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BioTime, Inc. Reports First Quarter Results and Recent Corporate Accomplishments

On May 10, 2017 BioTime, Inc. (NYSE MKT and TASE: BTX), a clinical-stage biotechnology company developing and commercializing products addressing degenerative diseases, reported financial results for the first quarter ended March 31, 2017 (Press release, BioTime, MAY 10, 2017, View Source;p=RssLanding&cat=news&id=2271990 [SID1234519038]).

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"At BioTime we are continuing to make meaningful clinical progress with our core development programs in Ophthalmology, Aesthetics and Therapeutics Delivery. We are generating an increasing amount of positive human data from our clinical trials that provide a solid foundation for our optimism," said Adi Mohanty, Co-Chief Executive Officer. "We are excited to be announcing top line safety and efficacy data next month from our Renevia pivotal trial in Europe. This week, we are presenting encouraging ophthalmic clinical trial data at ARVO from the OpRegen trial in dry-AMD. Separately at ARVO, tomorrow we are presenting promising pre-clinical data in retinal restoration."

"Our strategies for Simplification and Unlocking Value are moving forward with the formation of AgeX Therapeutics last month. AgeX is a new subsidiary that is doing exciting work in the field of Aging. BioTime has already successfully demonstrated its ability to create value by building subsidiary companies. Our publicly-traded affiliates Asterias and OncoCyte continue to report encouraging positive clinical data as they move their therapies for spinal cord injury and lung cancer diagnostics forward," concluded Mr. Mohanty.

Highlights

Clinical Progress

Renevia (adipose cells + cell delivery matrix)

The schedule to read-out the Renevia top-line pivotal trial results was accelerated to June 2017. If the data are positive the Company plans to submit an application for CE Mark approval in Europe by year end, which could lead to approval and commercial launch in about a year.
The ongoing pivotal clinical trial in Europe is assessing the efficacy and safety of Renevia in treating HIV-associated lipoatrophy (facial fat loss). The Company intends to conduct additional trials in the U.S. that target a broader $7 billion aesthetics market opportunity, which is consistent with the previously stated goal of indication and geographic expansion for Renevia.
The trial in Europe is fully enrolled and continues to progress well with no safety related issues to date.
OpRegen (retinal pigment epithelial cells)

New positive clinical data on OpRegen were reported at the Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) this week. The data show OpRegen cells engraft (remain in place) and possible evidence of a biological response. Should the data establish that OpRegen cells safely engraft and remain alive in the patient, then the Company believes OpRegen may have a higher probability of success when compared to molecular therapeutics. The treatment continues to be well-tolerated, which includes some patients with more than one year of follow-up.
The data presented at ARVO is from the first and second cohorts of the ongoing Phase I/IIa clinical trial in the advanced form of dry-AMD. Patients from the second cohort, in which patients are receiving a higher and more clinically meaningful 200,000 cell dose, were included in the data.
The Company anticipates DSMB review of cohort 2 by the end of the second quarter and, upon approval, to begin enrolling cohort 3 immediately, thereafter. Cohort 3 is expected to enroll more quickly due to reduced patient staggering requirements. The trial is being expanded to U.S. sites as previously announced.
AST-OPC1 (oligodendrocyte progenitor cells)

In April, BioTime’s affiliate, Asterias (NYSE MKT: AST) announced that the Data Monitoring Committee (DMC) unanimously recommended continuation of the SCiStar Phase I/IIa clinical trial for AST-OPC1 following a review of the accumulated safety data. AST-OPC1 is for patients with spinal cord injury. Following positive results earlier this year in January, Asterias plans to initiate discussions with the FDA in mid-2017 to determine the most appropriate clinical and regulatory path forward for AST-OPC1.
Liquid Biopsy (lung cancer confirmatory test)

BioTime’s affiliate, OncoCyte (NYSE MKT: OCX) is on track to be first to market with a lung cancer confirmatory liquid biopsy diagnostic test in the second half of this year. The test targets a market opportunity believed to exceed $4 billion annually.
In preparation for commercialization, OncoCyte submitted its application for CLIA lab certification in late March. Earlier is month, OncoCyte established a Medical Advisory Committee to provide guidance and advice in several areas including commercialization, unmet clinical needs and future pipeline products. The committee is comprised of four recognized lung cancer experts.
On May 22, 2017, results from OncoCyte’s 300-patient R&D validation study will be presented at the American Thoracic Society 2017 International Conference (ATS) in Washington, D.C. by Dr. Anil Vachani, and will be discussed on an investor call later that day.
Simplification and Unlocking Value

New Subsidiary AgeX Therapeutics, Inc.

In April, BioTime announced the formation of AgeX Therapeutics, Inc. as a new subsidiary. AgeX will consolidate certain BioTime subsidiaries and programs in the field of interventional gerontology. Two of the objectives in forming AgeX are to: 1) quickly establish leadership in the emerging biotechnology field of Aging by accelerating development of its pluripotent cell and iTR assets; and 2) continue the implementation of BioTime’s strategy to simplify its corporate structure and operations as well as focus its resources on continued clinical development and product commercialization in Ophthalmology; Aesthetics and Delivery.
Value of Holdings in Public Affiliates

At March 31, 2017, BioTime held common stock in publicly-traded affiliates valued at $161.3 million. This amount was the market value of BioTime’s 21.7 million shares in Asterias (NYSE MKT: AST) and 14.7 million shares in OncoCyte (NYSE MKT: OCX).
First Quarter Financial Results

Cash Position and Marketable Securities: Cash and cash equivalents totaled $23.8 million as of March 31, 2017, compared to $22.1 million as of December 31, 2016, which included OncoCyte’s cash and cash equivalents of $10.2 million.

Revenues: BioTime’s revenues are generated primarily from research grants, licensing fees and royalties, and subscription and advertising from the marketing of online database products. Total revenues were $0.4 million for the first quarter, compared to $2.1 million in the first quarter of 2016. Asterias’ total revenues included in 2016 were $1.6 million compared to no revenues in the first quarter of 2017 due to the deconsolidation in May 2016.

R&D Expenses: Research and development expenses were $6.5 million for the first quarter, compared to $13.7 million for the comparable period in 2016, a decrease of $7.2 million. This decrease was primarily attributable to the deconsolidation of Asterias in May 2016 and OncoCyte in February 2017. Asterias and OncoCyte combined, contributed to $7.4 million of the decrease in research and development expenses in the first quarter of 2017 as compared to 2016. This decrease was offset to some extent by an increase of $1.0 million in BioTime’s research and development programs, including OpRegen, Renevia, PureStem progenitor and pluripotent cell lines, and orthopedic therapy.

G&A Expenses: General and administrative expenses were $5.1 million for the first quarter compared to $11.9 million for the comparable period in 2016. The $6.8 million decrease was primarily due to the deconsolidation of financial statements of Asterias and OncoCyte. The deconsolidation of these former subsidiaries contributed to $7.4 million of the total decrease. This decrease in our general and administrative expenses was offset by increases in BioTime’s general and administrative expenses amounting to $0.9 million primarily due to: an increase of $0.3 million in compensation and related expenses due to additional key personnel hires.

Cash used by BioTime tends to be higher in the first quarter due to payments of annual bonuses and other compensation related costs.

Net Income (loss) attributable to BioTime: Net income attributable to BioTime was $49.3 million, or $0.46 per basic and diluted common share for the three months ended March 31, 2017, compared to net loss of $17.1 million, or ($0.19) per basic and diluted common share. The 2017 net income attributable to BioTime was primarily due to the $71.7 million gain on deconsolidation of OncoCyte and $16.1 million gain recognized from the increase in the market value of the OncoCyte shares owned by BioTime from February 17, 2017, the date of deconsolidation, through the end of the quarter. These gains were offset by the $11.3 million loss in operations, $3.9 million in deferred income tax expenses, and $26.1 million loss recognized from the decrease in the market value of the Asterias shares owned by BioTime from December 31, 2016 to the end of the quarter. BioTime deconsolidated Asterias in May 2016.

Argos Provides Update on its ADAPT Trial Following Meeting with FDA

On May 10, 2017 Argos Therapeutics Inc. (NASDAQ:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis precision immunotherapy technology platform, reported an update on the ADAPT trial, a randomized, active controlled, open-label, multi-center Phase 3 trial of Rocapuldencel-T in combination with sunitinib/standard-of-care for the treatment of newly diagnosed metastatic renal cell carcinoma (mRCC), following a meeting with the FDA (Press release, Argos Therapeutics, MAY 10, 2017, View Source [SID1234518972]).

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As previously reported, the Company has continued to conduct the ADAPT trial notwithstanding the recommendation by the Independent Data Monitoring Committee in February 2017 to terminate the trial for futility. In making this determination, Argos considered, among other factors, the degree of maturity of the data set, the mechanism of action of Rocapuldencel-T, which involves the induction of a long-term memory immune response, and the IDMC’s assessment of the safety profile of Rocapuldencel-T. Of note, at the time of the IDMC’s February interim analysis, the median duration of follow-up was 20.0 months and more than half the patients in both treatment groups were still alive.

The Company submitted information related to its analysis of the interim data to the FDA and met with the FDA to discuss the future direction of the ADAPT trial and the Rocapuldencel-T development program. Participating in the meeting along with representatives from the Company were Robert Figlin, MD, Chairman of Hematology Oncology and Professor of Medicine, Cedars Sinai Medical Center; Nizar Tannir, MD, Professor and Deputy Chairman, Department of Genitourinary Medical Oncology, MD Anderson Cancer Center; and Gary Koch, PhD, Professor of Biostatistics, University of North Carolina.

The FDA agreed with the Company’s plan to continue the trial in accordance with the current protocol to 290 events, the pre-specified number of events at which the analysis of overall survival, the primary endpoint, is to be conducted. The Company believes that 290 events will have occurred by late 2017 or early 2018. The Company also proposed to submit, and the FDA agreed to review, a protocol amendment to increase the pre-specified number of events for the primary analysis of overall survival beyond 290 events, which the Company believes could enhance its ability to detect whether Rocapuldencel-T has a delayed treatment effect. The Company can extend the study past 290 events without needing to enroll additional patients.

As previously reported, the Company has analyzed interim data from a predefined subset of patients who demonstrated an immune response to Rocapuldencel-T at 48 weeks, whose immune response is consistent with the mechanism of action of the therapy and correlates with survival, suggesting that the treatment is biologically active. Analysis of the data from the ADAPT trial, including immune response data, remains ongoing. The Company expects to provide further updates on the future direction of the ADAPT trial and the Rocapuldencel-T program following further analysis of the data from the trial and further discussions with the FDA.

"We are pleased to be able to continue the ADAPT trial," noted Robert Figlin, MD, principal investigator for the trial. "We believe that Rocapuldencel-T may offer patients and their physicians an important new option for the treatment of mRCC, a disease that remains an area of high unmet medical need. By amending the protocol to extend the ADAPT trial, we believe we can potentially increase the likelihood of detecting a treatment effect, if one exists, given that immunotherapy is expected to result in a delayed treatment effect. We appreciate the collaborative efforts of the FDA as we seek to determine the potential utility of Rocapuldencel-T in the treatment of this difficult disease."

"We remain committed to the clinical development of Rocapuldencel-T, and look forward to providing additional updates on the ADAPT trial and the Rocapuldencel-T development program moving forward," noted Jeff Abbey, CEO of Argos. "We appreciate the continued commitment of the investigators and patients in the ADAPT trial as we continue to explore the potential benefit of this unique therapy."

About the Arcelis Technology Platform

Arcelis is a precision immunotherapy technology that captures both mutated and variant antigens that are specific to each patient’s individual disease. It is designed to overcome immunosuppression by producing a specifically targeted, durable memory T cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to the treatment of a wide range of different cancers and infectious diseases, and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized immunotherapies. The Arcelis process uses only a small disease sample or biopsy as the source of disease-specific antigens, and the patient’s own dendritic cells, which are optimized from cells collected by a single leukapheresis procedure. The proprietary process uses RNA isolated from the patient’s disease sample to program dendritic cells to target disease-specific antigens. These activated, antigen-loaded dendritic cells are then formulated with the patient’s plasma, and administered via intradermal injection as an individualized immunotherapy.

Otic Pharma Completes Merger with Tokai Pharmaceuticals

On May 10, 2017 Otic Pharma, Ltd., a pharmaceutical company focusing on the development of ear, nose, and throat (ENT) products, reported the close of the previously announced combination with Tokai Pharmaceuticals, Inc. (NASDAQ: TKAI, through May 10, 2017). In connection with the previously announced transaction, Tokai changed its name to Novus Therapeutics, Inc. and effected a 1-for-9 reverse split of its common stock (Press release, Novus Therapeutics, MAY 10, 2017, View Source [SID1234521947]). The common stock is expected to commence trading on a post-reverse split basis upon the opening of trading on May 11, 2017 on the NASDAQ Capital Market under the symbol "NVUS."

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"The completion of this transaction and emergence of Novus as one of the few publicly-listed ENT companies marks a significant milestone," said Gregory J. Flesher, President and CEO of Novus Therapeutics, Inc. "Our pipeline provides a compelling opportunity for value creation as we move our product candidates through development. With the capital obtained through this transaction and continued access to the capital markets, we will be able to accelerate development of OP-01 for acute otitis externa and OP-02 for chronic and recurrent otitis media."

The combined company has approximately $30 million in cash at close, excluding $7 to 8 million in estimated transaction-related expenses. Following the completion of the transaction, together with the $7 million concurrent financing and reverse stock split, the company has approximately 7 million shares of common stock outstanding.

Novus Therapeutics will operate under the leadership of Gregory J. Flesher, President and Chief Executive Officer; Christine G. Ocampo, Chief Financial and Chief Compliance Officer; and Dr. Catherine C. Turkel, Chief Development Officer. The Board of Directors of the company is initially comprised of seven directors: Keith A. Katkin (Chairman), Gregory J. Flesher, Gary A. Lyons, Erez Chimovits, Cheryl Cohen, John S. McBride, and Jodie P. Morrison. The corporate headquarters is located in Irvine, California.

Inovio Pharmaceuticals Reports 2017 First Quarter Financial Results

On May 10, 2017 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported financial results for the quarter ended March 31, 2017 (Press release, Inovio, MAY 10, 2017, View Source [SID1234519033]).

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Total revenue was $10.4 million for the three months ended March 31, 2017, compared to $8.1 million for the same period in 2016. Total operating expenses were $32.3 million compared to $23.6 million.

The net loss attributable to common stockholders for the quarter ended March 31, 2017, was $23.1 million, or $0.31 per share, compared to $8.0 million, or $0.11 per share, for the quarter ended March 31, 2016. The increase in net loss for the quarter resulted primarily from a higher non-cash accounting expense related to the change in fair value of the investment in our affiliated entity.

Revenue

The increase in revenue was primarily due to the revenue recognized from the termination payment received from Roche during Q1 2017.

Operating Expenses

Research and development expenses for Q1 2017 were $24.5 million compared to $18.2 million for Q1 2016. The increase in R&D expenses was related to increased investment in all our product development programs. General and administrative expenses were $7.8 million for Q1 2017 versus $5.4 million for Q1 2016. The increase in G&A expenses primarily related to an increase in non-cash stock based compensation.

Capital Resources

As of March 31, 2017, cash and cash equivalents and short-term investments were $89.7 million compared with $104.8 million as of December 31, 2016. At quarter end the company had 74.6 million shares outstanding and 84.1 million fully diluted.

Under a collaboration and license agreement established with ApolloBio Corporation in February, Inovio expects to receive up to $50 million in payments and an equity investment. Details of this agreement are discussed under Corporate Development below.

Inovio’s balance sheet and statement of operations are provided below. Form 10-Q providing the complete 2017 first quarter financial report can be found at: View Source

Corporate Update

Clinical Development

VGX-3100: Cervical Pre-Cancer (Phase 3)

Subsequent to the quarter, Inovio submitted a complete response relating to the clinical hold imposed by the U.S. FDA regarding device-related questions and comments pertaining to its VGX-3100 phase 3 program. Inovio’s new CELLECTRA 5PSP commercial delivery device has been the focus of a clinical hold since 4Q 2016. The FDA’s information request sought to confirm details on various parameters of this new fully automated device developed for the phase 3 clinical study and future commercial use. Inovio’s response involved the generation of extensive testing and validation data. If this complete response is deemed satisfactory by the FDA to lift the clinical hold, Inovio would be in a position to start the phase 3 study in the second quarter.
We have been preparing investigational sites for the phase 3 study and are prepared to enroll patients after the clinical hold is lifted and the study is initiated.
VGX-3100: Vulvar Pre-Cancer (Phase 2)

Subsequent to the quarter, Inovio commenced a randomized, open label phase 2 trial to evaluate the efficacy of VGX-3100 in 36 women with high-grade HPV-related pre-cancerous lesions of the vulva, or vulvar intraepithelial neoplasia, a disease with a high unmet medical need. The immunotherapy will be administered with Inovio’s CELLECTRA intramuscular delivery device. The primary endpoint of the study is histologic clearance of high-grade lesions and virologic clearance of the HPV virus in vulvar tissue samples. The study will also evaluate safety and tolerability.
MEDI0457: HPV-Related Head & Neck Cancer (Phase 1/2)

MedImmune, AstraZeneca’s global biologics research and development arm, will start a combination trial with MEDI0457, an immunotherapy designed to generate antigen specific killer T-cell responses targeting HPV-related tumors, and MedImmune’s recently approved PDL-1 checkpoint inhibitor, durvalumab. MEDI0457, previously known as INO-3112, was developed by Inovio and licensed to MedImmune in 2015. In the second quarter, we expect enrollment to begin of patients with metastatic HPV-related squamous cell carcinoma of the head & neck with persistent or recurrent disease after chemotherapy treatment. The open-label study is designed to evaluate the safety and efficacy of the combination therapy in approximately 50 subjects at multiple U.S. sites. The primary endpoints of the study are safety and tumor regression. The study will also evaluate immunological impact, progression-free survival and overall survival.
Infectious Disease Studies

Completed enrollment of 90 patients in phase 1 study of hepatitis B DNA immunotherapy, INO-1800, and expect to report preliminary immune response data in 2H 2017. The study has completed interim safety reviews with a favorable safety profile.
Reported that in our first 40-subject phase 1 study of GLS-5700 (Zika-001) high levels of binding antibodies were measured in 100% (39 of 39) of evaluated subjects after three doses. The vaccine was safe and well-tolerated. We also expect that our second phase 1 Zika vaccine study of GLS-5700 (ZIKA-002), which is being conducted in Puerto Rico, will fully enroll 160 subjects in 2Q. In this randomized, placebo-controlled, double-blind trial, 80 subjects will receive vaccine and 80 subjects will receive placebo. The study is evaluating the safety, tolerability and immunogenicity of GLS-5700 administered with Inovio’s CELLECTRA-3P intradermal device. The study will also assess differences in Zika infection rates between the arms as an exploratory signal of vaccine efficacy.
Reported that our fully enrolled 75-subject phase 1 study of our MERS DNA vaccine GLS-5300 generated high levels of binding antibodies in 92% (57 of 62) of evaluated subjects after three vaccinations. The vaccine was safe and well-tolerated.
Preliminary results from the expanded stage of our phase 1 study, EBOV-001, demonstrated that 95% (170 of 179) of evaluable subjects generated an Ebola-specific antibody immune response, with the mean antibody titer comparable or superior to those reported from viral vector-based Ebola vaccines; and a favorable safety profile compared to such vaccines.
Corporate Development

Inovio entered into an immuno-oncology collaboration agreement with Regeneron Pharmaceuticals, Inc. Inovio will conduct a phase 1/2 study against newly-diagnosed glioblastoma multiforme (GBM) combining its INO-5401 T-cell activating immunotherapy encoding multiple antigens and INO-9012, an immune activator encoding IL-12, with Regeneron’s PD-1 checkpoint inhibitor, REGN2810. This 50-subject open-label trial will be conducted at multiple U.S. sites and will evaluate safety, tolerability, immunological impact, tumor regression, progression-free survival and overall survival. Inovio expects to begin enrollment in the second half of the year.
Under a collaboration and license agreement established with ApolloBio Corporation in February, ApolloBio is awaiting approval of the agreement by Chinese regulatory authorities. Upon receiving regulatory approval, ApolloBio will pay Inovio a $3 million signing fee and a $12 million milestone tied to the lifting of the VGX-3100 phase 3 clinical hold by the FDA. Under a separate equity agreement, ApolloBio will invest in Inovio common stock subsequent to lifting of the clinical hold at a volume weighted average price encompassing a trading period prior to and following the lifting of the clinical hold. The aggregate investment, which is expected to be completed in the first half of 2017, will not exceed $35 million and may be a lower amount such that ApolloBio will not be the largest shareholder in Inovio. ApolloBio will fund all clinical development costs within the licensed territory (Greater China), and will pay Inovio up to $20 million based upon the achievement of certain regulatory milestones in the US and China, and tiered double digit royalties on net sales of VGX-3100. The agreements are subject to People’s Republic of China (PRC) corporate and regulatory approvals, and payments are subject to PRC currency approvals.
Inovio academic and industry collaborators received a multi-year $6.95 million grant from the NIH’s National Institute of Allergy and Infectious Diseases to develop a single or combination therapy using Inovio’s PENNVAX-GP and a PD-1 checkpoint inhibitor with the goal of attaining long-term HIV remission in the absence of antiviral drugs.
Inovio’s Board of Directors appointed as a director Mr. George Bickerstaff, an internationally recognized expert in finance, healthcare and information technology. He served Novartis Pharma AG as its chief financial officer and held senior financial positions at IMS Health, Dun & Bradstreet and General Electric. He serves on various boards and is currently partner and managing director of M.M. Dillon & Co., an investment bank and financial advisory firm. Mr. Bickerstaff will stand for election by shareholders with other existing directors at the 2017 annual general meeting.
Preclinical Development

Molecular Therapy published a paper entitled, "A novel DNA vaccine platform enhances neo-antigen-like T-cell responses against WT1 to break tolerance and induce anti-tumor immunity," showing that this DNA-encoded antigen induced T cell responses that caused tumor regression in pre-clinical studies. The WT1 antigen is over-expressed in multiple cancer types but not found in most normal tissue, giving it potential to be used as part of a universal cancer vaccine against multiple tumor types. Inovio has combined WT1 with its hTERT and PSMA antigens, which are also prevalent across many cancer types, to create INO-5401; this new immunotherapy product is advancing into human studies in combination with a Regeneron PD-1 checkpoint inhibitor in patients with GBM.

Immunomedics Announces Third Quarter Fiscal 2017 Results and Clinical Program Developments

On May 10, 2017 Immunomedics, Inc., (NASDAQ:IMMU) ("Immunomedics" or "the Company") reported financial results for the third quarter ended March 31, 2017 (Press release, Immunomedics, MAY 10, 2017, View Source [SID1234519032]). The Company also highlighted recent key developments and planned activities for its clinical pipeline.

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"This was clearly a milestone quarter for Immunomedics," stated Behzad Aghazadeh, Chairman of the Board of Immunomedics. "While our financial results were generally in-line with expectations, what is most important is that we have made significant progress towards ensuring that the Company has the financial flexibility to focus on optimizing our organization and bringing IMMU-132, our breakthrough therapy candidate to treat metastatic triple-negative breast cancer, to market on our own. Immunomedics now has a clear strategic plan in place to become a recognized leader in the field of antibody-drug conjugates, which we believe will deliver maximum potential value to all stakeholders."

Third Quarter Fiscal 2017 Results

Total revenues for the third quarter of fiscal 2017, which ended on March 31, 2017, were $1.3 million, compared to $0.9 million for the same quarter for the prior fiscal year, an increase of $0.4 million, or approximately 44%. The increase was due primarily to a $0.4 million increase in LeukoScan product sales.

Total costs and expenses for the quarter ended March 31, 2017 were $23.4 million, compared to $15.5 million for the same quarter in fiscal 2016, an increase of $7.9 million, or approximately 51%, due primarily to a $8.9 million increase in general and administrative expenses, including a $5.9 million increase in legal and advisory fees associated with the proxy contest, professional services in connection with the Licensing Agreement with Seattle Genetics (SGEN) (which was subsequently terminated), a $2.4 million accrual for executive severance compensation, and a $0.6 million increase in other corporate legal fees; offset partially by a $0.8 million decrease in research and development expenses.

The Company recognized a $28.3 million non-cash expense during the three-month period ended March 31, 2017, reflecting the increase in the fair value of warrant liabilities at March 31, 2017 resulting from the increase in price of our common stock during the three-months ended March 31, 2017. The Company also recognized a $7.6 million non-cash expense representing the excess of fair value of the SGEN warrant issued on February 10, 2017 over proceeds received for the issuance of common stock and the warrant. Interest expense related to the 4.75% Convertible Senior Notes due 2020 was $1.4 million for both quarters ended March 31, 2017, and March 31, 2016, including the amortization of $0.2 million debt issuance costs in each quarter.

The Company did not realize any income tax benefit for the quarter ended March 31, 2017, compared to a $1.9 million income tax benefit for the same quarter in fiscal 2016 from the sale of a portion of our New Jersey State tax net operating losses (NOLs) and research and development (R&D) tax credits.

Net loss attributable to stockholders was $59.3 million, or $0.55 per share, for the third quarter of fiscal 2017, compared to net loss attributable to stockholders of $14.0 million, or $0.15 per share, for the same quarter in fiscal 2016, an increase of $45.3 million, or approximately 324%. The increase was due primarily to the $28.3 million increase in the fair value of warrant liabilities, the $8.9 million increase in general and administrative expenses, the $7.6 million SGEN warrant-related expense, and the non-recurring $1.9 million income tax benefit received in fiscal 2016, offset partially by the $0.8 million decrease in research and development expenses.

Nine Months Fiscal 2017 Results

Total revenues for the nine-month period of fiscal 2017 were $2.4 million, compared to $2.3 million for the same period for the prior fiscal year, an increase of $0.1 million, or approximately 4%. The increase was due primarily to a $0.1 million increase in LeukoScan sales.

Total costs and expenses for the nine-month period ended March 31, 2017 were $54.9 million, compared to $46.7 million for the same period in fiscal 2016, an increase of $8.2 million, or approximately 18%, due primarily to a $9.0 million increase in general and administrative expenses, including a $7.0 million increase in legal and advisory fees associated with the proxy contest, professional services in connection with the now-terminated Licensing Agreement with SGEN, a $2.4 million accrual for executive severance compensation, and a $1.4 million increase in legal fees, offset partially by a $1.7 million adjustment for deferred unearned executive bonuses, and a $0.7 million decrease in research and development expenses.

The Company recognized a $35.6 million non-cash expense during the nine-month period ended March 31, 2017, reflecting the increase in the fair value of warrant liabilities from the increase of the common stock price from the issuance dates of February 10, 2017 and October 11, 2016 through March 31, 2017. The Company also recognized a $7.6 million non-cash expense representing the excess of fair value of the SGEN warrant issued on February 10, 2017 over the proceeds received for the issuance of common stock and the warrant. Interest expense related to the 4.75% Convertible Senior Notes due 2020 was $4.1 million for both periods ended March 31, 2017 and March 31, 2016, including the amortization of $0.5 million debt issuance costs in each period.

The Company did not realize any income tax benefit for the nine-month period ended March 31, 2017, compared to a $5.1 million income tax benefit for the same period in fiscal 2016, from the sale of a portion of our New Jersey State tax NOLs or R&D tax credits.

Net loss attributable to stockholders was $100.0 million, or $0.97 per share, for the nine-month period ending March 31, 2017, compared to net loss attributable to stockholders of $43.1 million, or $0.46 per share, for the same period last fiscal year, an increase of $56.9 million, or approximately 132%. The increase was due primarily to the $35.6 million increase in the fair value of warrant liabilities, the $9.0 million increase in general and administrative expenses, the $7.6 million SGEN warrant-related expense, and the non-recurring $5.1 million income tax benefit received in fiscal 2016.

Cash, cash equivalents, and marketable securities were $46.0 million as of March 31, 2017. On May 10, 2017, the Company closed on the previously announced $125 million private placement financing with institutional investors. This financing, along with the Company’s current cash on hand, provides Immunomedics with the capital necessary to fully support the development of IMMU-132, including the goal of filing a Biologics License Application (BLA) with the FDA for Accelerated Approval of IMMU-132 for patients with metastatic triple-negative breast cancer (mTNBC), initiate the Phase 3 confirmatory trial in mTNBC (a prerequisite to filing the BLA), continue large-scale manufacturing of IMMU-132, and begin preparations to market IMMU-132 to mTNBC patients in the United States. It will also be used to fund general corporate and operational enhancements through the third quarter of calendar year 2018, which, the Company believes, is sufficient to attain Accelerated Approval for IMMU-132 in mTNBC subject to meeting all standards, completing review and final determination by the FDA.

"The completion of this financing will give Immunomedics significant financial flexibility," stated Michael R. Garone, Vice President Finance and Chief Financial Officer. "It was highly gratifying to see the enthusiastic response from institutional investors in the market when given the opportunity to invest in the Company. Beyond allowing us to fund the development of IMMU-132, our enhanced capital position will give us the ability to further improve and invest in our organization."

"We are absolutely committed to bring IMMU-132 to the U.S. market ourselves," said Dr. Behzad Aghazadeh, Chairman of the Board of Directors. "Our immediate goals for IMMU-132 are to begin enrolling mTNBC patients in the Phase 3 confirmatory trial during the second half of 2017 and to submit a BLA in mTNBC to the FDA during the late fourth quarter of 2017 or the first quarter of 2018. We are also evaluating strategic opportunities with regional partners for IMMU-132 and plans for further development of IMMU-132 beyond mTNBC," he further stated.

During the third quarter, Immunomedics achieved the following development milestones:

Results from a Phase 2 study of IMMU-132 in patients with relapsed or refractory metastatic urothelial cancer were updated at the 2017 Genitourinary Cancers Symposium.1 Among the 36 assessable patients, an objective response rate (ORR) of 31%, including one confirmed complete response and ten confirmed partial responses, was reported. The median duration of response for these ten patients was 7.5 months. For the 41 intention-to-treat (ITT) patients, interim median progression-free survival (PFS) and interim median overall survival (OS) were 7.2 months and 15.5 months, respectively.

In patients with metastatic small-cell lung cancer, results with IMMU-132 were updated at the 2017 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper).2 Sixty percent of patients showed tumor shrinkage from baseline measurements. On an ITT basis (N= 50), the ORR was 14% and the median response duration was 5.7 months. Median PFS and median OS were 3.7 months and 7.5 months, respectively.

Results with IMMU-132 in heavily-pretreated patients with metastatic triple-negative breast cancer were published online in the Journal of Clinical Oncology.3