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.

On November 14, 2022 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported that financial results for the third quarter ended September 30, 2022 (Press release, Compugen, NOV 14, 2022, View Source [SID1234623975]).

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Corporate Update
"We continue to execute and delivered encouraging clinical data in MSS-CRC patients at the recent annual SITC (Free SITC Whitepaper) conference," said Anat Cohen-Dayag, Ph.D., President, and Chief Executive Officer of Compugen. "We were excited to show an overall response rate of 12% in MSS-CRC patients with liver metastases, a patient population in whom responses to immunotherapy treatment has been rare or non-existent. The two partial responses reported were supported by potent immune activation in the tumor microenvironment, indicative of a COM701 mediated mechanism of action. The drug combination was well tolerated with no serious adverse events assessed by the investigator as related to study drugs. Based on the totality of our data supporting the DNAM-1 axis hypothesis, we plan to move ahead with the clinical evaluation of COM701 in triple combination with an anti-PD-1 and our potential best-in-class anti-TIGIT, COM902, in MSS-CRC patients."

Dr. Cohen-Dayag continued, "We are excited to be presenting new encouraging clinical data from the fully enrolled platinum resistant ovarian cancer cohorts treated with COM701 in combination with nivolumab with or without BMS-986207 at the upcoming ESMO (Free ESMO Whitepaper)-IO conference. We believe COM701 combinations warrant further investigation in this indication. This opens the door for us to evaluate our drugs in a more favorable competitive landscape compared to NSCLC. For this reason, we have decided to pursue this indication and we are evaluating the various options for the planned NSCLC studies."

Dr. Cohen-Dayag concluded, "I am excited about the progress we have made and look forward to our continued focus on execution and delivery of meaningful clinical data. We have a solid balance sheet, with cash balances of $88 million which we expect to support our operations at least through the end of 2024."

Financial Results
As of September 30, 2022, cash, cash equivalents, short-term bank deposits and restricted cash totaled approximately $88 million, compared with approximately $118 million as of December 31, 2021. The Company expects its existing cash and cash related balances to fund its operating plans at least through the end of 2024. Compugen does not have any debt.

R&D expenses for the third quarter ended September 30, 2022, were approximately $9.3 million, compared to approximately $8.7 million for the comparable period in 2021.

General and administrative expenses for the third quarter ended September 30, 2022, were approximately $2.6 million compared with approximately $2.8 million for the comparable period in 2021.

Net loss for the third quarter ended September 30, 2022, was approximately $11.7 million, or $0.14 per basic and diluted share, compared with a net loss of approximately $6.2 million, or $0.07 per basic and diluted share, in the comparable period of 2021.

Full financial tables are included below

Conference call and webcast information
The Company will hold a conference call today, November 14, 2022, at 8:30 AM ET to review its third quarter 2022 results. To access the live conference call by telephone, please dial 1-866-744-5399 from the U.S., or +972-3-918-0644 internationally. The call will be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.

On November 14, 2022 Chemomab Therapeutics, Ltd. (Nasdaq: CMMB) (Chemomab), a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for fibrotic and inflammatory diseases with high unmet need, reported the appointment of Matthew Frankel, MD, MBA as Chief Medical Officer (CMO) and Vice President of Drug Development (Press release, Chemomab, NOV 14, 2022, View Source,-MD,-MBA-as-Chief-Medical-Officer [SID1234623974]).

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"We believe Dr. Frankel’s wealth of experience across all aspects of clinical development and medical affairs, along with his outstanding performance in helping to bring biologic and small molecule drugs to market for both rare and chronic diseases, will be invaluable as we advance the CM-101 clinical program," said Dale Pfost, PhD, Chief Executive Officer of Chemomab. "We have greatly benefitted from the singular talents of interim CMO Dave Weiner, who will be staying on as a Senior Advisor, and are fortunate now to have Matt Frankel, with his exceptional breadth of experience and track record of success, joining as our full-time CMO."

Dr. Frankel most recently served as Vice President, Clinical Development and Medical Affairs, Specialty Pharma at Boehringer Ingelheim, where he led functional teams developing new drugs for oncology, immunology, pulmonary, and central nervous system diseases. Previously Dr. Frankel was Vice President & Head, Immunology and Dermatology Medical Unit at Novartis, where he oversaw medical affairs activities and late phase clinical development for Cosentyx, Ilaris, and Zortress. At the Sandoz unit of Novartis, Dr. Frankel successfully built and led the medical affairs organization supporting the biopharmaceutical, biosimilar and generics businesses for launches including Kerydin, Glatopa and Zarxio.

"Chemomab’s CM-101 is an intriguing investigational drug, with its novel CCL24 target, dual mechanism of action, breadth of application and disease-modifying potential in serious progressive diseases with few effective treatment options," said Dr. Frankel. "Chemomab scientists have assembled an impressive body of preclinical and early clinical evidence supporting the utility of their approach, and I welcome the opportunity to join this talented team as we move to rapidly expand and accelerate our CM-101 clinical programs."

Earlier in his career, Dr. Frankel held clinical development leadership roles across geographies and therapeutic disease areas at Reata, Fibrogen, Abbott Labs, and Schering Plough. Dr. Frankel received a BA degree from Vassar College, an MD degree from the University of California School of Medicine, Los Angeles and an MBA from the J. L. Kellogg Graduate School of Management at Northwestern University. He is board certified in internal medicine.

On November 14, 2022 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision-oncology biopharmaceutical company, reported its financial results for the third quarter ended September 30, 2022 (Press release, Calithera Biosciences, NOV 14, 2022, View Source,months%20ended%20September%2030%2C%202022. [SID1234623973]).

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"Earlier in the fourth quarter, we were very pleased to announce that we received FDA Fast Track designation for sapanisertib. This designation facilitates more frequent communication with the Agency, as well as a number of other benefits that could support our efforts to bring sapanisertib to patients in this area of high unmet need more quickly," said Susan Molineaux, PhD, president and chief executive officer of Calithera. "Today we also share that we have experienced site activation delays on both our sapanisertib and mivavotinib trials, leading to slower than anticipated enrollment for both these programs. We expect initial data from these studies will not be available until mid-2023."

Third Quarter 2022 and Other Recent Highlights

Received FDA Fast Track designation for sapanisertib (dual mTORC 1/2 inhibitor). In October, Calithera announced that sapanisertib has been granted Fast Track designation by the FDA for the treatment of adult patients with unresectable or metastatic squamous non-small cell lung cancer (sqNSCLC) whose tumors harbor the NRF2 mutation. Fast Track designation, which is designed to facilitate the development and expedite the review of therapeutic candidates with the potential to treat a serious or life-threatening condition where there is a major unmet medical need, provides a number of potential benefits including increased communication with the FDA, the ability to submit a marketing application on a rolling basis and the possibility of priority review.
Began enrolling patients in Phase 2 trial evaluating sapanisertib in sqNSCLC. In July 2022, the Company began enrolling patients in its phase 2 clinical trial (NCT05275673) of the dual mTORC 1/2 inhibitor sapanisertib (CB-228) in patients with relapsed/refractory NRF2 (NFE2L2)-mutated sqNSCLC. The study is designed to confirm the selective activity of sapanisertib in NRF2-mutated tumors compared to wild-type tumors, and to refine dose in this biomarker-defined population. The primary endpoints of the study are investigator-assessed overall response rate (ORR) per RECIST v1.1, and safety. Calithera presented a trial-in-progress poster detailing the study design at the North American Conference on Lung Cancer in September 2022.

Continued patient enrollment activities in Phase 2 trial evaluating mivavotinib (SYK inhibitor) in r/r non-GCB DLBCL. In June 2022, the Company began enrolling patients in its multicenter Phase 2 clinical trial (NCT05319028) evaluating mivavotinib (CB-659) in patients with relapsed/refractory non-germinal center B-cell like (non-GCB) diffuse large B-cell lymphoma (DLBCL). The main objectives of the study are to confirm previously observed single-agent activity in non-GCB DLBCL patients, evaluate activity according to MYD88/CD79b mutation status and refine dose/schedule in this patient population. The primary endpoints of the study are overall response rate (as assessed by an independent radiology review committee) and safety. Details of the Phase 2 study design were presented in a trial-in-progress poster at the Pan Pacific Lymphoma Conference in July.
Continued to advance VPS4 program through lead optimization. Calithera continued to advance multiple vacuolar protein sorting-associated protein 4A (VPS4A) and VPS4B inhibitors through lead optimization and plans to share updates on this program by the end of 2022.
Selected Third Quarter 2022 Financial Results

Cash and cash equivalents totaled $34.1 million at September 30, 2022. Based on its current operating plan, the Company expects it has sufficient cash to fund its operations into the second quarter of 2023. The Company is currently evaluating all options for its programs, including strategic collaboration or licensing agreements and actively considering the sale of certain programs, in order to extend its cash runway.

Research and development expenses for the third quarter 2022 were $6.5 million, compared to $11.6 million in the same period prior year. The decrease of $5.1 million was primarily due to decreases in the telaglenastat and CB-280 programs and investments in early stage research, partially offset by increases in the sapanisertib and mivavotinib programs.

General and administrative expenses for the third quarter 2022 were $3.0 million, compared to $6.3 million in the same period prior year. The decrease of $3.3 million was primarily due to decreased personnel-related costs and legal expenses.

Net loss was $9.8 million for the three months ended September 30, 2022.

Conference Call Information

Calithera will host an update conference call today, Monday, November 14, at 2:00 p.m. Pacific Time/5:00 p.m. Eastern Time. To register for dial-in access to the call, please use this link. To access the live audio webcast or the subsequent archived recording, visit the Investors section of the Calithera website at www.calithera.com. The webcast will be recorded and available for replay on Calithera’s website for 30 days.