On May 10, 2022 Sensei Biotherapeutics, Inc. (NASDAQ: SNSE), an immunotherapy company focused on the discovery and development of next generation therapeutics for cancer, reported financial results for the first quarter ended March 31, 2022, and provided recent corporate updates (Press release, Sensei Biotherapeutics, MAY 10, 2022, View Source [SID1234614052]).

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"We continue to make significant progress in the development of our TMAb platform, which is designed to address the challenge of resistance to checkpoint blockade. New preclinical data show that SNS-101, our anti-VISTA antibody, binds selectively in low-pH environments to inhibit tumor growth, offering high potential for therapeutic benefit while avoiding the pharmacokinetic sinks and on-target, off-tumor toxicities that have made multiple immune targets difficult to drug," said John Celebi, president and chief executive officer of Sensei Biotherapeutics. "Importantly, we have extended our cash runway into the first quarter of 2025 by prioritizing near-term milestones for SNS-101 and other TMAb programs, while also continuing to optimize our ImmunoPhage platform."

Highlights and Milestones

TMAb (Tumor Microenvironment Activated Biologics) Platform

SNS-101

Sensei continues preclinical studies to evaluate SNS-101, a monoclonal antibody targeting the immune checkpoint VISTA (V-domain Ig suppressor of T cell activation), which is implicated in resistance to PD-1/PD-L1 and correlates with poor survival across numerous cancers. Recent updates for SNS-101 include:

In April 2022 Sensei presented preclinical data demonstrating that SNS-101 had a favorable pharmacokinetic profile in a single-dose mouse model. Notably, pH-selective SNS-101 demonstrated a long mean residence time in the blood, indicating a lack of significant target-mediated drug disposition and clearance in non-malignant tissues.
SNS-101 demonstrated synergistic anti-tumor activity in vivo in combination with anti-PD-1 in a MC38 syngeneic tumor model in human VISTA knock-in mice.
SNS-101 has demonstrated great manufacturing productivity to date and Sensei anticipates reviewing pharmacokinetic and toxicology data from its single dose non-human primate studies in mid-2022.
Sensei has initiated GMP manufacturing for SNS-101 and remains on track to submit an IND in the first half of 2023.
SNS-102

Sensei intends to select a product candidate and initiate IND-enabling studies in 2023 for SNS-102, a monoclonal antibody targeting VSIG4 (V-Set and Immunoglobulin Domain Containing 4), a B7-family related protein that is frequently overexpressed on tumor-associated macrophages.
VSIG4 is a potent inhibitor of T-cell activity and potential driver of immunosuppressive macrophage polarization. Given its expression within normal tissues and the resulting potential safety challenges, Sensei believes that VSIG4 is an ideal candidate for development through its TMAb platform.
Sensei has generated the first set of parental tumor-selective antibodies targeting VSIG4 aimed at developing an inhibitory antibody with high selectivity for VSIG4 in the tumor microenvironment versus normal tissue environments.
SNS-103

Sensei remains on track to select a product candidate in 2023 for SNS-103, a monoclonal antibody targeting ENTPDase1 (ecto-nucleoside triphosphate diphosphohydrolase-1, also known as CD39), the upstream, rate-limiting enzyme leading to the breakdown of extracellular ATP.
ImmunoPhage Platform and SNS-401-NG

Sensei is optimizing its ImmunoPhage platform to offer a potentially transformative approach to generating new T cells to fight cancer, with potential to address multiple tumor types. Current work in this platform area extending into 2023 is focused on SNS-401-NG, a potential first-in-class, multi-antigenic bacteriophage designed to deliver anti-tumor antigens to the immune system. Sensei believes that a measured approach to development will position the company to advance the most potent ImmunoPhage product candidate when ready.

Corporate

In April 2022, Robert Pierce, M.D., Chief R&D Officer, presented an update on SNS-101 at the World Vaccine Congress, held April 18-21, 2022, in Washington DC.
In March 2022, Sensei announced the appointment of William Ringo as Chair of the Board of Directors.
In January 2022, Sensei announced the promotions of Erin Colgan to Chief Financial Officer and Robert Pierce, M.D., to Chief R&D Officer.
First Quarter 2022 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $136.2 million as of March 31, 2022, as compared to $147.6 as of December 31, 2021. Sensei expects the current cash balance to fund operations into the first quarter of 2025.

Research and Development (R&D) Expenses: R&D expenses were $7.5 million for the quarter ended March 31, 2022, compared to $3.4 million for the quarter ended March 31, 2021. The increase in R&D expenses was primarily attributable to increased headcount to support Sensei’s research, development, and manufacturing activities.

General and Administrative (G&A) Expenses: G&A expenses were $5.0 million for the quarter ended March 31, 2022, compared to $4.6 million for the quarter ended March 31, 2021, with the increase mainly driven by franchise tax increases. The company is focused on carefully managing the growth of G&A expenses in the near term.

Net Loss: Net loss was $12.4 million, for the quarter ended March 31, 2022, compared to $8.0 million for the quarter ended March 31, 2021.

On May 10, 2022 Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, reported that, as previously announced, a presentation entitled "Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination for Glioblastoma" will be made today at 11:10 a.m., at the Frontiers of Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) of the New York Academy of Sciences (Press release, Northwest Biotherapeutics, MAY 10, 2022, View Source [SID1234614069]). The presentation will be made by Dr. Paul Mulholland of University College Hospital.

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This presentation can be viewed virtually by registering online at the Academy’s website at: View Source

Additionally, the slides used in the presentation will be posted online concurrently with or promptly following the presentation at Virtualtrials.org/Dcvax. The slides will not be posted on the Company’s website.

On May 10, 2022 Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs), reported financial results for the first quarter ended March 31, 2022 and highlighted recent corporate progress (Press release, Avidity Biosciences, MAY 10, 2022, View Source [SID1234614084]).

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"This year will prove to be significant for Avidity as we look forward to sharing a mid-point update from the AOC 1001 MARINATM trial in adults with myotonic dystrophy type 1 in Q4 and advancing two additional programs, AOC 1020 and AOC 1044, into the clinic," said Sarah Boyce, president and chief executive officer. "We continue to build our infrastructure to support our goal of having three programs addressing three distinct rare diseases in clinical development by the end of this year. With our AOC platform technology, we aim to revolutionize the delivery of RNA therapeutics as we fulfill our mission of profoundly improving people’s lives affected by serious diseases."

"We are well funded into 2024 with a cash balance of $397 million at the end of Q1 2022. This will allow us to complete the AOC 1001 MARINA trial, advance our programs for facioscapulohumeral muscular dystrophy and Duchenne muscular dystrophy Exon 44 into the clinic and continue to progress our AOC platform in other indications," said Mike MacLean, chief financial and chief business officer.

Recent Highlights

Presented two oral and three poster presentations at the American Academy of Neurology (AAN) 2022 Annual Meeting. Key highlights included:
A review of the MARINA trial including a high level update on safety and enrollment. The company reiterated that the trial is on track for a preliminary assessment in approximately half of patients in Q4 2022
Data from an in vivo proof-of-concept study using the MDX mouse model supporting Avidity’s Duchenne muscular dystrophy programs and demonstrating that an AOC effectively delivered RNA therapeutics to muscle and heart tissues
Appointed Steve Hughes, M.D., as chief medical officer and, in April, expanded the role of Michael MacLean to chief financial and chief business officer.
First Quarter 2022 Financial Results

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities totaled $397.1 million as of March 31, 2022, compared to $405.5 million as of December 31, 2021.
Collaboration Revenue: Collaboration revenue, including reimbursable expenses, primarily relates to Avidity’s partnership with Eli Lilly and Company and totaled $1.8 million for the first quarter of 2022 compared with $2.7 million for the first quarter of 2021.
Research and Development (R&D) Expenses: R&D expenses include external and internal costs associated with research and development activities. These expenses were $27.7 million for the first quarter of 2022 compared with $20.7 million for the first quarter of 2021. The increase was primarily driven by the advancement of AOC 1001, AOC 1020 and AOC 1044, as well as costs related to the expansion of the company’s overall research capabilities.
General and Administrative (G&A) Expenses: G&A expenses primarily consist of employee-related expenses, professional fees, insurance costs, and patent filing and maintenance fees. These expenses were $8.6 million for the first quarter of 2022 compared with $5.9 million for the first quarter of 2021. The increase was primarily due to higher personnel costs and professional fees to support the company’s expanded operations.

On May 10, 2022 PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, reported financial results for the first quarter ended March 31, 2022, and provided a corporate update (Press release, PMV Pharma, MAY 10, 2022, View Source [SID1234614100]).

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"Our priority in 2022 is execution of the ongoing Phase 1/2 trial evaluating PC14586, our investigational first-in-class p53 Y220C reactivator, in patients with solid tumors, as well as continued progress on our pipeline" said David Mack, Ph.D., President, and Chief Executive Officer. "We look forward to presenting initial data from the Phase 1 dose escalation trial at the 2022 ASCO (Free ASCO Whitepaper) annual meeting."

Corporate Highlights:

PC14586 initial data from the dose escalation portion of the Phase 1/2 PYNNACLE study selected for an oral presentation at the 2022 ASCO (Free ASCO Whitepaper) annual meeting on June 7th. For more information on the Phase 1/2 trial, refer to www.clinicaltrials.gov (NCT study identifier NCT04585750).
Poster titled "Small Molecule Reactivators of Y220C Mutant p53 Modulate Tumor Infiltrating Leukocytes and Synergize with Immune Checkpoint Inhibitors" presented at the American Association of Cancer Research Annual Meeting 2022.
Continued progress on research pipeline with WIP1 (Wild-Type p53-Induced Phosphatase) inhibitor and p53 mutant programs.
First Quarter 2022 Financial Results

As of March 31, 2022, PMV Pharma had $294.8 million in cash, cash equivalents, and marketable securities, compared to $314.1 million as of December 31, 2021. Net cash used in operations was $18.0 million for the three months ended March 31, 2022 compared to $12.9 million for the three months ended March 31, 2021.
Net loss for the quarter ended March 31, 2022 was $18.4 million compared to $11.6 million for the quarter ended March 31, 2021.
Research and development (R&D) expenses were $11.8 million for the quarter ended March 31, 2022 compared to $7.5 million for the quarter ended March 31, 2021. The increase in R&D expenses was primarily related to increased headcount and clinical development expenses to advance PC14586, the Company’s lead drug candidate.
General and administrative (G&A) expenses were $6.8 million for the quarter ended March 31, 2022, compared to $4.2 million for the quarter ended March 31, 2021. The increase in G&A expenses was primarily due to expanding the infrastructure necessary for operating as a public company.
About PC14586

PC14586 is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the crevice present in the p53 Y220C mutant protein, hence, restoring the wild-type, or normal, p53 protein structure and tumor-suppressing function. PC14586 is being developed for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation. For more information on the Phase 1/2 PYNNACLE trial (PMV-586-101), refer to www.clinicaltrials.gov (NCT study identifier NCT04585750).

On May 10, 2022 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company reported its financial results for the first quarter ended March 31, 2022 (Press release, Aurinia Pharmaceuticals, MAY 10, 2022, View Source [SID1234614116]). Amounts, unless specified otherwise, are expressed in U.S. dollars.

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Net product revenues were $21.6 million for the quarter ended March 31, 2022, compared to $914 thousand in the prior year period, reflecting FDA approval of LUPKYNIS in late January 2021.

"As previously reported on our fourth quarter call, LUPKYNIS revenues in the first quarter were impacted by care disruptions to both patients and the healthcare system caused by the COVID-19 Omicron variant. We are quite pleased that exiting the quarter, as Omicron abated, we began to see a significant increase in prescribing, patient starts, and refills, leading to a monthly record for received patient start forms and patient starts in March," said Peter Greenleaf, President and Chief Executive Officer of Aurinia. "Heading into the second half of the year, in addition to expected growth in LUPKYNIS revenues, we look forward to multiple expected corporate milestones, including potential European LUPKYNIS approval, the presentation of additional clinical data sets and continued development progress with our pipeline products, AUR200 and AUR300."

For fiscal year 2022, the Company maintains its net revenue guidance of $115 million 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. Aurinia’s guidance does not include any potential milestone payments, royalties or contract manufacturing revenue related to the Company’s licensing agreement with Otsuka Pharmaceutical or associated with the marketing of voclosporin in the European Union or Japan.

First Quarter 2022 and Recent Highlights & Upcoming Milestones:

Aurinia added 461 patient start forms (PSFs) during the first quarter 2022, as compared to 257 in the first quarter 2021.
As of Friday, May 6, 2022, the Company recorded 647 total PSFs since January 1, 2022.
PSF conversion rates are now at 80% after 90 days; confirmed patient access to LUPKYNIS through payors and plans remains steady representing about 90% of U.S. total lives.
There were approximately 1,071 patients on LUPKYNIS therapy at March 31, 2022, compared with 884 at the end of 2021. At 6 months post-treatment-start, an average of approximately 70% of patients remain on treatment.
Per recent healthcare provider (HCP) surveys, unaided brand awareness of LUPKYNIS is over 70% while aided brand awareness is over 90% and intent to use in the next 3 months is over 70%, the highest level since launch.
The first presentations of final AURORA 2 continuation study data are expected at the 59th European Renal Association (ERA) Congress and at the European Congress of Rheumatology at the end of May, 2022 and at the European Alliance of Associations for Rheumatology (EULAR) 2022 in June. Submission of a manuscript with the full results is expected in the second half of 2022.
With the start of the year, the Aurinia commercial team initiated several new HCP and patient-targeted marketing programs that include the AURORA 2 data and patient brand ambassadors.
Regulatory review of the European Medicines Agency (EMA) marketing authorization application (MAA) remains on track with a European Commission (EC) approval decision expected in second half of 2022.
Recruitment of patients and initiation of new sites into both the VOCAL pediatric study and the ENLIGHT-LN registry is continuing.
Financial Liquidity at March 31, 2022

As of March 31, 2022, Aurinia had cash, cash equivalents and restricted cash and investments of $418.8 million compared to $466.1 million at December 31, 2021. The decrease in cash, cash equivalents and restricted cash and investments is primarily related to the continued investment in commercialization activities, payments made for our ongoing post approval obligations and advancement of our pipeline, payments associated with inventory purchases to ensure adequate supply to meet forecasted demand and a payment for the achievement of a one-time milestone, partially offset by an increase in cash receipts from sales of LUPKYNIS.

Aurinia believes that it has sufficient financial resources to fund its current operations, 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 and operating activities for at least the next few years.

Financial Results for the Quarter Ended March 31, 2022

Total net revenue was $21.6 million and $914 thousand for the quarters ended March 31, 2022 and March 31, 2021, respectively. Net revenues primarily consisted of product revenue, net of adjustments for LUPKYNIS, following FDA approval in late January 2021. Quarter over quarter revenue growth is attributed to continued progress in the launch of LUPKYNIS, driven predominantly by further penetration into the LN market.

Total cost of sales and operating expenses for the quarter ended March 31, 2022 were $59.5 million in comparison to $51.5 million for the quarter ended March 31, 2021.

Cost of sales were $256 thousand and $48 thousand for the quarters ended March 31, 2022 and March 31, 2021, respectively. The increase was primarily due to the growth of LUPKYNIS sales, in comparison to the prior year period.

Gross margin for the quarters ended March 31, 2022 and March 31, 2021 was approximately 99% and 95% respectively. The fluctuation in gross margin is driven primarily by fixed specialty pharmacy costs in the first quarter of 2021, as a larger percentage of the overall cost of sales in the quarter.

Selling, general and administrative (SG&A) expenses were $45.2 million and $39.8 million for the quarters ended March 31, 2022 and March 31, 2021, respectively, which is consistent with the prior quarter and represents a fully burdened quarter, as the Company did not have approval until late January 2021. The increase was primarily due to an increase in employee related expenses, professional fees related to various corporate matters, pharmacovigilance costs and consulting related expenses tied to the increased investment in back office infrastructure to support the commercialization of LUPKYNIS.

Non-cash SG&A share-based compensation expense for the quarters ended March 31, 2022 and March 31, 2021 was $6.0 million and $6.6 million, respectively.

R&D expenses were $12.6 million and $9.8 million for the quarters ended March 31, 2022 and March 31, 2021, respectively. The primary driver for the increase quarter over quarter was due to an increase in expenses related to AUR200 and AUR300 development, partially offset by a decrease in expenses related to the AURORA 2 continuation study which was completed during the fourth quarter of 2021 but had wind down activities ongoing in the quarter ended March 31, 2022.

Non-cash R&D share-based compensation expense for the quarters ended March 31, 2022 and March 31, 2021 was $1.0 million compared to $1.1 million, respectively.

For the quarter ended March 31, 2022, Aurinia recorded a net loss of $37.6 million or $0.27 net loss per common share, as compared to a net loss of $50.4 million or $0.40 net loss per common share for the quarter ended March 31, 2021.

This press release is intended to be read in conjunction with the Company’s unaudited condensed consolidated financial statements and Management’s Discussion and Analysis for the quarter ended March 31, 2022 in the Company’s Quarterly Report on Form 10-Q, 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 ended March 31, 2022 financial results today, Tuesday, May 10, 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 (866) 682-6100 / (862) 298-0702 (Toll-free U.S. & Canada). An audio webcast can 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.

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.