On March 1, 2022 Tiziana Life Sciences Ltd.’s (Nasdaq: TLSA) former subsidiary, AccuStem Sciences, Inc. (OTC PINK: ACMSY) (formerly AccuStem Sciences Ltd.), reported publication of new data in the European Journal of Cancer (Press release, Tiziana Life Sciences, MAR 1, 2022, View Source [SID1234609260]). Results demonstrate that StemPrintER is highly prognostic for risk of distant recurrence in women with breast cancer.

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Investigators from the European Institute of Oncology (IEO) in Milan and The Royal Marsden Hospital in London evaluated 776 tumor samples from the TransATAC cohort, a subgroup of estrogen receptor positive (ER+), post-menopausal patients from the prospective, randomized ATAC trial. The pivotal TransATAC study has been used to evaluate many of the commonly used breast cancer risk scoring assays, including OncotypeDX, Prosigna, EndoPredict and Breast Cancer Index.

In this analysis, investigators demonstrated that patients with a StemPrintER Risk Score (SPRS) Low result had significantly better outcomes than patients with a SPRS High result. Patients with a SPRS Low result had a 5.8% risk of distant recurrence at 10 years versus 23.2% risk of distant recurrence in patients with a SPRS High result.1

"Many genomic classifiers have been evaluated in the TransATAC cohort," said Salvatore Pece, Full Professor at the Milan University Medical School and Director of the Hormone-Related Cancers and Stem Cell Pathobiology Lab at IEO. "It is exciting that StemPrintER appears to perform as well as other commercially-available tests and indicates the potential for this novel test to inform clinical decision making."

On March 1, 2022 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies and adjuvants designed to activate immune response to cancers and infections, reported financial results for the fourth quarter and full year 2021 (Press release, Agenus, MAR 1, 2022, View Source [SID1234609252]).

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"We made several important advancements in 2021," said Garo Armen, PhD, Chief Executive Officer of Agenus. "Our Phase 1 data presentation at SITC (Free SITC Whitepaper) demonstrated the best-in-class potential of our flagship program, botensilimab, consistent with its Fc-enhanced design. We partnered our Fc-enhanced TIGIT bispecific with BMS to accelerate its development in high priority indications such as NSCLC. This year, we expect to launch several new botensilimab studies to unlock its franchise potential. In parallel, our R&D team continues to advance novel discoveries, with our macrophage targeting program expected to enter the clinic this year."

Botensilimab is the first anti-CTLA-4 antibody to demonstrate clinical responses across 9 cold, treatment-resistant cancers; Phase II studies planned in melanoma, colorectal, and pancreatic cancers

Phase 1 data from >100 patients treated with botensilimab, as monotherapy or in combination with our PD-1 antibody, balstilimab, presented at SITC (Free SITC Whitepaper).

Based on these data, Agenus plans to commence Phase 2 trials in melanoma, MSS-colorectal, and pancreatic cancers in order to:

Demonstrate superiority to ipilimumab, which has been approved and extensively studied in melanoma; new melanoma response to botensilimab monotherapy observed since SITC (Free SITC Whitepaper) presentation in a patient who progressed on prior ipilimumab treatment.

Build upon potential best-in-class signal in MSS-colorectal cancer; among 20 patients in our Phase I study, we observed a 20% response rate for the botensilimab/balstilimab combination compared to a reported 1% response rate for a first generation CTLA-4/PD-(L)1 combination.

Establish botensilimab as superior combination agent for chemotherapy in cold tumors, by evaluating botensilimab in combination with standard of care chemotherapy in pancreatic cancer.

Positive data in these studies can unlock the franchise potential of botensilimab, supporting further development in indications where first-generation CTLA-4 has been approved or demonstrated benefit, as well as expansion into indications where botensilimab has shown benefit but other CTLA-4 agents have not.

Internal infrastructure build underway to support botensilimab development and potential launch: Emeryville site designed to manufacture inventory worth >$10B in annual sales.

AGEN1571 is entering clinical development in 2022

AGEN1571 targets tumor associated macrophages, which promote resistance to PD-1 and CTLA-4 therapy.

The importance of this target class has been validated by Merck’s ILT4 antagonist, discovered by Agenus, which has shown durable responses in PD-1 resistant cancers.

6 clinical-stage programs advancing through strategic partnerships; $220M in upfront and achieved milestone payments received in 2021

AGEN1777 (Fc-enhanced TIGIT bispecific) was licensed to BMS for $220M in upfront and achieved milestones plus $1.36B in future milestones and royalties. BMS plans to advance AGEN1777 in high priority tumor indications including NSCLC.

Merck is advancing a myeloid cell-targeting antibody, MK-4830, discovered by Agenus, across a range of cancers – including pancreatic, lung, renal, breast, ovarian, gastric and glioblastoma.

Incyte is advancing four clinical stage partnered programs, including a combination trial evaluating our TIM-3 and LAG-3 antagonists with PD-1 in PD-1 r/r melanoma.

Across our partnerships, we are eligible for $2.8B in milestones plus royalties, as well as the option to participate in development and commercialization for certain programs.

Cell therapy subsidiary, MiNK Therapeutics, launched via an IPO

MiNK Therapeutics launched a successful IPO to support clinical development of its allogeneic cell therapies.

Clinical programs are underway in solid tumors and multiple myeloma.

SaponiQx to generate GMP grade QS-21 STIMULON adjuvant from proprietary plant cell culture manufacturing process in 2022 to enable partner clinical studies

QS-21 STIMULON is a proven adjuvant in GSK’s shingles vaccine (SHINGRIX), with durability lasting >9 years.

While data supports broad applicability across >20 disease settings, supply is limited by a complicated extraction process from a Chilean soap bark tree.

SaponiQx’s plant cell culture method of manufacturing offers a more sustainable, scalable, and cost-effective supply of QS-21 STIMULON.

GMP grade material from this manufacturing process is expected to be available this year to enable partner clinical trials.

SaponiQx is also developing next-generation adjuvants designed to increase mucosal immunity through intranasal delivery, critical for addressing respiratory pandemic threats such as COVID-19.

Fourth Quarter and Full Year 2021 Financial Results

We ended the year 2021 with a cash and short-term investment balance of $307 million as compared to $100 million at December 31, 2020.

We recognized revenue of $296 million and $88 million for the years ended December 31, 2021, and 2020, respectively, which includes revenue related to upfront license fees received, non-cash royalties earned, and revenue recognized under our collaboration agreements.

Our cash provided by operations for the year ended December 31, 2021, was $10 million with a reported net loss of $29 million or $0.11 per share compared to cash used in operations of $139 million and a net loss for the year ended 2020 of $183 million or $1.05 per share. Non-cash operating expenses for the year ended December 31, 2021, were $49 million compared to $37 million for the year ended 2020.

Net loss for the fourth quarter ended 2021 was $68 million or $0.26 per share compared to a net loss for the same period in 2020 of $38 million, or $0.20 per share. For the fourth quarter ended December 31, 2021, our cash used in operations was $23 million compared to $36 million for the same period in 2020.

Webcast

A live webcast and replay of the conference call will be accessible from the Events & Presentations page of the Company’s website at View Source and via View Source

On March 1, 2022 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, reported fourth quarter and full year 2021 financial results (Press release, Precigen, MAR 1, 2022, View Source [SID1234609251]).

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"In 2021, Precigen was able to demonstrate significant progress in our core therapeutic platforms with indicators of strong early efficacy and favorable safety profiles across each of our most clinically advanced assets," said Helen Sabzevari, PhD, President and CEO of Precigen. "As we advance assets with the most promising paths to licensure, we will continue to focus on strengthening our financial position by continuing to ensure operational efficiency while seeking strategic non-dilutive funding opportunities where appropriate."

Key Business Highlights

Public Offering: In January, Precigen closed a public offering of 17,250,000 shares of common stock, which resulted in gross proceeds to Precigen of approximately $129.4 million before deducting the underwriting discount and other offering expenses payable by Precigen;
PRGN-3006 UltraCAR-T in Acute Myeloid Leukemia (AML): In 2021, enrollment in the dose escalation phase of the Phase 1/1b PRGN-3006 UltraCAR-T clinical trial for the treatment of patients with relapsed or refractory AML or higher-risk myelodysplastic syndromes (MDS) was completed for both the lymphodepletion and non-lymphodepletion cohorts. Interim data for patients treated in Dose Levels 1-3 of the non-lymphodepletion cohort and Dose Levels 1-2 of the lymphodepletion cohort were presented at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in December 2021;
PRGN-3005 UltraCAR-T in Ovarian Cancer: In 2021, enrollment in the dose escalation phase of the Phase 1/1b clinical trial for the treatment of patients with advanced, recurrent platinum-resistant ovarian cancer was completed for both the intraperitoneal (IP) and intravenous (IV) arms. Interim data for patients treated in Dose Levels 1-3 of the IP arm were presented at the Company’s 2021 research and development (R&D) Virtual Event in November 2021;
PRGN-3007 Next Generation UltraCAR-T with Intrinsic PD-1 Inhibition: In 2021, Precigen received investigational new drug (IND) application clearance from the US Food and Drug Administration (FDA) to initiate a Phase 1 study of PRGN-3007 UltraCAR-T in advanced receptor tyrosine kinase-like orphan receptor 1 positive (ROR1+) hematological tumors, including chronic lymphocytic leukemia (CLL), mantle cell leukemia (MCL), acute lymphoblastic leukemia (ALL) and diffuse large B-cell lymphoma (DLBCL) and solid tumors, including triple negative breast cancer (TNBC). An abstract highlighting PRGN-3007 preclinical data was presented as a poster presentation at the 63rd ASH (Free ASH Whitepaper) Annual Meeting and Exposition in December 2021;
PRGN-2012 AdenoVerse Immunotherapy in Recurrent Respiratory Papillomatosis (RRP): In 2021, Precigen received IND clearance from the FDA to initiate a Phase 1 study of PRGN-2012, an off-the-shelf (OTS) AdenoVerse immunotherapy, in patients with RRP and began dosing patients in the study. Precigen completed enrollment in the Phase 1 dose escalation and expansion cohorts. Interim data for the Phase 1 study were presented at the Company’s 2021 R&D Virtual Event in November 2021;
PRGN-2009 AdenoVerse Immunotherapy in HPV-associated Cancers: In 2021, Precigen completed enrollment in the PRGN-2009 Phase 1 monotherapy arm and enrollment is ongoing in the Phase 1 combination arm of the study. The Phase 2 monotherapy arm in newly diagnosed oropharyngeal squamous cell carcinoma (OPSCC) patients is also ongoing. In November 2021, interim data for patients in the Phase 1 monotherapy and combination arms were presented at the Company’s 2021 R&D Virtual Event and Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2021 Annual Meeting; and
AG019 ActoBiotics in Type 1 Diabetes (T1D): In 2021, Precigen completed the Phase 1b/2a AG019 ActoBiotics clinical trial in T1D. Positive results from the trial were presented at the Federation of Clinical Immunology Societies (FOCIS) Virtual Annual Meeting in June 2021 and European Association for the Study of Diabetes (EASD) 57th Annual Meeting in October 2021.
Fourth Quarter and Full Year 2021 Financial Highlights

Net cash used in operating activities of $55.8 million in 2021 compared to $77.0 million in 2020;
Net proceeds received from the issuance of common stock in January 2021 were $121.0 million;
Cash, cash equivalents, and short-term and long-term investments totaled $163.7 million as of December 31, 2021;
The Company anticipates that its cash, cash equivalents and short-term and long-term investments as of December 31, 2021 should enable the Company to fund operations well into 2023, assuming the Company’s programs advance as currently contemplated; and
The Company’s non-core businesses continued to generate increased revenues and profitability.
Fourth Quarter 2021 Financial Results Compared to Prior Year Period
For the quarter ended December 31, 2021, R&D expenses increased $2.3 million, or 22%, from the quarter ended December 31, 2020. This was primarily the result of an increase in salaries, benefits, and other personnel costs of $1.4 million and an increase in contract research organization costs and lab supplies of $0.8 million due primarily to the advancement of the Company’s clinical and preclinical programs. Selling, general and administrative (SG&A) expenses decreased $13.3 million, or 44%, due primarily to a noncash $11.4 million loss on a settlement agreement in the prior year as well as decreased salary, benefit and other personnel costs, including noncash share-based compensation expenses attributable to equity grants made in the first quarter of 2020. Net loss from continuing operations was $25.0 million, or $(0.13) per share for the quarter ended December 31, 2021, of which $5.0 million was for noncash charges, compared to net loss from continuing operations in the prior year’s fourth quarter of $39.7 million, or $(0.22) per share, of which $19.7 million was for noncash charges in 2020.

Total revenues increased $4.9 million, or 25%, over the quarter ended December 31, 2020. This was primarily the result of product and service revenues generated by Trans Ova and Exemplar, which increased $5.8 million. This increase was due to higher customer demand for Trans Ova’s products and services as a result of stronger beef and dairy industries in the current year and a change in pricing structure with certain customers, as well as increased services provided by Exemplar to new and existing customers. Collaboration and licensing revenues decreased $0.8 million primarily due to a decrease in the recognition of previously deferred revenue in the current period resulting from fewer services being performed pursuant to the Company’s historical collaboration agreements.

Full Year 2021 Financial Results Compared to Prior Year Period
For the year ended December 31, 2021, R&D expenses increased $8.5 million, or 20%, over the prior year. This was the result of an increase in contract research organization costs and lab supplies of $6.7 million due primarily to the advancement of the Company’s clinical and preclinical programs. SG&A expenses decreased $17.6 million, or 19%, from the prior year due primarily to certain costs incurred in 2020 that were not recurring in 2021 and a reduction in salary, benefit and other personnel costs. Costs incurred in 2020 that did not recur in 2021 included $13.9 million for certain legal settlements. Salaries, benefits, and other personnel costs decreased $4.9 million in 2021 primarily due (i) to reduced headcount as the Company scaled down its corporate functions to support a more streamlined organization and (ii) reduced stock compensation costs for previously granted awards that became fully vested in early 2021. Net loss from continuing operations for the year ended December 31, 2021 was $96.8 million, or $(0.49) per share, of which $29.4 million was for noncash charges compared to net loss from continuing operations of $103.8 million in the prior year, or $(0.62) per share, of which $45.9 million was for noncash charges in 2020.

Total revenues were comparable year-over-year, with increased revenues generated by Trans Ova and Exemplar being offset by a decrease in collaboration and licensing revenue as a result of the Company’s changing business. The increase in Trans Ova and Exemplar revenues was $21.6 million. This increase was primarily due to higher customer demand for Trans Ova’s products and services as a result of stronger beef and dairy industries in the current year, as well as increased services provided by Exemplar to new and existing customers combined with a change in pricing structure with certain customers for both Trans Ova and Exemplar. Collaboration and licensing revenues decreased $20.7 million as the Company accelerated the recognition of previously deferred revenue in the prior period upon the mutual termination of two of its collaboration agreements in 2020. Gross margin on products and services improved as a result of the increased revenues, the change in pricing structure for certain customers, and operational efficiencies that have been gained through reductions in workforce and improved inventory management.

On March 1, 2022 Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune and inflammatory diseases, reported that members of its management team will participate at the following investor conferences in March 2022 (Press release, Alpine Immune Sciences, MAR 1, 2022, View Source [SID1234609250]):

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Cowen’s 42nd Annual Health Care Conference
Date: Monday, March 7, 2022
Time: 2:50 p.m. ET/11:50 a.m. PT
Event: Fireside Chat

Oppenheimer 32nd Annual Healthcare Conference
Date: Thursday, March 17, 2022
Time: 2:40 p.m. ET/11:40 a.m. PT
Event: Fireside Chat

Webcasts of the Cowen and Oppenheimer fireside chats will be available online in the investor relations section of the company’s website at View Source A replay of the fireside chats will be available on the company website for 90 days following the webcast.

On March 1, 2022 AbbVie (NYSE: ABBV) reported that it will participate in the Cowen 42nd Annual Health Care Conference on Tuesday, March 8, 2021 (Press release, AbbVie, MAR 1, 2022, https://news.abbvie.com/news/press-releases/abbvie-to-present-at-cowen-42nd-annual-health-care-conference.htm [SID1234609249]). Robert A. Michael, vice chairman, finance and commercial operations and chief financial officer, Michael E. Severino, M.D., vice chairman and president, and Jeffrey R. Stewart, executive vice president, chief commercial officer, will present virtually at 11:50 a.m. Central Time.

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A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.