On November 7, 2022 Hummingbird Bioscience, a data-driven precision biotherapeutics company discovering and developing transformative biologic medicines for hard-to-treat diseases, reported two poster presentations for HMBD-002, a unique anti-VISTA antibody, at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) being held November 10-12, 2022 in Boston (Press release, Hummingbird Bioscience, NOV 7, 2022, View Source [SID1234623193]). The company will present a Trials in Progress poster summarizing the Phase 1 clinical trial design for HMBD-002 (NCT05082610) and a poster examining the anti-tumor effects of VISTA blockade by HMBD-002 in preclinical studies.

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The first poster describes the Phase 1, open-label, multi-center, first-in-human trial evaluating HMBD-002 as a monotherapy and in combination with the anti-PD-1 therapy KEYTRUDA (pembrolizumab). The pembrolizumab combination arm of the study will be conducted in collaboration with Merck & Co., Inc., Rahway, NJ, USA.

The second poster shares preclinical data demonstrating that VISTA blockade with HMBD-002 reprograms tumor-associated macrophages to an inflammatory phenotype and promotes cytotoxic T-cell response. HMBD-002 in combination with anti-PD-1 treatment shows enhanced anti-tumor efficacy compared to monotherapy arms.

"As we gain a better understanding of the complex biology of VISTA, our confidence regarding the potential benefit of VISTA blockade to cancer patients who do not respond to current therapies continues to grow," said Jerome Boyd-Kirkup, Ph.D., Hummingbird Bioscience’s Chief Scientific Officer. "We are excited to share the compelling new preclinical data for HMBD-002, our potential first-in-class anti-VISTA antagonist antibody with a unique epitope and antibody format and look forward to discussing longer-term clinical development plans and combination strategies with the wider immuno-oncology community at SITC (Free SITC Whitepaper)."

SITC Trials In Progress Poster Details:

Abstract Title: A phase 1 first-in-human study of HMBD-002, an IgG4 monoclonal antibody targeting VISTA, as a monotherapy and combined with pembrolizumab in patients with advanced solid malignancies

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About HMBD-002

HMBD-002 is an investigational IgG4 anti-VISTA antagonist antibody produced by our Rational Antibody Discovery ("RAD") platform to target the region where VISTA interacts with binding partners that have been shown to play an important role in modulating T cell activity, potentially unlocking the immune system to attack cancer cells. Due to complex biology, VISTA has not been adequately drugged to date. We believe HMBD-002 is the first Fc-independent anti-VISTA antibody designed to bind a computationally predicted functional epitope distinct from the epitopes of other known anti-VISTA antibodies in development. In the Company’s preclinical studies, HMBD-002 demonstrated potent anti-tumor activity both as monotherapy and in combination with pembrolizumab, in multiple syngeneic and humanized mouse models of cancers. HMBD-002 is being developed for various VISTA-expressing cancers, both as a monotherapy and in combination with pembrolizumab. The development of HMBD-002 is supported in part by a grant from the Cancer Prevention and Research Institute of Texas (CPRIT, DP190027).

On November 7, 2022 GSK plc (LSE/NYSE: GSK) reported that DREAMM-3, the phase III open-label, randomised head-to-head superiority trial of Blenrep (belantamab mafodotin) monotherapy versus pomalidomide in combination with low dose dexamethasone (PomDex) in patients with relapsed or refractory multiple myeloma (RRMM), did not meet its primary endpoint of progression-free survival (PFS) (Press release, GlaxoSmithKline, NOV 7, 2022, View Source [SID1234623192]).

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In the DREAMM-3 trial, the primary endpoint of PFS demonstrated a hazard ratio (HR) of 1.03 (95% CI: 0.72 1.47). The observed median progression-free survival was longer for belantamab mafodotin vs PomDex (11.2 months vs 7 months). Secondary endpoints include overall response rate (ORR), duration of response (DOR) and overall survival (OS). The ORR was 41% for belantamab mafodotin and 36% for PomDex. Belantamab mafodotin demonstrated a deeper response rate when compared with PomDex (25% VGPR or better with belantamab mafodotin compared to 8% with PomDex). The median follow-up was 11.5 months for belantamab mafodotin and 10.8 months for PomDex; the median DOR was not reached for belantamab mafodotin (95% CI: 17.9, –) vs 8.5 months (95% CI: 7.6, –) for PomDex; DOR rates at 12 months were 76.8% and 48.4% for belantamab mafodotin and PomDex respectively. The safety and tolerability profile of belantamab mafodotin was consistent with the known safety profile, and no new safety signals were identified. Overall rates of grade 3 keratopathy are consistent with prior reported data.

At the time of the primary analysis, the OS data had only achieved 37.5% overall maturity. The median OS was 21.2 and 21.1 months for belantamab mafodotin and PomDex, respectively, with an HR of 1.14 (95% CI: 0.77, 1.68).

Blenrep was granted accelerated approval by the US Food and Drug Administration (FDA) as a monotherapy for treating adult patients with RRMM who have received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. The accelerated approval was based on the results of the DREAMM-2 overall response rate, DOR and contingent upon a confirmed clinical benefit from a randomised phase III clinical trial. Data from DREAMM-3 is in the process of being shared with health authorities. Discussions with health authorities are currently ongoing.

Additional trials within the DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clinical trial programme will continue. These trials are designed to demonstrate the benefit of Blenrep in combination treatment with novel therapies and standard-of-care treatments in earlier lines of therapy and dosing optimisation to maintain efficacy while reducing corneal events. Data from the DREAMM-7 and DREAMM-8 phase III trials are anticipated in the first half of 2023.

About DREAMM-3
The DREAMM-3 phase III trial is an open-label, randomised trial evaluating the efficacy and safety of single-agent belantamab mafodotin compared to PomDex in patients with RRMM. A total of 325 participants were randomised in a 2:1 ratio to receive either single agent belantamab mafodotin administered as a 2.5 mg/kg dose every three weeks (Q3W), or PomDex. Pomalidomide was administered daily on days 1 to 21 of each 28-day cycle, with dexamethasone administered once weekly (days 1, 8, 15, and 22 of each cycle). The primary endpoint was PFS. Secondary endpoints include safety, OS, overall response rate, DOR and assessment of minimal residual disease.

About DREAMM-7
DREAMM-7 is evaluating the safety and efficacy of belantamab mafodotin in combination with bortezomib and dexamethasone versus daratumumab in combination with bortezomib and dexamethasone.

About DREAMM-8
DREAMM-8 is assessing the efficacy and safety of belantamab mafodotin in combination with pomalidomide and dexamethasone compared with that of a combination of pomalidomide, bortezomib and dexamethasone in participants with relapsed/refractory multiple myeloma.

About multiple myeloma
Multiple myeloma is the second most common blood cancer in the US and is generally considered treatable, but not curable.[1],[2] In the US, more than 32,000 people are estimated to be diagnosed with multiple myeloma this year and nearly 13,000 people will die from the disease.[3] Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.[4]

About B-cell maturation antigen (BCMA)
The normal function of BCMA is to promote plasma cell survival by transduction of signals from two known ligands, BAFF (B-cell activating factor) and APRIL (a proliferation-inducing ligand). This pathway has been shown to be important for myeloma cell growth and survival. BCMA expression is limited to B cells at later stages of development. BCMA is expressed at varying levels in myeloma patients and BCMA membrane expression is universally detected in myeloma cell lines.[5]

About Blenrep
Blenrep is an antibody drug conjugate comprising a humanised BCMA monoclonal antibody conjugated to the cytotoxic agent auristatin F via non-cleavable linker. The drug linker technology is licensed from Seagen Inc.; monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa Inc. a member of the Kyowa Kirin Group.

GSK in oncology
GSK is focused on maximising patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, tumour cell targeting therapies and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, and antibody-drug conjugates, either alone or in combination.

On November 7, 2022 Enterome, a clinical stage biopharmaceutical company developing first-in-class immunomodulatory drugs based on its bacterial Mimicry drug discovery platform, reported it will present updated safety, immunogencity and efficacy data from its Phase 1/2 trial of EO2401 in combination with nivolumab +/- bevacizumab, in patients with first progression/recurrence of glioblastoma (ROSALIE trial) in an oral presentation and a poster presentation at the 37th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting which will be held both virtually and in person in Boston, MA, USA on November 10-12, 2022 (Press release, Enterome, NOV 7, 2022, View Source [SID1234623191]).

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Oral Presentation Details – Abstract #642

Title: EO2401 microbiome derived therapeutic vaccine + nivolumab, with/without standard continuous, or low-dose symptom directed, bevacizumab, in recurrent glioblastoma: phase 1-2 EOGBM1-18/ROSALIE study
Authors: D. Reardon et al.
Date: November 10, 2022
Time: 12:03 p.m. EST
Location: Boston Convention and Exhibition Center, Ballroom West, Concurrent Session 105
Presenter: Prof. David Reardon, M.D., Professor of Medicine at Harvard Medical School and Clinical Director for Dana Farber Cancer Institute
Poster Presentation Details – Abstract #641

Title: Strong immune response to therapeutic vaccination with EO2401 microbiome derived therapeutic vaccine + nivolumab: interim report of the EOGBM1-18/ROSALIE study
Authors: A. Maia et al.
Date: November 10, 2022
Location: Boston Convention and Exhibition Center, Hall C
Presenter: Dr Ana Maia, Tübingen University Hospital, Interfaculty Institute for Cell Biology ("IFIZ")
The abstracts will be published at 8 a.m. EST on November 7, 2022 in a supplement to The Journal for ImmunoTherapy of Cancer (JITC) and via this link.

About EO2401

EO2401 is Enterome’s first-in-class off-the-shelf OncoMimics peptide-based immunotherapy. It combines three microbial-derived OncoMimics peptides that closely mimic specific cytotoxic T cell (CD8+ T cell) epitopes on the Tumor-Associated Antigens IL13Ra2, BIRC5 and FOXM1, combined with the helper peptide (CD4+ T cell epitope) Universal Cancer Peptide 2 (UCP2). EO2041 is designed to trigger the immune system into recognizing these epitopes on glioblastoma cells as foreign (non-self) and eliciting a targeted memory T-cell driven cell-killing response against the tumor cells.

About ROSALIE

ROSALIE (EOGBM1-18, NCT04116658) is a multicenter, open-label, Phase 1/2 trial investigating EO2401 in combination with nivolumab, and in combination with nivolumab/bevacizumab in patients with glioblastoma at first progression/recurrence after surgery and adjuvant radiotherapy/temozolomide. The trial is assessing safety, tolerability, immunogenicity and preliminary efficacy in approximately 80 patients at centers in the US and Europe.

Promising data presented during 2022 at ASCO (Free ASCO Whitepaper) and ESMO (Free ESMO Whitepaper)

Data confirm that EO2401 in combination with nivolumab +/- bevacizumab is well tolerated with a safety profile consistent with the safety profiles of nivolumab and bevacizumab, with the addition of local administration site reactions.
EO2401 in combination with nivolumab generated strong systemic immune responses through activation of specific effector memory CD8+ T cells, correlating with efficacy.
Addition of bevacizumab to EO2401 and nivolumab supported longer treatment durations, and an increase of objective response rate (ORR – 54.5% vs. 10.3%), disease control rate (DCR – 81.8% vs. 34.5%), and progression-free survival (PFS – 5.5 months vs 1.8 months), with 3 out of the first 11 patients showing complete remission.
Additional patients are to be treated with triple combination of EO2401/nivolumab/bevacizumab to support final regimen selection for further studies.

On November 7, 2022 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported financial results for the three and nine months ended September 30, 2022 (Press release, Eagle Pharmaceuticals, NOV 7, 2022, View Source [SID1234623190]).

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Business and Recent Highlights:

Submitted an IND application to FDA for CAL02, a novel first-in-class broad-spectrum anti-virulence agent for the treatment of severe community-acquired bacterial pneumonia ("SCABP"). The IND filing includes a protocol for an adequately powered global Phase 2 study to evaluate the efficacy and safety of CAL02 when added to standard of care therapy in patients with SCABP.
Acquired an equity stake in, with an option to purchase, Enalare Therapeutics Inc. ("Enalare"), adding a portfolio of novel NCEs with strong intellectual property protection, from the mid-2030s into the 2040s, including composition of matter patents. Enalare’s lead compound, ENA-001 is an investigational, one-of-a-kind NCE being developed as an agnostic respiratory stimulant for multiple patient populations experiencing acute respiratory depression. The initial targeted indications include post-operative respiratory depression; community drug overdose; and Apnea of Prematurity, a common condition in preterm infants. The Company believes this investment strengthens Eagle’s position as a diversified pharmaceutical company and a leader in hospital/anesthesia.
Enalare secured a contract for up to $50.3 million from the Biomedical Advanced Research and Development Authority ("BARDA"), part of the Administration for Strategic Preparedness and Response in the U.S. Department of Health and Human Services (contract number 75A50122C00072). In partnership with BARDA, ENA-001 is being developed in an intramuscular ("IM") formulation for potential use in patients experiencing community drug overdose and as a potential medical countermeasure for mass casualty events.
FDA granted Orphan Drug Designation ("ODD") to ENA-001 for the treatment of Apnea of Prematurity ("AoP"). AoP is a development disorder attributed to immaturity of the pulmonary system characterized by either cessation of breathing for more than 20 seconds or cessation of breathing that lasts less than 20 seconds but is accompanied by either bradycardia or hypoxemia.
Received favorable ruling in vasopressin litigation. The U.S. Court of Appeals for the Federal Circuit affirmed the U.S. District Court for the District of Delaware’s decision that Eagle’s vasopressin product does not infringe on any of the patents asserted by Par Pharmaceutical, Inc.
Appointed pharmaceutical industry veteran, Debra M. Hussain, as Senior Vice President, Head of Commercial, with responsibility for FDA-approved new chemical entities, BARHEMSYS and BYFAVO, acquired as part of the acquisition of Acacia Pharma Group plc ("Acacia").
Amended and restated its credit agreement providing for a three-year $100 million revolving credit facility and $50 million term loan facility and repaid all other debt.
Financial Highlights

Third Quarter 2022

Total revenue for Q3 2022 was $65.9 million, compared to $39.9 million in Q3 2021.
Q3 2022 net loss was $(3.5) million, or $(0.27) per basic and diluted share, compared to net loss of $(5.6) million, or $(0.43) per basic and diluted share, in Q3 2021.
Q3 2022 adjusted non-GAAP net income was $14.9 million, or $1.13 per basic and $1.12 per diluted share, compared to adjusted non-GAAP net income of $7.5 million, or $0.57 per basic and $0.56 per diluted share, in Q3 2021.
Cash and cash equivalents were $15.4 million, net accounts receivable was $96.9 million, and debt was $59.3 million, as of September 30, 2022.
Recorded a $3.8 million milestone payment from SymBio on TREAKISYM in Q3 2022, $1.2 million ($0.07 per basic and diluted share) less than anticipated due to currency declines of the Japanese Yen.
"It was another strong quarter for Eagle, and we are pleased that the earnings growth has continued. We are posting record earnings this year, as evidenced by the fact that in the first nine months of the year, we have already earned $6.69 per share, topping our previous best full year ever," stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.

"We expect another strong year in 2023 and anticipate deploying the cash from our earnings and strong balance sheet not only to fund our key clinical initiatives but also to potentially make an accretive acquisition to round out our portfolio. Between business development activities and our own R&D engine, we believe Eagle can grow significantly larger as it transitions into a branded pharmaceutical company with a diversified portfolio of assets," concluded Tarriff.

Third Quarter 2022 Financial Results

Total revenue for the three months ended September 30, 2022 was $65.9 million, as compared to $39.9 million for the three months ended September 30, 2021.

Q3 2022 RYANODEX net product sales were $7.6 million, compared to $4.5 million in the third quarter of 2021.

Q3 2022 BELRAPZO net product sales were $8.5 million, compared to $4.9 million in the third quarter of 2021.

Q3 2022 PEMFEXY net product sales were $1.7 million and vasopressin net product sales were $13.8 million.

Gross margin was 64% during the third quarter of 2022, as compared to 79% in the third quarter of 2021. The decrease in gross margin was driven by a change in the revenue mix, including the launch of PEMFEXY and vasopressin and amortization expense related to BARHEMSYS and BYFAVO.

R&D expense was $9.3 million for the third quarter of 2022, compared to $23.3 million for the third quarter of 2021. The decrease was primarily due to lower spend of $6.6 million on CAL02 and $4.8 million on landiolol due to the upfront license fees paid in Q3 2021 and non-recurrence of development costs of $2.1 million on vasopressin and $1.4 million on PEMFEXY. This was partially offset by an increase in spend on fulvestrant of $0.9 million compared to Q3 2021.

SG&A expenses in the third quarter of 2022 totaled $23.5 million compared to $18.5 million in the third quarter of 2021. This increase was primarily related to $1.1 million of external sales and marketing and $1.2 million of headcount costs for BARHEMSYS and BYFAVO re-launches, $1.1 million of financial and other professional fees, $0.6 million of severance related to the integration of Acacia, $0.5 million of external legal costs, and $0.2 million of sales and marketing costs for PEMFEXY, partially offset by lower general and administrative head count costs.

Net loss for the third quarter of 2022 was $(3.5) million, or $(0.27) per basic and diluted share, compared to net loss of $(5.6) million, or $(0.43) per basic and diluted share, in the third quarter of 2021, primarily as a result of the factors discussed above.

Adjusted non-GAAP net income for the third quarter of 2022 was $14.9 million, or $1.13 per basic and $1.12 per diluted share, compared to adjusted non-GAAP net income of $7.5 million, or $0.57 per basic and $0.56 per diluted share, in the third quarter of 2021.

2022 Full Year Expense Guidance

Adjusted non-GAAP R&D expense for the full year 2022 is expected to be less than $40 million, as compared to $32.5 million in 2021.
Adjusted non-GAAP SG&A expense for the full year 2022 is expected to be in the range of $64 million to $68 million, as compared to $54.9 million in 2021.
Liquidity

As of September 30, 2022, Eagle had $15.4 million in cash and cash equivalents and $96.9 million in net accounts receivable, and $59.3 million in outstanding debt. Therefore, as of September 30, 2022, Eagle had cash plus net receivables of $112.3 million.

In the third quarter of 2022, Eagle repurchased $10 million of its common stock as part of its current $160 million Share Repurchase Program. From August 2016 through September 30, 2022, Eagle has repurchased $246.1 million of its common stock.

Conference Call

As previously announced, Eagle management will host its third quarter 2022 conference call as follows:

A replay of the conference call will be available for two weeks after the call’s completion by dialing 800-934-4548 (U.S.) or 402-220-1175 (International) and entering conference call ID EGRXQ322. The webcast will be archived for 30 days at the aforementioned URL.

Investor Day Registration Information

Eagle will host an Investor Day on Tuesday, December 6, 2022, at the Lotte New York Palace Hotel, at 8:00am ET.

The program will provide an opportunity for an in-depth look at the Company’s hospital-based products and product candidates, including CAL02, BARHEMSYS and BYFAVO, landiolol, and Enalare’s ENA-001. Featured speakers include Scott Tarriff, President and Chief Executive Officer, senior members of Eagle’s clinical and commercial teams, and noteworthy Key Opinion Leaders, who will discuss the scientific rationale and potential unmet medical needs for each pipeline asset and commercial product.

Advance registration is required for this event. Institutional investors and analysts are kindly requested to RSVP through this link to attend.

On November 7, 2022 Avalo Therapeutics, Inc. (Nasdaq: AVTX), reported business updates and financial results for the third quarter of 2022 (Press release, Avalo Therapeutics, NOV 7, 2022, View Source [SID1234623189]).

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"We have made great operational progress on the enrollment of our Phase 2 PEAK trial of AVTX-002 in NEA. We expect to complete enrollment by the end of the year, which keeps us on track to release topline data in the first half of 2023," said Dr. Garry Neil, Chief Executive Officer and Chairman of the Board. "Additionally, we expect to further strengthen our balance sheet with the $5 million to be received from the sale of economic rights of previously out-licensed assets upon the transaction closing, which further demonstrates the execution of our strategy to utilize business development to fund our core programs. Once completed, we will have raised $20 million through nondilutive transactions since August. Avalo is focused on closing out the year with further operational and strategic success."

Business Updates:

On November 4, 2022, Avalo entered into an agreement with ES Therapeutics, LLC, an affiliate of Armistice Capital LLC (Armistice), to sell its net economic rights to future payments of previously out-licensed assets including AVTX-007, AVTX-501, and AVTX-611 for proceeds of $5 million. The sale is expected to close in November.
In August 2022, Avalo’s Board of Directors appointed Dr. Garry Neil, MD, Avalo’s Chief Executive Officer and Director, as Chairman of the Board. Steven Boyd and Keith Maher, MD, both of Armistice, left Avalo’s Board of Directors. The former directors expressed that they were pleased with Avalo’s strategic progress under Dr. Neil and continued to be supportive of Avalo.
Avalo sharpened its focus to dysregulated inflammation specifically as it relates to the LIGHT-signaling network. We have two drug candidates that modulate the LIGHT-signaling network, AVTX-002, an anti-LIGHT monoclonal antibody in Phase 2, and AVTX-008, a BTLA agonist fusion protein in lead optimization.
Program Updates and Milestones:

AVTX-002: Anti-LIGHT monoclonal antibody (mAb) targeting immune-inflammatory diseases.
NEA: Topline data expected in the first half of 2023 from the Phase 2 PEAK trial evaluating the safety and efficacy of AVTX-002 in approximately 80 patients with poorly controlled NEA.
AVTX-008: B and T Lymphocyte Attenuator (BTLA) agonist fusion protein targeting immune dysregulation disorders.
Avalo identified a lead molecule and is currently evaluating several immune dysregulation disorders, with a target IND submission planned in 2024.
AVTX-803: Fucose replacement for leukocyte adhesion deficiency type II (LAD II, also known as SLC35C1-CDG), a congenital disorder of glycosylation (CDG).
Pivotal data expected in the first half of 2023 from the pivotal LADDER trial evaluating the safety and efficacy of AVTX-803 in approximately 2 patients with LAD II.
Third Quarter 2022 Financial Update:

Avalo had $16.9 million in cash as of September 30, 2022, representing a $37.7 million decrease compared to December 31, 2021. The decrease was primarily driven by operating expenditures to fund and support pipeline development and a $15.0 million partial prepayment under its loan and security agreement, partially offset by the $14.5 million upfront payment received from the out-license of AVTX-007 to Apollo Therapeutics ("Apollo") in July 2022. Subsequent to September 30, 2022, Avalo entered into a transaction to sell its net economic rights to future payments of certain previously out-licensed legacy assets for consideration of $5.0 million to be received upon closing, which is expected in November.

Total net revenues increased $12.0 million for the nine months ended September 30, 2022, as compared to the same period in 2021. The increase was mainly driven by the $14.5 million upfront consideration received pursuant to the out-license and transfer of AVTX-007 to Apollo.

Total operating expenses decreased $23.6 million for the nine months ended September 30, 2022. Research and development expenses decreased $23.2 million due to a $10.0 million upfront license fee incurred in the first quarter of 2021, which did not repeat. The remaining $13.2 million decrease was primarily driven by timing of manufacturing and reduced non-clinical and clinical trial activities as a result of pipeline prioritization and the out-license of AVTX-007. Selling, general and administrative expenses decreased $0.9 million due to reduced legal, consulting and marketing expenses from cost savings initiatives, partially offset by increased severance and stock-based compensation expense driven by headcount reductions from the pipeline prioritization plan announced in the first quarter of 2022 and other separations. Cost of product sales increased $1.7 million due to the net profit share of our non-core commercialized product, Millipred, that began in the third quarter of 2021 and a $1.0 million reserve recognized in the second quarter of 2022 related to a receivable due in December 2024 pursuant to the transition service agreement with the third party that previously managed Millipred’s commercial operations.

The net loss and change in net loss for the nine months ended September 30, 2022 was largely driven by operating expenses, partially offset by license revenue.

1 Results for prior periods presented have been retroactively adjusted to reflect the 1-for-12 reverse stock split effected on July 7, 2022.

The unaudited condensed consolidated balance sheets as of September 30, 2022 and December 31, 2021 have been derived from the reviewed financial statements, but do not include all of the information and footnotes required by accounting principles accepted in the United States for complete financial statements.

1 Results for prior periods presented have been retroactively adjusted to reflect the 1-for-12 reverse stock split effected on July 7, 2022.

The unaudited condensed consolidated statements of operations for the three and nine months ended September 30, 2022 and 2021 have been derived from the reviewed financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.

About AVTX-002

AVTX-002 is a fully human monoclonal antibody, directed against human LIGHT (Lymphotoxin-like, exhibits Inducible expression, and competes with Herpes Virus Glycoprotein D for Herpesvirus Entry Mediator (HVEM), a receptor expressed by T lymphocytes). AVTX-002 is currently in Phase 2 development for non-eosinophilic asthma (PEAK trial) with proof-of-concept data in inflammatory bowel diseases and COVID-19 acute respiratory distress syndrome.

About AVTX-002 PEAK Trial

The Phase 2 PEAK trial (n=approximately 80) is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of AVTX-002 for the treatment of poorly controlled NEA (NCT05288504). The primary endpoint is the proportion of subjects who experience an asthma-related event. At baseline, subjects will be randomized to receive either AVTX-002 or placebo once monthly.

About AVTX-008

AVTX-008 is a fully human B and T Lymphocyte Attenuator (BTLA) agonist fusion protein. IND-enabling activities have been initiated with a target IND submission date in 2024.

About AVTX-803

The active pharmaceutical ingredient (API) in AVTX-803 is fucose. Fucose is a plant-derived, naturally occurring monosaccharide with high solubility in water and is isolated as a white crystalline powder. AVTX-803 is an oral formulation of fucose that enhances fucosylation of proteins in the absence of a functioning GDP-fucose transporter, partially restoring protein function. AVTX-803 was granted Fast Track Designation (FTD), Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD), making it potentially eligible for a Priority Review Voucher (PRV).

About AVTX-803 LADDER Trial

The LADDER trial is a pivotal, randomized, double-blind, two-period crossover, withdrawal study to assess the efficacy and safety of AVTX-803 in patients with LAD II (n=at least 2). The primary endpoint is the comparison of leukocyte function as determined by sialyl Lewis-X (SLx) antigen expression on leukocytes between treatment periods. The trial will conclude with the End of Study/Early Termination Visit at which time subjects will be permitted to enroll into a long-term open-label, safety and efficacy study.