurred in 2023 as a direct result of the cyber-incident in early April, including additional external expenditures and internal recovery contributions.
Total EVT Execute revenues (incl. intersegment revenues) up 3% to € 543.4 m (9M 2022: € 526.7 m), strongly affected by cyber-incident; EVT Innovate revenues up 64% to € 199.9 m (9M 2022: € 121.9 m).
Adjusted Group EBITDA increased by 13% to € 50.2 m (9M 2022: € 44.6 m); continued work on key collaborations has partially compensated for underutilised capacities as a result of the cyber-attack.

STRENGTHENING ACTIVITIES THROUGH INTEGRATED R&D AND PRECISION MEDICINE PLATFORMS

Multiple new and extended integrated drug discovery and development agreements all along the drug discovery & development value chain (e.g., new INDiGO agreement with Matchpoint Therapeutics)
Extension and expansion of strategic neurodegeneration partnership with Bristol Myers Squibb ("BMS"), and strong progress in strategic targeted protein degradation partnership with BMS
Co-owned pipeline progress: Positive Phase I read-out for EVT8683, start of Phase I trial for EVT401
Further value creation through academic partnerships (BRIDGEs): Launch of "LAB eN²" with Novo Nordisk and academic institutions Harvard University, Mass General Brigham, Yale University, and Beth Israel Deaconess Medical Center
New partnering agreement to strengthen biotech innovators in shared R&D economy with LabCentral, BioLabs, and MBC BioLabs

Events after Period-End

Launch of "65LAB", Evotec’s first BRIDGE partnership in Asia
Co-owned pipeline updates: Presentation of biomarkers data on EVT801, Exscientia decided to de-prioritise EXS21546
New participation in iCARE4CVD, a consortium to personalise prevention and treatment of cardiovascular diseases
New strategic partnership with Dewpoint Therapeutics in oncology

CORPORATE
Opening of new state-of-the-art biology facility on Dorothy Crowfoot Hodgkin Campus

Events after Period-End

Evotec receives SBTi validation and approval of its near-term emission reduction targets
In October, Evotec’s management started the social process of redeploying its chemistry activities out of Marcy (Lyon), as part of its Value Protection Plan ("VPP")

BUSINESS OUTLOOK FOR FULL-YEAR 2023 AND MID-TERM GOALS 2025 CONFIRMED
Group revenues expected to be in a range of € 750 – 790 m or € 765 – 805 m at constant exchange rates (2022: € 751 m).
Adjusted Group EBITDA expected to be in the range of € 60 – 80 m, translating into € 70 – 90 m at constant exchange rates (2022: € 102 m).
Unpartnered research and development expenses expected to be in a range of € 60 – 70 m (2022: € 70 m).
Mid-term goals target revenue growth to > € 1,000 m, adjusted EBITDA of ≥ € 300 m and unpartnered research and development expenses of > € 100 m.

Due to the criminal cyber-attack discovered on 6 April 2023, productivity was affected in the second and third quarters. In response to the criminal cyber-attack, Evotec took immediate action to contain and remediate the attack by taking its external-facing systems offline. This was deemed necessary to protect all the Company’s partners and stakeholders and meant Evotec could ensure that the integrity of scientific data remained unaffected.

More detailed information and financial tables are available in our interim statement 9M published on the Evotec website under the following link: View Source

WEBCAST / CONFERENCE CALL
The Company is going to hold a conference call to discuss the results as well as provide an update on its performance. The conference call will be held in English.

Webcast details

Date: Wednesday, 08 November 2023

Time: 2.00 pm CET (01.00 pm GMT, 08.00 am EST)

To join the audio webcast and to access the presentation slides, please register via this link.

The on-demand version of the webcast will be available on our website: www.evotec.com/financial-reports.

Conference call details

To join via phone, please pre-register via this link. You will then receive a confirmation email with dedicated dial-in details such as telephone number, access code and PIN to access the call.

A simultaneous slide presentation for participants dialling in via phone is available under this link.

EMERGENT BIOSOLUTIONS REPORTS THIRD QUARTER 2023 FINANCIAL RESULTS

On November 8, 2023 Emergent BioSolutions Inc. (NYSE: EBS) reported selected financial results for the third quarter ended September 30, 2023 (Press release, Emergent BioSolutions, NOV 8, 2023, View Source [SID1234637255]). The selected financial results reported include limited third quarter and year-to-date results, as well as selected balance sheet and cash flow information. As part of our quarterly review process, the Company determined that its state deferred tax liability was overstated as of December 31, 2022, resulting in an understatement of the income tax benefits reflected on the Company’s income statement. While these non-cash items do not have any impact on the Company’s liquidity, cash flow, historical management compensation or covenant compliance, we have concluded that it is appropriate to delay the disclosure of full third quarter and year-to-date earnings information and the filing of our Quarterly Report on Form 10-Q for the period ended September 30, 2023 while we work to correct our prior period financial statements. We expect to complete this work in the near future.

"As we work diligently toward filing our Form 10-Q, Emergent continues to strengthen its financial position and streamline operations, which remains critical to the company’s strategy to return to growth and preserve its unique capabilities to help protect and enhance life," said interim Chief Executive Officer Haywood Miller. "We are proud of the progress we are making across our core products business, including the recent over-the-counter launch of NARCAN Nasal Spray, which expands access and awareness to help save more lives impacted by the devastating opioid crisis. As we look ahead, we plan to continue protecting against public health threats for years to come."

Cullinan Oncology Provides Corporate Update and Reports Third Quarter 2023 Financial Results

On November 8, 2023 Cullinan Oncology, Inc. (Nasdaq: CGEM; "Cullinan") a biopharmaceutical company focused on modality-agnostic targeted oncology therapies, reported on recent and upcoming business highlights and announced its financial results for the third quarter ended September 30, 2023 (Press release, Cullinan Oncology, NOV 8, 2023, View Source [SID1234637254]).

"We have made tremendous strides through the first three quarters of 2023, while positioning Cullinan for a data-rich 2024," said Nadim Ahmed, Chief Executive Officer of Cullinan Oncology. "We are rapidly progressing CLN-619 and look forward to providing initial data from the combination therapy module, as well as additional monotherapy data, from the Phase 1 dose escalation study in the second quarter of 2024. We also expect to provide initial data from our disease-specific expansion cohorts in the first half of 2025. Our broad zipalertinib development program, being conducted in collaboration with our partners at Taiho, is also continuing, and we expect to complete enrollment in the pivotal Phase 2b portion of the REZILIENT1 study by the end of 2024. We expect to present data for CLN-049 and CLN-418 in the second half of 2024 as well. We finished Q3 with cash and investments of $482 million, which we now expect to provide runway into the second half of 2026, two quarters beyond previous guidance."

Portfolio Highlights

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CLN-619 (Anti-MICA/MICB monoclonal antibody): Solid tumors
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Enrollment continues in the ongoing Phase 1 study evaluating CLN-619 as both monotherapy and in combination with checkpoint inhibitor therapy. Accrual to the dose escalation phase of the combination module has been completed. Recruitment continues to the monotherapy disease specific expansion cohorts for patients with endometrial and cervical cancers. Cullinan also continues to evaluate additional disease specific expansion cohorts.

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At the 2023 SITC (Free SITC Whitepaper) Annual Meeting, initial biomarker data from the ongoing Phase 1 study of CLN-619 were presented at a poster session, providing evidence for CLN-619’s mechanism of action and demonstrating that clinical activity, including objective response, has been observed in patients with tumor characteristics not typically responsive to checkpoint inhibitor therapy.

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Zipalertinib (EGFR ex20ins inhibitor): EGFR ex20ins NSCLC
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In August 2023, Cullinan Oncology, in collaboration with our partners at Taiho Oncology, Inc., announced the initiation of REZILIENT3, a global Phase 3 study evaluating zipalertinib plus chemotherapy versus chemotherapy alone in patients with EGFR exon 20 insertion mutation non-small-cell lung cancer (EGFR ex20ins NSCLC) in the first-line setting.
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Enrollment continues in the pivotal Phase 2b portion of the REZILIENT1 study, evaluating zipalertinib in a cohort of patients with EGFR ex20ins NSCLC who have progressed after prior systemic therapy, as well as in a separate cohort of patients progressing after prior treatment with a currently approved agent for EGFR ex20ins NSCLC.
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CLN-049 (FLT3xCD3 T cell-engaging bispecific antibody): AML and MDS
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Enrollment continues in the ongoing Phase 1 multi-ascending dose study using subcutaneous administration.
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CLN-418 (B7H4x4-1BB bispecific immune activator): Solid tumors
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Preclinical data, including target expression profiling data and robust anti-tumor activity supporting the development of CLN-418 in multiple solid tumors, were presented at the 2023 SITC (Free SITC Whitepaper) Annual Meeting.
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Enrollment continued in the ongoing Phase 1 dose escalation study in patients with advanced solid tumors.
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CLN-978 (CD19xCD3 T cell engager): B-NHL
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In August 2023, Cullinan dosed the first patient in a Phase 1 study of CLN-978 in patients with R/R B-NHL.
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Preclinical data demonstrating the effectiveness of CLN-978 against lymphoma cells expressing very low levels of CD19 were presented at the 2023 SITC (Free SITC Whitepaper) Annual Meeting.
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CLN-617 (IL-2 and IL-12 cytokine fusion protein): Solid tumors
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Cullinan anticipates dosing the first patient in the CLN-617 first-in-human Phase 1 study by year end 2023.
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A poster at the 2023 SITC (Free SITC Whitepaper) Annual Meeting highlighted preclinical data demonstrating the mechanism by which CLN-617 mediates a robust abscopal anti-tumor effect in preclinical models. A Trial in Progress poster for the ongoing Phase 1 study of CLN-617 in combination with pembrolizumab was also presented.

Upcoming Milestones

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CLN-619
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Cullinan expects to report initial data from the combination dose escalation module as well as an update on the monotherapy dose escalation module at a medical conference in the second quarter of 2024.
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Cullinan expects to report initial data from disease specific dose expansion cohorts in the first half of 2025.
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Zipalertinib
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Cullinan expects completion of enrollment in the pivotal Phase 2b portion of the REZILIENT1 study by year-end 2024.
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CLN-049
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Cullinan expects to provide a clinical data update in the second half of 2024.
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CLN-418
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Cullinan expects to provide a clinical data update in the second half of 2024.
Third Quarter 2023 Financial Results

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Cash Position: Cash, cash equivalents, investments, and interest receivable were $481.9 million as of September 30, 2023. Cullinan now expects its cash resources to provide runway into the second half of 2026 based on its current operating plan. The extension from prior guidance is primarily driven by the receipt of approximately $38 million in net proceeds from Cullinan’s ATM equity program, increased interest income, and the prioritization of development plans in the longer term. Cullinan’s operating plan includes continued advancement of all programs to key data milestones in the near term.
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R&D Expenses: Research and development (R&D) expenses were $33.8 million for the third quarter of 2023, compared to $27.4 million for the second quarter of 2023. R&D expenses for the third and second quarters of 2023 included $3.2 million and $3.2 million of equity-based compensation expenses, respectively. The increase in R&D expenses was primarily related to increased chemistry, manufacturing and controls costs and higher clinical costs.
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G&A Expenses: General and administrative (G&A) expenses were $11.0 million for the third quarter of 2023, compared to $10.2 million for the second quarter of 2023. G&A expenses in the third and second quarters of 2023 included $4.5 million and $4.7 million of equity-based compensation expenses, respectively. The increase in G&A expenses, excluding equity-based compensation, was primarily driven by higher personnel costs.
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Net Loss: Net loss (before items attributable to noncontrolling interest) for the third quarter of 2023 was $39.2 million, compared with net loss of $32.2 million for the second quarter of 2023. Net losses included the items described above, partially offset by interest income of $5.9 million and $5.3 million in the third quarter and second quarter of 2023, respectively.

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Shares Outstanding: As of October 31, 2023, Cullinan had 42,780,644 common shares outstanding plus 647,500 shares of non-voting preferred stock outstanding, each of which is convertible into 10 shares of common stock.