On November 8, 2023 Arbutus Biopharma Corporation (Nasdaq: ABUS) ("Arbutus" or the "Company"), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop a cure for people with chronic hepatitis B virus (cHBV) infection, reported that the Arbutus management team will participate in and host one-on-one meetings at the following investor conference (Press release, Arbutus Biopharma, NOV 8, 2023, View Source [SID1234637244]):

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Jefferies London Healthcare Conference: Formal presentation on Wednesday, November 15, 2023 at 11:30 am GMT / 6:30 am EDT.

To access the live webcast of the presentation please visit: View Source An archived replay of the webcast will be available on the Arbutus website for a limited time after the event.

On November 8, 2023 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported that management will participate in a fireside chat at the Stifel Healthcare Conference on Tuesday, November 14, 2023, at 11:30 a.m. ET (Press release, Alector, NOV 8, 2023, View Source [SID1234637243]).

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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.

On November 8, 2023 Akoya Biosciences, Inc. (Nasdaq: AKYA) ("Akoya"), The Spatial Biology Company, reported its financial results for the third quarter ending September 30, 2023 (Press release, Akoya Biosciences, NOV 8, 2023, View Source [SID1234637242]).

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"Akoya delivered strong financial performance in the third quarter with another record revenue quarter while maintaining operating expenses at a steady or reduced level, solidifying the path towards achieving positive cash flow," explained Brian McKelligon, Chief Executive Officer of Akoya Biosciences. "We are executing on our plan to improve workflow throughput, with the ongoing 2.0 instrument field upgrades across the industry’s largest installed base and by expanding our menu of ready-to-use panels. Akoya is strategically positioned to scale spatial biology by setting the standard in the industry."

Third Quarter 2023 Financial Highlights

Total revenue was $25.2 million in the third quarter of 2023, compared to $18.9 million in the prior year period; an increase of 34%.
Product revenue (which includes instruments, reagents, and software) was $18.0 million in the third quarter of 2023, compared to $14.4 million in the prior year period; an increase of 25%.
Instrument revenue was $12.0 million, compared to $9.5 million in the prior year period; an increase of 27%.
Reagent revenue was $5.7 million, compared to $4.7 million in the prior year period; an increase of 21%.
Service and other revenue totaled $7.2 million in the third quarter of 2023, compared to $4.4 million in the prior year period; an increase of 62%.
Gross profit was $15.3 million in the third quarter of 2023, compared to $10.9 million in the prior year period; an increase of 40%.
Gross profit margin was 60.6% in the third quarter of 2023, compared to 57.9% in the prior year period.
$78.6 million of cash and cash equivalents as of September 30, 2023, with $11.3 million in additional debt capacity.
Third Quarter 2023 Business Highlights

69 instruments were sold in the third quarter of 2023: 27 PhenoCyclers, 42 PhenoImagers (which includes Fusion and HT), compared to 55 instruments sold in the prior year period (17 PhenoCyclers, 38 PhenoImagers).
Instrument installed base of 1,132 as of September 30, 2023 (327 PhenoCyclers, 805 PhenoImagers), compared to an installed base of 863 in the prior year period (229 PhenoCyclers, 634 PhenoImagers); an increase of 31%.
Combined-unit PhenoCycler-Fusion installed base of 186 as of September 30, 2023, compared to 72 in the prior year period.
1,070 total publications citing Akoya’s technology as of September 30, 2023, compared to 691 total publications in the prior year period: an increase of 55%.
The University of Queensland and Akoya Biosciences have comprehensively mapped the spatial proteome of head and neck squamous cell carcinoma (HNSCC) using ultrahigh-plex phenotyping (100+ protein biomarkers) on the PhenoCycler-Fusion, as published in an article in the inaugural issue of GEN Biotechnology.
Ongoing Fusion 2.0 and HT 2.0 field upgrades with rolling launch of new ready-to-use PhenoCode Panels.
Showcased Akoya’s new 2.0 solutions, data, and applications at the 2023 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) conference held November 1-5 in San Diego, CA.
YTD 2023 Financial and Business Highlights

Total revenue was $70.1 million YTD as of September 30, 2023, compared to $53.6 million in the prior year period; an increase of 31%.
Product revenue was $50.7 million YTD as of September 30, 2023, compared to $41.9 million in the prior year period; an increase of 21%.
Services and other revenue totaled $19.4 million YTD as of September 30, 2023, compared to $11.7 million in the prior year period; an increase of 66%.
Gross profit was $39.7 million YTD as of September 30, 2023, compared to $31.3 million in the prior year period and gross profit margin was 56.6% YTD as of September 30, 2023, compared to 58.4% in the prior year period.
198 instruments were sold YTD as of September 30, 2023; 73 PhenoCyclers, 125 PhenoImagers, compared to 166 instruments sold in the prior year period; an increase of 19%.
2023 Financial Outlook

The Company, based on its current plans and initiatives, continues to expect full year 2023 revenue in the range of $95-98 million.

Webcast and Conference Call Details

Akoya will host a conference call today, November 8, 2023, at 5:00 p.m. Eastern Time to discuss its third quarter 2023 financial results. Investors interested in listening to the conference call are required to register online. 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.

On November 8, 2023 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, reported financial results for the third quarter ended September 30, 2023 and reviewed recent business highlights (Press release, Akebia, NOV 8, 2023, View Source [SID1234637240]).

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In September, Akebia completed its resubmission to its New Drug Application for vadadustat to the U.S. Food and Drug Administration (FDA) as a treatment for anemia due to chronic kidney disease (CKD) in adult patients on dialysis. FDA subsequently accepted the resubmission and assigned a user fee goal date ("PDUFA date") of March 27, 2024. The resubmission includes post-marketing safety data from tens of thousands of patients in Japan where vadadustat is approved and has been in the market for more than three years.

"Akebia is extremely well-positioned following the acceptance of our vadadustat NDA resubmission, with a March 27, 2024 PDUFA date," said John P. Butler, Chief Executive Officer of Akebia. "We are preparing for a commercial launch if vadadustat is approved and stand ready with a commercial team in place and product supply on the shelf. We also added Australia and Taiwan to the list of countries where vadadustat is approved for CKD patients on dialysis. Additionally, we have strengthened our financial position by deferring our Pharmakon principal payments until October 2024."

Auryxia (ferric citrate) net product revenue for the third quarter was $40.1 million and management reaffirms previously issued 2023 net product revenue guidance of $170.0 – $175.0 million for Auryxia.

Third Quarter 2023 and Recent Business Highlights

•Australia’s Therapeutic Goods Administration granted approval for Vafseo (vadadustat) for the treatment of anemia associated with CKD in adults on chronic maintenance dialysis. Vadadustat was also authorized for use in Taiwan during this time, marking approval in 36 countries.
•Akebia supported five posters presented at the American Society of Nephrology Kidney Week 2023, which took place on November 2-5, 2023. Notably, one poster presented data on a potential alternative dosing regimen for vadadustat.
•Akebia modified the terms of its loan agreement with Pharmakon Advisors, LP to extend the maturity of the loan from November 2024 until March 2025, and to defer its principal payments until October 31, 2024.

Third Quarter Financial Results

Total Revenues: Total revenues were $42.0 million for the third quarter of 2023, compared to $48.7 million for the third quarter of 2022. The decrease is primarily due to a decrease in license, collaboration and other revenue.

Net Product Revenues: Net product revenues were $40.1 million for the third quarter of 2023, compared to $42.0 million for the third quarter of 2022. The decrease was primarily due to a reduction in volume and the impact of shifting payor mix, partially caused by contracting dynamics and a decline in the phosphate binder market. The decline was partially offset by price increases in January 2023 and July 2023.

License, Collaboration and Other Revenues: License, collaboration and other revenues were $1.9 million for the third quarter of 2023, compared to $6.7 million for the third quarter of 2022. The decrease is primarily due to the transfer and assignment of a supply agreement to Akebia’s collaboration partner.

Cost of Goods Sold (COGS): COGS was $18.0 million for the third quarter of 2023, compared to $38.3 million for the third quarter of 2022. COGS reflects the costs of Auryxia, including non-cash intangible amortization charge of $9.0 million per quarter through the fourth quarter of 2024 and third-party royalties. The decrease was primarily due to a reduction in a non-cash charge related to the prior liability for excess purchase commitments, a decrease in inventory write-downs and lower volume of sales resulting in reduced product costs.

Research and Development (R&D) Expenses: R&D expenses were $13.3 million for the third quarter of 2023, compared to $28.0 million for the third quarter of 2022. The decrease was primarily due to a reduction in spending for vadadustat development, including clinical trial costs, and curtailment of outsourced contract services.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses were $22.7 million for the third quarter of 2023, compared to $31.9 million for the third quarter of 2022. The decrease was primarily due to a reduction in headcount related costs, the benefits realized from the assignment of the Boston lease in May 2023 and a targeted cutback in Auryxia marketing and promotional expense which were offset by some one-time non-recurring expenses.

Net Loss: Net loss was $14.5 million for the third quarter of 2023, compared to net loss of $54.1 million for the third quarter of 2022.

Cash Position: Cash, cash equivalents and restricted cash as of September 30, 2023, totaled $48.2 million. Akebia expects its existing cash resources and cash from operations will be sufficient to fund its current operating plan for at least the next twelve months.

Conference Call Information

Akebia will host a conference call and webcast on Wednesday, November 8 at 8:00 a.m. ET to discuss its financial results and recent business highlights. To access the call, please register by clicking on this Registration Link, and you will be provided with dial in details. To avoid delays and ensure timely connection, we encourage dialing into the conference call 15 minutes ahead of the scheduled start time.

A live webcast of the conference call will be available via the "Investors" section of Akebia’s website at: View Source/." target="_blank" title="View Source/." rel="nofollow">View Source An online archive of the webcast can be accessed via the Investors section of Akebia’s website at View Source approximately two hours after the event.

On November 8, 2023 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM"), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, reported encouraging translational data from an ongoing Phase 2 clinical trial utilizing AIM’s drug Ampligen in patients with platinum-sensitive advanced recurrent ovarian cancer (Press release, AIM ImmunoTech, NOV 8, 2023, View Source [SID1234637239]).

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The abstract with data illustrations, titled "Combination intraperitoneal chemoimmunotherapy triggers a T-cell chemotactic locoregional response in patients with recurrent platinum-sensitive ovarian cancer," was presented by collaborators from the Magee-Womens Research Institute at the University of Pittsburgh School of Medicine ("UPMC") – one of the world’s top centers for the treatment of gynecological cancers – at the recent Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 38th Annual Meeting, in San Diego, Calif. The data was also made available at the conference in a poster presentation.

Data highlighted in the abstract were collected by UPMC through translational studies focused on the immune tumor microenvironment (TME), using a longitudinal collection of biospecimens, including plasma, PBMC, IP washes and tumor tissue collected from patients treated in a Phase 2, efficacy/safety trial (NCT03734692) combining intraperitoneal (IP) chemotherapy (cisplatin) with dual agent immunotherapy using intravenous (IV) pembrolizumab (anti-PD1, Keytruda, provided by Merck) and IP rintatolimod (Ampligen, a dsRNA acting as toll-like receptor 3 -TLR-3- agonist, provided by AIM).

Key Highlights:

Sequential sampling of the IP cavity showed an increase in cellularity immediately after treatment consistent with an "acute" pro-inflammatory reaction.
Mesoscale Delivery (MSD) measurements in IP washes revealed an acute increase in granzyme B, perforin, TNF alpha, CXCL9, CXCL10, and CXCL11 after treatment (p<0.05). Longitudinal data revealed a progressive increase in some biomarkers (p<0.05).
RNA sequencing data showed a significant upregulation acutely in STAT1 and downstream targets, CXCL9, 10, 11 and TH1 type response genes (p<0.05).
Robert P. Edwards, MD, Chief Medical Officer of the UPMC Community and Ambulatory Services Division and Co-Director of the Women’s Cancer Research Center at the UPMC Hillman Cancer Center, stated, "The profound local T-cell cytoxicity activation we see with this combination is markedly improved over previous work we have published on this platform with this recurrent disease profile."

David Strayer, MD, AIM’s Medical Officer, a Board-Certified oncologist and a former Professor of Medicine and Neoplastic Diseases at Hahnemann University, stated, "We continue to be encouraged by the data being demonstrated by Dr. Robert Edwards and his team at UPMC. These data highlight the effectiveness of combinatorial treatments including Ampligen in modulating the cellular make-up of the tumor microenvironment through cytokine profile changes. These data show a similar profile to previously published data from Roswell Park in Stage 4 triple negative breast cancer. The thing that intrigues me most is the persistent upregulation of the T-lymphotactic cytokines over time, and the lack of immune exhaustion as demonstrated in the ability of the treatment to cause a statistically significant upregulation of these cytokines after repeated treatment. As a whole, these data demonstrate an encouraging result in the promotion of increased T cell chemotaxis and cytolytic function for improved clinical outcomes in patients with advanced recurrent ovarian cancer."

AIM Chief Executive Officer Thomas K. Equels stated, "There is a significant unmet need in advanced recurrent ovarian cancer and these findings continue to bolster our confidence in Ampligen’s potential. Additionally, we hope to announce topline interim survival results from UPMC in the near future."

For more information about the Phase 2 clinical trial of platinum-sensitive advanced recurrent ovarian cancer utilizing Ampligen, visit clinicaltrials.gov and reference identifier: NCT03734692.