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AC Immune Reports Second Quarter 2021 Financial Results and Provides Corporate Update

On August 4, 2021 AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, reported its financial results for the quarter ended June 30, 2021, and provided a corporate update (Press release, AC Immune, AUG 4, 2021, View Source [SID1234585766]).

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Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "AC Immune continues its expansion with the transformative acquisition of PD01, which significantly strengthens our active vaccines portfolio by adding a clinically validated candidate in Parkinson’s disease, whilst maintaining a strong financial position of CHF 199.1 million in cash. In Q1, the Company released positive data on the safety and immunogenicity of ACI-24 and ACI-35.030, our anti-Abeta and anti-Tau vaccines in Alzheimer’s disease. We firmly believe that a vaccine approach coupled with the right diagnostic tools can bring an alternative therapeutic approach to prevent neurodegenerative diseases in large populations, like for Covid-19."

Q2 2021 and Subsequent Highlights

Announced an all-stock acquisition of Affiris’ portfolio of therapeutics targeting alpha-synuclein notably PD01, a clinically validated active vaccine candidate that places AC Immune at the forefront of Parkinson’s disease drug development. Through the planned acquisition and a concurrent financing, AC Immune will also strengthen its cash position and add Athos Service GmbH (Strüngmann family office), First Capital Partner GmbH (Egger Family Office), and MIG Fonds, the three lead investors in Covid-19 vaccine innovator BioNTech SE, to its shareholder base.
Presented the full results from the landmark Phase 1b clinical trial evaluating the anti-Abeta vaccine ACI-24 in subjects with Down syndrome at the Alzheimer’s Association International Conference (AAIC) 2021, showing that ACI-24 generated evidence of immunogenicity along with a positive pharmacodynamic response and a favorable safety and tolerability profile. Based on these results, the Company plans to advance an optimized formulation of ACI-24 into mid-stage clinical testing to treat and prevent the progression of Down syndrome (DS)-related Alzheimer’s disease (AD).
Provided key clinical and preclinical updates for its AD vaccine candidates targeting pathological amyloid beta (Abeta). The 18 months treatment and additional six-months safety observation is completed for all participants. The study is currently under analysis and AC Immune plans to present the results at an international Alzheimer conference. Non-human primate data further highlight the strong immunogenicity of our optimized ACI-24 formulation against pathological Abeta species, including oligomeric and pyroglutamate Abeta.
Expanded the Phase 1b/2a trial evaluating the first-in-class anti-phosphorylated-Tau (pTau) vaccine candidate ACI-35.030 for the treatment of AD in collaboration with Janssen Pharmaceuticals, Inc. The trial expansion, which was based on encouraging interim safety, tolerability and immunogenicity results to date, specifically includes vaccination of additional AD patients at the second highest dose to support continued development of ACI-35.030.
Achieved and Anticipated 2021 milestones
Clinical Milestones

ACI-35.030 anti-pTau vaccine: reported Phase 1b/2a interim results in AD patients in Q1 (second highest dose); further Phase 1b/2a interim analysis in Q4 (highest dose)
JACI-35.054 alternative anti-pTau vaccine: reported a Phase 1b/2a interim analysis in AD patients in Q2 (low dose)
Alpha-synuclein PET imaging agent: advanced third-generation candidate to first-in-human clinical study in Q1; readout expected in Q3
ACI-24 anti-Abeta vaccine in DS: reported Phase 1b topline results in Q1
ACI-24 in AD: reported Phase 2, 12-month interim analysis in Q1; reported 18-month interim analysis in Q2
Semorinemab anti-Tau antibody: Phase 2 trial primary completion (estimated last patient, last visit) in moderate AD in Q3
ACI-3024 small molecule Morphomer Tau aggregation inhibitor: select NeuroOrphan indication for further development in H2
ACI-24 in DS: submit investigational new drug (IND) application for optimized vaccine formulation in Q4
Preclinical Milestones

Alpha-synuclein small molecule inhibitor: identified first biologically active small molecule in Q1; start in vivo proof-of-concept studies in Q3
TDP-43 imaging agent: initiate investigational new drug (IND)-enabling studies in Q3
Morphomer NLRP3-ASC: report in vivo proof-of-concept results in a non-central nervous system (CNS) disease model and begin in vivo proof-of-concept studies with validated candidate in CNS in Q4
Anti-NLRP3-ASC antibody: begin in vivo proof-of-concept studies in Q4
Anti-TDP-43 antibody: initiate IND-enabling toxicology studies in Q4
TDP-43 biofluid diagnostic: establish validation-ready assay in Q4
Analysis of Financial Statements for the quarter ended June 30, 2021

Cash Position: The Company had a total cash balance of CHF 199.1 million, composed of CHF 104.1 million in cash and cash equivalents and CHF 95.0 million in short-term financial assets. This compares to a total cash balance of CHF 225.9 million as of December 31, 2020. The Company’s cash balance provides enough capital resources to progress through at least Q1 2024 without consideration of potential incoming milestone payments.
Contract Revenues: The Company did not record contract revenues for the three months ended June 30, 2021, a decrease of CHF 1.1 million from the comparable period. The overall decrease is predominantly related to CHF 0.9 million of contract revenue associated with R&D activities in our agreement with Lilly that were recognized in 2020 and did not repeat in the current period.
R&D Expenditures: R&D expenses increased by CHF 0.9 million for the three months ended June 30, 2021, to CHF 13.7 million.
Discovery and preclinical expenses (+0.8 million): The Company increased expenditures across a variety of its discovery and preclinical programs. These include investments for the development of our anti-TDP-43 antibody with the initiation of IND-enabling studies, the expansion of our Morphomer Tau program into NeuroOrphan indications and various other investments across our programs.
Clinical expenses (-0.6 million): The Company decreased expenditures across multiple clinical programs, as certain clinical activities completed or incurred significant scaling up in the prior period. For example, the Company completed its clinical activities of the Phase 1 trial of our Morphomer Tau asset in partnership with Lilly. Additionally, the Company incurred less expense for ACI-24 for DS-related AD as a result of prior period scaling up activities for a Phase 2 clinical trial which were not repeated in the current period.
Salary- and benefit-related costs (+0.4 million): The Company’s salary- and benefit-related costs increased primarily due to the internal reallocation of certain employees’ salaries and annualization of 2020 hires and increases in share-based compensation
G&A Expenditures: For the three months ended June 30, 2021, G&A increased by CHF 1.1 million to 5.2 million. This increase is predominantly related transaction costs incurred in completing the asset acquisition for Affiris’ alpha-synuclein portfolio and cash, the internal reallocation of certain employees’ salaries and other administrative items.
Other Operating Income: The Company recognized CHF 0.3 million in grant income for R&D activities performed under our Michael J. Fox Foundation for Parkinson’s Research (MJFF) and Target ALS grants, an increase of CHF 0.1 million compared to the prior period.
IFRS Loss for the Period: The Company reported a net loss after taxes of CHF 19.1 million for the three months ended June 30, 2021, compared with a net loss of CHF 15.8 million for the comparable period in 2020.

argenx to Present at 2021 Wedbush PacGrow Virtual Healthcare Conference

On August 4, 2021 argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, reported that members of management will participate in a fireside chat at the 2021 Wedbush PacGrow Virtual Healthcare Conference on Wednesday, August 11, 2021 at 11:30 a.m. ET (Press release, argenx, AUG 4, 2021, View Source [SID1234585765]).

A live webcast of the presentation may be accessed on the Investors section of the argenx website at argenx.com/investors. A replay of the webcast will be available on the argenx website for approximately 90 days following the call.

Immunovia, Inc. Receives Approval to Begin Testing Patients for Pancreatic Cancer with the IMMray™ PanCan-d Test

On August 4, 2021 Immunovia AB (publ) ("Immunovia"), a diagnostic company that develops highly accurate blood tests for the early detection of cancer and autoimmune diseases, reported that Immunovia, Inc. has received final approval to begin patient testing for the IMMray PanCan-d test – the first blood test on the market dedicated to the early detection of pancreatic cancer (Press release, Immunovia, AUG 4, 2021, View Source [SID1234585760]). This approval was received from the Massachusetts Department of Public Health on August 3, 2021. Immunovia, Inc. received its CLIA Certificate of Registration on June 21, 2021 (CLIA Number: 22D2227265). As a result, Immunovia, Inc. can immediately begin selling the IMMray PanCan-d test for early detection of pancreatic cancer in the US exclusively through their laboratory in Marlborough, Massachusetts.

"We are extremely pleased to have achieved this important milestone and to be able to launch the first non-invasive, highly accurate blood test that can help detect pancreatic cancer in early stages. The IMMray PanCan-d test meets a huge clinical need and our ambition is to make the test available to individuals in all the high-risk groups for pancreatic cancer. As a first step, we will launch the test for the familial/hereditary high-risk group," said Patrik Dahlen, Immunovia’s CEO.

"With the Massachusetts State approval, we are excited to be the first to offer commercial testing for individuals at high risk for pancreatic cancer using the IMMray PanCan-d test," said Thomas King, MD, PhD, Medical Director of Immunovia, Inc.

The IMMray PanCan-d test is a laboratory developed test (LDT) that will be the first blood test on the market dedicated to the early detection of pancreatic cancer. By recognizing biomarker signatures, or signs of the disease in the blood, the IMMray PanCan-d test has the potential to significantly increase the survival of patients by detecting pancreatic cancer earlier, when surgical resection is possible.

ABL Bio Receives IND Approval for Phase 1 Clinical Trial of ABL501, an anti-LAG-3/PD-L1 Bispecific Antibody

On August 4, 2021 ABL Bio, Inc. (KOSDAQ: 298380), a clinical-stage biotech developing bispecific antibody technology for immuno-oncology and neurodegenerative diseases, reported that the Investigational New Drug (IND) application for ABL501 has been approved by South Korea’s Ministry of Food and Drug Safety (MFDS) (Press release, ABL Bio, AUG 4, 2021, View Source [SID1234585755]).

The Phase 1 clinical trial is an open-label, multi-center dose escalation and dose expansion study designed to evaluate the safety, tolerability, maximum tolerated dose (MTD) and preliminary efficacy of ABL501 in patients with advanced or metastatic solid tumors.

ABL501 uses Grabody-I platform technology to simultaneously block PD-L1 and LAG-3-mediated T cell inhibition. Preclinical results demonstrate a synergistic increase of T cell activation that is higher than the enhancements induced by combination of anti-PD-L1 and LAG-3. ABL501 also showed a good safety profile in monkeys.

"LAG-3 is emerging as a promising target for cancer immunotherapy. We look forward to verifying ABL501’s potential as a best-in-class bispecific antibody that overcomes the limitations of current LAG-3 targeting antibodies," said Sang Hoon Lee, Ph.D., CEO of ABL Bio. "This is already our third IND approval this year, demonstrating our strong commitment to building a robust portfolio of bispecific antibody immunotherapies. Carrying on this momentum, we expect to submit multiple additional INDs next year."

Ampio Pharmaceuticals, Inc. Announces Second Quarter 2021 Financial Results and Provides Corporate Update

On August 4, 2021 Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions for which there are limited treatment options, reported results for the second quarter period ended June 30, 2021, and provided a corporate overview and business update.

Mr. Michael Macaluso, President and Chief Executive Officer, commented, "This was an exciting quarter for Ampio, and I am proud of our accomplishments over the past three months. We completed our Phase I trial utilizing inhaled Ampion for COVID-19 patients with respiratory distress, which showed that Ampion reduced all-cause mortality by 78% over the Standard of Care. On the basis of those results, during the current quarter we worked with the Federal Drug Administration (FDA) to initiate Phase II trials utilizing inhaled Ampion and intravenous (IV) Ampion for COVID-19 patients with respiratory distress that may support an Emergency Use Authorization (EUA). We have commenced enrollment, which we expect to see incrementally increase in the near term as a result of expanding the inhaled Ampion Phase II study to India, which had, and is continuing to experience, a significant wave of serious COVID-19 infections. Additionally, we are exploring the first at-home inhalation treatment for long COVID patients in a Phase I study utilizing inhaled Ampion. The study is currently enrolling and could represent a significant breakthrough in patient care."

"Ampio Pharmaceuticals has joined the Russell 2000 and Russell 3000 Indexes," continued Macaluso, "which I take as a sign that the market now understands the broad potential of Ampion as a platform anti-inflammatory treatment for patients with unmet medical needs."

Mr. Michael Macaluso, President and Chief Executive Officer, Dr. David Bar-Or, Director and Founder, Ms. Holli Cherevka, Chief Operating Officer and Mr. Daniel Stokely, Chief Financial Officer will be hosting a Conference Call for the Investment Community this afternoon beginning at 4:30 PM ET (see details below).

The key areas of focus during the call will be as follows:

Osteoarthritis of the Knee (OAK) Clinical Trial 2021 Timeline / Update
COVID-19 Platform / Pipeline Overview and Update
Update on Other Pre-Clinical Research Programs
JUNE 30, 2021, FINANCIAL RESULTS

Cash and cash equivalents totaled $20.5 million as of June 30, 2021, compared to $17.3 million on December 31, 2020. The increase of $3.2 million, or 18%, is primarily attributable to net proceeds received from the utilization of our at-the-market (ATM) equity offering and stock option / warrant exercises of $9.5 million and $0.2 million, respectively; partially offset by cash required to fund the operating activities of $6.5 million.

Operating Expenses: Operating expenses consist of research and development ("R&D") expenses and general and administrative ("G&A") expenses, both of which are further explained below.

Research and Development Expenses: R&D expenses for the three months ended June 30, 2021 increased by approximately $1.2 million, or 103%, from R&D expenses for the three months ended June 30, 2020. The increase was primarily attributable to costs incurred related to the AP-013 study database contract whereby outsourced efforts were utilized to ensure the validity and accuracy of the study database prior to submission to the FDA. The AP-013 study was paused in April 2020. In addition, the Company incurred costs during the current period related to start-up / launch related costs for three incremental clinical trials (i.e., AP-017, AP-018 and AP-019) to study the effects of inhaled / intravenous Ampion on patients suffering from COVID-19 related issues.

R&D expenses for the six months ended June 30, 2021 decreased by approximately $0.8 million, or 15%, from R&D expenses for the six months ended June 30, 2020. The decrease was primarily attributable to an overall decrease in clinical trial and sponsored research expenses in the current period of $1.4 million, attributable to the pause of the AP-013 study in April 2020, which was partially offset by the incremental costs associated with the AP-013 database costs and incremental COVID-19 and other research studies in the current period.

General and Administrative Expenses: G&A expenses for the three months ended June 30, 2021, decreased by approximately $0.1 million, or 6%, from G&A expenses for the three months ended June 30, 2020. G&A expenses for the six months ended June 30, 2021, decreased by approximately $0.3 million, or 10%, from G&A expenses for the six months ended June 30, 2020. The decrease for both periods was primarily attributable to a decrease in litigation-related legal costs as a result of the dismissal of the securities class action and derivative cases during the third quarter 2020.

The total shares of common stock outstanding were 200,070,419 on June 30, 2021, compared to 193,378,996 on December 31, 2020.

Financial Guidance

Based on its current operating plans and expected access to equity financing, Ampio expects to have cash and cash equivalents along with access to external sources of liquidity sufficient to fund research and development programs and business operations through the fourth quarter of 2022.

Conference Call and Webcast

Ampio will host a conference call today at 4:30 pm EDT (1:30 pm PDT) to discuss these second quarter 2021 results and provide a corporate business update.

A replay of the conference call will also be available from the Investors Relations section of the Company’s website at www.ampiopharma.com and will be archived there shortly after the live event.