1stOncology™: Cancer Intelligence Service – Page 3454 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

CytomX Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Update

On November 7, 2023 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated, localized biologics, reported third quarter 2023 financial results and provided a business update (Press release, CytomX Therapeutics, NOV 7, 2023, View Source [SID1234637131]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

"2023 has been a year of highly focused execution against our key priorities, including continued progress in Phase 1 dose escalation for CX-904 and the advancement of our next-generation molecules CX-2051 and CX-801 towards IND filings later this year. We have continued to diligently manage our financial resources and drive towards value-inflecting pipeline milestones," said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX Therapeutics.

Continued Dr. McCarthy, "Looking ahead to 2024, we are on track to provide initial CX-904 Phase 1 dose escalation data and to initiate our clinical evaluation of CX-2051 and CX-801, leading to a potentially milestone-rich 2024 and 2025."

Third Quarter Business Highlights and Recent Developments

Pipeline

CX-904, T-cell-engaging bispecific (TCB) targeted to EGFRxCD3, Phase 1 dose escalation data anticipated in the first half of 2024 – CX-904 is a conditionally activated TCB designed to target the epidermal growth factor receptor (EGFR) on cancer cells and the CD3 receptor on T cells within the tumor microenvironment. CX-904 is partnered with Amgen in a global co-development alliance and is being evaluated in an ongoing Phase 1 study in patients with advanced solid tumors. Backfilling of certain dose escalation cohorts is being initiated during Q4 2023. Initial Phase 1a data for CX-904 is anticipated in the first half of 2024. A decision to initiate Phase 1b expansion cohorts in certain EGFR positive tumor types is anticipated in 2024.
Preclinical profile of EpCAM-directed antibody drug conjugate CX-2051 presented at 2023 World ADC Conference – In October 2023, Dr. Marcia Belvin, chief scientific officer, CytomX Therapeutics, presented data characterizing the preclinical profile for CX-2051. CX-2051 is tailored for treatment of EpCAM-expressing cancers by matching target expression and tumor sensitivity with a topoisomerase-1 inhibitor payload. EpCAM is a broadly expressed, previously validated anti-cancer target that to date has been limited in its development potential due to systemic, on-target off-tumor dose-limiting toxicities. CX-2051 is designed to mask target binding in normal tissues to potentially mitigate systemic toxicities and open a therapeutic window. CX-2051 could potentially address a large patient population as EpCAM is highly expressed across many indications including colorectal, gastric, endometrial, and ovarian cancers. The IND for CX-2051 is expected to be filed by the end of 2023. CX-2051 Phase 1 dose escalation in solid tumors is anticipated in 2024, with metastatic colorectal cancer as a priority indication.
IND filing for CX-801 (Interferon alpha-2b) expected by year-end 2023 – CX-801 is a dually masked, Probody Therapeutic interferon alpha-2b. Interferon-alpha 2b was the first approved cancer immunotherapy but has been limited in its clinical use due to systemic toxicities. Preclinically, Probody IFN-a2b has demonstrated a widened predicted therapeutic index with an improved tolerability profile compared to unmasked interferon alpha-2b, including preferential anti-cancer activity in the tumor microenvironment and increased anti-tumor effects when combined with checkpoint inhibitors. In November 2023, at the Society for Immunotherapy for Cancer (SITC) (Free SITC Whitepaper) 38th Annual Meeting, additional preclinical data were presented demonstrating enhancement of PD-1 anti-tumor efficacy and inflammation of the tumor microenvironment by Probody IFN-a2b. An IND filing for CX-801 is expected by the end of 2023 with planned clinical initiation in 2024.
Continued progress in Phase 2 clinical evaluation of Bristol Myers Squibb’s anti-CTLA-4 non-fucosylated Probody, BMS-986288 – In the first quarter of 2023, BMS prioritized the BMS-986288 Probody program as its lead next-generation CTLA-4 program and advanced the program to Phase 2. BMS-986288 is a masked version of a non-fucosylated anti-CTLA-4 antibody, BMS-986218, which is designed to be more potent than ipilimumab (YERVOY). BMS-986288 utilizes CytomX’s Probody technology to potentially localize the potent effect of the non-fucosylated CLTA-4 antibody to tumors while reducing systemic toxicity. The Phase 2 clinical evaluation of BMS-986288 is ongoing and includes proof of concept studies for microsatellite stable (MSS) colorectal cancer (CRC) and non-small cell lung cancer (NSCLC). BMS anticipates data from the study will be available in 2024. CytomX and BMS continue to collaborate on multiple preclinical research programs.
Corporate Alliances

Continued progress in strategic alliances – Throughout 2023, CytomX made substantial progress across its research alliances including with Astellas, where, in January, the first T-cell engaging bispecific clinical candidate was nominated to proceed to IND enabling activities. Additionally, CytomX initiated activities under its newest collaborations with Regeneron and Moderna. Preclinical research programs continue to progress across each of the Company’s collaborations (Bristol Myers Squibb, Amgen, Astellas, Regeneron, and Moderna) which extend the reach of the Company’s Probody pipeline and provide for the potential to build value through the achievement of future milestones and royalties.
Company Priorities and Potential Milestones for 2023 and 2024

CX-904 (EGFRxCD3): Continue enrollment into Phase 1a dose escalation. Phase 1a dose escalation data are expected in the first half of 2024. A decision to initiate Phase 1b expansion cohorts in certain EGFR positive tumor types is anticipated in 2024.
CX-2051 (EpCAM): File IND by the end of 2023 and begin Phase 1 dose escalation in solid tumors with known EpCAM expression in 2024, with metastatic colorectal cancer as a priority indication
CX-801 (IFNa2b): File IND by the end of 2023, with clinical initiation in 2024
Next-Generation CTLA-4 Program: Continued clinical progress for BMS-986288 including proof-of-concept studies in MSS CRC and NSCLC. BMS anticipates data from the study will be available in 20241.
CX-2029 (CD71): Based on current priorities, the Company will not be directing significant additional investment in this program in the near-term.
Collaborations: Continuation of drug discovery activities with Bristol Myers Squibb, Amgen, Astellas, Regeneron, and Moderna
Third Quarter 2023 Financial Results

Cash, cash equivalents and investments totaled $194.1 million as of September 30, 2023, compared to $180.9 million as of June 30, 2023. The cash balance as of September 30, 2023, includes approximately $30.0 million of gross proceeds from the financing transaction that closed with BVF Partners L.P. in July of 2023, partially offset by cash burn of $16.8 million during the third quarter of 2023.

Total revenue was $26.4 million for the three months ended September 30, 2023, compared to $11.1 million for the corresponding period in 2022 and was driven primarily by a higher percentage of completion for research programs in the Bristol Myers Squibb collaboration and the recent collaborations with Regeneron and Moderna.

Research and development expenses decreased by $14.0 million during the three months ended September 30, 2023, to $16.4 million, compared to $30.4 million for the corresponding period in 2022. The reduction in research and development expenses was primarily due to a decrease in personnel related expenses, as well as winding down of laboratory contract services and clinical study activities related to the CX-2009 and CX-2029 programs, partially offset by an increase in laboratory contract services related to IND enabling activities.

General and administrative expenses decreased by $3.7 million during the three months ended September 30, 2023, to $6.8 million, compared to $10.5 million for the corresponding period in 2022. The reduction in general and administrative expenses was primarily due to a decrease in personnel related expenses as a result of the workforce reduction in 2022, reduced external vendor services, and lower building rent as a result of a partial sublease of the Company’s headquarters.

Conference Call & Webcast
CytomX management will host a conference call and simultaneous webcast today at 5 p.m. EDT (2 p.m. PDT) to discuss the financial results and provide a business update. Participants may access the live webcast of the conference call from the Events and Presentations page of CytomX’s website at View Source Participants may register for the conference call here and are advised to do so at least 10 minutes prior to joining the call. An archived replay of the webcast will be available on the company’s website.

CymaBay Reports Third Quarter and Nine Months Ended September 30, 2023 Financial Results and Provides Corporate Update

On November 7, 2023 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, reported corporate updates and financial results for the third quarter ended September 30, 2023 (Press release, CymaBay Therapeutics, NOV 7, 2023, View Source [SID1234637130]).

Sujal Shah, President and CEO of CymaBay, stated, "This past quarter has been a momentous one for CymaBay where we achieved multiple significant milestones advancing us towards our goal of improving lives of people living with PBC. The consistency and depth of the clinical data set generated from Phase 2, ENHANCE and now RESPONSE demonstrates that seladelpar has the potential to be the first ever approved treatment for patients with PBC to significantly reduce both markers related to the risk of disease progression and symptoms. I am incredibly proud of the team here at CymaBay and commend them for the progress they helped achieve and equally grateful to patients and patient advocacy groups, their caregivers and our investigators for their partnership and support. We are eager to continue the positive momentum and are working diligently on our near-term milestones for seladelpar."

Corporate Updates:

On September 7, 2023, we announced topline results from our seladelpar Phase 3 RESPONSE study. The study evaluated the safety and efficacy of seladelpar for the treatment of PBC. The trial achieved the primary and all key secondary endpoints.

Primary composite endpoint at 12 months of serum alkaline phosphatase and bilirubin was met by 61.7% of patients treated with seladelpar 10 mg vs. 20.0% of placebo treated patients (p<0.0001)
Normalization of alkaline phosphatase at 12 months was achieved by 25.0% of patients treated with seladelpar vs. 0% on placebo (p<0.0001)
In patients having moderate-to-severe itch at baseline, the seladelpar treated group improved their pruritus at 6 months compared to those in the placebo group (p<0.005)
Overall safety and tolerability were comparable between placebo and seladelpar groups and consistent with previous studies
Treatment-emergent adverse events, serious adverse events, and patient discontinuations were generally balanced across the treatment and placebo arms. There were no treatment-related serious adverse events in the study.
On October 23, 2023, we announced that the U.S. Food and Drug Administration (FDA) has revised the originally granted Breakthrough Therapy Designation for seladelpar to now reflect treatment of primary biliary cholangitis (PBC) including pruritus in adults without cirrhosis or with compensated cirrhosis (Child Pugh A) and are inadequate responders to or intolerant to UDCA. Seladelpar is the only potent, selective, orally active PPARδ agonist, or delpar, with Phase 3 results demonstrating a statistically significant improvement in PBC-related cholestatic pruritus.
A late-breaking presentation highlighting results from the RESPONSE Phase 3 study of seladelpar in patients with PBC will be presented at The Liver Meeting of the American Association for the Study of Liver Diseases (AASLD), in Boston, MA (November 10th – 14th).
Announced the initiation of AFFIRM, a randomized, placebo-controlled confirmatory study to evaluate the effect of seladelpar on clinical outcomes in patients with compensated cirrhosis due to PBC. The AFFIRM study is planned to enroll approximately 192 patients with PBC who have compensated cirrhosis (Child-Pugh A or Child-Pugh B) based on prespecified clinical criteria. Patients will be randomly assigned using a 2:1 ratio to oral, once daily seladelpar or placebo for a fixed duration of three years. The primary outcome measure is the time from start of treatment to the first occurrence of clinical events (all-cause death, liver transplant, hospitalization for other serious liver-related events, and progression to Child-Pugh C decompensated cirrhosis). Additional key outcomes include overall survival, liver transplant-free survival, and time to hospitalization for serious liver-related events.
Continued enrollment in ASSURE, an 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 300 patients in this study taking seladelpar daily, including those from our prior studies of seladelpar and patients who have completed RESPONSE.
Findings from post-hoc analysis of the Phase 3 ENHANCE study of seladelpar for the treatment of PBC, showing baseline intensity of patient-reported pruritus was associated with higher levels of serum IL-31 was presented at American College of Gastroenterology (ACG), by Professor Andreas E. Kremer, MD, Ph.D., MHBA, a leading authority in cholestatic pruritus from the University of Zurich. Featured results included novel aspects of the anti-pruritic and anti-cholestatic mechanisms of seladelpar, CymaBay’s first-in-class oral, selective PPARδ agonist, or "delpar," being investigated for the treatment of patients with PBC.
Completed an upsized public equity offering in September 2023, in which we sold 14,521,307 shares of common stock at $17.13 per share and pre-funded warrants to purchase 583,771 shares of common stock at $17.1299 per underlying share. Net proceeds of the offering were $242.8 million, after deducting the underwriting discount and other offering expenses.
The Phase 2a proof-of-pharmacology study to assess whether MBX-2982 can enhance glucagon secretion during insulin-induced hypoglycemia in subjects with type 1 diabetes (T1D) has been completed. The study found that there was no change in glucagon secretion during clamps in subjects with T1D dosed with MBX-2982 versus placebo. In contrast, healthy volunteers showed a glucose dependent increase in glucagon during hypoglycemia. Further, target engagement by MBX-2982 was demonstrated by increases in GLP-1 levels in subjects with T1D. While disappointing, the results demonstrate a well-designed and executed study that demonstrated pharmacodynamic action of MBX-2982 but without demonstrating the pharmacology needed to benefit the T1D population. The scientific questions were answered and CymaBay is not planning any further studies with MBX-2982. We would like to thank Dr. Richard Pratley and his team at the AdventHealth Research Institute in Orlando, Florida as well as ProSciento Inc., California for conducting a well-designed and executed study and The Leona M. and Harry B. Helmsley Charitable Trust for their support of the study through a grant to AdventHealth. We are also grateful to the patients with T1D and healthy volunteers for their participation in the study.
Financial Updates:

Held $438.8 million in cash, cash equivalents and investments as of September 30, 2023. We believe that cash and investments on hand are sufficient to fund CymaBay’s operating expenses into the first half of 2026.
Third Quarter and Nine Months Ended September 30, 2023 Financial Results

Collaboration revenue recognized for the nine months ended September 30, 2023 was $31.0 million and was associated with the collaboration and license agreement with Kaken Pharmaceutical Co., Ltd. (Kaken) entered into in January 2023, to develop and commercialize seladelpar in Japan. As reported earlier, this revenue was recognized upon completion of the initial technology transfer to Kaken in the second quarter of 2023. No incremental collaboration revenue was recognized for the three months ended September 30, 2023. Of the $34.2M upfront payment received from Kaken, $2.7 million remains deferred as of September 30, 2023 and will be recognized upon completion of the CymaBay’s ongoing clinical data delivery and CMC development performance obligations.
Research and development expenses for the three months ended September 30, 2023, and 2022 were $20.0 million and $15.5 million, respectively. Research and development expenses for the nine months ended September 30, 2023 and 2022 were $58.1 million and $51.8 million, respectively. Research and development expenses for the three- and nine-month periods ended September 30, 2023 increased compared to the corresponding periods in 2022 driven by higher clinical activities supporting our clinical studies.
General and administrative expenses for the three months ended September 30, 2023 and 2022 were $12.2 million and $5.9 million, respectively. General and administrative expenses for the nine months ended September 30, 2023 and 2022 were $32.1 million and $17.9 million, respectively. General and administrative expenses for the three and nine months ended September 30, 2023 were higher than the corresponding period in 2022 driven by investments to prepare for potential commercialization of seladelpar in PBC as well as an increase in other corporate expenses.
Net loss for the three months ended September 30, 2023 and 2022 was $33.9 million and $24.5 million, or ($0.32) and ($0.28) per share, respectively. Net loss for the nine months ended September 30, 2023 and 2022 was $63.5 million and $79.4 million, or ($0.62) and ($0.90) per share, respectively. Net loss for the three months ended September 30, 2023 was higher than the three months ended September 30, 2022 primarily due to higher operating expenses. Net loss for the nine months ended September 30, 2023 was lower than the corresponding periods in 2022 due primarily to the recognition of $31.0 million of collaboration revenue related to the Kaken upfront payment during the second quarter of 2023 and higher interest income earned on our investments and other income due to refundable tax credits, offset in part by an increase in operating expenses. Overall, we expect operating expenses to increase in the future as we continue to support our ongoing drug development activities and expand on initiatives to prepare for potential commercialization of 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 1-877-407-0784 from the U.S. and Canada, or 1-201-689-8560 internationally, Conference ID #13740701. 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

Cumberland Pharmaceuticals Reports
Third Quarter 2023 Financial Results

On November 7, 2023 Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company, reported that its product portfolio of FDA-approved brands delivered combined revenues of $10.1 million during the third quarter of 2023 and $30.2 million year to date (Press release, Cumberland Pharmaceuticals, NOV 7, 2023, View Source [SID1234637129]).

Net loss for the third quarter was $1.0 million, while year-to-date net income was $15,086. Adjusted earnings were $260,146 for the third quarter and $4.2 million, or $0.29 a share, year to date. Cash flow from operations during 2023 has totaled $5.1 million.

The company ended the third quarter with $88 million in total assets, $52 million in total liabilities, and $36 million of shareholders’ equity.

"During 2023 our team has been working diligently to advance our long-term business strategy, building our brands and progressing our clinical programs," said Cumberland Pharmaceuticals CEO A.J. Kazimi. "Moreover we have refined our mission statement, to reflect our collaborative efforts and patient focus – as we provide unique products that improve the quality of their care."
Cumberland will report its full third quarter 2023 financial results and provide a company update via a conference call today at 4:30 p.m. Eastern Time.

Recent Company developments include:

New Bank Credit Facility
On September 5, 2023, Cumberland entered into a new Revolving Credit Loan Agreement with Pinnacle Bank for a three-year term. The agreement provides for an aggregate principal funding amount of up to $25 million. It provides an initial revolving credit line with $20 million of availability, and the ability of Cumberland to increase the amount to $25 million under certain conditions. The interest rate is based on Benchmark (Term SOFR) plus a spread of 2.75%, and Cumberland is subject to one financial covenant, the maintenance of a Funded Debt Ratio, determined on a quarterly basis.

New Vibativ Pediatric Study Publication

In October 2023, Cumberland announced a new publication in Antimicrobial Agents and Chemotherapy detailing the results of the first clinical study investigating the safety and pharmacokinetics of its Vibativ injection in children 2 to 17 years of age. Vibativ is an intravenous antibiotic approved by the FDA for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia as well as complicated skin and skin structure infections caused by certain gram-positive bacteria in adults.

This is the first reported study evaluating Vibativ in pediatric patients. The results of the study suggest that a single dose of Vibativ is safe in children and they experience reduced exposure to Vibativ, compared with the same body weight-based dosing in adults.

Federal NOPAIN Act

Cumberland expects its Caldolor injection, a non-opioid analgesic product, will be eligible for special Medicare reimbursement under the Non-Opioids Prevent Addiction in the Nation Act (the "NOPAIN Act"), which was enacted as part of the Consolidated Appropriations Act of 2023.
The NOPAIN Act requires Medicare to provide separate reimbursement for non-opioid products that are used to manage pain during surgeries conducted in hospital outpatient departments or in ambulatory surgical centers. The NOPAIN Act applies, in part, to products that are indicated to provide analgesia without acting upon the body’s opioid receptors.
The reimbursement for non-opioid pain alternatives under the NOPAIN Act will apply to those products that are furnished between January 1, 2025 and January 1, 2028. It is anticipated that in 2024, the Centers for Medicare & Medicaid Services will issue regulations implementing the NOPAIN Act and detailing the conditions for, and amount of, the separate reimbursement. Cumberland submitted a comment letter along with clinical information in the third quarter, explaining why Caldolor should be included and separately reimbursed.
Caldolor is approved by the FDA for use in adults and pediatric patients 3 months and older for the management of mild to moderate pain as a sole therapy, and for the management of moderate to severe pain as an adjunct to an opioid. A series of published clinical studies have demonstrated that Caldolor significantly reduces patient pain, while also significantly reducing patients’ need for opioids.
Sancuso Acquisition and Approval of New Manufacturing Plant
Early last year, Cumberland acquired the U.S. rights to the FDA-approved oncology-supportive care medicine Sancuso from Kyowa Kirin, Inc., the U.S. affiliate of Japan-based Kyowa Kirin Co., Ltd.
Sancuso is the first and only FDA-approved prescription patch for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment.
As of September 2023, the transition of Sancuso to Cumberland is complete. In late 2022, the FDA approved moving the product’s manufacturer to a new facility, and the production of supplies for Cumberland at that plant is now underway during the fourth quarter of 2023.
Vaprisol Supply Update
Cumberland continues to work with its new manufacturing partner for Vaprisol, Nephron Pharmaceuticals, to provide interim supplies of a special compounded conivaptan product to the market in support of critically ill patients. The companies will share in the sales of this compounded product, which has been successfully manufactured and expected to be available by the end of 2023. Cumberland then plans to file for the approval to manufacture branded Vaprisol once Nephron addresses the FDA’s Form 483 and warning letter issues.
Clinical Development Programs
Cumberland has been evaluating its ifetroban product candidate, a selective thromboxane-prostanoid receptor antagonist, in a series of clinical studies. It has been dosed in nearly 1,400 subjects and has been found to be safe and well tolerated in healthy volunteers and various patient populations.

Patient enrollment is well underway in two company sponsored Phase II clinical programs to evaluate ifetroban in Systemic Sclerosis or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs; and the Cardiomyopathy associated with Duchenne Muscular Dystrophy ("DMD"), a rare and fatal genetic neuromuscular disease that results in deterioration of the skeletal, heart and lung muscles.
Cumberland is sponsoring the FIGHT DMD trial, a multicenter, randomized, placebo-controlled Phase II study evaluating the safety, pharmacokinetics and efficacy of two doses of oral ifetroban for the treatment of the cardiomyopathy associated DMD. The trial is evaluating 12 months of oral ifetroban in 24 subjects with early-stage cardiomyopathy and 24 subjects with advanced-stage heart disease across 10 U.S. centers that specialize in DMD cardiomyopathy.
In May 2023, Cumberland announced that the FDA has cleared the Investigational New Drug Application for a Phase II study in patients with Idiopathic Pulmonary Fibrosis ("IPF"), the most common form of progressive fibrosing interstitial lung disease. As a result, the company is initiating its FIGHTING FIBROSIS trial designed to enroll 128 patients in over 20 medical centers of excellence across the U.S. This Phase II clinical trial will study the safety, tolerability and efficacy of oral ifetroban in patients with IPF. Recent studies have shown ifetroban can both prevent and enhance resolution of lung fibrosis in multiple preclinical models.
Cumberland’s plan going forward is to complete each of its company-sponsored studies, analyze their final data, announce top-line results and decide on the best development path for the registration of ifetroban, which the company continues to believe has the potential to benefit many patients with orphan diseases that represent unmet medical needs.
FINANCIAL RESULTS:
Net Revenue: For the three months ended September 30, 2023, net revenues were $10.1 million and included $3.9 million for Kristalose, $2.8 million for Vibativ, $1.9 million for Sancuso and $1.2 million for Caldolor. Year-to-date 2023 net revenues were $30.2 million and included $12.3 million for Kristalose, $6.8 million for Vibativ, $5.7 million for Sancuso and $3.3 million for Caldolor.
Operating Expenses: Total operating expenses were $12.0 million for the third quarter of 2023 and $33.6 million for the first nine months of the year.
Net Income (Loss): The net loss for the third quarter of 2023 was $1.0 million, while the year-to-date net income was $15,086.
Adjusted earnings: Adjusted earnings for the third quarter of 2023 were $260,146, or $0.02 a share and $4.2 million year to date, or $0.29 a share. The adjusted earnings calculation does not include the benefit of the $0.5 million of Vibativ cost of goods, which was received with the product acquisition. It also does not include the benefit of the $0.3 million of Sancuso cost of goods, which was received with that product’s acquisition.
Balance Sheet: At September 30, 2023, Cumberland had $87.8 million in total assets, including $18.5 million in cash and cash equivalents.
Total liabilities were $52.1 million, including $12.9 million outstanding on the Company’s revolving line of credit. Total shareholders’ equity was $36.0 million.

EARNINGS REPORT CALL:

A conference call will be held on Nov. 7, 2023, at 4:30 p.m. Eastern Time to discuss the results. To participate in the call, please register at
https://register.vevent.com/register/BI9c23410ae1a342fab9f11ecec96f52fa.
Registered participants can dial in from their phone using a dial-in and PIN number that will be provided to them. Alternatively, they can choose a "Call Me" option to have the system automatically call them at the start of the conference.
A replay of the call will be available for one year and can be accessed via Cumberland’s website or by visiting View Source

10-Q – Quarterly report [Sections 13 or 15(d)]

On November 7, 2023 Cogent Biosciences reported its quarterly report (Filing, 3 mnth, SEP 30, Cogent Biosciences, 2023, NOV 7, 2023, View Source [SID1234637128]).

Crinetics Pharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Corporate Update

On November 7, 2023 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) reported financial results for the third quarter ended September 30, 2023 (Press release, Crinetics Pharmaceuticals, NOV 7, 2023, View Source [SID1234637127]).

"The resounding success of paltusotine in our PATHFNDR-1 Phase 3 study for acromegaly is a significant step toward fulfilling our strategic vision of building a premier, fully integrated endocrine company that can consistently create pioneering therapies for people around the world," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "We intend to build additional momentum around our investigational compound paltusotine in the next few months. In December, we plan to analyze initial data from approximately half of the study participants in our ongoing Phase 2 study in carcinoid syndrome that should provide a preliminary indication of pharmacokinetic exposure, safety, and efficacy in this important second indication. We anticipate the full Phase 2 dataset from carcinoid to be available in the first half of 2024, and we remain on track to announce Phase 3 data from the PATHFNDR-2 study in the first quarter of 2024. We are enthusiastic about these upcoming key milestones for the paltusotine franchise."

THIRD QUARTER 2023 AND OPERATING HIGHLIGHTS
Phase 3 PATHFNDR-1 study met primary and all secondary endpoints. In September 2023, Crinetics reported positive topline results from its placebo-controlled Phase 3 clinical study of paltusotine in participants with acromegaly switching from standard-of-care injected depot somatostatin analogs which is designed to support an indication for the maintenance of acromegaly treatment. The study met statistical significance (p<0.0001) on the primary endpoint, based on the proportion of participants taking paltusotine (83%) who maintained an insulin-like growth factor 1 (IGF-1) level ≤ 1.0 times the upper limit of normal (xULN) compared to those taking placebo (4%). All secondary endpoints also met statistical significance as compared to placebo: change from baseline in IGF-level (p<0.0001), change from baseline in acromegaly symptoms diary (ASD) total score (p=0.02), and proportion of participants who maintained growth hormone level of <1.0 ng/mL (p=0.0003).
Completed enrollment in paltusotine’s Phase 3 PATHFNDR-2 study. PATHFNDR-2 is a placebo-controlled Phase 3 clinical study of oral paltusotine in participants with acromegaly who are treatment-naïve or not currently receiving medical therapy which is designed to support an indication for the treatment of acromegaly. The study completed enrollment of 112 participants with acromegaly who were either treatment-naïve or untreated for at least four months (Stratum 1: n=82), or who washed out of prior octreotide or lanreotide monotherapy (Stratum 2: n=30). Topline data from the study is expected in the first quarter of 2024.
Hosted Key Opinion Leader (KOL) webinar discussing acromegaly unmet need. In August 2023, Crinetics hosted a webinar featuring presentations by KOLs Beverly MK Biller, M.D. and Karen JP Liebert, R.N., BSN, both of Massachusetts General Hospital, who discussed the current landscape and unmet medical need in acromegaly, as well as the treatment burden associated with standard-of-care injectable somatostatin receptor ligands (SRLs). A replay of the webinar can be accessed here.
Paltusotine NDA submission anticipated in 2024. Pending successful data from the PATHFNDR-2 study, Crinetics plans to submit a new drug application (NDA) to the Food and Drug Administration seeking regulatory approval for both the treatment of acromegaly and maintenance of acromegaly treatment indications.
Initial data from Phase 2 study of paltusotine in carcinoid syndrome expected December 2023. The Phase 2 open-label study of paltusotine in carcinoid syndrome associated with neuroendocrine tumors is completing enrollment. A preliminary analysis from a subset of approximately half of the expected 30 participants is anticipated in December 2023. The study is designed primarily to assess the pharmacokinetic exposure and safety profile of paltusotine in participants with carcinoid syndrome. In addition, the study should provide descriptive efficacy information on the frequency of bowel movements and flushing episodes.
CRN04894 studies for Cushing’s disease and congenital adrenal hyperplasia (CAH). Based on successful Phase 1 studies demonstrating pharmacologic proof-of-concept, Crinetics is advancing clinical studies of CRN04894 in both Cushing’s disease and congenital adrenal hyperplasia. Data from the ongoing studies are expected in the second half of 2024.
Strengthened balance sheet with $350 million public offering. In September 2023, Crinetics announced the pricing of an upsized underwritten public offering of 11,441,648 shares of its common stock at $30.59 per share. Gross proceeds from the offering were $350.0 million.
THIRD QUARTER 2023 FINANCIAL RESULTS
Research and development expenses were $43.8 million for the three months ended September 30, 2023, compared to $32.0 million for the same period in 2022. The change was primarily due to an increase in personnel costs of $8.3 million, increased net spending on manufacturing and development activities of $1.8 million associated with our clinical and nonclinical programs, and increased outside services of $1.2 million.
General and administrative expenses were $15.5 million for the three months ended September 30, 2023, compared to $11.9 million for the same period in 2022. The change was primarily due to an increase in personnel costs of $3.2 million.
Net loss for the three months ended September 30, 2023, was $57.5 million, compared to a net loss of $41.9 million for the same period in 2022.
Revenues were $0.3 million for the three months ended September 30, 2023, compared to $0.5 million for the same period in 2022. Revenues in both periods were primarily derived from the paltusotine licensing arrangement with Sanwa Kagaku Kenkyusho Co., Ltd.
Unrestricted cash, cash equivalents, and investments totaled $554.7 million as of September 30, 2023, compared to $334.4 million as of December 31, 2022. Based on its current projections, the company now expects that its cash, cash equivalents and short-term investments will be sufficient to fund its current operating plan into 2026.
The company had 66,799,257 common shares outstanding as of October 31, 2023.