On August 8, 2019 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported its financial and operational results for the second quarter ended June 30, 2019 (Press release, Autolus, AUG 8, 2019, View Source [SID1234550688]).

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Operational Highlights:

In April, Autolus announced the presentation of initial data from the ongoing Phase 1/2 ALLCAR19 clinical trial of AUTO1 in adult ALL at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 in Atlanta, Georgia. As of the data cutoff date of May 18, 2019, 13 patients were leukapheresed, and products for 12 patients were manufactured, including 7 with Autolus’ semi-automated, fully enclosed manufacturing process. Using the Lee criteria, there were no patients with severe cytokine release syndrome (CRS) (≥ Grade 3), and only 2 of 10 patients (20%) with Grade 2 CRS. Tocilizumab was used in 2 of 10 patients (20%). None of the patients were admitted to intensive care due to CRS. One patient developed delayed Grade 3 neurotoxicity following high levels of CAR T expansion, which resolved promptly following administration of steroids. Four patients died while enrolled in the trial, 2 due to progression of the disease and 2 due to sepsis, a common complication in patients with advanced ALL. Nine patients were evaluable for response at 1 month with 8 (88%) achieving a molecular complete response. One patient died of sepsis before the one-month evaluation point. At a median follow-up of 5 months (range 0.62-10.6 months), 6 of 10 patients were alive and continue to be in molecular remission with continued evidence of ongoing B cell aplasia and CAR T persistence.
In April, Autolus completed an underwritten public offering of 4,830,000 American Depositary Shares ("ADSs") representing 4,830,000 ordinary shares, at a public offering price of $24.00 per ADS, which includes an additional 630,000 ADSs issued upon the exercise in full of the underwriters’ option to purchase additional ADSs. Aggregate net proceeds to Autolus, after underwriting discounts but before estimated offering expenses, were $108.8 million.
Pipeline Updates and Anticipated Milestones:

Initiation of a Phase 2 registration trial of AUTO1 in adult ALL in the fourth quarter of 2019 (pending regulatory feedback). Updated Phase 1 data from the ALLCAR19 clinical trial is expected at ASH (Free ASH Whitepaper) 2019.

Decision on Phase 2 initiation for the Alexander study of AUTO3 in DLBCL is expected for mid-2020. Interim Phase 1 data is expected at ASH (Free ASH Whitepaper) 2019.

Development of AUTO1 in pediatric ALL as part of a pediatric investigational program (PIP). Next data update from CARPALL clinical trial is expected at ASH (Free ASH Whitepaper) 2019. Development program includes a next generation version of AUTO1 (AUTO1NG), which incorporates the CD19 CAR of AUTO1 and a novel CD22 CAR. First preclinical data on CD22 CAR expected to be presented at ASH (Free ASH Whitepaper) 2019.

Additional presentations targeted for ASH (Free ASH Whitepaper) 2019 are: data from AMELIA clinical trial of AUTO3 in pediatric ALL and data from clinical trial of AUTO2 in multiple myeloma.

Next generation (NG) programs for AUTO1, AUTO2, AUTO3 and AUTO6 are expected to enter the clinic in 2020.
"This quarter we have focused on expanding operations at our clinical manufacturing site at the Catapult Cell and Gene facility in Stevenage, UK, enabling us to meet our expected clinical trial demand, including a registration trial with AUTO1. In April, we presented encouraging data on our ALLCAR19 clinical trial of AUTO1 in adult ALL. These data show that AUTO1 is well differentiated from the standard of care in ALL and other CAR T products in development, reaching a high level of clinical activity without inducing severe cytokine release syndrome," stated Dr. Christian Itin, chairman and chief executive officer of Autolus. "For the remainder of 2019, our efforts are focused on moving AUTO1 into a Phase 2 registration trial in adult ALL and advancing AUTO3 in DLBCL toward a Phase 2 decision point in Q2 2020."

Financial results for second quarter 2019:

Cash and equivalents at June 30, 2019 totaled $266.2 million, compared with $217.5 million at December 31, 2018.

Net total operating expenses for the three months ended June 30, 2019 were $37.2 million, net of grant income of $0.3 million, as compared to net operating expenses of $16.5 million, net of grant income of $0.4 million, for the same period in 2018. The increase was due, in general, to the increase in development activity; increased headcount primarily in our development and manufacturing functions; and the cost of being a public company.

Research and development expenses increased to $26.2 million for the three months ended June 30, 2019 from $8.9 million for the three months ended June 30, 2018. Cash costs, which exclude depreciation as well as share-based compensation, increased to $20.2 million from $7.1 million. The increase in research and development cash costs of $13.1 million consisted primarily of an increase of compensation-related costs of $5.6 million primarily due to an increase in headcount to support the advancement of our product candidates in clinical development, an increase of $2.3 million in facilities costs supporting the expansion of our research and translational science capability and investment in manufacturing facilities and equipment, an increase of $3.3 million in research and development program expenses related to the activities necessary to prepare, activate, and monitor clinical trial programs, an increase of $0.8 million in professional fees, an increase of $0.5 million in telecom and software costs, and other additional costs in the amount of $0.4 million.

General and administrative expenses increased to $11.4 million for the three months ended June 30, 2019 from $8.1 million for the three months ended June 30, 2018. Cash costs, which exclude depreciation as well as share-based compensation, increased to $7.3 million from $6.9 million. The increase of $0.4 million consisted primarily of an increase in commercial costs of $1.2 million, compensation-related expense of $0.5 million due to an overall increase in headcount, offset by a decrease in legal and professional fees of $1.3 million related to certain corporate reorganization costs that were incurred in the three months ended June 30, 2018.

Net loss attributable to ordinary shareholders was $28.5 million for the three months ended June 30, 2019, compared to $7.7 million for the same period in 2018.

The basic and diluted net loss per ordinary share for the three months ended June 30, 2019 totaled $(0.65) compared to a basic and diluted net loss per ordinary share of $(0.26) for the three months ended June 30, 2018.

Autolus anticipates that cash on hand provides a runway into the second half of 2021.
Conference Call and Presentation Information

Autolus management will host a conference call today, August 8, at 8:30 a.m. EDT/ 1:30pm BST, to discuss the company’s financial results and operational update.

To listen to the webcast and view the accompanying slide presentation, please go to: View Source

The call may also be accessed by dialing (866) 679-5407 for U.S. and Canada callers or (409) 217-8320 for international callers. Please reference conference ID 2763978. After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for U.S. and Canada callers or (404) 537-3406 for international callers. Please reference conference ID 2763978.

On August 8, 2019 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to developing and commercializing next-generation medicines to improve the lives of patients with immune-mediated diseases, reported quarter ended June 30, 2019 financial results and provided a corporate update (Press release, Aldeyra Therapeutics, AUG 8, 2019, View Source [SID1234539799]).

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"With Part 1 of our first Phase 3 trial in dry eye disease expected to be completed later this year, Aldeyra continues to advance reproxalap, the lead product candidate in our novel RASP inhibitor platform, towards commercialization," commented Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. "In addition, in the fourth quarter of 2019, we expect to confirm the design of our second Phase 3 trial of reproxalap in allergic conjunctivitis and initiate Phase 3 clinical testing of ADX-2191 in our first retinal indication, proliferative vitreoretinopathy, a rare and potentially blinding inflammatory disorder with no approved therapies."

Recent Highlights and Corporate Updates

Dry Eye Disease – Part 1 of the Adaptive Phase 3 RENEW Trial Expected to be Completed in Fourth Quarter of 2019. Aldeyra announced completion of enrollment in Part 1 of the two-part adaptive Phase 3 RENEW Trial of topical ocular reproxalap in dry eye disease. Following completion of Part 1 of RENEW, expected in the fourth quarter of 2019, Aldeyra plans to report the endpoints, dosing regimen, and sample size for Part 2 of the trial. Top-line results of the RENEW Trial are expected to be announced following completion of Part 2.

Allergic Conjunctivitis – FDA Meeting Scheduled for Fourth Quarter to Confirm Design of Second Phase 3 Clinical Trial. In March 2019, Aldeyra reported positive top-line results from the Phase 3 ALLEVIATE Trial of topical ocular reproxalap in allergic conjunctivitis, and plans to present full results of ALLEVIATE at the American Academy of Ophthalmology 2019 Annual Meeting in October 2019. In addition, in June of 2019, Aldeyra announced results of topical ocular reproxalap in an allergen chamber trial, which demonstrated that ocular itching and redness in reproxalap-treated patients were statistically lower than that of vehicle-treated patients. A meeting with the U.S. Food and Drug Administration (FDA) has been scheduled in the fourth quarter of 2019 to confirm the design of a second Phase 3 trial.

Proliferative Vitreoretinopathy – the Adaptive Phase 3 GUARD Clinical Trial of ADX-2191 Expected to Initiate in the Fourth Quarter of 2019. Later this year, Aldeyra expects to initiate the adaptive Phase 3 GUARD Trial of ADX-2191 for the prevention of proliferative vitreoretinopathy (PVR). The trial will compare recurrence rates across patients treated with ADX-2191 or standard of care following surgical repair of retinal detachment due to PVR. PVR is expected to be the first indication in Aldeyra’s retinal disease platform to begin clinical testing.

Sjögren-Larsson Syndrome – Part 1 of the Phase 3 RESET Trial Completed. In Part 1 of the two-part adaptive Phase 3 RESET trial in Sjögren-Larsson Syndrome, investigator-assessed dermal scaling scores in the six patients treated with 1% reproxalap topical dermatologic formulation were statistically lower than pre-treatment values over six months of therapy, an improvement that was numerically greater than that observed in the three patients treated with vehicle, when adjusted for baseline score. Prior to initiating subsequent clinical testing, Aldeyra plans to discuss the RESET Part 1 results with regulatory authorities. The RESET Trial is a randomized, multi-center, double-masked Phase 3 clinical trial of 1% topical dermal reproxalap for the treatment of ichthyosis, a severe skin disease associated with Sjögren-Larsson Syndrome.

Programs in Systemic Immune-Mediated Diseases Expected to Begin Clinical Testing in 2019. As Aldeyra expands to the development of therapies for the treatment of systemic immune-mediated disease, a Phase 2 clinical trial of ADX-1612 in post-transplant lymphoproliferative disorder and a Phase 1 clinical trial of ADX-629 for the treatment of systemic autoimmune and metabolic disease remain on track to be initiated in the second half of 2019.

Quarter Ended June 30, 2019 Financial Review

For the quarter ended June 30, 2019, Aldeyra reported a net loss of approximately $13.3 million, compared to a net loss of approximately $9.1 million for the quarter ended June 30, 2018. Basic and diluted net loss per share was $0.49 for the quarter ended June 30, 2019, compared to $0.46 per share for the same period in 2018. Losses have resulted from the costs of research and development programs, as well as from general and administrative expenses.

Research and development expenses were $10.7 million for the quarter ended June 30, 2019, compared to $6.8 million for the same period in 2018. The increase of $3.9 million is primarily related to an increase in manufacturing, preclinical, and clinical development costs; an increase in personnel costs; and non-cash compensation costs related to a portion of upfront acquisition consideration that is subject to vesting based on continued service.

General and administrative expenses were $3.1 million for the quarter ended June 30, 2019, compared to $2.4 million for the quarter ended June 30, 2018. The increase of $0.7 million is primarily related to an increase in personnel costs.

For the quarter ended June 30, 2019, total operating expenses were approximately $13.7 million, compared to total operating expenses of approximately $9.2 million for the same period in 2018.

Cash, cash equivalents, and marketable securities were $69.5 million as of June 30, 2019.

Conference Call & Webcast Information

Aldeyra will hold a conference call on Thursday, August 8, 2019, at 8:00 a.m. Eastern Time. The dial-in numbers are 1-877-211-4098 for domestic callers and 1-647-689-6613 for international callers. The conference ID number for the live call will be 9329328. A live webcast of the conference call will also be available on the investor relations page of the Aldeyra Therapeutics corporate website at www.aldeyra.com. After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for one year.

On August 8, 2019 LineaRx reported that it has acquired the assets and intellectual property of Vitatex, a developer of invasive circulating tumor cell (iCTC) analysis technologies (Press release, Vitatex, AUG 8, 2019, View Source [SID1234538579]).

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According to LineaRx — an Applied DNA Sciences subsidiary formed around technologies for DNA design, manufacture, and chemical modification by large scale PCR — Vitatex’s technologies allows iCTCs to be isolated from standard blood samples. These cells can then be cultured and challenged against panels of cancer therapies to help personalize treatments, such as CAR T immunotherapies, for specific patients.

Following the acquisition, LineaRx said that it will work with other companies to enhance their cancer assays, generate personalized redirected cell therapies against cancers with high mutation burdens and metastatic potential, out-license Vitatex’s technologies for use in early cancer diagnostics and prognostics, and design synthetic genes to redirect immune cells against antigens that are recognized by leukocytes that comigrate with iCTCs. It also aims to develop therapeutics that use its proprietary DNA manufacturing methods.

On August 8, 2019 Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH, OTC:MCUJF), a pharmaceutical company, reported its results from operations for the quarter ended June 30, 2019 (Press release, Medicure, AUG 8, 2019, View Source [SID1234538566]).

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Quarter Ended June 30, 2019 Highlights:

Recorded net revenue from the sale of AGGRASTAT (tirofiban hydrochloride) of $6.2 million during the quarter ended June 30, 2019 compared to $7.2 million for the quarter ended June 30, 2018 and $4.8 million for the quarter ended March 31, 2019;
$45.7 million in cash as at June 30, 2019;
Adjusted earnings before interest, taxes, depreciation and amortization (EBITDA1) for the quarter ended June 30, 2019 was $103,000 compared to adjusted EBITDA of $882,000 for the quarter ended June 30, 2018; and
Net loss for the quarter ended June 30, 2019 was $957,000 (of which, $813,000 was due to a loss from foreign exchange) compared to net income of $1.6 million for the quarter ended June 30, 2018.
Financial Results

Net revenues for the three months ended June 30, 2019 were $6.3 million compared to $7.8 million for the three months ended June 30, 2018. Net revenues from AGGRASTAT for the three months ended June 30, 2019 were $6.2 million compared to $7.2 million for the three months ended June 30, 2018. Additionally, ReDSTM point of care system ("ReDSTM"), contributed $51,000 of net revenue for the three months ended June 30, 2019 and the three months ended June 30, 2018 contained $606,000 of revenue from ZYPITAMAGTM following the launch of the product in the period.

Net revenues for the six months ended June 30, 2019 were $11.2 million compared to $13.9 million for the six months ended June 30, 2018. Net revenues from AGGRASTAT for the six months ended June 30, 2019 were $11.0 million compared to $13.3 million for the six months ended June 30, 2018. Additionally, ReDSTM, contributed $154,000 of net revenue for the six months ended June 30, 2019 and the six months ended June 30, 2018 contained $606,000 of revenue from ZYPITAMAGTM following the launch of the product in the period.

The Company continued to experience strong patient market share and strong hospital demand for AGGRASTAT during the three and six months ended June 30, 2019, however increases in volume compared to the three and six months ended June 30, 2018 were offset by increased price competition that resulted in lower discounted prices for AGGRASTAT throughout the quarter.

Diversification of revenues remains an important aspect of the Company’s focus with Medicure concentrating on the sales and marketing of AGGRASTAT, growing the sales of ZYPITAMAGTM (pitavastatin) and marketing the ReDSTM system.

Adjusted EBITDA for the three months ended June 30, 2019 was $103,000 compared to $882,000 for the three months ended June 30, 2018. The decrease in adjusted EBITDA for the three months ended June 30, 2019 is the result of the lower revenues experienced during the quarter ended June 30, 2019.

Adjusted EBITDA for the six months ended June 30, 2019 was negative $1.6 million compared to $1.8 million for the six months ended June 30, 2018. The decrease in adjusted EBITDA for the six months ended June 30, 2019 is the result of lower revenues and higher selling costs, as a result of the increase in the Company’s product portfolio, experienced during the quarter ended June 30, 2019.

Net loss for the three months ended June 30, 2019 was $957,000 or $0.06 per share. This compares to net income of $1.6 million or $0.10 per share for the three months ended June 30, 2018. Net loss for the three months ended June 30, 2019 is the result of lower revenues experienced during the quarter and a foreign exchange loss relating to a decrease in the value of the U.S. dollar experienced during the quarter ended June 30, 2019.

Net loss for the six months ended June 30, 2019 was $3.7 million or $0.24 per share. This compares to net income of $3.0 million or $0.19 per share for the six months ended June 30, 2018. Net loss for the six months ended June 30, 2019 is the result of lower revenues, higher selling costs and cost of goods sold experienced during the period and a foreign exchange loss relating to a decrease in the value of the U.S. dollar experienced during the six months ended June 30, 2019.

At June 30, 2019, the Company had unrestricted cash totaling $45.7 million compared to $71.9 million of cash and short-term investments as of December 31, 2018. The decrease in cash is primarily due to the investment of U.S. $10 million made in Sensible Medical Innovations Ltd., the purchase of $3.6 million of the Company’s common shares under its normal course issuer bid, a significant reduction in the Company’s accounts payable and accrued liabilities and a decrease in the value of the U.S. dollar as at June 30, 2019 compared to December 31, 2018. Cash flows used in operating activities for the three months ended June 30, 2019 totaled $7.1 million.

All amounts referenced herein are in Canadian dollars unless otherwise noted.

Notes

(1) The Company defines EBITDA as "earnings before interest, taxes, depreciation, amortization and other income or expense" and Adjusted EBITDA as "EBITDA adjusted for non-cash and non-recurring items". The terms "EBITDA" and "Adjusted EBITDA", as it relates to the three and six months ended June 30, 2019 and 2018 results prepared using International Financial Reporting Standards ("IFRS"), do not have any standardized meaning according to IFRS. It is therefore unlikely to be comparable to similar measures presented by other companies.

Conference Call Info:

Topic: Medicure’s Q2 2019 Results

Call date: Friday, August 9, 2019

Time: 7:30 AM Central Time (8:30 AM Eastern Time)

Canada toll-free: 1 (888) 465-5079 Canada toll: 1 (416) 216-4169

United States toll-free: 1 (888) 545-0687

Passcode: 7554403#

Webcast: This conference call will be webcast live over the internet and can be accessed from the Medicure investor relations page at the following link: View Source

You may request international country-specific access information by e-mailing the Company in advance. Management will accept and answer questions related to the financial results and operations during the question-and-answer period at the end of the conference call. A recording of the call will be available following the event at the Company’s website.

On August 8, 2019 Trovagene, Inc. (Nasdaq: TROV), a clinical-stage Precision Cancer Medicine company, developing drugs that target cell division (mitosis) for the treatment of leukemias, lymphomas and solid tumor cancers, reported company highlights and financial results for the second quarter ended June 30, 2019 (Press release, Trovagene, AUG 8, 2019, View Source [SID1234538549]). The company is issuing this press release in lieu of conducting a conference call.

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"We continue to make great progress with our clinical development of onvansertib with three clinical trials actively enrolling patients and advancing as planned," said Dr. Thomas Adams, Chief Executive Officer and Chairman of Trovagene. "We initiated enrollment in our third study, a Phase 1b/2 clinical trial in metastatic Colorectal Cancer (mCRC) at USC Morris Comprehensive Cancer Center and the Mayo Clinic, and look forward to providing preliminary safety and efficacy readouts later this year. Additionally, we recently announced the acceptance of three abstracts for presentation at ESMO (Free ESMO Whitepaper) in September, including our AML clinical trial for an oral presentation. We believe this is an indication of the level of interest in, and potential value of onvansertib in the evolving cancer treatment landscape across a number of different cancer types."

Dr. Adams added, "We achieved a number of key milestones in the second quarter of 2019, including: preclinical data demonstrating significant synergy of onvansertib in combination with venetoclax (Venclexta – AbbVie), the emerging first-line standard of care in AML; updates to our Phase1b/2 AML trial showing patients achieving a complete response (CR and CRi) to treatment with onvansertib in combination with decitabine; early data from our Phase 2 study of onvansertib in combination with Zytiga in patients with mCRPC demonstrating response to treatment and the first patient to achieve the primary efficacy endpoint of disease stabilization; and our research collaboration with Nektar Therapeutics to evaluate the combination of onvansertib and Nektar’s pegylated irinotecan, Onzeald, in models of CRC."

The Company has advanced its business, with the following recent activities and milestone achievements:

Clinical Development:

Announced ESMO (Free ESMO Whitepaper) Accepts Trovagene AML Clinical Trial Abstract for Oral Presentation
On July 22, 2019, Trovagene announced the acceptance of three abstracts for presentation at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) conference in Barcelona on September 27 to October 1, 2019. The abstract accepted for an oral presentation (Abstract #2411), "Polo-like Kinase Inhibitor, Onvansertib, in Combination with Low-Dose Cytarabine or Decitabine in Patients with Relapsed/Refractory Acute Myeloid Leukemia in Phase 1b," will be presented by Amer Zeidan, MBBS, MHS, Yale University, and will feature safety and preliminary efficacy data, including patients who achieved a complete response, as well as biomarker data and correlation with treatment response.

Announced Initiation of Enrollment for Phase 1b/2 Clinical Trial in KRAS-Mutated Colorectal Cancer at Leading Cancer Centers
On July 9, 2019, Trovagene announced the initiation of patient enrollment of its Phase 1b/2 study of onvansertib in combination with FOLFIRI and Avastin (bevacizumab) for second-line treatment of patients with metastatic colorectal cancer (mCRC) with a KRAS mutation (NCT03829410). The trial is being conducted at USC Norris Comprehensive Cancer Center, Hoag Cancer Center and The Mayo Clinic, under the leadership of recognized colorectal cancer key opinion leaders, Heinz-Josef Lenz, MD, FACP, Section Head of GI Oncology and Co-Director of the Colorectal Center at USC Norris, and Afsaneh Barzi, MD, PhD, oncologist at USC Norris and principal investigator of the trial.

Announced Research Collaboration with Nektar Therapeutics to Evaluate Efficacy of the Combination of Onvansertib and ONZEALD in Models of Colorectal Cancer
On May 23, 2019, Trovagene announced that it had entered into a research collaboration to explore the combination of Trovagene’s PLK1 inhibitor, onvansertib, and Nektar’s topoisomerase I inhibitor, ONZEALD, for the treatment of metastatic colorectal cancer (mCRC). Under the collaboration, the two companies will evaluate the antitumor activity and tolerability of the combination of onvansertib and ONZEALD in two (HT29 – BRAF mutant and HCT-116 – KRAS mutant) preclinical tumor models of colorectal cancer.

Announced Data Demonstrating Significant Synergy of Onvansertib in Combination with Venetoclax in Cell Model of Venetoclax Resistant AML
On April 23, 2019, Trovagene announced preclinical data that provides support for clinical evaluation of onvansertib in combination with venetoclax (Venclexta – AbbVie) in patients with difficult-to-treat relapsed or refractory acute myeloid leukemia (AML). Preclinical data showed that the combination demonstrated synergy (the combined effect of the two drugs is greater than the sum of their individual effects) with a significant decrease in tumor cell viability.

Announced Update to Phase 1b/2 AML Trial Data Presented at AACR (Free AACR Whitepaper) – Additional Patients Achieve Complete Response at Two Highest Dose Levels of Onvansertib
On April 5, 2019, Trovagene announced updates to the Phase1b/2 AML trial data presented at the AACR (Free AACR Whitepaper) conference on April 1, 2019. Complete response (2 CRs and 1 CRi) to treatment with onvansertib in combination with decitabine was achieved in 3 of 6 (50%) evaluable patients at the highest doses (27mg/m2 and 40mg/m2). The first complete response was achieved at the highest dose of onvansertib (40mg/m2) in combination with low-dose cytarabine (LDAC). Overall, approximately a 90% clinical benefit rate has been achieved to-date in the trial and there have been no dose limiting toxicities observed. Dose escalation is continuing with enrollment in the onvansertib 60mg/m2 cohort.

Announced Early Data from Phase 2 Trial Indicates Activity of Onvansertib in Prostate Cancer Patients Showing Initial Resistance to Anti-Androgen Therapy
On April 2, 2019, Trovagene announced early data from its ongoing Phase 2 study evaluating onvansertib in combination with Zytiga in patients with mCRPC. Early prostate specific antigen ("PSA") response was observed when onvansertib is added to abiraterone (Zytiga) in 2 of 6 patients to-date; the first patient achieved the primary efficacy endpoint of disease stabilization. The PSA trajectory in the patient achieving the primary efficacy endpoint indicates alteration of the natural history of early signs of resistance to Zytiga. Patients with observed responses to-date harbor the highly aggressive androgen receptor variant (AR-V7) which is known to be resistant to treatment with Zytiga.

Announced Phase 1b/2 Dose Escalation Trial of Onvansertib in Relapsed/Refractory AML Demonstrates Safety, Tolerability and Relative Durability with Complete Responses at Highest Dose Levels
On April 1, 2019, Trovagene announced the presentation of new data from its ongoing Phase 1b/2 study evaluating onvansertib in combination with standard-of-care chemotherapy in AML. The greatest anti-leukemic activity has been observed in the onvansertib + decitabine arm, with complete response in 2 (1 CR and 1 CRi) of 4 (50%) evaluable patients from the two highest dose levels. There have been no dose-limiting toxicities observed to-date and two-thirds of patients have completed ≥2 cycles of treatment, with 2 patients currently on treatment for more than 11 and 5 months, respectively. There has been a significant association observed between biomarker-positive patients and response to onvansertib treatment.

Financial:

Announced Equity Investments of $3.0 Million at Premium to Market Price from Institutional Investor, Lincoln Park Capital
On April 5 and May 13, 2019, respectively, Trovagene announced that it has entered into definitive purchase agreements with Lincoln Park Capital Fund, LLC ("Lincoln Park") an existing institutional investor, in which Lincoln Park agreed to purchase in a registered direct offering shares of common stock and pre-funded warrants at a premium to the closing sale price on April 5 and May 10, 2019, respectively, on the Nasdaq Capital Market. In a concurrent private placement, Lincoln Park agreed to purchase warrants to purchase shares of common stock.

Second Quarter 2019 Financial Results

Total operating expenses were approximately $4.4 million for the three months ended June 30, 2019, a decrease of $0.2 million from $4.6 million for the same period in 2018. The decrease in operating expenses is attributed to a reduction of $0.6 million in SG&A, $0.2 million for cost of revenues related to the disposition of the CLIA lab and $0.2 million restructuring, and partially offset by an increase of $0.9 million in R&D costs.

Net cash used in operating activities in the second quarter of 2019 was approximately $3.4 million, compared to $3.3 million in the same period in 2018. The year-over-year increase of $0.1 million can be attributed primarily to the development of onvansertib as we advance our clinical trials, and partially offset by lower salaries and staff costs.

Research and development expenses increased by approximately $0.9 million to $2.8 million for the three months ended June 30, 2019 from $1.9 million for the same period in 2018. The overall increase in research and development expenses was primarily due to the increased outside service costs for clinical studies related to the development of our drug candidate, onvansertib. We expect increases in research and development costs as we advance the onvansertib clinical development programs in AML, mCRPC and mCRC.

Selling, general and administrative expenses decreased by approximately $0.6 million to $1.5 million for the three months ended June 30, 2019 from $2.1 million for the same period in 2018. The significant components of the decrease were primarily due to the reduction in salaries and staff costs and stock-based compensation.

The weighted average diluted shares of common stock outstanding used to calculate per share results for the three months ended June 30, 2019 was 5.2 million shares.

As of June 30, 2019, Trovagene had approximately $10.8 million of cash and cash equivalents.