On August 7, 2024 Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, reported its financial results for the second quarter ended June 30, 2024 and provided a corporate update (Press release, Intra-Cellular Therapies, AUG 7, 2024, View Source [SID1234645496]).

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"We are very pleased with the strong performance of CAPLYTA during the second quarter and look forward to continued growth for the remainder of 2024," said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. "Our team is also focused on preparing our sNDA for MDD for submission later this year and continues to advance our robust pipeline."

Second Quarter Financial Highlights:

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Total revenues were $161.4 million for the second quarter of 2024, compared to $110.8 million for the same period in 2023. Net product sales of CAPLYTA were $161.3 million for the second quarter of 2024, compared to $110.1 million for the same period in 2023.

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Net loss for the second quarter of 2024 was $16.2 million compared to a net loss of $42.8 million for the same period in 2023.
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Cost of product sales was $11.4 million in the second quarter of 2024 compared to $7.2 million for the same period in 2023.

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Selling, general and administrative (SG&A) expenses were $121.6 million for the second quarter of 2024, compared to $101.0 million for the same period in 2023.

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Research and development (R&D) expenses were $56.2 million for the second quarter of 2024, compared to $49.8 million for the same period in 2023.
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Cash, cash equivalents, investment securities, and restricted cash totaled $1.025 billion at June 30, 2024.

Commercial Update

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CAPLYTA total prescriptions increased 36% in the second quarter of 2024, compared to the same period in 2023 and 10% in the second quarter of 2024, compared to the first quarter of 2024.

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To fully leverage the growing opportunity with primary care physicians in our current CAPLYTA indications, we plan to increase the size of our sales force during the third quarter of this year to expand our reach and frequency in primary care offices. In connection with this expansion, we are adding approximately 150 sales representatives. We expect to complete a second sales force expansion in 2025 in connection with the potential approval of CAPLYTA for the adjunctive treatment of MDD.

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Received notification from the Centers for Medicare and Medicaid Services that CAPLYTA qualified for the Specified Small Manufacturer Exception pertaining to the Part D redesign of the Inflation Reduction Act.

Fiscal 2024 Financial Outlook:
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CAPLYTA full year 2024 net product sales guidance range raised to $650 to $680 million.

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Full year 2024 SG&A expense guidance range increased to $480 to $510 million. This increase is primarily the result of sales, marketing and other expenses associated with the sales force expansion in the primary care segment in the second half of 2024.

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Full year 2024 R&D expense guidance range lowered to $210 to $230 million.

CLINICAL HIGHLIGHTS

Lumateperone:

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Adjunctive MDD program: Studies 501 and 502 are our global Phase 3 pivotal clinical trials evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of MDD. Following the positive and robust results in Study 501 in April 2024 and in Study 502 in June 2024, we anticipate submitting an sNDA with the U.S. Food and Drug Administration (FDA) in the second half of 2024.

In these studies, lumateperone robustly met the primary endpoint by demonstrating reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score compared to placebo plus antidepressants at Week 6. Results for the primary endpoint are summarized as follows:

Primary Endpoint: Change from baseline vs. placebo on the MADRS Total Score at Week 6 (modified intent-to-treat study population)

Least Squares (LS)
Mean Reduction vs.
Baseline1 LS mean
difference1
p value Cohen’s d
effect size
STUDY 501

Lumateperone 42 mg + ADT

placebo + ADT

14.7
9.8

-4.9 <0.0001 0.61
STUDY 502

Lumateperone 42 mg + ADT

placebo + ADT

14.7
10.2

-4.5 <0.0001 0.56

rounded to nearest tenth; ADT: Antidepressant therapy

Similarly, in both pivotal studies, lumateperone met the key secondary endpoint in the study by demonstrating a statistically significant and clinically meaningful reduction in the Clinical Global Impression Scale for Severity of Illness (CGI-S). Statistically significant efficacy was also seen in both studies in the patient reported Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) scale, a self-reported measure of symptom severity of depression.

Lumateperone was generally safe and well-tolerated in these studies and adverse events were similar to those seen in prior studies of lumateperone in bipolar depression, MDD with mixed features, and schizophrenia. In Study 501 and Study 502, mean changes in key metabolic parameters, including glucose, insulin, triglycerides, and total, LDL and HDL cholesterol, were similar between lumateperone and placebo. Importantly, mean changes in weight were also similar to placebo.

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Lumateperone bipolar mania program: In the second quarter of 2024, we initiated two multicenter, randomized, double-blind, placebo-controlled, Phase 3 studies evaluating lumateperone in the acute treatment of manic or mixed episodes associated with bipolar I disorder (bipolar mania).

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Lumateperone pediatric program: We expect to begin patient enrollment in two studies in pediatric patients for the treatment of irritability associated with autism spectrum disorder in the second half of 2024. In addition, patient enrollment is ongoing in our double-blind, placebo-controlled study in bipolar depression and in our open-label safety study in schizophrenia and bipolar disorder in pediatric patients.

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Lumateperone Long Acting Injectable (LAI) program: We expect to commence clinical conduct in a Phase 1 single ascending dose study with several formulations shortly. The goal of the program is to develop LAI formulations that are effective, safe, and well-tolerated with treatment durations of one month or longer.

Other pipeline programs:

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ITI-1284-ODT-SL program: We have initiated patient enrollment in our Phase 2 clinical study evaluating ITI-1284 as adjunctive therapy to anti-anxiety medications in patients with generalized anxiety disorder (GAD). We expect to initiate a second Phase 2 GAD study, evaluating ITI-1284 as monotherapy, later this year. We have also initiated patient enrollment in a Phase 2 clinical study evaluating ITI-1284 as monotherapy in patients with psychosis associated with Alzheimer’s disease. We anticipate commencing patient enrollment in our Phase 2 program in agitation associated with Alzheimer’s disease shortly.

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Phosphodiesterase type I inhibitor (PDE1) program: Our portfolio of PDE1 inhibitors continues to advance in clinical development.

Lenrispodun (ITI-214) Parkinson’s disease (PD) program: Our Phase 2 clinical trial is ongoing with topline results anticipated in 2025. The objective of this study is to evaluate improvements in motor symptoms in patients with PD. Changes in cognition and inflammatory biomarkers are also being assessed.

ITI-1020 cancer immunotherapy program: Our Phase 1 single ascending dose study in healthy volunteers is ongoing. The objective of this study is to evaluate pharmacokinetics, safety, and tolerability of different doses of ITI-1020.

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ITI-333 program: ITI-333, a 5-HT2A receptor antagonist and m-opioid receptor partial agonist, provides potential utility in the treatment of opioid use disorder and pain. A multiple ascending dose study and a positron emission tomography (PET) study are both ongoing.

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ITI-1500 Non-Hallucinogenic Neuroplastogen Program: This program, previously referred to as our non-hallucinogenic psychedelic program, is focused on the development of novel neuroplastogens for the treatment of mood, anxiety, and other neuropsychiatric disorders without the hallucinogenic and cardiovascular effects of psychedelics. Our lead product candidate in this program, ITI-1549, continues to advance through IND enabling studies and is expected to enter human testing in 2025.

Conference Call and Webcast Details

The Company will host a live conference call and webcast today at 8:30 AM Eastern Time to discuss the Company’s financial results and provide a corporate update. To attend the live conference call by phone, please use this registration link (https://register.vevent.com/register/BIa69e7f7949b74f8d9bc7846c268b0ecd). All participants must use the link to complete the online registration process in advance of the conference call. The live and archived webcast can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software.CAPLYTA (lumateperone) is indicated in adults for the treatment of schizophrenia and for the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate.

Important Safety Information

Boxed Warnings:

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Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.

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Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies. All antidepressant-treated patients should be closely monitored for clinical worsening, and for emergence of suicidal thoughts and behaviors. The safety and effectiveness of CAPLYTA have not been established in pediatric patients.

Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g., allergic dermatitis, papular rash, and generalized rash), and urticaria.

Warnings & Precautions: Antipsychotic drugs have been reported to cause:

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Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above.

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Neuroleptic Malignant Syndrome (NMS), which is a potentially fatal reaction. Signs and symptoms include: high fever, stiff muscles, confusion, changes in breathing, heart rate, and blood pressure, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Patients who experience signs and symptoms of NMS should immediately contact their doctor or go to the emergency room.

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Tardive Dyskinesia, a syndrome of uncontrolled body movements in the face, tongue, or other body parts, which may increase with duration of treatment and total cumulative dose. TD may not go away, even if CAPLYTA is discontinued. It can also occur after CAPLYTA is discontinued.

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Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.

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Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Complete blood counts should be performed in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. CAPLYTA should be discontinued if clinically significant decline in WBC occurs in absence of other causative factors.

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Decreased Blood Pressure & Dizziness. Patients may feel lightheaded, dizzy or faint when they rise too quickly from a sitting or lying position (orthostatic hypotension). Heart rate and blood pressure should be monitored and patients should be warned with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension.

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Falls. CAPLYTA may cause sleepiness or dizziness and can slow thinking and motor skills, which may lead to falls and, consequently, fractures and other injuries. Patients should be assessed for risk when using CAPLYTA.

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Seizures. CAPLYTA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold.

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Potential for Cognitive and Motor Impairment. Patients should use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them.

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Body Temperature Dysregulation. CAPLYTA should be used with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics.

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Dysphagia. CAPLYTA should be used with caution in patients at risk for aspiration.

Drug Interactions: CAPLYTA should not be used with CYP3A4 inducers. Dose reduction is recommended for concomitant use with strong CYP3A4 inhibitors or moderate CYP3A4 inhibitors.

Special Populations: Newborn infants exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Dose reduction is recommended for patients with moderate or severe hepatic impairment.

Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation, dizziness, nausea, and dry mouth.

CAPLYTA is available in 10.5 mg, 21 mg, and 42 mg capsules.

Please click here to see full Prescribing Information including Boxed Warning.

About CAPLYTA (lumateperone)

CAPLYTA 42 mg is an oral, once daily atypical antipsychotic approved in adults for the treatment of schizophrenia and the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate. While the mechanism of action of CAPLYTA is unknown, the efficacy of CAPLYTA could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors.

Lumateperone is being studied for the treatment of major depressive disorder, and other psychiatric and neurological disorders. Lumateperone is not FDA-approved for these disorders.

On August 7, 2024 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported financial results for the quarter ended June 30, 2024 (Press release, Guardant Health, AUG 7, 2024, View Source [SID1234645495]).

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Second Quarter 2024 Financial Highlights

•Revenue of $177.2 million for the second quarter of 2024, an increase of 29% over the second quarter of 2023
•Reported 49,400 tests to clinical customers and 10,475 tests to biopharmaceutical customers in the second quarter of 2024, representing increases of 14% and 56%, respectively, over the second quarter of 2023
•Raised 2024 annual guidance for revenue to a new range of $690 to $700 million, representing growth of 22% to 24%

Recent Operating Highlights

•Received FDA approval for Shield as a first-line CRC screening option and initiated commercial launch of Shield IVD
•Shield now meets the requirements for Medicare coverage for 45 million eligible individuals
•Launched major upgrade of Guardant360 on Smart Liquid Biopsy platform, further extending best-in-class performance
•Upgraded Guardant360 TissueNext to a 498 gene panel to identify more treatment options for patients with advanced cancer
•Publication of COSMOS study data in Clinical Cancer Research further validates Reveal for MRD CRC surveillance testing in Stage II and III patients
"We had another strong quarter driven by solid volume growth, particularly for biopharma, and continued improvements to Guardant360 reimbursement," said Helmy Eltoukhy, co-founder and co-CEO. "We also reached major milestones across our oncology business with the upgrades of Guardant360 onto our Smart Liquid Biopsy platform, a revolutionary platform that combines genomics with epigenomics, and of Guardant360 TissueNext to identify more treatment options for patients with advanced cancer. Additionally, our COSMOS study was recently published in Clinical Cancer Research and submitted to MolDx for Medicare reimbursement of CRC surveillance. We look forward to continuing this momentum throughout the remainder of the year as we deliver on our mission of giving us all more time free from cancer."
"FDA approval of our Shield blood test for first-line colorectal cancer screening is a huge victory for Guardant and patients," said AmirAli Talasaz, co-founder and co-CEO. "Commercial launch of Shield and CMS coverage make our blood-based screening option accessible to more than 45 million Medicare beneficiaries. Shield offers a more pleasant way to stay up to date with colorectal cancer screening and detect the disease early, when it is more easily treated."

Second Quarter 2024 Financial Results

Revenue was $177.2 million for the second quarter of 2024, a 29% increase from $137.2 million for the corresponding prior year period. Precision oncology revenue grew 33%, to $166.5 million for the second quarter of 2024, from $125.2 million for the corresponding prior year period, driven by an increase in clinical and biopharma testing volume, which grew 14% and 56%, respectively, over the prior year period. The increase in precision oncology revenue was also attributable to an increase in reimbursement for our tests, due to an increase in Medicare reimbursement for our Guardant360 LDT test to $5,000, effective January 1, 2024; and an increase in both Medicare Advantage and commercial payer reimbursement. Development services and other revenue was $10.7 million for the second quarter of 2024, compared to $11.9 million for the corresponding prior year period.

Gross profit, or total revenue less cost of precision oncology testing and cost of development services and other, was $104.8 million for the second quarter of 2024, an increase of $21.5 million from $83.3 million for the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 59%, as compared to 61% for the corresponding prior year period. Precision oncology gross margin was 61% in the second quarter of 2024, as compared to 61% in the prior year period. Development services and other gross margin was 37% in the second quarter of 2024, as compared to 62% in the prior year period.

Non-GAAP gross profit was $106.8 million for the second quarter of 2024, an increase of $21.5 million, from $85.4 million for the corresponding prior year period. Non-GAAP gross margin was 60% for the second quarter of 2024, as compared to 62% for the corresponding prior year period.Non-GAAP gross profit excluding screening was $109.7 million for the second quarter of 2024, an increase of $22.1 million, from $87.6 million for the corresponding prior year period. Non-GAAP gross margin excluding screening was 62% for the second quarter of 2024, as compared to 64% for the corresponding prior year period.
Operating expenses were $205.4 million for the second quarter of 2024, as compared to $202.9 million for the corresponding prior year period. Non-GAAP operating expenses were $178.8 million for the second quarter of 2024, as compared to $180.5 million for the corresponding prior year period.
Net loss was $102.6 million for the second quarter of 2024, as compared to $72.8 million for the corresponding prior year period. Net loss per share was $0.84 for the second quarter of 2024, as compared to $0.67 for the corresponding prior year period. The year-over-year increase in net loss is primarily due to a $79.5 million increase in unrealized losses recorded for our equity security investment, partially offset by a $23.6 million impairment for our non-marketable equity security investments and other related assets recorded during the corresponding prior year period, a $19.0 million year over year improvement in loss from operations, and a $7.2 million increase in interest income.
Non-GAAP net loss was $58.5 million for the second quarter of 2024, as compared to $88.7 million for the corresponding prior year period. Non-GAAP net loss per share was $0.48 for the second quarter of 2024, as compared to $0.82 for the corresponding prior year period.
Adjusted EBITDA loss was $61.9 million for the second quarter of 2024, as compared to a $85.2 million loss for the corresponding prior year period.
Free cash flow for the second quarter of 2024 was $(99.1) million, as compared to $(100.5) million for the corresponding prior year period. Cash, cash equivalents, and restricted cash were $1.0 billion as of June 30, 2024.
2024 Guidance
Guardant Health now expects full year 2024 revenue excluding screening to be in the range of $690 to $700 million, representing growth of 22% to 24% compared to full year 2023 This compares to the prior range of $675 to $685 million, representing growth of 20% to 21%. Guardant Health continues to expect full year 2024 non-GAAP gross margin excluding screening to be in the range of 61% to 63% and total non-GAAP operating expenses to be in the range of $720 to $730 million, representing a flat to 1% decrease compared to 2023. Guardant Health continues to expect free cash flow to be in the range of $(275) to $(285) million in 2024, representing an improvement of $60 million to $70 million compared to 2023.
Webcast Information
Guardant Health will host a conference call to discuss the second quarter 2024 financial results after market close on Wednesday, August 7, 2024 at 1:30 pm Pacific Time / 4:30 pm Eastern Time. A webcast of the conference call can be accessed at View Source The webcast will be archived and available for replay for at least 90 days after the event.

On August 7, 2024 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company focused on delivering next-generation therapies that improve the lives of those affected by cancer, and Pharmacosmos A/S, a leader in the development of innovative treatments for patients suffering from iron deficiency and iron deficiency anemia, reported that they have entered into a definitive merger agreement under which Pharmacosmos A/S, through its U.S. subsidiary Pharmacosmos Therapeutics Inc., will acquire all outstanding shares of G1 Therapeutics common stock for U.S. $7.15 per share in cash for a total equity value of approximately $405 million, which represents a 68% premium to G1’s closing share price on August 6, 2024 and a 133% premium to G1’s prior 30-day volume weighted average price (Press release, G1 Therapeutics, AUG 7, 2024, View Source [SID1234645494]). The Boards of Directors of the parties have unanimously approved the transaction, which is expected to close late in the third quarter of 2024.

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G1’s COSELA is the first and only product approved by the U.S. Food and Drug Administration 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 (ES-SCLC).

Together, Pharmacosmos and G1 Therapeutics will execute on the shared vision to grow and accelerate the availability of COSELA for all appropriate patients with ES-SCLC. G1 brings a well-established and successful commercial, sales, and medical platform to Pharmacosmos, which has complementary expertise in commercializing hematology and supportive care products, a robust global commercial presence, and significant resources to maximize the penetration of COSELA into the ES-SCLC market. Together, the combined company will be able to optimize the commercial reach to oncologists and expand the availability of COSELA among patients living with ES-SCLC.

"G1 and Pharmacosmos have a shared commitment to people living with cancer; the transaction announced today will enable a more rapid uptake of COSELA into the ES-SCLC market to maximize availability for patients who need this important drug," said Jack Bailey, Chief Executive Officer of G1 Therapeutics. "Importantly, this acquisition delivers significant value to G1’s stakeholders by providing better and broader access to this important product for the cancer patients we seek to treat and a significant premium to our shareholders. I am proud of all that the G1 team has accomplished over the years, thankful for their great effort, and excited about what’s possible by the combined Pharmacosmos/G1 team as we meet the needs of more cancer patients."

"The acquisition of G1 Therapeutics Inc., its intellectual property, and the addition of COSELA (trilaciclib) to our portfolio of innovative products is transformative for Pharmacosmos. By combining our existing colleagues with the great team at G1 Therapeutics, we will meaningfully expand our organization serving oncologists in the US. This will enable broader and better access for patients in need of COSELA as well as for our existing FDA approved drug, Monoferric (ferric derisomaltose)," said Tobias S. Christensen, President and Chief Executive Officer of Pharmacosmos A/S. "COSELA is a first-in-class product that brings important benefits to patients and fits very nicely together with our lead product Monoferric (ferric derisomaltose). While Monoferric is available around the World, COSELA is so far only approved in the US and in China. It will be a focus for us to bring this important product to more patients both in US and worldwide to help minimize the number of lung cancer patients suffering from myelosuppression after chemotherapy."

Transaction Terms

Under the terms of the merger agreement, Pharmacosmos has agreed to commence a cash tender offer to acquire all issued and outstanding shares of G1 common stock for US $7.15 per share in cash. The transaction will be fully financed by Pharmacosmos’ existing cash on hand and existing corporate credit facilities.

The closing of the tender offer will be subject to customary conditions, including the tender of shares which represent at least a majority of the total number of G1’s outstanding shares of common stock and the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. Upon successful completion of the tender offer, Pharmacosmos would acquire all shares not acquired in the tender offer through a second-step merger for the same consideration that the tendering stockholders will receive in the tender offer.

It is anticipated the transaction will close late in the third quarter of 2024. Upon completion of the transaction, G1’s common stock will no longer be publicly listed.

As previously announced, G1 will be releasing its second quarter 2024 financial results and filing its Form 10-Q Quarterly Report tomorrow. However, due to the pending transaction, we will no longer be hosting a conference call at 8:30 am ET, August 8 to review such results.

Advisors

For Pharmacosmos, MTS Health Partners, L.P. is serving as exclusive financial advisor, and Arnold & Porter Kaye Scholer LLP is serving as legal counsel. For G1, Centerview Partners LLC is serving as exclusive financial advisor, and Ropes & Gray LLP and Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. are serving as legal counsel.

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.

About Monoferric (ferric derisomaltose)

Indication

Monoferric (ferric derisomaltose) is indicated for the treatment of iron deficiency anemia (IDA) in adult patients:

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who have intolerance to oral iron or have had unsatisfactory response to oral iron

•
who have non-hemodialysis dependent chronic kidney disease (NDD-CKD)

Important Safety Information

Monoferric is contraindicated in patients with a history of serious hypersensitivity to Monoferric or any of its components. Reactions have included shock, clinically significant hypotension, loss of consciousness, and/or collapse.

Warnings and precautions include serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Monoferric. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Monoferric administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Monoferric when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Monoferric is contraindicated in patients with prior serious hypersensitivity reactions to Monoferric or any of its components. In clinical trials in patients with IDA and CKD, serious or severe hypersensitivity were reported in 0.3% (6/2008) of the Monoferric treated subjects. These included 3 events of hypersensitivity in 3 patients; 2 events of infusion-related reactions in 2 patients and 1 event of asthma in one patient.

Excessive therapy with parenteral iron can lead to excess iron storage and possibly iatrogenic hemosiderosis or hemochromatosis. Monitor the hematologic response (hemoglobin and hematocrit) and iron parameters (serum ferritin and transferrin saturation) during parenteral iron therapy. Do not administer Monoferric to patients with iron overload.

Adverse reactions were reported in 8.6% (172/2008) of patients treated with Monoferric. Adverse reactions related to treatment and reported by ≥1% of the treated patients were nausea (1.2%) and rash (1%). Adjudicated serious or severe hypersensitivity reactions were reported in 6/2008 (0.3%) patients in the Monoferric group. Hypophosphatemia (serum phosphate <2.0 mg/dL) was reported in 3.5% of Monoferric-treated patients in Trials 1 & 2.

To report adverse events, please contact Pharmacosmos at 1-888-828-0655. You may also contact the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.

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

On August 7, 2024 ChromaDex Corp. (NASDAQ:CDXC) reported financial results for the second quarter of 2024 (Press release, ChromaDex, AUG 7, 2024, View Source/news/news-details/2024/ChromaDex-Corporation-Reports-Second-Quarter-2024-Financial-Results/default.aspx" target="_blank" title="View Source/news/news-details/2024/ChromaDex-Corporation-Reports-Second-Quarter-2024-Financial-Results/default.aspx" rel="nofollow">View Source [SID1234645493]).

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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

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Second Quarter 2024 Financial and Recent Operational Highlights

Total net sales were $22.7 million, with $18.6 million from Tru Niagen, up 12%, and 10%, respectively, from the prior year quarter.
Solid gross margin of 60.2% and a $0.7 million reduction in total operating expenses from the prior year quarter.
Net loss and loss per share were approximately breakeven, a $2.2 million and $0.03 per share improvement from the prior year quarter.
Adjusted EBITDA, a non-GAAP measure, improved to $1.6 million from $0.2 million in the prior year quarter.
In June 2024, ChromaDex announced U.S. FDA Orphan Drug Designation and Rare Pediatric Disease Designation for nicotinamide riboside chloride, ChromaDex’s product candidate for the treatment of Ataxia Telangiectasia (AT). AT is a rare, progressive disease that typically presents in early childhood and affects the function of the nervous system, the immune system, and several other body systems. Plans are underway to file an Investigational New Drug application with the U.S. FDA in anticipation of conducting human clinical trials. If the application is approved, ChromaDex will pursue grant funding or other non-dilutive financing for the human clinical trials.
In June 2024, ChromaDex unveiled Niagen+, a product line featuring pharmaceutical-grade Niagen (patented nicotinamide riboside chloride or NRC). U.S. FDA-registered 503B outsourcing facilities will compound and distribute pharmaceutical-grade Niagen, which will be available in intravenous (IV) and injectable forms exclusively at clinics with prescription. Beginning this month, Niagen IV and injections will debut at select IV clinics. Clinical study results (1) support Niagen IV offering a 75% shorter infusion time, a higher and faster rise in NAD+ blood levels three hours post-infusion, based on dried blood spot analysis, and is well-tolerated as compared to the common alternative, NAD+ IV.
In July 2024, ChromaDex launched Niagen+ NAD+ Test Kits, available exclusively to healthcare practitioners. The Niagen+ NAD+ Test Kits provide a reliable method for measuring patient blood NAD+ levels, enabling practitioners to create more personalized and effective protocols using ChromaDex’s NAD+-boosting products, Tru Niagen and Niagen+.
"We delivered solid financial results in the second quarter, with $22.7 million in revenue and lower operating expenses resulting in virtually breakeven net loss and operating cash flows, as well as positive Adjusted EBITDA of $1.6 million," said ChromaDex Chief Executive Officer, Rob Fried. "Moreover, we are thrilled to finally unveil our new product line, Niagen+, for healthcare practitioners and clinics. This launch marks a significant milestone for ChromaDex, as we believe we are the first company to offer NR in both oral and intravenous forms, reinforcing our position as the global authority in the NAD+ market."

(1) Source: MedRxiv Randomized, placebo-controlled, pilot clinical study evaluating acute Niagen+ IV and NAD+ IV in healthy adults

Results of operations for the three months ended June 30, 2024 compared to the prior year quarter

ChromaDex recorded net sales of $22.7 million, an increase of 12% or $2.4 million from the prior year quarter. The growth in total net sales was primarily due to higher Tru Niagen and Niagen ingredient sales.

Gross margin percentage declined 60 basis points to 60.2% primarily driven by changes in business mix.

Operating expense decreased 5%, or $0.7 million, to $13.9 million driven by lower general and administrative expense, partially offset by increased investments in sales and marketing expense.

Net loss and loss per share were approximately breakeven, both up compared to a net loss of $2.2 million, or $0.03 loss per share, for the second quarter of 2023. Adjusted EBITDA, a non-GAAP measure, improved to $1.6 million from $0.2 million in the second quarter of 2023. See "Reconciliation of Non-GAAP Financial Measures" for a reconciliation of non-GAAP Adjusted EBITDA to net loss, the most directly comparable GAAP measure.

Net cash inflow from operating activities was approximately breakeven for the six months ended June 30, 2024 compared to a net cash inflow of $6.1 million in the prior year. The approximately $6.0 million reduction in cash provided by operating activities was largely driven by a relatively greater increase in trade receivables of $4.2 million and a greater reduction in accounts payable of $2.5 million.

2024 Full Year Outlook

Looking forward, for the full year, the Company expects between 10% – 15% revenue growth year-over-year, driven by continued revenue growth through our e-commerce business as well as established partnerships, and assumes upside from opportunities with new partnerships, channels, and products. The Company projects that gross margin will improve slightly year-over-year. Moreover, selling and marketing expense will increase in absolute dollars but remain stable as a percentage of net sales, as the Company continues to make focused investments to drive brand awareness and support new market launches, while maintaining efficiency. The Company plans to continue to invest in research and development to drive future innovation and expects general and administrative expense to be down $1.5 million year over year.

Investor Conference Call

A live webcast will be held Wednesday, August 7, 2024 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss ChromaDex’s second-quarter financial results and provide a general business update.

To listen to the webcast, or to view the earnings press release and its accompanying financial exhibits, please visit the Investors Relations section of ChromaDex’s website at View Source . The toll-free dial-in information for this call is 1-888-596-4144 with Conference ID: 8584242.

The webcast will be recorded, and will be available for replay via the website from 7:30 p.m. Eastern time on August 7, 2024 through 11:59 p.m. Eastern time on August 14, 2024. The replay of the call can also be accessed by dialing 800-770-2030, using the Replay ID: 8584242.

On August 7, 2024 Charles River Laboratories International, Inc. (NYSE: CRL) reported its results for the second quarter of 2024 (Press release, Charles River Laboratories, AUG 7, 2024, View Source [SID1234645492]). For the quarter, revenue was $1.03 billion, a decrease of 3.2% from $1.06 billion in the second quarter of 2023.

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The impact of foreign currency translation reduced reported revenue by 0.3%, a divestiture reduced reported revenue by 0.2%, and an acquisition contributed 0.5% to consolidated second-quarter revenue. Excluding the effect of these items, revenue also declined 3.2% on an organic basis. On a segment basis, organic revenue growth in the Manufacturing Solutions (Manufacturing) segment was more than offset by lower revenue in the Discovery and Safety Assessment (DSA) and Research Models and Services (RMS) segments.

In the second quarter of 2024, the GAAP operating margin decreased to 14.8% from 15.6% in the second quarter of 2023. This GAAP decrease was primarily driven by lower operating margins in the RMS and DSA segments, due in part to costs associated with the Company’s restructuring initiatives. On a non-GAAP basis, the second-quarter operating margin increased to 21.3% from 20.4%, driven primarily by lower performance-based compensation accruals, as well as operating margin improvement in the Manufacturing segment.

On a GAAP basis, second-quarter net income attributable to common shareholders was $90.0 million, a decrease of 7.2% from $97.0 million for the same period in 2023. Second-quarter diluted earnings per share on a GAAP basis were $1.74, a decrease of 7.9% from $1.89 for the second quarter of 2023. The GAAP net income and earnings per share decreases were driven primarily by lower revenue and operating income, which included higher costs associated with the Company’s restructuring initiatives. On a non-GAAP basis, net income was $144.9 million for the second quarter of 2024, an increase of 4.8% from $138.3 million for the same period in 2023. Second-quarter diluted earnings per share on a non-GAAP basis were $2.80, an increase of 4.1% from $2.69 per share for the second quarter of 2024. The increases in non-GAAP net income and earnings per share were driven primarily by lower performance-based compensation accruals, as well as higher revenue and operating income in the Manufacturing segment.

James C. Foster, Chair, President and Chief Executive Officer, said, "Our financial performance through the first half of this year has been largely in line with our initial outlook; however, forward-looking DSA trends suggest that demand will not improve during the second half of the year as we had previously anticipated, and in fact, will decline for global biopharmaceutical clients. This has caused us to take a much more negative view of our growth prospects for the second half of the year. We believe that our clients are currently more focused on reassessing their budgets and reprioritizing their pipelines, but continue to view strategic outsourcing as a compelling solution to improve their cost efficiency and speed to market, presenting a longer-term opportunity for us."
"Therefore, it is imperative for us to navigate through this period of softer demand by aggressively managing our cost structure, initiating new and innovative ways to transform our business, being disciplined with our investments, and enhancing our commercial efforts to win new business. We firmly believe that our clients will continue to seek life-saving treatments for rare diseases and other unmet medical needs, which drives us to take further steps to position Charles River for the future. These steps will enable us to emerge as a stronger, leaner partner to help our clients achieve their goals by utilizing our scientific expertise and flexible solutions," Mr. Foster concluded.

Second-Quarter Segment Results

Research Models and Services (RMS)

Revenue for the RMS segment was $206.4 million in the second quarter of 2024, a decrease of 1.7% from $209.9 million in the second quarter of 2023. The Noveprim acquisition in November 2023 contributed 2.7% to second-quarter RMS reported revenue, and the impact of foreign currency translation reduced revenue by 0.5%. Organic revenue decreased by 3.9%, due primarily to lower revenue for non-human primates (NHPs) in China. In addition, lower revenue for research model services and the Cell Solutions business also contributed to the decline. The decline was partially offset by higher sales of small research models, particularly in Europe and China.
In the second quarter of 2024, the RMS segment’s GAAP operating margin decreased to 14.5% from 23.3% in the second quarter of 2023. On a non-GAAP basis, the operating margin decreased to 23.1% from 26.4%. The GAAP and non-GAAP operating margin declines were driven primarily by lower NHP revenue. On a GAAP basis, the lower operating margin also reflects higher costs associated with the Company’s restructuring initiatives, including site consolidation costs related to the Company’s CRADL operations in California.
Discovery and Safety Assessment (DSA)

Revenue for the DSA segment was $627.4 million in the second quarter of 2024, a decrease of 5.4% from $663.5 million in the second quarter of 2023. A divestiture of a small Safety Assessment site reduced reported revenue by 0.3% and the impact of foreign currency translation reduced DSA revenue by 0.1%. Organic revenue decreased by 5.0%, driven by lower revenue in the Discovery Services and Safety Assessment businesses.

In the second quarter of 2024, the DSA segment’s GAAP operating margin decreased to 22.1% from 24.3% in the second quarter of 2023. On a non-GAAP basis, the operating margin decreased to 27.1% from 27.6% in the second quarter of 2023. The GAAP and non-GAAP operating margin decreases were driven primarily by the impact of lower sales volume, partially offset by lower performance-based compensation accruals. On a GAAP basis, the lower operating margin also reflects higher costs associated with the Company’s restructuring initiatives, as well as higher acquisition-related adjustments associated with Noveprim.

Manufacturing Solutions (Manufacturing)

Revenue for the Manufacturing segment was $192.3 million in the second quarter of 2024, an increase of 3.1% from $186.5 million in the second quarter of 2023. The impact of foreign currency translation reduced Manufacturing revenue by 0.6%. Organic revenue growth of 3.7% reflected higher revenue across all of the segment’s businesses.
In the second quarter of 2024, the Manufacturing segment’s GAAP operating margin increased to 19.4% from 13.1% in the second quarter of 2023, and on a non-GAAP basis, the operating margin increased to 26.6%, from 22.9% in the second quarter of 2023. The GAAP and non-GAAP operating margin increases were driven primarily by improved profitability for each of segment’s businesses. On a GAAP basis, lower third-party legal costs related to the Microbial Solutions business and lower acquisition-related adjustments also contributed to the increase.
New Stock Repurchase Authorization
The Company’s Board of Directors has approved a new stock repurchase authorization of $1.0 billion. This new authorization replaces a prior stock repurchase authorization of $1.3 billion that had $129.1 million remaining on the plan when it was terminated.

Revises 2024 Guidance

The Company is revising its financial guidance for 2024, which was previously updated on May 9, 2024. The reduced guidance primarily reflects the lack of a recovery in demand from our small and mid-sized biotechnology clients in the second half of the year, as well as softer demand trends from global biopharmaceutical clients whose deterioration has become increasingly evident in the past couple of months. As a result, the Company no longer expects that overall demand trends will improve during the second half of the year. In particular, these trends will have a meaningful impact on the outlook for the DSA segment. The Company is implementing restructuring initiatives that are expected to result in annualized cost savings of over $150 million (inclusive of actions implemented last year through the third quarter of 2024), of which approximately $100 million will be realized in 2024.