Karyopharm Reports Strong Third Quarter 2021 Financial Results and Provides Business Highlights

On November 3, 2021 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported financial results for the quarter ended September 30, 2021 and provided business highlights (Press release, Karyopharm, NOV 3, 2021, View Source [SID1234594251]).

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"Driven by acceleration in demand growth for XPOVIO, Karyopharm delivered a strong third quarter, which saw a significant increase in net product revenues versus the second quarter of 2021. XPOVIO continues to move into earlier lines of therapy in multiple myeloma as a new and effective modality that can become the standard of care in second line plus where utilizing new mechanisms is critical to improve patient outcomes," said Richard Paulson, President and Chief Executive Officer of Karyopharm. "With respect to the pipeline, we remain focused on expanding key clinical trials in multiple myeloma, as well as in additional cancer indications such as endometrial cancer, myelodysplastic syndromes and myelofibrosis, as emerging data continue to guide our clinical programs. Looking ahead, we have several key upcoming milestones including reporting top-line data from the Phase 3 SIENDO study in endometrial cancer where recruitment remains on track. Finally, we look forward to hosting an Investor Day in early December to present further details on our commercial and pipeline priorities."

Third Quarter 2021 and Recent Highlights

XPOVIO Commercial Performance

Achieved U.S. net product revenue for the third quarter of 2021 of $26.7 million. This represents 32% growth compared to the second quarter of 2021 and 25% growth compared to the third quarter of 2020.
Moving into earlier lines of treatment and increasing use of once weekly XPOVIO-based triplet regimen.
Growing breadth and depth of adoption and building physician confidence in the community with the new, once weekly, lower dose XPOVIO-based triplet regimen.
Payer coverage remains robust at 97%.
R&D Highlights for Selinexor and Eltanexor

Hematologic Malignancies: Karyopharm is actively building its hematologic oncology franchise through several key initiatives, including pursuing NEXPOVIO (selinexor) marketing approval in Europe in the second-line plus treatment setting for multiple myeloma, expanding approved multiple myeloma indications in the U.S. to include combinations with certain approved therapies, and pursuing additional high unmet need indications beyond multiple myeloma, such as myelofibrosis (MF) and myelodysplastic syndromes (MDS).

European Medicines Agency has validated the Marketing Authorization Application (MAA) for NEXPOVIO in combination with Velcade (bortezomib) and low-dose dexamethasone for the treatment of multiple myeloma following at least one prior therapy. The MAA will be reviewed by the Committee for Medicinal Products for Human Use, which will issue an opinion to the European Commission regarding the potential approval for the expanded indication. Karyopharm expects this review to be completed in the first half of 2022.
Commenced dosing in the Phase 2 expansion of an ongoing Phase 1/2 study evaluating eltanexor, Karyopharm’s novel oral selective inhibitor of nuclear export (SINE) compound, in patients with intermediate or high-risk hypomethylating agents refractory MDS (KPT-8602-801; NCT02649790).
Commenced dosing in a new Phase 1/2 study evaluating selinexor in combination with Jakafi (ruxolitinib) in patients with treatment-naïve myelofibrosis (XPORT-MF-034; NCT04562389).
XPOVIO in Solid Tumors: The Company is exploring solid tumor indications for XPOVIO, either alone or in combination with other agents, including in endometrial cancer, glioblastoma, melanoma, colorectal cancer and non-small cell lung cancer.
Enrollment in the Phase 3 SIENDO study in patients with endometrial cancer remains on track; expecting to report top-line results by the end of 2021 or early 2022.
Commenced dosing in a new Phase 2 study evaluating selinexor in combination with Keytruda (pembrolizumab) in patients with locally advanced or metastatic melanoma (XPORT-MEL-033; NCT04768881).
Corporate and Business Highlights

Earned $10 million in milestone payments from Antengene Therapeutics Limited (Antengene) in the third quarter of 2021 following the July 2021 approval of selinexor in South Korea for the treatment of patients with multiple myeloma and diffuse large B-cell lymphoma (DLBCL).
Karyopharm to host a virtual Investor Day on Wednesday, December 8, 2021 from 10:00 a.m. to 12:30 p.m. ET to outline commercial and pipeline priorities and objectives. The event will feature presentations from Karyopharm management and recognized thought leaders in multiple myeloma, gynecological malignancies, and other core focus indications. The event will take place virtually and will be accessible via conference call and webcast. Full details will be made available closer to the Investor Day.
Third Quarter 2021 Financial Results

"We are pleased with the continued expansion of our international program in the third quarter, which was highlighted by our progressing partnership with Antengene in South Korea and the subsequent milestone payment received by Karyopharm," said Michael P. Mason, Chief Financial Officer of Karyopharm. "Based on our current operating plans, we believe our cash, cash equivalents and investments, together with growing XPOVIO sales and revenues from existing collaborators, provide us with a cash runway that extends into mid-2023."

Net product revenue: Net product revenue for the third quarter of 2021 was $26.7 million, compared to $21.3 million for the third quarter of 2020.

License and other revenue: License and other revenue for the third quarter of 2021 was $11.0 million. During the third quarter of 2021, Karyopharm recognized $9.8 million pursuant to its agreement with Antengene, following the July 2021 approval of selinexor for the treatment of patients with multiple myeloma and DLBCL in South Korea and $1.2 million of revenue associated with named patient programs.

Cost of sales: Cost of sales for the third quarter of 2021 were $0.6 million, compared to $0.4 million for the third quarter of 2020. Cost of sales reflect 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 third quarter of 2021 were $45.8 million, compared to $37.0 million for the third quarter of 2020. The increase in R&D expenses in the third quarter of 2021 compared to the third quarter of 2020 was primarily attributable to the acquisition of certain assets from Neumedicines Inc., which closed in the third quarter of 2021.

Selling, general and administrative (SG&A) expenses: SG&A expenses for the third quarter of 2021 were $35.1 million, compared to $31.0 million for the third quarter of 2020. The increase in SG&A expenses in the third quarter of 2021 compared to the third quarter of 2020 was due primarily to increased personnel costs.

Interest expense: Interest expense for the third quarter of 2021 was $8.0 million, compared to $6.8 million for the third quarter of 2020. The increase in interest expense was primarily attributable to a $3.0 million increase in interest expense due to the increased deferred royalty obligation following Karyopharm’s June 2021 amendment of its Revenue Interest Agreement with HealthCare Royalty Management, LLC, partially offset by a $1.8 million decrease in non-cash interest expense related to Karyopharm’s 3.00% senior convertible notes due 2025, as a result of the January 1, 2021 adoption of ASU No. 2020-06, Debt—Debt with Conversion and Other Options and Derivatives and Hedging—Contracts in Entity’s Own Equity.

Net loss: Karyopharm reported a net loss of $51.8 million, or $0.69 per share, for the third quarter of 2021, compared to a net loss of $53.5 million, or $0.73 per share, for the third quarter of 2020. Net loss included non-cash stock-based compensation expense of $7.4 million and $6.5 million for the third quarters of 2021 and 2020, respectively.

Cash position: Cash, cash equivalents, restricted cash and investments as of September 30, 2021 totaled $209.3 million, compared to $276.7 million as of December 31, 2020.

2021 Financial Outlook

Based on its current operating plans, Karyopharm expects the following for full year 2021:

Non-GAAP R&D and SG&A expenses, excluding stock-based compensation expense, are expected to be in the range of $270 million to $290 million. Karyopharm has not reconciled the full year 2021 outlook for non-GAAP R&D and SG&A expenses to full year 2021 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 2021 outlook for non-GAAP R&D and SG&A expenses.
The Company expects that its existing cash, cash equivalents and investments, together with growing XPOVIO sales and revenues from existing collaborators, provide it with a cash runway that extends into mid-2023.
Non-GAAP Financial Information

Karyopharm uses a non-GAAP financial measure, including 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, Wednesday, November 3, 2021, at 8:30 a.m. Eastern Time, to discuss the third quarter 2021 financial results and 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 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 Selective Inhibitor of Nuclear Export (SINE) compound. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). XPOVIO blocks the nuclear export of tumor suppressor, growth regulatory and anti-inflammatory proteins, leading to accumulation of these proteins in the nucleus and enhancing their anti-cancer activity in the cell. The forced nuclear retention of these proteins can counteract a multitude of the oncogenic pathways that, unchecked, allow cancer cells with severe DNA damage to continue to grow and divide in an unrestrained fashion. Karyopharm received accelerated U.S. Food and Drug Administration (FDA) approval of XPOVIO in July 2019 in combination with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) 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. NEXPOVIO (selinexor) has also been granted conditional marketing authorization for adult patients with heavily pretreated multiple myeloma by the European Commission. Karyopharm’s supplemental New Drug Application (sNDA) requesting an expansion of its indication to include the treatment for patients with multiple myeloma after at least one prior therapy was approved by the FDA on December 18, 2020. In June 2020, Karyopharm received accelerated FDA approval of XPOVIO for its second indication in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including as a potential backbone therapy in combination with approved myeloma therapies (STOMP) and in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with approved therapies in a variety of tumor types to further inform Karyopharm’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.

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 2 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.

Spectrum Pharmaceuticals to Report Third Quarter 2021 Financial Results and Provide Corporate Update

On November 3, 2021 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported it will host a conference call to discuss the third quarter 2021 financial results and provide a corporate update on Wednesday, November 10, 2021 at 4:30 p.m. Eastern/1:30 p.m. Pacific (Press release, Spectrum Pharmaceuticals, NOV 3, 2021, View Source [SID1234594250]).

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The conference call will also be available from the Investor Relations section of the company’s website at View Source and will be archived there shortly after the live event.

Plus Therapeutics to Host Key Opinion Leader Roundtable on ReSPECT™-GBM Trial

On November 3, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported that it will host a key opinion leader roundtable discussion on the ReSPECT-GBM trial on Thursday, November 18, 2021, 4:00 to 5:00 p.m. ET (Press release, Cytori Therapeutics, NOV 3, 2021, View Source [SID1234594249]).

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The webinar will feature a comprehensive discussion about the ongoing ReSPECT-GBM trial including key safety, tolerability, dosing, feasibility and efficacy data. Speakers will include:

Andrew J. Brenner, M.D., Ph.D., Associate Professor of Medicine, Neurology, and Neurosurgery at The University of Texas, Health Services Center at San Antonio and principal investigator of the ReSPECT-GBM trial, will provide an update on the trial and provide insight on the trial data.
Toral Patel, M.D., Associate Professor, Department of Neurosurgery, UT Southwestern Medical Center, will provide her prospective on the use of convection enhanced delivery in neurosurgery.
Marc H. Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics, will discuss the technology behind 186RNL as well as an overview of the opportunities for radiotherapeutic development.
The webinar is intended to provide a comprehensive discussion of the trial data and an opportunity for questions from analysts, physicians and advocacy groups.

The ReSPECT-GBM Phase 1 clinical trial is evaluating the Company’s lead investigational asset, Rhenium-186 NanoLiposome (186RNL), in patients with recurrent glioblastoma (GBM). Dr. Brenner will also present ReSPECT-GBM data during a poster session on November 19, 2021, 7:30 – 9:30 p.m. ET, at the 2021 Society for Neuro-Oncology Annual Meeting and Education Day being held in Boston, Massachusetts.

Webcast Details

A live webinar with accompanying slides will be available in the Events page of the Investor Relations section of the Plus Therapeutics website. Individuals can participate in an interactive Q&A session by submitting pertinent questions via the webcast platform.

Please log in approximately 10 minutes prior to the scheduled start time. The archived webcast will be available in the Events section of the Company’s website for 90 days.

A live audio conference will be available by dialing (833) 340-0285 (toll-free) or (236) 712-2475 and entering Conference ID 3170796.

G1 Therapeutics Provides Third Quarter 2021 Financial Results and Operational Highlights

On November 3, 2021 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported financial update for the third quarter ended September 30, 2021 (Press release, G1 Therapeutics, NOV 3, 2021, View Source [SID1234594248]).

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"The third quarter of 2021 was a period of rapid execution on initiatives designed to maximize the current and future opportunity of COSELA for patients, physicians, and investors," said Jack Bailey, Chief Executive Officer of G1 Therapeutics. "We believe COSELA is a paradigm-changing drug. In just a matter of months, we have a number of important drivers such as exceptional reimbursement, high awareness and intention to treat, and excellent physician experience. However, our recent sales were impacted by less-than-optimal execution and access challenges at key accounts that treat up to 50 percent of patients diagnosed with small cell lung cancer. We are moving aggressively to address this, including by the deployment of a supplemental sales force to target these largest accounts. Longer term, our clinical programs are strategically designed to maximize the potential of trilaciclib and meaningfully improve the lives of people living with cancer, including our plans to initiate two new Phase 2 trials this quarter. We expect these studies to add to our broader development effort to demonstrate the potential of trilaciclib with therapies likely to be relevant in future treatment paradigms."

Third Quarter 2021 and Recent Highlights

Financial

Achieved Net COSELA (trilaciclib) Revenue of $3.6 Million.
Ended the Third Quarter of 2021 with Cash and Cash Equivalents of $212.1 million.
Upsized Debt Facility with Hercules Capital: The Hercules loan terms were amended to provide total commitments of $150 million, with $100 million fully available as November 1, 2021. The Company’s current financial position is expected to be sufficient to fund G1’s operations and capital expenditures into 2024.
Commercial

Announced New Supplemental COSELA Sales Force: G1 is in the process of hiring and training up to 15 people for the Company’s supplemental oncology sales force. The expansion will allow G1 to target top tier accounts to accelerate sales activities and help maximize the adoption of COSELA. The new G1 sales representatives will supplement the existing Boehringer Ingelheim oncology commercial team. (Press release here)
Permanent J-code for COSELA Effective for Provider Billing as of October 1, 2021: The permanent J-code that was issued in July 2021 by the Centers for Medicare & Medicaid Services (CMS) is now effective for provider billing for all sites of care. All hospital outpatient departments, ambulatory surgery centers and physician offices in the United States now have one consistent Healthcare Common Procedure Coding System (HCPCS) code to standardize the submission and payment of COSELA insurance claims across Medicare, Medicare Advantage, Medicaid and commercial plans. The New Technology Add-on Payment (NTAP) for COSELA when administered to Medicare beneficiaries in the hospital inpatient setting is also effective. (Press release here)
Clinical

Initiation of New Phase 2 Study of Trilaciclib to Support its Immune-based Mechanism of Action Expected in 4Q21: The Company confirmed its expectation to initiate a Phase 2 study of trilaciclib and chemotherapy in patients with early-stage triple negative breast cancer (TNBC) in the fourth quarter of 2021 to further investigate the role of trilaciclib in modulating the anti-tumor immune response.
Initiation of New Phase 2 Study of Trilaciclib in Combination with an Antibody-Drug Conjugate (ADC) in Triple-Negative Breast Cancer Expected in 4Q21: G1 intends to initiate a Phase 2 single arm study of trilaciclib administered prior to an ADC in patients with unresectable locally advanced or metastatic TNBC in the fourth quarter of 2021.
Received Fast Track designation for Trilaciclib for Use in in Triple-Negative Breast Cancer (TNBC): The U.S. Food and Drug Administration (FDA) granted Fast Track designation to trilaciclib for use in combination with chemotherapy for the treatment of locally advanced or metastatic triple negative breast cancer. Trilaciclib is currently being evaluated in PRESERVE 2, a pivotal Phase 3, randomized, double-blind, placebo-controlled study in patients receiving first- or second-line gemcitabine and carboplatin chemotherapy for TNBC. (Press release here)
NSCLC Market Changes Drive Strategic Decision to Discontinue Phase 2 Trial of Trilaciclib in 2L/3L NSCLC and Shift Resources to New Phase 2 MOA and ADC Trials: The future treatment paradigm in 2L/3L NSCLC is expected to shift further away from docetaxel, the chemotherapy backbone in PRESERVE 4, suggesting minimal future market opportunity in this setting. As such G1 is discontinuing this trial and shifting those resources to support the new Phase 2 MOA and ADC trials
Initiation of Investigator Initiated Study (IIS) of Trilaciclib in 1L Non-Small Cell Lung Cancer (NSCLC) Expected in 1Q22: As part of its broad investigator-initiated study program, G1 expects to support an IIS assessing the anti-tumor efficacy of trilaciclib in first-line NSCLC in combination with chemo and a checkpoint inhibitor.
Third Quarter 2021 Financial Results

As of September 30, 2021, cash and cash equivalents totaled $212.1 million, compared to $207.3 million as of December 31, 2020. On November 1, 2021, G1 and Hercules Capital amended Hercules’ loan terms to provide total commitments of $150 million, of which $100 million was fully available as of amendment closing. The Company has drawn down $75 million in total from the Hercules debt facility; $30 million had been drawn as of the end of the quarter and an additional $45 million was drawn on November 1, 2021.

Total revenues for the third quarter of 2021 were $4.9 million, including $3.6 million in net product sales of COSELA and license revenue of $1.3 million. This license revenue is primarily related to clinical trial reimbursements from EQRx and Simcere, and delivery of clinical drug supply and manufacturing services to Simcere, EQRx and Genor.

Operating expenses for the third quarter of 2021 were $46.0 million, compared to $36.3 million for the third quarter of 2020. GAAP operating expenses include stock-based compensation expense of $5.5 million for the third quarter of 2021, compared to $4.9 million for the third quarter of 2020.

Cost of goods sold expense for the third quarter of 2021 were $0.6 million, compared to $0 for third quarter of 2020. The increase related to the Company’s period costs for the sales of COSELA, including third-party logistics costs for the sales of COSELA, inventory overhead costs, and personnel costs.

Research and development (R&D) expenses for the third quarter of 2021 were $21.1 million, compared to $17.9 million for the third quarter of 2020. The increase in R&D expenses was primarily due to an increase in clinical trial spend, which is offset by a decrease in costs associated with the manufacturing of active pharmaceutical ingredients and drug product to support clinical trials.

Selling, general and administrative (SG&A) expenses for the third quarter of 2021 were $24.3 million, compared to $18.4 million for the third quarter of 2020. The increase in SG&A expenses was largely due to an increase in commercialization activities, an increase in compensation due to increases in headcount, increased spend on medical affairs costs related to trilaciclib and information technology, professional services, and other administrative costs.

The net loss for the third quarter of 2021 was $42.5 million, compared to $11.7 million for the third quarter of 2020. The basic and diluted net loss per share for the third quarter of 2021 was $(1.00) compared to $(0.31) for the third quarter of 2020.

Financial Guidance

Including the contribution from the amended Hercules agreement, the Company expects its current financial position to be sufficient to fund its operations and capital expenditures into 2024.

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 third quarter 2021 ended September 30, 2021. The live call may be accessed by dialing (866) 763-6020 (domestic) or (210) 874-7713 (international) and entering the conference code: 4404009. 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.

Shattuck Labs Announces Participation in Upcoming November Investor Conferences

On November 3, 2021 Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease with three ongoing Phase 1 clinical trials, reported that company management will participate in four virtual investor conferences in November 2021 (Press release, Shattuck Labs, NOV 3, 2021, View Source [SID1234594247]).

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Presentation Details

Conference: Berenberg US CEO Conference 2021
Format: 1×1 meetings
Date: November 10, 2021

Conference: Cowen 4th Annual IO Next Summit
Format: Fireside chat with covering analyst, Marc Frahm, Ph.D.
Presenter: Taylor Schreiber, M.D., Ph.D., Shattuck’s Chief Executive Officer
Date: November 15, 2021
Time: 1:45 p.m. EST

Conference: Piper Sandler 33rd Annual Healthcare Conference
Format: Corporate presentation
Presenter: Taylor Schreiber, M.D., Ph.D., Shattuck’s Chief Executive Officer
Date: November 22, 2021
Time: 10:00 a.m. EST

Conference: Evercore ISI 4th Annual HealthCONx Conference
Format: Fireside chat with covering analyst, Umer Raffat
Presenter: Taylor Schreiber, M.D., Ph.D., Shattuck’s Chief Executive Officer
Date: December 3, 2021
Time: 1:50 p.m. EST

A live webcast of the fireside chats and presentations will be available on the Events & Presentations section of the Company’s website. A replay of the webcasts will be archived for up to 90 days following the presentation date.