On May 14, 2019 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, reported that it will host an Investor Day in Paris to present a comprehensive corporate update, with a focus on its advancing R&D pipeline (Press release, Ipsen, MAY 14, 2019, View Source [SID1234536234]).

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David Meek, Chief Executive Officer of Ipsen stated: "The business momentum of Ipsen is strong, delivering industry-leading top-line growth and investing to build an innovative and sustainable pipeline. The execution of our R&D strategy over the last two years through accelerating key internal programs and externally sourcing innovation has significantly strengthened the focus and value of our pipeline.

"Ipsen currently has five new chemical entities in clinical development, nine significant regulatory submissions planned from 2019 to 2022 and several mid-to-late-stage program readouts in the coming months. We remain committed to executing on our top-line, bottom-line and pipeline growth strategy to create and deliver long-term value to patients and shareholders."

In Rare Diseases, palovarotene is a late-stage and largely de-risked drug candidate for the treatment of rare and extremely disabling bone disorders with no current treatment options. Palovarotene has Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations and is supported by robust clinical data. The company expects to submit an NDA to the FDA in the second half of 2019 for the first indication of fibrodysplasia ossificans progressiva (FOP).

In Neuroscience, Ipsen is pursuing two new therapeutic indications to maximize the potential of Dysport. The Company is also leveraging its research and development expertise building upon its neurotoxin franchise to advance its proprietary next-generation neurotoxin program with a fast-acting neurotoxin to enter Phase 2 clinical development in the second half of 2019 and a long-acting neurotoxin in preclinical development.

In Oncology, there are numerous ongoing mid-to-late-stage programs to broaden the scope of Cabometyx (cabozantinib) and Onivyde (irinotecan liposomal). The Phase 3 CheckMate 9ER trial in combination with nivolumab has the potential to strengthen Cabometyx’s presence in the first-line renal cell cancer market, with top-line results expected in the first half of 2020. In addition, the Phase 3 trial in combination with atezolizumab for first-line hepatocellular carcinoma has the potential to expand the use of Cabometyx earlier in the treatment paradigm and to serve as the registrational trial to enter China.

Regarding Onivyde, the interim analysis of the Phase 2 combination trial for the treatment of first-line metastatic pancreatic cancer indicates encouraging results on the disease control rate and has been accepted as an oral presentation by the ESMO (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer in July 2019. There is also an ongoing Phase 2 trial for second-line small cell lung cancer with top-line results expected in the second half of 2019.

In earlier-stage Oncology development, Ipsen is advancing its innovative Systemic Radiation Therapy program with satoreotide (IPN 1070 and IPN 1072) which is expected to move into a Phase 2/3 trial in neuroendocrine tumors by the first quarter of 2020 and IPN 1087 which is currently in Phase 1 development for pancreatic cancer. Both are platform technologies with the possibility to expand to additional solid tumors and to provide precision targeted treatment to patients.

_______________
1 Assuming current level of exchange rates

Ipsen will also execute on its external innovation and business development model in its key therapeutic areas, building on its strong balance sheet and cash flow generation to acquire assets and invest in R&D pipeline for long term shareholders’ value.

Along with an R&D pipeline update, Ipsen will also provide updates on its corporate strategy, commercial highlights of its key Specialty Care products, and new objectives on its capital allocation strategy and mid-term financial outlook.

2022 Financial outlook

Ipsen provides its 2022 financial outlook to reflect the strong momentum of its Specialty Care business and the impact from the acquisition of Clementia closed in April 2019:

Group Net Sales around €3.2 billion2
Core Operating margin greater than 32.0% of net sales
This outlook includes only the existing commercial portfolio of products under current approved indications and assumes the approval and launch of palovarotene in FOP indications3 only. It assumes the earliest possible entry of somatostatin analog (SSA) generics based on market intelligence. It does not include the potential short-term, low single-digit Core Operating margin dilution of business development transactions to further accelerate building an innovative and sustainable pipeline.

Webcast and Conference call

Ipsen will host an audio and video webcast and conference call of the Investor Day on Tuesday 14 May 2019 at 1:00 p.m. (CEST, BST+1) available at www.ipsen.com. Participants should dial in to the call approximately 5 to 10 minutes prior to its start. No reservation is required to participate in the conference call.

Standard International: +44 (0) 2071-928-000
France and continental Europe: + 33 (0) 1 76 70 07 94
UK: 08-445-718-892
U.S.: 1-6315-107-495

Conference ID: 8463129

A recording will be available for 7 days on Ipsen’s website.

On May 14, 2019 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, reported its financial results for the quarter ended March 31, 2019 and provided a corporate update (Press release, BioLineRx, MAY 14, 2019, View Source;p=RssLanding&cat=news&id=2398500 [SID1234536259]).

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Highlights and achievements during the first quarter 2019 and subsequent period:

Presented successful engraftment data from Phase 3 GENESIS trial of BL-8040 in multiple myeloma patients at 45th Annual Meeting of European Society for Blood and Marrow Transplantation. These data follow previously announced successful mobilization data which led the Data Monitoring Committee to recommend proceeding to the randomized placebo-controlled Part 2 of the study.

Received FDA Orphan Drug Designation for BL-8040 for the treatment of pancreatic cancer. This is an addition to prior orphan drug designations that have been granted for BL-8040 in AML and stem cell mobilization.

Received approval from the FDA for Investigational New Drug (IND) application for AGI-134, which will enable expansion of the ongoing Phase 1/2a study, currently being carried out in the UK and Israel, to the US by the first half of 2020.

"As we progress through 2019, we are approaching important data milestones with our lead program, the CXCR4 antagonist BL-8040, in two cancer indications with high unmet medical need," said Philip Serlin, Chief Executive Officer of BioLineRx. "In pancreatic cancer, an extremely difficult cancer indication to treat, we are optimistic that we can build upon the encouraging results that we observed in the dual combination arm of our ongoing COMBAT/KEYNOTE-202 Phase 2a study of BL-8040 and Merck’s KEYTRUDA with the addition of chemotherapy, and we are eager to see top-line results for the triple combination arm of the study by the end of this year. Similarly, in consolidation AML, we look forward to important data from our Phase 2b trial that will help inform later stage development of this promising program."

"In parallel, our second clinical candidate, AGI-134, is progressing through a phase 1/2a clinical trial, and we anticipate initial safety data later this year as we look to efficiently advance this promising candidate into the second part of the study where we can assess efficacy in multiple tumor types. We continue to execute on our clinical development plan, and believe these upcoming data readouts can drive near-term value creation while generating additional partnering interest," Mr. Serlin concluded.

Expected significant milestones through end of 2019 and early 2020:

Top-line results from the Phase 2 triple combo pancreatic cancer trial of BL-8040, KEYTRUDA and chemotherapy under the Company’s collaboration with Merck in the second half of 2019;

Potential interim results from the Phase 2 AML consolidation study in the second half of 2019;

Initial safety results from part 1 of the Phase 1/2a trial of AGI-134 in the second half of 2019;

Top-line results from one or more of the ongoing solid tumor trials under the Company’s collaboration with Genentech, potentially by the end of 2019 or early 2020.

Financial Results for the Quarter Ended March 31, 2019

Research and development expenses for the quarter ended March 31, 2019 were $4.4 million, a decrease of $0.7 million, or 13.4%, compared to $5.1 million for the comparable period in 2018. The decrease resulted primarily from a decrease in share-based compensation.

Sales and marketing expenses for the quarter ended March 31, 2019 were $0.3 million, a decrease of $0.2 million, or 47%, compared to $0.5 million for the comparable period in 2018. The decrease resulted primarily from a one-time compensation payment in the 2018 period, as well as a decrease in share-based compensation.

General and administrative expenses for the quarter ended March 31, 2019 were $0.9 million, a decrease of $0.2 million, or 13.5% compared to $1.1 million for the comparable period in 2018. The decrease resulted primarily from a decrease in share-based compensation.

The Company’s operating loss for the quarter ended March 31, 2019 amounted to $5.6 million, compared with an operating loss of $6.6 million for the comparable period in 2018.

Non-operating expenses amounted to $0.3 million for the quarter ended March 31, 2019, compared with non-operating income of $0.5 million for the comparable period in 2018. Non-operating expenses for the three months ended March 31, 2019 primarily relate to warrant offering expenses offset by fair-value adjustments of warrant liabilities on our balance sheet. Non-operating income for the three months ended March 31, 2018 primarily relate to fair-value adjustments of warrant liabilities on our balance sheet. These fair-value adjustments were highly influenced by the Company’s share price at each period end (revaluation date).

Net financial expenses amounted to $0.2 million for the quarter ended March 31, 2019 compared to an immaterial amount of net financial expenses for the three months ended March 31, 2018. Net financial expenses for the 2019 period primarily relate to interest paid on loans, offset by investment income earned on bank deposits. Net financial expenses for the 2018 period primarily relate to losses recorded on foreign currency hedging transactions, offset by investment income earned on bank deposits.

The Company’s net loss for the quarter ended March 31, 2019 amounted to $6.2 million, similar to the comparable period in 2018.

The Company held $40.6 million in cash, cash equivalents and short-term bank deposits as of March 31, 2019.

Net cash used in operating activities was $4.6 million for the three months ended March 31, 2019, compared with net cash used in operating activities of $6.8 million for the three months ended March 31, 2018. The $2.2 million decrease in net cash used in operating activities during the three-month period in 2019, compared to the three-month period in 2018, was primarily the result of changes in operating asset and liability items between the two periods – i.e., a decrease in prepaid expenses and other receivables in 2019 versus an increase in 2018, as well as a decrease in accounts payable and accruals in 2018.

Net cash used in investing activities was $9.3 million for the three months ended March 31, 2019, compared to net cash provided by investing activities of $8.1 million for the three months ended March 31, 2018. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits.

Net cash provided by financing activities was $14.9 million for the three months ended March 31, 2019, compared to net cash provided by financing activities of $1.4 million for the three months ended March 31, 2018. The increase in cash flows from financing activities reflects the underwritten public offering completed in February 2019.

Conference Call and Webcast Information

BioLineRx will hold a conference call today, May 14, 2019 at 10:00 a.m. EDT. To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0644 internationally. The call will also be available via webcast and can be accessed through the Investor Relations page of BioLineRx’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.

A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx’s website. A dial-in replay of the call will be available until May 16, 2019; please dial +1-888-782-4291 from the U.S. or +972-3-925-5925 internationally.

On May 14, 2019 Medigene AG (FSE: MDG1, Frankfurt, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, reported financial results for the first three months of 2019 and provided a review of recent accomplishments and anticipated upcoming milestones (Press release, MediGene, MAY 14, 2019, View Source [SID1234536275]). The company further adjusted its financial guidance for the fiscal year 2019 following two business transactions announced in the second quarter of 2019.

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Major events since the beginning of 2019:
* Medigene treated the first patient in the Phase I/II clinical trial of the T cell receptor-modified T cell immunotherapy (TCR-T) MDG1011
* Medigene and Roivant affiliate Cytovant entered into a strategic partnership for the research and development of cell therapies in Asia
* bluebird bio presented preclinical data of first TCR candidate from ongoing collaboration with Medigene and announced plans to start clinical development of this MAGE-A4 targeting TCR in 2020
* Medigene licensed a chimeric co-stimulatory receptor to enhance TCR therapies for solid tumors
* Medigene sold the remaining rights and stocks of the legacy product Veregen
* Medigene presented positive results from in vitro tests to assess the potential TCR-mediated off-target toxicity for neuronal cells at the annual meeting of the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) and presented preclinical data on the selective killing of tumor cells by PRAME TCR-transduced T cells at the AACR (Free AACR Whitepaper) conference
* Medigene obtained two European patents for its dendritic cell (DC) vaccine platform and for the TCR building block library to develop neoantigen-specific TCRs
* Medigene appointed Axel-Sven Malkomes as CFO/CBDO

Prof. Dolores Schendel, CEO of Medigene AG, comments: "We have had a very productive start to 2019 with progress in our own clinical projects and in the development of partner programs. Patient treatment in our TCR-T study MDG1011 has started, and we anticipate accelerating patient recruitment following the upcoming expansion of the number of clinical centers in this trial. Additionally, our licensing agreement with Roivant/Cytovant will enable us to generate and deliver our TCR constructs and Dendritic Cell vaccine to Cytovant, who will ultimately develop, manufacture and commercialize these promising immunotherapies for the East Asian patient populations."
"Moreover, we were thrilled that the first TCR discovery project we developed for our partner bluebird bio yielded a TCR candidate displaying convincing preclinical data and has been selected for clinical development by bluebird bio."
"Finally, with the sale of the remaining Veregen rights, we have completed our transformation into a pure-play immuno-oncology company. With an improved financial forecast and sufficient liquid assets, we are well positioned to continue making further progress across our immunotherapy platform and development candidates."

Three months’ financial results:
* Revenue from immunotherapies stable at EUR 1.4 m
* Research and development expenses (R&D) increased as planned by 28% to EUR 5.5 m due to expansion of clinical activities
* EBITDA loss increased as planned by 31% to EUR 5.0 m due to progress in immunotherapy programs
* Net loss for the period increased as planned by 36% to EUR 5.7 m
* Cash and cash equivalents and time deposits of EUR 65.5 m as at March 31, 2019

Financial guidance 2019:

Medigene revises the financial guidance for 2019 published in the 2018 Annual Report following the Roivant/Cytovant partnership in cellular immunotherapies and the sale of remaining rights to Veregen, both closed in April 2019.
* The Company improves its revenue guidance and expects to generate total revenues of between EUR 10 – 11 m (previous guidance: EUR 5.5 – 6.5 m) in 2019, approximately EUR 5 m anticipated from the cell therapy deal with Roivant/Cytovant.
* Medigene continues to expect research and development expenses of EUR 24 -29 m in 2019 due to progress of the preclinical and clinical development programs including manufacturing costs for clinical trial material.
* The Company also confirms its EBITDA-guidance and continues to expect a loss at EBITDA level of EUR 23 – 28 m, as the additional revenue from the Roivant/Cytovant deal will be compensated by a non-cash effect of EUR -4 and -5 m resulting from the Veregen deal, as announced in the press release from April 8, 2019.

Outlook immunotherapies:
Medigene confirms its outlook for immunotherapies published in the Annual Report 2018:

T cell receptor-modified T cells (TCR-Ts)

Current Phase I/II clinical trial with MDG1011: In addition to the three active study centers to date, it is anticipated that up to five new centers will begin recruiting patients in the second quarter and early third quarter of 2019. The University Clinic of Dresden was the first new study center to open. In 2019, the focus of the trial will be the recruitment of the first dose cohorts to assess the safety and tolerability of the treatment with MDG1011.

Development of additional TCR candidates: In 2019, in addition to the MDG1011 clinical trial, Medigene will work on characterizing new TCR candidates for future clinical trials under the responsibility and funding of Medigene and collecting preclinical data to prepare further clinical TCR trials.

Evaluation of HA-1 TCR as a potential clinical candidate: Medigene is assessing the in-licensed HA-1-specific T cell receptor to determine if it is a suitable candidate for expansion of Medigene’s TCR-T clinical development program.

Optimization of future TCR therapies for solid tumors: In addition, the chimeric co-stimulatory receptor (the PD-1/4-1BB molecule) exclusively licensed from HMGU will be assessed in combination with Medigene’s tumor-specific T cells (TCR-Ts) in preclinical models in order to optimize future TCR therapies for solid tumors.

TCR partnerships: Within the framework of the collaboration entered into with Roivant/Cytovant, Medigene will now, together with the collaboration partner, undertake preparations to generate TCR constructs tailored specifically to Asian patients using its proprietary TCR discovery platform. In addition, Medigene continues the successful collaboration with bluebird bio.

IIT from academic partners: In addition to the Company’s own development activities, the start of the academic investigator initiated TCR-modified T cell therapy clinical trial (IIT) under the responsibility of Max-Delbrück-Center and Charité University Hospital in Berlin, Germany is expected.

Dendritic cell vaccines (DCs)

Conclusion of the Phase I/II clinical trial at the end of 2019: Medigene will continue the current Phase I/II clinical trial for DC vaccines for the treatment of acute myeloid leukemia (AML) as planned and bring it to a conclusion at the end of 2019. The data from the interim analysis will be presented beforehand at the Annual Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) taking place from June 13 – 16 in Amsterdam. The final data will be available towards the end of 2019/beginning of 2020.

The full version of the quarterly statement 3M-2019 can be downloaded here: View Source

Conference call and webcast: A telephone conference (webcast) in English will be held today at 3:00 pm CET (Munich/Frankfurt) / 9:00 am EST (New York) and transmitted live via webcast. Access and transmission of the synchronized presentation slides and a recording of the presentation is available on the homepage of Medigene at View Sourcewebcasts/

On May 14, 2019 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage immunotherapeutics company, reported financial results for the first quarter ended March 31, 2019 and provided a business update (Press release, Altimmune, MAY 14, 2019, View Source [SID1234536296]).

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"We made great progress in the first quarter, as we executed on our strategy and worked to build long-term shareholder value," said Vipin K. Garg, Ph.D., President and Chief Executive Officer. "We are diligently exploring opportunities to expand our pipeline via acquisition and in-licensing opportunities in both immuno-oncology and liver disease indications. We continue to advance the development of our current key assets, HepTCell and ALT-702, and anticipate achieving significant milestones in both these programs during the next 12 to 18 months. In addition, we have made important advances in both our NasoVAX and NasoShield programs."

Recent Highlights

HepTcell Phase 1 Clinical Trial Data Presented at International Liver Congress
The Company presented results of its HepTcell Phase 1 clinical trial at The International Liver CongressTM sponsored by The European Association for the Study of the Liver (EASL). Mark Thursz, MBBS, MD, FRCP, Professor of Hepatology at Imperial College, London, presented HepTcell Phase 1 data in the session entitled "Hepatitis B – Drug Development." As previously announced, the successful clinical trial met its primary endpoint of safety and showed that HepTcell treatment was associated with increased HBV-specific cellular immune responses. The Company is preparing to initiate a Phase 2 clinical study in the U.S. in 2020.

ALT-702 Preclinical Development Initiated
Recently initiated preclinical development of its immunostimulant product candidate, ALT-702. ALT-702 is based on a new synthetic peptide conjugate technology platform that allows localized immune stimulation without the safety risk of systemic inflammation. ALT-702 represents a new approach in immuno-oncology that can act alone or improve the effectiveness of immune checkpoint inhibitors, oncolytic viruses and other approaches in immuno-oncology. The Company expects to provide an update on the progress of ALT-702 later this year.

NasoVAX Phase 2 Extension Study Completed Showing Durable Immune Response
The Company presented results of its NasoVAX Phase 2 study and the recently completed extension study at the World Vaccine Congress. As previously announced, the Phase 2 data showed that NasoVAX was well-tolerated and highly immunogenic, demonstrating 100% seroprotection at two of the three dose levels studied. Data from the extension study showed that the immunogenic responses were durable with 100% of the evaluated subjects remaining seroprotected with no decrease in seroconversion rate more than one year after vaccination. Durable responses on the order of one year are not expected from current injected influenza vaccines and suggest that the immune response induced by NasoVAX could be protective for the duration of a long flu season. The Company is actively looking for a strategic partner to further develop and commercialize NasoVAX.

NasoShield Investigation Completed with Potential Path Forward in the Clinic
Completed the investigations of potential causes that may have contributed to the lower than expected immune response in the Phase I study of NasoShield funded through a contract (HHSO100201600008C) with the Biomedical Advanced Research and Development Authority ("BARDA"). The results of these investigations are very encouraging and clearly show that while the vaccine product used in the clinical study continues to meet all manufacturing standards, the immune response to NasoShield is strongly affected by the intranasal administration method. Based on these findings, the Company believes that a simple adjustment to the intranasal dosing procedure may allow NasoShield to elicit a full immune response in humans.

Completed Registered Direct Offering Raising Gross Proceeds of $14 Million
Completed a Registered Direct Offering in March 2019 that raised gross proceeds of $14 million, which brings total gross proceeds received from equity offerings since September 2018 to $56 million. These financings provide the Company with the necessary resources to further develop its programs and position itself for potential acquisitions.

Financial Results for the First Quarter Ended March 31, 2019

The Company had cash, restricted cash and cash equivalents of $44.9 million at March 31, 2019. This was an increase of $10.6 million since the prior year end due to the receipt of net proceeds of $12.7 million through the Registered Direct Offering offset by operating cash burn of $2.1 million.

Revenue in the first quarter was $2.96 million compared to $2.69 million in the prior year period. The increase was due primarily to billings under the Company’s NasoShield contract with BARDA.

Research and development expenses in the first quarter were $3.22 million compared to $5.75 million in the prior year period. The decrease was primarily attributable to lower spending on its NasoVAX and HepTcell programs.

General and administrative expenses in the first quarter were $2.07 million compared to $2.45 million in the prior year period. The decrease was due primarily to a reduction in legal and professional costs.

Net loss attributed to common stockholders for the first quarter was $2.55 million, or ($0.27) per share, compared to $5.06 million, or ($7.49) per share in the same period of 2018.

Conference Call Details

Date:

Wednesday, May 15, 2019

Time:

8:30am Eastern Time

Domestic:

877-423-9813

International:

201-689-8573

Conference ID:

13690295

Webcast:
View Source

On May 14, 2019 OncoCyte Corporation (NYSE American: OCX), a developer of novel, non-invasive tests for the early detection of lung cancer, reported financial and operating results for the first quarter ended March 31, 2019 and provided a corporate update (Press release, BioTime, MAY 14, 2019, View Source;p=RssLanding&cat=news&id=2398606 [SID1234536260]).

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"During the first quarter and now into the second quarter, we continued to make great strides advancing DetermaVu through clinical development," commented William Annett, President and Chief Executive Officer of OncoCyte. "In addition to the previously-reported positive results of our R&D Validation study, we recently announced positive results from our Analytical Validation study of DetermaVu. We have moved quickly into the next phase and expect to complete CLIA Laboratory Validation soon. We will then proceed to the final study before commercialization, an approximately 440 patient blinded prospective Clinical Validation study."

"With each successful validation step, we are rapidly approaching commercial availability, which we anticipate in the second half of this year. In parallel, we have begun to develop plans to explore the utility of DetermaVu in other solid tumor cancer indications with the goal of making this novel technology available to as many patients as possible. We continue to believe that DetermaVu, which leverages our proprietary Immune System Interrogation approach to detect subtle changes in immune biomarkers in response to early-stage cancer, is poised to change the paradigm in lung cancer diagnostics. We look forward to efficiently completing the remaining development steps and transitioning to a commercial-stage company."

Highlights

Successfully completed Analytical Validation and initiated CLIA Laboratory Validation study

Announced a late-breaking abstract and discussion session at the American Thoracic Society 2019 International Conference detailing the compelling results from the R&D Validation study, a blinded, prospective study demonstrating best-in-class performance with sensitivity of 90% and specificity of 75%

Completed a successful equity raise of $37.3 million in net proceeds which provides the funding to complete the development of DetermaVu and initiate commercialization efforts.

On-track to complete remaining validation studies by mid-year and make DetermaVu commercially available in the second half of 2019

Remaining Validation Pathway for DetermaVu:

2Q 2019: CLIA Laboratory Validation study – Currently underway to rerun between 100 and 120 patient blood samples previously run in the R&D Validation study to confirm that the same positive results are obtained on the analytically validated systems in OncoCyte’s CLIA laboratory

Mid-year 2019: Clinical Validation study – Will run approximately 440 blinded, prospectively-collected blood samples to establish DetermaVu’s performance in an independent, blinded data set as a final confirmation of test sensitivity and specificity in OncoCyte’s CLIA lab setting

2H 2019: Anticipated commercial availability of DetermaVu

Post-launch (2020 initiation): Clinical Utility study – Will conduct a real world evidence study to demonstrate a net improvement in patient outcomes and cost savings for the healthcare system from the use of DetermaVu as a confirmatory diagnostic test for lung cancer

First Quarter 2019 Financial Highlights

At March 31, 2019, OncoCyte had cash, cash equivalents and marketable securities of $39.9 million as compared to $8.4 million at December 31, 2018. The balance sheet was strengthened in February 2019 with the successful equity raise of $37.3 million in net proceeds from an underwritten public offering.

For the first quarter ended March 31, 2019, OncoCyte incurred a net loss of $3.9 million, or $(0.08) per share, as compared to $3.8 million, or $(0.12) per share, for the three months ended March 31, 2018.

Operating expenses for the three months ended March 31, 2019 were $4.0 million, and $3.2 million on an as-adjusted basis, as compared to $3.9 million, or $3.4 million on an as adjusted basis, for the same period in 2018.

The reconciliation between GAAP and non-GAAP operating expenses is provided in the financial tables included with this earnings release.

Research and development expenses for the quarter ended March 31, 2019 were $1.3 million as compared to $1.5 for the same period in 2018, relatively unchanged quarter over quarter, as OncoCyte continued to focus resources on the development and commercialization of DetermaVu.

General and administrative expenses for the three months ended March 31, 2019 were $2.4 million, as compared to $1.7 million for the same period in 2018, an increase of $0.7 million. This increase is primarily attributable to $0.4 million in personnel and related expenses and $0.3 million in stock-based

compensation expense due to increased grants of equity awards.

Sales and marketing expenses for the three months ended March 31, 2019 were $0.2 million, as compared to $0.7 million for the same period in 2018, a decrease of $0.5 million, primarily attributable to a decrease in marketing personnel and consultants as OncoCyte concentrated its resources on the development of DetermaVu rather than on marketing related activities.

Conference Call

The Company will host a conference call today, May 14, 2019, at 4:30 pm EDT / 1:30 pm PDT to discuss the results along with recent corporate developments.

The dial-in number in the U.S./Canada is 877-407-9716; for international participants, the number is 201-493-6779. For all callers, please refer to Conference ID 13689785. To access the live webcast, go to the investor relations section on the Company’s website, View Source

About DetermaVu

DetermaVu is being developed as an intermediate step to confirm the absence of cancer between imaging modalities (LDCTs) detecting suspicious lung nodules and downstream invasive procedures that determine if the nodules are malignant. OncoCyte estimates that a $2 billion to $4.7 billion annual market could develop in the U.S. for its confirmatory lung cancer liquid biopsy test, depending on the scope of physician utilization, market penetration and reimbursable pricing.

DetermaVu has the potential to dramatically reduce U.S. healthcare costs by billions of dollars each year by eliminating unnecessary biopsies, which, according to a study of Medicare data by an independent health economics firm, cost on average $14,634 each. In addition, DetermaVu can provide great benefit to patients by avoiding invasive biopsies and the complications that arise in up to 24% of those procedures, and deaths that occur in up to 1% of cases.

DetermaVu is a trademark of OncoCyte Corporation.