On August 13, 2020 Precision BioSciences, Inc. (Nasdaq: DTIL) a clinical-stage biotechnology company dedicated to improving life with its novel and proprietary ARCUS genome editing platform, reported financial results for the second quarter ended June 30, 2020 and provided a business update (Press release, Precision Biosciences, AUG 13, 2020, View Source [SID1234563569]).

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"We have continued to make important progress across our clinical portfolio, including the initiation of our Phase 1/2a study of BCMA-targeted PBCAR269A, bringing us to three CAR T candidates now in clinical trials. However, due to study site activation and patient enrollment delays related to the COVID-19 pandemic, we now anticipate reporting updated interim data from our lead candidate, PBCAR0191, targeting CD19 in heavily pretreated patients with R/R NHL or B-ALL, no earlier than the fourth quarter of 2020," said Matt Kane, CEO and co-founder of Precision BioSciences. "Our pre-clinical work also continued to progress, including our lead gene correction program targeting PH1, for which we look forward to nominating a clinical candidate later this year. We anticipate sharing more about this program as it advances towards the clinic, including what we believe are prudent safety and delivery advantages with ARCUS genome editing that support additional in vivo targets of interest."

Recent Developments and Upcoming Milestones

Allogeneic CAR T Portfolio

PBCAR0191: PBCAR0191 is an investigational allogeneic chimeric antigen receptor (CAR T) candidate targeting CD19 and is being evaluated in a Phase 1/2a study in relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) or R/R B-cell precursor acute lymphoblastic leukemia (B-ALL). The NHL cohort includes patients with mantle cell lymphoma (MCL), an aggressive subtype of NHL, for which Precision has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA). The PBCAR0191 clinical trial has continued to progress, although site activation and patient enrollment across all studies, including PBCAR0191, has slowed due to the COVID-19 pandemic. Precision expects to share an update of this trial no earlier than the fourth quarter of this year. PBCAR0191 is being developed in collaboration with Servier, an international pharmaceutical company.

PBCAR20A: PBCAR20A is a wholly-owned investigational allogeneic CAR T candidate targeting CD20 for the treatment of hematological malignancies. Precision’s Phase 1/2a clinical trial is evaluating PBCAR20A in two patient cohorts: R/R NHL, and R/R chronic lymphocytic leukemia (CLL) or R/R small lymphocytic lymphoma (SLL). The NHL cohort will include patients with MCL, an aggressive subtype of NHL, for which Precision has received Orphan Drug Designation from the FDA.

PBCAR269A: PBCAR269A is a wholly-owned investigational allogeneic CAR T candidate targeting B-cell maturation antigen (BCMA) for the treatment of R/R multiple myeloma, for which Precision has received Orphan Drug Designation from the FDA. In June 2020, the Company dosed the first patient in a Phase 1/2a study of PBCAR269A, at a starting dose of 6 x 105 CAR T cells/kg body weight. Subsequent cohorts will be treated with escalating doses to a maximum dose of 6 x 106 CAR T cells/kg body weight. This is the first study for which all clinical trial materials will be produced at the Company’s in-house manufacturing facility, which is compliant with current Good Manufacturing Practices. In preclinical disease models, PBCAR269A demonstrated potent in vivo clearance of BCMA+ tumor cells and overall volume reduction, with no evidence of graft-versus-host disease.

In Vivo Gene Correction Portfolio

PH1 Program: Precision’s lead, wholly-owned in vivo gene correction program applies its ARCUS genome editing technology to knock out the HAO1 gene as a potential one-time treatment for primary hyperoxaluria type 1 (PH1), a rare genetic disease. Precision expects to select a clinical candidate to advance into human trials for this program during 2020.

HBV Program: In July 2020, Precision announced it will regain full clinical development and commercialization rights and all data it generated for the in vivo chronic hepatitis B virus (HBV) program developed under its 2018 collaboration agreement with Gilead Sciences, effective September 4, 2020. The Company is exploring partnership or alternative opportunities that enable the continued development and potential commercialization of ARCUS-based HBV therapies.

Elo Life Systems

Dole Collaboration: On August 4, 2020, Elo Life Systems, a wholly-owned subsidiary of Precision BioSciences, announced its strategic collaboration with Dole Food Company, one of the world’s largest food producers of high-quality fresh fruit and vegetables, with the aim to develop banana varieties resistant to Fusarium wilt Tropical Race 4 (TR4). The TR4 strain of the fungal pathogen, Fusarium oxysporum threatens the continued cultivation of the Cavendish variety, one of the world’s most popular bananas. Under the terms of the collaboration, Dole will fully fund research and development efforts executed by Elo to co-develop banana varieties resistant to a pathogen that is otherwise unresponsive to any control measures. Elo is eligible to receive royalties on any commercialized plant product.

Quarter Ended June 30, 2020 Financial Results

Cash and Cash Equivalents: As of June 30, 2020, Precision had approximately $126.9 million in cash and cash equivalents. The Company expects that existing cash, cash equivalents and available credit will be sufficient to fund operating expenses and capital expenditure requirements into 2022.

Revenues: Total revenues for the quarter ended June 30, 2020 were $1.1 million, compared to $5.4 million for the quarter ended June 30, 2019. This decrease of $4.3 million was primarily due to a decrease in collaboration revenue recognized from Servier and Gilead.

Research and Development Expenses: Research and development expenses were $25.2 million for the quarter ended June 30, 2020, as compared to $22.8 million for the same period in 2019. This increase of $2.4 million was primarily due to increases in direct research and development expenses related to the commencement of our CD20 and BCMA Phase 1/2a clinical trials and our ongoing CD19 clinical program.

General and Administrative Expenses: General and administrative expenses were $8.7 million for the quarter ended June 30, 2020, as compared to $6.5 million for the same period in 2019. The increase of $2.2 million was primarily due to costs associated with the Company’s growing infrastructure needs.

Net Loss: Net loss was $32.7 million, or $(0.63) per share, for the quarter ended June 30, 2020, compared to a net loss of $19.4 million, or $(0.39) per share, for the same period in 2019.

On August 13, 2020 VBL Therapeutics (Nasdaq: VBLT) reported financial results for the second quarter ended June 30, 2020, and provided a corporate update (Press release, VBL Therapeutics, AUG 13, 2020, View Source [SID1234563568]).

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"We have made excellent progress advancing our lead candidate VB-111 during 2020," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "The first interim analysis in our OVAL Phase 3 pivotal study in ovarian cancer demonstrated the potential benefit of VB-111 over standard-of-care in a randomized-controlled study, and the recent positive second interim analysis indicates that the trial continues to be on the right track. OVAL has shown strong recruitment despite the COVID-19 pandemic. Also, when the Company blindly reviews response rate data in all trial participants, that is in the treatment and control groups combined, we are very encouraged by the high response rate of over 50% of the total evaluable patients, which has been maintained. The investigator sponsored studies of VB-111 in GBM and colorectal cancer are headed for initiation. Our MOSPD2 programs are gaining momentum, with pre-IND application for our lead candidate VB-601 for inflammation, and recent scientific presentations in NASH and colitis at DDW, in rheumatoid arthritis at EULAR 2020 and in oncology at the AACR (Free AACR Whitepaper) meeting."

Second Quarter and Recent Key Corporate Highlights:

VB-111

●Efficacy data from first interim analysis in the OVAL were reported in March and presented at the ASCO (Free ASCO Whitepaper)20 Annual Meeting, showing 58% or higher objective response rate.

oOVAL independent DSMC reviewed unblinded data and determined that the study has met the interim pre-specified criterion of an absolute percentage advantage of 10% or higher in CA-125 response in the VB-111 treated arm compared to control. The DSMC recommended that the study proceed without modification.

oOverall response rate in the first 60 randomized evaluable patients was 53%. Assuming a balanced randomization, it can be deduced that the response rate in the treatment arm (VB-111 in addition to weekly paclitaxel) was 58% or higher.

oIn patients with post-treatment fever, the response was 69%. Fever is frequently observed after VB-111 treatment.

●Successful second pre-planned interim analysis, with a positive DSMC review of OS data, the primary endpoint of the OVAL Phase 3 potential registration study, was completed on August 11.

oIndependent DSMC reviewed unblinded data of the first 100 patients with follow-up of at least 3 months and determined that the study should proceed without modification.

●Two investigator sponsored VB-111 Phase 2 studies, in rGBM, at Dana Farber Cancer Center and other leading neuro-oncology centers, and in metastatic colorectal cancer by the NCI, are on track for initiation.
MOSPD2

●Pre-IND application for VBL’s VB-601 mAb for immune-inflammatory indications was submitted to the FDA in June. The application is currently under review by the agency.

●Announced new data implicating the potential of its anti-MOSPD2 antibodies for treatment of nonalcoholic steatohepatitis (NASH) and colitis at DDW 2020.

oTreatment with anti-MOSPD2 antibodies was shown to decrease inflammation and fibrosis in a NASH model and significantly reduce disease activity in a colitis model. VBL’s study was rated in the top 10% of all abstracts in this category and was selected as Poster of Distinction.

●Presented new data at the European League Against Rheumatism (EULAR) implicating the potential of proprietary anti-MOSPD2 antibodies for treatment of rheumatoid arthritis (RA).

oTreatment with anti-MOSPD2 antibodies significantly inhibited arthritis progression in the collagen-induced arthritis model (p<0.005). The treatment reduced >50% of disease severity and blocked further disease progression.

oAnti-MOSPD2 demonstrated higher activity than anti-TNFa in the advanced phase of the disease.

●Published a new manuscript demonstrating the potential of MOSPD2 antibodies in multiple sclerosis (MS). The results add to a growing body of data demonstrated activity of VBL’s antibodies in models of chronic inflammatory disease.

●Presented new data demonstrating the potential of anti-MOSPD2 immune-mediated targeting of solid tumors at the Annual American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II.

oMOSPD2 bi-specific antibody candidates induced T-cell activation and significantly extended the survival of animals carrying established metastatic cervical and breast cancer.

oThe data presented demonstrated that the bi-specific antibody candidates mediated killing of tumor cells by CD8 T-cells in a dose-dependent manner and induced T-cell activation in-vivo.
VB-201

●The world-leading European animal health company partner, that is evaluating VB-201 for veterinary applications, advised that the program met a pre-determined milestone. This triggered an undisclosed cash payment to VBL.
Corporate:

●Raised $18.1 million of gross proceeds in two registered direct offerings

●Awarded a non-dilutive grant of up to 3.175 million New Israeli Shekels (NIS; approximately $0.9 million) by the Israel Innovation Authority (IIA).
Quarter Ended June 30, 2020 Financial Results:

●Cash Position: At June 30, 2020, VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposit totaling $41.3 million and working capital of $36.1 million. VBL expects that its cash and cash equivalents and short-term bank deposits will be sufficient to fund operating expenses and capital expenditure requirements into the third quarter of 2022.

●Revenue: Revenues for the second quarter, 2020 were $158 thousand, compared to $138 thousand for the comparable period in 2019.

●Research and Development Expenses: Research and Development expenses, net, were approximately $4.9 million for the second quarter, compared to approximately $3.7 million in the comparable period of 2019.

●General and Administrative Expenses: General and administrative expenses for the second quarter were $1.1 million, compared to $1.2 million for the same period of 2019.

●Comprehensive Loss: VBL reported a net loss for three-month period ended June 30, 2020 of $5.8 million, or ($0.14) per diluted share, compared to a net loss of $4.7 million, or ($0.13) per diluted share, in the same period of 2019.
For further details on VBL’s financials, please refer to Form 6-k filed with the SEC.

On August 13, 2020 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for umbralisib, the Company’s investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with previously treated marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen and follicular lymphoma (FL) who have received at least two prior systemic therapies (Press release, TG Therapeutics, AUG 13, 2020, View Source [SID1234563567]). The MZL indication, under Breakthrough Therapy Designation (BTD), has been accepted for Priority Review and has a Prescription Drug User Fee Act (PDUFA) goal date of February 15, 2021. The FL indication has been accepted for standard review with a PDUFA goal date of June 15, 2021. The FDA also notified the Company that it is not currently planning to hold an advisory committee meeting to discuss this application.

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Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics stated, "We are extremely pleased with the FDA’s acceptance of our first NDA submission and look forward to working with the FDA during the review process. This is a significant achievement in our path towards accomplishing our goal of developing novel treatments for patients with B-cell diseases." Mr. Weiss continued, "If approved, we believe umbralisib could become an important treatment option for patients with previously treated MZL and FL. We look forward to presenting the data from the UNITY-NHL trial that supported this NDA submission by year end."

The NDA for umbralisib was based primarily on data from the umbralisib monotherapy MZL and FL cohorts of the UNITY-NHL Phase 2b trial evaluating patients with relapsed/refractory MZL or FL. The Company has previously announced that each cohort met its primary endpoint of overall response rate (ORR), meeting the Company’s target guidance of 40-50% ORR, as confirmed by an Independent Review Committee (IRC). The FDA has also previously granted umbralisib Breakthrough Therapy Designation (BTD) for MZL and orphan drug designation (ODD) for MZL and FL.

ABOUT THE UNITY-NHL PHASE 2b STUDY—MZL & FL COHORTS
The UNITY- NHL trial is a global multicenter, open-label Phase 2b trial.

The MZL cohort was designed to evaluate the safety and efficacy of single agent umbralisib in patients with MZL who have received at least one prior anti-CD20 regimen. In February of 2019, the Company announced that the primary endpoint of overall response rate (ORR) as determined by Independent Review Committee (IRC) was met for all treated MZL patients. The results met the Company’s target guidance of 40-50% ORR. Interim safety and efficacy data from the MZL cohort were presented in oral presentations in 2019 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting and the International Conference on Malignant Lymphoma (ICML).

The FL cohort was designed to evaluate the safety and efficacy of single agent umbralisib in patients with FL who were relapsed or refractory following at least two prior lines of therapy, including an anti-CD20 regimen and an alkylating agent. In October of 2019, the Company announced that the primary endpoint of ORR as determined by IRC was met for all treated FL patients. The results met the Company’s prespecified response target of 40-50% ORR.

On June 15, 2020, the Company announced the completion of the rolling submission of a NDA to the FDA requesting accelerated approval of umbralisib as a treatment for patients with previously treated MZL and FL.

On August 12, 2020, the Company received notification from the FDA of its acceptance of the Company’s NDA for umbralisib as a treatment for patients with previously treated MZL and FL.

ABOUT MARGINAL ZONE LYMPHOMA
Marginal zone lymphoma (MZL) comprises a group of indolent (slow growing) mature B-cell non-Hodgkin lymphomas (NHLs). MZL is generally considered a chronic and incurable disease. With an annual incidence of approximately 7,500 newly diagnosed patients in the United States1, MZL is the third most common B-cell NHL, accounting for approximately eight percent of all NHL cases. MZL consists of three different subtypes: extranodal MZL of the mucosal-associated lymphoid tissue (MALT), nodal marginal zone lymphoma (NMZL), and splenic marginal zone lymphoma (SMZL)2.

ABOUT FOLLICULAR LYMPHOMA
Follicular lymphoma (FL) is typically an indolent form of non-Hodgkin lymphoma (NHL) that arises from B-lymphocytes. It is the second most common form of NHL. FL is generally not curable and is considered a chronic disease, as patients can live for many years with this form of lymphoma. With an annual incidence in the United States of approximately 15,000 newly diagnosed patients3, FL is the most common indolent lymphoma accounting for approximately 20 percent of all NHL cases4.

On August 13, 2020 ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF) ("ProMIS or the Company"), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, reported its operational and financial results for the three and six months ended June 30, 2020 (Press release, ProMIS Neurosciences, AUG 13, 2020, View Source [SID1234563557]).

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"Over the course of the second quarter of 2020, the value of our unique discovery and development platform was further evidenced as ProMIS made considerable progress in expanding its portfolio of opportunities across multiple neurodegenerative diseases and also in initiated two new diagnostic

programs." stated Eugene Williams, ProMIS’ Executive Chairman. "We look forward to continued progress applying our unique technology platform to the development of disease-modifying antibody therapies, diagnostics and potential vaccines for Alzheimer’s disease, as well as the development of highly accurate assays for detection of antibodies against the virus causing COVID-19."

Corporate Highlights

In April and May 2020, the Company received gross proceed of $1,239,195 from the exercise of 9,532,276 warrants from the warrant repricing program announced in March 2020. The exercise price of the Warrants was repriced to $0.13 per share, effective April 8, 2020 until May 22, 2020 (Warrant Repricing Period). At the end of the Warrant Repricing Period, the Warrants reverted to the original exercise price. All other terms of the Warrants remain unchanged.
On April 7, 2020, we announced that the Alzheimer’s Association International Conference (AAIC) had accepted several abstracts for our Alzheimer’s disease (AD) program. The AAIC also invited ProMIS’ Chief Development Officer, Dr. Johanne Kaplan, to chair a session on novel immunotherapeutic approaches for the treatment of AD.
On April 9, 2020, we announced that the journal Neurology would publish abstracts of data demonstrating the strength of ProMIS’ antibody programs targeting toxic forms of alpha-synuclein in Parkinson’s disease (PD) and toxic forms of TAR DNA-binding protein 43 (TDP-43) in amyotrophic lateral sclerosis (ALS). The data appeared in the April 14, 2020 online supplement to Neurology, the most widely read, highly cited peer-reviewed neurology journal.
On April 30, 2020, we announced we had generated intrabodies highly selective for misfolded forms of TDP-43 implicated in ALS, frontotemporal dementia (FTD) and several other neurologic disorders. Early data support the use of these intrabodies within gene therapy vectors based on their selectivity and ability to promote degradation of toxic species of TDP-43 while preserving normal forms of the protein.
On May 6, 2020, we announced the identification of novel antagonists against the receptor for activated protein kinase C1(RACK1) that prevent the formation of dysfunctional protein aggregates and act to restore normal function. Evidence indicates that targeting RACK1 is a promising new strategy to address the complex mechanisms involved in the pathogenesis of neurodegenerative diseases, including ALS.
On May 12, 2020, the Company announced its program to develop a high-throughput, highly accurate test for detection of antibodies to SARS CoV-2, the causative agent of COVID-19. ProMIS has identified 18 potential antibody targets unique to the spike protein halo of SARS CoV-2.
On May 19, 2020, we announced that, in addition to its ongoing program to develop a high-throughput and accurate test for detection of antibodies to the causative agent of COVID-19, it has expanded its collaboration with BC Neuroimmunology (BCNI) to include development of highly sensitive and specific assays to support accurate screening and diagnosis of AD.
On May 28, 2020, together with a team of commercial and academic collaborators, we shared a Digital Technology Supercluster award from the Government of Canada for 1.8 million Canadian dollars. The project, "Predicting the evolution of COVID-19," brings together six commercial and academic collaborators to predict likely mutations of SARS-CoV-2. The findings will inform the early design of effective tests, therapies and vaccines, allowing public health systems globally to prepare and ideally prevent future pandemics caused by evolving strains of the virus.
On June 17, 2020 the Company and BCNI announced significant progress on development of a highly accurate antibody test for COVID-19. The serology test achieves 99.9% sensitivity and 99.5% specificity for SARS CoV-2. ProMIS’ proprietary peptide antigens are currently under evaluation for their potential ability to detect neutralizing antibodies in the next phase of assay development.
On June 24, 2020, the Board of Directors, having considered current COVID-19 public health restrictions, determined it to be in the best interests of the company and its shareholders to adjourn the company’s annual meeting of shareholders ("AGM") to 9:00 a.m. (Pacific Time) on July 29, 2020 and to change the location of the AGM to Suite 1500, 1055 West Georgia Street, Vancouver, British Columbia.
Financial Results

Results of Operations – Three months ended June 30, 2020 and 2019

The Company’s net loss for the three months ended June 30, 2020 was $1,650,218, compared to a net loss of $1,858,530 for the three months ended June 30, 2019. Included in the net loss amount for the three months ended June 30, 2020 were non-cash expenses of $76,310, representing share-based compensation and amortization of an intangible asset, compared to $153,461 for the three months ended June 30, 2019. The decrease in the net loss for the three months ended June 30, 2020 reflects decreased costs associated with external contract research organizations for internal programs, decreased consulting and professional fees and share-based compensation offset by increased patent expense and foreign exchange losses.

Research and development expenses for the three months ended June 30, 2020 were $898,887, as compared to $1,042,618 in the three months ended June 30, 2020. The decrease in research and development expense for the three months ended June 30, 2020, is primarily attributed to decreased costs associated with external contract research organizations for internal programs and share-based compensation offset by increased patent expense.

General and administrative expenses for the three months ended June 30, 2020 were $752,896, as compared to $815,937 in the three months ended June 30, 2019. The decrease for the three months ended June 30, 2020, compared to the same period in 2019, is primarily attributable to a reduction in consulting and professional fees offset by increased foreign exchange losses.

Results of Operations – Six months ended June 30, 2020 and 2019

The Company’s net loss for the six months ended June 30, 2020 was $3,412,137, compared to a net loss of $4,305,107 for the six months ended June 30, 2019. Included in the net loss amount for the six months ended June 30, 2020 were non-cash expenses of $290,048, representing share-based compensation, warrant modification and amortization of an intangible asset, compared to $417,334 for the six months ended June 30, 2019. The decrease in the net loss for the six months ended June 30, 2020 reflects decreased costs associated with external contract research organizations for internal programs, patent costs, decreased consultant salaries and associated costs and share-based compensation offset by foreign exchange losses.

Research and development expenses for the six months ended June 30, 2020 were $1,874,473, as compared to $2,813,271 in the six months ended June 30, 2019. The decrease in the research and development expenses for the six months ended June 30, 2020, is primarily attributed to decreased costs associated with external contract research organizations for internal programs, patent costs, decreased consultant salaries and associated costs and share-based compensation offset by increased consulting expense.

General and administrative expenses for the six months ended June 30, 2020 were $1,541,242, as compared to $1,491,861 in the six months ended June 30, 2019. The increase for the six months ended June 30, 2020, compared to the same period in 2019, is primarily attributable to warrant modification expense and increased foreign exchange losses offset by a reduction in consulting and professional fees.

Outlook

As a prelude to the first PMN310 clinical trial in AD, we plan on using a novel biomarker approach that may show evidence of slowing of neuronal death as early as Phase 1 in the anticipated clinical development program. Furthermore, as the ability to achieve early detection of AD develops, based on the advent of reliable blood-based biomarkers for AD detection, the need for preventive treatment will grow. Therapeutic vaccines can be used for that purpose. Using our discovery platform, our aim is to devise a safe and effective AD vaccine to induce a specific immune response against toxic oligomers of amyloid beta.

The Company will also continue to further characterize the potential benefits of its programs selectively targeting toxic aggregates of TDP-43 in ALS, toxic forms of alpha-synuclein in PD and toxic aggregates of tau in AD and other dementias. Our unique platform produces antibodies that meet a key success factor for the development of therapeutics and vaccines for neurodegenerative diseases: the ability to selectively target the neurotoxic form of a protein implicated as a root cause of disease, while sparing the normal forms of the protein.

In the infectious disease setting, we will focus our unique technology platform to identify peptide antigens that can be used as an essential component to create accurate and sensitive serological assays to detect the presence of potentially neutralizing antibodies that arise in response to a specific infection, such as COVID-19.

On August 13, 2020 Isofol Medical AB (publ) ("Isofol"), (Nasdaq First North Premier Growth Market: ISOFOL) reported that it entered into a license agreement with Solasia Pharma K.K ("Solasia") (TSE: 4597), a specialized oncology company headquartered in Japan, to develop and commercialize Isofol’s proprietary late-stage drug candidate arfolitixorin in Japan (Press release, Isofol Medical, AUG 13, 2020, View Source [SID1234563556]). Under the terms of the agreement, Isofol will receive a total amount of ~$ 100 million* (SEK 890 million*) as upfront, development, regulatory and sales-based milestone payments and clinical development cost. In addition, Isofol will receive tiered royalties on net sales in solid double digit figures.

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The license agreement is initially focused on the development and commercialization of arfolitixorin as first-line treatment for metastatic colorectal cancer (mCRC) patients in Japan, which is projected to be the second largest addressable patient market for arfolitixorin. Additional indications will be evaluated jointly by Solasia and Isofol. Isofol retains rights to arfolitixorin in the rest of the world.

"This agreement represents an important next step for the development and commercialization of arfolitixorin. This is Isofol’s biggest milestone yet in the development process of our proprietary drug candidate and a strong validation from a specialized innovative oncology partner in the local Japanese market. Solasia’s proven capabilities to develop and commercialize oncology treatments in Japan and other Asian markets as well as their commitment to cancer patients make them the ideal partner to support our development and commercialization efforts in Japan," said Ulf Jungnelius, M.D, CEO of Isofol.

Isofol will remain as global sponsor of the AGENT study and Solasia will supervise clinical development activities in Japan and be responsible for registrational filing, and following potential regulatory approvals, Solasia will, as the Market Authorization holder, be responsible for the commercialization of arfolitixorin in Japan. Furthermore, Solasia will pay solid double digit tiered royalty rates on future net sales applicable for the deal.

"Arfolitixorin is an important addition to our expanding portfolio of innovative oncology therapies. Japan is the second largest market for arfolitixorin with more than 150,000** people diagnosed with CRC annually. We look forward to working collaboratively with Isofol to accelerate our goal of bringing a new treatment option to patients living with mCRC in Japan," said Yoshihiro Arai, President & CEO of Solasia.
Isofol’s drug candidate arfolitixorin is being evaluated in the ongoing global Phase 3 AGENT study, as a first-line treatment for mCRC. The study is currently being conducted in the U.S., Canada, Europe, Australia and Japan. On February 18, Isofol announced that the first patient in Japan had initiated treatment in the AGENT study. Isofol together with Solasia plans to expand the study with additional sites in Japan, in addition to the 90 clinics that are already open worldwide.

* The total value of upfront, development, regulatory, sales-based milestone payments and clinical development cost is up to JPY 10.4 billion. The amount given in USD and SEK is subject to exchange rate.

** Source: Center for Cancer Control and Information Services, National Cancer Center

Isofol was advised on the transaction by Shadow Lake Group Inc., and the Setterwalls lawfirm.

Invitation to a conference call and webcast on August 13, 2020 at 11:00 (CEST)
Isofol invites investors, analysts and media to a conference call in connection with the licensing agreement with Solasia. The presentation will be held by CEO Ulf Jungnelius in English and will conclude with a Q&A session. Questions can be asked on the telephone conference or in written form through the webcast. No preregistration is needed.

This information is information that Isofol Medical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08:30 CEST on August 13, 2020.