On November 8, 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 nine months ended September 30, 2022 and highlighted recent corporate updates (Press release, Heron Therapeutics, NOV 8, 2022, View Source [SID1234623401]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Recent Corporate Updates

Acute Care Franchise

ZYNRELEF:
Net product sales of ZYNRELEF (bupivacaine and meloxicam) extended-release solution for the three and nine months ended September 30, 2022 were $2.7 million and $6.3 million, respectively. Net product sales of ZYNRELEF for both the three and nine months ended September 30, 2021 were $2.1 million (ZYNRELEF was launched July 1, 2021). ZYNRELEF end-user (ambulatory surgical centers (ASCs) and hospitals) demand unit sales were 15,077 in the third quarter of 2022, representing an increase of 18% over the prior quarter. Growth has substantially increased in October with weekly average ZYNRELEF demand unit sales increasing 27% over the weekly average in the third quarter. We currently expect fourth quarter 2022 ZYNRELEF net product sales to increase in the range of 30% to 40% over the prior quarter.
Since launch on July 1, 2021 through September 30, 2022, 704 unique accounts purchased ZYNRELEF with 84% of those accounts reordering the product.
All clinical studies planned for inclusion in the supplemental New Drug Application (NDA) to further expand the ZYNRELEF indication to soft tissue and orthopedic procedures are complete, with submission planned for late 2022.
APONVIE:
The APONVIE (aprepitant) injectable emulsion NDA was approved by the U.S. Food and Drug Administration (FDA) on September 16, 2022. We expect to make APONVIE commercially available in the U.S. in the first quarter of 2023.
APONVIE is the only intravenous (IV) substance P/neurokinin-1 (NK1) receptor antagonist (RA) indicated for the prevention of postoperative nausea and vomiting (PONV) in adults.
PONV represents a significant opportunity that leverages our existing sales organization in the acute care setting. There are approximately 36 million surgical procedures annually in patients at moderate to high risk for PONV, where guidelines recommend using multiple agents for prophylaxis.
Oncology Care Franchise

2022 Oncology Care Franchise Net Product Sales: For the three and nine months ended September 30, 2022, oncology care franchise net product sales were $23.9 million and $71.3 million, respectively, compared to $21.1 million and $63.6 million, respectively, for the same periods in 2021.
CINVANTI Net Product Sales: Net product sales of CINVANTI (aprepitant) injectable emulsion for the three and nine months ended September 30, 2022 were $21.2 million and $64.2 million, respectively, compared to $18.0 million and $56.2 million, respectively, for the same periods in 2021.
Validation of large-scale manufacturing of CINVANTI was completed, which will result in a significant reduction in cost of product sales in the fourth quarter of 2022 and beyond.
SUSTOL Net Product Sales: Net product sales of SUSTOL (granisetron) extended-release injection for the three and nine months ended September 30, 2022 were $2.7 million and $7.1 million, respectively, compared to $3.1 million and $7.4 million, respectively, for the same periods in 2021.
2022 Oncology Care Franchise Net Product Sales Guidance: Heron currently expects full-year 2022 net product sales for the oncology care franchise of $93 million to $95 million.
"Approval of APONVIE expands our acute care franchise to cover the two most common concerns of patients and clinicians after surgery, pain and PONV. We are gratified to see improved growth of ZYNRELEF in October following the slower than anticipated growth in the third quarter, which coincided with a greater than 10% decline in indicated surgical procedures," said Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron. "Our oncology care franchise reported solid net product sales of $23.9 million for the third quarter of 2022 and we remain on track to achieve our full-year 2022 guidance of $93 million to $95 million. In addition, we strengthened our balance sheet with a $75 million private placement to advance our commercial franchises and extend our runway against a challenging external backdrop."

Financial Results

Net product sales for the three and nine months ended September 30, 2022 were $26.6 million and $77.6 million, respectively, compared to $23.2 million and $65.7 million, respectively, for the same periods in 2021.

Heron’s net loss for the three and nine months ended September 30, 2022 was $41.9 million, or $0.38 per share, and $162.2 million, or $1.54 per share, respectively, compared to $52.4 million, or $0.51 per share, and $166.0 million, or $1.71 per share, respectively, for the same periods in 2021. Net loss for the three and nine months ended September 30, 2022 included non-cash, stock-based compensation expense of $11.2 million and $32.5 million, respectively, compared to $11.2 million and $34.0 million, respectively, for the same periods in 2021.

As of September 30, 2022, Heron had cash, cash equivalents and short-term investments of $121.7 million, compared to $157.6 million as of December 31, 2021. Net cash used for operating activities for the three and nine months ended September 30, 2022 was $37.1 million and $109.4 million, respectively, compared to $53.2 million and $158.1 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, as well as a decrease in net loss.

Conference Call and Webcast

Heron will host a conference call and webcast on November 8, 2022 at 4:30 p.m. ET. The conference call can be accessed by dialing (646) 307-1963 for domestic callers and (800) 715-9871 for international callers. Please provide the operator with the passcode 4433557 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 APONVIE for PONV

APONVIE (aprepitant) injectable emulsion is a substance NK1 RA, indicated for the prevention of postoperative nausea and vomiting in adults. Delivered via a 30-second intravenous (IV) injection, APONVIE 32 mg was demonstrated to be bioequivalent to oral aprepitant 40 mg with rapid achievement of therapeutic drug levels. APONVIE is the same formulation as Heron’s approved CINVANTI. APONVIE is supplied in a single-dose vial that delivers the full 32 mg dose for PONV. APONVIE was approved by the FDA in September 2022.

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

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 November 8, 2022 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported financial results for the third quarter of 2022, and associated Company developments (Press release, Supernus, NOV 8, 2022, View Source [SID1234623400]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Qelbree Launch Update

Total IQVIA prescriptions were 94,328 in the third quarter of 2022, an increase of 50% compared to total prescriptions of 62,938 in the second quarter of 2022. In September 2022, the most recent month available, total prescriptions reached 34,633.
Qelbree continues to expand its base of prescribers, with approximately 14,265 prescribers in the third quarter of 2022, up from 9,276 prescribers from the second quarter of 2022.
Product Pipeline Update

SPN-830 (apomorphine infusion device) – Continuous treatment of motor fluctuations ("off" episodes) in Parkinson’s disease (PD)

In October 2022, the Company announced the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the SPN-830 New Drug Application (NDA). The CRL does not request additional efficacy and safety clinical studies, but rather requires additional information and analysis related to the infusion device and drug product across several areas of the NDA, including labeling, product quality and manufacturing, device performance and risk analysis. In addition, the FDA mentions that approval of the NDA requires inspections that could not be completed in a timely manner due to COVID-19 travel restrictions. Supernus will continue to work closely with its partners and the FDA to address all questions, and when possible, provide clarity regarding the potential timing of a resubmission of the NDA. The FDA has made an initial determination that the amendment to the Company’s application in response to the CRL will be subject to a Class 2, or six-month, review timeline.
SPN-820 – Novel first-in-class activator of mTORC1

The Phase II multi-center, randomized double-blind placebo-controlled parallel design study of SPN-820 in adults with treatment-resistant depression is ongoing. The study will examine the efficacy and safety of SPN-820 over a course of five weeks of treatment in approximately 270 patients. The primary outcome measure is the change from baseline to end of treatment period on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score, a standard depression rating scale.
SPN-817 – A novel product candidate for the treatment of epilepsy

An open-label Phase II clinical study of SPN-817 in patients with treatment-resistant seizures is expected to start in the fourth quarter of 2022.
Financial Highlights

Net Product Sales

For the three months ended September 30, 2022, net product sales were $172.7 million, a 19% increase over net product sales of $145.5 million for the same period in 2021. For the nine months ended September 30, 2022, net product sales were $485.6 million, an 18% increase over net product sales of $412.5 million for the same period in 2021. The increases in both periods were primarily due to net product sales of GOCOVRI and growth in net product sales of Qelbree and Oxtellar XR.

The following table provides information regarding net product sales during the three and nine months ended September 30, 2022 and 2021 (dollars in millions):

Operating earnings (GAAP and non-GAAP)

For the three months ended September 30, 2022, operating loss (GAAP) was $1.5 million, as compared to operating earnings (GAAP) of $32.6 million for the same period in 2021. For the nine months ended September 30, 2022 operating earnings (GAAP) were $11.8 million, as compared to $79.9 million for the same period in 2021. The decreases in both periods were primarily due to activities to support the launch of Qelbree to the adult population, the Qelbree direct-to-consumer campaign, which substantially occurred in the third quarter of 2022, and amortization of acquired intangible assets from the Adamas Acquisition.

For the three months ended September 30, 2022, adjusted operating earnings (non-GAAP) were $25.4 million, compared to $43.3 million in the third quarter of 2021. For the nine months ended September 30, 2022, adjusted operating earnings (non-GAAP) were $91.1 million, compared to $106.0 million for the same period of 2021.

Reconciliation of GAAP to Non-GAAP Adjustments

An itemized reconciliation between operating earnings on a GAAP basis and operating earnings on a non-GAAP basis is as follows (dollars in millions):

Non-GAAP operating earnings adjusts for non-cash items including amortization of intangible assets, share-based compensation expense, change in fair value of contingent consideration, and depreciation. The increase in amortization of intangible assets for the three and nine months period ended September 30, 2022 was due to the amortization of acquired intangible assets from the Adamas Acquisition in November 2021.

Net earnings (GAAP)

For the three months ended September 30, 2022, net earnings (GAAP) and diluted earnings per share (GAAP) were $1.7 million and $0.03, respectively, as compared to $21.6 million, or $0.40 per diluted share, in the same period in 2021.

For the nine months ended September 30, 2022, net earnings (GAAP) and diluted earnings per share (GAAP) were $35.2 million and $0.62, respectively, as compared to $51.0 million, or $0.94 per diluted share, in the same period in 2021.

Cash, cash equivalents and marketable securities

At September 30, 2022, the Company’s cash, cash equivalents, current and long-term marketable securities are approximately $523.7 million, compared to $458.8 million as of December 31, 2021. This increase was primarily due to cash generated from operations.

Full Year 2022 Financial Guidance (GAAP)

For full year 2022, the Company is raising the midpoint and narrowing the expected ranges of full year 2022 financial guidance for total revenues and operating earnings (GAAP). The Company’s revised full-year 2022 financial guidance is set forth below (dollars in millions):

Full Year 2022 Financial Guidance – GAAP to Non-GAAP Adjustments

An itemized reconciliation between projected operating earnings on a GAAP basis and projected operating earnings on a non-GAAP basis is as follows (dollars in millions):

Non-GAAP Financial Information

This press release contains a financial measure, non-GAAP operating earnings, which does not comply with United States generally accepted accounting principles (GAAP). The non-GAAP financial measure should be considered in addition to, not as a substitute for or in isolation from, or superior to measures prepared in accordance with GAAP. Non-GAAP operating earnings adjusts for non-cash share-based compensation expense, depreciation and amortization, and accretion of contingent consideration, and for factors that are unusual, non-recurring or unpredictable, and excludes those costs, expenses, and other specified items presented in the reconciliation tables in this press release. We believe the use of non-GAAP operating earnings is useful supplemental information to investors regarding the Company’s results of operations and assist management, analysts, and investors in evaluating the performance of the business. There are limitations associated with the use of non-GAAP financial measures. Including such measures may not be entirely comparable to similarly titled measures used by other companies, may not reflect all items of income and expense, as applicable, that affect our operations, potential differences among calculation methodologies, may differ from the non-GAAP information used by other companies, including peer companies, and therefore comparability may be limited. We mitigate these limitations by reconciling the non-GAAP financial measure to the most comparable GAAP financial measure. Investors are encouraged to review the reconciliation. The Company’s 2022 financial guidance is also being provided on both a reported and a non-GAAP basis.

Conference Call Details

Supernus will host a conference call and webcast today, November 8, 2022, at 4:30 p.m. Eastern Time to discuss these results. A live webcast will be available in the Events & Presentations section of the Company’s Investor Relations website www.supernus.com/investors.

Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.

Following the live call, a replay will be available on the Company’s Investor Relations website www.supernus.com/investors. The webcast will be available on the Company’s website for 60 days following the live call.

On November 8, 2022 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology and innate immuno-oncology, reported third quarter 2022 financial results and recent portfolio and business updates (Press release, Alector, NOV 8, 2022, View Source [SID1234623399]). As of September 30, 2022, Alector’s cash, cash equivalents and investments totaled $758.3 million.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Commentary on the Quarter:

"In the third quarter, we expanded our first-in-class clinical immuno-neurology pipeline with AL044, a biologic targeting MS4A, a brain immune checkpoint molecule and a genetic risk factor for Alzheimer’s disease. We also continued to advance our INFRONT-3 Phase 3 pivotal study of latozinemab for frontotemporal dementia with progranulin mutations, or FTD-GRN, and our INVOKE-2 Phase 2 Alzheimer’s disease study with AL002, which activates TREM2 receptor signaling," said Arnon Rosenthal, Ph.D., Chief Executive Officer of Alector. "We will be reporting new data from the Phase 1 study of AL101 later this year at CTAD in addition to follow-up data from the INFRONT-2 Phase 2 trial in patients with symptomatic FTD-C9orf72 in 2023."

"We anticipate biomarker data from the AL044 healthy volunteer study and completion of enrollment in our INVOKE-2 study in 2023. We believe that our immuno-neurology drug candidates, which are designed to regulate key aspects of microglial proliferation, survival, migration, lysosomal function and immune response, could prove important in effectively treating neurodegeneration either as stand-alone therapies or potentially in combination with anti-beta amyloid drugs."

Sara Kenkare-Mitra, Ph.D., President and Head of Research and Development at Alector, added, "Our immuno-oncology pipeline continues to advance as well. We remain on track to submit an IND for AL009, Alector’s first-in-class multi-Siglec inhibitor, by the end of the year."

"We are also thrilled to have expanded our talented leadership team over the past quarter as we welcomed Peter Heutink, Ph.D., as Chief Scientific Officer," said Dr. Kenkare-Mitra. "Peter’s expertise in the human genetics of neurodegenerative disease is important to our efforts at Alector."

Clinical Programs

Immuno-Neurology Portfolio
Progranulin Assets (Latozinemab, AL101)

Enrollment is ongoing globally in the INFRONT-3 randomized, placebo-controlled, pivotal Phase 3 trial evaluating the efficacy and safety of latozinemab (AL001) in at-risk and symptomatic patients with FTD-GRN. The first patient has been enrolled in the open-label extension study.

The company expects to report follow-up data from the INFRONT-2 Phase 2 clinical trial of latozinemab in frontotemporal dementia patients with a C9orf72 genetic mutation (FTD-C9orf72) in 2023.

Alector will present a poster, Repeat IV and SC dosing of the Anti-Sortilin Antibody AL101, with data from the Phase 1 trial of AL101 in healthy volunteers at the 15th Clinical Trials on Alzheimer’s Disease (CTAD) conference, being held in San Francisco, California from November 29 to December 2, 2022. AL101 is intended to elevate progranulin levels in a manner similar to latozinemab, and the company plans to investigate AL101 for the treatment of Alzheimer’s disease (AD) and Parkinson’s disease (PD).

Latozinemab and AL101 are being developed in collaboration with GSK.
TREM2 Asset (AL002)

Enrollment in the INVOKE-2 Phase 2 study of AL002 continues. The INVOKE-2 Phase 2 clinical trial is designed to evaluate the efficacy and safety of AL002 in slowing disease progression in individuals with early AD. AL002 is being developed in collaboration with AbbVie and targets Triggering Receptor Expressed on Myeloid cells 2 (TREM2) to increase TREM2 signaling and the functionality of microglia, which are brain-specific immune cells.
Novel MS4A Asset (AL044)

The company commenced its first-in-human Phase 1 trial of AL044, the first clinical-stage drug candidate to target MS4A, a major genetic risk factor for AD and an immune checkpoint expressed on microglia. The study, initiated in September of this year, is investigating the safety profile, pharmacokinetics (PK), pharmacodynamics (PD) and target engagement of AL044 in healthy adults. Safety and biomarker data from this study are anticipated in 2023. The company views MS4A as a master inhibitory checkpoint for the brain’s immune system and believes its inhibition will activate microglia in a disease-selective manner to broadly counteract Alzheimer’s disease and potentially orphan neurodegenerative indications.
Immuno-Oncology Portfolio
Multi-Siglec and SIRPα Assets (AL009, AL008)

Alector anticipates submitting an IND for its AL009 innate immuno-oncology program before the end of the year. The company will present a poster, Characterization of suppressive myeloid cells in solid tumors to refine disease selection in a Phase 1 study of the multi-Siglec inhibitor AL009, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting being held in Boston, Massachusetts and virtually from November 8 to 12, 2022. AL009 is a dual function biologic that inhibits multiple Siglec receptors on myeloid cells and simultaneously activates a stimulating receptor on the same cells. The company plans to prioritize tumor types that have immunosuppressive phenotypes and expects to study AL009 as a monotherapy and in combination with standard of care.
The company plans to utilize data and documentation from a regulatory filing previously submitted by Innovent to Chinese authorities for AL008 to support a potential IND submission in the U.S. AL008 is a novel innate immuno-oncology candidate with a dual mechanism of action, targeting SIRP-alpha (SIRPα) to inhibit the CD47- SIRPα pathway and activating Fc receptors to promote immuno-stimulatory pathways that drive anti-tumor immunity.
Recent Corporate Updates

Peter Heutink, Ph.D., began his role as Alector’s Chief Scientific Officer in October. Leveraging nearly 30 years of experience in the neurodegenerative disease space, Dr. Heutink provides scientific oversight of the company’s significant research pipeline and helps drive business strategy.
Third Quarter 2022 Financial Results

Revenue. Collaboration revenue for the quarter ended September 30, 2022, was $14.9 million, compared to $182.4 million for the same period in 2021. The decrease of $167.6 million was due to $173.4 million collaboration revenue recognized from AL001 FTD-GRN license provided as part of the GSK Agreement in 2021.

R&D Expenses. Total research and development expenses for the quarter ended September 30, 2022, were $48.3 million, compared to $43.1 million for the quarter ended September 30, 2021. The increase in R&D expenses was mainly driven by increased personnel-related expenses as well as an increase in AL002 expenses.

G&A Expenses. Total general and administrative expenses for the quarter ended September 30, 2022, were $14.3 million, compared to $13.0 million for the same period in 2021. The increase is primarily due to personnel-related expenses.

Net Income (Loss). For the quarter ended September 30, 2022, Alector reported net loss of $46.1 million, or $0.56 net loss per share, compared to a net income of $126.6 million, or $1.56 net income per share, for the same period in 2021.

Cash Position. Cash, cash equivalents, and investments were $758.3 million as of September 30, 2022. Management anticipates that this will be sufficient to fund current operations through 2024.

On November 8, 2022 INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and prevent infectious diseases, cancer, and diseases associated with HPV, reported financial results for the quarter and nine months ended September 30, 2022 (Press release, Inovio, NOV 8, 2022, View Source [SID1234623397]). INOVIO’s management will host a live conference call and webcast at 4:30 p.m. Eastern Time today to discuss financial results and provide a general business update for the third quarter. The live webcast and replay may be accessed by visiting INOVIO’s website at View Source

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Jacqueline Shea, INOVIO’s President and Chief Executive Officer, said, "INOVIO continues to implement its strategy of delivering the potential of DNA medicines to patients, focusing its resources on those candidates that have the greatest opportunity for near-term success. In the third quarter, INOVIO announced positive Phase 1/2 data for INO-3107, a promising DNA medicine candidate as a potential treatment for recurrent respiratory papillomatosis. These results are exciting to us because they build upon our ongoing work indicating that DNA medicines have the potential to treat HPV-associated diseases. We are also encouraged by other candidates in our pipeline, such as INO-5401, which has also shown positive results this year as a potential treatment for glioblastoma. We look forward to continuing to advance these programs as well as other pipeline programs for which we continue to anticipate data announcements in the coming months."

Dr. Shea continued: "In the third quarter, we also continued our efforts to create a more focused company rooted in operational excellence and optimized capital and resource allocation. Our decision to discontinue our internally funded development of INO-4800 as a heterologous COVID-19 booster is in line with this strategy and we will deploy cost savings from this effort to the development of other promising candidates. We will also leverage the strengths and capabilities developed by our COVID-19 program across our portfolio, where appropriate, such as our new intradermal 3PSP investigational delivery device."

Recent Corporate Highlights

Positive Phase 1/2 Trial Results INO-3107 – In the third quarter, INOVIO announced positive interim Phase 1/2 results for INO-3107 in participants with recurrent respiratory papillomatosis (RRP). In the open-label, multicenter trial (NCT:04398433), INO-3107 demonstrated statistical significance based on the clinical endpoint of a reduction in the number of RRP surgical interventions in the year following administration of INO-3107 compared with the year prior to treatment, in an initial cohort of 21 participants. In the trial, there was a median decrease of three (3) surgical interventions. (95% confidence interval 1, 3). In addition, 16 of 21 (76%) participants in the trial experienced a decrease in the number of surgical interventions in the year following administration of INO-3107 relative to the number of surgeries in the year prior to the trial. Of those 16 participants, six (29%) required no surgical intervention during the 52-week trial period.

In the trial, treatment with INO-3107 induced cellular responses against both HPV 6 and HPV 11, inducing both CD4 and CD8 T cells. T-cell responses were still observed at Week 52, indicating a persistent cellular memory response.

INO-3107 demonstrated a favorable safety and tolerability profile in the trial. Results from the second cohort of 11 participants are expected in the first half of 2023.

Internally Funded Development of INO-4800 Heterologous Boost Trials Discontinued – In October, INOVIO announced that following a comprehensive review of its portfolio, market conditions, and global demand for COVID-19 vaccines, it had discontinued internally-funded efforts to develop INO-4800 as a COVID-19 heterologous booster vaccine. INOVIO’s efforts towards the global COVID-19 pandemic response will continue through its participation in the Solidarity Trial Vaccines (STV) sponsored by the World Health Organization (WHO) and its preclinical work on a pan-COVID vaccine candidate. In addition, INOVIO’s partner Advaccine will continue to develop INO-4800 as a heterologous booster vaccine using its own resources. Future updates related to this trial will be provided by Advaccine.

Third Quarter 2022 Financial Results

As of September 30, 2022, cash and cash equivalents and short-term investments were $281.9 million compared to $401.3 million as of December 31, 2021. As of September 30, 2022, INOVIO had 249.5 million common shares outstanding and 268.7 million common shares outstanding on a fully diluted basis, after giving effect to the exercise, vesting, and conversion, as applicable, of its outstanding options, restricted stock units, convertible preferred stock, and convertible debt.

INOVIO reported total revenue of $9.2 million for the three months ended, September 30, 2022, compared to $292,000 for the same period in 2021. The increase in revenue resulted from the fulfillment of obligations under its contract with the U.S. Department of Defense. Total operating expenses were $44.9 million compared to $60.2 million for the same period in 2021.

INOVIO’s net loss for the quarter ended September 30, 2022, was $37.8 million, or $0.15 per basic and diluted share, compared to net loss of $60.2 million, or $0.29 per basic and diluted share, for the quarter ended September 30, 2021.

Operating Expenses

Research and development (R&D) expenses for the three months ended September 30, 2022, were $33.1 million compared to $47.1 million for the same period in 2021. The decrease in R&D expenses was primarily related to lower drug manufacturing, outside services and clinical study expenses related to INO-4800 and VGX-3100, and lower engineering services and expensed equipment related to our CELLECTRA 3PSP device array automation project. These decreases were offset by $8.2 million lower contra-research and development expenses recorded from grant agreements, among other variances.

General and administrative (G&A) expenses were $11.8 million for the three months ended September 30, 2022, versus $13.2 million for the same period in 2021. The decrease in G&A expenses was primarily related to a decrease in employee and consultant non-cash stock-based compensation, among other variances.

INOVIO’s balance sheet and statement of operations are provided below. Additional information is included in INOVIO’s quarterly report on Form 10-Q for the quarter ended September 30, 2022, which can be accessed at: View Source

Financial Guidance

INOVIO is updating its prior guidance and now expects its cash runway to extend into the first quarter of 2025. This projection includes its cash burn estimate of approximately $45 million for the fourth quarter of 2022 and its ongoing expectation that cash burn will decrease incrementally from there into the first quarter of 2025. These projections do not include any funds that may be raised through the Company’s existing at-the-market program or other capital-raising activities.

Conference Call / Webcast Information

INOVIO’s management will host a live conference call and webcast at 4:30 p.m. ET today to discuss INOVIO’s financial results and provide a general business update. The live webcast and replay may be accessed by visiting INOVIO’s website at View Source

On November 8, 2022 OPKO Health, Inc. (NASDAQ: OPK) reported that business highlights and financial results for the three months ended September 30, 2022 (Press release, Opko Health, NOV 8, 2022, View Source [SID1234623396]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Business highlights for the third quarter of 2022 and subsequent weeks include the following:

Pfizer’s NGENLA (somatrogon) launched in Japan, Germany and other global markets; Pfizer seeking pricing approvals in additional European countries and continuing to work with FDA to obtain approval in the U.S. NGENLA treats pediatric patients with decreased growth due to insufficient growth hormone and reduces the injection frequency from once daily to once weekly. NGENLA is the first once weekly product approved for the treatment of pediatric growth hormone deficiency in Japan, Canada, Australia, Taiwan, UAE and Brazil. Its European Union marketing authorization is valid in all EU Member States as well as Iceland, Norway and Liechtenstein. In Australia, NGENLA is now offered through the Pharmaceutical Benefits Scheme, Australia’s national drug subsidy program.

ModeX Therapeutics, Inc. (ModeX) progresses proprietary immunotherapy pipeline. ModeX continues to advance its pipeline of antiviral and immune-oncology products utilizing its next generation multispecific antibodies. In addition, ModeX is pursuing potential licensing and collaboration arrangements with strategic partners for certain of its early stage pipeline candidates.

Innovation and cost cutting efforts continue at BioReference Laboratories (BRL). BRL continues significant cost reduction and business rationalization efforts following the decline of COVID testing volume. These efforts have resulted in a reduction of more than $100 million in annualized costs to date. Furthermore, BRL is exploring other revenue sources to work toward returning BRL to profitability.
Third Quarter Financial Results

Pharmaceuticals: Revenue in the third quarter of 2022 decreased to $32.4 million from $36.9 million in the third quarter of 2021, driven by foreign currency exchange and lower sales of RAYALDEE. During the third quarter of 2022, OPKO received gross profit share and royalty payments from Pfizer related to sales of NGENLA. We expect these payments to increase as Pfizer receives additional pricing approvals and launches the product in other geographies. Revenue from sales of RAYALDEE in the third quarter of 2022 was $6.9 million compared with $8.5 million in the prior-year period; however, we also began to receive royalty payments from sales of RAYALDEE by CSL Vifor in Germany and Switzerland during the third quarter of 2022. We expect these payments to increase as CSL Vifor launches RAYALDEE in additional territories throughout Europe. There were several significant events that positively impacted third quarter 2021 results, and should be considered when comparing those results to 2022. Revenue from the transfer of intellectual property was $4.5 million in the third quarter of 2022 compared with $8.8 million in the 2021 period. The third quarter of 2021 also included $4.9 million related to an exclusive license agreement with CAMP4 Therapeutics Corp. and $1.0 million due to the joint venture with LeaderMed Health Group Ltd. Total costs and expenses were $65.2 million in the third quarter of 2022 compared with $17.0 million in the prior-year period, which included a $31.5 million gain on the sale of OPKO’s fill-finish manufacturing facility in Ireland to Horizon Therapeutics. In addition, the increase in total costs and expenses in the third quarter of 2022 was primarily attributable to higher amortization expenses related to the reclassification of NGENLA’s in-process research and development upon its approval in Europe and Japan, higher employee expenses associated with the ModeX acquisition and higher research and development costs for somatrogon, partially offset by foreign currency exchange. The operating loss of $28.3 million in the third quarter of 2022 compared to operating income of $28.6 million in the third quarter of 2021 reflects these events.

Diagnostics: Revenue from services in the third quarter of 2022 was $142.8 million compared with $340.1 million in the prior-year period, the decrease primarily due to lower COVID-19 testing volume. BRL processed approximately 0.2 million COVID-19 PCR tests in the third quarter of 2022 versus 2.2 million tests in the third quarter of 2021. Total costs and expenses were $192.3 million in the third quarter of 2022 compared with $320.5 million in the third quarter of 2021, resulting in an operating loss of $49.5 million compared with operating income of $19.7 million in the 2021 period. BRL continues to implement significant cost-reduction initiatives and scaled back digital health investments as it looks to return to profitability following the buildup and then decline of COVID-related testing. The third quarter of 2022 included $5.1 million in severance costs as the company reduced employee costs on an annualized basis by over $46 million.

Consolidated: Consolidated total revenues for the third quarter of 2022 were $179.7 million compared with $385.8 million for the comparable period of 2021. Operating loss for the third quarter of 2022 was $87.8 million compared with operating income of $37.8 million for the 2021 quarter. Net loss for the third quarter of 2022 was $86.1 million, or $0.11 per share, compared with net income of $28.7 million, or $0.04 per diluted share, for the 2021 quarter. Net loss for the third quarter of 2022 included a non-cash expense of $30.6 million due to a decrease in the fair value of OPKO’s Sema4 investment, while the comparable quarter of 2021 included a $31.5 million gain on the sale of the facility in Ireland.

Cash and cash equivalents: Cash and cash equivalents were $180.8 million as of September 30, 2022.
Conference Call and Webcast Information

OPKO’s senior management will provide a business update, discuss third quarter financial results and answer questions during a conference call and live audio webcast today beginning at 4:30 p.m. Eastern time. Participants are encouraged to pre-register for the conference call using this link. Callers who pre-register will receive a unique PIN to gain immediate access to the call and bypass the live operator. Participants may register at any time, including up to and after the call start time. Those unable to pre-register may participate by dialing (833) 630-0584 (U.S.) or (412) 317-1815 (International). A webcast of the call can also be accessed at OPKO’s Investor Relations page and here.

A telephone replay will be available until November 15, 2022 by dialing (877) 344-7529 (U.S.) or (412) 317-0088 (International) and providing the passcode 5757952. A webcast replay will be available beginning approximately one hour after the completion of the live conference call here.