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Alligator Bioscience Announces Commencement of Investigator Initiated Phase I Clinical Trial at Erasmus University Rotterdam

On November 8, 2021 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported the initiation of a proof-of-concept Phase Ib clinical trial to assess the safety and efficacy of mitazalimab in combination with MesoPher, an experimental dendritic cell vaccine, in patients with pancreatic cancer (Press release, Alligator Bioscience, NOV 8, 2021, View Source [SID1234594700]). The trial will be led by investigators at Erasmus MC University Medical Center Rotterdam, The Netherlands.

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The first patient has been dosed in the phase I proof-of-concept study trial, REACtiVe-2, that will enroll up to 18 patients with pancreatic cancer. REACtiVe-2 will assess the safety and efficacy of Alligator´s second generation CD40 agonist, mitazalimab in combination with the investigational cancer vaccine MesoPher, which is comprised of autologous dendritic cells loaded with allogeneic tumor lysate (PheraLys), in patients with progressive metastatic pancreatic cancer. Mitazalimab is currently in Phase II trial in pancreatic cancer patients in combination with chemotherapy. MesoPher, under development by Amphera B.V., is currently in a Phase III trial in mesothelioma and a phase II trial in pancreatic cancer. The investigator sponsored trial, REACtiVe-2, will be performed at Erasmus MC University Medical Center Rotterdam.

The clinical study is supported by strong preclinical data that was recently published in the high-ranking peer-reviewed journal "Journal of Immunotherapy of cancer" (Lau SP, et al. J Immunother Cancer 2020). This study demonstrates that CD40 agonists in combination with dendritic cells loaded with allogeneic tumor lysate mediates powerful and significant anti-tumor effects in pancreatic cancer models.

"This new trial is an important step forward in expanding the potential of mitazalimab in a patient population with high medical needs," said Alligator’s CEO, Søren Bregenholt. "Erasmus MC University Medical Center Rotterdam is the ideal partner for the clinical evaluation of mitazalimab´s ability to enhance the response of a promising cancer vaccine in pancreatic cancer."

Allakos Provides Business Update and Reports Third Quarter 2021 Financial Results

On November 8, 2021 Allakos Inc. (the "Company") (Nasdaq: ALLK), a biotechnology company developing lirentelimab (AK002) for the treatment of eosinophil and mast cell-related diseases, reported financial results for the third quarter ended September 30, 2021 (Press release, Allakos, NOV 8, 2021, View Source [SID1234594699]).

Recent Accomplishments

Presented data at American College of Gastroenterology (ACG) 2021 Annual Scientific Meeting from prospective study showing high prevalence rates of eosinophilic gastritis and/or eosinophilic duodenitis (EG/EoD) with systemic evaluation. Forty-five percent (45%, 181/405) of patients with moderate-to-severe unexplained gastrointestinal symptoms who underwent upper endoscopy with biopsy met the diagnostic criteria for EG/EoD. This data suggests that these conditions are significantly underdiagnosed and may be a common cause of moderate-to-severe gastrointestinal symptoms.
Upcoming 2021 Milestones

Topline data from a Phase 3 randomized, double-blind, placebo-controlled study of lirentelimab in patients with EG/EoD expected in the fourth quarter of 2021 or early in the first quarter of 2022.
Topline data from a Phase 2/3 randomized, double-blind, placebo-controlled study of lirentelimab in patients with EoE expected in the fourth quarter of 2021 or early in the first quarter of 2022.
Initiation of a Phase 2/3 randomized, double-blind, placebo-controlled study of subcutaneous lirentelimab in patients with EG and/or EoD expected in the fourth quarter of 2021.
Initiation of a Phase 2 randomized, double-blind, placebo-controlled study in a non-eosinophilic gastrointestinal disease in the fourth quarter of 2021.
Third Quarter 2021 Financial Results

Research and development expenses were $43.6 million in the third quarter of 2021 as compared to $30.4 million in the same period in 2020, an increase of $13.2 million.

General and administrative expenses were $19.1 million in the third quarter of 2021 as compared to $12.1 million in the same period in 2020, an increase of $7.0 million.

Allakos reported a net loss of $62.7 million in the third quarter of 2021 as compared to $42.1 million in the same period in 2020, an increase of $20.6 million. Net loss per basic and diluted share was $1.16 for the third quarter of 2021 compared to $0.86 in the same period in 2020.

Allakos ended the third quarter of 2021 with $505.6 million in cash, cash equivalents and marketable securities.

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.

"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.