On May 9, 2019 Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, reported results for its third quarter ended March 31, 2019 (Press release, Palatin Technologies, MAY 9, 2019, View Source [SID1234536043]).

Recent Highlights and Program Updates

Female Sexual Dysfunction / Vyleesi(bremelanotide)

●Vyleesi, the trade name for bremelanotide – Under development for Hypoactive Sexual Desire Disorder ("HSDD"):

●The Prescription Drug User Fee Act ("PDUFA") date for completion of FDA review of the Vyleesi New Drug Application ("NDA") is June 23, 2019

●The U.S. Food and Drug Administration ("FDA") requested a Phase 1 study in premenopausal volunteers assessing short term daily use of Vyleesi. This study, conducted by Palatin and our exclusive licensee for North America, AMAG Pharmaceuticals, was completed and data has been submitted to the FDA

●Palatin is in discussions with potential collaboration partners for certain regions outside of the licensed territories of North America, China and South Korea

Anti-Inflammatory / Autoimmune Programs

●Melanocortin Agonists under development for the treatment of inflammatory and autoimmune diseases such as dry eye, uveitis, diabetic retinopathy and inflammatory bowel diseases:

●PL-8177, a selective MC1r peptide agonist:

●Announced positive top line results of an oral clinical study for ulcerative colitis and other inflammatory bowel diseases

●Phase 2 proof-of-concept clinical study with the oral formulation in ulcerative colitis patients anticipated to commence in the fourth quarter of calendar year 2019

●Phase 2 proof-of-concept clinical study with a systemic formulation in non-infectious uveitis (NIU) patients anticipated to commence in the fourth quarter of calendar year 2019

●Continuing investigation of other possible indications for systemic administration

●Program is under internal evaluation for orphan designations

●PL-9643, a melanocortin peptide agonist:

●Continuing with preclinical Investigational New Drug ("IND") enabling activities for ocular diseases

●Program is under internal evaluation for orphan designations

Natriuretic Peptide Receptor ("NPR") System Program

●We have designed and are developing potential NPR candidate drugs that are selective for one or more different natriuretic peptide receptors, including natriuretic peptide receptor-A ("NPR-A"), natriuretic peptide receptor B ("NPR-B"), and natriuretic peptide receptor C ("NPR-C"):

●PL-3994, an NPR-A agonist that has potential utility in treatment of a number of cardiovascular diseases, including genetic and orphan diseases resulting from a deficiency of endogenous active NPR-A:

● Active collaborations with several institutions ongoing

●PL-5028, a dual NPR-A and NPR-C agonist in development for cardiovascular diseases, including reducing cardiac hypertrophy and fibrosis:

●Active collaborations with several institutions ongoing

Genetic Obesity Program

●Melanocortin receptor 4 ("MC4r") peptide PL-8905 and orally-active small molecule PL-9610 under investigation for the treatment of rare genetic metabolic and obesity disorders:

●Program is under internal evaluation for orphan designation

Corporate

●Decreased debt and related liabilities from $7.2 million at June 30, 2018 to $1.8 million at March 31, 2019.

Third Quarter Fiscal 2019 Financial Results
Palatin reported a net loss of $(5.7) million, or $(0.03) per basic and diluted share, for the quarter ended March 31, 2019, compared to a net loss of $(0.7) million, or $(0.00) per basic and diluted share, for the same period in 2018.

The difference in financial results between the three months ended March 31, 2019 and 2018 was mainly attributable to the recognition of $9.0 million in license and contract revenue during the 2018 period pursuant to our license agreement with AMAG.

Revenue
There were no revenues recorded in the quarter ended March 31, 2019.

For the quarter ended March 31, 2018, all the revenue Palatin recognized was related to our license agreement with AMAG.

Operating Expenses
Total operating expenses for the quarter ended March 31, 2019 were $5.8 million compared to $9.5 million for the comparable quarter in 2018. The decrease in operating expenses was mainly attributable to the completion of the Vyleesi Phase 3 clinical trial program and ancillary studies necessary to file the NDA for Vyleesi in March 2018.

Other Income/Expense
Total other income, net was $35,648 for the quarter ended March 31, 2019 compared to total other expense, net of $(0.2) million for the same period in 2018. The difference consisted primarily of the decrease in interest expense related to Palatin’s venture debt.

Income Tax
There was no income tax expense, or benefit, recorded in the quarter ended March 31, 2019.

Pursuant to the license agreements with our Chinese and South Korean licensees, $500,000 and $82,500, respectively, was withheld in accordance with tax withholding requirements in China and the Republic of Korea, respectively, and was recorded as an expense during the fiscal year ended June 30, 2018. For the quarter ended March 31, 2018, Palatin recorded an income tax benefit of $18,746 related to those withholding amounts utilizing an estimated effective annual income tax rate applied to the loss for the quarter and the remaining balance as of March 31, 2018 of $275,111 was included in prepaid expenses and other current assets. Any potential credit to be received by Palatin on its United States tax returns is currently offset by Palatin’s valuation allowance.

Cash Position
Palatin’s cash and cash equivalents were $19.8 million as of March 31, 2019, compared to cash and cash equivalents of $38.0 million at June 30, 2018. Current liabilities were $4.9 million as of March 31, 2019, compared to $10.8 million as of June 30, 2018.

Palatin believes that existing capital resources will be sufficient to fund our planned operations through at least May 31, 2020.

CONFERENCE CALL / WEBCAST
Palatin will host a conference call and webcast on May 9, 2019 at 11:00 a.m. Eastern Time to discuss the results of operations in greater detail and provide an update on corporate developments. Individuals interested in listening to the conference call live can dial 1-800-667-5617 (domestic) or 1-334-323-0509 (international), conference ID 7024541. The webcast and replay can be accessed by logging on to the "Investor/Webcasts" section of Palatin’s website at View Source A telephone and webcast replay will be available approximately one hour after the completion of the call. To access the telephone replay, dial 1-888-203-1112 (domestic) or 1-719-457-0820 (international), passcode 7024541. The webcast and telephone replay will be available through May 16, 2019.

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On May 9, 2019 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported financial results for the first quarter of 2019 and recent operational highlights (Press release, Atara Biotherapeutics, MAY 9, 2019, View Source [SID1234536061]).

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"We have made important progress advancing our T-cell immunotherapy programs across our three major value drivers: tab-cel, multiple sclerosis and next-generation CAR T," said Isaac Ciechanover M.D., Chief Executive Officer and President of Atara Biotherapeutics. "Discussions with EMA and FDA to align on a tab-cel global regulatory strategy for patients with Epstein-Barr virus associated post-transplant lymphoproliferative disease are progressing, with outcomes of these discussions expected in the first half of 2019. We are also looking forward to upcoming clinical milestones for our off-the-shelf, allogeneic ATA188 Phase 1 program in progressive multiple sclerosis with initial safety and efficacy results expected this year. In addition, recent clinical results presented by our MSK collaborators reaffirm mesothelin as a promising target for patients with advanced mesothelioma and establish an important proof-of-concept advance for CAR T immunotherapy in solid tumors."

Atara continues to progress tab-cel (tabelecleucel) Phase 3 studies for patients with Epstein-Barr virus associated post-transplant lymphoproliferative disease (EBV+ PTLD), with enrollment proceeding slower than anticipated. The Company is in discussions with the European Medicines Agency (EMA) and U.S. Food & Drug Administration (FDA) regarding the development of tab‑cel and Atara’s intention is to align on a global regulatory strategy for patients with EBV+ PTLD. Atara now plans to submit a tab‑cel EU conditional marketing authorization (CMA) application based on initial Phase 3 results in 2020. To ensure the integrity of the ongoing, open-label tab-cel Phase 3 study, the Company anticipates disclosing initial top-line EBV+ PTLD results following acceptance of the EMA CMA application.

"Global regulators recognize the critical need of new therapies to treat patients with EBV+ PTLD," said Dietmar Berger, M.D., Ph.D., Global Head of Research and Development of Atara Biotherapeutics. "We look forward to our continued discussions with the FDA under Breakthrough Therapy Designation and EMA based on the Priority Medicines (PRIME) regulatory pathway to bring tab‑cel to patients with this often life-threating disease as expeditiously as possible."

The Company is also advancing an off-the-shelf, allogeneic ATA188 Phase 1 study in patients with progressive multiple sclerosis (MS). Initial safety results for this study are expected to be presented at the 5th Congress of the European Academy of Neurology (EAN) in June 2019. Additional safety and efficacy results from this study are expected to be presented at a scientific congress in the second half of 2019.

Atara’s collaborators at Memorial Sloan Kettering Cancer Center (MSK) reported positive Phase 1 clinical results for their mesothelin-targeted CAR T immunotherapy for patients with solid tumors at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019. Efficacy and safety results were presented for patients with malignant pleural mesothelioma who may also have received pembrolizumab and lymphodepleting chemotherapy. Following administration of a novel mesothelin-targeted CAR T, MSK investigators observed a 72% response rate in a subset of these patients. Atara expects additional results from this study to be presented at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

Based on these encouraging results, Atara and MSK are advancing development of a next-generation, mesothelin-targeted CAR T immunotherapy using a novel 1XX CAR signaling domain and PD-1 dominant negative receptor (DNR) checkpoint inhibition technologies, with an IND expected in 2020.

Recent Highlights and Anticipated Upcoming Milestones

Tab-cel (tabelecleucel)

Two Phase 3 clinical studies are ongoing (MATCH and ALLELE) to evaluate tab-cel for patients with EBV+ PTLD who have failed rituximab following hematopoietic cell transplant (HCT) or solid organ transplant (SOT).
In the United States and Australia, 32 sites are available for enrollment, with additional sites expected to open in the United States and other geographies.
2019 ASCO (Free ASCO Whitepaper) Annual Meeting

Expect presentations highlighting tab-cel and next-generation CAR T immunotherapy technology to be presented at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting to be held May 31 to June 4 in Chicago.
Oral Presentation: Regional delivery of mesothelin-targeted CAR T cells for pleural cancers: Safety and preliminary efficacy in combination with anti-PD-1 agent. Abstract 2511, S406, Tuesday, June 4, 2019, 8:36 a.m. – 8:48 a.m. CDT.
Poster Presentation: Correlation of circulating EBV-targeted cytotoxic T lymphocyte precursors (EBV-CTLp) and clinical response following tabelecleucel (tab-cel) infusion in patients with EBV-driven disease. Abstract 2532, Hall A, Saturday, June 1, 2019, 8:00 a.m. – 11:00 a.m. CDT.
Poster Presentation: Tabelecleucel in combination with pembrolizumab (Pembro) in platinum-pretreated, recurrent/metastatic Epstein-Barr virus (EBV)-positive nasopharyngeal carcinoma (EBV+ NPC). Abstract TPS6092, Hall A, Saturday, June 1, 2019, 1:15 p.m. – 4:15 p.m. CDT.
ATA188 & ATA190 for Multiple Sclerosis (MS)

A Phase 1 clinical study of off-the-shelf, allogeneic ATA188 in patients with progressive MS is ongoing across clinical sites in the United States and Australia.
Atara expects to present initial safety results from this study during at the 5th Congress of the European Academy of Neurology (EAN) to be held June 29 to July 2 in Oslo, Norway.
Additional safety and efficacy results from this study are expected to be presented at a scientific congress in the second half of 2019.
Expect to initiate a randomized study of autologous ATA190 in progressive MS patients during the second half of 2019.
Next-Generation CAR T

Positive Phase 1 clinical results for MSK’s mesothelin-targeted CAR T immunotherapy were recently presented by our MSK collaborators at the AACR (Free AACR Whitepaper) Annual Meeting 2019.
Encouraging safety results and anti-tumor responses observed in combination with a PD-1 checkpoint inhibitor, support Atara’s plans to progress development of a next-generation, mesothelin-targeted CAR T immunotherapy using MSK’s novel 1XX CAR signaling domain and PD-1 DNR checkpoint inhibition technologies for patients with mesothelin-associated solid tumors.
Atara plans to prioritize mesothelin CAR T development and anticipates that this program will be the first CAR T program to enter the clinic, with an IND expected in 2020.
Additional results from ongoing MSK investigator-sponsored mesothelin-targeted CAR T studies are expected to be presented at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting.
Corporate

Atara’s Board of Directors is conducting a search for a new Chief Executive Officer following Dr. Ciechanover’s transition plan announced in January. Dr. Ciechanover will remain in his role as President and CEO until the earlier of the appointment of his successor or June 30, 2019.
First Quarter 2019 Financial Results

Cash, cash equivalents and short-term investments as of March 31, 2019 totaled $237.5 million, which the Company believes will be sufficient to fund planned operations to mid-2020.
The Company reported net losses of $66.3 million, or $1.44 per share, for the first quarter of 2019 as compared to $41.4 million, or $1.05 per share, for the same period in 2018.
Total operating expenses include total non-cash expenses of $13.9 million for the first quarter of 2019 as compared to $7.3 million for the same period in 2018.
Research and development expenses were $48.7 million for the first quarter of 2019 as compared to $28.5 million for the same period in 2018. The increase in the first quarter of 2019 was due to costs associated with the Company’s continuing expansion of research and development activities, including:
clinical study, manufacturing and outside service costs related to tab-cel and the Phase 1 clinical study of off-the-shelf, allogeneic ATA188;
higher employee-related and overhead costs from increased headcount and operations, and
an increase in facilities and information technology expenses that are allocated to our research and development function.
Research and development expenses include $6.1 million of non-cash stock-based compensation expense for the first quarter of 2019 as compared to $2.9 million for the same period in 2018.
General and administrative expenses were $19.2 million for the first quarter of 2019 as compared to $14.0 million for the same period in 2018. The increase in the first quarter of 2019 was primarily due to increases in professional services costs and employee-related costs driven by increased headcount to support the Company’s expanding operations.
General and administrative expenses include $6.2 million of non-cash stock-based compensation expense for the first quarter of 2019 as compared to $4.1 million for the same period in 2018.
Conference Call and Webcast Information
Atara will host a live conference call and webcast today at 8:30 a.m. EDT to discuss the Company’s financial results and recent operational highlights. Analysts and investors can participate in the conference call by dialing (888) 540-6216 for domestic callers and (734) 385-2715 for international callers, using the conference ID 1956289. A live audio webcast can be accessed by visiting the Investor Events and Presentations section of atarabio.com. An archived replay will be available on the Company’s website for approximately 14 days following the live webcast.

On May 9, 2019 AVEO Oncology (NASDAQ: AVEO) reported financial results for the first quarter ended March 31, 2019 and provided a business update (Press release, AVEO, MAY 9, 2019, View Source [SID1234536077]).

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"With a successful recent equity offering, together with the triggering of a FOTIVDA (tivozanib) milestone from EUSA, AVEO’s strengthened balance sheet provides us with a cash runway that we expect will take us into the fourth quarter of 2020," said Michael Bailey, president and chief executive officer of AVEO. "We remain committed to our goal of improving outcomes and patient experience in renal cell carcinoma (RCC), and look forward to reporting more mature interim OS results from our TIVO-3 study in advanced or metastatic RCC, which we expect will occur in the fourth quarter of 2019, as well as the subsequent decision regarding a potential NDA filing in the U.S. We also continue to make progress with the balance of our programs and pipeline, most notably the ongoing clinical collaborations combining FOTIVDA with Bristol Myers Squibb’s OPDIVO (nivolumab) for the TiNivo study in RCC and with AstraZeneca’s IMFINZI (durvalumab) in first-line hepatocellular carcinoma, ongoing studies of ficlatuzumab in multiple oncology indications, and the emerging potential of a new ocular formulation of tivozanib for the treatment of age-related macular degeneration."

Recent Highlights

$2 Million Milestone Payment from EUSA Pharma Triggered. In April 2019, AVEO announced the triggering of a $2 million milestone payment from EUSA Pharma related to the February 2019 reimbursement approval and subsequent commercial launch of FOTIVDA (tivozanib) in Spain as a first-line treatment of adult patients with RCC.

Closing of Public Offering of Common Stock and Warrants. In April 2019, AVEO completed an underwritten public offering of 21,739,131 shares of common stock and 25,000,000 warrants to purchase common stock at the public offering price of $1.14 per share and $0.01 per warrant. The warrants have a two-year term and a strike price of $1.25 per share. Gross proceeds of the offering were approximately $25.0 million and are expected to be used for ongoing clinical and preclinical development of AVEO’s product candidates, as well as for working capital and other general corporate purposes.

Announced Positive Results from Phase 1b Ficlatuzumab-Cytarabine Trial (CyFi) in Patients with Relapsed and Refractory AML. In April 2019, AVEO announced the presentation of positive data from an investigator-sponsored Phase 1b expansion cohort of ficlatuzumab, AVEO’s potent hepatocyte growth factor (HGF) inhibitory antibody in combination with cytarabine in patients with relapsed and refractory acute myeloid leukemia (AML), at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, held March 29 – Apr 3, 2019 in Atlanta. Of 18 AML patients enrolled in the study, all had disease that was refractory to initial treatment, 17 were evaluable and 9 achieved a complete response. The most frequent grade 3/4 treatment emergent adverse events observed were febrile neutropenia, LFT abnormalities, and electrolyte disturbance.

There was one death from sepsis and multi-organ failure that was determined to be disease related, and one patient withdrew from the study due to grade 4 gastrointestinal bleed, determined to be likely ficlatuzumab related. A copy of the presentation is currently available in the Publications & Presentation section of AVEO’s website.

Based on these results, the Company is evaluating potential next steps for this program in collaboration with its ficlatuzumab development and commercialization partner, Biodesix, Inc.

Appointed Gregory T. Mayes to Board of Directors. In February 2019, the Company announced the appointment of Gregory T. Mayes to its Board of Directors. Mr. Mayes brings to the AVEO Board over 20 years of experience as a biopharmaceutical executive with deep expertise in public company governance, business strategy and the commercialization of life sciences products.

Presented Topline Results from TIVO-3 in an Oral Presentation at the 2019 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium and Announced Updated NDA Timing. In February 2019, AVEO presented topline results from the TIVO-3 trial, AVEO’s Phase 3 randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in 350 subjects with refractory advanced or metastatic RCC at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium held February 14-16, 2019 in San Francisco. The results were presented during an oral presentation titled "TIVO-3: A Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib to Sorafenib in Subjects with Refractory Advanced Renal Cell Carcinoma (RCC)." A copy of the presentation is currently available in the Publications & Presentation section of AVEO’s website.

The presentation noted that the TIVO-3 trial met its primary endpoint of demonstrating a statistically significant benefit in progression-free survival (PFS) versus sorafenib. There was also a significant PFS improvement demonstrated for tivozanib both in the subgroups of patients who received prior PD-1 therapy and those who received two prior VEGF TKI therapies. The secondary endpoint of overall response rate demonstrated a statistically significant improvement for patients receiving tivozanib compared to sorafenib. The analysis of the secondary endpoint of overall survival (OS) was not mature at the time of the final PFS analysis, but the hazard ratio at the time of the analysis favored sorafenib. Tivozanib was generally well-tolerated, with grade 3 or higher adverse events consistent with those observed in previous tivozanib trials. Infrequent but severe adverse events reported in greater number in the tivozanib arm were thrombotic events similar to those observed in previous tivozanib studies. The most common adverse event in patients receiving tivozanib was hypertension, an adverse event known to reflect effective VEGF pathway inhibition.

AVEO intends to initiate an additional interim OS analysis in August 2019, the results of which are expected to be reported in the fourth quarter of 2019 and would be the first planned update since the prior OS analysis was initiated in the fourth quarter of 2018. At the recommendation of the U.S. Food and Drug Administration, AVEO plans to make a

New Drug Application (NDA) filing decision following the availability of more mature OS results.

First Quarter 2019 Financial Results

AVEO ended Q1 2019 with $23.5 million in cash, cash equivalents and marketable securities as compared with $24.4 million at December 31, 2018.

Total revenue for Q1 2019 was approximately $1.6 million compared with $1.0 million for Q1 2018.

Research and development expense for Q1 2019 was $6.9 million compared with $5.4 million for Q1 2018.

General and administrative expense for Q1 2019 was $2.5 million compared with $2.6 million for Q1 2018.

Net income for Q1 2019 was $0.6 million, or net income of $0.01 and net loss of $0.06 per basic and diluted share, respectively, compared with a net loss of $9.0 million for Q1 2018, or net loss of $0.08 per basic and diluted share.

The Q1 2019 net income was driven by an approximate $8.8 million non-cash gain attributable to the decrease in the fair value of the 2016 PIPE warrant liability that principally resulted from the decrease in the stock price that occurred during the fiscal quarter. In Q1 2018, the non-cash loss attributable to the increase in the fair value of such warrant liability was $1.5 million.

Financial Guidance

AVEO believes that our approximate $23.5 million in cash, cash equivalents and marketable securities at March 31, 2019, along with approximately $24.2 million in additional net funding received in the second quarter of 2019 to-date, as described above, would allow us to fund our planned operations into the fourth quarter of 2020. This estimate excludes possible additional clinical trials we may sponsor and, subject to our decision whether to submit an NDA for tivozanib to the FDA following the availability of more mature OS results, remaining costs to prepare and filing fees in connection with a possible NDA submission, any related drug manufacturing and drug supply distribution, and pre-commercialization activities that we may undertake. This estimate also assumes no receipt of additional milestone payments from our partners, no funding from new partnership agreements, no additional equity financings, no debt financings, no additional sales of equity under our Leerink Sales Agreement and no additional sales of equity through the exercise of our outstanding warrants. Accordingly, the timing and nature of activities contemplated for the remainder of 2019 and thereafter will be conducted subject to the availability of sufficient financial resources.

About Tivozanib (FOTIVDA)

Tivozanib (FOTIVDA) is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) discovered by Kyowa Hakko Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway and Iceland. It is a potent, selective and long half-life inhibitor of all three VEGF

receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.1,2 Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models3 and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC. Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, colorectal and breast cancers. In addition, a new formulation of tivozanib is in pre-clinical development for the treatment of age-related macular degeneration.

About Ficlatuzumab

Ficlatuzumab (formerly known as AV-299) is a potent hepatocyte growth factor (HGF) inhibitory antibody that binds to the HGF ligand with high affinity and specificity to inhibit HGF/c-Met biological activities. AVEO and Biodesix, Inc. have a worldwide agreement to develop and commercialize ficlatuzumab. Ficlatuzumab is currently being evaluated in investigator-sponsored trials in squamous cell carcinoma of the head and neck (HNSCC), metastatic pancreatic ductal cancer (PDAC), and acute myeloid leukemia (AML).

On May 9, 2019 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immunotherapy company, reported its financial and operational results for the first quarter ended March 31, 2019 (Press release, IMV, MAY 9, 2019, View Source [SID1234536094]).

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"The DPX-Survivac program continues to be a major value-driver for IMV, with its unique mechanism of action providing significant clinical differentiation and, potentially, a much-needed innovation for hard-to-treat cancers," said Frederic Ors, IMV’s Chief Executive Officer. "Highlights of our overall progress this quarter include:

Reported promising initial data from the phase 2 cohort of the DeCidE1 clinical study, which underscores the potential of DPX-Survivac as a monotherapy;
Awarded a grant with le Centre de Recherche du CHU de Québec-Université Laval to develop a first-in-class dual target T cell therapy in bladder cancer; and
Completed a C$29.46 million financing with Wells Fargo acting as lead underwriter that provided the Company with increased financial flexibility."
DPX-Survivac Clinical Program Updates:

Phase 2 Cohort of the DeCidE1 Clinical Study in Ovarian Cancer

IMV provided a clinical update in March indicating that six patients receiving DPX-Survivac monotherapy with intermittent low-dose cyclophosphamide (mCPA) had reached the first CT scan assessment. Key related findings were as follows:

83% of the participants (5 of 6) showed stable disease (SD), including two tumor regressions; and
80% (4 of 5) of those with stable disease were subjects with a lower baseline tumor burden (BTB) of less than 5 centimeters, which also included the two tumor regressions.
In earlier stages of this trial, durable clinical responses occurred after 140 days, and at the date of this latest update, they had lasted for 20 months or more. The amended phase 2 cohort of the DeCidE1 trial focuses on patients with low BTB (less than 5 centimeters). The Corporation is targeting enrollment of at least 16 additional patients at sites in the U.S. and Canada.

IMV will present additional data on DeCidE1 at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting.

Phase 2 Study in Combination with KEYTRUDA in Relapsed/Refractory DLBCL (SPiReL)

As of April 5, 2019, investigators had enrolled ten patients in four different clinical sites in Canada. Additional patients are being screened and IMV expects to report updated clinical data at the bi-annual International Conference on Malignant Lymphoma, which will be held in Lugano Switzerland in June 2019.

Phase 2 Basket Trial in Combination with KEYTRUDA in Multiple Solid Tumors

Screening and enrollment of patients is ongoing at multiple clinical sites across the U.S. and Canada for 5 cohorts of patients with bladder, liver (hepatocellular carcinoma), ovarian, or non-small cell lung (NSCLC) cancers, as well as tumors shown to be positive for the microsatellite instability high (MSI-H) biomarker.

The first patients have been treated in the ovarian, NSCLC and MSI-H cohorts and IMV expects to report preliminary clinical results on several of the solid tumor indications before the end of 2019.

The Corporation expects to reach the following milestones between now and the first half of 2020:

Milestones Key dates
Phase 2 monotherapy clinical results in Ovarian – ASCO (Free ASCO Whitepaper) June 2019
Phase 2 clinical results with Merck Keytruda in DLBCL – ICML June 2019
Preliminary clinical results Basket trial in 5 indications H2 2019
Topline monotherapy clinical results in Ovarian H2 2019
Top line clinical results for Basket trial H1 2020

"We are pleased at the steady progress we’ve made this far in 2019, and look forward to leveraging our technology to improve immunotherapy treatment options, particularly in underserved cancers," continued Mr. Ors. "We are grateful for the continued support of our shareholders and partners and look forward to a very productive remainder of 2019."

Q1 2019 Operational Highlights

Completion of an underwritten public offering: IMV completed, in early March 2019 an underwritten public offering of 5,404,855 common shares at a price to the public of C$5.45 per common share, for aggregate gross of approximately C$29.46 million, before deducting the underwriting commissions and estimated Offering expenses. Wells Fargo Securities and Raymond James acted as joint book-running managers for the Offering. B. Riley FBR acted as co-manager.

The Corporation intends to use the net proceeds of the Offering to accelerate the development of DPX-Survivac in combination with Keytruda as part of the basket trial in select advanced or recurrent solid tumors in bladder, liver (hepatocellular carcinoma), ovarian or non-small-cell lung cancers, as well as tumors shown to be positive for the microsatellite instability high biomarker and for general corporate purposes.

Grant awarded by CQDM to IMV to develop first-in-class dual target T cell therapy: In March, a grant was awarded by CQDM to develop a first-in-class dual target T Cell therapy in bladder cancer based on IMV’s DPX technology to IMV and Centre de Recherche du CHU de Québec-Université Laval.

The work will target immunogenic peptides from the MAGE protein family member A9 (MAGE-A9) as identified by a team from Centre de Recherche du CHU de Québec-Université Laval. This protein is frequently expressed in various human cancers including bladder, lung, and kidney. These peptides will be combined with selected immunogenic peptides from the survivin protein composing the DPX-Survivac T cell drug candidate.

Overview of Q1 2019 Financial Results

The net loss and comprehensive loss of $5,943,000 ($0.13 per share) for the three-month period ended March 31, 2019, was $2,876,000 higher than the net loss and comprehensive loss for three-month period ended March 31, 2018. This relates mainly to a $2,131,000 increase in research and development (R&D) expenses, a $670,000 increase in general and administrative expenses and a $71,000 increase in government assistance in the three-month period ended March 31, 2019.

At March 31, 2019, the Corporation had cash and cash equivalents of $34,207,000 and working capital of $33,893,000, compared with $14,895,000 and $12,247,000, respectively at December 31, 2018. For the three-month period ended March 31, 2019, IMV’s cash burn rate (defined as net loss for adjusted for non-cash transactions including amortization, depreciation, accretion of long-term debt and stock-based compensation) was approximately $5.2 million. Based on the current business plan, the Corporation forecasts the quarterly cash burn rate to be between $5 million and $6 million for 2019.

As of May 9, 2019, the number of issued and outstanding common shares was 50,597,306. A total of 2,030,471 stock options, warrants, and deferred share units were outstanding on May 9, 2019.

The Corporation’s unaudited interim condensed consolidated results of operations, financial condition and cash flows for the three months ended March 31, 2019 and the related management’s discussion and analysis (MD&A) are available on SEDAR at www.sedar.com.

On May 9, 2019 EnGeneIC Limited, a clinical-stage biopharmaceutical company advancing its proprietary EDV nanocell platform for targeted cyto-immunotherapy in cancer, reported that the first four patients have been dosed in a Phase I/IIa study using the Company’s tumor-targeting, immunogenic EDVs to deliver a cytotoxic drug payload directly to tumors of patients who have exhausted curative treatment options (Press release, EnGeneIC, MAY 9, 2019, View Source [SID1234536197]). The study is enrolling patients with advanced pancreatic cancer and other EGFR-expressing solid tumors in a second cohort, which is currently underway at Frankston Private Hospital in Victoria, Australia, with Professor Vinod Ganju, MBBS, FRACP, as the Principal Investigator.

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EnGeneIC’s second-generation EDV nanocells deliver an extremely cytotoxic nemorubicin derivative (D682) directly to solid tumors via EGFR targeting on the tumor cell surface, keeping healthy tissue protected from damage. The novel therapy also includes EDVs carrying an immune-boosting adjuvant to further augment the anti-tumor immune response stimulated by the bacterially-derived EDVs and perpetuated by tumor cell destruction.

Jennifer MacDiarmid, Ph.D., and Himanshu Brahmbhatt, Ph.D., joint-CEOs and Directors of EnGeneIC, stated, "We developed our second-generation EDVs to address multi-drug resistance in patients who have failed multiple lines of chemotherapy and therefore have the highest unmet need. D682 is an extremely potent drug that is far too toxic to be delivered systemically, but has proven safe in patients when encapsulated in our EDVs. We have named the study, the Carolyn Trial, after a close friend who had end-stage pancreatic cancer and was treated in a compassionate use case study. Carolyn was the first patient in the world to receive D682, and we observed highly encouraging results. Not only was survival extended, but quality of life improved considerably for the patient. Moreover, there was significant evidence of tumor regression coincident with a decrease in a key pancreatic cancer blood marker and a robust increase in anti-tumor CD8+ T cells and other anti-tumor immune cells. We are now executing a more rigorous clinical trial, not only for pancreatic cancer patients, but also for other advanced-stage patients with drug-refractory tumors."

Professor Ganju commented "Novel therapies for these late stage patients with drug-resistant tumors are desperately needed. Four patients have been enrolled on the study and so far we have been impressed with the tolerability and safety of this therapy. We will be getting some efficacy data in coming months."

About the Phase 1/2a Study

The two-cohort study will enroll up to 40 evaluable patients per cohort: 1) patients with advanced pancreatic cancer and 2) patients with EGFR-expressing solid tumors who have failed first- and second-line therapy or for whom standard therapies are not appropriate. The test article is EnGeneIC’s second-generation EGFR-targeted, D682-carrying EDV (EEDVD682) plus EDVs carrying an immune adjuvant (EDVadj) which acts to augment the anti-tumor immunity. Study objectives include assessing the safety and tolerability of EEDVD682 plus EDVadj, assessing anti-tumor response and overall survival. Exploratory objectives include biomarker assessment for immune response such as cellular immune response (CD8+ T cells, NK cells), and activated dendritic cells. In addition to the current clinical site, the study is expected to be opened in at least one other major cancer center in Sydney, Australia. For more information visit View Source;isReview=true