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Alkermes Announces Receipt of Notices of Partial Termination From Janssen Pharmaceutica

On November 8, 2021 Alkermes plc (Nasdaq: ALKS) reported that it received notices of partial termination (the "Notices") in respect of two license agreements with Janssen Pharmaceutica N.V. ("Janssen"), a subsidiary of Johnson & Johnson and, under these agreements, a licensee and recipient of Alkermes’ nanoparticulate formulation technology, known as NanoCrystal technology (Press release, Alkermes, NOV 8, 2021, View Source [SID1234594698]). The terminations impact know-how royalties related to sales of long-acting paliperidone products, such as INVEGA SUSTENNA and INVEGA TRINZA, and other products in the United States. Pursuant to the agreements, the partial termination is to become effective three months from the date of receipt of the Notices. Janssen maintains that it has not utilized, and does not utilize, Alkermes’ NanoCrystal technology licensed under the agreements. Alkermes strongly disagrees with Janssen’s position and will explore all options at its disposal to enforce its contractual rights and address any unauthorized use of its intellectual property.

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"For years, Janssen has highlighted the use of our NanoCrystal technology in its long-acting INVEGA products and has paid us know-how royalties consistent with this fact. We are not aware of any changes that have occurred to these products that would have altered their use of our intellectual property. We will continue our efforts to engage with Janssen to explore if a mutually agreeable resolution can be reached and will consider all options to enforce our contractual and intellectual property rights," said Richard Pops, Chief Executive Officer of Alkermes. "Over the last several years, we have been engineering the business to become less reliant on revenues from partnered products. For the expected growth drivers within our commercial portfolio – LYBALVI, ARISTADA, VIVITROL and VUMERITY – nothing has changed. We are energized by the opportunities in our pipeline and remain focused on advancing the assets that we believe will drive the future growth of the business and value for our shareholders."

"With the exception of VUMERITY, royalty revenue streams have become less core to Alkermes’ growth. We had been planning for a wind down of the Janssen royalty payments in the coming years and, while the potential earlier loss of these royalty streams will adversely impact our cash flow over the next few years, our long-term outlook remains unchanged," stated Iain Brown, Chief Financial Officer of Alkermes. "We do not expect any impact on our 2021 financial results related to these events. As we look ahead to 2022, we will incorporate any necessary changes from these developments when we provide our financial expectations for the year in February. We will continue to focus on driving operational efficiencies and managing expenses across the business, and we believe we are well-positioned to advance our business objectives and drive profitable growth in the business in the long-term."

Conference Call

Alkermes will host a conference call and webcast at 5:00 p.m. ET (10:00 p.m. GMT) on Monday, Nov. 8, 2021. The webcast may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call may be accessed by visiting Alkermes’ website.

Alector to Present at the Stifel 2021 Virtual Healthcare Conference

On November 8, 2021 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported that Arnon Rosenthal, Ph.D., Chief Executive Officer of Alector, will participate in a fireside chat at the Stifel 2021 Virtual Healthcare Conference on Monday, November 15, 2021, at 2:00 p.m. ET (Press release, Alector, NOV 8, 2021, View Source [SID1234594697]).

A live webcast of the fireside chat will be available on the "Events & Presentations" page within the Investors section of the Alector website at View Source A replay will be available on the Alector website for 90 days following the event.

Akoya Reports Third Quarter 2021 Financial Results and Issues Full Year 2021 Guidance

On November 8, 2021 Akoya Biosciences, Inc. (Nasdaq: AKYA) ("Akoya"), The Spatial Biology Company, reported its financial results for the third quarter ending September 30, 2021 (Press release, Akoya Biosciences, NOV 8, 2021, View Source [SID1234594696]).

"Our strong performance in the third quarter shows that we have great momentum in all phases of our business," said Brian McKelligon, Chief Executive Officer, Akoya Biosciences. "We generated strong quarterly revenue, and with over 650 installed instruments worldwide, we are a leader in the fast-growing spatial biology market. We continue to see robust growth and interest in our platforms from discovery to translational and clinical research. We also made key additions to our management team and Board of Directors, as we continue to attract industry leaders to help drive our business forward. Expansion in our commercial and R&D organizations will help drive product development and growth, while CLIA certification for our ABS lab, which is expected before year-end, will enhance our ability to support larger and later stage clinical trials."

Third Quarter Financial Highlights

Total revenue was $13.5 million in the third quarter of 2021, compared to $10.0 million in the prior year period; an increase of 35%.
Product revenue was $10.9 million in the third quarter of 2021, compared to $7.9 million in the prior year period; an increase of 38%.
Services and other revenue totaled $2.6 million in the third quarter of 2021, compared to $2.1 million in the prior year period.
Gross profit was $8.5 million in the third quarter of 2021, compared to $6.0 million in the prior year period; an increase of 42% and gross profit margin was 62.7% for the current quarter.
33 instruments were sold in the third quarter of 2021; 16 CODEX, 17 Phenoptics (includes Polaris, Vectra, and Mantra).
Instrument installed base of 651 as of September 30, 2021; CODEX 161, Phenoptics 490.
Year to date Financial Highlights

Total revenue was $38.8 million YTD, compared to $29.5 million in the prior year period; an increase of 31%.
Product revenue was $31.6 million YTD, compared to $23.0 million in the prior year period; an increase of 37%.
Services and other revenue totaled $7.2 million YTD, compared to $6.6 million in the prior year period.
Gross profit was $24.0 million YTD, compared to $18.0 million in the prior year period; an increase of 33% and gross profit margin was 61.9%.
101 instruments were sold YTD; 49 CODEX, 52 Phenoptics (includes Polaris, Vectra, and Mantra).
Third Quarter Business Highlights

$13.5 million for the third quarter of 2021 is the highest quarterly revenue number in Akoya history.
As of September 30, 2021, through the first nine months of the year, there have been 192 publications featuring the Akoya platform, compared with 109 for calendar year 2020.
Announced the inaugural members of the Akoya Imaging Innovators (I2) Network, a collaboration of pioneering scientists from world-class research organizations, with ambitions to advance the field of spatial biology by exploring novel approaches using Akoya’s CODEX platform for single-cell spatial phenotyping and analysis.
Appointment of Myla Lai-Goldman, MD to our Board of Directors, a visionary and seasoned executive in the diagnostics industry with over 30 years of leadership experience in diagnostic research and development, as well as commercialization, at innovative organizations.
Appointment of Pascal Bamford, PhD as Executive Vice President of R&D, a pioneer in genomic clinical and diagnostic testing who brings deep scientific and operational experience leading teams in developing and implementing successful innovative digital pathology products and cloud-based analysis platforms.
$120.2 million of cash and cash equivalents as of September 30, 2021, providing for sufficient runway to make key investments in the business.
2021 Guidance

Akoya expects fourth quarter revenue of at least $15 million, and full year revenue of at least $53.8 million. Full year guidance has been increased from the prior guidance which had a range of $52.5 million to $53.0 million.

Webcast and Conference Call Details

Akoya will host a conference call today, November 8, 2021, at 5:00 p.m. Eastern Time to discuss its third quarter 2021 financial results. The dial-in numbers are (833) 562-0146 for domestic callers or (661) 567-1226 for international callers, followed by Conference ID: 6875504. A live webcast of the conference call will be available on the "Investors" section of the Company’s website at View Source The webcast will be archived on the website following the completion of the call for three months.

Chinook Therapeutics Provides Business Update and Reports Third Quarter 2021 Financial Results

On November 8, 2021 Chinook Therapeutics, Inc. (Nasdaq: KDNY), a biopharmaceutical company focused on the discovery, development and commercialization of precision medicines for kidney diseases, reported financial results for the third quarter ended September 30, 2021 (Press release, Aduro Biotech, NOV 8, 2021, View Source [SID1234594695]).

"During the third quarter of 2021, we focused on execution and advancement of our lead clinical programs, atrasentan and BION-1301 for IgA nephropathy, a serious progressive disease for which there are no approved therapies. We are advancing enrollment in the ALIGN and AFFINITY studies of atrasentan, and the data we recently presented at ASN from the ongoing phase 1/2 study of BION-1301 in patients with IgAN shows consistent mechanistic biomarker responses and clinically meaningful reductions in proteinuria within three months of initiating treatment, demonstrating its potential as a novel disease-modifying therapy," said Eric Dobmeier, president and chief executive officer of Chinook Therapeutics. "We’re enthusiastic about the potential of precision medicine to provide new treatments for kidney disease, and we look forward to continuing to advance our other pipeline programs, including initiating a phase 1 study of CHK-336 next year and making progress on our research and discovery programs."

Atrasentan

Atrasentan is a potent and selective endothelin A (ETA) receptor antagonist that has the potential to provide benefit in multiple chronic kidney diseases by reducing proteinuria and having direct anti-inflammatory and anti-fibrotic effects to preserve kidney function. The phase 3 ALIGN trial of atrasentan is currently enrolling patients with IgAN, and the phase 2 AFFINITY basket trial of atrasentan is currently enrolling patients with proteinuric glomerular diseases.

Enrollment of the phase 3 ALIGN trial of atrasentan continues to progress with the activation of new trial sites and expansion into additional countries. Chinook expects to report topline data from the six-month interim proteinuria endpoint analysis in 2023 to support an application for accelerated approval under Subpart H in the U.S.

Chinook continues to enroll all four cohorts of the phase 2 AFFINITY basket trial, including patients with lower proteinuria IgAN (between 0.5 and 1.0 g/day), focal segmental glomerulosclerosis (FSGS), Alport syndrome and diabetic kidney disease in combination with SGLT2 inhibitors. Chinook expects to present data from the IgAN patient cohort of this study in the first half of 2022, with data from one or more additional cohorts expected in the second half of 2022.

Several abstracts on atrasentan were delivered as poster presentations at ASN Kidney Week 2021, including:

Data demonstrating endothelin pathway activation in the kidneys of patients with IgAN has a strong association with clinical progression. Atrasentan was also shown to inhibit endothelin-1 mediated transcriptional networks, including cell proliferation, inflammation and fibrosis in human mesangial cells. This translational research was conducted in collaboration with the laboratory of Matthias Kretzler, M.D., Professor of Nephrology and Professor of Computational Medicine & Bioinformatics at University of Michigan Medical School, and supports the therapeutic potential of ETA receptor blockade with atrasentan in patients with IgAN at high risk of progression.
Analysis of three separate single-dose, randomized phase 1 studies of atrasentan demonstrated consistent and predictable safety, tolerability and pharmacokinetic profiles in healthy Chinese, Japanese and North American adults of non-Asian descent. The consistent profile of atrasentan across these ethnicities and geographic regions, supports the inclusion of patients with IgAN in Asia, where there is an increased prevalence and potentially accelerated disease progression, in the ongoing global phase 3 ALIGN study.
BION-1301

BION-1301 is a novel anti-APRIL monoclonal antibody currently in phase 1/2 development for patients with IgAN. BION-1301’s potentially disease-modifying approach to treating IgAN by reducing circulating levels of galactose-deficient IgA1 (Gd-IgA1) has been demonstrated preclinically as well as clinically in both healthy volunteers and patients with IgAN.
Chinook completed enrollment of Cohort 1 of Part 3 of the ongoing phase 1/2 study of BION-1301 and presented additional patient data and follow-up from this cohort at ASN Kidney Week 2021, indicating BION-1301 was well-tolerated and caused durable reductions in Gd-IgA1, IgA, IgM, and to a lesser extent, IgG levels in patients with IgAN. BION-1301 demonstrated a greater than 50% geometric mean reduction in 24-hour urine protein creatinine ratio (UPCR) after three (n=6) to six (n=4) months of treatment, with further reductions in two patients through one year of treatment.
Chinook recently initiated enrollment of Cohort 2 of Part 3 of the ongoing phase 1/2 study of BION-1301. Patients in Cohort 2 will receive a subcutaneous dose of 600 mg of BION-1301 every two weeks for up to 52 weeks.
Chinook expects to present additional data from the ongoing phase 1/2 trial of BION-1301 in patients with IgAN and provide an update on planned later-stage clinical trials of BION-1301 in the first half of 2022.
CHK-336

CHK-336 is an oral small molecule lactate dehydrogenase A (LDHA) inhibitor with liver-targeted tissue distribution that Chinook is developing for the treatment of patients with primary hyperoxaluria, secondary hyperoxaluria due to increased endogenous oxalate production and idiopathic stone formation.
Chinook has completed IND-enabling toxicology studies and is advancing CHK-336 towards IND submission and initiation of a phase 1 clinical trial in healthy volunteers in the first half of 2022.
Research & Discovery

Chinook is focused on the discovery and development of novel precision medicines for rare, severe chronic kidney diseases (CKDs) with defined genetic or molecular drivers of disease initiation and progression, and efficient development paths.

Chinook has multiple preclinical programs across the discovery, target validation, lead identification and lead optimization stages to generate future clinical pipeline candidates.

Chinook is leveraging its ongoing strategic collaboration with Evotec to identify and validate novel targets and enable patient stratification strategies through access to the NURTuRE CKD Patient Biobank, which provides comprehensive PANOMICS characterization of thousands of CKD patients with prospective clinical follow-up and retained bio-samples of urine and blood for exploratory biomarker analysis.
Third Quarter 2021 Financial Results

Cash Position – Cash, cash equivalents and marketable securities totaled $204.8 million at September 30, 2021, compared to $250.4 million at December 31, 2020.

Revenue – Total revenue increased by less than $0.1 million for the third quarter of 2021 and increased by $0.4 million for the nine months ended September 30, 2021, compared to the same periods in 2020 due to revenue recognized related to research and development services provided under the collaboration agreement with Lilly, which was acquired under the merger with Aduro.

Expenses –

Research and development expenses were $23.6 million for the third quarter of 2021 and $72.1 million for the nine months ended September 30, 2021, compared to $7.6 million and $14.3 million, respectively, for the same periods in 2020. The increase was primarily due to external clinical and manufacturing expenses related to the atrasentan and BION-1301 clinical programs; higher employee-related costs, including salaries, benefits and stock-based compensation expense associated with hiring staff to build out Chinook’s clinical and development capabilities; increased spending for consulting and outside services; costs related to our collaboration with Evotec; and an increase in facilities and other costs.

General and administrative expenses were $6.8 million for the third quarter of 2021 and $24.2 million for the nine months ended September 30, 2021, compared to $2.9 million and $8.0 million, respectively, for the same periods in 2020. The increase was primarily due to higher employee-related costs, including salaries, benefits and stock-based compensation expense associated with the addition of administrative staff to build out Chinook’s public-company infrastructure; higher legal, consulting and outside services costs; and an increase in facilities and other costs.

Expenses due to the change in fair value of contingent consideration and contingent value rights liabilities were $0.2 million for the third quarter of 2021 and $21.6 million for the nine months ended September 30, 2021, compared to nil for the same periods in 2020. These non-cash expenses are due to the quarterly revaluation of assets and liabilities related to the Sairopa transaction and an updated valuation of Chinook’s CVR liability under the Merck collaboration, as a result of the merger with Aduro. In the second quarter of 2021, Merck informed Chinook that it intends to explore the potential benefit of the product candidate MK-5890 in a phase 2 clinical study for a new indication, which may result in potential milestone and royalty payments under the Merck collaboration for the benefit of CVR holders.

Other –

The sale of certain of Chinook’s non-renal assets to Sairopa in the second quarter of 2021 resulted in a $7.2 million gain for the nine months ended September 30, 2021.
Net Loss – Net loss for the third quarter of 2021 was $30.7 million or $0.69 per share and $110.5 million or $2.54 per share for the nine months ended September 30, 2021, compared to net loss of $18.8 million or $4.50 per share and $31.7 million or $7.65 per share, respectively, for the same periods in 2020.

Cash Used in Operations – For the nine months ended September 30, 2021, cash used in operations totaled $80.2 million.

VBI Vaccines Announces Third Quarter 2021 Financial Results and Provides Corporate Update

On October 8, 2021 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported financial results for the third quarter ending September 30, 2021 and provided a corporate update (Press release, VBI Vaccines, NOV 8, 2021, View Source [SID1234594682]).

Jeff Baxter, VBI’s President and CEO commented: "The third quarter of 2021 was a notably busy and productive time as we support the ongoing regulatory reviews of our prophylactic 3-antigen HBV vaccine candidate, prepare for the potential launch of this candidate in the U.S., Europe, and Canada, and advance both our immunotherapeutic vaccine candidates against GBM and chronic HBV, as well as our coronavirus pipeline, with the objective of creating vaccines that provide long-term breadth of protection with good safety and tolerability profiles. We look forward to sharing data and updates from the various milestones expected over the next six months across our portfolio. The public health space is constantly evolving, evidenced by the renewed focus on prevention of HBV with the recently revised adult vaccination guidelines, plus the mutational evolution of COVID-19 with new and emerging variants. We are working hard to address significant and relevant unmet medical and public health needs, we believe this dedication and focus on successfully achieving these fundamentals will drive shareholder value."

Recent Accomplishments and Key Anticipated Upcoming Milestones

Hepatitis B (HBV)

3-Antigen HBV Prophylactic Vaccine Candidate

Commercial preparations are ongoing and continue to ramp-up in anticipation of potential regulatory approvals
November 3, 2021: the CDC’s Advisory Committee on Immunization Practices (ACIP) unanimously voted to change the adult recommendations for HBV vaccination from risk based in all ages to a universal recommendation for adults age 19-59, keeping risk-based recommendations for adults age 60+
November 30, 2021: U.S. Prescription Drug User Fee Act (PDUFA) target action date set by U.S. Food and Drug Administration (FDA)
European Medicines Agency (EMA) regulatory review ongoing
Submissions to United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada are in process and are expected to complete in 2022
VBI-2601 (BRII-179) : HBV Immunotherapeutic Candidate

H2 2022: Top-line interim clinical data expected from Phase 2 combination study of VBI-2601 (BRII-179) and BRII-835 (VIR-2218), Vir Biotechnology’s investigational HBV-targeting siRNA; study conducted by partner, Brii Biosciences (Brii Bio)
COVID-19 & Coronaviruses

VBI-2900 : eVLP Coronavirus Vaccine Program

September 2021 : Initiation of Phase 1b study of VBI-2905, VBI’s eVLP vaccine candidate targeting the Beta variant, as both a single-dose booster in adults previously vaccinated with a full course of messenger RNA (mRNA) vaccine, and as a two-dose regimen in unvaccinated adults
Q1 2022 : Initial data expected from one-dose booster study arm, in previously vaccinated adults, in ongoing Phase 1b study
Mid-year 2022 : Expected initiation of the first clinical study of VBI’s trivalent pan-coronavirus vaccine candidate, VBI-2901, designed to increase the breadth of immunity against emerging COVID-19 variants and betacoronviruses
Glioblastoma (GBM)

VBI-1901: Cancer Vaccine Immunotherapeutic Candidate

Based on data seen to-date, we anticipate assessing VBI-1901 in randomized, controlled clinical studies in both primary and recurrent GBM patients as part of the next phase of development
Q1 2022 : Expected initiation of enrollment of expanded number of patients in ongoing study in recurrent GBM, subject to discussions with FDA, increasing study size and adding a control arm to support the potential for accelerated approval based on tumor response data and improvement in overall survival
Mid-year 2022 : Expected initiation of a randomized, controlled clinical study with registration potential in primary GBM patients, subject to discussions with FDA
Recent Publications

May 2021: The Lancet Infectious Diseases publication of data from PROTECT – Phase 3 immunogenicity and safety study assessing VBI’s 3-antigen HBV vaccine candidate compared to Engerix-B in adults age 18 and older. Link to publication can be found here.
June 2021: Vaccine publication of data from a Phase 3 immunogenicity and safety study, conducted in Vietnam and completed in 2007, assessing VBI’s 3-antigen HBV vaccine candidate in healthy Asian adults. Link to publication can be found here.
July 2021: Vaccine publication of data from VBI-2902a preclinical and challenge COVID-19 studies. Link to publication can be found here.
September 2021: JHEP Reports, an open access companion title to Journal of Hepatology, publication of data from the recently completed Phase 1a/2b study of VBI-2601 (BRII-179) in adults with chronic HBV. Link to publication can be found here.
September 2021: bioRxiv publication of preclinical and challenge COVID-19 data from VBI-2902, VBI-2905, and VBI-2901 demonstrating broadened immunity against COVID-19 variants. Link to publication can be found here.
October 2021: The Journal of the American Medical Association Network Open publication of data from CONSTANT – Phase 3 lot-to-lot consistency and immunogenicity study assessing VBI’s 3-antigen HBV vaccine candidate in adults age 18-45. Link to publication can be found here.
Third Quarter 2021 Financial Results

Cash Position: VBI ended the third quarter of 2021 with $137.5 million in cash, cash equivalents, and short-term investments compared with $93.8 million as of December 31, 2020.
Net Cash Used in Operating Activities: Net cash used in operating activities for the nine months ended September 30, 2021 was $21.4 million, compared to $30.6 million for the same period in 2020. The decrease in cash outflows is largely a result of the change in operating working capital, notably the cash received in advance from the CEPI funding agreement, offset by an increase in net loss.
Cash Used for Purchase of Property and Equipment: Cash used for the purchase of property and equipment was $1.4 million for the nine months ended September 30, 2021, compared to $0.5 million for the same period in 2020. The increase is a result of routine purchases of property and equipment at our manufacturing facility in Rehovot, Israel.
Revenue: Revenue in the third quarter of 2021 was $0.1 million, compared to $0.3 million for the same period in 2020. The decrease in revenues was due to a decrease in R&D services revenue as part of the collaboration with Brii Bio. Fewer manufacturing and non-clinical research services were done in the three months ending September 30, 2021 compared to the three months ending September 30, 2020.
Cost of Revenues: Cost of revenues was $2.5 million in the third quarter of 2021 as compared to $2.1 million for the same period in 2020. The increase in the cost of revenues was due to increased outsourced testing costs and inventory-related costs incurred in the three months ending September 30, 2021 compared to the same period in 2020.
Research and Development (R&D): R&D expenses for the third quarter of 2021 were $3.0 million compared to $4.5 million in the third quarter of 2020. The decrease was a result of the government grants and funding arrangements, offset by an increase in the costs related to our coronavirus vaccine program, including the Phase 1a and Phase 1b portions of VBI-2902 and VBI-2905, respectively, and development and manufacturing of VBI-2905. The increase was also due to an increase in R&D expenses related to the development of our other vaccine candidates.
General and Administrative (G&A): G&A expenses were $9.7 million for the third quarter of 2021, compared to $5.6 million for the same period in 2020. The increase was a result of the increased commercialization preparation activities related to the 3-antigen prophylactic HBV vaccine candidate in anticipation of potential regulatory approvals, in addition to increased insurance and labor costs.
Net Loss: Net Loss and net loss per share for the third quarter of 2021 were $15.8 million and $0.06, respectively, compared to a net loss of $13.0 million and a net loss per share of $0.06 for the third quarter of 2020.