On November 7, 2022 Allakos Inc. (the "Company") (Nasdaq: ALLK), a biotechnology company developing lirentelimab (AK002) and AK006 for the treatment of allergic and inflammatory diseases, reported a business update and reported financial results for the third quarter ended September 30, 2022 (Press release, Allakos, NOV 7, 2022, View Source [SID1234623220]).

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Recent Allakos Events

Allakos’s lirentelimab clinical development is focused on atopic dermatitis and chronic spontaneous urticaria.
Initiated a Phase 2b randomized, double-blind, placebo-controlled study of subcutaneous lirentelimab in patients with chronic spontaneous urticaria (CSU) in the third quarter of 2022. The Phase 2b CSU clinical trial follows positive results from an open-label Phase 2a clinical trial with intravenous lirentelimab in patients with chronic urticaria, including cohorts of patients with omalizumab naïve CSU and omalizumab refractory CSU.
Reported topline data from Phase 3 EoDyssey study of lirentelimab in patients with eosinophilic duodenitis (EoD) in the third quarter of 2022. Allakos is currently not planning to conduct additional studies in eosinophilic gastrointestinal diseases, but may do so in the future.
Closed an underwritten common stock offering in September 2022. Aggregate proceeds received from the offering were approximately $140.5 million, net of underwriting commissions and related expenses. Investors who purchased shares in the offering include Logos Capital, BVF Partners L.P., Deep Track Capital, New Enterprise Associates (NEA), Vivo Capital, Frazier Life Sciences, Braidwell LP, Commodore Capital, RTW Investments, L.P., TCGX, Surveyor Capital (a Citadel Company), and Alta Partners.
Upcoming Allakos Milestones

Complete IND-enabling studies of AK006 during 2022 and initiate the first-in-human study in the first half of 2023.
Report topline data from the Phase 2 study of subcutaneous lirentelimab in patients with atopic dermatitis in the second half of 2023.
Report topline data from the Phase 2b study of subcutaneous lirentelimab in patients with chronic spontaneous urticaria in the second half of 2023.
Third Quarter 2022 Financial Results

Research and development expenses were $18.4 million in the third quarter of 2022 compared to $43.6 million in the third quarter of 2021. Third quarter of 2022 research and development expenses included a $12.2 million benefit from selling or receiving refunds from the disposal of previously expensed raw materials. Excluding the $12.2 million benefit, research and development expenses decreased from the prior year third quarter due to a decrease in contract research and development and clinical costs primarily relating to lirentelimab, partially offset by an increase in equipment and overhead costs.

General and administrative expenses were $13.0 million in the third quarter of 2022 compared to $19.1 million in the third quarter of 2021. Third quarter of 2022 general and administrative expenses decreased by $6.1 million compared to the same period in 2021 due to decreases in personnel-related costs, equipment and overhead related costs and other general and administrative expenses.

Including the $12.2 million benefit received from raw material disposals, Allakos reported a net loss of $30.8 million in the third quarter of 2022 compared to $62.7 million in the third quarter of 2021. Additionally, the third quarter of 2022 included non-cash expenses for stock-based compensation of $10.7 million, compared to $12.5 million in the same period in 2021, and depreciation of $1.5 million, compared to $0.4 million in the same period in 2021. Net loss per basic and diluted share was $0.53 for the third quarter of 2022 compared to $1.16 in the third quarter of 2021. Weighted-average shares outstanding used to calculate basic and diluted loss per share was 58.2 million and 54.1 million for the third quarter of 2022 and 2021 respectively. As part of the September 21, 2022 common stock offering, 29.9 million shares were sold resulting in 85.2 million shares outstanding as of September 30, 2022.

Allakos ended the third quarter of 2022 with $325.3 million in cash, cash equivalents and investments.

On November 7, 2022 Akoya Biosciences, Inc., (Nasdaq: AKYA), The Spatial Biology Company, reported the launch of PhenoCode Signature Panels for high-throughput spatial biomarker discovery and validation on the PhenoImager platforms (Press release, Akoya Biosciences, NOV 7, 2022, View Source [SID1234623219]). Each of the customizable multiplex panels includes key markers for phenotyping the tumor microenvironment (TME) and immune status. When combined with the high-speed and robust imaging of the PhenoImager platforms, a rapid, quantitative, end-to-end spatial phenotyping workflow is enabled. The workflow accelerates development and validation of predictive signatures and prognostic biomarkers for immuno-oncology applications.

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Poster presentations and a symposium describing the application of PhenoCode Signature Panels will be offered at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting, being held in Boston, Massachusetts, November 8-12, 2022.

Akoya’s symposium, titled ‘Supercharging Spatial Signature Development’, will be held on November 10 from 7:30 pm to 9:00 pm ET in BCEC 156 at the Boston Convention Center. Speakers include:

Patrick Savickas PhD, Immunochemist, HistoWiz
Arutha Kulasinghe, PhD, Senior Research Fellow, University of Queensland
Oliver Braubach, PhD, Head of Applications, Akoya Biosciences
More details about Akoya’s SITC (Free SITC Whitepaper) activities and poster presentations can be found here.

"The rapidly expanding immuno-oncology therapeutic and clinical trial landscape is necessitating the need for more predictive tissue-based biomarker solutions," said Brian McKelligon, Chief Executive Officer of Akoya Biosciences. "The PhenoCode Signature Panels provide our translational and clinical partners with a ready-made and customizable solution to rapidly advance their biomarker programs."

The PhenoCode Signature chemistry represents an important milestone in Akoya’s commitment to create a suite of platform solutions from discovery to diagnostics. As a powerful hybrid of Akoya’s legacy CODEX and Opal assays, the PhenoCode Signature Panels create a continuum of methodologies, enabling translational and clinical researchers to perform discovery on the PhenoCycler-Fusion and validation on the PhenoImager platforms.

"Invicro is excited to partner with Akoya for early access to the new PhenoCode Signature Panels, which will simplify approaches to create rich, contextual biomarker data and help us accelerate the discovery and validation of immunotherapy biomarkers," said Joseph Krueger, PhD, Vice President of Invicro’s Advanced Pathology Services. "What is particularly unique is that the panels deliver the efficiency of an off-the-shelf assay with the power of customization to enable rapid deployment of panels to follow the natural process of scientific exploration."

On November 7, 2022 Akoya Biosciences, Inc. (Nasdaq: AKYA) ("Akoya"), The Spatial Biology Company, reported its financial results for the third quarter ending September 30, 2022 (Press release, Akoya Biosciences, NOV 7, 2022, View Source [SID1234623218]).

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"Akoya continues to deliver strong financial performance with record growth this quarter and healthy system placement across the discovery, translational and clinical markets," said Brian McKelligon, Chief Executive Officer, Akoya Biosciences. "Our industry leading portfolio and installed base, commercial execution, and success across multiple market segments, from discovery to clinical, are key drivers of our success."

Third Quarter 2022 Financial Highlights

Total revenue was $18.9 million in the third quarter of 2022, compared to $13.5 million in the prior year period; an increase of 40%.
Product revenue was $14.4 million in the third quarter of 2022, compared to $10.9 million in the prior year period; an increase of 32%.
Instrument revenue was $9.5 million, compared to $7.1 million; an increase of 34%.
Reagent revenue was $4.7 million, compared to $3.4 million; an increase of 38%.
Services and other revenue totaled $4.4 million in the third quarter of 2022, compared to $2.6 million in the prior year period; an increase of 69%.
Gross profit was $10.9 million and gross profit margin was 58% in the third quarter of 2022.
55 instruments were sold in the third quarter of 2022; 17 PhenoCyclers, 38 PhenoImagers (which includes Fusion, HT and Mantra); compared to 33 instruments sold in the prior year period (16 PhenoCyclers, 17 PhenoImagers); an increase of 67%.
Instrument installed base of 863 as of September 30, 2022; 229 PhenoCyclers, 634 PhenoImagers.
Combined-unit PhenoCycler-Fusion installed base of 72 as of September 30, 2022.
$82 million of cash, cash equivalents, and marketable securities as of September 30, 2022.
YTD 2022 Financial Highlights

Total revenue was $53.6 million YTD as of September 30, 2022 compared to $38.8 million in the prior year period; an increase of 38%.
Product revenue was $41.9 million YTD as of September 30, 2022, compared to $31.6 million in the prior year period; an increase of 33%.
Services and other revenue totaled $11.7 million YTD as of September 30, 2022, compared to $7.2 million in the prior year period; an increase of 63%.
Gross profit was $31.3 million and gross profit margin was 58% YTD as of September 30, 2022.
166 instruments were sold YTD as of September 30, 2022; 47 PhenoCyclers, 119 PhenoImagers (which includes Fusion, HT and Mantra), compared to 101 instruments sold in the prior year period; an increase of 64%.
Third Quarter 2022 Business Highlights

As of September 30, 2022, there have been 691 total publications featuring Akoya’s platforms; 81% growth from 382 total publications as of September 30, 2021.
At the upcoming Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) conference taking place in Boston, MA (November 8-12, 2022), Akoya will unveil the PhenoCode Signature Panels (previously referred to as universal protein chemistry) on the PhenoImager workflows; please see the accompanying PhenoCode Signature Panels press release for more details.
At SITC (Free SITC Whitepaper), 6 key posters will be presented highlighting the development of PhenoCode Signature Panels and other novel phenotyping applications; Akoya will also be hosting a dinner symposium titled "Supercharging Spatial Signature Development."
Akoya will be hosting our 2nd annual Spatial Day on December 15, 2022, for which registration details can be found here: Akoya’s 2nd Annual Spatial Day.
2022 Financial Outlook

The Company, based on its updated plans and initiatives, is raising its full year 2022 revenue guidance range to $73-75 million.

Webcast and Conference Call Details

Akoya will host a conference call today, November 7 2022, at 5:00 p.m. Eastern Time to discuss its third quarter 2022 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 7, 2022 ADC Therapeutics SA (NYSE: ADCT) reported that Ameet Mallik, Chief Executive Officer, will participate in a fireside chat at the Jefferies London Healthcare Conference on Tuesday, November 15th at 9:45 a.m. GMT (Press release, ADC Therapeutics, NOV 7, 2022, View Source [SID1234623217]).

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A live webcast of the presentation will be available via the Events & Presentations page in the Investors section of ADC Therapeutics’ website, ir.adctherapeutics.com. A replay of the webcast will be available for approximately 30 days.

On November 7, 2022 2seventy bio, Inc. (Nasdaq: TSVT), a leading immuno-oncology cell therapy company, reported financial results and recent highlights for the third quarter ended September 30, 2022 (Press release, 2seventy bio, NOV 7, 2022, View Source [SID1234623216]).

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"In our first year of operations, 2seventy bio has made tremendous progress in our mission of delivering more time to patients with cancer," said Nick Leschly, chief kairos officer. "Abecma has exceeded our expectations and is gaining momentum with potential to become a multi-billion dollar product. We now have hundreds of patients treated in the commercial setting and importantly we continue to see consistent efficacy and safety results between our clinical trials and our real-world data. We are excited to share our plans to initiate the KarMMa-9 study in newly diagnosed patients, in partnership with BMS. In addition, we have made important progress towards establishing a highly differentiated pipeline and sustainable product engine: our DARIC-33 and bbT369 studies in AML and B-NHL, respectively, are enrolling patients and our solid tumor programs with Regeneron are fast approaching the starting line with our MUC-16 CAR program. More broadly, we have made great progress on building translational throughput capacity with our internal drug product manufacturing facility nearing completion and we expect our strategic collaboration with JW Therapeutics to accelerate solid tumor development starting with putting our MAGE-A4 program into the clinic. Taken together, we believe we are on track to establishing a unique end to end cell therapy product engine, exploring four clinical-stage assets by 2024 and continuing to expand Abecma into earlier lines. As we wrap up 2022, we look forward to presenting important Abecma data at ASH (Free ASH Whitepaper) and more broadly on our pipeline in 2023."

RECENT PIPELINE HIGHLIGHTS

STRATEGIC PARTNERSHIP WITH JW THERAPEUTICS – Last month, 2seventy bio and JW Therapeutics announced a strategic alliance to establish a translational and clinical cell therapy development platform designed to more rapidly explore T cell-based immunotherapy therapy products in the Chinese mainland, Hong Kong (China), and Macao (China). The initial focus of the collaboration is 2seventy bio’s MAGE-A4 t cell receptor (TCR) program in solid tumors which is being developed as part of a collaboration with Regeneron. Under the terms of the agreement, 2seventy bio will grant JW Therapeutics a license for the MAGE-A4 cell therapy in the Chinese mainland, Hong Kong (China), and Macao (China). JW Therapeutics will be responsible for development, manufacturing, and commercialization within China. 2seventy bio is eligible to receive milestones and royalties on product revenues in China.
ADDITIONAL PROGRESS – 2seventy bio’s clinical studies of DARIC-33 in acute myeloid leukemia (AML) and bbT369 in B cell non-Hodgkin lymphoma (B-NHL) are open and enrolling. We plan to share clinical data from these programs in the future. The company continues to execute pre-investigational new drug (IND) work to support a MUC-16 IND in 2023.
Abecma Commercial Summary
Our partner, Bristol Myers Squibb (BMS) reported total U.S. Abecma (idecabtagene vicleucel; ide-cel) third quarter revenues of $75 million. Based on strong commercial demand for Abecma, we remain on track to achieve the upper end of our stated 2022 U.S. Abecma revenue guidance of $250-300 million. Given the continued strong demand for Abecma and our growing belief in its potential to play an important role in earlier lines of therapy, we plan to initiate the KarMMa-9 study in partnership with BMS in patients with newly diagnosed multiple myeloma who have a suboptimal response to transplant and we are continuing to advance our manufacturing strategy to expand capacity across the supply chain.

We reported collaborative arrangement revenue of $4.1 million for the third quarter, which includes our share of gross profit/loss less costs associated with the commercialization of Abecma in the U.S. Vector and drug product supply remains on track to meet our commercial plan for 2022 and we are continuing to invest in increasing manufacturing capacity in the future.

ABECMA HIGHLIGHTS

KARMMA-2 DATA AT ASH (Free ASH Whitepaper) – Earlier this month, 2seventy bio announced that data from two cohorts of the KarMMa-2 study of Abecma (idecabtagene vicleucel), conducted in partnership with BMS, in patients who have suboptimal response to transplant or early relapse will be presented at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition. Data from KarMMa-2 Cohorts 2a and 2c suggest the potential for early treatment with Abecma in patients with second-line and newly diagnosed multiple myeloma, and that promising outcomes can be achieved treating patients with suboptimal response after transplant. These results support further evaluation of Abecma in patients with newly diagnosed multiple myeloma in the KarMMa-9 study.
KARMMA-9 STUDY IN NEWLY-DIAGNOSED MULTIPLE MYELOMA – In September, 2seventy bio announced plans to initiate the KarMMa-9 study, in partnership with BMS, to evaluate Abecma in newly diagnosed multiple myeloma patients who have suboptimal response to transplant. The company intends to provide additional information about the design and timing of the study at the earliest upcoming opportunity
SELECT THIRD QUARTER 2022 FINANCIAL RESULTS

Our partner, BMS, reported total U.S. revenues of $75 million for Abecma for the three months ended September 30, 2022. 2seventy bio and BMS share equally in all profits and losses related to development, manufacture and commercialization of Abecma in the U.S. We reported collaborative arrangement revenue of $4.1 million for the three months ended September 30, 2022. For the first and second quarters of 2022, we reported a share of collaboration loss of $5.4 million and $4.3 million, respectively.
Total 2seventy bio revenues were $13.4 million for the three months ended September 30, 2022 compared to $19.3 million for the three months ended September 30, 2021. Total revenues were $35.3 million for the nine months ended September 30, 2022 compared to $38.5 million for the nine months ended September 30, 2021. The decrease for the three-month period was primarily driven by a decrease in Abecma collaborative arrangement revenue and the decrease for the nine-month period was largely attributable to a decrease in ide-cel ex-U.S. service revenue and royalty and other revenue.
Research and development expenses were $61.7 million for the three months ended September 30, 2022 compared to $61.1 million for the three months ended September 30, 2021. Research and development expenses were $199.4 million for the nine months ended September 30, 2022, compared to $202.4 million for the nine months ended September 30, 2021. The slight increase for the three-month period was primarily driven by increases in IT and other facility-related costs and collaboration research funding costs, partially offset by decreased license and milestone fees. The decrease for the nine -month period was primarily driven by decreased collaboration research funding costs due to a decrease in our share of research and development costs under our collaboration with BMS, partially offset by an increase in IT and other facility-related costs.
Selling, general and administrative expenses were $19.6 million for the three months ended September 30, 2022, compared to $23.0 million for the three months ended September 30, 2021. Selling, general and administrative expenses were $60.7 million for the nine months ended September 30, 2022, compared to $69.0 million for the nine months ended September 30, 2021. The decrease for both the three- and nine-month periods was primarily driven by decreased employee compensation expenses, reflective of efforts to streamline 2seventy bio’s operating model and a decrease in IT and other facility-related costs.
Net loss was $67.9 million for the three months ended September 30, 2022, compared to $60.0 million for the three months ended September 30, 2021. Net loss was $231.0 million for the nine months ended September 30, 2022, compared to $231.2 million for the nine months ended September 30, 2021.
2seventy bio ended the third quarter of 2022 with cash, cash equivalents and marketable securities of $324.5 million.