On August 2, 2023 GlycoMimetics, Inc. (Nasdaq: GLYC), a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers and inflammatory diseases, reported its financial results and highlights for the second quarter ended June 30, 2023 (Press release, GlycoMimetics, AUG 2, 2023, View Source [SID1234633649]). Cash and cash equivalents as of June 30, 2023 were $58.0 million.

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"With the addition of a time-based analysis option to our pivotal Phase 3 study, we look forward to reporting topline uproleselan results in R/R AML by the end of Q2 2024. This readout will draw from a clinically mature dataset with more than three years of median follow-up and can potentially bring us closer to delivering this therapy to patients in need of new treatment options," said Harout Semerjian, Chief Executive Officer of GlycoMimetics. "We continue to execute our broad development strategy for uproleselan while we explore potential benefit in AML patients of all ages as evidenced by the FDA agreement on the pediatric study plan as well as the NCI sponsored, and investigator initiated pediatric studies. In addition to these advances, we are excited to expand our clinical pipeline and move GMI-1687, a novel, highly potent E-selectin antagonist into first-in-human studies. We look forward to initiating our Phase 1a study in the coming weeks."

Operational Highlights

In June 2023, GlycoMimetics announced FDA clearance of a protocol amendment to the company’s pivotal Phase 3 study of uproleselan for R/R AML. This amendment will allow conduct of a time-based analysis of the primary endpoint of overall survival after a defined cutoff date, if the 295 survival events of the originally planned event-driven analysis have not been observed by that date. With the addition of a time-based analysis, the company now expects to report topline results by the end of Q2 2024.

The NCI Alliance for Clinical Trials in Oncology will conduct a planned interim analysis of event-free survival in 267 patients randomized to its Phase 2/3 clinical trial (NCI protocol A041701) evaluating uproleselan in newly diagnosed older adults with AML who are fit for chemotherapy. Enrollment of the Phase 2 portion of the study was completed in December of 2021. When available, the company will share these results.

In May 2023, FDA agreed to the initial Pediatric Study Plan (iPSP) submitted by GlycoMimetics. As part of the iPSP, NCI has agreed to sponsor a Phase 1/2 dose escalation study (NCI protocol PEPN2113) to explore safety and preliminary activity of uproleselan plus fludarabine and high dose cytarabine (FLA) in pediatric AML patients after 2 or more prior therapies. The Children’s Oncology Group will conduct this study. Enrollment in the Phase 1 portion is open and expected to be up to 18 patients.

In June, the first pediatric patient was treated with uproleselan in an investigator-initiated single arm, multi-center Phase 1/2 study to assess safety and tolerability, as well as determine a recommended phase 2 dose (RP2D) of uproleselan plus myeloablative, busulfan-based, pre-transplant conditioning for treatment of AML. This study, led by John Horan, MD, MPH, of the Boston Children’s Hospital and Dana Farber Cancer Institute, will enroll up to 28 patients (Age ≥12 months and ≤ 30 years) and will also assess preliminary uproleselan efficacy at the RP2D.

GlycoMimetics plans to initiate in Q3 2023 a Phase 1a study for GMI-1687 in healthy volunteers. GMI-1687 is a highly potent E-selectin antagonist that has potential application in inflammatory diseases with initial focus on sickle cell disease.
Second Quarter 2023 Financial Results:

Cash position: As of June 30, 2023, GlycoMimetics had cash and cash equivalents of $58.0 million as compared to $47.9 million as of December 31, 2022.

R&D Expenses: The Company’s research and development expenses decreased to $4.1 million for the quarter ended June 30, 2023, as compared to $8.0 million for the same period in 2022. The decreased expenses were primarily due to lower clinical trial and development costs related to our global Phase 3 clinical trial of uproleselan in individuals with R/R AML, which completed enrollment November 2021.

G&A Expenses: The Company’s general and administrative expenses decreased to $4.9 million for the quarter ended June 30, 2023, as compared to $5.5 million for the same period in 2022, primarily due to lower outside consulting and professional expenses.

Shares Outstanding: Shares of common stock outstanding as of June 30, 2023, were 64,313,333.
The company will host a conference call and webcast today at 8:30 a.m. ET. To access the call by phone, please go to this registration link, and you will be provided with dial in details. Participants are encouraged to connect 15 minutes in advance of the scheduled start time.

A live webcast of the call will be available on the "Investors" tab on the GlycoMimetics website. A webcast replay will be available for 30 days following the call.

About Uproleselan

Discovered and developed by GlycoMimetics, uproleselan is an investigational first-in-class, E-selectin antagonist. Uproleselan (yoo’ pro le’se lan), currently in a broad Phase 3 development program in acute myeloid leukemia (AML), has received Breakthrough Therapy and Fast Track designations from the U.S. FDA and Breakthrough Therapy designation from the Chinese National Medical Products Administration for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan is designed to block E-selectin binding and stimulation of myeloid cells. E-selectin is expressed on the surface of blood vessels, and its binding to myeloid cells confers a pro-survival effect. Uproleselan is intended to enable a novel approach to disrupting established mechanisms of leukemic cell resistance.

About GMI-1687

Discovered and developed by GlycoMimetics, GMI-1687 is a highly potent E-selectin antagonist that has been shown in animal models to be fully bioavailable following subcutaneous administration. It is a second-generation compound that has potential application in inflammatory diseases with initial focus on sickle cell disease (SCD). E-selectin is believed to play a major role in vaso-occlusive crisis (VOC), the vascular clots and blockages that cause pain crises in people living with SCD. The administration of GMI-1687 via subcutaneous injection, if this treatment method is successfully developed in the clinic, may enable the drug to address certain challenges of IV therapies for SCD as well as offer a potential point-of-care treatment option at the onset of VOC.

On August 2, 2023 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported a corporate and financial update for the second quarter ended June 30, 2023 (Press release, G1 Therapeutics, AUG 2, 2023, View Source [SID1234633648]).

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"We know the impact that trilaciclib can have on the lives of people battling cancer; we see it every day in patients with extensive stage small cell lung cancer who receive COSELA prior to their chemotherapy. And, we’ve made good progress in further developing the potential of the drug in clinical trials for additional indications," said Jack Bailey, Chief Executive Officer of G1 Therapeutics. "As such, our focus remains on driving depth of COSELA usage and adoption in our top accounts, despite a national platinum-based chemotherapy shortage. We are also preparing for multiple important data readouts expected early next year, and ensuring our continued financial strength."

Second Quarter 2023 and Recent Highlights

Financial

Recognized $11.1 Million in Net COSELA Revenue: Results represent a 6% increase in net sales over the first quarter of 2023. G1 recognized total revenues of $42.4 million for the second quarter of 2023.

Received Net Proceeds of $27.0 Million for Relief of Future Royalty Payments from Simcere: An additional $18.0 million would be due to G1 upon filing and approval of COSELA in mainland China for patients with TNBC. All other aspects of the strategic collaboration remain in place. G1 retains the rights to trilaciclib throughout the rest of the world, other than Greater China.

Ended the Second Quarter of 2023 with Cash, Cash Equivalents, and Marketable Securities of $104.2 Million. The Company’s current financial position is expected to be sufficient to fund G1’s operations and capital expenditures well beyond its clinical trial readouts in the first quarter of 2024.

Amended Debt Facility With Hercules Capital: In June 2023, the debt facility was mutually amended, providing G1 with additional financial flexibility. As of June 30, 2023, the total loan amount outstanding is $50.0 million.
Clinical

Confirmed Expected Timing for Initial Results from Pivotal Phase 3 Clinical Trial of Trilaciclib in Patients with mTNBC; Interim Overall Survival (OS) Analysis Expected in the First Quarter of 2024: The primary endpoint of PRESERVE 2 is to evaluate the effect of trilaciclib on OS compared with placebo in patients receiving first-line gemcitabine/carboplatin. G1 expects the interim OS analysis to be conducted by its data monitoring committee in the first quarter of 2024. If the trial meets the interim analysis stopping rule, it will be unblinded and G1 will report the top line results. If it does not, the trial will continue to the final analysis. If positive, the Company intends to meet with the U.S. Food and Drug Administration to discuss filing a supplemental new drug application (sNDA) as soon as possible in 2024.

Presented Preliminary Phase 2 Results Confirming Benefit of Trilaciclib in Reducing Adverse Events Related to an ADC; OS Endpoints Expected in the First Quarter of 2024: New results presented at the 2023 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Breast Cancer Congress showed a clinically meaningful on-target effect of trilaciclib to reduce (>50%) the rates of multiple adverse events compared to the previously published sacituzumab govitecan-hziy single agent safety profile. The Company expects to reach the OS endpoints in the first quarter of 2024. (press release here)

Presented Phase 2 Results Showing that Trilaciclib Increases the Pool of Memory T Cells in the Tumor Microenvironment that Could Contribute to Long Term Immune Surveillance and Efficacy: New results presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting highlight the potential for trilaciclib to increase the pool of functional memory T cells that could contribute to long-term immune surveillance and efficacy, as measured by longer term endpoints like OS. (press release here)

Provided Initial Results from Phase 2 Bladder Cancer Trial of Trilaciclib (PRESERVE 3); OS Endpoints Expected in the First Quarter of 2024: Data generated across multiple preclinical and clinical studies to date show that trilaciclib has the greatest effect on longer term endpoints including OS rather than earlier efficacy measures such as overall response rate (ORR) and progression free survival (PFS), consistent with other immunotherapies. As of the data cutoff on July 5, 2023, PFS is similar between patients receiving trilaciclib prior to gemcitabine/platinum + avelumab and patients receiving gemcitabine/platinum + avelumab alone (median PFS=6.0 months and 6.1 months, respectively; hazard ratio=1.07). Median PFS was also similar across arms in both PD-L1 subsets. Median duration of response (DOR) favored participants that received trilaciclib (7.0 months) compared to those that did not (6.0 months); median DOR also favored the trilaciclib arms in both PD-L1 subsets. The Company expects to reach the OS endpoints in the first quarter of 2024.
Medical

Presented Real World Data Confirming Consistent Risk of Myelosuppression Across Patients Receiving Chemotherapy for Small Cell Lung Cancer (SCLC): Results presented at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2023 meeting showed that grade ≥3 myelosuppression (neutropenia, anemia, thrombocytopenia) occurred in 61% of patients included in the overall population of studied patients. No significant associations between patient characteristics and myelosuppression were identified. (press release here)

Announced New Publication Describing the Immune-Based Mechanism of Trilaciclib: G1’s manuscript entitled, "Investigating Potential Immune Mechanisms of Trilaciclib Administered Prior to Chemotherapy in Patients with Metastatic Triple-Negative Breast Cancer" has been published in the Journal of Breast Cancer Research and Treatment. (publication here)
Corporate

Appointed Monica Roberts Thomas as General Counsel and Chief Compliance Officer: Mrs. Thomas brings nearly two decades of leadership experience in securities filings and corporate governance, global regulatory engagement, and all aspects of legal support for commercial organizations. (press release here)
Second Quarter 2023 Financial Results

As of June 30, 2023, cash and cash equivalents and marketable securities totaled $104.2 million, compared to $145.1 million as of December 31, 2022. On June 6, 2023, G1 and Hercules Capital Inc. amended their loan and security agreement. The amended terms modified certain tranche advances, lowered the minimum cash covenant, and removed the existing minimum revenue covenant and replaced it with a conditional borrowing base limit, beginning with the financial reporting for the period ending June 30, 2023. On closing, G1 paid down the loan by $25.0 million, resulting in a total loan amount outstanding of $50.0 million as of June 30, 2023.

Total revenues for the second quarter of 2023 were $42.4 million, including $11.1 million in net product sales of COSELA and license revenue of $31.3 million, primarily related to the one-time payment for the relief of future royalties from Simcere, supply and manufacturing services and royalty revenue from Simcere, and clinical trial reimbursements from EQRx and Simcere, compared to $10.6 million in total revenues in the second quarter of 2022.

Operating expenses for the second quarter of 2023 were $30.9 million, compared to $47.5 million for the second quarter of 2022. GAAP operating expenses include stock-based compensation expense of $3.8 million for the second quarter of 2023, compared to $5.6 million for the second quarter of 2022.

Cost of goods sold expense for the second quarter of 2023 was $1.4 million compared to $1.0 million for the second quarter of 2022, primarily due to an increase in product sales.

Research and development (R&D) expenses for the second quarter of 2023 were $12.0 million, compared to $20.8 million for the second quarter of 2022. The decrease in R&D expenses was primarily due to a decrease in the Company’s clinical program costs.

Selling, general, and administrative (SG&A) expenses for the second quarter of 2023 were $17.4 million, compared to $25.7 million for the second quarter of 2022. The decrease in SG&A expenses was primarily due to decreases in commercialization activities, personnel costs, and medical affairs.

The net income for the second quarter of 2023 was $8.7 million, compared to a net loss of $39.4 million for the second quarter of 2022. The basic and diluted net income per share for the second quarter of 2023 was $0.17 and $0.14, respectively, compared to a basic and diluted net loss per share of $(0.92) for the second quarter of 2022.

2023 Financial Guidance

G1 today reiterated its full year 2023 net revenue guidance. The Company expects to generate between $50 million and $60 million in COSELA net revenue in 2023. G1’s product revenue guidance was initially provided in its fourth quarter and full year 2022 financial results and business update, and is based on expectations for continued acceleration of sales performance of COSELA in the U.S.

Webcast and Conference Call

G1 will host a webcast and conference call at 8:30 a.m. ET today to provide a corporate and financial update for the second quarter ended June 30, 2023.

Please note the new process to access the call via telephone: To register and receive a dial in number and unique PIN to access the live conference call, please follow this link to register online. While not required, it is recommended that you join 10 minutes prior to the start of the event. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.

About COSELA (trilaciclib) for Injection

COSELA (trilaciclib) was approved by the U.S. Food and Drug Administration on February 12, 2021.

Indication

COSELA (trilaciclib) is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer.

Important Safety Information

COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib.

Warnings and precautions include injection-site reactions (including phlebitis and thrombophlebitis), acute drug hypersensitivity reactions, interstitial lung disease (pneumonitis), and embryo-fetal toxicity.

The most common adverse reactions (>10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia.

This information is not comprehensive. Please click here for full Prescribing Information. View Source

To report suspected adverse reactions, contact G1 Therapeutics at 1-800-790-G1TX or call FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

On August 2, 2023 Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, reported that it will announce its second quarter 2023 financial results on Wednesday, August 9, 2023 (Press release, Deciphera Pharmaceuticals, AUG 2, 2023, View Source [SID1234633647]).

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In connection with the earnings release, Deciphera’s management team will host a live conference call and webcast at 8:00 AM ET on Wednesday, August 9, 2023, to discuss the Company’s financial results and provide a corporate update.

The conference call may be accessed via this link: https://register.vevent.com/register/BI74ff2d04fe8541f48da1cf0ad35339ae

A live webcast of the conference call will be available in the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay will be available on the Company’s website approximately two hours after the conference call and will be available for 30 days following the call.

On August 2, 2023 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrine, oncology, metabolism and neurology disorders by modulating the effects of the hormone cortisol, reported results for the quarter ended June 30, 2023 (Press release, Corcept Therapeutics, AUG 2, 2023, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-second-quarter-financial-1 [SID1234633646]).

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Financial Results

Revenue of $117.7 million, a 14 percent increase from second quarter 2022
Increase in 2023 revenue guidance to $455 – $470 million, from $435 – $455 million
Net income per common share of $0.25 (diluted), compared to $0.24 in second quarter 2022
Cash and investments of $363.3 million as of June 30, 2023
Purchase of 6.6 million shares of Corcept common stock for $145.4 million
"The strong results of our commercial business in the second quarter reflect the early returns on our substantial investment to help improve the ability of physicians to recognize and treat hypercortisolism. Korlym is an excellent treatment for patients with Cushing’s syndrome and there are many eligible patients who have yet to receive it. We are confident in the growth potential of our Cushing’s syndrome business and are raising our 2023 revenue guidance again, to $455 – $470 million," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer.

Corcept’s second quarter 2023 revenue was $117.7 million, compared to $103.4 million in the second quarter of 2022. Second quarter operating expenses were $88.1 million, compared to $72.0 million in the second quarter of 2022, due to increased spending on our development programs and to support the expansion of our clinical development and commercial teams. Net income was $27.5 million in the second quarter of 2023 compared to $27.4 million in the same period last year.

Cash and investments were $363.3 million at June 30, 2023 compared to $465.1 million at March 31, 2023. In April 2023, Corcept purchased 6.6 million shares of its common stock for $145.4 million.

Clinical Development

"We are also very excited by the potential of our clinical development programs. In the next twelve months we expect data from our GRACE, GRADIENT and CATALYST studies, submission of an NDA for relacorilant in Cushing’s syndrome, completion of enrollment of our ROSELLA and DAZALS studies and initiation of a Phase 2b trial of miricorilant in patients with NASH," added Dr. Belanoff.

Cushing’s Syndrome

Enrollment completed in Phase 3 GRACE trial of relacorilant as a treatment for patients with all etiologies of Cushing’s syndrome – new drug application (NDA) submission expected in the second quarter of 2024
Enrollment nears completion in Phase 3 GRADIENT trial of relacorilant as a treatment for patients with Cushing’s syndrome caused by adrenal adenomas
Enrollment continues in CATALYST – 1,000-patient Phase 4 trial examining the prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes; patients with hypercortisolism may enter a randomized, double-blind, placebo-controlled study of Korlym
"With enrollment in GRACE complete, we are focused on finishing the trial and preparing our NDA. Relacorilant has tremendous promise as a treatment for patients with all types of Cushing’s syndrome and we are eager to make it available. Our GRADIENT trial will produce valuable data about an etiology of Cushing’s syndrome that affects many patients whose hypercortisolism frequently goes undiagnosed and untreated," said Bill Guyer, PharmD, Corcept’s Chief Development Officer.

"Additionally, we are very excited that our CATALYST trial is progressing ahead of schedule. CATALYST is the largest study ever conducted to establish the prevalence of hypercortisolism in patients with difficult-to-control diabetes. We expect that it will further enable physicians to identify and provide effective treatment for a substantial group of patients with Cushing’s syndrome, whose condition, in most cases, now goes undiagnosed. We have received very positive feedback from leading endocrinologists regarding this study and expect to complete enrollment in the fourth quarter," added Dr. Guyer.

Oncology

Enrollment continues in ROSELLA – 360-patient pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in patients with recurrent, platinum-resistant ovarian cancer
Enrollment continues in open-label, Phase 1b trial of relacorilant plus pembrolizumab in patients with adrenal cancer with cortisol excess
Randomized, placebo-controlled Phase 2 trial of relacorilant plus enzalutamide in patients with prostate cancer, in collaboration with the University of Chicago, expected to begin in the third quarter
"Relacorilant combined with nab-paclitaxel has the potential to become a new standard of care for the treatment of patients with platinum-resistant ovarian cancer. The results of our positive Phase 2 trial were recently published in the prestigious Journal of Clinical Oncology. Our pivotal ROSELLA trial aims to replicate those results. We are on track to complete enrollment by the end of this year," said Dr. Guyer.

Amyotrophic Lateral Sclerosis (ALS)

Enrollment continues in DAZALS – 198-patient, randomized, double-blind, placebo-controlled Phase 2 trial of dazucorilant in patients with ALS
"We are conducting our DAZALS study in collaboration with TRICALS, the leading ALS academic consortium in Europe, to investigate dazucorilant’s potential to significantly improve the lives of patients with ALS. We recently added clinical trial sites in the United States and are on track to complete enrollment by early 2024," said Dr. Guyer.

Non-alcoholic Steatohepatitis (NASH)

Enrollment continues in Phase 1b trial of miricorilant in patients with presumed NASH – Phase 2b trial to begin in the fourth quarter
"Miricorilant, a potent, oral, selective cortisol modulator with targeted activity in the liver, continues to demonstrate great promise as a treatment for NASH. Our Phase 1b study has identified a dosing regimen that effectively reduced liver fat, improved liver health and key metabolic and lipid measures and was well-tolerated. We plan to start a Phase 2b trial in the fourth quarter," said Dr. Guyer.

Conference Call

We will hold a conference call on August 2, 2023, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). Participants must register in advance of the conference call by clicking here. Upon registering, each participant will receive a dial-in number and a unique access PIN. Each access PIN will accommodate one caller. Additionally, a listen-only webcast will be available by clicking here. A replay of the call will be available on the Investors / Events tab of www.corcept.com.

Hypercortisolism

Hypercortisolism, often referred to as Cushing’s syndrome, is caused by excessive activity of the hormone cortisol. Endogenous Cushing’s syndrome is an orphan disease that most often affects adults aged 20-50. In the United States, an estimated 20,000 patients have Cushing’s syndrome, with about 3,000 new patients diagnosed each year. Symptoms vary, but most patients experience one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper-body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Hypercortisolism can affect every organ system and can be lethal if not treated effectively. Corcept holds patents directed to the composition of relacorilant and the use of cortisol modulators, including Korlym, in the treatment of patients with hypercortisolism.

On August 2, 2023 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), reported financial results for the quarter ended June 30, 2023, and recent business highlights (Press release, Coherus Biosciences, AUG 2, 2023, View Source [SID1234633645]):

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RECENT BUSINESS HIGHLIGHTS

CIMERLI

CIMERLI (ranibizumab-eqrn) net product sales more than quadrupled to $26.7 million compared to the prior quarter following the April 1, 2023 implementation of the permanent, product-specific Q-code.
UDENYCA

Coherus launched a single-dose, prefilled autoinjector (AI) presentation of UDENYCA (pegfilgrastim-cbqv) on May 22, representing the first pegfilgrastim presentation innovation in eight years.
The U.S. Food and Drug Administration (FDA) review of the prior approval supplement for Coherus’ third pegfilgrastim presentation, the UDENYCA On-body Injector (OBI), is ongoing. Coherus plans to launch UDENYCA OBI directly upon potential approval later this year.
Toripalimab

The FDA completed inspection of the toripalimab manufacturing site in China in May, and has scheduled the clinical site inspections in China to begin in the second half of August 2023. Coherus anticipates potential FDA approval and U.S. commercial launch of toripalimab in the second half of 2023.
The final analysis of the JUPITER-02 clinical trial (NCT03581786) presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in June demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) for nasopharyngeal carcinoma (NPC) patients who were treated with toripalimab in combination with chemotherapy versus chemotherapy alone. Median OS was 33.7 months in the chemotherapy-only treatment arm, and median OS was not reached in the toripalimab arm, with a hazard ratio of 0.63, representing a 37% reduction in risk of death (95% CI 0.45-0.89; p=0.0083).
YUSIMRY

Coherus launched YUSIMRY, a Humira biosimilar, with a citrate-free and sting-free formulation delivered via a state-of-the-art autoinjector on July 3rd. YUSIMRY is now available for sale nationwide through retail, mail order and specialty pharmacy channels.
Surface Oncology Merger and Novel Immuno-oncology Pipeline

Coherus announced that it had entered into a definitive agreement and plan of merger on June 16, 2023 that would result in the acquisition of Surface Oncology, Inc. ("Surface Oncology"), if completed. The merger is expected to significantly advance Coherus’ next-generation immuno-oncology pipeline focused on the tumor micro-environment with clinical stage anti-IL-27 and anti-CCR8 development programs. The merger is expected to close following the Surface Oncology special meeting of stockholders scheduled on September 7, 2023.
Patient enrollment continues in the U.S.-based Phase 1/2a dose expansion clinical trial evaluating CHS-006, a TIGIT-targeted antibody, in combination with toripalimab in patients with advanced solid tumors (NCT05757492).
Coherus plans to file an Investigational New Drug ("IND") application by year end for CHS-1000, a novel ILT4-targeted antibody.
"In the second quarter, we had strong execution on our strategy to build an innovative immuno-oncology company funded by revenues from FDA-approved products, and we made good progress across all areas of our business. Compared to the prior quarter, net revenues increased by 81% to $58.7 million, and we expect continued revenue growth in the second half of this year driven by continued success with CIMERLI, the UDENYCA autoinjector and YUSIMRY new product launches, as well as the launches of UDENYCA On-body Injector and of toripalimab for the treatment of NPC later this year, if approved," said Denny Lanfear, Coherus’ Chairman and Chief Executive Officer. "Coherus is successfully diversifying into a multi-product commercial organization with growing revenues supporting the development of our next-generation immuno-oncology franchise."

Mr. Lanfear added, "We look forward to closing the merger with Surface Oncology in the third quarter, reprioritizing our portfolio, and ultimately advancing a highly competitive, next-generation immuno-oncology clinical pipeline of innovative therapeutics focused on the tumor microenvironment. We will be well positioned to deliver the next step change in cancer treatment, with the goal of driving enhanced therapeutic benefit to patients beyond the outcomes achieved with checkpoint inhibitors alone."

SECOND QUARTER 2023 FINANCIAL RESULTS

Net revenue was $58.7 million during the three months ended June 30, 2023 and included $31.7 million of net sales of UDENYCA and $26.7 million of net sales of CIMERLI, which was launched in October 2022. Net revenue for the three months ended June 30, 2022, consisting primarily of UDENYCA net sales, was $60.2 million. Net revenue was $91.2 million and $120.3 million for the six months ended June 30, 2023 and 2022, respectively. Net revenue in the first half of 2023 was reduced by a $1.7 million charge for a contingent liability related to resolving a dispute regarding certain UDENYCA sales from October 2020 through December 2021. The declines were primarily due to a reduction in the number of units of UDENYCA sold as well as a lower net realized price due to increased competition. These factors were partially offset by increasing revenue from CIMERLI sales during the first two quarters of 2023.

Cost of goods sold (COGS) for the three months ended June 30, 2023 and 2022 was $24.8 million and $11.3 million, respectively, and $41.7 million and $20.6 million during the six months ended June 30, 2023 and 2022, respectively. The increases compared to prior year periods primarily result from COGS associated with CIMERLI which was launched in October 2022. UDENYCA COGS includes a mid-single digit royalty on net sales payable through the first half of 2024, and CIMERLI COGS includes a low to mid 50% royalty on gross profits. COGS for the first half of 2023 also includes $3.0 million in contract modification fees with one of our manufacturers and $2.3 million in write-offs of inventory that was damaged during processing at one of our manufacturers. In addition, gross margins were unfavorably impacted due to product mix resulting from increased volumes of CIMERLI sold following the product specific Q-code implementation on April 1st and the launch of UDENYCA AI in May 2023.

Research and development (R&D) expense for the three months ended June 30, 2023 and 2022 was $23.3 million and $41.6 million, respectively. For the six months ended June 30, 2023 and 2022, R&D expense was $57.4 million and $124.5 million, respectively. The decline in R&D expense compared to the prior year periods primarily resulted from the reduction in scope of the toripalimab collaboration agreement and from the recognition in the first quarter of 2022 of the $35.0 million option exercise fee paid to Junshi Biosciences to license CHS-006.

Selling, general and administrative (SG&A) expense was $45.1 million and $51.3 million during the three months ended June 30, 2023 and 2022, respectively, and $94.3 million and $100.0 million during the six months ended June 30, 2023 and 2022, respectively. The decline in SG&A expense compared to the prior year periods primarily reflects lower headcount.

Net loss for the second quarter of 2023 was $42.9 million, or $(0.49) per share on a diluted basis, compared to a net loss of $50.2 million, or $(0.65) per share on a diluted basis for the same period in 2022. Net loss for the first half of 2023 was $118.6 million, or $(1.42) per share on a diluted basis, compared to a net loss of $146.2 million, or $(1.89) per share on a diluted basis for the first half of 2022.

Non-GAAP net loss for the second quarter of 2023 was $32.8 million, or $(0.38) per share on a diluted basis, compared to non-GAAP net loss of $36.3 million, or $(0.47) per share on a diluted basis for the same period in 2022. Non-GAAP net loss for the first half of 2023 was $92.3 million, or $(1.11) per share on a diluted basis, compared to non-GAAP net loss of $113.3 million, or $(1.46) per share on a diluted basis for the first half of 2022. See "Non-GAAP Financial Measures" below for a discussion on how Coherus calculates non-GAAP net loss and a reconciliation to the most directly comparable GAAP measures.

Cash, cash equivalents and investments in marketable securities were $144.7 million as of June 30, 2023, compared to $191.7 million at December 31, 2022.

2023 Revenue and R&D and SG&A Expense Guidance

Coherus expects its 2023 net product revenue will exceed $275 million, including at least $100 million of CIMERLI net revenue.

Coherus projects combined R&D and SG&A expenses for 2023 to be in the range of $315 to $335 million. This guidance range includes stock-based compensation expense and excludes the Surface Oncology acquisition cost as well as any potential collaboration upfront payments to Klinge Pharma for the in-license of its Eylea biosimilar program or milestones payments to Junshi Biosciences due upon U.S. approval of toripalimab.

This financial guidance also excludes the effects of any potential future strategic acquisitions, collaborations or investments, the exercise of rights or options related to collaboration programs, and any other transactions or circumstances not yet identified or quantified. This guidance is subject to a number of risks and uncertainties. See Forward-Looking Statements described in the section below.

Conference Call Information
When: Wednesday, August 2nd, 2023, starting at 5:00 p.m. Eastern Time

To access the conference call, please pre-register through the following link to receive dial-in information and a personal PIN to access the live call: https://register.vevent.com/register/BI3fdbdc05783442f89d11db6b94e74a28

Please dial-in 15 minutes early to ensure a timely connection to the call.

Webcast Link: View Source

A replay of the webcast will be archived on the "Investors" section of the Coherus website at View Source