On November 14, 2022 Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders with high unmet medical need, reported financial results for the third quarter 2022 and provided an update on its clinical development programs (Press release, Equillium, NOV 14, 2022, View Source [SID1234623982]).

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"I am proud of what our team has accomplished in the third quarter, including executing a definitive agreement to acquire Metacrine and announcing interim data from the Type B portion of the EQUALISE study in lupus nephritis. Since then, we have also initiated two new studies – a Phase 2 study of EQ101 in subjects with alopecia areata, and a Phase 1 study of EQ102 that will be positioned to treat patients with celiac disease," said Bruce Steel, chief executive officer at Equillium. "The Metacrine acquisition will meaningfully strengthen our cash position, which at closing is expected to add approximately $35 million to the balance sheet and extend our cash runway into 2024, taking us through multiple data catalysts from three different clinical programs over the next year."

Highlights Since the Beginning of Q3 2022:

Announced definitive merger agreement to acquire Metacrine in an all-stock transaction, anticipated to add $35 million in cash to Equillium’s balance sheet at closing. The acquisition also includes Metacrine’s farnesoid X receptor (FXR) platform, including lead molecule MET642, an orally delivered FXR agonist that is a potential first-in-class, non-immunosuppressive treatment for inflammatory bowel disease.

Announced positive interim results from the Type B portion of the EQUALISE study of itolizumab in subjects with lupus nephritis. Subjects were highly proteinuric with a baseline mean urine protein creatinine ratio (UPCR) of 5.8 g/g. Clinically meaningful responses were observed:

By week 28 (or end of study):

3 of 6 (50%) subjects achieved complete response (UPCR < 0.7 g/g)

2 of 6 (33%) subjects achieved partial response (UPCR > 50% reduction)

4 of 6 (67%) subjects achieved greater than 80% reduction in UPCR

In all subjects receiving more than one dose:

8 of 12 (67%) subjects achieved greater than 50% reduction in UPCR

60% average reduction in UPCR (over 3g of proteinuria)

Subjects titrated steroid dose to < 7.5 mg/day consistent with EULAR/ERA-EDTA recommendations

Initiated a multicenter, Phase 2 open-label, proof-of-concept study of EQ101 in adult subjects between 18 and 60 years of age, with at least 35% scalp hair loss due to alopecia areata. Approximately 30 subjects will be enrolled in the study where they will be dosed intravenously once weekly for 24 weeks.

Initiated a Phase 1 randomized, double-blind, placebo-controlled study of EQ102 administered subcutaneously as single or multiple doses in up to 64 healthy volunteers. The first cohort of eight study participants has been completed and the second cohort has initiated.

Presented data highlighting:

EQ101, a first-in-class, tri-specific cytokine inhibitor selectively targeting IL-2, IL-9 and IL-15 at the receptor level, that may afford significant advantages over other approaches to the treatment of alopecia areata, including JAK inhibition, at the 6th Annual Dermatology Drug Development Summit
Urinary soluble ALCAM (sALCAM) could be a potential biomarker of disease severity in lupus nephritis (LN) and indicative of a patient’s response to treatment at annual meeting of the American College of Rheumatology

Design and development of multi-specific cytokine inhibitors, and the importance of targeting biological synergy to optimize therapeutic outcomes at the 3rd Annual Cytokine-Based Drug Development Summit

Therapeutic potential for multi-cytokine inhibitors such as EQ101 and EQ102, as potentially effective strategies for the treatment of certain autoimmune diseases at the Annual La Jolla Immunology Conference

Anticipated Upcoming Milestones & Catalysts:

Itolizumab – EQUALISE Phase 1b study: topline data from the Type B part of the study in patients with lupus nephritis expected mid-2023

EQ101 – Phase 2 study in subjects with alopecia areata: data expected in 2023

EQ102 – Phase 1 study in healthy volunteers and subjects with celiac disease: data expected in 2023

Third Quarter 2022 Financial Results

Research and development (R&D) expenses for the third quarter of 2022 were $8.8 million, compared with $7.0 million for the same period in 2021. The increase was primarily due to greater clinical development expenses, driven by start-up costs related to the Phase 3 EQUATOR study.

General and administrative (G&A) expenses for the third quarter of 2022 were $4.5 million, compared with $2.9 million for the same period in 2021. The increase was primarily due to higher legal fees related to business development activities and greater employee compensation and overhead expenses.

Net loss for the third quarter of 2022 was $13.7 million, or $(0.40) per basic and diluted share, compared with a net loss of $10.3 million, or $(0.35) per basic and diluted share for the same period in 2021. The increase in net loss was largely attributable to greater operating expenses.

Cash, cash equivalents and short-term investments totaled $44.5 million as of September 30, 2022, compared to $57.6 million as of June 30, 2022. Equillium believes that its cash and investments, together with the additional cash that will be acquired with the expected closing of the Metacrine acquisition, will be sufficient to fund its operations into 2024.

About Itolizumab

Itolizumab is a clinical-stage, first-in-class anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited.

About Multi-Cytokine Platform: EQ101 & EQ102

Our proprietary Multi-Cytokine Platform (MCP) generates rationally designed composite peptides that selectively block key cytokines at the shared receptor level targeting pathogenic cytokine redundancies and synergies while preserving non-pathogenic signaling. This approach provides multi-cytokine inhibition at the receptor level and is expected to avoid the broad immuno-suppression and off-target safety liabilities that may be associated with other therapeutic classes, such as JAK inhibitors. Many immune-mediated diseases are driven by the same combination of dysregulated cytokines, and we believe identifying the key cytokines for these diseases will allow us to target and develop customized treatment strategies for multiple autoimmune and inflammatory diseases.
Current MCP assets include EQ101, a first-in-class, selective, tri-specific inhibitor of IL-2, IL-9 and IL-15, and EQ102, a first-in-class, selective, bi-specific inhibitor of IL-15 and IL-21.

On November 14, 2022 Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC)(OTC PINK:ENSCW), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety to reduce abuse and overdose, reported financial results for the third quarter of 2022 (Press release, Ensysce Biosciences, NOV 14, 2022, View Source [SID1234623981]).

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Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, commented, "We remain focused on progressing our clinical development plans for our programs and achieving each milestone we have identified. I could not be more pleased with the recently reported positive topline results from our human abuse potential (HAP) study for intranasal administration of PF614. These results were in-line with our expectations and importantly, consistent with the unique properties of PF614 as well as prior findings that we believe demonstrate PF614 will provide advantages over currently marketed products. The highly significant results from this study represent a major accomplishment towards our mission of reducing abuse and overdose, ultimately enhancing drug safety."

Dr. Kirkpatrick continued, "Additionally, we were very happy to provide today’s announcement regarding the written guidance we received from the FDA which indicated that a development program for PF614 in acute pain may be appropriate. As a result of this FDA guidance, we believe the non-clinical program for PF614 will be significantly shortened for acute pain. We are pleased we can develop PF614 for acute pain while we also continue with our chronic pain development pathway."

TAAPTM (Opioid Abuse Deterrent Program) Updates

PF614 is the first product in a new class of analgesia, a "Trypsin-Activated Abuse Protection" (TAAPTM) oxycodone product. The Company’s TAAPTM technology is designed to be highly resistant to tampering and abuse and is a unique chemical modification creating a new generation of opioid pain products as compared to traditional Abuse Deterrent Formulations (ADFs). TAAP controls or "turns on" the release of the active ingredient in PF614 providing abuse deterrence.

On October 31, 2022, the Company announced positive topline results from a human abuse potential (HAP) study, PF614-103, with intranasal administration of PF614 as compared to crushed oxycodone or placebo. PF614 demonstrated significantly reduced "drug liking," the primary endpoint, when compared to intranasal crushed immediate-release oxycodone.
On October 28, 2022, the Company announced first subjects dosed in its second HAP study, PF614-104, comparing oral administration of PF614 versus oxycodone or placebo. Data from this study is expected in early 2023. These HAP studies are intended to support abuse-deterrent labeling upon final approval of PF614.
On July 27, 2022, the Company announced positive date from a bioequivalence (BE) study PF614-102 of its novel TAAP opioid PF614 compared to OxyContin which the company believes will support the substitution of PF614 for OxyContin in the market. The Company believes that the BE data from this study will also support the 505(b)(2) regulatory path for clinical development of PF614, an abbreviated pathway to FDA approval. This pathway allows reference to available safety and clinical data from an approved product, and the BE data established by this study will move PF614 closer to registration.
MPARTM (Opioid Abuse Deterrent and Overdose Protection Program) Updates

PF614-MPAR is a combination product designed to have overdose protection along with the abuse protection of TAAP. MPAR (Multi-Pill Abuse Resistance) turns off the release of the opioid in an overdose situation, providing the additional layer of protection to Ensysce’s TAAP pain medications.

On August 31, 2022, the Company announced a partnership with Quotient Sciences on the Development and Clinical Testing of PF614-MPARTM. Quotient Sciences is currently using its integrated Translational Pharmaceutics platform to identify a PF614-MPAR combination that allows conversion into oxycodone within the prescribed dose range but reduces conversion to oxycodone at higher than prescribed dose levels in an overdose scenario.
On June 27, 2022, the Company announced its notice of award for the 4th year of funding for its MPAR platform to support the final part of the ongoing clinical trial PF614-MPAR-101. The amount awarded was $2.8 million and this brings total funding from NIDA under this grant to $10.8 million.
Financial Results

Cash – Cash and cash equivalents were $4.5 million as of September 30, 2022, as compared to $3.7 million as of June 30, 2022.
Federal Grants – Funding from federal grants was $0.3 million for the third quarter of 2022 compared to $1.2 million in the comparable year ago quarter. The decrease is a result of timing of pre-clinical and clinical activities for the MPAR program.
Research & Development Expenses – R&D expenses were $4.8 million for the third quarter of 2022 compared to $1.7 million in the comparable year ago quarter. The increase in expenses results from increased pre-clinical and clinical activities for PF614.
General & Administrative Expenses – G&A expenses were $1.7 million for the third quarter of 2022 compared to $16.4 million for the same period in 2021. The decrease in expenses is largely attributable to significant non-cash expenses recorded in the prior year period related to the valuation of warrants issued.
Other Income (Expense) – Total other income (expense) was expense of $3.7 million in the third quarter of 2022 and expense of $0.3 million in the third quarter of 2021. The change in other expenses is primarily due to non-cash fair value adjustments for convertible notes and warrants.
Net Loss – Net loss for the third quarter of 2022 was $9.9 million compared to net loss of $17.2 million for the comparable year ago period. As a clinical stage biotech company, our continued research and development efforts toward regulatory approvals for our product candidates are expected to result in losses for the foreseeable future.
Corporate Update Conference Call

As previously announced, CEO, Dr. Lynn Kirkpatrick, CFO, Dave Humphrey, and CMO, Dr. William Schmidt, will host a corporate update conference call on Wednesday, November 16, 2022, at 11:00am ET to provide a corporate update and review the recently discussed results from the HAP study of PF614. The call will conclude with Q&A from participants. An accompanying presentation will be posted prior to the call to the Company’s investor relations website.

Please dial in at least 10 minutes before the start of the call to ensure timely participation. A playback of the call will be available through Wednesday, November 16, 2022. To listen, call 1-844-512-2921 within the United States and Canada or 1-412-317-6671 when calling internationally. Please use the replay pin number 13734017.

On November 14, 2022 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported corporate updates and financial results for the third quarter ended September 30, 2022 (Press release, CymaBay Therapeutics, NOV 14, 2022, View Source [SID1234623979]).

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Sujal Shah, President and CEO of CymaBay, stated, "Early in the third quarter we completed enrollment in RESPONSE, our global registration study of seladelpar in patients with PBC. This achievement was a direct result of the tireless efforts of our teams and the relationships we have been fortunate to leverage among partners, health care providers and patient advocacy groups around the world. In addition to clinical presentations highlighting some of the important benefits of seladelpar for patients, we connected with all of these groups at The Liver Meeting last week and are aligned, coordinated and energized to deliver on transformational catalysts that lie ahead of us in 2023. With over 300 patients with PBC taking seladelpar daily across our active clinical studies, we continue to execute on what we believe is the most robust development program in PBC being conducted today. Our focus at CymaBay is clear and will remain so as we drive towards sharing top-line data from RESPONSE in the third quarter of 2023."

Recent Corporate Highlights

Enrollment was completed in the RESPONSE study, a 52-week, placebo-controlled, randomized, global, Phase 3 registrational study evaluating the safety and efficacy of seladelpar in patients with PBC. This study has enrolled 193 patients who have an inadequate response or intolerance to ursodeoxycholic acid in a 2:1 ratio to receive once daily oral seladelpar 10 mg or placebo. The primary outcome measure is the responder rate at 52 weeks. A responder is defined as a patient who achieves an alkaline phosphatase level < 1.67 times the upper limit of normal with at least a 15% decrease from baseline and has a normal level of total bilirubin. Additional key outcomes of efficacy will compare the rate of normalization of alkaline phosphatase at 52 weeks and the level of pruritus at 6-months for patients with moderate to severe pruritus at baseline as assessed by a validated numerical rating scale recorded with an electronic diary.
Continued strong enrollment in ASSURE, the restarted open-label, long-term study of seladelpar in patients with PBC intended to collect additional long-term safety and efficacy data to support registration. There are now over 180 patients in this study taking seladelpar daily. After completing the RESPONSE study, eligible patients will be able to roll over into ASSURE.
Data presented at The Liver Meeting of the American Association for the Study of Liver Diseases, in Washington, DC. The clinical presentations featured:

A poster presentation titled "Seladelpar Improved the Lipid Profile of Patients with Primary Biliary Cholangitis (PBC): Results from Phase 2 and 3 Clinical Studies" delivered by Christopher L. Bowlus MD, the chief of the Division of Gastroenterology and Hepatology at the University of California Davis. This poster highlighted the results of a pooled analysis of the improvements in lipids observed over 6 months from an open-label phase 2 study and a placebo (Pbo) controlled phase 3 study (ENHANCE) assessing seladelpar at a daily dose of 5 mg or 10 mg in PBC patients. This analysis found that of the 373 patients analyzed, total cholesterol, LDL-cholesterol and triglyceride levels were elevated in 77%, 54% and 21% of patients at baseline, respectively. Treatment with seladelpar through 6 months resulted in significant improvements in all three of these parameters. Interestingly, a comparison of lipid lowering in patients with and without background lipid therapy revealed that seladelpar achieved similar treatment effects. Confirmation of the effects of seladelpar treatment on lipid profiles in the RESPONSE and ASSURE studies is of interest given that dyslipidemia is a common feature in patients with PBC.

A second poster presenting clinical data titled "Seladelpar, a PPAR-delta Agonist, Improves Inflammatory Lipid Mediators in the Serum Metabolome in Patients with Primary Biliary Cholangitis (PBC)" examined changes from baseline to 3 months in the serum metabolome of 160 patients in the ENHANCE study dosed daily with placebo, seladelpar 5 mg and seladelpar 10 mg. Seladelpar dose-dependently increased serum markers of mitochondrial and peroxisomal fatty acid oxidation and significantly reduced levels of inflammatory lipid mediators. This study of 1,474 untargeted global serum metabolites provided mechanistic insight into metabolic pathways altered by seladelpar treatment of patients with PBC. These results suggest novel aspects by which the action of seladelpar may improve cholestasis and liver function in patients with PBC.
Held virtual analyst day featuring a presentation from a hepatology key opinion leader, Kris Kowdley, MD, FACP, FACG, AGAF, FAASLD, Director of Liver Institute Northwest and Professor of Medicine at Washington State University, who discussed the current treatment landscape and future goals for treating patients with PBC.
Announced the promotion of Dr. Charles McWherter to President of Research and Development, in addition to his continuing role as Chief Scientific Officer since 2013. Dr. McWherter’s extensive experience in the pharmaceutical industry as an executive focused on discovery, research and development and the depth of knowledge he has attained in our therapeutic areas of focus make him a perfect fit to serve in this expanded capacity.
Planning and execution progressed in our manufacturing and supply chain functions to support NDA submission and post-approval launch. Pre-commercial market analysis and planning became an increasing focus to support our planned product launch.
Held $153.4 million in cash, cash equivalents and investments as of September 30, 2022. We believe that cash and investments on hand are sufficient to fund CymaBay’s operating plan through 2023.
Third Quarter and Nine Months Ended September 30, 2022, Financial Results

Research and development expenses for the three months ended September 30, 2022, and 2021 were $15.5 million and $17.0 million, respectively. Research and development expenses for the nine months ended September 30, 2022, and 2021 were $51.8 million and $46.1 million, respectively. Research and development expenses in the three months ended September 30, 2022 were lower than the corresponding period in 2021 primarily due to the completion of enrollment of our RESPONSE trial in July 2022. Research and development expenses in the nine months ended September 30, 2022 were higher than the corresponding period in 2021 primarily due to the hiring of additional personnel and an expansion of clinical trial activities associated with the ongoing late-stage development of seladelpar in PBC. Specifically, higher costs were primarily driven by site activation, patient enrollment, and other clinical trial activities associated with RESPONSE and ASSURE, our two active global late-stage clinical trials in PBC.
General and administrative expenses for the three months ended September 30, 2022 and 2021 were $5.9 million and $5.2 million, respectively. General and administrative expenses for the nine months ended September 30, 2022 and 2021 were $17.9 million and $16.9 million, respectively. General and administrative expenses in the three months ended September 30, 2022 were higher than the corresponding period in 2021 due to the hiring of additional personnel to support our corporate growth. General and administrative expenses in the nine months ended September 30, 2022 were higher than the corresponding period in 2021 due to the hiring of additional personnel, partially offset by a reduction in legal and consulting expenses.
Net loss for the three months ended September 30, 2022 and 2021 was $24.5 million and $22.7 million, or ($0.28) and ($0.33) per share, respectively. Net loss for the nine months ended September 30, 2022, and 2021 was $79.4 million and $63.5 million, or ($0.90) and ($0.92) per share, respectively. Net loss in the three months ended September 30, 2022 was higher than the corresponding period in 2021 due primarily to an increase in interest expense accretion related to the Abingworth development financing agreement, partially offset by a decline in research and development expense. Net loss in the nine months ended September 30, 2022 was higher than the corresponding period in 2021 due primarily to an increase in interest expense accretion and to a lesser extent, an increase in research and development and other operating expenses associated with the ongoing late-stage development of seladelpar in PBC. Overall, we expect operating expenses to increase in the future as we continue to execute on our development plans for seladelpar in PBC.
Conference Call Details

CymaBay will host a conference call today at 4:30 p.m. ET to discuss third quarter financial results and provide a business update. To access the live conference call, please dial 855-327-6837 from the U.S. and Canada, or 631-891-4304 internationally, Conference ID #10020554. To access the live and subsequently archived webcast of the conference call, go to the Investors section of the company’s website at View Source

On November 14, 2022 Cullinan Oncology, Inc. (Nasdaq: CGEM) a biopharmaceutical company focused on modality-agnostic targeted oncology, reported its financial results for the third quarter ended September 30, 2022 (Press release, Cullinan Oncology, NOV 14, 2022, View Source [SID1234623977]).

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"We continued to execute across our programs through the third quarter and will deliver multiple important milestones in 2023," said Nadim Ahmed, Chief Executive Officer of Cullinan Oncology. "For our lead program, zipalertinib, we have initiated the pivotal study in patients with EGFR exon 20 non-small cell lung cancer. We remain on track to report initial clinical data for our two additional clinical-stage programs, CLN-049 and CLN-619, in mid-2023 and to file IND applications for CLN-617 and CLN-978 in the first half of 2023, which will advance our portfolio to potentially five clinical stage programs. With $607 million of cash and investments at the end of the quarter, we have cash runway well beyond these important milestones. We will continue to strategically deploy our capital for pipeline investment, acceleration, and expansion, such as our recent purchase of additional ownership in our Cullinan MICA subsidiary. Lastly, we made important additions to our leadership team and Board of Directors with the appointments of Jacquelyn Sumer as Chief Legal Officer and Dr. David Ryan as a new independent director. Both individuals will provide important expertise to support our evolution into a late-stage oncology company."

Portfolio Highlights

Zipalertinib (previously CLN-081/TAS6417): Cullinan Oncology, in collaboration with our partners at Taiho Oncology, Inc., has initiated a pivotal study of zipalertinib in EGFR exon 20 non-small-cell lung cancer patients progressing after prior systemic therapy. As previously planned, the study will enroll patients at the 100 mg BID dose, and will now also include a limited cohort of patients to evaluate safety and efficacy at 150 mg BID administered with food.

CLN-049: CLN-049 is a FLT3/CD3 T cell-engaging bispecific antibody being investigated in patients with relapsed/refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). CLN-049 is currently in Phase I investigation with initial clinical data expected in mid-2023.

CLN-619: CLN-619 is a monoclonal antibody that stabilizes expression of MICA/MICB on the tumor cell surface to promote tumor cell lysis from both cytotoxic innate and adaptive immune cells. CLN-619 has broad therapeutic potential and is being investigated as both monotherapy and in combination with checkpoint inhibitor therapy in an ongoing Phase I study in patients with advanced solid tumors with initial clinical data expected in mid-2023.

Cullinan Oncology presented a poster at the Society for Immunotherapy (SITC) (Free SITC Whitepaper) meeting further characterizing the unique mechanism of action of CLN-619. The preclinical data demonstrated the requirement of Fc functionality for the potency of CLN-619, as well as a further potential mechanism of action, antibody dependent cellular phagocytosis (ADCP), to mediate anti-tumor activity.

In October, Cullinan Oncology announced that it increased its ownership in its Cullinan MICA Corp. (MICA) subsidiary, which holds the worldwide rights to CLN-619. Ownership increased from 54% to 92% through the purchase of equity from two of MICA’s financial investors. The Myeloma Investment Fund, a venture philanthropy fund for the Multiple Myeloma Research Foundation (MMRF), retained its ownership in the entity.

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. Cullinan Oncology remains on track to file an Investigational New Drug (IND) application in the first half of 2023.

Cullinan Oncology presented a poster at the recent Society for Immunotherapy (SITC) (Free SITC Whitepaper) meeting. The preclinical data demonstrate that CLN-617 can mobilize a systemic, tumor-specific cellular immune response, remodeling the tumor microenvironment in both the injected and distal tumors.

CLN-978: CLN-978 is a novel CD19/CD3-bispecific therapeutic with extended serum half-life and robust potency against target cells expressing low levels of CD19. Cullinan Oncology remains on track to file an IND application in the first half of 2023.

Corporate Updates

In August, Cullinan Oncology strengthened its leadership team by adding Jacquelyn Sumer as Chief Legal Officer.

In November, Dr. David Ryan was appointed to Cullinan Oncology’s Board of Directors. Dr. Ryan is Chief of Hematology/Oncology, Massachusetts General Hospital (MGH) Cancer Center, the Clinical Director of the MGH Cancer Center, and a Professor of Medicine, Harvard Medical School.

Third Quarter 2022 Financial Results

Cash Position: Cash and investments1 were $606.7 million as of September 30, 2022. During the third quarter of 2022, we received the remaining $5.0 million of the $275.0 million upfront payment and paid $32.6 million in taxes from the sale of our equity interest in Cullinan Pearl to Taiho Pharmaceutical Co. Ltd. Based on our current estimate, we expect to pay approximately $7 million in cash in the fourth quarter for the remaining tax liability resulting from the transaction. Subsequent to the end of the quarter, we spent an additional $30.7 million in cash to increase our ownership in our Cullinan MICA subsidiary to 92%.

R&D Expenses: Research and development (R&D) expenses were $19.7 million for the third quarter of 2022, compared to $26.4 million for the prior quarter. R&D expenses for the third and second quarters of 2022 included $1.1 million and $4.4 million of equity-based compensation expenses, respectively. The decrease in R&D expenses was primarily related to a decrease in chemistry, manufacturing, and control activities for zipalertinib, CLN-619 and CLN-617 and the initiation of expense reimbursement for zipalertinib due to the collaboration agreement with Taiho Oncology, Inc. in the third quarter.

G&A Expenses: General and administrative (G&A) expenses were $10.1 million for the third quarter of 2022, compared to $10.7 million for prior quarter. G&A expenses in each of the third and second quarters of 2022 included $4.2 million of equity-based compensation expenses. The decrease in G&A expenses is primarily driven by nonrecurring expenses related to the Cullinan Pearl transaction of $1.7 million in the second quarter of 2022, partially offset by an increase in professional services expense.

Net Loss: Net loss (before items attributable to noncontrolling interest) for the third quarter of 2022 was $24.9 million.

On November 14, 2022 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), reported financial results for the third quarter ended September 30, 2022 (Press release, Crinetics Pharmaceuticals, NOV 14, 2022, View Source [SID1234623976]).

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"This has been yet another successful quarter of executing our strategy to build a leading endocrinology company by advancing our clinical pipeline of internally discovered drug candidates and preparing to add to that pipeline with our highly productive drug discovery efforts. Progress includes completion of enrollment in the Phase 3 PATHFNDR-1 trial and reporting Phase 2 open-label extension data demonstrating maintenance of IGF-1 as well as a strong preference among acromegaly patients for oral paltusotine over the injected standard-of-care," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "We remain on track for two Phase 3 readouts in acromegaly next year. Beyond acromegaly, we maintained strong momentum with our efforts to demonstrate paltusotine’s utility in carcinoid syndrome with a Phase 2 readout expected next year. We also continue to advance CRN04777 and CRN04894 toward patient trials based on the positive proof-of-pharmacology data we reported earlier this year."

THIRD QUARTER 2022 AND RECENT HIGHLIGHTS
Completed enrollment in Phase 3 PATHFNDR-1 study. PATHFNDR-1 is one of two ongoing, placebo-controlled Phase 3 clinical trials evaluating the safety and efficacy of paltusotine in acromegaly patients. Topline data from PATHFNDR-1 are expected in the third quarter of 2023 and topline data from paltusotine’s second Phase 3 trial, PATHFNDR-2, are expected in the fourth quarter of 2023. If successful, Crinetics plans to submit data from the PATHFNDR trials to regulatory authorities in support of applications seeking approval for the broad use of paltusotine for all acromegaly patients who require pharmacotherapy, including untreated patients and those switching from other therapies.
Reported new long-term safety and efficacy data from ACROBAT Advance open-label extension trial of paltusotine in acromegaly. Results showed that once-daily oral paltusotine lowered and maintained IGF-1 at levels comparable to prior injected somatostatin receptor ligand (SRL) therapy for up to 103 weeks. In addition, paltusotine was well tolerated in the study and 89% of study participants surveyed selected paltusotine as their preferred treatment option over injected SRLs.
Received a UK Medicines and Healthcare products Regulatory Agency (MHRA) Innovation Passport for CRN04777 for the treatment of congenital hyperinsulinism. The Innovation Passport enables Crinetics to access the Innovative Licensing and Access Pathway (ILAP). The ILAP aims to reduce the time to market for designated medicines by enabling enhanced coordination between sponsors and MHRA leading up to Marketing Authorization Application (MAA) submissions and by providing the opportunity for accelerated MAA reviews.
Reviewed analyses from preclinical and Phase 1 clinical studies of CRN04894 in an oral presentation at the 10th International Congress of Neuroendocrinology. CRN04894 is an adrenocorticotropic hormone (ACTH) antagonist being developed as a treatment for Cushing’s disease, congenital adrenal hyperplasia (CAH) and other conditions of ACTH excess. The presentation was delivered by the Crinetics’ vice president of clinical endocrinology, Dr. Peter J. Trainer, and featured the results of a Phase 1 healthy volunteer study demonstrating pharmacologic proof-of-concept for CRN04894. These results showed dose-dependent increases in CRN04894 plasma concentrations as well as reductions of both basal cortisol and elevated cortisol following an ACTH challenge.
Strengthened leadership team with appointment of Dana Pizzuti, M.D. as chief development officer. Dr. Pizzuti is a board-certified physician with more than 30 years of pharmaceutical industry experience in clinical development, pharmacovigilance, medical and regulatory affairs.
THIRD QUARTER 2022 FINANCIAL RESULTS
Research and development expenses were $32.0 million for the three months ended September 30, 2022, compared to $21.6 million for the same period in 2021. The increase was primarily attributable to an increase in spending on manufacturing and development activities of $5.2 million associated with our clinical and nonclinical activities for paltusotine, CRN04777, CRN04894 and our other clinical and preclinical programs and an increase in personnel costs of $4.2 million.
General and administrative expenses were $11.9 million for the three months ended September 30, 2022, compared to $6.2 million for the same period in 2021. The increase was primarily attributable to an increase in personnel costs of $3.0 million.
Net loss for the three months ended September 30, 2022, was $41.9 million, compared to a net loss of $27.9 million for the same period in 2021.
Revenues were $0.5 million for the three months ended September 30, 2022, consisting of license revenue recognized from the license agreement entered into with Sanwa Kagaku Kenkyusho Co., Ltd. in February 2022.
Unrestricted cash, cash equivalents and investments totaled $368.4 million as of September 30, 2022, compared to $333.7 million as of December 31, 2021.
The company had 53,810,476 common shares outstanding as of November 9, 2022.