On August 9, 2022 Applied DNA Sciences, Inc. (NASDAQ: APDN) (the "Company"), a leader in polymerase chain reaction ("PCR")-based technologies, reported that The City University of New York (CUNY), the largest urban university in the United States, has extended its health services contract for COVID-19 testing and vaccine policy management with the Company’s wholly-owned clinical laboratory subsidiary, Applied DNA Clinical Labs, LLC (ADCL), for 12 months through July 2023 and at the prior contract terms (Press release, Applied DNA Sciences, AUG 9, 2022, View Source [SID1234617905]). ADCL’s COVID-19 testing volumes, including the CUNY contract, fueled the Company’s record fiscal 2021 revenues and consecutive quarterly record revenues in the first half of fiscal 2022 ended March 31, 2022 .

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The contract has been successfully operational since August 2021. Through a partnership with Cleared4 software platform, ADCL provides a wide range of COVID-19 related health services to help CUNY mitigate COVID-19 associated risks. These services, which are provided to CUNY’s 25 campuses and covering 300,000+ students, employees, auxiliary workers, contractors and visitors, include: (i) high-throughput RT-PCR COVID-19 testing (weekly testing and a robust randomized testing program); (ii) vaccination policy and documentation management; and, (iii) facility access control.

"We commend the CUNY Board of Trustees for taking a forward-thinking approach to ensure the continued health and safety of all CUNY stakeholders while remaining committed to the promise and value of in-person learning. As New York City grapples with a resurgence of infections fueled by the Omicron BA.5 subvariant that can potentially elude rapid test detection and more easily reinfect people, including those who have been vaccinated, boosted and/or previously infected, our ability to deliver rapid PCR-based results with actionable reporting and access management for safeCircle clients remains a standout," stated Dr. James A. Hayward, president and CEO of Applied DNA. "Given our infrastructure and client concentration in New York City, we are pleased to continue servicing CUNY while we expand our test offering and services."

About safeCircle
safeCircle is a fully integrated health testing platform that offers a customized suite of services to institutions and their personnel/members that encompasses: program design, RT-PCR and rapid antigen testing, sample kit distribution and collection, test site management, results reporting to individuals and program administrators, facilities access management, variant tracking, and vaccination documentation management.

On August 9, 2022 Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) reported financial results for the second quarter of 2022 and recent business achievements (Press release, Ionis Pharmaceuticals, AUG 9, 2022, View Source [SID1234617904]).

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"Over the first half of this year, we moved significantly closer to delivering an abundance of new medicines to the market. We reported positive Phase 3 data from the NEURO-TTRansform study of eplontersen in patients with hereditary ATTR polyneuropathy and we are on track to file an NDA in the second half of this year. We were also pleased that the FDA accepted the NDA for tofersen and granted priority review, enabling tofersen to potentially be the first disease modifying treatment approved for a genetic form of ALS. These achievements mean eplontersen and tofersen could be our next marketed products as early as next year," said Brett P. Monia, Ph.D., chief executive officer of Ionis. "We also significantly advanced our late- and mid-stage pipeline. The pelacarsen Lp(a) HORIZON and olezarsen BALANCE Phase 3 studies recently completed enrollment. Additionally, we reported positive data from six mid-stage programs, positioning us to grow our rich Phase 3 pipeline to at least eight medicines across 10 indications. We are looking forward to continuing our positive momentum in the second half of this year by presenting Phase 3 eplontersen data at the International Symposium on Amyloidosis in September, filing our eplontersen NDA, and reporting data from several important programs. These upcoming catalysts, together with our recent achievements, position us well to drive increasing value for all stakeholders."

Second Quarter 2022 Summary Financial Results

On track to achieve 2022 financial guidance, based on the following second quarter results:

$134 million in total revenues
$195 million of operating expenses on a non-GAAP basis(1) and $220 million on a GAAP basis
$80 million net loss on a non-GAAP basis(1) and $105 million on a GAAP basis
$2.0 billion of cash and short-term investments
"We had a strong first half with year-over-year revenue growth of more than 15 percent. We continued to generate revenue from multiple diverse sources, with just over half from our marketed products and the balance from our numerous advancing partnered medicines. Additionally, our financial results reflect our accelerating investments in our rich late-stage pipeline and in our commercial readiness activities for eplontersen, olezarsen and donidalorsen," said Elizabeth L. Hougen, chief financial officer of Ionis. "With $2 billion of cash and investments, we have the financial resources to achieve our goal of bringing transformational medicines to the market. These results for the first half of the year keep us on track to meet our 2022 financial guidance."

Recent Marketed Products Highlights

SPINRAZA: the global market leader for the treatment of spinal muscular atrophy (SMA) patients of all ages

$431 million in worldwide SPINRAZA sales in the second quarter
Biogen reported new results from the RESPOND study of SPINRAZA, stating the results indicate there are residual unmet clinical needs in infants and toddlers with SMA who were previously treated with gene therapy
Biogen reported final data from Part A of the ongoing, three-part DEVOTE study demonstrating that a higher dosing regimen of SPINRAZA leads to higher levels of the drug in the cerebrospinal fluid and is generally well-tolerated
TEGSEDI and WAYLIVRA: important medicines approved for the treatment of patients with polyneuropathy caused by hereditary TTR amyloidosis (ATTRv-PN) and familial chylomicronemia syndrome (FCS), respectively

Continued to expand into new markets in Europe and Latin America through Swedish Orphan Biovitrum AB (Sobi) and PTC Therapeutics, respectively
Second Quarter 2022 and Recent Events

Advancing Ionis’ next two potential marketed products

Reported eplontersen met the co-primary and key secondary endpoints in the interim analysis of the Phase 3 NEURO-TTRansform study in patients with ATTRv-PN; on track to file the New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in the second half of this year
Biogen reported longer-term data from the Phase 3 VALOR study and ongoing open-label extension study of tofersen showing clinical benefit in patients with SOD1-ALS at the European Network to Cure ALS (ENCALS) meeting
Biogen reported that an NDA for tofersen was accepted and granted priority review by the FDA with a Prescription Drug User Fee Act (PDUFA) action date of January 25, 2023
Advancing Ionis’ late-stage pipeline

Novartis achieved full enrollment in the Phase 3 Lp(a) HORIZON cardiovascular outcomes study of pelacarsen in patients with established cardiovascular disease and elevated Lp(a) with data expected in 2025
Achieved full enrollment in the Phase 3 BALANCE study of olezarsen in patients with FCS with data expected in 2023
Advancing Ionis’ mid-stage pipeline

GSK presented positive data from the Phase 2b B-Clear study of bepirovirsen in patients with chronic hepatitis B at the European Association for the Study of the Liver’s (EASL) International Liver Congress. Based on these results, GSK plans to advance bepirovirsen into a Phase 3 monotherapy study in the first half of 2023
Roche reported positive data from the Phase 2 study of IONIS-FB-LRx in patients with immunoglobulin A nephropathy (IgAN). Based on these results, Roche licensed and plans to advance IONIS-FB-LRx into a Phase 3 study
Bayer reported fesomersen met the primary endpoint in the Phase 2b RE-THINc ESRD study in patients with end-stage renal disease. Fesomersen also demonstrated substantial and statistically significant reductions in Factor XI activity levels
Achieved full enrollment in the Phase 2b study of IONIS-AGT-LRx in patients with treatment-resistant hypertension, with data expected in the second half of 2022
Initiated a Phase 2 study of ION904, a follow-on medicine to IONIS-AGT-LRx in patients with treatment-resistant hypertension
Granted orphan drug designation and rare pediatric disease designation by the FDA for ION582 for the treatment of patients with Angelman syndrome
2022 Pipeline Milestones(2)

Anticipated 2022 Regulatory Updates

All non-GAAP amounts referred to in this press release exclude non-cash compensation expense related to equity awards and the related tax effects. In 2021 all non-GAAP amounts also excluded expenses related to the Akcea Merger and restructured commercial operations and the related tax effects. Please refer to the detailed reconciliation of non-GAAP and GAAP measures, which is provided later in this press release.

The Company’s revenue in the first half of 2022 increased more than 15 percent compared to the same period last year. The increase was driven by significant partner payments Ionis earned across multiple partnered programs, including $37 million from AstraZeneca for its share of the global Phase 3 development costs for eplontersen. Refer to the detailed table of costs and reimbursements for the eplontersen collaboration provided later in this release. The Company also earned $57 million from Biogen for advancing several neurology disease programs and $22 million from Roche for advancing IONIS-FB-LRx. Already in the third quarter of 2022, the Company has earned nearly $45 million from Roche and Biogen.

The Company’s commercial revenue in the first half of 2022 decreased 12 percent compared to the same period last year. SPINRAZA royalties decreased primarily due to competition outside of the U.S. In the U.S., SPINRAZA sales stabilized in the first half of 2022 compared to the same period last year, increasing two percent. TEGSEDI and WAYLIVRA revenue decreased due to the shift from product sales to distribution fees based on net sales generated by Sobi. The Company successfully completed the transition of its TEGSEDI and WAYLIVRA operations in the EU and North America to Sobi in the first and second quarters of 2021, respectively. As part of the transition, Ionis restructured its commercial operations in 2021 resulting in substantial cost savings. These decreases were partially offset by increasing licensing and royalty revenue.

Operating Expenses

Ionis is advancing a large late-stage pipeline and as a result, its non-GAAP operating expenses increased in the first half of 2022 compared to the same period in 2021. Higher R&D expenses were driven by the expanded number of Phase 3 studies the Company is conducting, which doubled from three to six studies in 2021. Lower SG&A expenses were largely due to the substantial savings Ionis achieved from integrating Akcea and restructuring its commercial operations in 2021. Ionis is redeploying these savings to advance its pipeline and go-to-market activities for eplontersen, donidalorsen and olezarsen.

Net Loss

Ionis’ non-GAAP net loss in the first half of 2022 increased compared to the same period in 2021, primarily related to higher R&D expenses, partially offset by higher revenue and lower SG&A expenses, as discussed above.

Balance Sheet

As of June 30, 2022, Ionis had cash, cash equivalents and short-term investments of $2.0 billion, compared with $2.1 billion at December 31, 2021. Ionis’ debt obligations and working capital did not change significantly from December 31, 2021 to June 30, 2022.

Webcast

Ionis will conduct a webcast today at 11:30 a.m. Eastern time to discuss this announcement and related activities. Interested parties may access the webcast here. A webcast replay will be available for a limited time at the same address.

On August 9, 2022 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care, reported financial results for the three and six months ended June 30, 2022 and highlighted recent corporate updates (Press release, Heron Therapeutics, AUG 9, 2022, View Source [SID1234617903]).

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Recent Corporate Updates

Acute Care Franchise

ZYNRELEF:
Net product sales of ZYNRELEF (bupivacaine and meloxicam) extended-release solution for the three and six months ended June 30, 2022 were $2.5 million and $3.6 million, respectively. During the second quarter, ZYNRELEF net product sales grew by 140% over the prior quarter. Heron currently expects third quarter 2022 ZYNRELEF net product sales to increase in the range of 40% to 50% over the prior quarter.
ZYNRELEF end-user (ambulatory surgical centers (ASC) and hospitals) demand unit sales were 12,773 in the second quarter of 2022, representing an increase of 47% over the prior quarter.
During the first year of commercial launch and as of June 30, 2022, 602 unique accounts purchased ZYNRELEF with 84% of those accounts reordering the product.
As of July 31, 2022, ZYNRELEF has received 384 formulary approvals, reflecting a greater than 90% approval rate of formulary evaluations, with an estimated 68% of approvals supporting unrestricted use. Approximately 80 additional formulary review meetings are scheduled for the remainder of 2022.
Effective April 1, 2022, ZYNRELEF became the only local anesthetic separately reimbursed for Medicare patients in the Hospital Outpatient Department (HOPD) setting of care under a 3-year transitional pass-through status. Multiple commercial and Medicaid payers covering over 123 million lives have agreed to reimburse ZYNRELEF outside of the surgical bundle payment for surgeries performed in ASCs, with many of these covered lives also having their hospital outpatient procedures reimbursed outside the surgical bundle payment. Commercial and Medicaid payers represent greater than 80% of our targeted patients in the outpatient setting. Additionally, a specific C-code (C9088) for separate reimbursement in the ASC setting of care has been received.
All clinical studies planned for inclusion in the supplemental NDA to further expand the ZYNRELEF indication to soft tissue and orthopedic procedures are fully enrolled, with submission planned for late 2022.
HTX-019 for Prevention of PONV
Postoperative nausea and vomiting (PONV) represents a significant market opportunity in the acute care setting that leverages our existing sales organization. There are approximately 39 million surgical procedures annually where patients are at risk for PONV.
NDA Submission for HTX-019 for Prevention of PONV in Adults Under Review: A 505(b)(2) New Drug Application (NDA) for HTX-019 for the prevention of postoperative nausea and vomiting (PONV) in adults was submitted to the U.S. Food and Drug Administration (FDA) in November 2021. The FDA accepted the NDA for filing and set a Prescription Drug User Fee Act (PDUFA) goal date of September 17, 2022.
Oncology Care Franchise

2022 Oncology Care Franchise Net Product Sales: For the three and six months ended June 30, 2022, oncology care franchise net product sales were $25.1 million and $47.5 million, respectively, compared to $22.4 million and $42.5 million, respectively, for the same periods in 2021. During the second quarter, Heron’s oncology care franchise net product sales grew by 12% over the prior quarter with continued moderate growth compared to the prior year expected for the remainder of 2022.
CINVANTI Net Product Sales: Net product sales of CINVANTI (aprepitant) injectable emulsion for the three and six months ended June 30, 2022 were $22.7 million and $43.0 million, respectively, compared to $19.7 million and $38.2 million, respectively, for the same periods in 2021.
SUSTOL Net Product Sales: Net product sales of SUSTOL (granisetron) extended-release injection for the three and six months ended June 30, 2022 were $2.4 million and $4.5 million, respectively, compared to $2.7 million and $4.3 million, respectively, for the same periods in 2021.
2022 Oncology Care Franchise Net Product Sales Guidance Increased: Heron currently expects full-year 2022 net product sales for the oncology care franchise of $93 million to $95 million, up from prior guidance of $89 million to $93 million.
Corporate Restructuring and Cost Reduction Plan

In June 2022, we announced a corporate restructuring and cost reduction plan to address the current market dynamics and prepare the company for long-term sustainability. Annualized cost savings the Company expects from this restructuring, improved operating margins and other cost cutting efforts are expected to achieve over $50 million in reductions in annual operating expense in 2023.

The Company’s restructuring and cost reduction plan included the following:

Workforce reduction: The majority of the cost savings will result from a significant workforce reduction across the Company’s research and development organization, with approximately 70% of the total employee reductions coming from research and development. The remaining research and development team will support the label expansion for ZYNRELEF and the HTX-019 NDA for PONV. In total, these actions will result in a reduction of the total Company employee base by 34%.
Streamlined operational expenditures: Includes reductions and reallocations in overall sales, general and administrative expenses, as well as savings related to reduced external spend.
Improved operating margins: Heron has invested heavily in large-scale manufacturing capacity for both CINVANTI and ZYNRELEF, which are both expected to come on-line in 4Q2022. Larger scale production from these efforts should significantly improve cost of goods for both products.
"Our recent private placement financing is another important strategic step for Heron. Along with our restructuring and cost reduction plans, we now believe we have sufficient cash to take us through 2024 and to become cash flow positive," said Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron. "We are also excited to report today strong growth across both our business units, with a 140% increase in net product sales of ZYNRELEF compared to first quarter. We expect continued momentum in the second half of the year as more hospitals switch to ZYNRELEF due to its favorable clinical profile and strong reimbursement. For the oncology care franchise, we are pleased that our portfolio beat our guidance with net product sales of $25.1 million for the second quarter of 2022 and we are on track to achieve full-year 2022 net product sales of $93 million to $95 million, an increase from prior guidance. We look forward to large-scale manufacturing of CINVANTI coming on-line later this year, which is expected to substantially improve margins and drive greater profitability of the oncology care franchise. With recent changes in CMS reimbursement, CINVANTI has the opportunity for continued growth through 2023. Finally, as we near our September PDUFA date, interactions with the FDA regarding our pending NDA for HTX-019 for PONV remain on track."

Financial Results

Net product sales for the three and six months ended June 30, 2022 were $27.6 million and $51.1 million, respectively, compared to $22.4 million and $42.5 million, respectively, for the same periods in 2021.

Heron’s net loss for the three and six months ended June 30, 2022 was $56.4 million, or $0.55 per share, and $120.2 million, or $1.18 per share, respectively, compared to $61.0 million, or $0.62 per share, and $113.6 million, or $1.20 per share, respectively, for the same periods in 2021. Net loss for the three and six months ended June 30, 2022 included non-cash, stock-based compensation expense of $10.4 million and $21.3 million, respectively, compared to $11.2 million and $22.7 million, respectively, for the same periods in 2021.

As of June 30, 2022, Heron had cash, cash equivalents and short-term investments of $83.5 million. Adjusting for net proceeds of $75.2 million from our August 2022 private placement, Heron had pro-forma cash, cash equivalents and short-term investments of $158.7 million. This compares to $157.6 million as of December 31, 2021. Net cash used for operating activities for the three and six months ended June 30, 2022 was $28.4 million and $72.3 million, respectively, compared to $63.0 million and $104.9 million, respectively, for the same periods in 2021. The decrease in our net cash used for operating activities was primarily due to changes in working capital related to the launch of ZYNRELEF, including manufacturing of commercial inventory, partially offset by an increase in net loss.

With the proceeds from the recent private placement, pro-forma cash at the end of second quarter was $158.7 million, which we believe is projected to provide a cash runway through 2024.

Conference Call and Webcast

Heron will host a conference call and webcast on August 9, 2022 at 8:30 a.m. ET. The conference call can be accessed by dialing 1-646-307-1963 for domestic callers and 1-800-715-9871 for international callers. Please provide the operator with the passcode 4215874 to join the conference call. The conference call will also be available via webcast under the Investor Relations section of Heron’s website at www.herontx.com. An archive of the teleconference and webcast will also be made available on Heron’s website for 60 days following the call.

About ZYNRELEF for Postoperative Pain

ZYNRELEF is the first and only dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF was initially approved by the FDA in May 2021 for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. In December 2021, the FDA approved an expansion of ZYNRELEF’s indication. ZYNRELEF is now indicated in the U.S. in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures. In September 2020, the European Commission granted a marketing authorization for ZYNRELEF for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. As of January 1, 2021, ZYNRELEF is approved in 31 European countries including the countries of the European Union and European Economic Area and the United Kingdom. In March 2022, Health Canada issued a Notice of Compliance for ZYNRELEF for instillation into the surgical wound for postoperative analgesia after bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty surgical procedures.

Please see full prescribing information, including Boxed Warning, at www.ZYNRELEF.com.

About HTX-019 for PONV

HTX-019 is an IV injectable emulsion formulation designed to directly deliver aprepitant, the active ingredient in EMEND (aprepitant) capsules, which is the only substance P/neurokinin-1 (NK1) receptor antagonist (RA) to be approved in the U.S. for the prevention of PONV in adults. The FDA-approved dose of oral EMEND is 40 mg for PONV prevention, which is given within 3 hours prior to induction of anesthesia for surgery. In a Phase 1 clinical trial, 32 mg of HTX-019 as a 30-second IV injection was demonstrated to be bioequivalent to oral aprepitant 40 mg. The NDA for HTX-019 for PONV was submitted in November 2021 and the FDA set a PDUFA goal date of September 17, 2022.

About CINVANTI for Chemotherapy Induced Nausea and Vomiting (CINV) Prevention

CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen, delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen, and nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen. CINVANTI is an IV formulation of aprepitant, an NK1 RA. CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND capsules. Aprepitant (including its prodrug, fosaprepitant) is the only single-agent NK1 RA to significantly reduce nausea and vomiting in both the acute phase (0–24 hours after chemotherapy) and the delayed phase (24–120 hours after chemotherapy). The FDA-approved dosing administration included in the U.S. prescribing information for CINVANTI include 100 mg or 130 mg administered as a 30-minute IV infusion or a 2-minute IV injection.

Please see full prescribing information at www.CINVANTI.com.

About SUSTOL for CINV Prevention

SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-hydroxytryptamine type 3 RA that utilizes Heron’s Biochronomer drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL’s efficacy and safety in more than 2,000 patients with cancer. SUSTOL’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0–24 hours after chemotherapy) and delayed phase (24–120 hours after chemotherapy).

On August 9, 2022 Prelude Therapeutics Incorporated (Prelude) (Nasdaq: PRLD), a clinical-stage precision oncology company, reported financial results for the second quarter ended June 30, 2022 and provided an update on recent clinical and development pipeline progress (Press release, Prelude Therapeutics, AUG 9, 2022, View Source [SID1234617902]).

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"We continue to execute on building a deep portfolio of highly differentiated small molecules by delivering an IND submission every 12-18 months. Today, Prelude is pleased to announce the acceptance of our latest IND for PRT3645, a differentiated and highly brain penetrant CDK4/6 inhibitor. We believe PRT3645 has the potential to extend the reach of CDK4/6 inhibition beyond HR+ breast cancers, for which the first generation CDK4/6 inhibitors were approved," said Kris Vaddi, Ph.D., Chief Executive Officer of Prelude. "Our current cash runway is expected to fund our operations into the second half of 2024 enabling us to reach significant pipeline milestones."

Jane Huang, M.D., President and Chief Medical Officer of Prelude, shared "Having multiple programs in clinical development is a clear testament to the strength of Prelude’s drug discovery engine and the research team. It’s now the clinical organization’s responsibility to take these highly potent and selective molecules from our research colleagues and execute efficient clinical trials. By adding a differentiated CDK4/6 inhibitor to our growing clinical portfolio, we strengthen our likelihood of achieving effective treatments for multiple cancers and underserved patient populations."

Recent Highlights and Upcoming Objectives

Brain Penetrant CDK4/6: Phase 1 clinical trial, to begin in Q4, will include select cancer types including sarcomas, P16 mutated mesothelioma, gliomas, HPV negative head and neck cancers and CDK pathway-altered non-small cell lung cancer, in addition to HR+/HER2+ and HR+/HER2- breast cancer with or without brain metastases.

PRMT5 Inhibitor Program: As previously announced, Prelude has prioritized PRT811 for clinical development in select expansion cohorts. Prelude will complete data analyses of the ongoing expansion cohorts and expects to announce next steps for the PRMT5 program in the second half of 2022.

MCL1 Inhibitor Program: Prelude remains on track to begin evaluating combinations with PRT1419 and report early findings by the end of 2022. MCL1 inhibition has potential in hematologic indications such as acute myeloid leukemia, mantle cell lymphoma and chronic lymphocytic leukemia.

CDK9 Inhibitor Program: Prelude remains on track to complete dose escalation and identify a recommended Phase 2 dose for PRT2527 in the upcoming months. CDK9 inhibition has shown strong preclinical activity in both prostate and MYC-amplified solid tumors and hematological malignancies.

SMARCA2/BRM Protein Degrader Program: Prelude remains on track to complete IND-enabling studies and submit an IND application by year-end 2022. SMARCA2 inhibition has the greatest potential in patients with SMARCA4 deficient cancers, including up to 10% of all non-small cell lung cancers.
Second Quarter 2022 Financial Results

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents, and marketable securities as of June 30, 2022, were $246.3 million. Prelude anticipates that its existing cash, cash equivalents and marketable securities will fund Prelude’s operations into the second half of 2024.

Research and Development (R&D) Expenses: For the second quarter of 2022, R&D expense decreased by $1.1 million to $21.3 million for the three months ended June 30, 2022 from $22.4 million for the three months ended June 30, 2021. Included in research and development expenses for the quarter ending June 30, 2022, was $2.5 million of non-cash expense related to stock-based compensation expense, including employee stock options, compared to $2.2 million for the three months ended June 30, 2021. The decrease in research and development expense was primarily due to the wind down of PRT543 clinical development in the PRMT5 programs as we are concentrating further development efforts on our PRT811 candidate in biomarker-selected patients in specific cancer types. We expect our research and development expenses to vary from quarter to quarter, primarily due to the timing of our clinical development activities.

General and Administrative (G&A) Expenses: For the second quarter of 2022, G&A expenses increased to $8.2 million for the three months ended June 30, 2022, from $5.5 million for the three months ended June 30, 2021. Included in the general and administrative expenses for the quarter ended June 30, 2022, was $3.6 million of non-cash expense related to stock-based compensation expense, including employee stock options, as compared to $2.0 million for the same period in 2021. The increase in general and administrative expense was primarily due to an increase in non-cash stock-based compensation expense, and an increase in professional fees as we expanded our operations to support our research and development efforts.

Net Loss: For the three months ended June 30, 2022, net loss was $27.4 million, or $0.58 per share of common stock, basic and diluted compared to $26.9 million, or $0.58 per share, respectively, for the prior year period. Included in the net loss for the quarter ended June 30, 2022, was $6.0 million of non-cash expense related to the impact of expensing share-based payments, including employee stock options, as compared to $4.2 million for the prior year period.

On August 9, 2022 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, 2022 and provided a corporate update (Press release, Intra-Cellular Therapies, AUG 9, 2022, View Source [SID1234617901]).

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"In this quarter, CAPLYTA experienced significant revenue growth, increasing nearly 60% over the first quarter of 2022, driven by strong uptake in bipolar depression. We expect to continue to deliver strong revenue growth throughout 2022 and also look forward to advancing our development programs," said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies.

SECOND QUARTER FINANCIAL HIGHLIGHTS

Total revenues were $55.6 million for the second quarter of 2022, compared to $20.0 million for the second quarter of 2021. Net product revenues of CAPLYTA were $55.1 million for the second quarter of 2022, compared to $19.0 million for the same period in 2021, representing a year-over-year increase of 190% and a 58% increase over the first quarter of 2022.
Cost of product sales were $4.7 million in the second quarter of 2022, compared to $2.0 million for the second quarter of 2021.
Selling, general and administrative (SG&A) expenses were $100.3 million for the second quarter of 2022, compared to $69.9 million for the second quarter of 2021. This increase is primarily due to an increase in marketing and advertising expenses and labor related costs.
Research and development (R&D) expenses for the second quarter of 2022 were $38.5 million, compared to $17.3 million for the second quarter of 2021. This increase is due to higher lumateperone clinical trial and non-clinical related costs and an increase in non-lumateperone project costs.
Net loss for the quarter ended June 30, 2022 was $86.6 million, compared to a net loss of $68.7 million for the quarter ended June 30, 2021.
Cash, cash equivalents, restricted cash and investment securities totaled $679.2 million at June 30, 2022, compared to $413.7 million at December 31, 2021. In January 2022, the Company completed a $460.0 million public offering resulting in net proceeds to the Company of approximately $433.7 million from the sale of 10,952,381 shares of its common stock, after deducting underwriting discounts and commissions and offering expenses.
COMMERCIAL HIGHLIGHTS

Q2 2022 marks the second full quarter of the launch of the CAPLYTA’s bipolar depression indication following U.S. Food and Drug Administration (FDA) approval in late December 2021. CAPLYTA is the first and only FDA-approved treatment for depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults as monotherapy and as adjunctive therapy with lithium or valproate.
The significant launch inflection continued in both new and total prescriptions, reflecting sustained robust growth following approval in bipolar depression. Second quarter CAPLYTA new and total prescriptions increased by 55% and 51%, respectively, versus the first quarter of 2022. Second quarter CAPLYTA new and total prescriptions increased by 225% and 191%, respectively, versus the second quarter of 2021.
Following FDA approval during the second quarter of 2022, two new dosage strengths of CAPLYTA, 10.5 mg and 21 mg, are expected to be available in pharmacies this month. This will expand the patient population who has access to CAPLYTA, specifically for patients taking strong or moderate CYP3A4 inhibitors and patients with moderate or severe hepatic impairment.
CAPLYTA maintained broad coverage in the Medicare Part D and Medicaid channels, with greater than 98% of lives covered and, during the quarter, we further expanded coverage in the Commercial channel to approximately 85% of lives covered. Our LytaLink patient support program continues to be highly effective in supporting patient access.
CLINICAL HIGHLIGHTS

Lumateperone:

Mixed Features program: Patient enrollment is progressing well in Study 403, a global clinical trial evaluating lumateperone 42 mg in patients with major depressive disorder (MDD) and in patients with bipolar depression who exhibit mixed features. The primary endpoint is change from baseline versus placebo on the MADRS total score at week 6, and the CGI-S scale is the key secondary endpoint. We expect to complete clinical conduct in this study in late 2022.
Adjunctive MDD program: Patient enrollment in pivotal global studies 501 and 502 evaluating lumateperone 42 mg as adjunctive treatment to anti-depressants is ongoing. We expect to file a supplemental New Drug Application (sNDA) with the FDA for lumateperone as an adjunctive therapy to antidepressants for the treatment of MDD in 2024.
Presentations: In the second quarter of 2022, there were lumateperone research presentations at the American Psychiatric Association (APA) Meeting, the International Conference for Bipolar Disorders (ISBD) Annual Meeting, the American Society of Clinical Psychopharmacology (ASCP), and the Schizophrenia International Research Society (SIRS). The presentations included additional analyses from our lumateperone bipolar depression program including findings consistent with broad antidepressant effects, marked improvements in patients’ daily functioning, and further evidence of a favorable metabolic profile.

At SIRS, we presented safety analyses from our open-label safety switching study evaluating lumateperone 42 mg in patients with stable schizophrenia. Overall, data from this post-hoc analysis further support the favorable safety and tolerability profile of lumateperone 42 mg in patients with schizophrenia who switched from another antipsychotic, irrespective of the previous antipsychotic. In addition, patients switching from risperidone/paliperidone or olanzapine to lumateperone had significant improvements in cardiometabolic parameters and prolactin concentrations.
Lumateperone Long Acting Injectable (LAI) formulation: We have completed the preclinical development of an LAI formulation, and we have conducted a Phase 1 single ascending dose study with this formulation. This study evaluated the pharmacokinetics, safety and tolerability of lumateperone LAI in patients with stable symptoms of schizophrenia. We are exploring alternate sites of injection with this formulation as well as progressing other formulations. This will assist us in evaluating dosing strategies and formulation for our efficacy studies. The goal of our program is to develop LAI formulations that are effective, safe and well-tolerated with treatment durations of one month and longer.
Other Programs:

ITI-1284-ODT-SL program: ITI-1284 is a deuterated form of lumateperone, a new chemical entity formulated as an oral disintegrating tablet for sublingual administration. We are presently evaluating ITI-1284-ODT-SL in Phase 1 studies including drug-drug interaction studies. We expect to commence clinical conduct in Phase 2 clinical trials in agitation in patients with probable Alzheimer’s disease, in dementia-related psychosis and certain depressive disorders in the elderly in 2023.
Phosphodiesterase type I inhibitor (PDE1) program: We have initiated our Phase 2 clinical program with lenrispodun for Parkinson’s disease and expect to commence patient enrollment in the second half of 2022.

We continue to investigate the anti-cancer effects of PDE1 inhibitors. In April of this year, we presented preclinical data at the AACR (Free AACR Whitepaper) Annual meeting describing the antitumor effects of PDE1 inhibitors, when administered in conjunction with checkpoint inhibitor immunotherapy in an animal model of triple negative breast cancer. We have now shown that our PDE1 inhibitors can potentiate the action of checkpoint inhibitors in various models of colorectal, kidney, breast and glioblastoma cancers. We plan to present additional data from this program at future scientific meetings.
ITI-333 program in Opioid Use Disorder: We continue to advance the development of ITI-333. Following the recent completion of our single ascending dose study, we have commenced a neuroimaging study to investigate brain occupancy for receptors that play a role in substance use disorder and also have applicability for pain. The results of this study will support the dose selection for future studies.
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. The live webcast and subsequent replay may be accessed by visiting the Company’s website at www.intracellulartherapies.com. Please connect to the Company’s website at least 5-10 minutes prior to the live webcast to ensure adequate time for any necessary software download. Alternatively, please call 1-(877) 407-8291 (U.S.) or 1-(201) 689-8345 (international) to listen to the live conference call. Please dial in approximately 10 minutes prior to the call.

CAPLYTA (lumateperone) is indicated in adults for the treatment of schizophrenia and 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:

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.
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:

Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above.
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.
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.
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.
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.
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.
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.
Seizures. CAPLYTA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold.
Potential for Cognitive and Motor Impairment. Patients should use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them.
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.
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. Breastfeeding is not recommended. 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.

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 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 neuropsychiatric and neurological disorders. Lumateperone is not FDA-approved for these disorders.