On August 2, 2023 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported financial results for the quarter ended June 30, 2023 (Press release, Karyopharm, AUG 2, 2023, View Source [SID1234633650]). In addition, Karyopharm highlighted select corporate milestones and progress on its key clinical development programs and announced further optimization of its organization and cost structure aimed at prioritizing focus on advancing its late-stage clinical pipeline and positioning the Company for sustained growth.

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"We had a strong second quarter executing against our key priorities with our late-stage clinical pipeline and XPOVIO commercial performance. We achieved an important milestone this quarter with the initiation of our pivotal Phase 3 study evaluating selinexor in combination with ruxolitinib in JAKi-naïve patients with myelofibrosis. We are highly encouraged by the updated exploratory subgroup analyses from SIENDO presented at the ASCO (Free ASCO Whitepaper) Plenary in July, which further strengthen the rationale of and our growing confidence in our ongoing XPORT-EC-042 study in patients with TP53 wild-type advanced or recurrent endometrial cancer. Finally, in multiple myeloma, we are pleased to see continued growth in patients treated with XPOVIO, in both the community and academic settings despite increased competition."

"As we continue to focus on our near-term Phase 3 clinical programs, driving benefit for our patients and creating value for our shareholders, we’ve also taken further actions to streamline our operations and optimize our cost structure and workforce to maximize the potential of these programs. We truly appreciate the hard work and dedication of all our employees, past and present," said Richard Paulson, President and Chief Executive Officer of Karyopharm.

Second Quarter 2023 and Recent Highlights

XPOVIO Commercial Performance

Achieved U.S. net product revenue for the second quarter of 2023 of $28.5 million, compared to $29.0 million U.S. net product revenue in the second quarter of 2022.

Total demand1 growth for XPOVIO was 9% in the second quarter year over year, amidst increasing competition in the late line setting, with total demand growth of 11% and 6% in the community and academic settings, respectively. Growth in the community setting was driven by increased use of XPOVIO in earlier lines as a novel mechanism of action and a convenient oral therapy, while expansion of use in the academic setting was driven by the use of XPOVIO pre and post T-cell therapies. The use of XPOVIO in the second to fourth lines grew to greater than 60% of XPOVIO new starts in these settings, up from 49% in the second quarter of 2022, with continued improvement in perception of XPOVIO in the third line setting according to Intent to Prescribe data2.

U.S. net product revenue in the second quarter of 2023 was adversely impacted by approximately $3.0 million due to continued higher utilization of the KaryForward Patient Assistance Program (PAP) (free drug) resulting from ongoing funding constraints at certain multiple myeloma foundations.3 US net product revenues were also impacted by higher gross-to-net driven by increased 340B discounts and Medicare and Medicaid rebates year over year.
R&D Highlights

Myelofibrosis

Initiated pivotal Phase 3 portion of the XPORT-MF-034 clinical trial (NCT04562389) to assess the efficacy and safety of once-weekly selinexor 60mg in combination with ruxolitinib in JAKi-naïve patients with myelofibrosis. The randomized, double-blind, placebo-controlled study is expected to enroll 306 JAKi-naive patients with intermediate or high-risk myelofibrosis. Patients are randomized 2:1 to ruxolitinib plus selinexor 60mg or ruxolitinib plus placebo. The ruxolitinib dose is determined by the investigators based on the patients’ baseline platelet count per the drug’s prescribing information. The co-primary endpoints are spleen volume response rate of ≥ 35% (SVR35) and symptom improvement of ≥ 50% (TSS50) at week 24, with a key secondary endpoint of anemia response at week 24. Top-line data from this study are expected in 2025.

Updated results from the Phase 1 portion of this study were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and European Hematology Association (EHA) (Free EHA Whitepaper) conferences. As of the April 10, 2023 data cut-off date, 78.6% (11/14) of the intent to treat (ITT) patients who were treated with the 60mg dose of selinexor in combination with ruxolitinib, achieved SVR35 and 58.3% (7/12) of the ITT patients achieved TSS50, at week 24. SVR35 responses were consistent across all subgroups, including males and patients treated with low dose ruxolitinib. The most common treatment emergent grade ≥3 adverse events (AE) experienced with the 60mg selinexor dose, in combination with ruxolitinib were anemia (42.9%), thrombocytopenia (28.6%) and back pain (14.3%). Further details can be found here.

The Company received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for selinexor for the treatment of patients with myelofibrosis, including primary myelofibrosis, post-essential thrombocythemia myelofibrosis, and post-polycythemia vera myelofibrosis.
Endometrial Cancer (EC)

Long term exploratory subgroup analysis was presented from the SIENDO (NCT03555422) study in patients with advanced or recurrent TP53 wild-type endometrial cancer at the virtual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) July 2023 Plenary Series. The primary analysis of the Phase 3 SIENDO study of selinexor maintenance therapy in advanced or recurrent endometrial cancer in 2022 showed improvements in progression-free survival (PFS) for the ITT population but were not clinically meaningful. However, an exploratory analysis of a pre-specified subgroup of patients with TP53 wild-type endometrial cancer showed a promising efficacy signal. As of the March 30, 2023 data cut-off date, median PFS was 27.4 months in the selinexor treatment arm (n=77) as compared to 5.2 months (n=36) in the placebo arm. In the TP53 wild-type/ Microsatellite Stable (MSS/pMMR) population, the median PFS has not been reached. The most common AEs in the TP53 wild-type subgroup were nausea (91%), vomiting (61%) and diarrhea (40%), the majority of which were grades 1-2. The most common reported grade 3-4 treatment-emergent AEs (TEAEs) included neutropenia (18%), nausea (12%), and thrombocytopenia (9%). TEAEs leading to discontinuations were reported in 16% of patients.

Following the primary analysis of the SIENDO study, Karyopharm initiated the pivotal Phase 3 study (XPORT-EC-042; NCT05611931) of selinexor specifically in patients with TP53 wild-type advanced or recurrent endometrial cancer, and entered into a global collaboration with Foundation Medicine, Inc. to develop FoundationOneCDx, a tissue-based comprehensive genomic profiling test to identify and enroll patients whose tumors are TP53 wild type in this study. Top-line data from this study are expected in late 2024 to early 2025.
Update on Intellectual Property

The United States Patent and Trademark Office issued a certificate extending the term of the patent covering the composition of matter of XPOVIO (selinexor) (U.S. patent 8,999,996) by 342 days to July 3, 2033.
Optimization of Corporate Organization, Financial Position and Cost Structure

Karyopharm has further positioned its organization to focus on its late-stage core programs by taking steps to optimize its cost structure to further strengthen its financial position to invest in its three ongoing Phase 3 studies. As a result, there has been a ~20% reduction of the Company’s workforce, including full time employees and contractors.

The Company entered into an amendment to its Revenue Interest Financing Agreement with affiliates of Healthcare Royalty Partners in August 2023. The amendment extended the minimum aggregate payment amount date by six months from December 31, 2024 to June 30, 2025 and increased the payment cap from 185% to 195% of the investment amount. In addition, the Company agreed to issue to Healthcare Royalty Partners warrants exercisable for 250,000 shares of common stock with a termination date of August 1, 2030 and an exercise price of $2.25 per share.

These initiatives further position the Company to enhance its financial strength and are expected to provide a cash runway into late 2025, with the capital needed to deliver top-line readouts from its three Phase 3 studies.
Second Quarter 2023 Financial Results

Total Revenues: Total revenue for the second quarter of 2023 was $37.6 million, compared to $39.7 million for the second quarter of 2022. The slight decrease was due primarily to a decline in license and other revenue.

Net product revenue: Net product revenue for the second quarter of 2023 was $28.5 million, compared with $29.0 million for the second quarter of 2022.

License and other revenue: License and other revenue for the second quarter of 2023 was $9.1 million, compared to $10.7 million for the second quarter of 2022. The decrease was primarily attributable to a decrease in revenue for the reimbursement of development-related expenses from the Menarini Group due to a corresponding decrease in the underlying expenses.

Cost of sales: Cost of sales for the second quarter of 2023 was $1.2 million, compared to $0.9 million for the second quarter of 2022. Cost of sales reflects the costs of XPOVIO units sold and third-party royalties on net product revenue.

Research and development (R&D) expenses: R&D expenses for the second quarter of 2023 were $31.5 million, compared to $44.3 million for the second quarter of 2022. The decrease was attributable to a decrease in personnel costs, stock-based compensation and clinical trial costs related to our non-core programs, partially offset by costs incurred in 2023 related to our Phase 3 EC-042 study. The decrease in stock-based compensation is primarily due to $3.8 million of severance-related stock-based compensation expenses incurred during the quarter ended June 30, 2022, in connection with the departure of our former Chief Scientific Officer.

Selling, general and administrative (SG&A) expenses: SG&A expenses for the second quarter of 2023 were $34.5 million, compared to $37.3 million for the second quarter of 2022. The decrease is primarily due to severance-related stock-based compensation expenses incurred during the quarter ended June 30, 2022, in connection with the departure of our former Chief Executive Officer.

Interest income: Interest income for the second quarter of 2023 was $2.8 million, compared to $0.3 million for the second quarter of 2022 due to higher average interest rates on our investments.

Interest expense: Interest expense for the second quarter of 2023 was $5.8 million, compared to $6.3 million for the second quarter of 2022.

Net loss: Karyopharm reported a net loss of $32.6 million, or $0.29 per share, for the second quarter of 2023, compared to a net loss of $49.1 million, or $0.62 per share, for the second quarter of 2022.

Cash position: Cash, cash equivalents, restricted cash and investments as of June 30, 2023, totaled $237.7 million, compared to $279.7 million as of December 31, 2022.

2023 Financial Outlook

Based on its current operating plans, Karyopharm’s guidance for full year 2023 is as follows:

Total revenue to be in the range of $145 million to $160 million. Total revenue consists of U.S. XPOVIO net product revenue and license, royalty and milestone revenue earned from partners.

U.S. XPOVIO net product revenue to be in the range of $110 million to $125 million, driven by the expectation that the increased use of PAP will continue in 2023, including a cumulative effect from refills.

Non-GAAP R&D and SG&A expenses*, which exclude stock-based compensation expense, to be in the range of $240 million to $255 million, as a result of cost savings from further optimization of infrastructure and cost structure and workforce reduction of approximately 20%.

The Company continues to expect that its existing cash, cash equivalents and investments, and the revenue it expects to generate from XPOVIO net product sales, as well as revenue generated from its license agreements, will be sufficient to fund its planned operations into late 2025.
* Karyopharm has not reconciled the full year 2023 outlook for non-GAAP R&D and SG&A expenses to full year 2023 outlook for GAAP R&D and SG&A expenses because Karyopharm cannot reliably predict without unreasonable efforts the timing or amount of the factors that substantially contribute to the projection of stock compensation expense, which is excluded from the full year 2023 outlook for non-GAAP R&D and SG&A expenses.

Non-GAAP Financial Information

Karyopharm uses a non-GAAP financial measure, non-GAAP R&D and SG&A expenses, to provide operating expense guidance. Non-GAAP R&D and SG&A expenses exclude stock-based compensation expense. Karyopharm believes this non-GAAP financial measure is useful to investors because it provides greater transparency regarding Karyopharm’s operating performance as it excludes non-cash stock compensation expense. This non-GAAP financial measure should not be considered a substitute or an alternative to GAAP R&D and SG&A expenses and should not be considered a measure of Karyopharm’s liquidity. Instead, non-GAAP R&D and SG&A expenses should only be used to supplement an understanding of Karyopharm’s operating results as reported under GAAP.

Conference Call Information

Karyopharm will host a conference call today, August 2, 2023, at 8:00 a.m. Eastern Time, to discuss the second quarter 2023 financial results and financial outlook for 2023 and to provide other business highlights. To access the conference call, please dial (888) 349-0102 (local) or (412) 902-4299 (international) at least 10 minutes prior to the start time and ask to be joined into the Karyopharm Therapeutics call. A live audio webcast of the call, along with accompanying slides, will be available under "Events & Presentations" in the Investor section of the Company’s website, View Source An archived webcast will be available on the Company’s website approximately two hours after the event.

About XPOVIO (selinexor)

XPOVIO is a first-in-class, oral exportin 1 (XPO1) inhibitor and the first of Karyopharm’s Selective Inhibitor of Nuclear Export (SINE) compounds to be approved for the treatment of cancer. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein XPO1. XPOVIO is approved in the U.S. and marketed by Karyopharm in multiple oncology indications, including: (i) in combination with VELCADE (bortezomib) and dexamethasone (XVd) in patients with multiple myeloma after at least one prior therapy; (ii) in combination with dexamethasone in patients with heavily pre-treated multiple myeloma; and (iii) in patients with diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. XPOVIO (also known as NEXPOVIO in certain countries) has received regulatory approvals in a growing number of ex-U.S. territories and countries, including Europe, the United Kingdom, China, South Korea and Israel, and is marketed in those areas by Karyopharm’s global partners. Selinexor is also being investigated in several other mid- and late-stage clinical trials across multiple high unmet need cancer indications, including in endometrial cancer and myelofibrosis.

For more information about Karyopharm’s products or clinical trials, please contact the Medical Information department at:
Tel: +1 (888) 209-9326
Email: [email protected]

XPOVIO (selinexor) is a prescription medicine approved:

In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (XVd).

In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti‐CD38 monoclonal antibody (Xd).

For the treatment of adult patients with relapsed or refractory diffuse large B‐cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
SELECT IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Thrombocytopenia: Monitor platelet counts throughout treatment. Manage with dose interruption and/or reduction and supportive care.
Neutropenia: Monitor neutrophil counts throughout treatment. Manage with dose interruption and/or reduction and granulocyte colony‐stimulating factors.
Gastrointestinal Toxicity: Nausea, vomiting, diarrhea, anorexia, and weight loss may occur. Provide antiemetic prophylaxis. Manage with dose interruption and/or reduction, antiemetics, and supportive care.
Hyponatremia: Monitor serum sodium levels throughout treatment. Correct for concurrent hyperglycemia and high serum paraprotein levels. Manage with dose interruption, reduction, or discontinuation, and supportive care.
Serious Infection: Monitor for infection and treat promptly.
Neurological Toxicity: Advise patients to refrain from driving and engaging in hazardous occupations or activities until neurological toxicity resolves. Optimize hydration status and concomitant medications to avoid dizziness or mental status changes.
Embryo‐Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential and males with a female partner of reproductive potential, of the potential risk to a fetus and use of effective contraception.
Cataract: Cataracts may develop or progress. Treatment of cataracts usually requires surgical removal of the cataract.
Adverse Reactions

The most common adverse reactions (≥20%) in patients with multiple myeloma who receive XVd are fatigue, nausea, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, decreased weight, cataract and vomiting. Grade 3‐4 laboratory abnormalities (≥10%) are thrombocytopenia, lymphopenia, hypophosphatemia, anemia, hyponatremia and neutropenia. In the BOSTON trial, fatal adverse reactions occurred in 6% of patients within 30 days of last treatment. Serious adverse reactions occurred in 52% of patients. Treatment discontinuation rate due to adverse reactions was 19%.

The most common adverse reactions (≥20%) in patients with multiple myeloma who receive Xd are thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea and upper respiratory tract infection. In the STORM trial, fatal adverse reactions occurred in 9% of patients. Serious adverse reactions occurred in 58% of patients. Treatment discontinuation rate due to adverse reactions was 27%.

The most common adverse reactions (incidence ≥20%) in patients with DLBCL, excluding laboratory abnormalities, are fatigue, nausea, diarrhea, appetite decrease, weight decrease, constipation, vomiting, and pyrexia. Grade 3‐4 laboratory abnormalities (≥15%) are thrombocytopenia, lymphopenia, neutropenia, anemia, and hyponatremia. In the SADAL trial, fatal adverse reactions occurred in 3.7% of patients within 30 days, and 5% of patients within 60 days of last treatment; the most frequent fatal adverse reactions was infection (4.5% of patients). Serious adverse reactions occurred in 46% of patients; the most frequent serious adverse reaction was infection (21% of patients). Discontinuation due to adverse reactions occurred in 17% of patients.
Use In Specific Populations
Lactation: Advise not to breastfeed.

For additional product information, including full prescribing information, please visit www.XPOVIO.com.

To report SUSPECTED ADVERSE REACTIONS, contact Karyopharm Therapeutics Inc. at 1‐888‐209‐9326 or FDA at 1‐800‐FDA‐1088 or www.fda.gov/medwatch.

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]).

Schedule your 30 min Free 1stOncology Demo!
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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!

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]).

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!

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.