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Alector Reports Third Quarter 2022 Financial Results and Provides Business Update

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.

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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.

INOVIO Reports Financial Results and Highlights for the Third Quarter 2022

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

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

OPKO Health Reports Third Quarter 2022 Business Highlights and Financial Results

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]).

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.

Athenex to Participate in the 5th Annual Evercore ISI HealthCONx Conference

On November 8, 2022 Athenex (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported that management will participate in the 5th Annual Evercore ISI HealthCONx Conference, taking place virtually November 29 to December 1, 2022 (Press release, Athenex, NOV 8, 2022, https://ir.athenex.com/news-releases/news-release-details/athenex-participate-5th-annual-evercore-isi-healthconx [SID1234623395]).

Dr. Johnson Lau, Chief Executive Officer of Athenex, and Dr. Dan Lang, President of Athenex Cell Therapy, will be participating in a fireside chat on Wednesday, November 30, 2022, beginning at 3:05pm Eastern Time. Athenex management will also be available for one-on-one investor meetings during the event. Please contact your representative at Evercore ISI to schedule a virtual one-on-one meeting with management during the conference.

Kronos Bio Reports Recent Business Progress and Third-Quarter 2022 Financial Results

On November 8, 2022 Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, reported recent business progress and third-quarter 2022 financial results (Press release, Kronos Bio, NOV 8, 2022, View Source [SID1234623394]).

In a press release issued earlier this afternoon, the company announced the prioritization of its clinical portfolio to focus on its next-generation SYK inhibitor, lanraplenib, and its CDK9 inhibitor, KB-0742, and the decision to discontinue the Phase 3 entospletinib trial. Kronos Bio believes that focusing on lanraplenib and KB-0742 will allow the company to direct its resources to the highest value programs and deliver on its mission of bringing cancer drugs to the patients with the greatest need.

Third Quarter and Recent Company Updates

Entospletinib
After a recent review of enrollment data that projected significant delays, Kronos Bio will discontinue the Phase 3 entospletinib trial and close enrollment in the fourth quarter of 2022. The trial is not being discontinued due to adverse events or lack of efficacy signals.
Lanraplenib
The company anticipates sharing initial data from the Phase 1b/2 study of lanraplenib in combination with gilteritinib in patients with relapsed/refractory FLT3-mutated acute myeloid leukemia (AML), along with a recommended Phase 2 dose (RP2D), in the fourth quarter of 2023 or first quarter of 2024.
KB-0742
Kronos Bio remains on track to report pharmacokinetic (PK), pharmacodynamic (PD) and safety data, as well as the RP2D, from the Phase 1/2 study of KB-0742 in solid tumors in the fourth quarter of 2022.
After reaching RP2D, the company plans to enroll two cohorts of patients in the next stage of the trial: patients with MYC-amplified solid tumors and patients with transcriptionally addicted cancers.
Initial KB-0742 efficacy data are anticipated in the second half of 2023.
Third Quarter 2022 Financial Highlights

Cash, Cash Equivalents and Investments: With its ongoing and currently planned clinical programs and $270.3 million in cash, cash equivalents and investments as of September 30, 2022, the company anticipates sufficient resources to fund its planned operations into the second quarter of 2025.

R&D Expenses: Research and development expenses were $23.4 million for the third quarter of 2022, which includes non-cash stock-based compensation expense of $3.5 million.

G&A Expenses: General and administrative expenses were $10.1 million for the third quarter of 2022, which includes non-cash stock-based compensation expense of $4.0 million.

Net Loss: Net loss for the third quarter of 2022 was $32.3 million, or $0.57 per share, including non-cash stock-based compensation expense of $7.5 million.