On August 14, 2019 Nuvo Pharmaceuticals Inc. (Nuvo or the Company) (TSX:NRI;OTCQX:NRIFF), a Canadian focused, healthcare company with global reach and a diversified portfolio of commercial products, reported its financial and operational results for the three and six months ended June 30, 2019 (Press release, Nuvo Pharmaceuticals, AUG 14, 2019, View Source [SID1234538750]). For further details on the results, please refer to Nuvo’s Management, Discussion and Analysis (MD&A) and Condensed Consolidated Interim Financial Statements which are available on the Company’s website (www.nuvopharmaceuticals.com). All figures are in Canadian dollars, unless otherwise noted.

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"During the second quarter, our operating segments continued to perform in line with our expectations and our second quarter financial results reinforce the increase in scale the Aralez Transaction has made to our business," said Jesse Ledger, Nuvo’s President & CEO. "While the Vimovo news during the quarter was disappointing, we have made cost-saving adjustments to our operations and our underlying business and financial performance is expected to benefit from these changes moving forward."

Second Quarter Financial Summary

Adjusted total revenue(1) was $19.1 million for the three months ended June 30, 2019 compared to $6.0 million for the three months ended June 30, 2018.

Adjusted EBITDA(1) was $5.7 million for the three months ended June 30, 2019 compared to $2.0 million for the three months ended June 30, 2018.

Gross profit on total revenue was $9.6 million or 58% for the three months ended June 30, 2019 compared to a gross profit of $3.5 million or 60% for the three months ended June 30, 2018.

Cash and short-term investments were $14.7 million as at June 30, 2019 compared to $28.1 million as at December 31, 2018. The decrease was primarily related to the settlement of transaction costs and indebtedness acquired by Nuvo upon close of the Aralez Transaction.
(1)

Non-International Financial Reporting Standards (IFRS) financial measure defined by the Company below.

Second Quarter and 2019 Business Update

Canadian prescriptions of Blexten increased 64% to 105,407 for the three months ended June 30, 2019 compared to 64,404 for the three months ended June 30, 2018.

Canadian prescriptions of Cambia increased 30% to 19,500 for the three months ended June 30, 2019 compared to 15,036 for the three months ended June 30, 2018.

On April 2, 2019, the Company announced the Marketing Authorization Application for Pennsaid 2% had been accepted for review by the Austrian Agency for Health and Food Safety (AGES) acting as the reference member state for Austria, Italy, Greece and Portugal. It is anticipated that a review decision will be made in early 2020.

On May 3, 2019, the Suvexx registration dossier passed screening with Health Canada and is now under formal review. The Company anticipates a review decision from Health Canada during the first half of 2020.

On May 15, 2019, the Company announced the United States Court of Appeals for the Federal Circuit (the Court of Appeals) had reversed the decision by the United States District Court for the District of New Jersey (the District Court) that had upheld the validity of U.S. Patent Nos. 6,926,907 (the ‘907 patent) and 8,557,285 (the ‘285 patent). On July 30, 2019, the Court of Appeals rejected the Company’s en banc request to have the Court of Appeals reconsider its decision. On June 26, 2019, the Company amended its financing agreement with Deerfield Management Company, L.P. (Deerfield), to provide, among other things, for a payment deferral of a portion of mandatory minimum quarterly prepayments should Vimovo U.S. market exclusivity be lost due to a generic entry.

On June 17, 2019, the Company announced that in the second half of 2019, it will start to realize on synergies resulting from organizational changes and its acquisition of Aralez Canada that will reduce its operating expenses by approximately $7.0 million annually.
Second Quarter 2019 Financial Results

Total revenue is comprised of product sales, license revenue and contract revenue. Total revenue was $16.6 million for the three months ended June 30, 2019 compared to $5.9 million for the three months ended June 30, 2018. The significant increase in total revenue for the current quarter was the result of the timing of the Aralez Transaction. Total revenue for the six months ended June 30, 2019 was $31.1 million compared to $10.3 million for the comparative six-month period.

Adjusted total revenue increased to $19.1 million for the three months ended June 30, 2019 compared to $6.0 million for the three months ended June 30, 2018. The $13.1 million increase in adjusted total revenue in the current quarter was primarily related to the timing of the Aralez Transaction, which provided an incremental $9.7 million of total revenue contributed from the Commercial Business segment and $4.7 million attributable to the Vimovo royalties related to the U.S. and ex-U.S. territories, partially offset by a $1.2 million decrease in Production and Service revenue. Adjusted total revenue increased to $36.2 million for the six months ended June 30, 2019 compared to $10.6 for the six months ended June 30, 2018.

Adjusted EBITDA increased to $5.7 million for the three months ended June 30, 2019 compared to $2.0 million for the three months ended June 30, 2018. The increase in adjusted EBITDA for the current quarter was primarily attributable to the increase in gross profit as a result of the Aralez Transaction, partially offset by an increase in sales and marketing and general and administrative (G&A) expenses, including $1.0 million of one-time restructuring expenses. Adjusted EBITDA increased to $10.9 million for the six months ended June 30, 2019 compared to $2.7 million for the six months ended June 30, 2018.

Gross profit on total revenue was $9.6 million or 58% for the three months ended June 30, 2019 compared to a gross profit of $3.5 million or 60% for the three months ended June 30, 2018. The increase in gross profit for the current quarter was primarily attributable to an increase in gross margin on product sales and an increase in license revenue due to the timing of the Aralez Transaction. Gross profit on total revenue was $18.7 million or 60% for the six months ended June 30, 2019 compared to a gross profit of $6.1 million or 59% for the six months ended June 30, 2018.

Non-IFRS Financial Measures
The Company discloses non-IFRS measures (such as adjusted total revenue, adjusted EBITDA and adjusted EBITDA per share) that do not have standardized meanings prescribed by IFRS. The Company believes that shareholders, investment analysts and other readers find such measures helpful in understanding the Company’s financial performance and in interpreting the effect of the Aralez Transaction and the Deerfield Financing on the Company. Non-IFRS financial measures do not have any standardized meaning prescribed by IFRS and may not have been calculated in the same way as similarly named financial measures presented by other companies.

Adjusted Total Revenue
The Company defines adjusted total revenue as total revenue, plus amounts billed to customers for existing contract assets, less revenue recognized upon recognition of a contract asset. Management believes adjusted total revenue is a useful supplemental measure from which to determine the Company’s ability to generate cash from its customer contracts that is used to fund its operations.

The following is a summary of how adjusted total revenue is calculated:

Adjusted EBITDA
EBITDA refers to net income (loss) determined in accordance with IFRS, before depreciation and amortization, net interest expense (income) and income tax expense (recovery). The Company defines adjusted EBITDA as net income before net interest expense (income), depreciation and amortization and income tax expense (recovery) (EBITDA), plus amounts billed to customers for existing contract assets, inventory step-up expense, stock-based compensation expense, Other Expenses, less revenue recognized upon recognition of a contract asset and other income. Management believes adjusted EBITDA is a useful supplemental measure from which to determine the Company’s ability to generate cash available for working capital, capital expenditures, debt repayments, interest expense and income taxes.

The following is a summary of how EBITDA and adjusted EBITDA are calculated:

Management to Host Conference Call/Webcast
Management will host a conference call to discuss the results today (Wednesday, August 14, 2019) at 8:30 a.m. ET. To participate in the conference call, please dial 1 888 390 0546 or 416 764 8688. Please call in 15 minutes prior to the call to secure a line. You will be put on hold until the conference call begins.

A taped replay of the conference call will be available two hours after the live conference call and will be accessible until midnight on August 21, 2019 by calling 1 888 390 0541 or 416 764 8677 playback passcode 509912#.

A live audio webcast of the conference call will be available through www.nuvopharmaceuticals.com. Please connect at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to hear the webcast.

On August 14, 2019 AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported positive results from the Phase 3 PAOLA-1 trial in women with advanced ovarian cancer (Press release, Merck & Co, AUG 14, 2019, View Source [SID1234538713]). The trial, in the first-line maintenance setting, compared LYNPARZA added to standard-of-care bevacizumab versus bevacizumab alone in women with or without BRCA-gene mutations.

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The trial met its primary endpoint in the intent-to-treat (ITT)* population with a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) for women taking LYNPARZA plus bevacizumab, versus those taking bevacizumab alone, as a first-line maintenance treatment following response to standard first-line platinum-based chemotherapy and bevacizumab. The results, including biomarker sub-group analyses, will be presented at a forthcoming medical meeting. The safety and tolerability profiles observed in PAOLA-1 were generally consistent with those known for each medicine. PAOLA-1 is the second positive Phase 3 trial with LYNPARZA in first-line advanced ovarian cancer.

Dr. José Baselga, executive vice president, Oncology R&D, AstraZeneca, said, "The positive results from the PAOLA-1 trial demonstrate a clear potential benefit of adding LYNPARZA to the standard treatment bevacizumab for women with advanced ovarian cancer. Following positive results from the SOLO-1 trial for women with a BRCA gene mutation, the PAOLA-1 trial marks yet another positive Phase 3 trial for LYNPARZA as a first-line maintenance treatment for women with advanced ovarian cancer. We look forward to discussing the results with global health authorities as soon as possible."

Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said, "The Phase 3 PAOLA-1 trial demonstrates Merck and AstraZeneca’s continued commitment to improving clinical outcomes for women with advanced ovarian cancer. In this co-operative group trial sponsored by ARCAGY Research, maintenance treatment with LYNPARZA when added to a standard-of-care treatment was evaluated in an environment representative of real clinical practice. By studying LYNPARZA in this broader patient population, we have learned more about how it may help even more patients with advanced ovarian cancer in the future."

Eric Pujade-Lauraine, Medical Director of ARCAGY Research, said: "The PAOLA-1 trial is a positive example of the strength and promise of academia-industry collaboration in advancing science and new treatment options for patients. We greatly appreciate the commitment of AstraZeneca and Merck in working with academic cooperative groups in ENGOT and look forward to sharing the full PAOLA-1 results at a forthcoming medical meeting."

PAOLA-1 is an ENGOT (European Network for Gynecological Trial) trial, sponsored by ARCAGY Research (Association de Recherche sur les CAancers dont Gynecologiques) on behalf of GINECO (Groupe d’Investigateurs National des Etudes des Cancers Ovariens et du sein). ARCAGY-GINECO is an academic group specializing in clinical and translational research in women’s cancers and a member of the GCIG (Gynecologic Cancer InterGroup).

About PAOLA-1

PAOLA-1 is a randomized, double-blind Phase 3 trial evaluating the efficacy and safety of LYNPARZA when added to standard-of-care bevacizumab versus bevacizumab alone, as first-line maintenance treatment for advanced FIGO Stage IIIB-IV high grade serous or endometroid ovarian, fallopian tube, or peritoneal cancer patients who had a complete or partial response to first-line treatment with platinum-based chemotherapy and bevacizumab. *The ITT (intent-to-treat) population refers to all patients enrolled in the trial.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

There are no contraindications for LYNPARZA.

WARNINGS AND PRECAUTIONS

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in <1.5% of patients exposed to LYNPARZA monotherapy, and the majority of events had a fatal outcome. The duration of therapy in patients who developed secondary MDS/AML varied from <6 months to >2 years. All of these patients had previous chemotherapy with platinum agents and/or other DNA-damaging agents, including radiotherapy, and some also had a history of more than one primary malignancy or of bone marrow dysplasia.

Do not start LYNPARZA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤Grade 1). Monitor complete blood count for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities, interrupt LYNPARZA and monitor blood count weekly until recovery.

If the levels have not recovered to Grade 1 or less after 4 weeks, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. Discontinue LYNPARZA if MDS/AML is confirmed.

Pneumonitis: Occurred in <1% of patients exposed to LYNPARZA, and some cases were fatal. If patients present with new or worsening respiratory symptoms such as dyspnea, cough, and fever, or a radiological abnormality occurs, interrupt LYNPARZA treatment and initiate prompt investigation. Discontinue LYNPARZA if pneumonitis is confirmed and treat patient appropriately.

Embryo-Fetal Toxicity: Based on its mechanism of action and findings in animals, LYNPARZA can cause fetal harm. A pregnancy test is recommended for females of reproductive potential prior to initiating treatment.

Females

Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 6 months following the last dose.

Males

Advise male patients with female partners of reproductive potential or who are pregnant to use effective contraception during treatment and for 3 months following the last dose of LYNPARZA and to not donate sperm during this time.

ADVERSE REACTIONS—First-Line Maintenance BRCAm Advanced Ovarian Cancer

Most common adverse reactions (Grades 1-4) in ≥10% of patients in clinical trials of LYNPARZA in the first-line maintenance setting for SOLO-1 were: nausea (77%), fatigue (67%), abdominal pain (45%), vomiting (40%), anemia (38%), diarrhea (37%), constipation (28%), upper respiratory tract infection/influenza/ nasopharyngitis/bronchitis (28%), dysgeusia (26%), decreased appetite (20%), dizziness (20%), neutropenia (17%), dyspepsia (17%), dyspnea (15%), leukopenia (13%), UTI (13%), thrombocytopenia (11%), and stomatitis (11%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients in clinical trials of LYNPARZA in the first-line maintenance setting for SOLO-1 were: decrease in hemoglobin (87%), increase in mean corpuscular volume (87%), decrease in leukocytes (70%), decrease in lymphocytes (67%), decrease in absolute neutrophil count (51%), decrease in platelets (35%), and increase in serum creatinine (34%).

ADVERSE REACTIONS—Maintenance Recurrent Ovarian Cancer

Most common adverse reactions (Grades 1-4) in ≥20% of patients in clinical trials of LYNPARZA in the maintenance setting for SOLO-2 were: nausea (76%), fatigue (including asthenia) (66%), anemia (44%), vomiting (37%), nasopharyngitis/upper respiratory tract infection (URI)/influenza (36%), diarrhea (33%), arthralgia/myalgia (30%), dysgeusia (27%), headache (26%), decreased appetite (22%), and stomatitis (20%).

Study 19: nausea (71%), fatigue (including asthenia) (63%), vomiting (35%), diarrhea (28%), anemia (23%), respiratory tract infection (22%), constipation (22%), headache (21%), decreased appetite (21%), and dyspepsia (20%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients in clinical trials of LYNPARZA in the maintenance setting (SOLO-2/Study 19) were: increase in mean corpuscular volume (89%/82%), decrease in hemoglobin (83%/82%), decrease in leukocytes (69%/58%), decrease in lymphocytes (67%/52%), decrease in absolute neutrophil count (51%/47%), increase in serum creatinine (44%/45%), and decrease in platelets (42%/36%).

ADVERSE REACTIONS—Advanced gBRCAm ovarian cancer

Most common adverse reactions (Grades 1-4) in ≥20% of patients in clinical trials of LYNPARZA for advanced gBRCAm ovarian cancer after 3 or more lines of chemotherapy (pooled from 6 studies) were: fatigue/asthenia (66%), nausea (64%), vomiting (43%), anemia (34%), diarrhea (31%), nasopharyngitis/upper respiratory tract infection (URI) (26%), dyspepsia (25%), myalgia (22%), decreased appetite (22%), and arthralgia/musculoskeletal pain (21%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients in clinical trials of LYNPARZA for advanced gBRCAm ovarian cancer (pooled from 6 studies) were: decrease in hemoglobin (90%), mean corpuscular volume elevation (57%), decrease in lymphocytes (56%), increase in serum creatinine (30%), decrease in platelets (30%), and decrease in absolute neutrophil count (25%).

ADVERSE REACTIONS—gBRCAm, HER2-negative metastatic breast cancer

Most common adverse reactions (Grades 1-4) in ≥20% of patients in OlympiAD were: nausea (58%), anemia (40%), fatigue (including asthenia) (37%), vomiting (30%), neutropenia (27%), respiratory tract infection (27%), leukopenia (25%), diarrhea (21%), and headache (20%).

Most common laboratory abnormalities (Grades 1-4) in >25% of patients in OlympiAD were: decrease in hemoglobin (82%), decrease in lymphocytes (73%), decrease in leukocytes (71%), increase in mean corpuscular volume (71%), decrease in absolute neutrophil count (46%), and decrease in platelets (33%).

DRUG INTERACTIONS

Anticancer Agents: Clinical studies of LYNPARZA in combination with other myelosuppressive anticancer agents, including DNA-damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity.

CYP3A Inhibitors: Avoid concomitant use of strong or moderate CYP3A inhibitors. If a strong or moderate CYP3A inhibitor must be co-administered, reduce the dose of LYNPARZA. Advise patients to avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice during LYNPARZA treatment.

CYP3A Inducers: Avoid concomitant use of strong or moderate CYP3A inducers when using LYNPARZA. If a moderate inducer cannot be avoided, there is a potential for decreased efficacy of LYNPARZA.

USE IN SPECIFIC POPULATIONS

Lactation: No data are available regarding the presence of olaparib in human milk, its effects on the breastfed infant or on milk production. Because of the potential for serious adverse reactions in the breastfed infant, advise a lactating woman not to breastfeed during treatment with LYNPARZA and for 1 month after receiving the final dose.

Pediatric Use: The safety and efficacy of LYNPARZA have not been established in pediatric patients.

Hepatic Impairment: No adjustment to the starting dose is required in patients with mild or moderate hepatic impairment (Child-Pugh classification A and B). There are no data in patients with severe hepatic impairment (Child-Pugh classification C).

Renal Impairment: No adjustment to the starting dose is necessary in patients with mild renal impairment (CLcr=51-80 mL/min), but patients should be monitored closely for toxicity. In patients with moderate renal impairment (CLcr=31-50 mL/min), reduce the dose to 200 mg twice daily. There are no data in patients with severe renal impairment or end-stage renal disease (CLcr ≤30 mL/min).

INDICATIONS

LYNPARZA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:

First-Line Maintenance BRCAm Advanced Ovarian Cancer

For the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients with gBRCAm advanced epithelial ovarian, fallopian tube or primary peritoneal cancer for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

Maintenance Recurrent Ovarian Cancer

For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy.

Advanced gBRCAm ovarian cancer

For the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with 3 or more prior lines of chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

gBRCAm, HER2-negative metastatic breast cancer

In patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

Please click here for complete Prescribing Information, including Patient Information (Medication Guide).

About LYNPARZA (olaparib)

LYNPARZA is a first-in-class PARP inhibitor and the first targeted treatment to potentially exploit DNA damage response (DDR) pathway deficiencies, such as BRCA mutations, to preferentially kill cancer cells. Inhibition of PARP with LYNPARZA leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death. LYNPARZA is being tested in a range of tumor types with defects and dependencies in the DDR.

LYNPARZA, which is being jointly developed and commercialized by AstraZeneca and Merck, has a broad and advanced clinical trial development program, and AstraZeneca and Merck are working together to understand how it may affect multiple PARP-dependent tumors as a monotherapy and in combination across multiple cancer types.

About Ovarian Cancer

Ovarian cancer the eighth most common cause of death from cancer in women worldwide, with a five-year survival rate of approximately 19%. In 2018, there were nearly 300,000 new cases diagnosed and around 185,000 deaths. For newly-diagnosed advanced ovarian cancer, the primary aim of treatment is to delay progression of the disease for as long as possible and maintain the patient’s quality of life with the intent of achieving complete remission or cure.

About GINECO

GINECO (Groupe d’Investigateurs Nationaux pour l’Étude des Cancers Ovariens et du sein) is the French Cooperative Group in Oncology labelled by INCA (Institut National du Cancer or French NCI) developing and conducting gynaecological and metastatic breast cancer clinical trials at the national and international level. Founded in 1993, the GINECO group is member of international consortia such as ENGOT and GCIG.

About ENGOT

ENGOT (European Network for Gynaecological Oncological Trial groups) is a research network of the European Society of Gynaecological Oncology (ESGO). Founded in 2007, ENGOT includes 21 cooperative groups from 25 European countries.

About GCIG

The GCIG (Gynecological Cancer InterGroup) aims to promote and facilitate high quality clinical trials in order to improve outcomes for women with gynaecological cancer. Founded in 1998, GCIG includes 23 cooperative groups from 28 countries worldwide.

About the AstraZeneca and Merck Strategic Oncology Collaboration

In July 2017, AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US, known as MSD outside the United States and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialize LYNPARZA, the world’s first PARP inhibitor, and potential new medicine selumetinib, a MEK inhibitor, for multiple cancer types. Working together, the companies will develop LYNPARZA and selumetinib in combination with other potential new medicines and as monotherapies. Independently, the companies will develop LYNPARZA and selumetinib in combination with their respective PD-L1 and PD-1 medicines.

Merck’s Focus on Cancer

Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck, the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. As part of our focus on cancer, Merck is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. We also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers. For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.

On August 14, 2019 BioInvent International AB (OMXS: BINV) reported that it will issue its interim report for the second quarter 2019 on Thursday August 22 at 8.30 a.m. CEST, followed by an audiocast with teleconference at 11.00 a.m. CEST, hosted by Martin Welschof, CEO and members of the management team (Press release, BioInvent, AUG 14, 2019, View Source [SID1234538735]). The presentation will be held in English.

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To participate, please call any of the following phone numbers from:
Sweden: +46-8-566-426-92
UK: +44-333-300-9272
US: +1-833-526-8383

Webcast: View Source

On August 14, 2019 AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, repored updated clinical data from its ongoing glioblastoma Phase 2 clinical trial, investigating AIVITA’s platform immunotherapy targeting tumor-initiating cells (Press release, AIVITA Biomedical, AUG 14, 2019, View Source [SID1234538751]). Blood plasma biomarker analyses have identified a robust immune response and a decrease of tumor biomarkers in 65% of treated patients, in a sample that represents 29% of the total Phase 2 clinical trial size.

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Blood was collected from subjects at multiple time points, one week after each dose administration, and assayed for 450 different immune and tumor biomarkers. Treatment elicited a robust immune response, with biomarkers suggesting progressive activation of dendritic cell cross-presentation and progressive activation of a type II hypersensitivity antibody-mediated cytotoxic response. Most notably, 65% of the treated glioblastoma patients also showed a robust decrease of 27 different biomarkers associated with tumor development, including markers of tumor-associated angiogenesis, tumor-associated growth factors, and tumors themselves.

"An objective tumor biomarker response, combined with a robust and appropriate immune response, suggests a decrease of tumor burden in 65% of our treated patients," said Dr. Hans S. Keirstead, AIVITA’s Chief Executive Officer. "Should this translate to survival, it would represent a major step forward in our fight against glioblastoma."

AIVITA is currently conducting three distinct clinical studies investigating its platform immunotherapy, in patients with ovarian cancer, glioblastoma and melanoma. AIVITA uses 100% of proceeds from the sale of its ROOT of SKIN skincare line to support the treatment of women with ovarian cancer.

CLINICAL TRIAL DETAIL

OVARIAN CANCER

AIVITA’s ovarian Phase 2 double-blind study is active and enrolling approximately 99 patients who are being randomized in a 2:1 ratio to receive either the autologous tumor-initiating cell-targeting immunotherapy or autologous monocytes as a comparator.

Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient monocytes were obtained, (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), and (5) who have completed primary therapy. The trial is not open to patients with recurrent ovarian cancer.

For additional information about AIVITA’s AVOVA-1 trial patients can visit: www.clinicaltrials.gov/ct2/show/NCT02033616

GLIOBLASTOMA

AIVITA’s glioblastoma Phase 2 single-arm study is active and is enrolling approximately 55 patients to receive the tumor-initiating cell-targeting immunotherapy.

Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established, (3) have a Karnofsky Performance Status of > 70 and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC). The trial is not open to patients with recurrent glioblastoma.

For additional information about AIVITA’s AV-GBM-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03400917

MELANOMA

AIVITA’s melanoma Phase 1B open-label, single-arm study will establish the safety of administering anti-PD1 monoclonal antibodies in combination with AIVITA’s tumor-initiating cell-targeting immunotherapy in patients with measurable metastatic melanoma. The study will also track efficacy of the treatment for the estimated 14 to 20 patients. This trial is not yet open for enrollment.

Patients eligible for treatment will be those (1) for whom a cell line has been established, (2) who have undergone leukapheresis from which sufficient monocytes were obtained, (3) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), (4) who have either never received treatment for metastatic melanoma or were previously treated with enzymatic inhibitors of the BRAF/MEK pathway because of BRAF600E/K mutations and (5) are about to initiate anti-PD1 monotherapy.

For additional information about AIVITA’s AV-MEL-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03743298

On August 14, 2019 AC Immune SA (NASDAQ: ACIU), a Swiss-based, biopharmaceutical company with a broad clinical-stage pipeline focused on neurodegenerative diseases, reported its business and clinical plan and strategy, reported consolidated financial results for the second quarter of 2019 and its revised cash guidance (Press release, AC Immune, AUG 14, 2019, View Source [SID1234538736]).

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Prof. Andrea Pfeifer, Ph.D., CEO of AC Immune, commented: "Our business strategy is based on a three-pillar approach in the development of treatments for Alzheimer’s disease, NeuroOrphan therapeutics and diagnostics. Our Roadmap to Successful Therapies for Neurodegenerative Diseases is based on treating earlier, targeting Tau, incorporating homogeneous populations, applying precision medicine and targeting neuroinflammation."

There is a growing body of clinical evidence that Tau drives disease progression. AC Immune has one of the broadest anti-Tau pipelines with antibodies, small molecules, vaccines and diagnostics, covering five clinical trials and partnerships with four major pharmaceutical companies.

"SupraAntigenTM and MorphomerTM, our proprietary discovery platforms are the foundation for multiple product candidates," added Dr. Pfeifer. "The productivity of these platforms has recently demonstrated significant clinical, value-creating milestones."

Research & Development Highlights Q2 2019 and Beyond

Dosing of the first subject in a Phase 1 study of ACI-3024, a first-in-class investigational oral small molecule Tau Morphomer inhibitor that will be studied in neurodegenerative diseases that are characterized by the presence of pathological Tau aggregates. This is the first significant advancement in AC Immune’s collaboration with Eli Lilly and Company
Initiation of a Phase 1b/2a clinical trial to evaluate ACI-35.030, a clinically advanced anti-phospho-Tau designed to reduce and to prevent the spread and development of Tau pathology to treat early and moderate Alzheimer’s disease (AD)
Initial interim data from an ongoing Phase 1b trial of AC Immune’s ACI-24 anti-Abeta vaccine, to treat AD like symptoms in subjects with Down syndrome (DS), demonstrated strong safety and preliminary immunogenicity results
Hosted a Key Opinion Leader (KOL) event, where presentations underscored the significant need and opportunity for studying AD-like symptoms in DS, a high-risk and genetically homogeneous population
Initiation of a substudy by Genentech, a member of the Roche Group, in the ongoing Phase 2 Alzheimer’s Prevention Initiative (API) trial of AC Immune’s investigational candidate, crenezumab. The substudy, which measures Tau burden using Positron Emission Tomography (PET), aims to increase the understanding of disease progression in the preclinical stage of autosomal dominantly inherited, or familiar, AD
Initiation of a research partnership with leading scientists in the Perelman School of Medicine at the University of Pennsylvania (Penn) focused on studying the pathological mechanisms of TDP-43 misfolding and aggregation
Anticipated Near-Term Milestones

H2:2019: Proof-of-concept data from three NeuroOrphan indications from our SupraAntigen platform
H2:2020: Read out from a Phase 2 clinical trial in prodromal/mild AD patients from the SupraAntigen platform
Multiple clinical trial readouts from collaboration partners in 2020/2021 confirming Tau antibodies as a viable approach to halting the progression of AD and other neurodegenerative conditions
Analysis of Financial Statements for the Three and Six Months Ended June 30, 2019

Cash Position: The Company had a total cash balance of CHF 285.7 million, comprised of CHF 205.7 million in cash and cash equivalents and CHF 80.0 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 99.2 million is principally due to the CHF 80 million upfront payment and USD 50 million convertible equity note related to the agreement with Lilly. Further details are available in our Statements of Cash Flows in the accompanying Form 6-K.
The total shareholders’ equity position increased from December 31, 2018 to CHF 273.3 million from CHF 177.6 million. Further details are available in our corresponding Financial Statements filed on the accompanying Form 6-K.
Revenues: Revenues for the three and six months ended June 30, 2019 totaled CHF 1.5 million and CHF 76.6 million, respectively. This represents a decrease of CHF 0.5 million and increase of CHF 73.1 million compared to the respective periods in 2018. The decrease for the three-month period relates to 2018 Biogen revenues not repeated in 2019, as this contract concluded in April. The increase for the six-month period is driven by the recognition of CHF 74.3 million from the right-of-use license and research and development activities linked to the 2018 Lilly agreement. Revenues fluctuate as a result of payments associated with our collaborations with current and potential new partners, the timing of milestone achievements and the size of each milestone payment.
R&D Expenditures: R&D expenditures increased by CHF 2.2 million (+21%) and CHF 3.7 million (+18%) for the three and six months ended June 30, 2019 compared to the comparable periods in 2018, respectively. The Company largely increased its investments in AD, non-AD and new discovery programs. For AD, the Company prepared activities for its Phase 1b/2a and Phase 2 studies for ACI-35 and ACI-24 AD, respectively. For non-AD, the Company increased investment in its MorphomerTM alpha-synuclein programs and continued to advance ACI-24 DS through clinical development. Finally, in new discovery, the Company continues to focus on its neuroinflammation discovery programs.
G&A Expenses: For the three and six months ended June 30, 2019, G&A increased CHF 0.5 million (+17%) and CHF 1.1 million (+19%) to CHF 3.6 million and CHF 6.9 million, respectively. Increases are driven by rental, personnel and IT expenses.
IFRS Income/(Loss) for the period: The Company incurred net loss and net income after taxes of CHF 16.9 million and CHF 46.7 million for the three and six months ended June 30, 2019, respectively, compared with net losses of CHF 11.1 million and CHF 22.8 million for the comparable periods in 2018.