On May 07, 2024 Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop a functional cure for people with chronic hepatitis B virus (cHBV) infection, reported that the Arbutus management team will participate in and host one-on-one meetings at the following two upcoming investor conferences which are being held in New York (Press release, Arbutus Biopharma, MAY 7, 2024, View Source [SID1234642756]):

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The Citizens JMP Life Sciences Conference: Fireside Chat on May 14, 2024 at 9:30 am ET
H.C. Wainwright 2nd Annual BioConnect Investor Conference: Fireside Chat on May 20, 2024 at 3:30 pm ET
To access the live webcast of the fireside chats please visit: View Source An archived replay of the webcast will be available on the Arbutus website for a limited time after the event.

On May 7, 2024 Aligos Therapeutics, Inc. (Nasdaq: ALGS, "Aligos"), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, reported recent business progress and financial results for the first quarter 2024 (Press release, Aligos Therapeutics, MAY 7, 2024, View Source [SID1234642755]).

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"We have executed on a number of key deliverables to position Aligos for success," stated Lawrence Blatt, Ph.D., MBA, Chairman, President & CEO of Aligos Therapeutics. "Importantly, we began dosing in the Phase 2a HERALD study of our THR- drug candidate, ALG-055009, and we expect topline data in Q4 2024. In addition, we recently presented data from our three clinical programs at scientific conferences, showcasing our robust pipeline of potentially best-in-class small molecule drug candidates. In particular, we demonstrated positive safety, tolerability, and antiviral activity data after dosing for up to 64 weeks with our hepatitis B virus capsid assembly modulator, ALG-000184, and positive safety and PK data for our ritonavir-free, pan-coronavirus protease inhibitor, ALG-097558. We remain excited by the potential of these programs and look forward to continuing to deliver for our shareholders."

Recent Business Progress

Aligos Portfolio of Drug Candidates

ALG-055009: Potential best-in-class small molecule THR-β agonist for MASH

Data presented at the Asian Pacific Association for the Study of the Liver (APASL) conference highlighted ALG-055009 Phase 1 data that showed multiple-ascending doses (MAD) over 14 days in hyperlipidemic subjects produced favorable, dose-dependent pharmacodynamic effects on atherogenic lipids and sex hormone binding globulin (SHBG), an indicator of target engagement in the liver
The Phase 2a HERALD study was initiated in Q1 2024 with the first subject dosed in April 2024
Topline HERALD data are anticipated in Q4 2024
ALG-000184: Potential first-/best-in-class small molecule CAM-E for CHB

Interim data from Parts 3 and 4 of Study ALG-000184-201 were presented at the APASL conference and showed consistent, potent antiviral activity across multiple cohorts of untreated chronic hepatitis B (CHB) patients receiving once daily doses of ALG-000184 as monotherapy or in combination with entecavir (ETV) x ≤ 64 weeks
Dosing continues in this ongoing Phase 1a/1b study, with subjects planning to dose for up to 96 weeks. Additional interim data readouts are planned to be presented this year at the following conferences: European Association for the Study of the Liver (EASL) and American Association for the Study of Liver Diseases (AASLD)
Phase 2 enabling activities, including regulatory interactions and drug supply manufacturing, are underway
ALG-097558: Potential best-in-class small molecule pan-coronavirus protease inhibitor

Topline data presented at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Annual Meeting demonstrated single (up to 2000 mg) and multiple (up to 800 mg Q12 for 7 days) doses of ALG-097558 were well tolerated in healthy volunteers with a pharmacokinetic (PK) profile supporting twice daily, ritonavir-free dosing without a food effect
Received an additional $1.3M grant from the National Institutes of Health (NIH)
Phase 2 enabling activities, including nonclinical and clinical studies, are underway with financial support from the NIH
Financial Results for the First Quarter 2024

Cash, cash equivalents and investments totaled $112.7 million as of March 31, 2024, compared with $135.7 million as of December 31, 2023. Additionally, in October 2023, we raised $92.1 million in gross proceeds in private placement financing, before deducting placement agent’s fees and other expenses. Including the proceeds from the private placement financing, we continue to believe our cash balance provides sufficient cash to fund planned operations through the end of 2025.

Net losses for the three months ended March 31, 2024 were $34.9 million or basic and diluted net loss per common share of $(0.22), compared to net losses of $23.0 million or basic and diluted net loss per common share of $(0.53) for the three months ended March 31, 2023.

Research and development (R&D) expenses for the three months ended March 31, 2024 were $16.4 million, compared with $18.1 million for the same period of 2023. The decrease was primarily due to a decrease in employee related costs, partially offset by an increase in third party expenses. Total R&D stock-based compensation expense incurred for the three months ended March 31, 2024 was $1.4 million, compared with $2.2 million for the same period of 2023.

General and administrative (G&A) expenses for the three months ended March 31, 2024 were $6.7 million, compared with $8.5 million for the same period of 2023. The decrease in G&A expenses for this comparative period is primarily due to a decrease in third party expenses including legal expenses. Total G&A stock-based compensation expense incurred for the three months ended March 31, 2024 was $1.2 million, compared with $1.5 million for the same period of 2023.

Interest and other income (expense), net, for the three months ended March 31, 2024 was an expense of $12.8 million compared with income of $1.0 million for the same period of 2023. The change in interest and other income (expense), net, is primarily due to an increase in the fair value of the Common Warrants liability, which resulted in a non-cash charge, associated with the Securities Purchase Agreement entered into in October 2023 following the private investment in public equity (PIPE) offering.

On May 7, 2024 Agenus Inc. ("Agenus") (Nasdaq: AGEN), a leader in discovering and developing novel immunological agents to treat various cancers, reported results for the first quarter 2024 (Press release, Agenus, MAY 7, 2024, View Source [SID1234642754]). In a concurrent press release accompanying Agenus’ earnings announcement, a $100M royalty financing agreement between Ligand and Agenus was reported. This pivotal, minimally dilutive capital infusion will support the key development and launch readiness initiatives needed to advance the company’s lead program, BOT/BAL, in relapsed/refractory non-MSI high colorectal cancer without liver metastases (r/r MSS CRC NLM).

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"We are thrilled to announce a significant $100 million royalty financing agreement with Ligand, a milestone that investors have eagerly anticipated. This capital infusion is pivotal for advancing the development and market readiness of our BOT/BAL treatment," said Garo Armen, CEO of Agenus. He continued, "The BOT/BAL combination has consistently demonstrated deep and durable responses in ‘cold’ solid tumors, especially in our advanced studies of relapsed/refractory MSS CRC. With the promising results we have seen, and additional data from our ongoing Phase 2 study, we plan to engage with the FDA in the second half of 2024. Pending the outcomes of these discussions, we aim to commence the submission of a Biologics License Application under the accelerated approval provision for BOT/BAL in refractory MSS CRC NLM."

In parallel, Agenus has successfully reduced its cash burn rate. The company successfully executed a 20:1 reverse stock split during Q1 2024. This reverse stock split was implemented to achieve multiple key objectives, including satisfying the eligibility criteria for inclusion in the Russell Indices, regaining compliance with Nasdaq listing requirements, and maintaining a stock price above $5 per share, enabling investment by certain institutional investors. Regaining of compliance with NASDAQ listing requirements was confirmed in a press release on April 30th, 2024. This reverse stock split comes as part of a series of strategic initiatives meant to lower Agenus’ cost of capital and to broaden its investor base, benefitting both shareholders and patients.

Q1 2024 Highlights on Botensilimab:

Colorectal cancer:

•
Data presented from the company’s lead BOT/BAL program included an update of the Phase 1b trial in patients with relapsed-refractory MSS CRC NLM.
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This updated dataset (n=77) demonstrated a minimum of 23% RECIST-confirmed overall response rate (ORR) with a median overall survival (mOS) of 21.2 months, a 12-month overall survival (OS) estimate of 71%, and an 18-month OS estimate of 62% in 77 patients after a median follow up of 13.6 months. As of the data cutoff of March 1, 2024, the median duration of response was not yet reached.
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These data, which continue to mature, stand in stark contrast to standard of care therapies in this treatment setting with standard of care therapies ranging from 1% to 6.1% with a median OS of 12.9 months1, 2.
•
The most common safety observations are immune-related diarrhea and colitis, which are managed in accordance with standard therapies. Grade 3+ treatment related diarrhea/colitis occurred in approximately 16% of patients.
•
A poster presentation at the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting in June on this same r/r MSS CRC cohort from the Phase 1b includes results from a sub-analysis conducted to determine whether treatment outcomes are correlated with specific sites of metastatic disease in patients with non-active liver metastases.
Neoadjuvant CRC:

•
Clinical data from an ongoing Investigator Sponsored Study (IST) at Weill-Cornell testing BOT/BAL in the neoadjuvant CRC population were presented at ASCO (Free ASCO Whitepaper)-GI in January 2024.
•
In this IST (NEST-1) led by Dr. Pashtoon Kasi, patients diagnosed with resectable localized colon or rectal cancer were treated with one dose of BOT and two doses of BAL approximately 4 weeks prior to planned surgery.
•
After surgery, pathologic analysis reported significant tumor shrinkage: 3/3 patients (100%) with microsatellite instability-high (MSI-H) CRC experienced major pathological responses (>90% tumor shrinkage) in less than 4 weeks, while 6/9 (67%) MSS CRC patients had tumor shrinkage of 50% or more.
•
Longer follow-up on these initial 12 patients (NEST-1) will be presented at an upcoming medical meeting.
o
Part 2 of this IST is rapidly enrolling and allows a total of four BAL doses with one dose of BOT followed by surgery at 8 weeks (compared to surgery at 4 weeks in Part 1)
•
Based upon these early encouraging data, Agenus plans to prioritize clinical development activities in the neoadjuvant MSS CRC treatment setting and is evaluating study designs for subsequent pivotal trials.
Outside of CRC, Agenus expects to release updated Phase 1 and 2 data in melanoma, lung cancer, sarcoma and pancreatic cancer later this year.

In parallel with these ongoing BOT/BAL development and regulatory activities around the company’s planned BLA submission, Agenus has prioritized resources and efforts towards advancing critical commercial launch readiness activities. This includes ensuring quality and availability of BOT/BAL supply,

through both third-party CMO partners and Agenus’ wholly owned cGMP-grade facility in Emeryville, and the hiring of an established and seasoned commercial leadership team with extensive experience in launching oncology therapeutics. "We are partnering closely with our Global Medical Affairs and Clinical Team to gather insights from the world’s experts in GI oncology and have conducted market research with over 150 US-based GI oncologists, both in the academic and community hospital settings. It is clear to us that there is significant anticipation for BOT/BAL, which underscores the urgency we feel to deliver this important treatment option to patients," said Robin Taylor, Chief Commercial Officer of Agenus.

First Quarter 2024 Financial Overview:

We ended our first quarter 2024 with a cash and cash equivalent balance of $52.9 million, compared to $76.1 million on December 31, 2023. This morning, we announced a $100 million agreement with Ligand Pharmaceuticals, consisting of an initial investment of $75 million with an option to invest an additional $25 million. Our cash used in operations for this first quarter was $38.2 million, compared to $40.6 million during the fourth quarter ended December 31, 2023.

For the first quarter ended March 31, 2024, we recognized revenue of $28 million and incurred a net loss of $63.5 million (including non-cash expenses of $38.3 million) or $3.04 per share. This compares to a net loss of $70.9 million (including non-cash expenses of $24.9 million) or $4.31 per share for the same period in 2023.

On May 7, 2024 Adaptive Biotechnologies Corporation ("Adaptive Biotechnologies") (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, reported financial results for the quarter ended March 31, 2024 (Press release, Adaptive Biotechnologies, MAY 7, 2024, View Source [SID1234642750]).

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"This quarter, we implemented important decisions to maximize the value of our MRD and Immune Medicine businesses. I am confident in the steps we are taking to execute on their respective priorities with separate segment reporting," said Chad Robins, chief executive officer and co-founder of Adaptive Biotechnologies. "Our cash position is strong and will enable us to bridge the MRD business to profitability while advancing key programs in Immune Medicine through gated investments."

Recent Highlights

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Revenue for the first quarter of 2024 was $41.9 million. The MRD business, which contributed 78% of revenue, grew 52% versus the first quarter of 2023.
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clonoSEQ test volume in the first quarter of 2024 grew 41% to 17,040 tests delivered versus the first quarter of 2023.
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Recognized $4.5 million within MRD revenue upon the achievement of regulatory milestones from biopharmaceutical clinical studies.
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The FDA’s Oncologic Drug Advisory Committee (ODAC) voted unanimously in favor of the use of MRD as a primary endpoint to support the accelerated approval of new therapies for patients with multiple myeloma.
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Following a strategic review, MRD and Immune Medicine will operate under Adaptive with dedicated resources, separate segment reporting and disciplined capital allocation.
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Initiated antibody discovery campaign in Immune Medicine for multiple sclerosis and type 1 diabetes to discover, make and test select antibodies to generate preclinical data during 2024.
First Quarter 2024 Financial Results

Revenue was $41.9 million for the quarter ended March 31, 2024, representing an 11% increase from the first quarter in the prior year. MRD revenue was $32.6 million for the quarter, representing a 52% increase from the first quarter in the prior year. Immune Medicine revenue was $9.2 million for the quarter, representing a 43% decrease from the first quarter in the prior year.

Operating expenses were $90.6 million for the first quarter of 2024, compared to $94.8 million in the first quarter of the prior year, representing a decrease of 4%. MRD operating expenses were $59.9 million for the quarter, representing a 7% increase from the first quarter in the prior year. Immune Medicine operating expenses were $23.8 million for the quarter, representing a 25% decrease from the first quarter in the prior year.

Interest and other income, net was $4.2 million for the first quarter of 2024, compared to $3.0 million in the first quarter of the prior year. Interest expense from our revenue interest purchase agreement was $3.0 million in the first quarter of 2024, compared to $3.5 million in the first quarter of the prior year.

Net loss was $47.5 million for the first quarter of 2024, compared to $57.7 million for the same period in 2023.

Adjusted EBITDA (non-GAAP) was a loss of $28.2 million for the first quarter of 2024, compared to a loss of $37.1 million for the first quarter of the prior year. MRD Adjusted EBITDA (non-GAAP) was a loss of $17.3 million for the quarter, compared to a loss of $26.4 million for the first quarter of the prior year. Immune Medicine Adjusted EBITDA (non-GAAP) was a loss of $6.9 million for the quarter, compared to a loss of $7.4 million for the first quarter of the prior year.

Cash, cash equivalents and marketable securities was $308.9 million as of March 31, 2024.

2024 Updated Financial Guidance

Adaptive Biotechnologies expects full year revenue for the MRD business to be between $135 million and $140 million, updated from the previous range between $130 million and $140 million. No revenue guidance is provided for the Immune Medicine business.

We expect full year total company operating expenses, including cost of revenue, to be between $350 million and $360 million, updated from the previous range between $360 million and $370 million.

Management will provide further details on the outlook during the conference call.

Webcast and Conference Call Information

Adaptive Biotechnologies will host a conference call to discuss its first quarter 2024 financial results after market close on Tuesday, May 7, 2024 at 4:30 PM Eastern Time. The conference call can be accessed at View Source The webcast will be archived and available for replay at least 90 days after the event.

On May 7, 2024 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported its financial results for the first quarter of 2024 and provided a corporate update (Press release, Aclaris Therapeutics, MAY 7, 2024, View Source [SID1234642749]).

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"We are pleased to announce that following a review of the potential development pathways for ATI-2138, our investigational ITK/JAK3 compound with best-in-class potential, we have decided to progress ATI-2138 into a proof-of-concept Phase 2a trial in patients with moderate to severe atopic dermatitis," stated Dr. Neal Walker, co-founder and Interim Chief Executive Officer & President of Aclaris. "Across all of our programs, we remain focused on executing a capital efficient strategy to advance novel immuno-inflammatory therapies."

Research and Development Highlights:

ITK Inhibitor Programs
ATI-2138, an investigational oral covalent ITK/JAK3 inhibitor
Aclaris plans to progress ATI-2138 into a Phase 2a trial in subjects with moderate to severe atopic dermatitis.
In September 2023, Aclaris reported positive results from its Phase 1 multiple ascending dose (MAD) trial of ATI-2138.
ITK Selective Compound
Aclaris is progressing to development candidate selection a second generation ITK selective inhibitor for autoimmune indications.
Lepzacitinib (ATI-1777), an investigational topical "soft" JAK 1/3 inhibitor
In January 2024, Aclaris reported positive top-line results from its Phase 2b trial in atopic dermatitis (AD).
Aclaris is currently seeking a global development and commercialization partner for this program (excluding Greater China). As previously announced, in 2022 Aclaris granted Pediatrix Therapeutics exclusive rights to develop and commercialize lepzacitinib in Greater China.
Zunsemetinib (ATI-450), an investigational oral small molecule MK2 inhibitor
Aclaris plans to support Washington University in St. Louis in its investigator-initiated Phase 1b/2 trials of zunsemetinib as a potential treatment for pancreatic cancer and metastatic breast cancer. Aclaris expects these trials to be primarily funded by grants awarded to Washington University.
Financial Highlights:

Liquidity and Capital Resources

As of March 31, 2024, Aclaris had aggregate cash, cash equivalents and marketable securities of $161.4 million compared to $181.9 million as of December 31, 2023. A majority of cash expenditures in the first quarter of 2024 were related to payments associated with exit activities, including the wind down of discontinued R&D programs and the previously announced reduction in force. Aclaris anticipates payments associated with these activities to be substantially completed by the second quarter of 2024. As a result, Aclaris expects significantly lower quarterly cash expenditures in future quarters, without giving effect to any potential business development activities resulting from its ongoing strategic review of its business.

Financial Results

First Quarter 2024

Net loss was $16.9 million for the first quarter of 2024 compared to $28.2 million for the first quarter of 2023.
Total revenue was $2.4 million for the first quarter of 2024 compared to $2.5 million for the first quarter of 2023. The decrease was primarily driven by lower contract research revenue during the three months ended March 31, 2024.
Research and development (R&D) expenses were $9.8 million for the quarter ended March 31, 2024 compared to $22.6 million for the prior year period.

The $12.8 million decrease was primarily the result of lower:
Zunsemetinib development expenses associated with clinical activities for a Phase 2a trial for hidradenitis suppurativa, a Phase 2b trial for rheumatoid arthritis, and drug candidate manufacturing costs.
Costs associated with lepzacitinib preclinical development activities and a Phase 2b clinical trial for AD.
ATI-2138 development expenses, including costs associated with a Phase 1 MAD trial and other preclinical activities.
Compensation-related expenses due to a decrease in headcount and higher forfeiture credits.
General and administrative (G&A) expenses were $6.8 million for the quarter ended March 31, 2024 compared to $8.8 million for the prior year period. The decrease was primarily due to a reduction in compensation-related expenses due to lower headcount and higher forfeiture credits.
Licensing expenses were $1.0 million for the quarter ended March 31, 2024 compared to $1.1 million for the prior year period. The decrease was due to the achievement of a commercial milestone during the three months ended March 31, 2023, offset by an increase in royalties earned under the Lilly license agreement.
Revaluation of contingent consideration resulted in a $2.8 million loss for the quarter ended March 31, 2024 compared to a gain of $0.8 million for the prior year period.
Conference Call and Webcast

As previously disclosed on April 30, 2024, management will host a conference call and webcast, with an accompanying slide presentation, at 5:00 PM ET today to provide a corporate update. To access the live webcast of the call and the accompanying slide presentation, please visit the "Events" page of the "Investors" section of Aclaris’ website, www.aclaristx.com. The webcast will be archived for at least 30 days on the Aclaris website.