On August 13, 2018 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), reported financial results for the fiscal 2018 third quarter ended June 30, 2018 (Press release, Applied DNA Sciences, AUG 13, 2018, View Source [SID1234529276]).

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Commenting on Applied DNA’s results for the fiscal third quarter, Dr. James A. Hayward, president and CEO, stated, "Results for the quarter did not fulfill our expectations for recognized revenue due to the shipping of an initial cotton DNA order under extended payment terms. Nonetheless, our performance stands out for the progress we have made in driving commercial adoption of our DNA taggant platform through large commercial-scale feasibility activities:

·in pharmaceuticals, together with Colorcon we performed a larger scale production run for solid oral dosage form tagging;
·in leather, we are nearing the completion of a commercial-scale tagging and testing trial following the completion of the feasibility program supported by several global brands and supply chain stakeholders,
·and in cannabis, we designed, built and publicly unveiled our cannabis tracking system (CTS), a major milestone under our TheraCann agreement which will power seed-to-sale legal cannabis tracking.

In addition to these activities under existing development contracts, we signed new agreements with large marquee companies, UL and Everledger, that we expect will broaden our access to new markets and increase our value proposition to customers. Concurrently, business in our biopharma research and manufacturing offerings has been gaining promising momentum."

Continued, Dr. Hayward, "As global supply chains move to address growing business imperatives centered on supply chain traceability, transparency and trust, we are expanding our opportunities for revenue by seeding markets with partners that recognize the value proposition of our taggant technology. With momentum growing globally for the legalization of cannabis and supply chain participants seeking regulatory compliance, our launch of the industry’s first seed-to-sale cannabis tagging system with TheraCann is timely. Our partner Everledger, endorses our view that the linkage of digital blockchain-enabled transactions with a forensic physical goods identifier increases the value of the platform to global ecosystems. That identifier is our DNA taggant.

"We also reached new milestones in biotherapeutic contract research and contract manufacturing of linear DNA, with multiple firms throughout Europe and the US. We believe that our ability to deliver large-scale PCR-based DNA production for DNA/RNA vaccines, gene therapies, adoptive cell therapies and diagnostics, may eliminate the risks associated with current plasmid- and virus-based genetic methods. With these milestones, we demonstrate the potential to replace plasmid production methods and viral vectors, potentially opening large, high-value markets that will bring the benefits of our technology to patients.

Concluded Hayward, "Applied DNA sits at the nexus between global supply chains and market forces dictating the need for increased transparency and responsible procurement. With our taggant technology platform proven at scale, a foundation of recurring revenues, new commercial agreements that open previously untapped markets, we are well positioned to leverage tailwinds in the marketplace to deliver sustainable growth to our shareholders."

Fiscal Third Quarter Financial Results:

·Revenues decreased 43% for the third quarter of fiscal 2018 to $1.0 million, compared with $1.8 million reported in the third quarter of fiscal 2017, and remained flat as compared to revenues for the fiscal second quarter ended March 31, 2018. The year-over-year decrease in revenues is primarily attributable to shipments relating to the initial order of $1.2 million in our cotton vertical for the upcoming ginning season being recorded in deferred revenue at June 30, 2018 due to extended payment terms. This decrease was offset by an increase in revenues from feasibility pilots in pharmaceutical and cannabis industries.
·Deferred revenue increased to $2.3 million as of June 30, 2018 as compared to $352 thousand at September 30, 2017. The reason for this increase is due to the initial cotton order of $1.2 million noted above as well as fees paid for a variety of contracts that include specific milestones and therefore were not able to be fully recognized as revenue during the quarter ended June 30, 2018.
·Total operating expenses were $3.6 million, compared with $4.2 million in the prior year’s quarter, a decrease of approximately 13%. The decrease in year-over-year total operating expenses is primarily attributable to a decrease in stock-based compensation expense of $328 thousand and bad debt expense of $343 thousand.
·Net loss for the quarter ended June 30, 2017 was $2.9 million, or $0.10 per share, compared with a net loss of $2.6 million, or $0.10 per share for the same period in the prior fiscal year and a net loss of $2.1 million, or $0.07 per share for the first fiscal quarter ended March 31, 2018.
·Excluding non-cash expenses, Adjusted EBITDA for the quarter ended June 30, 2018 was negative $2.5 million, compared to negative Adjusted EBITDA of $1.5 million for the same quarter last fiscal year and negative Adjusted EBITDA of $2.3 million in the prior fiscal quarter. See below for information regarding non-GAAP measures.

Nine-Month Financial Highlights:

·Revenues for the first nine months of fiscal 2018 totaled $2.7 million, a decrease of 25% from $3.6 million from the same period in the prior fiscal year. The decrease in revenues was due to the deferral of approximately $1.2 million for product shipped for the marking of cotton with extended payment terms during the quarter ended June 30, 2018.
·Operating expenses for the nine months ended June 30, 2018 decreased by $2.8 million or 22% for the same period last fiscal year. The decrease is primarily attributable to a decrease in stock-based compensation, offset by an increase in R&D due to the government contract award.
·Net loss for the nine months ended June 30, 2018 was $8.2 million or $0.28 per share, compared with a net loss of $10 million or $0.38 per share for the nine months ended June 30, 2017.
·Excluding non-cash expenses and interest, Adjusted EBITDA for the nine months ended June 30, 2018 was a negative $7.6 million as compared to a negative $6.6 million for the same period in the prior fiscal year. See below for information regarding non-GAAP measures.

Recent Operational Highlights:

·On August 2, Applied DNA announced that it has reached new milestones in therapeutic contract research and contract manufacturing of Polymerase Chain Reaction (PCR)-produced linear DNA. PCR is a well-proven technique of DNA amplification that holds the potential to replace plasmid production methods and viral vectors in nucleic acid based therapeutics.

·On July 31, the Company announced the signing of a MOU with Everledger to build a CertainT Blockchain platform for high-end product markets. The molecular tag, test and track platform provides physical identity and traceability for Everledger’s digital platform with the leather supply chain as the first target market.

·On July 24, the Company announced that, in conjunction with TheraCann International, it will launch the cannabis industry’s first DNA based cannabis tagging system (CTS) using Applied DNA’s CertainT platform of tag, test and track. The device is designed to rapidly molecularly tag cannabis plants in commercial harvests of any scale.

·On July 17, Applied DNA announced the shipment of a $1.2 million order in its fiscal 2018 third quarter to tag cotton in the upcoming 2018/2019 ginning season. The order for the Company’s SigNature T platform technology will be used to tag, test and track three US cotton varietals, Pima, Acala and Delta. Revenues were deferred until payment is due.

·On July 10, the Company announced a strategic partnership with UL. The commercial agreement aims to expand product authentication and traceability solutions throughout the product supply chain.

·On May 8, Applied DNA announced that Louis Dreyfus Company (LDC) has installed Applied DNA Sciences’ SigNature T cotton traceability system at its Moree gin in Australia to tag, test and track pure HomeGrown Australian cotton.

Fiscal Third Quarter 2018 Conference Call Information

The Company will hold a conference call and webcast to discuss its fiscal third quarter-end 2018 results on Monday, August 13, 2018 at 4:30 PM ET. To participate on the conference call, please follow the instructions below. While every attempt will be made to answer investors’ questions on the Q&A portion of the call, due to the large number of expected participants, not all questions may be answered.

To Participate:

·Participant Toll Free: 1-844-887-9402
·Participant Toll: 1-412-317-6798
·Please ask to be joined to the Applied DNA Sciences call

Live webcast: View Source

Replay (available 1 hour following the conclusion of the live call through August 14, 2018):

·Participant Toll Free: 1-877-344-7529
·Participant Toll: 1-412-317-0088
·Participant Passcode: 10122259
·Webcast replay: View Source

Information about Non-GAAP Financial Measures

As used herein, "GAAP" refers to accounting principles generally accepted in the United States of America. To supplement our condensed consolidated financial statements prepared and presented in accordance with GAAP, this earnings release includes Adjusted EBITDA, which is a non-GAAP financial measure as defined in Rule 101 of Regulation G promulgated by the Securities and Exchange Commission. Generally, a non-GAAP financial measure is a numerical measure of a company’s historical or future performance, financial position, or cash flows that either excludes or includes amounts that are not normally excluded or included in the most directly comparable measure calculated and presented in accordance with GAAP. The presentation of this non-GAAP financial information is not intended to be considered in isolation or as a substitute for, or superior to, the financial information presented in accordance with GAAP. We use this non-GAAP financial measure for internal financial and operational decision making purposes and as a means to evaluate period-to-period comparisons of the performance and results of operations of our core business. Our management believes that these non-GAAP financial measures provide meaningful supplemental information regarding the performance of our business by excluding non-cash expenses that may not be indicative of our recurring operating results. We believe this non-GAAP financial measure is useful to investors as they allow for greater transparency with respect to key metrics used by management in its financial and operational decision making.

"EBITDA"- is defined as earnings (loss) before interest expense, income tax expense and depreciation and amortization expense.

"Adjusted EBITDA"- is defined as EBITDA adjusted to exclude (i) stock-based compensation and (ii) other non-cash expenses.

On August 10, 2018 Sangamo Therapeutics, Inc. (NASDAQ: SGMO) reported that management will present a corporate overview at the 2018 Wedbush PacGrow Healthcare Conference in New York City (Press release, Sangamo Therapeutics, AUG 10, 2018, View Source [SID1234528840]). The presentation is scheduled for Tuesday, August 14th at 4:15 p.m. ET.

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The presentation will be webcast live and may be accessed via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. The presentation will be archived on the Sangamo website following the event.

On August 10, 2018 Cellectar Biosciences (Nasdaq: CLRB)("Cellectar or "the Company"), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported financial results for the three and six months ended June 30, 2018 and provided a business update (Press release, Cellectar Biosciences, AUG 10, 2018, View Source [SID1234528818]).

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Second quarter 2018 and recent highlights:

·Closed a public offering raising gross proceeds of $16.56 million including the full exercise of the underwriters’ over-allotment option.

·Received orphan drug designations and rare pediatric disease designations from the U.S. Food and Drug Administration (FDA) for CLR 131 to treat rhabdomyosarcoma and neuroblastoma, both rare pediatric cancers.

·Received orphan drug designation from the FDA for CLR 131 to treat Ewing’s sarcoma, a rare pediatric cancer.

Expanded patient enrollment in the relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) cohort of the company’s Phase 2 clinical trial of CLR 131 and reported interim results showing a 33% overall response rate and a 50% clinical benefit response.

Provided an update on a patient with advanced Waldenstrom macroglobulinemia in the CLR 131 Phase 2 trial who experienced a 94% reduction in tumor burden and complete resolution in four of five targeted tumor masses.

Entered into a collaboration with Orano Med for the development of novel PDCs utilizing Orano Med’s unique alpha emitter, lead-212 (212Pb), conjugated to Cellectar’s phospholipid ether (PLE); the companies intend to evaluate the new Phospholipid Drug Conjugates (PDC) in up to three oncology indications.

Strengthened intellectual property with the issuance of a U.S. patent entitled "Alkylphosphocholine analogs for multiple myeloma imaging and therapy" covering the use of CLR 131 in multiple (MM), the issuance of a U.S. patent entitled "Ether and Alkyl Phospholipid Compounds for Treating Cancer and Imaging Detection of Cancer Stem Cells" enhancing coverage for the use of CLR 131 as a treatment for various cancers and cancer stem cells. In addition, the company was issued a composition-of-matter patent for CLR 131 in Japan.

Presented two late-breaking poster presentations at the AACR (Free AACR Whitepaper) Annual Meeting that highlighted the potential benefits of fractionated dosing regimens of CLR 131 and the ability of the company’s PDCs to provide improved targeting of tumor cells and the intracellular trafficking of these molecules.

CLR 131 Supply Update

On August 7, 2018, the Company was informed by Centre for Probe Development and Commercialization ("CPDC"), the Company’s sole supplier of CLR 131, that it is subject to an Import Alert 66-40 (the "Import Alert") by the United States Food and Drug Administration ("FDA"). While the basis for the Import Alert was not related to CLR 131, or CPDC’s production facility associated with CLR 131, CPDC informed the Company on August 8, 2018 that CPDC would not be able to supply CLR 131 to the Company until the Import Alert is lifted or alternative agreements are reached with the FDA. The Company intends to work with CPDC to resolve this issue as soon as practical. As a result of the supply disruption, the Company expects delays in enrollment in its ongoing clinical trials. At this time, the Company is not able to assess the extent of the delays or what impact the supply disruption will have on the Company, but the inability of CPDC to supply CLR 131 on a prolonged basis would result in further delayed patient enrollment in current and planned clinical trials for CLR 131.

"The second quarter was highly productive for the company as we executed on our corporate plan and achieved multiple clinical, regulatory and financial milestones. However, due to our supplier being placed on an import alert for activities unrelated to CLR 131 we are experiencing an unexpected interruption in drug supply and are working to resolve this as rapidly as possible" said James Caruso, president and CEO of Cellectar Biosciences. "On the clinical front, we announced positive DLBCL interim data from our Phase 2 trial and expanded the cohort. We received important FDA designations that underscore the potential of our rare pediatric disease portfolio. Also, in late July we raised capital that materially strengthened our balance sheet which we believe provides a runway into the first quarter of 2020".

2018 Second Quarter and First Half Financial Results

Research and development expenses for the second quarter of 2018 were $1.7 million, compared with $2.2 million for the second quarter of 2017. Research and development expenses for the first half of 2018 were $3.8 million, compared with $4.0 million for the first half of 2017. The year-over-year decrease in both periods is attributable to lower clinical project costs and manufacturing-related costs.

General and administrative expenses for the second quarter of 2018 were $1.2 million, compared with $1.0 million for the second quarter of 2017, and were $2.6 million for the first half of 2018, compared with $2.0 million for the first half of 2017. The year-over-year increase in both periods is attributable to higher consulting, legal and marketing expenses, as well as one-time personnel costs incurred in connection with the decision to outsource manufacturing.

The net loss attributable to common stockholders for the second quarter of 2018 was $2.9 million, or $1.69 per share, compared with a net loss attributable to common stockholders for the second quarter of 2017 of $3.1 million, or $2.32 per share. The net loss attributable to common stockholders for the first half of 2018 was $6.4 million, or $3.75 per share, compared with a net loss attributable to common stockholders of $6.0 million, or $4.72 per share, for the first half of 2017.

Cash and cash equivalents as of June 30, 2018 were $4.2 million, compared with $10.0 million as of December 31, 2017. As noted above, subsequent to the close of the second quarter the company raised gross proceeds of $16.56 million from an underwritten public offering. The Company expects net proceeds from this financing, after deducting underwriting discounts and commissions and estimated offering expenses, will be approximately $14.9 million. The Company’s pro forma cash balance at June 30, 2018 was approximately $19.1 million.

On August 10, 2018 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company developing highly selective medicines for patients with genomically defined cancers, reported that abstracts from its LOXO-292 and larotrectinib programs have been accepted for presentation at the International Association for the Study of Lung Cancer (IASLC) 19th World Conference on Lung Cancer to be held September 23-26, 2018, in Toronto, Canada (Press release, Loxo Oncology, AUG 10, 2018, View Source [SID1234528661]).

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The LOXO-292 oral presentation will provide an updated analysis of patients with RET fusion non-small cell lung cancer (NSCLC) enrolled in the dose escalation cohorts of the ongoing LIBERTTO-001 Phase 1/2 clinical trial. The larotrectinib poster will provide an analysis of patients with TRK fusion NSCLC enrolled to the larotrectinib clinical program.

The schedule for the presentations is as follows:

LOXO-292 Oral Presentation Session Date & Time: September 25, 2018, 3:15-4:45 p.m. ET
Title: Clinical Activity of LOXO-292, a Highly Selective RET Inhibitor, in Patients with RET Fusion+ Non-Small Cell Lung Cancer
Abstract Number: 13922
Session Title: Novel Therapies in MET, RET and BRAF
Presenter: Geoffrey R. Oxnard, M.D.

Larotrectinib Poster Presentation Session Date & Time: September 24, 2018, 9:45 a.m.-6:00 p.m. ET
Title: Rapid, Robust and Durable Responses to Larotrectinib in Patients with TRK Fusion Non-Small Cell Lung Cancer
Abstract Number: 14528
Session Title: Targeted Therapy
Presenter: Anna F. Farago, M.D., Ph.D.

About LOXO-292
LOXO-292 is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection (RET) kinase. RET fusions and mutations occur across multiple tumor types with varying frequency. LOXO-292 was designed to inhibit native RET signaling as well as anticipated acquired resistance mechanisms that could otherwise limit the activity of this therapeutic approach. LOXO-292 is currently being studied in the global LIBRETTO-001 Phase 1/2 trial. For additional information about the LOXO-292 clinical trial, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient RET Clinical Trial Hotline at 1-855-RET-4-292 or email [email protected].

About RET-Altered Cancers
Genomic alterations in the RET kinase, which include fusions and activating point mutations, lead to overactive RET signaling and uncontrolled cell growth. RET fusions have been identified in approximately 2% of non-small cell lung cancer, 10-20% of papillary and other thyroid cancers, and a subset of other cancers. Activating RET point mutations account for approximately 60% of medullary thyroid cancer (MTC). Both RET fusion cancers and RET-mutant MTC are primarily dependent on this single activated kinase for their proliferation and survival. This dependency, often referred to as "oncogene addiction," renders such tumors highly susceptible to small molecule inhibitors targeting RET.

About Larotrectinib
Larotrectinib is an oral and highly selective investigational tropomyosin receptor kinase (TRK) inhibitor in clinical development for the treatment of patients with cancers that harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. In clinical trials, larotrectinib demonstrated anti-tumor activity in patients with tumors harboring NTRK gene fusions, regardless of patient age or tumor type. In an analysis of 55 RECIST-evaluable adult and pediatric patients with NTRK gene fusions, larotrectinib demonstrated a 75 percent centrally-assessed confirmed overall response rate (ORR) and an 80 percent investigator-assessed confirmed ORR, across many different types of solid tumors. The majority of all adverse events were grade 1 or 2.

Larotrectinib has been granted Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation and Orphan Drug Designation by the U.S. FDA.

In November 2017, Loxo Oncology and Bayer entered into an exclusive global collaboration for the development and commercialization of larotrectinib and LOXO-195, a next-generation TRK inhibitor. Bayer and Loxo Oncology are jointly developing the two products with Loxo Oncology leading the ongoing clinical studies as well as the filing in the U.S., and Bayer leading ex-U.S. regulatory activities and worldwide commercial activities. In the U.S., Loxo Oncology and Bayer will co-promote the products.

For additional information about the larotrectinib clinical trials, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123 or visit www.loxooncologytrials.com/trk-trials.

About TRK Fusion Cancer
TRK fusion cancer occurs when a neurotrophic tyrosine receptor kinase (NTRK) gene fuses with another unrelated gene, producing an altered tropomyosin receptor kinase (TRK) protein. The altered protein, or TRK fusion protein, is constantly active, triggering a permanent signal cascade. These proteins become the primary driver of the spread and growth of tumors in patients with TRK fusion cancer. TRK fusion cancer is not limited to certain types of cells or tissues and can occur in any part of the body. NTRK gene fusions occur in various adult and pediatric solid tumors with varying prevalence, including appendiceal cancer, breast cancer, cholangiocarcinoma, colorectal cancer, GIST, infantile fibrosarcoma, lung cancer, mammary analogue secretory carcinoma of the salivary gland, melanoma, pancreatic cancer, thyroid cancer, and various sarcomas.

Only sensitive and specific tests can reliably detect TRK fusion cancer. Next-generation sequencing (NGS) can provide a comprehensive view of genomic alterations across a large number of genes. Fluorescence in situ hybridization (FISH) can also be used to test for TRK fusion cancer, and immunohistochemistry (IHC) can be used to detect the presence of TRK protein.

On August 10, 2018 Artios Pharma Limited (Artios), a leading DNA Damage Response (DDR) company developing innovative treatments for cancer, reported the completion of a $84 million (£65 million) Series B financing following high interest from investors (Press release, Artios Pharma, AUG 10, 2018, View Source [SID1234529507]).

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The financing, which was significantly oversubscribed, was led by Andera Partners (formerly EdRIP) and LSP (Life Sciences Partners), with participation by additional new investors Pfizer Ventures and Novartis Venture Fund (NVF). Artios’ existing shareholders Arix Bioscience, SV Health Investors, M Ventures, IP Group plc and AbbVie Ventures also participated in the fundraise.

Commenting on today’s announcement, Raphael Wisniewski, Partner of Andera Partners, said: "We believe Artios’ DDR programmes have the potential to bring real impact to cancer patients. DDR is an exciting field of biology, which has been clinically validated by the first generation PARP inhibitors currently on the market. The new funds will allow Artios to advance its portfolio of first-in-class, small molecule DDR programmes including its lead programme targeting DNA polymerase theta (Polθ), through clinical proof of concept trials. We are delighted to work with the management team in building a world class DDR targeted oncology company."

Dr Rene Kuijten, Managing Partner of LSP, commented: "Artios represents a unique opportunity to deliver a truly world class biotech company. LSP has worked with Artios’ team before at KuDOS (successfully sold to AstraZeneca) which developed olaparib, the first approved PARP inhibitor and used in ovarian and breast cancer, creating a billion dollar market. We are very excited to support this proven management team once again as it seeks to build on its leading position in the DDR field by advancing its programmes into clinical development."

Niall Martin, Chief Executive Officer of Artios, added: "We are delighted to welcome Andera Partners, LSP, Pfizer Ventures and Novartis Venture Fund to Artios and I would like to thank our existing investors for their continued support, which will help us develop and deliver our exciting DDR targeted therapies to cancer patients. This investor syndicate creates a very strong and committed shareholder base with a track record of supporting successful next generation companies. The oversubscribed Series B fundraise is a strong endorsement of our world-leading development pipeline and reflects the opportunity for DDR to yield new breakthrough oncology products."

Artios is actively developing a pipeline of highly promising first-in-class DDR therapies identified from a global network of leading researchers in the DDR field, including through Cancer Research UK. The inhibition of novel DNA repair targets like Polθ, in tumours where DNA damage response factors have been lost or down regulated, will lead to cancer cells being selectively killed without harming normal cells. This creates an opportunity for such products to be used both in monotherapy and in combination with existing and future cancer therapies.

In conjunction with the Series B financing, Raphael Wisniewski from Andera Partners, Rene Kuijten from LSP and Barbara Dalton from Pfizer Ventures, will join the Board of Artios as directors and Florian Muellershausen from NVF will join as an observer. This financing follows a $36 million Series A fundraise that was completed in September 2016.