On February 28, 2022 Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, reported that Elisabet de los Pinos, PhD, Chief Executive Officer of Aura, will participate in the "Auditory and Ophthalmology" panel discussion at the 42nd Annual Cowen Virtual Health Care conference taking place on Monday, March 7, 2022, at 2:10 p.m. Eastern Time (Press release, Aura Biosciences, FEB 28, 2022, View Source [SID1234609163]).

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A live webcast of the panel discussion will be available on the "Investors & Media" page under the "Events & Presentations" section of the Company’s website at View Source, where a replay of the webcast will be archived for 90 days following the presentation date.

On February 28, 2022 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported that it will report its fourth quarter and full-year 2021 financial results on Thursday, March 3, 2022 (Press release, Gossamer Bio, FEB 28, 2022, View Source [SID1234609161]).

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In connection with the earnings release, Gossamer’s management team will host a live conference call and webcast at 4:30 p.m. ET on Thursday, March 3, 2022, to discuss the Company’s financial results and provide a corporate update.

A replay of the audio webcast will be available for 30 days on the Investors section of the Company’s website, www.gossamerbio.com.

On February 28, 2022 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported operating results for the fourth quarter and full year ended December 31, 2021 (Press release, Sesen Bio, FEB 28, 2022, View Source [SID1234609160]). During the fourth quarter, the Company worked with the US Food and Drug Administration (FDA) to identify an anticipated regulatory path toward potential resubmission of a Biologics License Application (BLA) for the Company’s lead program, Vicineum for the treatment of non-muscle invasive carcinoma in situ (CIS) of the bladder in patients previously treated with adequate or less than adequate bacillus Calmette-Guérin (BCG).1

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"Our interactions with the FDA during the fourth quarter provided us further clarity on the steps required to resubmit a BLA for Vicineum and to bring a therapy to market that we believe has the potential to save and improve the lives of patients," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "We have bolstered our team’s expertise in order to carry out that mission, and we look forward to executing our strategic priorities leading into, and coming out of, our upcoming Type C Meeting in March."

US Regulatory Update

On October 29, 2021, Sesen Bio participated in a productive Chemistry, Manufacturing and Controls (CMC) Type A Meeting with the FDA. Following the meeting, the Company believes it has a clear understanding of what additional information regarding CMC is required for potential resubmission of a BLA. Other key takeaways from the meeting include the FDA confirming that:
Vicineum manufactured using the proposed commercial process is comparable to Vicineum used in prior clinical trials.
Sesen Bio can utilize Vicineum manufactured during process validation for any future clinical trials needed to address issues raised in the Complete Response Letter (CRL) regarding the BLA for Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), and that any of these future trials can proceed while addressing CMC issues raised in the CRL.

On December 8, 2021, Sesen Bio participated in a productive Clinical Type A Meeting with the FDA. Following the meeting, the Company announced that it plans to conduct an additional Phase 3 clinical trial for potential resubmission of a BLA. Other key takeaways from the meeting include:
The trial design may include a randomized clinical trial assessing the safety and efficacy of Vicineum compared to investigators’ choice of intravesical chemotherapy.
The trial may include both patients who have received adequate BCG and patients who have received less than adequate BCG.
The anticipated randomized trial design is aligned with guidance the Company has received from the European Medicines Agency, which may help to coordinate the regulatory paths forward for Vicineum in the US and the European Union. The Company was also encouraged by the FDA to submit the final results from the Phase 3 VISTA trial for Vicineum for the treatment of BCG-unresponsive NMIBC with a BLA resubmission.

On January 7, 2022, the FDA granted Sesen Bio’s request for a Type C Meeting to discuss the study protocol for an additional Phase 3 clinical trial that the Company plans to conduct for potential resubmission of a BLA for Vicineum for the treatment of non-muscle invasive carcinoma in situ (CIS) of the bladder in patients previously treated with adequate or less than adequate BCG. The Type C Meeting has been scheduled for March 28, 2022.
Other Business Updates

On January 6, 2022, Sesen Bio disclosed that it achieved a $20 million milestone payment pursuant to the Company’s exclusive license agreement (Roche License Agreement) with Roche for legacy Interleukin-6 (IL-6) antagonist antibody technology owned by Sesen Bio. Following this milestone payment, Sesen Bio has cumulatively received $50 million in upfront and milestone payments, with an additional $220 million in potential future milestone payments remaining under the Roche License Agreement.

On February 25, 2022, the Board of Directors (Board) of Sesen Bio disclosed the completion of an independent internal review conducted by outside counsel with the assistance of subject matter experts (Review). The Review took place over the course of five months, involved full cooperation from the Company’s management team, a review of more than 600,000 documents, and 39 interviews of current and former employees and consultants. As a result of the Review, the Board continues to fully support the Company’s current management team and believes no changes or amendments relating to the Company’s prior disclosures to the Securities and Exchange Commission (SEC) or FDA relating to Vicineum, the Phase 3 VISTA trial for Vicineum for the treatment of BCG-unresponsive NMIBC, or the Company’s BLA for Vicineum are warranted. The Company intends to work cooperatively with the FDA in preparing for an additional Phase 3 clinical trial for Vicineum.
Fourth Quarter and Full-Year 2021 Financial Results

Cash Position: Cash, cash equivalents and restricted cash were $162.6 million as of December 31, 2021, compared to $55.4 million as of December 31, 2020. The increase of $107.2 million was due primarily to net proceeds from at-the-market (ATM) offerings.
R&D Expenses: Research and development expenses for the fourth quarter of 2021 were $7.0 million compared to $5.6 million for the same period in 2020. For the year ended December 31, 2021, research and development expenses were $25.3 million compared to $29.2 million for the same period in 2020. The full year decrease of $3.9 million was due primarily to lower costs associated with technology transfer and manufacturing ($7.4 million). This was partially offset by increases in employee-related compensation driven by increased headcount and the retention program implemented after receipt of the CRL in August 2021 ($2.1 million), regulatory and clinical consulting fees ($1.0 million) and certain other R&D expenses, none of which were individually material ($0.5 million).
G&A Expenses: General and administrative expenses for the fourth quarter of 2021 were $8.6 million compared to $3.4 million for the same period in 2020. For the year ended December 31, 2021, general and administrative expenses were $29.4 million compared to $14.3 million for the same period in 2020. The full year increase of $15.1 million was due primarily to increases in employee-related compensation ($5.0 million), legal costs ($4.8 million), and marketing and commercial expenses driven by preparation for the commercial launch prior to receipt of the CRL ($4.1 million). Additionally, accounting services ($0.4 million), insurance expenses ($0.4 million), information technology expenses ($0.3 million) and other G&A expenses, none of which were individually material ($0.1 million), contributed to the increase.
Restructuring Charge: Restructuring expenses were $5.5 million for the year ended December 31, 2021 compared to no restructuring expenses for the year ended December 31, 2020. The increase was due to one-time costs associated with the Restructuring Plan implemented in response to the CRL for severance and other employee-related costs ($2.8 million) and the termination of certain contracts ($2.7 million).
Non-Cash Related Expenses:
Intangibles impairment charge for the year ended December 31, 2021 was $31.7 million. In light of the CRL, the Company performed an interim impairment test for In-Process Research and Development (IPR&D) assets, which resulted in the decrease in fair value of Vicineum’s US rights.
The change in fair value of contingent consideration was a decrease of $56.8 million for the year ended December 31, 2021 compared to a decrease of $11.2 million for the same period in 2020. This was primarily due to management’s assessment of a lower probability of regulatory success and a refinement of timelines given the CRL.
Income Tax Benefit (Provision): Benefit from income tax was $8.3 million for the year ended December 31, 2021 compared to $1.4 million tax expense for the same period in 2020. In connection with the intangibles impairment charge in the third quarter of 2021, the Company wrote-down the associated deferred tax liability by $8.6 million as a benefit.
Net Income (Loss): Net income was $8.9 million, or $0.04 per basic and per diluted share, for the fourth quarter of 2021, compared to net loss of $15.0 million, or $0.11 per basic and diluted share, for the same period in 2020. For the year ended December 31, 2021, net loss was $0.3 million, or $0.00 per share, compared to net loss of $22.5 million, or $0.19 per share, for the same period in 2020. The full year decrease of $22.2 million in net loss was due primarily to the $20 million milestone achieved by Roche initiating a Phase II clinical study pursuant to the Roche License Agreement.
1As per the 2018 FDA guidance on NMIBC, adequate BCG is defined as at least one of the following: (i) at least five of six doses of an initial induction course plus at least two of three doses of maintenance therapy or (ii) at least five of six doses of an initial induction course plus at least two of six doses of a second induction course.

About Vicineum

Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of non-muscle invasive carcinoma in situ (CIS) of the bladder in patients previously treated with adequate or less than adequate BCG. Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached to the antibody binding fragment until it is internalized by the cancer cell. This fusion protein design is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in non-muscle invasive bladder cancer (NMIBC) cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently in the follow-up stage of a Phase 3 clinical trial in the US for the treatment of BCG-unresponsive NMIBC. In February 2021, the FDA accepted the Company’s Biologics License Application (BLA) file for Vicineum for the treatment of BCG-unresponsive NMIBC, granted Priority Review for the BLA and set a Prescription Drug User Fee Act (PDUFA) date of August 18, 2021. On August 13, 2021, the Company received a Complete Response Letter (CRL) from the FDA regarding its BLA for Vicineum. After meeting with the FDA, the Company plans to conduct an additional Phase 3 clinical trial for Vicineum for the treatment of non-muscle invasive CIS of the bladder in patients previously treated with adequate or less than adequate BCG in connection with the potential resubmission of a BLA. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. For this reason, the activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

On February 28, 2022 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated oncology therapeutics, reported that Sean McCarthy, D.Phil., chief executive officer and chairman, will participate in a virtual panel discussion at the Cowen 42nd Annual Healthcare Conference on Monday, March 7, 2022 at 12:50 p.m. ET (Press release, CytomX Therapeutics, FEB 28, 2022, https://ir.cytomx.com/news-releases/news-release-details/cytomx-therapeutics-present-cowen-42nd-annual-healthcare [SID1234609159]).

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A live webcast of the panel will be available on the Events and Presentations page of CytomX’s website at www.cytomx.com. An archived replay will be available on the CytomX website for 30 days following the event. In addition, management will be available for one-on-one meetings with investors who are registered to attend the conference.

On February 28, 2022 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) reported its financial results for the fourth quarter and year ended December 31, 2021 (Press release, Aurinia Pharmaceuticals, FEB 28, 2022, View Source [SID1234609157]). Amounts, unless specified otherwise, are expressed in U.S. dollars.

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Aurinia achieved $23.4 million and $45.6 million for the quarter and full year ended December 31, 2021, respectively. These results align with the previously stated annual revenue estimate in the range of $40 to $50 million for 2021.

"In the fourth quarter 2021, we performed well against our commercial launch objectives, doubling our total revenue from the previous three quarters with increases in LUPKYNIS patient start forms and improved conversion rates and payor coverage," said Peter Greenleaf, President and Chief Executive Officer of Aurinia. "Despite unpredictable COVID realities, varying by geographic region, as well as the typical challenges we would expect to manage in the first year of a product launch, we are very pleased with the progress we have made to ensure awareness, adoption, and access to LUPKYNIS."

For fiscal year 2022, the Company is providing net revenue guidance of $115 to $135 million from sales of LUPKYNIS. This range is based on assumptions regarding the impact of COVID-19 on the current business environment and represents an increase of more than 150 to 200% in net revenue from sales of LUPKYNIS compared to fiscal year 2021.

"The positive results from the AURORA 2 two-year continuation study, announced in December 2021, will fuel our momentum and differentiate LUPKYNIS going forward as we have the first and only FDA-approved medicine for LN with three years of pivotal trial results, including long-term safety data. Outside of the U.S., we continue to work closely with our partner Otsuka Pharmaceutical Co., Ltd. (Otsuka) to secure regulatory approval of voclosporin in the EU and expand global access to this important treatment," added Mr. Greenleaf. "With a healthy balance sheet, including approximately $466.1 million of cash, cash equivalents and investments on hand as of year end, strong commercial, research and development programs, and talented, passionate employees, we are poised for continued growth and success as we work to change the course of lupus nephritis and other autoimmune diseases."

Fourth Quarter 2021 Highlights & Upcoming Milestones:

Aurinia added 477 patient start forms (PSFs) in Q4 2021, a 17% increase from Q3 2021, with a total of 1,572 PSFs received during 2021.
PSF conversion rates continue to increase with more than 70% of PSFs converted to patients on therapy. Time to convert continues to decrease since launch: 30- and 60-day conversion rates have improved each month.
Since January 2021 (launch of LUPKYNIS), the Company has secured a total of 1,773 PSFs to date.
Aurinia now has confirmed payor coverage in plans covering more than 90% of total lives in the United States.
In December 2021, the Company presented top-line data from the AURORA 2 two-year continuation study demonstrating a favorable risk/benefit profile for voclosporin over a three-year period, with safety comparable to AURORA 1, and sustained efficacy. Additional data from this study is expected to be published and presented in peer-reviewed journals and/or medical meetings throughout 2022.
Regulatory review of the European Medicines Agency (EMA) marketing authorization application (MAA) remains on track with a Committee for Medicinal Products for Human Use (CHMP) opinion expected in the second half of 2022 followed by a European Commission (EC) approval decision expected in the second half of 2022.
Further stabilized balance sheet through the utilization of an at the market offering (ATM), raising net proceeds of $196.7 million through December 31, 2021, at an average price of $19.91 and at an average discount of 2.63%. The Company has terminated the ATM sales agreement with no further sales to occur under the ATM.
Financial Liquidity at December 31, 2021

As of December 31, 2021, Aurinia had cash and cash equivalents and investments of $466.1 million compared to $422.7 million at December 31, 2020. The increase was primarily due to the receipt of net proceeds from the Company’s ATM offering, cash proceeds from the exercise of stock options and warrants and cash receipts from the sale of LUPKYNIS, offset by the commercial infrastructure spend to support the launch of LUPKYNIS. The offset also includes payments for inventory, an upfront payment made as part of a collaborative agreement with Lonza to build a dedicated manufacturing capability (or monoplant) and an upfront license payment related to its recently acquired developmental programs (AUR200 and AUR300).

Net cash used in operating activities was $157.7 million for the year ended December 31, 2021 compared to $69.9 million for the year ended December 31, 2020. The increase was primarily due to the commercial infrastructure spend to support the launch of LUPKYNIS, payments for inventory, an upfront payment made as part of a collaborative agreement with Lonza to build the monoplant, payments to advance clinical programs and one-time payments to a related party upon achievement of specific milestones partially offset by cash receipts from sales of LUPKYNIS.

The Company believes that it has sufficient financial resources to fund its current plans, which include funding commercial activities, including FDA related post approval commitments, manufacturing and packaging of commercial drug supply, funding its supporting commercial infrastructure, conducting planned research and development (R&D) programs, investing in its pipeline, executing on its business development strategy and funding its operating activities for at least the next few years.

Financial Results for the Quarter and Year Ended December 31, 2021

Total net revenue was $23.4 million and $50.0 million for the quarters ended December 31, 2021 and December 31, 2020, respectively. Total net revenue was $45.6 million and $50.1 million for the years ended December 31, 2021 and December 31, 2020, respectively. The net revenue for the quarter ended and year ended December 31, 2021, primarily consisted of commercial sales of LUPKYNIS, following FDA approval in January of 2021. Total revenue for the quarter and year ended December 31, 2020, was primarily due to an upfront payment from Otsuka of $50.0 million resulting from entering into its collaboration agreement with Otsuka.

Cost of sales were $0.5 million and nil for the quarters ended December 31, 2021 and December 31, 2020, respectively. Cost of sales were $1.1 million and nil for the years ended December 31, 2021 and December 31, 2020, respectively. In 2020, the Company did not have any drugs approved for commercial sale and the upfront payment from Otsuka did not have cost of sales associated with it. Gross margin for the three and twelve months ended December 31, 2021 was approximately 98%.

Selling, general and administrative (SG&A) expenses were $44.2 million and $38.8 million for the quarters ended December 31, 2021 and December 31, 2020, respectively. For the years ended December 31, 2021 and December 31, 2020, SG&A expenses were $171.4 million and $96.0 million, respectively. The increase for both periods was due to the increase in salaries, incentive pay and employee benefits related to the expansion of the commercial and administrative functions to support the launch and commercialization of LUPKYNIS which ramped up during the third quarter of 2020. Also contributing was an increase in travel, trade shows and sponsorships connected with the sales activity occurring in 2021.

Non-cash SG&A share-based compensation expense were $7.2 million and $4.5 million for the quarters ended December 31, 2021 and December 31, 2020, respectively. For the years ended December 31, 2021 and December 31, 2020, non-cash share-based compensation expense were $26.4 million and $13.6 million, respectively.

For the quarters ended December 31, 2021 and December 31, 2020, research and development (R&D) expenses were $11.1 million and $13.2 million, respectively. The primary driver for the decrease was due to the decrease in salaries, incentive pay and employee benefits due to the allocation of costs related to post approval support of LUPKYNIS to SG&A.

For the years ended December 31, 2021 and December 31, 2020, R&D expenses were $51.1 million and $50.3 million, respectively. The primary drivers for the increase were due to the upfront license and accrued milestone expenses related to its recently acquired developmental programs, AUR200 and AUR300, and higher clinical research organization expenses related to its new clinical programs offset by a decrease in voclosporin development costs following the approval of LUPKYNIS.

Non-cash R&D share-based compensation expense were $1.2 million and $0.6 million for quarters ended December 31, 2021 and December 31, 2020, respectively. For the years ended December 31, 2021 and December 31, 2020, non-cash share-based compensation expense were $4.4 million and $3.7 million, respectively.

For the quarter ended December 31, 2021, Aurinia recorded a net loss of $33.3 million or $0.25 net loss per common share, as compared to a net loss of $8.1 million or $0.06 net loss per common share for the quarter ended December 31, 2020. For the year ended December 31, 2021, Aurinia recorded a net loss of $181.0 million or $1.40 net loss per common share as compared to a net loss of $102.7 million or $0.87 net loss per common share for the previous period.

This press release is intended to be read in conjunction with the Company’s consolidated financial statements and Management’s Discussion and Analysis for the year ended December 31, 2021 in the Company’s Annual Report on Form 10-K, which will be accessible on Aurinia’s website at www.auriniapharma.com, on SEDAR at www.sedar.com or on EDGAR at www.sec.gov/edgar.

Conference Call Details

Aurinia will host a conference call and webcast to discuss the quarter and year ended December 31, 2021 financial results today, Monday, February 28, 2022 at 8:30 a.m. ET. The audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. In order to participate in the conference call, please dial +1-877-407-9170 (Toll-free U.S. & Canada).

About Lupus Nephritis

LN is a serious progression of systemic lupus erythematosus (SLE), a chronic and complex autoimmune disease. About 200,000-300,000 people live with SLE in the U.S. and approximately one out of three of these individuals have already developed LN at the time of SLE diagnosis. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in kidney failure. Black and Asian individuals with SLE are four times more likely to develop LN and individuals with Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.