On May 11, 2023 Loxo@Lilly, the oncology unit of Eli Lilly and Company (NYSE: LLY), reported that data from its oncology portfolio will be presented at the 2023 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting, to be held June 8 – 11, 2023, in Frankfurt, Germany, and virtually (Press release, Eli Lilly, MAY 11, 2023, View Source [SID1234631501]). The company-sponsored abstracts include new analyses of clinical data in approved and investigational uses based on the BRUIN Phase 1/2 trial evaluating Jaypirca (pirtobrutinib) in patients with B-cell malignancies previously treated with a covalent Bruton’s tyrosine kinase (BTK) inhibitor, including mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).

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A list of presentations, along with their viewing details, are shared below.

Medicine

Abstract Title

Presentation Details

Jaypirca (pirtobrutinib)

Genomic Evolution and Resistance to Pirtobrutinib in Covalent BTK-Inhibitor (cBTKi) Pre-treated Chronic Lymphocytic Leukemia (CLL) Patients: Results from the Phase 1/2 BRUIN Study

Abstract Number: S146

Session Type: Oral

Session Date / Time: June 9 at 14:45 – 16:00 CEST

Jaypirca (pirtobrutinib)

Comparison of Bleeding-Related Events in Patients who Received Pirtobrutinib with and without Antithrombotic Agents

Abstract Number: P1088

Session Type: Poster

Session Date / Time: June 9 at 18:00 – 19:00 CEST

Jaypirca (pirtobrutinib)

Matching-Adjusted Indirect Comparison (MAIC) of Pirtobrutinib vs Venetoclax Continuous Monotherapy in Patients with Relapsed/Refractory CLL Previously Treated with a Covalent BTK Inhibitor

Abstract Number: P623

Session Type: Poster

Session Date / Time: June 9 at 18:00 – 19:00 CEST

Jaypirca (pirtobrutinib)

Patient-Reported Outcomes (PRO) Among Patients with Mantle Cell Lymphoma Receiving Pirtobrutinib After Prior Covalent BTKi: Interim PRO Analysis from the BRUIN Phase 1/2 Study

Abstract Number: P1112

Session Type: Poster

Session Date / Time: June 9 at 18:00 – 19:00 CEST

LOXO-338

A First-in-Human Phase 1 Study of Oral LOXO-338, a Selective BCL2 Inhibitor, in Patients with Advanced Hematologic Malignancies

Abstract Number: P636

Session Type: Poster

Session Date / Time: June 9 at 18:00 – 19:00 CEST

About Jaypirca (pirtobrutinib)
Jaypirca (pirtobrutinib, formerly known as LOXO-305) (pronounced jay-pihr-kaa) is a highly selective (300 times more selective for BTK versus 98% of other kinases tested in preclinical studies), non-covalent (reversible) inhibitor of the enzyme BTK.1 BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including mantle cell lymphoma.2,3 Jaypirca is a U.S. FDA-approved oral prescription medicine, 100 mg or 50 mg tablets taken as a once-daily 200 mg dose with or without food until disease progression or unacceptable toxicity.

INDICATION FOR JAYPIRCA
Jaypirca is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor.

This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

IMPORTANT SAFETY INFORMATION FOR JAYPIRCA (pirtobrutinib)

Infections: Fatal and serious infections (including bacterial, viral, or fungal) and opportunistic infections have occurred in patients treated with Jaypirca. In the clinical trial, Grade ≥3 infections occurred in 17% of 583 patients with hematologic malignancies, most commonly pneumonia (9%); fatal infections occurred in 4.1% of patients. Sepsis (4.5%) and febrile neutropenia (2.9%) occurred. Opportunistic infections after Jaypirca treatment included, but are not limited to, Pneumocystis jirovecii pneumonia and fungal infection. Consider prophylaxis, including vaccinations and antimicrobial prophylaxis, in patients at increased risk for infection, including opportunistic infections. Monitor patients for signs and symptoms, evaluate promptly, and treat appropriately. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca.

Hemorrhage: Fatal and serious hemorrhage has occurred with Jaypirca. Major hemorrhage (Grade ≥3 bleeding or any central nervous system bleeding) occurred in 2.4% of 583 patients with hematologic malignancies treated with Jaypirca, including gastrointestinal hemorrhage; fatal hemorrhage occurred in 0.2% of patients. Bleeding of any grade, excluding bruising and petechiae, occurred in 14% of patients. Major hemorrhage occurred in patients taking Jaypirca with (0.7%) and without (1.7%) antithrombotic agents. Consider risks/benefits of co-administering antithrombotic agents with Jaypirca. Monitor patients for signs of bleeding. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca. Consider benefit/risk of withholding Jaypirca 3-7 days pre- and post-surgery depending on type of surgery and bleeding risk.

Cytopenias: Grade 3 or 4 cytopenias, including neutropenia (24%), anemia (11%), and thrombocytopenia (11%), have developed in patients with hematologic malignancies treated with Jaypirca. In a clinical trial, Grade 4 neutropenia (13%) and Grade 4 thrombocytopenia (5%) developed. Monitor complete blood counts regularly during treatment. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca.

Atrial Fibrillation and Atrial Flutter: Atrial fibrillation or flutter were reported in 2.7% of patients, with Grade 3 or 4 atrial fibrillation or flutter reported in 1% of 583 patients with hematologic malignancies treated with Jaypirca. Patients with cardiac risk factors such as hypertension or previous arrhythmias may be at increased risk. Monitor for signs and symptoms of arrhythmias (e.g., palpitations, dizziness, syncope, dyspnea) and manage appropriately. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca.

Second Primary Malignancies: Second primary malignancies, including non-skin carcinomas, developed in 6% of 583 patients with hematologic malignancies treated with Jaypirca monotherapy. The most frequent malignancy was non-melanoma skin cancer (3.8%). Other second primary malignancies included solid tumors (including genitourinary and breast cancers) and melanoma. Advise patients to use sun protection and monitor for development of second primary malignancies.

Embryo-Fetal Toxicity: Based on animal findings, Jaypirca can cause fetal harm in pregnant women. Administration of pirtobrutinib to pregnant rats during organogenesis caused embryo-fetal toxicity, including embryo-fetal mortality and malformations at maternal exposures (AUC) approximately 3-times the recommended 200 mg/day dose. Advise pregnant women of potential risk to a fetus and females of reproductive potential to use effective contraception during treatment and for one week after last dose.

Adverse Reactions (ARs) in Patients with Mantle Cell Lymphoma Who Received Jaypirca
Serious ARs occurred in 38% of patients. Serious ARs occurring in ≥2% of patients were pneumonia (14%), COVID-19 (4.7%), musculoskeletal pain (3.9%), hemorrhage (2.3%), pleural effusion (2.3%), and sepsis (2.3%). Fatal ARs within 28 days of last dose of Jaypirca occurred in 7% of patients, most commonly due to infections (4.7%), including COVID-19 (3.1%).

Dose Modifications and Discontinuations: ARs led to dosage reductions in 4.7%, treatment interruption in 32%, and permanent discontinuation of Jaypirca in 9% of patients. ARs resulting in dosage modification in >5% of patients included pneumonia and neutropenia. ARs resulting in permanent discontinuation of Jaypirca in >1% of patients included pneumonia.

ARs (all Grades %; Grade 3-4 %) in ≥10% of Patients: fatigue (29; 1.6), musculoskeletal pain (27; 3.9), diarrhea (19; -), edema (18; 0.8), dyspnea (17; 2.3), pneumonia (16; 14), bruising (16; -), peripheral neuropathy (14; 0.8), cough (14; -), rash (14; -), fever (13; -), constipation (13; -), arthritis/arthralgia (12; 0.8), hemorrhage (11; 3.1), abdominal pain (11; 0.8), nausea (11; -), upper respiratory tract infections (10; 0.8), dizziness (10; -).

Select Laboratory Abnormalities (all Grades %; Grade 3 or 4 %) that Worsened from Baseline in ≥10% of Patients: hemoglobin decreased (42; 9), platelet count decreased (39; 14), neutrophil count decreased (36; 16), lymphocyte count decreased (32; 15), creatinine increased (30; 1.6), calcium decreased (19; 1.6), AST increased (17; 1.6), potassium decreased (13; 1.6), sodium decreased (13; -), lipase increased (12; 4.4), alkaline phosphatase increased (11; -), ALT increased (11; 1.6), potassium increased (11; 0.8). Grade 4 laboratory abnormalities in >5% of patients included neutrophils decreased (10), platelets decreased (7), lymphocytes decreased (6).

All grade ARs with higher frequencies in the total BRUIN population of patients with hematologic malignancies (n=583) were decreased neutrophil count (41%), bruising (20%), diarrhea (20%).

Drug Interactions
Strong CYP3A Inhibitors: Concomitant use with Jaypirca increased pirtobrutinib systemic exposure, which may increase risk of Jaypirca adverse reactions. Avoid use of strong CYP3A inhibitors during Jaypirca treatment. If concomitant use is unavoidable, reduce Jaypirca dosage according to the approved labeling.

Strong or Moderate CYP3A Inducers: Concomitant use with Jaypirca decreased pirtobrutinib systemic exposure, which may reduce Jaypirca efficacy. Avoid concomitant use of Jaypirca with strong or moderate CYP3A inducers. If concomitant use with moderate CYP3A inducers is unavoidable, increase the Jaypirca dosage according to the approved labeling.

Sensitive CYP2C8, CYP2C19, CYP3A, P-gP, BCRP Substrates: Concomitant use with Jaypirca increased their plasma concentrations, which may increase risk of adverse reactions related to these substrates for drugs that are sensitive to minimal concentration changes. Follow recommendations for these sensitive substrates in their approved labeling.

Use in Special Populations
Pregnancy and Lactation: Inform pregnant women of potential for Jaypirca to cause fetal harm. Verify pregnancy status in females of reproductive potential prior to starting Jaypirca and advise use of effective contraception during treatment and for one week after last dose. Presence of pirtobrutinib in human milk and effects on the breastfed child or on milk production is unknown. Advise women not to breastfeed while taking Jaypirca and for one week after last dose.

Geriatric Use: In the pooled safety population of patients with hematologic malignancies, 392 (67%) were ≥65 years of age. Patients aged ≥65 years experienced higher rates of Grade ≥3 ARs and serious ARs compared to patients <65 years of age.

Renal Impairment: Severe renal impairment (eGFR 15-29 mL/min) increases pirtobrutinib exposure. Reduce Jaypirca dosage in patients with severe renal impairment according to the approved labeling. No dosage adjustment is recommended in patients with mild or moderate renal impairment.

PT HCP ISI MCL APP

Please see Prescribing Information and Patient Information for Jaypirca.

On May 11, 2023 LadRx Corporation (OTCQB: LADX) ("LadRx" or the "Company"), a biopharmaceutical innovator focused on research and development of life-saving cancer therapeutics, reported that it intends to effect a reverse stock split of its common stock at a ratio of 1 post-split share for every 100 pre-split shares (Press release, LadRx, MAY 11, 2023, View Source [SID1234631500]). The reverse stock split will become effective at 5:00 a.m. PDT on Wednesday, May 17, 2023. The Company’s common stock will continue to be traded on the OTC Capital Markets under the symbol "LADX" and will begin trading on a split-adjusted basis when the market opens on Thursday, May 18, 2023. The new CUSIP number for the common stock following the reverse stock split is 232828707.

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At the Annual Meeting of Stockholders held on July 27, 2022, the Company’s stockholders granted the Company’s Board of Directors (the "Board") the discretion to effect a reverse stock split of the Company’s common stock through the amendment to its Amended and Restated Certificate of Incorporation at a ratio in the range of 1-for-2 to 1-for-100, with such ratio to be determined by the Board and included in a public announcement. On March 15, 2023, the Company announced that it was undergoing a review of strategic alternatives that could include a strategic sale, a merger or reverse merger, implementing a reverse stock split for the purposes of up-listing to NASDAQ, seeking additional financing or some combination of the aforementioned scenarios. The Company believes that effecting the reverse split at this time, given the low trading price of the Company’s common stock, would best position the Company in pursuing any alternatives that result from the strategic review. The Company believes that having a consistently low share price makes the Company less attractive to potential strategic partners and renders it impossible to consider an up-listing to Nasdaq. At the effective time of the reverse stock split, every 100 shares of the Company’s issued and outstanding common stock will be converted automatically into one issued and outstanding share of common stock without any change in the par value per share. Stockholders holding shares through a brokerage account will have their shares automatically adjusted to reflect the 1-for-100 reverse stock split. It is not necessary for stockholders holding shares of the Company’s common stock in certificated form to exchange their existing stock certificates for new stock certificates of the Company in connection with the reverse stock split, although stockholders may do so if they wish.

The reverse stock split will affect all stockholders uniformly and will not alter any stockholder’s percentage interest in the Company’s equity, except to the extent that the reverse stock split would result in a stockholder owning a fractional share. Any fractional share of a stockholder resulting from the reverse stock split will be rounded up to the nearest whole number of shares. The reverse stock split will reduce the number of shares of the Company’s common stock outstanding from 48,190,080 shares to approximately 481,901 shares. Proportional adjustments will be made to the number of shares of the Company’s common stock issuable upon exercise or conversion of the Company’s equity awards, warrants and other convertible securities, as well as the applicable exercise or conversion price thereof. Stockholders with shares in brokerage accounts should direct any questions concerning the reverse stock split to their broker; all other stockholders may direct questions to the Company’s transfer agent, AST, at (718) 921-8300, ext 6462.

On May 11, 2023 CytoAgents, Inc., a clinical-stage biotechnology company developing a safe, effective treatment for Cytokine Release Syndrome (CRS), reported that it has received a Study May Proceed letter from the U.S. Food and Drug Administration (FDA) (Press release, CytoAgents, MAY 11, 2023, View Source [SID1234631499]). This clearance enables the initiation of a U.S. Phase 1b/2a clinical trial under its Investigational New Drug (IND) application for the therapeutic, CTO1681, to treat CRS in lymphoma patients receiving CAR T-Cell Therapy. This is an area of great unmet medical need as the majority of patients undergoing CAR T treatment for their cancer experience CRS and associated neurotoxicity.

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"We are thrilled to advance CTO1681 into the clinic and excited about how our novel therapeutic will potentially prevent and/or treat CRS," said Teresa Whalen, RPh, CEO of CytoAgents. "The FDA’s clearance to advance our clinical program for CTO1681 in the U.S. is another important milestone for our company."

CytoAgents is developing innovative pharmaceutical products to treat life-threatening conditions, diseases and disorders associated with CRS. Commonly referred to as cytokine storm, CRS is caused by excessive cytokine production and can be triggered by a range of diseases and treatments. Certain advanced immunotherapies in the oncology space such as CAR T-Cell and Bispecific Antibody Therapies suffer from high incidence of associated CRS. The condition can be lethal and requires hospitalization for adequate control in nearly all cases. The company expects that effective CRS management will support greater accessibility to and broader adoption of these highly effective therapies in the clinic.

Building on this news, the company also announced the initial closing of its second equity round of financing. "CytoAgents has a clear path forward and a team ready to execute," says Brian Shanahan, Managing Partner, PCG Capital. "We are excited to support the acceleration of CytoAgents’ clinical development efforts and look forward to generating meaningful clinical data in patients."

CytoAgents anticipates the clinical trial to launch at its first trial site in the summer of 2023.

On May 11, 2023 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical leader in cell cycle checkpoint control developing innovative medicines based on cancer cell biology, reported its first quarter financial results and provided a business update (Press release, Cyclacel, MAY 11, 2023, View Source [SID1234631498]).

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"We are on track to deliver on key readouts this year. For fadraciclib, our oral CDK2/9 inhibitor, we plan to report pharmacokinetic (PK), pharmacodynamic (PD), safety and activity data from the dose escalation stage of our 065-101 study followed by initial clinical activity data from the Phase 2 proof of concept (PoC) stage. We also expect to report PK, PD, safety and activity data from the dose escalation part of our 140-101 Phase 1/2 study of plogosertib, our oral PLK1 inhibitor," said Spiro Rombotis, President and Chief Executive Officer. "Data collected to date suggest that fadraciclib and plogosertib are differentiated from other molecules in their respective classes. Furthermore, the receipt of $4.7 million in non-dilutive capital from the R&D tax credit along with existing resources supports our ongoing clinical programs."

"Both clinical programs with fadraciclib and plogosertib are progressing well and are approaching important data readouts," said Mark Kirschbaum, M.D., Chief Medical Officer. "In 065-101, we are currently recruiting patients at dose level 6A of fadraciclib with the aim of optimizing the recommended Phase 2 dosing schedule before opening the PoC stage. Our Phase 2 clinical sites are ready to enroll patients with the tumor types that appear to be most sensitive to fadraciclib treatment. With plogosertib we are recruiting patients at dose level 4. After observing unexpected efficacy at lower dose levels with three patients on treatment for three to eight cycles, we are investigating the biological rationale for this effect and how we could exploit these findings in subsequent studies. We remain enthusiastic about our clinical stage pipeline and look forward to presenting emerging data from these two programs during the year."

Key Upcoming Milestones for 2023

· Report final data from dose escalation stage and RP2D determination from the 065-101 study of oral fadraciclib in patients with advanced solid tumors and lymphoma
· First patient dosed with oral fadraciclib in Phase 2 proof-of-concept stage of 065-101 study in patients with advanced solid tumors and lymphoma
· Report Phase 1 data from 140-101 study of oral plogosertib in patients with advanced solid tumors and lymphoma
· Report interim data from initial cohorts in Phase 2 proof-of-concept stage of 065-101 study with oral fadraciclib in patients with advanced solid tumors and lymphoma

Financial Highlights

As of March 31, 2023, pro forma cash and cash equivalents totaled $16.1 million, including the $4.7 million of United Kingdom research & development tax credits received after the end of the quarter. Cash and cash equivalents as of March 31, 2023 was $11.4 million, compared to $18.3 million as of December 31, 2022. Net cash used in operating activities was $6.9 million for the three months ended March 31, 2023 compared to $6.8 million for the same period of 2022. The Company estimates that its available cash will fund currently planned programs into the first quarter of 2024.

Research and development (R&D) expenses were $5.7 million for the three months ended March 31, 2023, as compared to $5.0 million for the same period in 2022. R&D expenses relating to fadraciclib were $4.1 million for the three months ended March 31, 2023, as compared to $3.6 million for the same period in 2022 due to increased non-clinical expenditures. R&D expenses related to plogosertib were $1.4 million for the three months ended March 31, 2023, as compared to $1.1 million for the same period in 2022 due to clinical trial costs associated with the progression of the Phase 1/2 study.

General and administrative expenses for the three months ended March 31, 2023 and 2022, remained relatively flat at $1.6 million.

Total other income, net, for the three months ended March 31, 2023, was $0.2 million compared to an income of $1.3 million for the same period of the previous year. The decrease of $1.1 million for the three months ended March 31, 2023, is primarily related to royalty income received in the previous year.

United Kingdom research & development tax credits for the three months ended March 31, 2023 were $1.3 million compared to $1.1 million for the same period of the previous year and are directly correlated to qualifying research and development expenditure.

Net loss for the three months ended March 31, 2023, was $5.8 million, compared to $4.1 million for the same period in 2022.

Conference call information:

US/Canada call: (800) 274-8461 / international call: (203) 518-9783

US/Canada archive: (800) 839-6975 / international archive: (402) 220-6061

Code for live and archived conference call is CYCCQ123. Webcast link

For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.

On May 11, 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 first quarter ended March 31, 2023 (Press release, Cullinan Oncology, MAY 11, 2023, View Source [SID1234631497]).

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"We made important progress in the first quarter of this year and believe that 2023 will be a transformational year for Cullinan Oncology," said Nadim Ahmed, Chief Executive Officer of Cullinan. "Consistent with our guidance on reporting first clinical data from two of our ongoing Phase 1 studies by mid-year, preliminary safety data for CLN-049 were published in abstract form today as part of the 2023 EHA (Free EHA Whitepaper) Congress and first clinical data for CLN-619 will be presented during a poster session at the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting. Additionally, enrollment in the zipalertinib pivotal study will now continue at the 100mg BID dose only. We also continue to progress our diverse pipeline: both CLN-978 and CLN-617 received FDA clearance of IND applications in the first quarter, which will allow us to initiate first-in-human studies this year. Finally, we recently expanded our pipeline through the licensing of U.S. development and commercial rights to CLN-418, a potential first-in-class B7H4x4-1BB bispecific immune activator currently in a Phase 1 study across a variety of solid-tumor indications. Together, these achievements position us well with six programs in the clinic this year as we work toward our mission of creating new standards of care for patients with cancer."

Portfolio Highlights

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Zipalertinib: Enrollment will continue solely at the 100 mg BID dose level in the pivotal study of zipalertinib in EGFR exon 20 insertion mutation non-small-cell lung cancer patients progressing after prior systemic therapy.

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Further enrollment in the 150mg BID cohort was recently discontinued based upon recommendation of the safety review committee.

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CLN-049: CLN-049 is a FLT3xCD3 T cell-engaging bispecific antibody being investigated in patients with relapsed/refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

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Preliminary safety data from an ongoing first in human study were published in abstract form as part of the 2023 EHA (Free EHA Whitepaper) Congress.
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Cytokine production and low-grade clinical cytokine release syndrome (CRS) consistent with the postulated mechanism of action were observed at the initial dose levels in the now completed single ascending dose study using IV administration.

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Enrollment continues in the ongoing Phase 1 multi-ascending dose study using subcutaneous administration.

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CLN-619: CLN-619 is a monoclonal antibody that stabilizes expression of MICA/B on the tumor cell surface to promote tumor cell lysis by both cytotoxic innate and adaptive immune cells. CLN-619 has broad therapeutic potential and is being investigated as both a monotherapy and in combination with checkpoint inhibitor therapy in an ongoing Phase 1 dose escalation study in patients with advanced solid tumors.
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First clinical data will be presented during a poster session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 Annual Meeting on June 3, 2023.

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New preclinical data on the anti-tumor mechanism of CLN-619 were presented in a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April.

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CLN-418: CLN-418 is a B7H4x4-1BB fully human bispecific immune activator designed to achieve conditional activation of 4-1BB by targeting B7H4, a tumor-associated antigen that is highly expressed across multiple cancers with minimal expression on normal tissues. Enrollment is ongoing in a Phase 1 dose escalation study at U.S. and Australian sites in patients with advanced solid tumors, with initial clinical data expected in 2024.

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In February, Cullinan Oncology licensed the exclusive U.S. development and commercial rights to CLN-418 from Harbour Biomed for an upfront fee of $25 million, with the potential for up to an additional $148 million in development and regulatory milestones and up to $415 million in sales-based milestones, as well as tiered royalties on potential U.S. commercial sales.

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CLN-978: CLN-978 is a novel CD19xCD3 bispecific therapeutic with extended serum half-life and robust potency against target cells expressing low levels of CD19.

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Cullinan received FDA clearance of its IND application for CLN-978 in January and anticipates initiating a Phase 1 clinical study in 2023.

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CLN-617: CLN-617 is a cytokine fusion protein uniquely combining IL-12 and IL-2 with a collagen binding domain designed for retention in the tumor microenvironment (TME) following intratumoral injection.

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Cullinan received FDA clearance of its IND application for CLN-617 in March and anticipates initiating a Phase 1 clinical study in 2023.

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New preclinical data highlighting the therapeutic potential of CLN-617 was presented in a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April.

First Quarter 2023 Financial Results

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Cash Position: Cash, cash equivalents, investments, and interest receivable were $503.5 million as of March 31, 2023. This balance reflects the $25 million upfront payment to Harbour Biomed upon the execution of the licensing agreement for CLN-418. Cullinan expects its cash resources to provide runway into 2026 based on its current operating plan.

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R&D Expenses: Research and development (R&D) expenses were $52.1 million for the first quarter of 2023, compared to $21.3 million for the fourth quarter of 2022. R&D expenses for the first quarter of 2023 and fourth quarter of 2022 included $3.1 million and $2.9 million of equity-based compensation expenses, respectively. Excluding the impact of equity-based compensation expenses, the increase in R&D expenses was primarily related to the upfront payment to Harbour Biomed upon the execution of the licensing agreement for CLN-418, and higher clinical and clinical supply costs driven by the advancement and expansion of our pipeline.

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G&A Expenses: General and administrative (G&A) expenses were $10.7 million for the first quarter of 2023, compared to $11.3 million for the fourth quarter of 2022. G&A expenses in the first quarter of 2023 and fourth quarter of 2022 included $4.2 million and $4.6 of equity-based compensation expenses, respectively. The decrease in G&A expenses, excluding equity-based compensation, was primarily driven by a decrease in professional fees.

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Net Loss: Net loss (before items attributable to noncontrolling interest) for the first quarter of 2023 was $58.1 million, compared with net loss of $27.1 million for the fourth quarter of 2022. Net losses included the items described above, partially offset by interest income of $4.5 million and $3.4 million in the first quarter of 2023 and fourth quarter of 2022, respectively, and an income tax benefit of $1.9 million in the fourth quarter of 2022.