On March 30, 2020 Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported updated efficacy and safety data in patients with ovarian cancer and non-small cell lung cancer (NSCLC) adenocarcinoma from its ongoing Phase 1 dose escalation study evaluating XMT-1536 (Press release, Mersana Therapeutics, MAR 30, 2020, View Source [SID1234555998]). The Company will host a call today, Monday, March 30, 2020, at 5:00 pm ET during which investigator Debra L. Richardson, MD, Associate Professor of Gynecologic Oncology at the Stephenson Cancer Center at the University of Oklahoma Health Sciences Center and the Sarah Cannon Research Institute and members of the Mersana executive team will present and discuss these data.

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"These data demonstrate that XMT-1536, our first-in-class Dolaflexin ADC targeting NaPi2b, delivers confirmed responses and durable stable disease in heavily pretreated ovarian cancer and NSCLC adenocarcinoma patients who have exhausted all other treatment options. These data also show that XMT-1536 is well tolerated without the severe toxicities of other ADC platforms such as neutropenia, neuropathy and ocular toxicity. Moreover, these data establish the potential for a biomarker-response relationship to identify patients most likely to benefit from XMT-1536," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "We look forward to advancing XMT-1536 for both ovarian cancer and NSCLC adenocarcinoma patients. Having already accumulated meaningful patient experience in the expansion cohorts, we remain on track to provide an interim update in the second quarter of 2020."

Of the 59 patients enrolled, tumor types included 37 ovarian cancer, 11 NSCLC adenocarcinoma, and 11 other tumor types previously disclosed at lower dose levels. Patients were heavily pre-treated, with a median of five prior lines of treatment (range 1-10). These data include new patients dosed at 30, 36 and 43 mg/m2. The majority of the ovarian cancer patients had received prior bevacizumab or PARP inhibitors. All NSCLC adenocarcinoma patients had received prior platinum and immunotherapy. Updated and new data as of February 3, 2020 includes:

·Safety profile consistent with previously reported data at lower doses.
oThe most common treatment-related adverse events (TRAEs) were Grade 1-2 nausea, fatigue, headache and the most frequent Grade 3 TRAE was transient AST elevation.
oThere were no dose limiting toxicities observed in the 43 mg/m2 cohort.
oThere was no reported severe neutropenia, peripheral neuropathy or ocular toxicity.

·Additional confirmed responses in heavily pretreated patients and favorable biomarker-response trend observed.
oFirst confirmed partial response seen in a NSCLC adenocarcinoma patient with prior treatments including carboplatin, pemetrexed, paclitaxel and nivolumab.
oAt the 43 mg/m2 dose level, 2/7 (29%) patients achieved partial responses (PRs) and 4/7 (57%) patients achieved stable disease (SD) for a disease control rate (DCR) of 6/7 (86%). In January 2020, the expansion portion of the Phase 1 study dose was amended from 36 mg/m2 to 43 mg/m2 for newly enrolled patients.
oFor the subset of evaluable patients treated at >30 mg/m2 who had higher NaPi2b expression, 5/15 (33%) achieved PR and 6/15 (40%) achieved SD for a DCR of 11/15 (73%).
oIn contrast, for the subset of evaluable patients treated at >30 mg/m2 who had lower NaPi2b expression, 0/9 (0%) achieved PR and 5/9 (55%) achieved SD for a DCR of 5/9 (55%).

Response – Ovarian Cancer
and NSCLC
adenocarcinoma N=39* N (%)
All Higher
NaPi2b o Lower
NaPi2b oo Indeterminate
NaPi2b **
20 mg/m2 N 10 7 2 1
PR 1 (10%) 0 (0%) 0 (0%) 1 (100%)
SD 6 (60%) 4 (57%) 2 (100%) 0 (0%)
DCR (PR+SD) 7 (70%) 4 (57%) 2 (100%) 1 (100%)
30, 36, 40 mg/m2 N 22 12 7 3
PR 3 (14%) 3 (25%) 0 (0%) 0 (0%)
SD 10 (45%) 6 (50%) 3 (43%) 1 (33%)
DCR (PR+SD) 13 (59%) 9 (75%) 3 (43%) 1 (33%)
43 mg/m2 N 7 3 2 2
PR 2 (29%) 2 (67%) 0 (0%) 0 (0%)
SD 4 (57%) 0 (0%) 2 (100%) 2 (100%)
DCR (PR+SD) 6 (86%) 2 (67%) 2 (100%) 2 (100%)

*Excludes 3 patients discontinued due to investigator/patient choice and 1 without RECIST scan

**Hypocellular specimen/indeterminate for H-score or not determined yet

O Higher NaPi2b Expression: at / above lowest H-score at which response observed (>110)

OO Lower NaPi2b Expression: below the lowest H-score at which response observed (<110)

Mersana plans to enroll approximately 45 patients in each of the ovarian cancer and NSCLC adenocarcinoma patient cohorts in the expansion portion of the XMT-1536 Phase 1 study. The Company expects to present interim data from the dose expansion study in the second quarter of 2020.

Conference Call Details

Mersana Therapeutics will host a conference call and webcast today at 5:00 p.m. ET to review these data. To access the call, please dial 877-303-9226 (domestic) or 409-981-0870 (international) and provide the Conference ID 2889994. A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com.

On March 30, 2020 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported financial results for the fourth quarter and year ended December 31, 2019.

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"This past year has been a very productive year for the company. We received orphan drug designations from the FDA, presented updated data at multiple conferences including ASH (Free ASH Whitepaper), ACR, SITC (Free SITC Whitepaper), and the Crohn’s & Colitis Congress, and completed enrollment in our Phase 1 study of ALPN-101, our lead therapeutic for the potential treatment of autoimmune and inflammatory diseases," said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine. "We have opened enrollment in BALANCE, a trial for ALPN-101 in acute GVHD, and NEON-1, a trial for ALPN-202 in advanced malignancies, beginning the next phase of evolution for the company as we test these novel molecules in patients in need of better therapeutic options."

Recent Corporate and Clinical Highlights

Key Clinical and Preclinical Data Presentations at Biomedical Meetings: We showcased clinical and/or preclinical data for our lead programs, ALPN-101 and ALPN-202, at the following recent medical meetings:

Initial ALPN-101 phase 1 healthy volunteer study data presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in December: In adult healthy volunteers, ALPN-101 was well tolerated as single intravenous or subcutaneous doses, without cytokine release, infusion-related reactions, hypersensitivity, or other signs of agonist activity. Dose-dependent pharmacodynamic activity was observed, including inhibition of T cell activation, assessed ex vivo based on inhibition of staphylococcal enterotoxin B (SEB)-induced cytokine production, and inhibition of antibody responses, assessed following immunization with keyhole limpet hemocyanin (KLH). Based on activity in models, together with favorable tolerability and pharmacodynamics in healthy volunteers, ALPN-101 has the potential to be a clinically meaningful immunomodulator for the treatment of inflammatory diseases such as GVHD.
ALPN-101 preclinical data presented at ACR: The two posters presented a unique potency of ALPN-101, often superior even to combinations of biologics individually targeting the CD28 and ICOS pathways, as measured by in vitro assays involving patient-derived immune cells and in vivo mouse models of inflammatory arthritis, lupus, and Sjögren’s Syndrome.
ALPN-202 preclinical data presented in posters at SITC (Free SITC Whitepaper): One poster presented mechanistic data supporting ALPN-202 inhibits both the PD-L1 and CTLA-4 checkpoint pathways while also providing PD-L1-dependent CD28 costimulation, as intentionally designed. A second poster demonstrated the ability of ALPN-202 to improve significantly upon the activity of existing cancer therapeutics when given alone and/or in combination in preclinical models. In addition, crystallographic study suggested ALPN-202 binds PD-L1 and CD28 at distinct, non-overlapping epitopes enabling its potentially unique functionality.
ALPN-101 preclinical data in IBD presented at 2020 Crohn’s & Colitis Congress: These new data showed ALPN-101 modulated inflammatory cytokines in vitro from human IBD peripheral blood mononuclear cells (PBMC) more potently than CD28 or ICOS single-pathway inhibitors, and significantly reduced disease activity in the CD4+CD45RBhi T cell transfer mouse colitis model.
ALPN-101 Received FDA Orphan Drug Designations for the Prevention and Treatment of Acute Graft Versus Host Disease: Earlier this month, the United States Food and Drug Administration (FDA) granted two orphan drug designations for ALPN-101, one for the prevention of and one for the treatment of acute GVHD.

Clinical Trials in Patients Now Open for Both Development Programs: A phase 1b/2 trial of ALPN-101 in acute GVHD (BALANCE, NCT04227938) and a phase 1 trial of ALPN-202 in advanced malignancies (NEON-1, NCT04186637) are now both open for enrollment.

Full Year 2019 Financial Results

As of December 31, 2019, we had cash, cash equivalents, restricted cash, and short-term investments totaling $40.9 million. Net cash used in operating activities for the year ended December 31, 2019 was $35.3 million compared to $28.4 million for the year ended December 31, 2018. We recorded a net loss of $41.9 million and $36.5 million for the years ended December 31, 2019 and 2018, respectively.

Collaboration revenue for the year ended December 31, 2019 was $1.7 million compared to $0.7 million for the year ended December 31, 2018. The increase was primarily attributable to $1.3 million in revenue recognized from the Adaptimmune Collaboration Agreement and a $0.4 million milestone payment from Laurel from the sale of our GSNOR assets.

Research and development expenses for the year ended December 31, 2019 were $35.8 million compared to $29.0 million for the year ended December 31, 2018. The increase was primarily attributable to an increase in clinical trial activity, direct research activities, personnel-related expenses as a result of growth in headcount to support ongoing discovery and development programs, related overhead and facility costs for these programs, and an increase in stock-based compensation.

General and administrative expenses for the year ended December 31, 2019 were $9.5 million compared to $8.4 million for the year ended December 31, 2018. The increase was primarily attributable to personnel-related expenses related to an increase in administrative headcount, increases in professional and legal services, and an increase in facility costs to support the growth of our business.

Fourth Quarter and Full Year 2019 Conference Call and Webcast Details

Alpine will hold a conference call and webcast to discuss results from the fourth quarter and full year 2019 on March 30, 2020 at 4:30 pm EDT. To access the live call by phone, dial (800) 816-3005 (domestic) or (857) 770-0069 (international) using participant passcode 6877935. To access a live webcast of the call, please visit the Investor Relations section of the Alpine Immune Sciences website at ir.alpineimmunesciences.com. The recorded webcast will be available for replay for approximately 30 days following the call.

About ALPN-101

ALPN-101 is a novel Fc fusion protein of a human inducible T cell costimulator ligand (ICOSL) variant immunoglobulin domain (vIgD), a first-in-class therapeutic designed to inhibit simultaneously the CD28 and ICOS inflammation pathways. CD28 and ICOS are closely related costimulatory molecules with partially overlapping roles in T cell activation likely playing a role in multiple autoimmune and inflammatory diseases. In preclinical models of graft versus host disease, inflammatory arthritis, connective tissue disease, and multiple sclerosis, ALPN-101 demonstrates efficacy superior to agents blocking the CD28 – CD80/86 and/or ICOS – ICOSL pathways alone. A phase 1b/2 trial of ALPN-101 in acute GVHD (BALANCE, NCT04227938) is open for enrollment.

About ALPN-202

ALPN-202 is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor with the potential to improve upon the efficacy of combined checkpoint inhibition while limiting significant toxicities. Preclinical studies of ALPN-202 have successfully demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. A phase 1 trial of ALPN-202 in advanced malignancies (NEON-1, NCT04186637) is open for enrollment.

On March 30, 2020 Bayer reported that Nubeqa (darolutamide) receives EU approval as a new treatment for men with non-metastatic castration-resistant prostate cancer (Press release, Bayer, MAR 30, 2020, View Source [SID1234555995]).

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The European Commission has granted marketing authorisation in the European Union (EU) for Nubeqa (darolutamide), an oral androgen receptor inhibitor (ARi). The approval is based on Phase III ARAMIS trial results showing a statistically significant improvement in metastasis-free survival (MFS) for darolutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT, and a favorable safety profile.

The compound, which is developed jointly by Orion Corporation and Bayer, is indicated for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease. Bayer is responsible for global commercialisation of darolutamide, with a co-promotion of Bayer and Orion in certain European markets, e.g. France, Germany, Italy, Spain, the UK, Scandinavia and Finland.

Nubeqa has a distinct chemical structure which inhibits the growth of prostate cancer cells while limiting the burden of side effects on patients’ everyday lives. The EU approval is based on the pivotal Phase III ARAMIS trial data evaluating the efficacy and safety of darolutamide plus androgen deprivation therapy (ADT) compared to placebo plus ADT. Results demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS) of darolutamide plus ADT, with a median of 40.4 months, versus 18.4 months for placebo plus ADT (p<0.001), and a favorable safety profile. Nubeqa is already approved in the U.S., Australia, Brazil, Canada, as well as Japan and filings in other regions are underway or planned by Bayer.

"As men with nmCRPC typically have no symptoms and are leading active lives, it is important to have treatment options that delay the progression of their cancer while minimising the burdensome side effects of treatment, allowing them to maintain their lifestyle with little disruption. Darolutamide provides a welcome new option with a favorable safety profile that helps patients to stay on therapy and allows us to meet these treatment goals," said Karim Fizazi, M.D., Ph.D., Professor of Medicine at the Institut Gustave Roussy, Villejuif, France.

Prostate cancer that is confined to the prostate region and is treated with ADT but keeps progressing, even when the amount of testosterone is reduced to very low levels in the body, is known as nmCRPC. In Europe over 67,000 men are estimated to have a CRPC diagnosis, based on 2018 prostate cancer incidence numbers. About one-third of men with nmCRPC go on to develop metastases within two years.

"We are pleased to collaborate with Bayer in combining our expertise in the development of Nubeqa and look forward to our co-promotion in Europe to support patients with non-metastatic castration-resistant prostate cancer and their healthcare professionals", said Satu Ahomäki, Senior Vice President, Commercial Operations of Orion Corporation.

"The approval of Nubeqa in Europe supports our commitment to delivering innovative medicines that are differentiated from current options and that address unmet medical needs, improve treatment outcomes and maintain quality of life for men at all stages of the prostate cancer continuum," said Robert LaCaze, Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of the Oncology Strategic Business Unit. "We expect to report results from the pre-planned OS analysis at an oncology meeting later this year."

In the ARAMIS trial, overall survival (OS) and time to pain progression were additional secondary efficacy endpoints. At the time of final MFS analysis, a positive trend in OS was observed; OS data were not yet mature. Results from the pre-planned final OS analysis are expected to be presented at an upcoming scientific meeting in 2020. The MFS result was additionally supported by a delay in time to pain progression as compared to placebo plus ADT. All other secondary endpoints, time to cytotoxic chemotherapy, and time to a symptomatic skeletal event (SSE), also demonstrated a benefit in favor of darolutamide at the time of final MFS analysis.

Darolutamide plus ADT has demonstrated a favorable safety profile. The most frequent adverse reactions in the darolutamide plus ADT arm, that occurred with an absolute increase in frequency of ≥2% compared to placebo plus ADT, were fatigue/asthenic conditions (16% vs. 11%), pain in extremity (6% vs. 3%), and rash (3% vs. 1%). Discontinuation due to adverse events occurred in 9% of patients in both arms of the study.

About the ARAMIS trial
The ARAMIS trial is a randomized, Phase III, multi-center, double-blind, placebo-controlled trial evaluating the safety and efficacy of oral darolutamide in patients with nmCRPC who are currently being treated with ADT and are at high risk for developing metastatic disease. In the clinical study, 1,509 patients were randomized in a 2:1 ratio to receive 600 mg of darolutamide orally twice daily or placebo along with ADT. Patients with a history of seizure were allowed in the study.

About Nubeqa (darolutamide)
Darolutamide was approved in March 2020 in the European Union under the brand name Nubeqa for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease. Nubeqa has also received regulatory approval in the U.S., Australia, Brazil, Canada as well as Japan, and filings in other regions are underway or planned by Bayer.

Nubeqa is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells. Darolutamide is also being investigated in a Phase III study in metastatic hormone-sensitive prostate cancer (ARASENS trial). Information about these trials can be found at www.clinicaltrials.gov.

About castration-resistant prostate cancer (CRPC)
Prostate cancer is the second most commonly diagnosed malignancy in men worldwide. In 2018, an estimated 1.2 million men were diagnosed with prostate cancer, and about 358,000 died from the disease worldwide. Prostate cancer is the fifth leading cause of death from cancer in men. Prostate cancer results from the abnormal proliferation of cells within the prostate gland, which is part of a man’s reproductive system. It mainly affects men over the age of 50, and the risk increases with age.

Treatment options range from surgery to radiation treatment to therapy using hormone-receptor antagonists, i.e., substances that stop the formation of testosterone or prevent its effect at the target location. However, in nearly all cases, the cancer eventually becomes resistant to conventional hormone therapy.

CRPC is an advanced form of the disease where the cancer keeps progressing despite ADT treatment, even when the amount of testosterone is reduced to very low levels in the body. In men with progressive nmCRPC, a rapid prostate specific antigen (PSA) doubling time has been consistently associated with reduced time to first metastasis and death.

On March 30, 2020 AC Immune SA (NASDAQ: ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, reported financial results for the year ended December 31, 2019, and provided a business and 2020 research and development outlook (Press release, AC Immune, MAR 30, 2020, View Source [SID1234555994]).

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Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "AC Immune is building on clinical and business accomplishments in 2019, and anticipates multiple clinical, value-creating milestones in 2020. We anticipate reporting data from two studies of our proprietary anti-Abeta vaccine program, ACI-24 as well as Phase 1 results for the small molecule Morphomer Tau aggregation inhibitor, ACI-3024, in partnership with Eli Lilly and Company.

Prof. Pfeifer continued: "In parallel, our heritage as a leader in delivering cutting-edge science enables our Company to advance novel preclinical therapeutic and diagnostic candidates focused on emerging targets and neuroinflammation towards the clinic, setting the stage for additional value creation and partnership opportunities. AC Immune’s leading position in the field is built upon our proprietary discovery technology platforms, SupraAntigenTM and MorphomerTM, as well as our personalized medicine approach and exceptional development execution."

2019 and Q1 2020 Research & Development Highlights

Successful execution in preclinical and clinical development during 2019 resulted in a stronger pipeline.

§A Phase 1 study is ongoing for ACI-3024, a first-in-class investigational oral small molecule Morphomer Tau specific aggregation inhibitor that will be studied in neurodegenerative diseases characterized by the presence of pathological Tau aggregates. The initial CHF 60 million milestone payment has been modified such that Lilly has paid AC Immune CHF 30

million during Q3 2019 and CHF 10 million in Q1 2020; and, AC Immune now is eligible for a new additional milestone payment of CHF 60 million within 60 days after dosing of the first patient in the first Phase 2 clinical trial of a Morphomer Tau in the United States or European Union. The amendment to the financial terms increases the total deal value by CHF 40 million to CHF 1.86 billion, up from CHF 1.82 billion.

§Initiation of a second Phase 2 trial of semorinemab in patients with moderate AD, by our collaboration partner Genentech, a member of the Roche Group. This antibody is also being studied in a separate Phase 2 trial in prodromal to mild AD

§Received a milestone payment from our collaboration partner, Life Molecular Imaging, in connection with the initiation of a Phase 2 study in AD of the Tau positron emission tomography (PET) tracer PI-2620

§Initiation of a Phase 1b/2a clinical trial in early AD to evaluate the anti-phospho-Tau vaccine, ACI-35.030, which targets pathological Tau and is intended as a disease-modifying treatment for AD and other Tauopathies in collaboration with Janssen Pharmaceuticals, Inc

§Initiation of a substudy by our partner Genentech, a member of the Roche Group, within the ongoing Phase 2 Alzheimer’s Prevention Initiative (API) trial of AC Immune’s investigational candidate, crenezumab. This substudy aims to measure Tau burden using PET in order to increase the understanding of disease progression in the preclinical stage of autosomal dominantly inherited AD

§Presented initial interim data from an on-going Phase 1b trial of the ACI-24 anti-Abeta vaccine to treat Down syndrome (DS)-related AD

§Discontinuation by our collaboration partner Roche of the CREAD and CREAD 2 Phase 3 studies of the anti-beta-amyloid antibody, crenezumab, in people with prodromal to mild sporadic AD

§Established a research collaboration with leading scientists at the Perelman School of Medicine, University of Pennsylvania focused on studying the pathological mechanisms of TDP-43 misfolding and aggregation

§Awarded a new grant from The Michael J. Fox Foundation (MJFF) for development of AC Immune’s pioneering alpha-synuclein PET tracers

§Hosted two Key Opinion Leader (KOL) events focused on "untangling" Tau pathology as an important therapeutic and diagnostic target for AD and other neurodegenerative diseases, and on treating DS-related AD

2020 Research & Development Outlook

The coming years will be transformational for the field of neuroscience and AC Immune is poised to make significant clinical contributions, capturing substantial interest and value in 2020 and beyond. The Company will deliver multiple near-term catalysts, including results from five clinical trials. The Company’s sustained growth is driven by its industry-leading Roadmap to Successful Therapies for Neurodegenerative Diseases, and is fueled by its proprietary technology platforms, SupraAntigenTM and MorphomerTM, which continue to generate therapeutic antibody, small molecule and vaccine candidates.

2020 Clinical Readouts

§Semorinemab, anti-Tau antibody: Phase 2 trial primary completion (estimated last patient, last visit) in prodromal/mild in Q2
§ACI-24 anti-Abeta vaccine in DS: Phase 1b full study reporting in H2
§ACI-35.030 anti-pTau vaccine: Phase 1b/2a in AD interim analysis in Q2
§ACI-3024 small molecule Morphomer Tau aggregation inhibitor: Phase 1 results in healthy volunteers in Q2; data disclosed by partner in H2 (expected)
§ACI-24 in AD: Phase 2, 12-month interim analysis in H2

2020 Preclinical Milestones

§Alpha-synuclein antibody: started investigational new drug (IND)-enabling studies for lead candidate in Q1
§Anti-TDP-43 antibody: declare clinical lead and start IND-enabling studies in Q2
§ Alpha-synuclein small molecule: identify first biologically active small molecule in Q2
§Alpha-synuclein imaging agent: advance third generation candidate to clinical stage in Q4
§Neuroinflammation: declare lead candidates for small molecule and antibody programs in Q4

Prof. Pfeifer concluded: "In summary, 2020 begins a decade with the potential for major neuroscience advances. With AC Immune’s remarkably broad development pipeline focused on neurodegenerative diseases we have multiple opportunities to contribute to the advancement of this field from a business, clinical and human perspective."

Analysis of Financial Statements for the year ended December 31, 2019Cash Position: The Company had a total cash balance of CHF 288.6 million, comprised of CHF 193.6 million in cash and cash equivalents and CHF 95 million in short-term financial assets. This compares to a total cash balance of CHF 186.5 million as of December 31, 2018. The increase of CHF 102.1 million is principally due to the CHF 80 million upfront payment, USD 50 million convertible equity note and CHF 30 million milestone payment related to the agreement with Lilly. The total shareholders’ equity position increased to CHF 272.4 million from CHF 177.6 million as of the prior year. The Company’s cash balance provides enough capital resources to progress through at least Q1 2024

Revenues: Revenues for the year ended December 31, 2019 totaled CHF 111.0 million. This represents an increase of CHF 103.8 million compared to 2018. The increase for the year end relates to the recognition of CHF 75.7 million from the right-of-use license and research and development activities linked to the 2018 Lilly agreement and a CHF 30 million payment for the first milestone achieved with Lilly. Additionally, the Company recorded a EUR 2 million (CHF 2.2 million) in connection with the initiation of a Phase 2 trial in AD of Tau PET Tracer with Life Molecular Imaging
§R&D Expenditures: R&D expenses increased by CHF 6.2 million to CHF 50.4 million for the year ended December 31, 2019. Of this increase, CHF 1.7 million relates to increases in R&D expenses directly allocated to R&D programs such as a CHF 0.9 million increase related to higher research, preclinical and manufacturing costs for the lead alpha-

3 / 8

synuclein antibody and a CHF 0.7 million increase for manufacturing and preparation of the Phase 2 study for ACI-24 for DS. Additionally, the personnel costs increased by CHF 1.6 million through the addition of 16 FTEs with remaining increases of CHF 2.8 million in the area of consumables, depreciation of R&D equipment and regulatory and quality assurance

§G&A Expenses: For the year ended December 31, 2019, G&A increased CHF 3.6 million to CHF 16.1 million. Increases were driven by personnel and IT expenses
§IFRS Income/(Loss) for the period: The Company recorded net income after taxes of CHF 45.4 million for the year ended December 31, 2019, compared with net losses of CHF 50.9 million for 2018

2020 Financial Guidance

For the full year 2020, the Company expects its total cash burn to range between CHF 65‒80 million at constant exchange rates.

On March 30, 2020 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the "Company") reported, with approval of the Supervisory Board, to increase the share capital using the Authorized Capital 2019/I. The Company’s share capital shall be increased from currently EUR 43,527,692.00 by up to EUR 3,602,154 to up to EUR 47,129,846.00 by issuing up to 3,602,154 new registered no par value shares of the Company against cash contributions (Press release, Epigenomics, MAR 30, 2020, View Source [SID1234555993]). The placement price per new share will be determined following a bookbuilding process. The new shares will be offered by way of a private placement to institutional investors with the exclusion of the shareholders’ subscription rights and carry full dividend rights as of January 1, 2019.

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M.M.Warburg & CO (AG & Co.) Kommanditgesellschaft auf Aktien is acting as sole underwriter of the transaction. The sole placement agent for the private placement in the U.S.A. is Raymond James & Associates, Inc.