On May 15, 2019 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation oncology therapeutics, reported its financial results for the quarter ended March 31, 2019 (Press release, Sutro Biopharma, MAY 15, 2019, View Source [SID1234536335]).

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"During the first quarter of 2019, we initiated a Phase 1 clinical trial for our second wholly-owned product candidate, STRO-002, for the treatment of ovarian and endometrial cancers. We will present initial safety data for STRO-001, for the treatment of multiple myeloma and non-Hodgkin lymphoma on June 15, 2019 at the EHA (Free EHA Whitepaper) Congress," said Bill Newell, Sutro’s Chief Executive Officer. "Further, the investigational new drug ("IND") clearance received by our partner Celgene for our BCMA ADC represents another significant moment for antibody drug conjugates ("ADCs") as important therapeutic modalities in fighting cancer.

Recent Business Highlights and Developments

STRO-001 Clinical Program

Potential first-in-class and best-in-class ADC directed against CD74, which is highly expressed in many B cell malignancies
Phase 1 dose-escalation, with dose expansion, clinical trial enrolling patients with multiple myeloma and non-Hodgkin lymphoma, with initial safety data to be presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress on June 15, 2019 and initial efficacy data expected by year end 2019
STRO-001 granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of multiple myeloma
STRO-002 Clinical Program

Potential best-in-class ADC directed against folate receptor-alpha, which is highly expressed in ovarian cancer
Phase 1 dose-escalation, with dose expansion, clinical trial enrolling women with advanced ovarian and endometrial cancers, with initial safety data expected by year end 2019

BCMA ADC Clinical Program and Celgene Collaboration

Third product candidate to originate from Sutro’s proprietary discovery and manufacturing platform to enter clinical development since early 2018

Existing pipeline bolstered with three bispecific assets from Sutro’s collaboration with Celgene, for which Sutro holds U.S. rights, targeting BCMA-CD3, PD1-LAG3 and PD1-TIM3.

Celgene receives FDA clearance on its IND application for an ADC targeting B-cell maturation antigen ("BCMA") for the treatment of multiple myeloma, for which product candidate Celgene has worldwide development and commercialization rights. Sutro is entitled to development and regulatory milestone payments and tiered royalties from Celgene for this BCMA ADC.

Under the Celgene collaboration, U.S. clinical development and commercialization rights to three collaboration programs (BCMA-CD3, PD1-LAG3 and PD1-TIM3) are now fully owned by Sutro, as Celgene elected not to pay the option fee to continue to have rights for these programs following IND clearance of the first collaboration program. For any products resulting from these three programs, Celgene will own ex-U.S. development and commercialization rights and will be obligated to pay Sutro development and regulatory milestone payments and tiered royalties.

Quarter 2019 Financial Highlights

Cash, Cash Equivalents and Marketable Securities

As of March 31, 2019, Sutro had cash, cash equivalents and marketable securities of $184.3 million.

Revenue

Revenue was $8.6 million for the quarter ended March 31, 2019, which included collaboration revenue from Celgene, Merck and EMD Serono. On January 1, 2019, Sutro adopted Accounting Standards Update No. 2014-09 Revenue from Contracts with Customers (Accounting Standards Codification Topic 606). For more information on the impact of the adoption of the new revenue standard, see "Notes to Unaudited Interim Condensed Financial Statements" contained in Part I, Item 1 of Sutro’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 15, 2019. Future collaboration revenue from Celgene, Merck and EMD Serono, and from any future collaboration partners, will fluctuate as a result of the amount and timing of revenue recognition of upfront, milestones and other collaboration agreement payments.

Operating Expenses

Total operating expenses for the quarter ended March 31, 2019, were $22.9 million compared with $17.5 million for the same period in 2018, including non-cash stock-based compensation of $2.3 million and $0.3 million, and depreciation and amortization expense of $1.1 million and $1.2 million, in the 2019 and 2018 quarters, respectively. Total operating expenses for the 2019 quarter were comprised of research and development expenses of $15.2 million and general and administrative expenses of $7.7 million, with both expense types expected to increase in 2019 as Sutro’s internal product candidates advance in clinical development and additional general and administrative expenses are incurred as a public company following its IPO that closed on October 1, 2018.

On May 15, 2019 ArQule, Inc. (Nasdaq: ARQL) reported that Dr. Marc Schegerin, Chief Financial Officer and Head of Strategy, will present at the 20th Annual B. Riley FBR Institutional Investor Conference on May 22, 2019 at 9:30 a.m. PT at the Beverly Hilton in Beverly Hills, CA (Press release, ArQule, MAY 15, 2019, View Source [SID1234536334]).

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The live webcast of the presentation will be available via the "Investors & Media" section of ArQule’s website, www.arqule.com, under "Events & Presentations." A replay of the webcast will be available shortly after the conclusion of the presentation.

On May 15, 2019 Eli Lilly and Company (NYSE: LLY) reported that it will participate in the Bank of America Merrill Lynch 2019 Health Care Conference on Wednesday, May 15, 2019 (Press release, Eli Lilly, MAY 15, 2019, View Source [SID1234536333]). Enrique Conterno, senior vice president of Lilly and president of Lilly Diabetes and Lilly USA, will participate in a fireside chat at 9:20 a.m. PDT (12:20 p.m. EDT).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

On May 15, 2019 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported the United States Food and Drug Administration (FDA) has recommended that the Company conduct a new Phase 3 randomized trial to evaluate the safety and efficacy of mirvetuximab soravtansine in patients with high folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer as part of a Type C meeting held this week (Press release, ImmunoGen, MAY 15, 2019, View Source [SID1234536332]).

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ImmunoGen requested the meeting to discuss the results of the Phase 3 FORWARD I trial and a potential path to registration for mirvetuximab monotherapy. The agency advised that, because FORWARD I did not meet its primary endpoint under the pre-specified statistical analysis plan, the data generated assessing the secondary endpoints from the study could not be used to support an application for accelerated approval. FDA acknowledged that platinum-resistant ovarian cancer is a disease with unmet need, provided guidance regarding the design and endpoints of a potential registration study, and encouraged the Company to return to discuss a proposed study design.

"We are encouraged by the consistent signal of anti-tumor activity and the favorable benefit-risk profile in patients with high FRα expression in our Phase 3 FORWARD I trial," said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. "We appreciate the constructive engagement with FDA and look forward to aligning with the agency on the design of a new registration trial in this population."

"Our meeting with FDA enabled us to clarify a regulatory path forward for mirvetuximab and we are evaluating all avenues to bring this promising therapy to ovarian cancer patients," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "The mirvetuximab combination cohorts continue to advance and, with approximately $270 million on the balance sheet as of the end of Q1, we remain focused on developing innovative ADC therapeutics and delivering more good days to people with cancer."

As previously announced, ImmunoGen is conducting an operational review of the business with the objective of extending the Company’s cash runway.

CONFERENCE CALL INFORMATION
ImmunoGen will host a conference call on May 15, 2019 at 8 a.m. ET to discuss the recent regulatory meeting with FDA. To access the live call by phone, dial 334-323-0505; the conference ID is 5203727. The call may also be accessed through the "Investors and Media" section of the Company’s website, www.immunogen.com. Following the live webcast, a replay of the call will be available at the same location through May 29, 2019.

ABOUT FORWARD I
FORWARD I is a Phase 3 trial in which 366 patients were randomized 2:1 to receive either mirvetuximab soravtansine or the physician’s choice of single-agent chemotherapy (pegylated liposomal doxorubicin, topotecan, or weekly paclitaxel). Eligible patients were diagnosed with platinum-resistant ovarian cancer that expresses medium or high levels of FRα and were treated with up to three prior regimens. The primary endpoint of this study was progression free survival (PFS), which was assessed in the entire study population and in the subset of patients with high FRα expression. ImmunoGen estimates that 12,000-14,000 patients per year in the U.S. meet these criteria, with a comparable number in the major markets in Europe.

ImmunoGen partnered with the GOG Foundation Inc., a leader in clinical research in gynecologic malignancies, on FORWARD I, which was conducted in North America and Europe.

ABOUT MIRVETUXIMAB SORAVTANSINE
Mirvetuximab soravtansine (IMGN853) is the first folate receptor alpha (FRα)-targeting ADC. It uses a humanized FRα-binding antibody to target the ADC specifically to FRα-expressing cancer cells and a potent anti-tumor agent, DM4, to kill the targeted cancer cells.

On May 15, 2019 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new cancer therapies, reported its financial results for the third quarter ended March 31, 2019 (Press release, DelMar Pharmaceuticals, MAY 15, 2019, View Source [SID1234536331]). DelMar executive management will host a business update conference call for investors, analysts and other interested parties on May 23, 2019 at 4:30 p.m. Eastern Time.

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"The third quarter proved to be an important period of progress as we advanced VAL-083 in both of our Phase 2 clinical trials in GBM with encouraging early results, especially in our first line GBM trial, while continuing the evaluation of this first-in-class, small molecule’s potential to treat a range of solid tumor cancers. I am also pleased by the establishment of our formal Scientific Advisory Board led by world-renowned oncology experts," commented Saiid Zarrabian, President and Chief Executive Officer of DelMar Pharmaceuticals. "In addition, we initiated execution of our planned rights offering to provide capital to continue the advancement of our clinical trials through their estimated planned completion in mid-calendar 2020, and we executed the necessary recent reverse stock split which potentially enables us to regain compliance with Nasdaq’s listing requirements."

Key Highlights and Recent Developments

Achieved the halfway enrollment point for VAL-083’s Phase 2, open-label, first-line temozolomide-naïve, MGMT-unmethylated glioblastoma multiforme (GBM) study at Sun Yat-sen University Cancer Center (SYSUCC) with encouraging results for 11 of the initial 15 patients treated

Continued enrolling patients in VAL-083’s Phase 2, open-label, second-line, Avastin-naïve, MGMT-unmethylated, recurrent GBM study being conducted at the MD Anderson Cancer Center (MDACC)

Received approval from MDACC’s Institutional Review Board (IRB) for protocol expansion to include maintenance stage, MGMT-unmethylated GBM patients. This provides an opportunity for enrollment of a larger patient population who may benefit from VAL-083 in an earlier stage of this hard-to-treat disease

Presented data supporting VAL-083 as potential treatment for pediatric brain tumors at the Society for Neuro-Oncology Pediatric Neuro-Oncology Basic and Translational Research Conference

Established Scientific Advisory Board with inaugural members Drs. Napoleone Ferrara and John de Groot
Potentially regained compliance with Nasdaq’s minimum bid price listing requirement of $1.00 by executing a 1-for-10 reverse stock split

Launched a financing via a shareholder rights offering

On February 20, 2019, DelMar announced that its Phase 2 study evaluating VAL-083 in patients with newly diagnosed GBM achieved its halfway enrollment point. This trial, targeted to enroll up to thirty patients, is a single-arm, open-label study testing VAL-083 in combination with standard radiotherapy in GBM patients who have an unmethylated promoter of the methylguanine DNA-methyltransferase (MGMT) gene. An estimated 60% of GBM patients possess an unmethylated MGMT gene, which confers a more limited response to current standard of care treatment as well as a lower survival probability. This clinical trial was initiated in February 2017 and is being conducted at SYSUCC in Guangzhou, China in collaboration with Guangxi Wuzhou Pharmaceutical Company. As of February 15, 2019, fifteen patients have been enrolled in this study.

The Company was pleased to report that for the 15 patients enrolled as of February 15, 2019, 11 completed their prospectively planned Magnetic Resonance Imaging (MRI) scans and have had their initial assessment for tumor progression. Tumor progression is based on the trial investigator’s clinical and radiologic assessment, according to the Response Assessment in NeuroOncology (RANO) criteria. Of these 11 patients, five were assessed by the Principal Investigator as having a "Complete Response," three of whom were based on significant tumor shrinkage, and two of whom were based on their tumors continuing to remain "below measurable level" from post-surgery baseline MRI to post-cycle three MRI. Additionally, six patients were assessed as having "Stable Disease." Of the remaining four patients, one died prior to their post-cycle three MRI and three have not been on study long enough to reach their planned post-cycle three MRI. As of the February 15, 2019 data cutoff, 12 of the 15 enrolled patients were still alive. Similar to prior experience, myelosuppression has been the most common adverse event observed. Two dose-limiting toxicities have been reported (thrombocytopenia) – one at the 40 mg/m2/day dose and one at the 30 mg/m2/day dose.

Throughout the quarter, DelMar continued to enroll patients in VAL-083’s Phase 2, open-label, second-line, Avastin-naïve, MGMT-unmethylated, recurrent GBM study being conducted at the MDACC. On April 3, 2019, the Company announced that the MDACC’s IRB approved a trial protocol amendment to expand the study with the addition of up to 35 patients at a dose of 30 mg/m2. Also, the MDACC IRB approved the addition of up to 24 patients in the pre-temozolomide (TMZ) maintenance setting. The biomarker driven trial, which was originally designed as a single arm study evaluating VAL-083 in patients with MGMT-unmethylated bevacizumab (Avastin)-naïve recurrent GBM, has been expanded to include an additional maintenance-stage (adjuvant therapy) treatment group. This protocol amendment, in addition to the Company’s ongoing Phase 2 trial in newly diagnosed patients with MGMT-unmethylated GBM being conducted at SYSUCC, expands DelMar’s evaluation range of VAL-083 as a potential treatment for unmethylated GBM patients to include newly-diagnosed, maintenance-stage, and recurrent patients. Maintenance-stage GBM provides the greatest opportunity to control disease progression after radiation therapy, and represents the largest addressable GBM market opportunity for VAL-083 given patients are typically healthier and as such, are able to optimally benefit therapeutically from increased treatment cycles compared to the recurrent treatment setting. Maintenance GBM patients may be able to receive 12+ cycles of VAL-083 versus five or six cycles for recurrent GBM patients.

At the American Association for Cancer Research (AACR) (Free AACR Whitepaper)’s annual meeting in April 2019, we reported that per investigator assessment at the end of cycle two for the MDACC study:

9/35 (25.7%) patients initially receiving 40 mg/m2 exhibited Stable Disease
4/10 (40.0%) patients initially receiving 30 mg/m2 exhibited Stable Disease
Two patients have not yet reached the end of cycle 2

The Company has launched a rights offering made available to stockholders of record as of Tuesday, May 21, 2019. If fully subscribed, this financing initiative will provide DelMar with sufficient cash to fund planned operations into the middle of calendar 2020, and the estimated enrollment completion date for all three of our Phase 2 trials.

For further details on the Company’s operating and financial results, as well as more detail about its updated strategy, refer to DelMar’s Form 10-K filed with the SEC on September 24, 2018, as well as the Company’s Quarterly Report on Form 10-Q for the three and nine months ended March 31, 2019 filed with the SEC on May 14, 2019:

View Source

CONFERENCE CALL DETAILS

DelMar will host a conference call to discuss its financial results for quarter ended March 31, 2019 and provide a corporate update on May 23, 2019, at 4:30 p.m. Eastern Time. For both "listen-only" participants and those who wish to take part in the question and answer portion of the call, the telephone Dial-in Number is 1-877‑876‑9173 (toll free) with Conference ID DELMAR.

A replay of the conference call will be available on the IR Calendar of the Investors section of the Company’s website at www.delmarpharma.com and will be archived for 30 days.

SUMMARY OF FINANCIAL RESULTS FOR PERIODS ENDED MARCH 31, 2019
At March 31, 2019, the Company had cash and cash equivalents on hand of approximately $2.2 million.

For the three months ended March 31, 2019, the Company reported a net loss of $1,663,985, or $0.67 per share, compared to a net loss of $2,933,057, or $1.31 per share, for the three months ended March 31, 2018.

For the nine months ended March 31, 2019, the Company reported a net loss of $5,465,486, or $2.27 per share, compared to a net loss of $8,761,061, or $4.41 per share, for the nine months ended March 31, 2018.

The following represents selected financial information as of March 31, 2019. The Company’s financial information has been prepared in accordance with U.S. GAAP and this selected information should be read in conjunction with DelMar’s consolidated condensed interim financial statements and management’s discussion and analysis, as filed.

DelMar’s financial statements as filed with the U.S. Securities Exchange Commission can be viewed on the company’s website at: View Source

Research and development expenses decreased to $735,844 during the three months ended March 31, 2019 from $1,779,609 for the three months ended March 31, 2018. The decrease was largely attributable to a decrease in clinical development costs, intellectual property, personnel, and preclinical research during the three months ended March 31, 2019 compared to the three months ended March 31, 2018.

General and administrative expenses decreased during the three months ended March 31, 2019 to $935,530 from $1,155,038 for the three months ended March 31, 2018, largely due to a decrease in non-cash, share-based compensation expense, professional fees and travel, partially offset by higher personnel costs in the cResearch and development expenses decreased to $2,702,213 during the nine months ended March 31, 2019 from $5,856,197 for the nine months ended March 31, 2018. The decrease was largely attributable to a decrease in clinical development costs, personnel, preclinical research, intellectual property and travel costs during the nine months ended March 31, 2019 compared to the nine months ended March 31, 2018.

General and administrative expenses were $2,796,884 for the nine months ended March 31, 2019 compared to $2,911,538 for the nine months ended March 31, 2018. The decrease was largely due to lower professional fees and travel, partially offset by higher personnel and non-cash, share-based compensation expense during the nine months ended March 31, 2019 compared to the nine months ended March 31, 2018.urrent quarter compared to the prior quarter.