On February 9, 2022 Purple Biotech Ltd. ("Purple Biotech", or the "Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class, effective and durable therapies by overcoming tumor immune evasion and drug resistance, reported financial results for the year and the six months ended December 31, 2021 (Press release, Purple Biotech, FEB 9, 2022, View Source [SID1234607877]).

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"We achieved significant progress in the advancement of our promising oncology pipeline during this year with notable data releases in both of our lead candidates," said Gil Efron, President and Chief Financial Officer of Purple Biotech. "For NT219, we are currently treating patients in the fourth dose cohort monotherapy arm of the ongoing Phase 1/2 clinical trial and have initiated the first dose level in the combination arm of the study together with cetuximab for patients with squamous cell carcinoma of head and neck (SCCHN). For CM24, we are about to complete dose escalation of the phase 1b/2 of the study and will soon initiate the expansion arms of the study in non-small-cell lung cancer (NSCLC) and pancreatic cancer. We are encouraged by the preliminary data reported from the first patients treated in each of the studies released in 2021 and are planning to expand both programs to additional promising indications in 2022."

"We continue to be focused on development of our robust oncology programs, supported by a strong balance sheet. With $47.4 million in cash, cash equivalent, short and long-term deposits at the end of December 2021, our cash runway extends into 2024," concluded Mr. Efron.

Financial Results for the Year Ended December 31, 2021

Research and Development Expenses were $11.8 million, an increase of $4.6 million, or 64%, compared to $7.2 million in the same period of 2020. The increase was due to expenses related to the ongoing NT219 and CM24 clinical trials, including the manufacturing of drug for the studies.

Selling, General and Administrative Expenses were $6.1 million, compared to $6.0 million in the same period of 2020, an increase of $0.1 million.

Operating Loss was $17.9 million, an increase of $4.7 million, or 36%, compared to $13.2 million in the same period of 2020. The increase was mainly due to the increase in research and development expenses.

On a non-IFRS basis (as reconciled below), adjusted operating loss was $15.8 million, an increase of $5.2 million, compared to $10.6 million in the same period of 2020, mainly due to the increased expenses for clinical studies and manufacturing of drug for these studies.

Net Loss for 2021 was $18.5 million, or $1.05 per basic and diluted share, compared to a net loss of $28 million, or $2.45 per basic and diluted share, in 2020. The decrease in net loss was mainly due to $15.7 million in expenses related to a change in the fair value of derivatives, offset by an increase of $4.7 million in operating expenses. Adjusted net loss for the year was $15.7 million, an increase from $10.4 million in the full year of 2020.

As of December 31, 2021, Purple Biotech had cash and cash equivalents and short- and long-term deposits of $47.4 million, compared to $60.8 million on December 31, 2020. The Company believes that its cash position will provide sufficient resources to support its currently anticipated ongoing needs into 2024.

Discontinued Operation. As previously reported, COVID-19 adversely impacted the launch of Consensi in the United States. In October 2021, the Company agreed, together with its then U.S distributor for Consensi, Coeptis Pharmaceuticals Inc., to terminate the distribution agreement. Despite our efforts to identify an alternative distributor for Consensi in the U.S., we concluded that commercialization of Consensi, both in the U.S market and elsewhere, is not likely to generate significant revenue and achieve profitability in the near term. In order to reduce the expenses involved in maintaining the product, it was concluded to discontinue Consensi activities and to allocate the funds to our core oncology activities. In parallel, the agreements with Kuhnil Pharmaceuticals Inc.’s for the territory of South Korea and Hebei Changshan Biochemical Pharmaceutical Co., Ltd. for the territory of China were terminated. Consequently, the Company is reporting Consensi as a discontinued operation. Loss from discontinued operation in 2021 was $0.6 million compared to profit from discontinued operation of $0.6 million in 2020. The decrease in profit is mainly due to a decrease in Consensi revenues of $1.0 million generated in 2020.

Financial Results for the Six Months Ended June 30, 2021

Research and Development Expenses were $4.9 million, an increase of $0.6 million, or 14%, compared to $4.3 million in the same period of 2020. The increase was due to expenses related to the CM24 clinical trials that started in the first half of 2021.

Selling, General and Administrative Expenses were $2.9 million, compared to $3.9 million in the same period of 2020, a decrease of $1 million. The decrease was mainly due to a $0.9 million decrease in employee equity-based compensation (ESOP) costs.

Operating Loss was $7.8 million, a decrease of $0.5 million, or 6%, compared to $8.3 million in the same period of 2020.

On a non-IFRS basis (as reconciled below), adjusted operating loss was $7.1 million, a decrease of $0.7 million, compared to $6.4 million in the same period of 2020, mainly to decrease in Selling, General and Administrative Expenses offset by increase in R&D expenses.

Net Loss for the second half of 2021 was $8.3 million, or $0.47 per basic and diluted share, compared to a net loss of $0.2 million, or $0.01 per basic share and $0.47 per diluted share, in the second half of 2020. The increase in net loss was mainly due to decrease of $7.9 million in income related to a change in the fair value of derivatives, offset by an increase of $0.5 million in operating expenses and decrease of $1 million in revenues. Adjusted net loss for the second half of 2021 was $7.0 million, an increase from $6.3 million in the second half of 2020.

On February 9, 2022 Seagen Inc. (Nasdaq:SGEN) reported financial results for the fourth quarter and year ended December 31, 2021 (Press release, Seagen, FEB 9, 2022, View Source [SID1234607898]). The Company also highlighted ADCETRIS (brentuximab vedotin), PADCEV (enfortumab vedotin-ejfv), TUKYSA (tucatinib) and TIVDAK (tisotumab vedotin-tftv) commercial and development accomplishments, as well as progress across its robust oncology pipeline.

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"Total revenues of $1.6 billion in 2021 were driven by strong net product sales and reflect growth across our oncology brands, as well as international launches of TUKYSA and the U.S. approval and launch of TIVDAK, our fourth marketed product," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seagen. "We are working to maximize the potential of our commercial portfolio through broad clinical development programs that are intended to support label expansions. Additionally, we are advancing our deep and diverse pipeline of more than thirteen clinical-stage programs for both solid tumors and hematologic malignancies. We expect to achieve many milestones in 2022, including important clinical data readouts, global regulatory and commercial progress, and advances across our pipeline. We are well-positioned with significant financial strength and an expanded geographic footprint to continue executing upon our strategy."

APPROVED PRODUCTS HIGHLIGHTS

ADCETRIS

Reported ADCETRIS Combination Significantly Improves Overall Survival (OS) in Newly Diagnosed Patients with Advanced Hodgkin Lymphoma: In February 2022, the Company announced that the phase 3 ECHELON-1 clinical trial demonstrated a statistically significant improvement in OS (p=0.009) in patients with advanced Hodgkin lymphoma following treatment with ADCETRIS in combination with chemotherapy. With approximately six years median follow up, patients receiving ADCETRIS plus doxorubicin, vinblastine, and dacarbazine (A+AVD) in the frontline setting had a 41 percent reduction in the risk of death (HR 0.59; [95% CI: 0.396 to 0.879]) compared with patients receiving doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD). The safety profile of ADCETRIS was consistent with previous studies and no new safety events were observed.
Presented Results from Frontline Combination Study in Hodgkin Lymphoma at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting: In December 2021, data were presented at ASH (Free ASH Whitepaper) from a phase 2 study demonstrating that frontline treatment with ADCETRIS in combination with nivolumab, doxorubicin and dacarbazine (AN+AD) showed a complete response rate of 88 percent, an overall response rate of 93 percent and a favorable safety profile in patients with stage III/IV Hodgkin lymphoma.
PADCEV

Completed Enrollment in EV-103 Cohort K for First-Line Metastatic Urothelial Cancer (mUC): In October 2021, Seagen and Astellas completed enrollment in Cohort K of the EV-103 trial. The cohort is evaluating PADCEV in combination with KEYTRUDA and as a single agent for first-line treatment of patients with mUC who are unable to receive cisplatin-based chemotherapy. The results are expected in the second half of 2022 and, along with other data from the EV-103 trial, could potentially support registration under the FDA’s accelerated approval pathway.
Received Positive CHMP (Committee for Medicinal Products for Human Use) Opinion: In December 2021, Seagen and Astellas announced the CHMP of the European Medicines Agency (EMA) adopted a positive opinion recommending approval as monotherapy for previously treated mUC. The European Commission decision-making process has been paused for additional CHMP questions related to severe skin reactions in a French compassionate access program.
Reporting Initial Results in Patients with Muscle-Invasive Bladder Cancer (MIBC) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU): Initial results from Cohort H of the EV-103 trial evaluating PADCEV as neoadjuvant monotherapy in patients with MIBC who are ineligible for cisplatin-based chemotherapy will be presented at the ASCO (Free ASCO Whitepaper) GU meeting being held February 17-19.
TUKYSA

Presented Updated Results from Pivotal HER2CLIMB Trial at the San Antonio Breast Cancer Symposium (SABCS): In December 2021, multiple abstracts highlighting TUKYSA were presented at SABCS. One presentation described exploratory analyses from the pivotal HER2CLIMB trial showing that patients with stable and active brain metastases treated with a TUKYSA regimen maintained a survival benefit compared to patients on the control therapy after an additional 15.6 months of follow-up.
Completed Enrollment in MOUNTAINEER trial for Metastatic Colorectal Cancer: In September 2021, the Company completed enrollment in the phase 2 MOUNTAINEER trial of TUKYSA in combination with trastuzumab and as a single agent in patients with HER2-positive metastatic colorectal cancer following previous treatment with first- and second-line standard-of-care therapies. The results are expected in the second half of 2022 and could potentially support registration under the FDA’s accelerated approval pathway.
Initiating Phase 3 HER2CLIMB-05 Trial in the Frontline Maintenance Setting: The Company expects to treat the first patient in a phase 3 trial evaluating TUKYSA or placebo in combination with standard of care frontline trastuzumab and pertuzumab as maintenance therapy for patients with metastatic HER2-positive breast cancer in the first quarter of 2022.
TIVDAK

Reporting Initial Results from Solid Tumor Basket Trial: Initial data from the innovaTV 207 phase 2 trial of TIVDAK in solid tumors will be presented at the Multidisciplinary Head and Neck Cancers Symposium to be held February 24-26.
PIPELINE PROGRAMS HIGHLIGHTS

Presented Data from SEA-CD40 in Combination with Other Therapies in Metastatic Pancreatic Cancer at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancer Symposium (ASCO GI): In January 2022, data from a phase 1 trial of SEA-CD40 in combination with chemotherapy and an anti-PD-1 in metastatic pancreatic cancer were presented at ASCO (Free ASCO Whitepaper) GI, demonstrating evidence of immune activation in patients with an acceptable safety profile and encouraging antitumor activity. Follow-up for survival is ongoing and will inform future development decisions.
Reported Data from SEA-BCMA at ASH (Free ASH Whitepaper) Annual Meeting: In December 2021,the Company reported data from a phase 1 trial evaluating SEA-BCMA in relapsed or refractory multiple myeloma patients. SEA-BCMA demonstrated an encouraging early safety and efficacy profile and the Company is enrolling an expansion cohort and evaluating additional combination regimens.
Initiated Phase 1 Trials with Novel Antibody-Drug Conjugates (ADCs): In January 2022, the Company initiated phase 1 clinical trials of two novel ADCs, SGN-PDL1V and SGN-B7H4V, for advanced solid tumors. The programs are based on promising antitumor activity demonstrated in preclinical studies.
For additional information on Seagen’s pipeline, visit www.seagen.com/science/pipeline.

CORPORATE HIGHLIGHTS

Appointed Lee Heeson, Executive Vice President (EVP), Commercial International: In February 2022, the Company announced the appointment of Lee Heeson as EVP, Commercial International. He is responsible for the continued expansion of Seagen’s Commercial operations in Europe, Canada and the rest of the world outside the United States. Mr. Heeson succeeded Tuomo Pätsi, who retired effective February 4, 2022.
Published Inaugural Corporate Responsibility Report: In December 2021, the Company issued its first Corporate Responsibility Report providing a comprehensive overview of environment, social, and governance priorities, achievements, and future commitments.
FOURTH QUARTER AND FULL YEAR 2021 FINANCIAL RESULTS

Revenues: Total revenues in the fourth quarter and year ended December 31, 2021 were $429.9 million and $1.574 billion, respectively, compared to $601.3 million and $2.176 billion for the same periods in 2020. Collaboration revenues for the fourth quarter and full year 2020 reflected license revenue related to the agreements with Merck for ladiratuzumab vedotin and TUKYSA (see Collaboration and License Agreement Revenues section below).

Revenues were comprised of the following components:

Collaboration and License Agreement Revenues

14.7

267.9

(95)%

38.3

1,048.2

(96)%

Note: Sum of product sales may not equal total net product sales due to rounding.

Net Product Sales: The increase in net product sales for the periods in 2021 compared to the same periods in 2020 were primarily attributable to TUKYSA and PADCEV. TUKYSA growth was driven by continued penetration in its current indication in the U.S. in addition to global expansion following approval in the European Union in February 2021. PADCEV growth was driven by continued penetration in the initial indication as well as by FDA approval in July 2021 for PADCEV’s use in an additional indication. ADCETRIS also generated modest growth, partially related to greater use in frontline advanced Hodgkin lymphoma. TIVDAK was approved by the FDA in September 2021.
Royalty Revenues: Royalty revenues are primarily driven by sales of ADCETRIS outside the U.S. and Canada by Takeda and, to a lesser extent, royalties from sales of Polivy (polatuzumab vedotin) by Roche and Blenrep (belantamab mafodotin) by GlaxoSmithKline, which are ADCs that use Seagen technology.
Collaboration and License Agreement Revenues: The decrease in collaboration and license agreement revenues for 2021 compared to 2020 is the result of $250.1 million recognized in the fourth quarter of 2020 and $975.2 million recognized in the full year 2020 related to the Merck collaborations for ladiratuzumab vedotin and TUKYSA that were entered into in September 2020. The 2021 periods reflect amounts earned under the Company’s collaboration agreements.
Cost of Sales: Cost of sales in the fourth quarter were $86.7 million, compared to $61.8 million in the fourth quarter of 2020. Cost of sales were $311.6 million for the full year in 2021, compared to $217.7 million for the same period in 2020. The increases in 2021 were primarily related to the gross profit share owed to our collaboration partners which were $46.2 million and $162.0 million in the fourth quarter and full year in total, respectively, compared to $32.1 million and $104.6 million for the same periods in 2020. Cost of sales also reflect amortization of TUKYSA acquired in-process technology costs, third-party royalties owed for ADCETRIS, PADCEV and TUKYSA net product sales, and cost of products sold.

Research and Development (R&D) Expenses: R&D expenses in the fourth quarter were $304.3 million, compared to $216.2 million in the fourth quarter of 2020. R&D expenses were $1.229 billion for the full year in 2021, compared to $827.1 million in 2020. The increase in full year 2021 primarily reflected a $200 million upfront payment due under the RemeGen collaboration agreement for disitamab vedotin. Additionally, the increase in R&D expenses was attributable to continued investment in clinical development of the Company’s approved drugs and to advance novel programs and technologies.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses in the fourth quarter were $210.9 million, compared to $158.4 million in the fourth quarter of 2020. SG&A expenses were $716.2 million for the full year in 2021, compared to $533.8 million for the same period in 2020. The increases in 2021 primarily reflected investments to support ongoing European TUKYSA launches and the U.S. commercial launch of TIVDAK.

Non-cash share-based compensation cost for the full year in 2021 was $173.1 million, compared to $147.2 million for the same period in 2020.

Net Income / Loss: Net loss for the fourth quarter of 2021 was $174.6 million, or $0.95 per diluted share, compared to net income of $167.1 million, or $0.90 per diluted share, for the fourth quarter of 2020. For the full year in 2021, net loss was $674.5 million, or $3.70 per diluted share, compared to net income of $613.7 million, or $3.37 per diluted share, for the year in 2020. Net loss in full year 2021 was impacted by the $200 million upfront payment owed to RemeGen. Net income for the 2020 periods were driven by the revenue recognized under the Merck collaborations.

Cash and Investments: As of December 31, 2021, Seagen had $2.2 billion in cash and investments.

2022 FINANCIAL OUTLOOK

Seagen anticipates 2022 revenues, operating expenses and other costs to be in the ranges shown in the table below.

1. TIVDAK sales guidance not provided and is excluded from product sales and total revenues guidance.

2. Non-cash costs include share-based compensation, depreciation and amortization of intangible assets.

Conference Call Details

Seagen management will host a conference call and webcast with supporting slides to discuss its fourth quarter and full year 2021 financial results and provide an update on business activities. The event will be held today at 1:30 p.m. Pacific Time (PT); 4:30 p.m. Eastern Time (ET). The live event will be simultaneously webcast and available for replay from the Seagen website at investor.seagen.com. Investors may also participate in the conference call by calling 844-763-8274 (domestic) or 412-717-9224 (international). The conference ID is 10163004. Supporting slides are available on the Seagen website at investor.seagen.com under the Investors section. A webcast replay will be archived on the Company’s website investor.seagen.com, under the Investors section.

On February 9, 2022 Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses, reported that Company’s Management will provide a corporate update and participate in one-on-one investor meetings at the SVB Leerink 11th Annual Global Healthcare Conference, to be held virtually February 14-18, 2022 (Press release, Selecta Biosciences, FEB 9, 2022, View Source [SID1234607914]).

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SVB Leerink 11th Annual Global Healthcare conference
Format: Presentation and one-on-one investor meetings
Presentation Date: Friday February 18th, 2022
Presentation Time: 1:00 p.m. EST
Webcast: Click Here

An archived webcast will also be accessible in the Investors & Media section of the company’s website at www.selectabio.com.

On February 9, 2022 AKSO Biopharmaceutical, Inc. ("AKSO"), a global biopharmaceutical company with an innovative and comprehensive approach to treat cancer, autoimmune disease, and genetic disorder, and Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Huadong Medicine Co., Ltd. (SZ.000963) ("Huadong Medicine"), a leading pharmaceutical company in Asia, reported that the companies have entered into an exclusive collaboration to develop and commercialize AB002, a bi-functional fusion protein inhibiting immune checkpoint and activating natural killer (NK) cells for the treatment of solid tumors, in the Asia Pacific Ex-Japan region. AKSO will retain all rights to AB002 in the rest of the world (Press release, AKSO Biopharmaceutical, FEB 9, 2022, View Source [SID1234607929]).

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This strategic collaboration enables AKSO to leverage Huadong Medicine’s leading expertise in clinical development, regulatory approval, and commercialization to access the second largest pharmaceutical market in the world, while augmenting Huadong Medicine’s portfolio of first-in-class innovative drug candidates and further cementing Huadong Medicine’s leadership position in the region.

"The strategic collaboration is an important milestone for AB002 as Huadong Medicine’s expertise and experience in drug development, and mature clinical and sales network will enable us to become the first to market in the critical region," said Amato Giaccia, Ph.D., Senior Scientific Strategist and Chairman of AKSO. "AB002 is a first-in-class molecule that leverages AKSO’s proprietary DEEP platform to neutralize PD-L2 and PD-L1, while activating NK cells via an IL-15 agonist. This unique approach addresses the immune-suppressive environment frequently found in patients not responding to immune checkpoint inhibitors. Furthermore, AB002’s precision cell targeting ability promotes NK cell activation in the tumor microenvironment. We are excited to partner with Huadong Medicine to accelerate AB002’s development and deliver this innovative therapeutic to patients with unmet urgent needs."

"AKSO Biopharmaceutical is a promising biopharmaceutical company innovating to treat cancer. AB002, which is a dual-target bi-specific fusion protein, represents the addition of an exciting cancer immunotherapy asset to Huadong Medicine’s increasing cancer therapy pipeline," stated Dongzhou J. Liu, Ph.D., Chief Scientific Officer of Huadong Medicine. "The cancer patient population is substantial in China, with unmet medical needs. Leveraging Huadong Medicine’s R&D capabilities, we will work closely with AKSO Biopharmaceutical to accelerate the development of AB002 to benefit the cancer patients all over the world."

Under the terms of the agreement, AKSO will be eligible to receive upfront and milestone payments of up to $75 million, as well as royalties from future product sales. Huadong Medicine will be responsible for clinical development, regulatory submissions and commercialization of AB002 in the region and jointly steer IND-enabling tasks with AKSO via the Joint Research Committee. AKSO will continue to be responsible for AB002’s development in the rest of the world.

AKSO is advised by Dragon Financial Partners Ltd. as financial advisor and Morrison Forrester LLP as legal counsel.

ABOUT AB002

AB002 is a late preclinical stage first-in-class bifunctional fusion protein comprising of a DEEP-engineered soluble PD-1 decoy receptor for immune checkpoint inhibition, and an IL-15 agonist for NK cell activation. AB002 traps PD-L2 and PD-L1 with ultra-high binding affinities, while activating NK cells with high precision and extended half-life.

On February 9, 2022 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (the "Company") reported that it will release its fourth quarter and year end 2021 financial results on Monday, February 28, 2022, before markets open (Press release, Aurinia Pharmaceuticals, FEB 9, 2022, View Source [SID1234607899]). Aurinia’s management team will host a conference call/webcast at 8:30 am ET that day to review the Company’s 2021 financial results, provide a general business update and discuss the Company’s outlook for 2022.

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Interested participants can dial +1-877-407-9170 (Toll-free U.S. & Canada). The audio webcast can also be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia’s website.