On August 8, 2023 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported financial results for the three and six months ended June 30, 2023 (Press release, Eagle Pharmaceuticals, AUG 8, 2023, View Source [SID1234633965]).

"We delivered a strong second quarter with impressive earnings and revenue, continuing the positive trajectory from an outstanding 18 months of business performance," stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals. "Our marketed drugs across oncology and our hospital business are performing well. We’re particularly excited with the revenue ramp for Barhemsys and Byfavo; our share of the commercial U.S. pemetrexed market has more than tripled since the end of 2022, and Bendeka and Belrapzo continue to outperform. In light of these and other positive factors, which we believe reflect a broader continuation of strength, we recently raised our full-year 2023 guidance and resumed our share repurchase program."

Adjusted non-GAAP net income, adjusted non-GAAP earnings per share, adjusted non-GAAP EBITDA, adjusted non-GAAP gross margin, adjusted non-GAAP gross profit, adjusted non-GAAP R&D expense and adjusted non-GAAP SG&A expense are non-GAAP financial measures. For descriptions and reconciliations of these non-GAAP financial measures for historical periods to their most comparable GAAP financial measures, please see below and the tables at the end of this press release.

"Our expectation is that the growth that began in 2022 will continue, and we have confidence that 2023 will be another great year for Eagle," stated Tarriff. "Going forward, we intend to build on our sales momentum and also to leverage our commercial infrastructure and working capital position to add complementary products, either through R&D or acquisition."

Recent Business Highlights:

· An estimated 19,000 patients were dosed with Barhemsys or Byfavo during the second quarter of 2023, and 275 health care facilities purchased the products out of a total targeted market of approximately 4,000.2 Combined sales of Barhemsys and Byfavo were $1.2 million, representing approximately 30% sequential growth for the last two quarters. A summary of the sequential quarter sales growth for Barhemsys and Byfavo is provided below:

Description automatically generated with medium confidence

· The Company completed the expansion of its hospital and oncology commercial teams. Eagle believes the new commercial infrastructure of approximately 80 people enables the Company to bring in additional products, through R&D or acquisition, with minimal additional commercialization costs.
· Eagle is scheduled to have a Type C meeting with the U.S. Food and Drug Administration (FDA) in August 2023 for EA-114, its estrogen receptor antagonist product candidate for the treatment of HR+/HER- advanced breast cancer.
· FDA granted Qualified Infectious Disease Product (QIDP) Designation and Fast Track Designation for CAL02, a novel first-in-class anti-toxin drug candidate, being developed to treat severe community-acquired bacterial pneumonia (SCABP) as an adjunctive therapy to standard of care, entitling Eagle to an additional five years of marketing exclusivity upon approval.
· First patients were randomized in a multi-center adaptive, randomized, double-blind, placebo-controlled Phase 2 study designed to assess the efficacy and safety of CAL02 administered intravenously in addition to standard of care in patients with SCABP. The study plans to enroll approximately 276 patients at more than 100 sites in over 20 countries worldwide, with 100 sites expected to be up by year-end in time for the northern hemisphere’s pneumonia season. Depending upon recruitment rates, Eagle anticipates having its 50% interim report around the first half of 2024.

Second Quarter 2023 Financial Results

Total revenue for the second quarter of 2023, was $64.6 million, as compared to $74.1 million for the second quarter of 2022.

Second quarter 2023 royalty revenue was $21.7 million, compared to $24.9 million in the prior year quarter.

A summary of total revenue is outlined below:

Three Months Ended June 30, Six Months Ended June 30,
2023 2022 2023 2022
(unaudited) (unaudited) (unaudited) (unaudited)
Revenue (in thousands):
Product sales, net $ 42,993 $ 49,201 $ 89,214 $ 139,289
Royalty revenue 21,653 24,935 41,737 50,721
Total revenue $ 64,646 $ 74,136 $ 130,951 $ 190,010

Gross margin was 74% during the second quarter of 2023, compared to 68% in the second quarter of 2022.

R&D expense was $9.8 million for the second quarter of 2023, compared to $11.4 million for the second quarter of 2022. The decrease was primarily due to lower spend on the Company’s EA-114 program, which was in a large-scale study during the second quarter of 2022.

SG&A expenses in the second quarter of 2023 were $27.7 million compared to $36.8 million in the second quarter of 2022. This decrease was driven largely by the non-recurrence of Acacia-related acquisition costs and severance, partially offset by higher personnel related costs given the Company’s expanded hospital and oncology sales teams as well as higher selling and marketing costs for Barhemsys and Byfavo.

Net income for the second quarter of 2023 was $5.2 million, or $0.39 per basic and diluted share, compared to net loss of $(9.5) million, or $(0.74) per basic and diluted share, in the second quarter of 2022, primarily as a result of the factors discussed above.

Adjusted non-GAAP net income for the second quarter of 2023 was $15.5 million, or $1.18 per basic and diluted share, compared to adjusted non-GAAP net income of $20.3 million, or $1.58 per basic and $1.56 per diluted share, in the second quarter of 2022.

Adjusted non-GAAP EBITDA for the second quarter of 2023 was $20.7 million, compared to adjusted non-GAAP EBITDA of $25.9 million in the second quarter of 2022.

2023 Full-Year Guidance

The Company reiterated its recently announced raised guidance as follows:

· Adjusted non-GAAP EBITDA of $78.0-$84.0 million
· Adjusted non-GAAP earnings per share of $4.40-$4.70
· Adjusted non-GAAP R&D expense of $41.0-$45.0 million
· Adjusted non-GAAP SG&A expense of $86.0-$90.0 million

Liquidity

As of June 30, 2023, Eagle had $15.4 million in cash and cash equivalents, $115.1 million in accounts receivable, net, and $71.3 million in outstanding debt on the Company’s $150.0 million credit facility with JPMorgan. As of June 30, 2023, the Company had drawn $25.0 million on its $100.0 million revolving credit facility, which is included in outstanding debt.

As of June 30, 2023, Eagle had working capital of $100.6 million, after significant direct investment in R&D to fund the Company’s promising product candidates, the acquisition of Acacia Pharma Inc.’s outstanding shares and debt in 2022, and the purchase of an equity stake in and option to acquire Enalare Therapeutics Inc.

Conference Call

As previously announced, Eagle management will host its second quarter 2023 conference call as follows:

Date Tuesday, August 8, 2023
Time 8:30 a.m. ET
Toll free (U.S.) 800-343-4136
International 203-518-9814
Webcast (live and replay) www.eagleus.com, under the "Investor Relations" section

On August 8, 2023 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated, localized biologics, reported second quarter 2023 financial results and provided a business update (Press release, CytomX Therapeutics, AUG 8, 2023, View Source [SID1234633964]).

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"In recent months, we have continued to advance our innovative Probody Therapeutic pipeline, while making significant progress with our partners across a wide range of programs and therapeutic modalities," said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX Therapeutics. "With a recent strategic financing completed with long-term CytomX shareholder, BVF Partners, we have strengthened our financial position and extended our cash runway into the second half of 2025."

Continued Dr. McCarthy, "During Q2 we also further strengthened our management team with the addition of Dr. Wayne Chu as Chief Medical Officer and the advancement of Dawn Benson to Senior Vice President of Quality and Product Manufacturing. Wayne’s extensive experience in oncology drug development across multiple therapeutic formats will be invaluable as we optimize our clinical development strategy and execution across our broad pipeline. Dawn’s contributions to CytomX during her tenure to date, and her 25-year biotech career leading quality and manufacturing-related activities, uniquely qualify her for this expanded role. We are poised to enter a period of considerable opportunity for CytomX in which we expect to reach multiple clinical milestones for key pipeline programs over the next 12 to 18 months."

Second Quarter Business Highlights and Recent Developments

Pipeline

CX-904, T-cell-engaging bispecific (TCB) targeted to EGFRxCD3, progressing towards initiation of backfill cohorts by the end of 2023 with initial 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 by CytomX in an ongoing Phase 1 study in patients with advanced solid tumors. The primary goal of the ongoing initial dose escalation portion of the study is to assess safety and reach dose levels and exposures by the end of 2023 that support enrollment into backfill cohorts in select EGFR positive tumors. Initial Phase 1 dose escalation data for CX-904 is anticipated in the first half of 2024. Also, a decision to initiate expansion cohorts is anticipated in 2024, which will support future selection of the recommended Phase 2 dose.

IND filings for CX-2051 (EpCAM-directed ADC) and CX-801 (Interferon alpha-2b) expected in the fourth quarter of 2023 – CytomX’s next wave of molecules to enter the clinic leverage validated anti-cancer pathways and mechanisms of action that have historically been limited in their potential due to systemic toxicities. The molecular design of CX-2051 and CX-801 incorporated CytomX’s platform expertise and clinical learnings to optimize the predicted therapeutic index and potentially broaden the clinical utility of these promising targets through tumor localized conditional activation.

Continued progress in Phase 2 clinical evaluation of Bristol Myers Squibb’s Anti-CTLA-4 non-fucosylated Probody, BMS-986288 – In Q1 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 a more potent version of ipilimumab (YERVOY). The non-fucosylated Probody, BMS-986288, utilizes CytomX’s masking technology to potentially localize the potent effect of a non-fucosylated CLTA-4 antibody to tumors while reducing systemic toxicity. The Phase 2 clinical evaluation of BMS-986288 is ongoing and includes a study arm evaluating third line or later colorectal cancer. CytomX and BMS also continue to collaborate on multiple preclinical research programs.
Corporate

Strategic financing extends cash runway into the 2nd half of 2025 and through multiple potential clinical milestones – In July 2023, CytomX entered into an agreement with BVF Partners L.P. ("BVF") for a private placement that resulted in initial gross proceeds of approximately $30.0 million. In the private placement, CytomX sold pre-funded warrants and accompanying tranche warrants at a combined price of $2.08 per share. CytomX also has the potential to receive up to an additional $60.0 million if all tranche warrants are fully exercised for cash.

Yu-Waye (Wayne) Chu, M.D., joins CytomX as Chief Medical Officer – In July 2023, CytomX announced the appointment of Yu-Waye (Wayne) Chu, M.D., as Chief Medical Officer (CMO). Dr. Chu joins CytomX with over 20 years of experience in oncology, in roles ranging from research to medicine to global clinical development. His drug development experiences have contributed to multiple approvals and span therapeutic modalities including antibody drug conjugates, checkpoint inhibitors, and bispecific immunotherapies. As CMO, Dr. Chu will oversee clinical development of the Company’s diversified portfolio of Probody therapeutic candidates.

Dawn Benson promoted to Senior Vice President of Quality and Product Manufacturing – In July 2023, CytomX announced the promotion of Dawn Benson from Vice President of Quality to Senior Vice President of Quality and Product Manufacturing. Ms. Benson brings more than 25 years of CMC experience in the biotechnology industry. Prior to joining CytomX, she was the Senior Vice President, Head of Quality at Coherus BioSciences and also has held various leadership positions at Sutro Biopharma, Jazz Pharmaceuticals, VaxGen and Nabi Biopharmaceuticals (acquired by Biotest Pharmaceuticals). Ms. Benson graduated from the University of North Carolina at Wilmington with a Bachelor of Chemistry and Biology.

Continued progress in strategic alliances – As a core component of the company business model, CytomX has leveraged strategic partnerships to extend the reach of its science, broaden its pipeline, and bring non-dilutive capital to the company. As part of this initiative, CytomX currently has five major partnerships, including the two most recently announced partnerships with Regeneron and Moderna. CytomX continues to make progress across its partnered research activities which has extended the reach of the Company’s technology and pipeline and provides for potential to build value through the achievement of future milestones and royalties over time.
Priorities for 2023

CX-904 (EGFRxCD3): Continue patient enrollment and dose escalation in ongoing Phase 1 study and initiate backfill cohorts by the end of 2023
File 2 New INDs (wholly-owned): CX-801 (IFNa2b) and CX-2051 (EpCAM) INDs projected in the fourth quarter of 2023
Next-Generation CTLA-4 Program: Continued clinical progress for BMS-986288
CX-2029 (CD71): Determine next steps for CD71 program, including CX-2029
Collaborations: Continuation of drug discovery activities within R&D alliances including those with our newest collaborators, Regeneron and Moderna

Second Quarter 2023 Financial Results

Cash, cash equivalents and investments totaled $180.9 million as of June 30, 2023, compared to $204.5 million as of March 31, 2023. The cash balance as of June 30, 2023 does not include approximately $30.0 million of gross proceeds from the financing transaction that closed with BVF Partners L.P. in July of 2023.

Total revenue was $24.7 million for the three months ended June 30, 2023, compared to $12.9 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, partially offset by a reduction in revenue from the AbbVie collaboration as a result of termination of the AbbVie CD71 agreement in the first quarter of 2023.

Research and development expenses decreased by $10.5 million during the three months ended June 30, 2023 to $20.7 million, compared to $31.2 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 $4.3 million during the three months ended June 30, 2023 to $7.4 million, compared to $11.7 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 and patent related legal expenses.

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.

On August 8, 2023 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), (Nasdaq: CRNX) reported financial results for the second quarter ended June 30, 2023 (Press release, Crinetics Pharmaceuticals, AUG 8, 2023, View Source [SID1234633963]).

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"The PATHFNDR program for acromegaly continues to progress as expected. Topline results from our Phase 3 PATHFNDR-1 study are expected in September and should provide insight into paltusotine’s potential as an alternative to standard-of-care somatostatin receptor ligand depot injections. Enrollment in our Phase 3 PATHFNDR-2 study is also now complete and we anticipate topline results in the first quarter of 2024," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "Unfortunately, we also suffered a setback with our CRN04777 program and made the difficult decision to wind down its development. We know that infants and children living with congenital hyperinsulinism are in desperate need of better treatment options and our hearts go out to them and their families. However, our recently evolved understanding of the nonclinical profile of CRN04777 suggests that it no longer meets the high standards to which we hold all drug candidates in our pipeline."

SECOND QUARTER 2023 AND RECENT HIGHLIGHTS:
Topline data from paltusotine’s Phase 3 PATHFNDR-1 study expected in September 2023. PATHFNDR-1 is a placebo-controlled Phase 3 clinical study of oral paltusotine in participants with acromegaly switching from standard-of-care peptide depots. The study enrolled 58 participants with acromegaly whose average IGF-1 levels during screening were within the normal range (IGF-1 ≤ 1.0x upper limit of normal) on octreotide or lanreotide depot monotherapy. The primary endpoint of the study is the proportion of participants whose average IGF-1 levels at weeks 34 and 36 are within the normal range after switching to paltusotine compared to placebo.
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. 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.
Paltusotine NDA submission anticipated in 2024. Pending successful data from the PATHFNDR program, Crinetics plans to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) seeking regulatory approval for the use of paltusotine in acromegaly with both treatment and maintenance of treatment indications.
Clinical and preclinical data presented at the ENDO 2023 Annual Conference. A podium presentation featured results from the ACROBAT Advance open-label extension study of paltusotine in acromegaly. In addition, pre-clinical studies of the company’s thyroid-stimulating hormone (TSH) receptor antagonist for the treatment of thyroid eye disease (orbitopathy) associated with Graves’ disease and of the parathyroid hormone receptor type 1 (PTH1R) antagonist being developed for the treatment of primary hyperparathyroidism (PHPT) were presented as poster presentations. In addition, Scott Struthers, Ph.D., Crinetics’ founder and CEO was awarded the John D. Baxter Prize to recognize extraordinary achievement in endocrinology entrepreneurship at ENDO 2023 and gave an award lecture on the history of discovering nonpeptide oral drugs acting at peptide hormone receptors.
Phase 2 open-label study of paltusotine in carcinoid syndrome ongoing. The Phase 2 open-label study of paltusotine in carcinoid syndrome associated with neuroendocrine tumors is continuing to enroll participants, and preliminary data is anticipated in the fourth quarter of 2023.
CRN04894 studies in Cushing’s disease and congenital adrenal hyperplasia are ongoing. Based on successful Phase 1 studies demonstrating pharmacologic proof-of-concept, Crinetics is conducting clinical studies of CRN04894 in Cushing’s disease and congenital adrenal hyperplasia. Data from both studies are expected in 2024.
CRN04777 update. While developing our response to the clinical hold issued by the FDA, results from additional nonclinical studies became available. These studies uncovered findings at exposure levels that eroded anticipated therapeutic margins for CRN04777. These other findings are not related to those originally cited by the FDA for the clinical hold and, importantly, are not present in nonclinical studies that have been conducted with other Crinetics product candidates under development. We believe them to be specific to CRN04777 and not associated with its somatostatin receptor type 5 (SST5) mechanism of action. In light of these findings, the company has decided to suspend further significant investment into the molecule at this time.
SECOND QUARTER 2023 FINANCIAL RESULTS
Research and development expenses were $40.6 million for the three months ended June 30, 2023, compared to $33.0 million for the same period in 2022. The increase was primarily attributable to an increase in personnel costs of $6.9 million, increased consulting and outside services of $1.6 million, increased other expenditures of $0.7 million, partially offset by decreased net spending on manufacturing and development activities of $1.6 million associated with our clinical and nonclinical programs.
General and administrative expenses were $13.3 million for the three months ended June 30, 2023, compared to $10.5 million for the same period in 2022. The increase was primarily attributable to an increase in personnel costs of $2.7 million.
Net loss for the three months ended June 30, 2023, was $51.0 million, compared to a net loss of $42.4 million for the same period in 2022.
Revenues were $1.0 million for the three months ended June 30, 2023, compared to $0.4 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 $264.5 million as of June 30, 2023, compared to $334.4 million as of December 31, 2022.
The company had 54,686,550 common shares outstanding as of August 4, 2023.
KEY OPINION LEADER (KOL) WEBINAR ON ACROMEGALY CURRENT TREATMENT LANDSCAPE AND UNMET NEED
Crinetics is hosting a KOL webinar today, August 8, 2023 at 12:00 pm ET. The webinar will feature key opinion leaders Beverly MK Biller, M.D. and Karen JP Liebert, R.N., B.S.N, both of Massachusetts General Hospital, who will discuss 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). In addition, the Crinetics management team will discuss its pipeline of internally discovered oral small molecule drug candidates, with a focus on the Phase 3 PATHFNDR-1 study of paltusotine.

A live question and answer session will follow the formal presentations. To register for the event, please click here. If you would like to ask a question during the live Q&A, please submit your request to [email protected]. A replay of the event will be available by clicking here.

On August 8, 2023 Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported a business update and provided financial results for the second quarter ended June 30, 2023 (Press release, Corvus Pharmaceuticals, AUG 8, 2023, View Source [SID1234633962]).

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"During the second quarter, we continued to strengthen the scientific and clinical foundation for the potential use of soquelitinib for a variety of cancers and have several important near-term milestones for our clinical programs," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "We believe that soquelitinib, our selective ITK inhibitor, may offer a new approach to cancer immunotherapy based on its unique mechanism of action, which is to increase infiltration of cytotoxic T cells into tumors, increase the cytolytic capacity of T cells and reduce T cell exhaustion. This mechanism is distinct and independent from current immuno-oncology therapies based on checkpoint inhibition. We remain on track to meet with the FDA this quarter to discuss a potential registrational Phase 3 clinical trial with soquelitinib in relapsed T cell lymphomas (TCL). We also are planning to initiate clinical studies with soquelitinib in solid tumors. Lastly, enrollment is ongoing in clinical trials evaluating our partner led programs, ciforadenant and mupadolimab, with the potential for initial ciforadenant data from the Phase 1b/2 trial in front line therapy for patients with metastatic renal cell cancer to be released by year end."

Business Update and Strategy

Prioritized Program: Soquelitinib (formerly CPI-818, Corvus’ selective ITK inhibitor)

Soquelitinib for T Cell Lymphoma

Corvus continues to enroll patients with relapsed TCL in a Phase 1/1b clinical trial evaluating single agent therapy with soquelitinib, including utilizing its recently incorporated biomarker based on absolute lymphocyte count (ALC). The latest data from the trial was reported at the International Conference on Malignant Lymphoma, which took place June 13-17, 2023 in Lugano, Switzerland. As of the May 18, 2023 cut-off date, a total of 30 patients were enrolled at the optimum 200 mg two-times a day dose, including 20 evaluable for tumor response. There were 3 complete responses (CR) and 3 partial responses (PR) with one of these PRs demonstrating continued regression of the tumor. One of the patients with a CR and two with PRs remained on therapy. A total of ten patients remained on therapy, including six who have not had their initial tumor response evaluation. For patients with ALC above 900 per cubic milliliter of blood, objective responses (CR plus PR) were seen in 6 of 14 patients with disease control (CR, PR and stable disease) in 12 of 14 patients. No objective responses were seen in six patients (0 for 6) with ALC below 900.
Based on the current enrollment rate of the Phase 1/1b clinical trial, Corvus believes that the number of patients treated in this clinical trial would provide adequate safety and preliminary efficacy data to inform the design of a potential registrational Phase 3 randomized clinical trial. As recommended by the FDA, Corvus plans to meet with the FDA to discuss such a clinical trial; it is anticipated that this meeting will take place during the third quarter of this year.
Soquelitinib Preclinical Data in Hematologic and Solid Tumors

On July 6, 2023, Corvus announced the publication of preclinical data on soquelitinib as a preprint at bioRxiv, which highlighted the selective inhibition of ITK to potentially enhance anti-tumor immune response to hematologic and solid tumors and provide a novel approach to cancer immunotherapy. Important findings from the preclinical studies include the demonstration of soquelitinib’s ability to induce skewing and enrichment of T-helper type 1 (Th1) cells and increase infiltration of cancer killing T cells into tumors with greater potency and less resistance due to exhaustion. Data also showed that soquelitinib monotherapy led to in vivo anti-tumor activity in several mouse tumor models, including colon, renal, melanoma, B cell and T cell tumors.
Partner Led Programs: Ciforadenant (adenosine 2a receptor inhibitor) and Mupadolimab (anti-CD73)

The Kidney Cancer Research Consortium (KCRC) is enrolling a Phase 1b/2 clinical trial evaluating ciforadenant as a potential first line therapy for metastatic renal cell cancer (RCC) in combination with ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1). The Phase 1b portion of this trial has been completed and patients are now being enrolled in the Phase 2 portion. The clinical trial is expected to enroll up to 60 patients and initial data is anticipated before the end of 2023.

Support for the mechanism of action and anti-tumor activity of ciforadenant was recently presented at the Japanese Cancer Association and American Association for Cancer Research (AACR) (Free AACR Whitepaper) (JCA-AACR) Precision Cancer Medicine International Conference, which took place June 28-30, 2023 in Kyoto, Japan. The presentation highlighted preclinical data suggesting a synergy between ciforadenant and immune checkpoint blockade (ICB), leading to a proinflammatory response.
Angel Pharmaceuticals, Corvus’ partner in China, is enrolling patients in a Phase 1/1b clinical trial of mupadolimab in patients with non-small cell lung cancer (NSCLC) and head and neck squamous cell cancers. In this clinical trial, patients will receive mupadolimab monotherapy or in combination with pembrolizumab.
Financial Results
As of June 30, 2023, Corvus had cash, cash equivalents and marketable securities of $37.0 million as compared to $42.3 million as of December 31, 2022. During the quarter ending June 30, 2023, the Company sold 2,329,851 shares of its common stock through its at-the-market (ATM) program, generating net proceeds to the Company of $7.5 million. Corvus expects full year 2023 net cash used in operating activities to be between approximately $20 million and $22 million, resulting in a projected cash balance of between $28 million and $30 million as of December 31, 2023. Based on its current plans, Corvus expects its cash to fund operations into the second half of 2024.

Research and development expenses for the three months ended June 30, 2023 totaled $4.0 million compared to $4.9 million for the same period in 2022. The decrease of $0.9 million was primarily due to lower clinical trial and manufacturing costs associated with the development of mupadolimab.

The net loss for the three months ended June 30, 2023 was $6.5 million compared to a net loss of $8.4 million for the same period in 2022. Total stock compensation expense for the three months ended June 30, 2023 was $0.5 million compared to $0.7 million for the same period in 2022 and the non-cash loss from Corvus’ equity method investment in Angel Pharmaceuticals was $1.3 million for the three months ended June 30, 2023 compared to $1.6 million in the same period in 2022.

Conference Call Details
Corvus will host a conference call and webcast today, Tuesday, August 8, 2023, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the second quarter 2023 financial results. The conference call can be accessed by dialing 1-855-327-6837 (toll-free domestic) or 1-631-891-4304 (international) or by clicking on this link for instant telephone access to the event. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days.

On August 8, 2023 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported financial results for the second quarter ended June 30, 2023 (Press release, Cogent Biosciences, AUG 8, 2023, View Source [SID1234633961]).

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"Cogent continues to deliver on our mission to bring best-in-class therapies to patients with genetically defined diseases," said Andrew Robbins, the Company’s President and Chief Executive Officer. "During the second quarter we presented positive data from the lead-in portion of our ongoing Phase 3 PEAK study reinforcing our belief that the combination of bezuclastinib and sunitinib has the potential to become a new treatment option for second-line GIST patients. With great support from new and existing investors, we completed a public equity offering that has put us in a very strong financial position, extending our cash runway into 2026. As we turn to the second half of 2023, we look forward to presenting initial results from the SUMMIT trial with bezuclastinib in patients with non-advanced systemic mastocytosis as well as presenting updated APEX data with bezuclastinib in patients with advanced systemic mastocytosis. Finally, we are excited to announce the selection of our FGFR2 clinical candidate, which we believe has a best-in-class potency and selectivity profile. We plan to present additional preclinical data later this year and are on track to initiate clinical trials in 2024."

Recent Business Highlights

Presented positive lead-in data from the ongoing Phase 3 PEAK trial evaluating bezuclastinib in combination with sunitinib in patients with Gastrointestinal Stromal Tumors (GIST) at the 2023 ASCO (Free ASCO Whitepaper) annual meeting.
As of the cutoff date of March 29, 2023, data demonstrated a 55% Disease Control Rate (DCR) in heavily pre-treated GIST patients, including 100% DCR and 17% overall response rate (ORR) in efficacy evaluable 2nd-line GIST patients.
The combination of bezuclastinib and sunitinib was generally well-tolerated with an encouraging safety profile.
Selected a potent, selective, reversible FGFR2 kinase inhibitor as the first internally developed clinical candidate from the Cogent Research Team.
In vivo characterization of the candidate shows a novel, selective, reversible FGFR2 inhibitor that has potency against molecular brake and gatekeeper mutations, with potential advantages over current covalent approaches.
Presented preclinical data describing a novel EGFR-sparing, brain-penetrant ErbB2 inhibitor with potency across key oncogenic ErbB2 mutations at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting.
Closed an underwritten public offering of 14,375,000 shares of common stock at a public offering price of $12.00 per share, including an additional 1,875,000 shares of common stock related to the underwriters’ option, which was exercised in full. Cogent received estimated net proceeds of approximately $161.8 million, after deducting underwriting discounts and commissions and estimated offering expenses.
Upcoming Milestones

Present initial clinical data from SUMMIT, a randomized, double-blind, placebo-controlled, global, multicenter, Phase 2 clinical trial of bezuclastinib in patients with non-advanced systemic mastocytosis (NonAdvSM) in the second half of 2023. Data will include safety/tolerability and measures of clinical activity.
Present updated clinical data from approximately 30 patients in Part 1 of APEX, a global, multicenter Phase 2 clinical trial of bezuclastinib in patients with advanced systemic mastocytosis (AdvSM) at a scientific meeting in the second half of 2023.
Upcoming Investor Conference

Cogent will participate in the Morgan Stanley 21st Annual Global Healthcare Conference on Wednesday, September 13, 2023 at 8:10 a.m. ET.
A live webcast of the event can be accessed on the Investors & Media page of Cogent’s website at investors.cogentbio.com/events. A replay will be available approximately two hours after completion of the event and will be archived for up to 30 days.
Second Quarter 2023 Financial Results

Cash Position: As of June 30, 2023, cash, cash equivalents and marketable securities were $350.9 million, as compared to $220.3 million as of March 31, 2023. The company expects its existing cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements into 2026.

R&D Expenses: Research and development expenses were $38.9 million for the second quarter of 2023 as compared to $29.5 million for the second quarter of 2022. The increase was primarily due to costs associated with the on-going APEX, SUMMIT and PEAK clinical trials and costs related to development of the research pipeline. R&D expenses include non-cash stock compensation expense of $3.6 million for the second quarter of 2023 compared to $2.1 million for the second quarter of 2022.

G&A Expenses: General and administrative expenses were $8.2 million for the second quarter of 2023 as compared to $6.4 million for the second quarter of 2022. The increase was primarily due to the growth of the organization. G&A expenses include non-cash stock compensation expense of $3.6 million for the second quarter of 2023 compared to $2.4 million for the second quarter of 2022.

Net Loss: Net loss was $44.1 million for the second quarter of 2023 as compared to a net loss of $34.9 million for the same period of 2022.