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.

On August 8, 2019 Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, reported financial results for the second quarter ending June 30, 2019 and provided a business update (Press release, Savara, AUG 8, 2019, View Source [SID1234538548]).

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"Our highest corporate priority continues to be the Molgradex aPAP program," said Rob Neville, Chief Executive Officer, Savara. "While the IMPALA study did not achieve statistical significance on its pre-specified primary endpoint, the totality of the efficacy data are encouraging and reinforce the important role of Molgradex to improve oxygenation and reduce surfactant burden in these patients. Additionally, with adverse event frequencies similar to placebo, we believe this drug has a compelling risk-benefit profile. We are proceeding with regulatory interactions to determine the best path forward, while simultaneously preparing for an additional Phase 3 study should that be required."

Recent Developments and Upcoming Highlights

Molgradex for autoimmune pulmonary alveolar proteinosis (aPAP)

Reported top line results from IMPALA, a pivotal Phase 3 clinical study.
Granted a Type C meeting with the FDA, expect written responses from the agency in October 2019.
Anticipate filing for Breakthrough Designation in the U.S.
Continued strong enrollment in IMPALA-X, an open-label, multicenter extension study to determine the long-term safety and utilization of Molgradex in patients with aPAP. 32 out of 35 eligible patients have enrolled in the extension study, with no whole lung lavages reported and no drop-outs to-date.
Molgradex for nontuberculous mycobacterial (NTM) lung infection

Expect top line results from OPTIMA, a Phase 2a clinical study evaluating Molgradex for the treatment of NTM in non-cystic fibrosis (CF) patients, in Q1 2020.
AeroVanc

Revised enrollment completion guidance for AVAIL, a pivotal Phase 3 clinical study of AeroVanc for the treatment of persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection in CF.
― As of August 1, 2019, the study has enrolled 168 patients out of a target of 200. The approximate 50% screen failure rate with younger subjects has slowed enrollment. The screen failures are largely due to exacerbations between time of screening and randomization.
― Expect to complete patient enrollment in the first half of 2020 with top line results now expected in late 2020 or early 2021.
Exploratory Pipeline

Deprioritized the amikacin/fosfomycin program in order to focus resources on the Company’s later stage programs. Future development will be considered at a later time.
Second Quarter Financial Results (Unaudited)

Savara’s net loss attributable to common stockholders for the three months ended June 30, 2019 was $21.9 million, or $(0.57) per share, compared with a net loss attributable to common stockholders of $11.6 million, or $(0.37) per share, for the three months ended June 30, 2018.

Research and development expenses were $10.5 million for the three months ended June 30, 2019, compared with $9.3 million for the three months ended June 30, 2018. The increase was primarily due to $2.2 million in increased development costs associated with the development of Molgradex and AeroVanc, which was partially offset by $1.0 million in expense in the form of common stock issued in connection with an asset purchase in the second quarter of 2018.

General and administrative expenses for the three months ended June 30, 2019 were $4.2 million, compared with $2.5 million for the three months ended June 30, 2018. The increase was primarily due to increased personnel costs and other legal, accounting, insurance, commercial strategy, business development, and operating activities.

During the three months ended June 30, 2019, we recognized a $7.4 million non-cash impairment charge to the carrying value of our goodwill following the results of our IMPALA study.

As of June 30, 2019, Savara had a carrying value of its debt of approximately $24.8 million and had cash, cash equivalents, and short-term investments of approximately $111.7 million. Under the current operating plan, the Company believes this is sufficient capital to fund planned operations into 2021.

Conference Call and Webcast

Savara will host a conference call today at 4:30 p.m. Eastern Time (ET)/1:30 p.m. Pacific Time (PT). Shareholders and other interested parties may access the conference call by dialing (855) 239-3120 from the U.S., (855) 669-9657 from Canada, and (412) 542-4127 from elsewhere outside the U.S. and request the "Savara Inc." call. A live webcast of the conference call will be available online in the Investors section of Savara’s website at View Source

Approximately one hour after the call, a replay of the webcast will be available on Savara’s website for 30 days, and a telephone replay will be available through August 15, 2019 by dialing (877) 344-7529 from the U.S., (855) 669-9658 from Canada and (412) 317-0088 from elsewhere outside the U.S. and entering the replay access code 10133438.

On August 8, 2019 Diffusion Pharmaceuticals Inc. (Nasdaq: DFFN), a cutting-edge biotechnology company developing new treatments for life-threatening medical conditions by improving the body’s ability to bring oxygen to the areas where it is needed most, reported financial results for the three and six months ended June 30, 2019 and provided a business update (Press release, Diffusion Pharmaceuticals, AUG 8, 2019, View Source [SID1234538539]).

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During the second quarter of 2019, the Company completed a public offering of 1,317,060 shares of its common stock, par value $0.001 per share (the "Common Stock") and a private placement of warrants to purchase 1,317,060 shares of Common Stock. The shares of Common Stock and warrants were sold for a combined purchase price of $4.895 per unit for total net proceeds of $5.6 million. The warrants are exercisable beginning on the date of their issuance until November 29, 2024 at an initial exercise price equal to $5.00.

Also during the second quarter, Diffusion announced that based on favorable safety data in a 19-patient dose-escalation run-in study, the Data Safety Monitoring Board (DSMB) has recommended the continuation of the Company’s Phase 3 clinical trial with trans sodium crocetinate (TSC) in inoperable glioblastoma multiforme (GBM) patients. The DSMB has recommended that the highest dose administered, 1.5 mg/kg of TSC, be used during the adjuvant treatment period of the Phase 3 INTACT trial. The INTACT (INvestigating Tsc Against Cancerous Tumors) trial is comparing standard of care (SOC) radiation therapy and chemotherapy plus TSC against SOC alone. In Phase 2 testing, TSC demonstrated a nearly four-fold improvement in overall survival at two years for the subset of inoperable GBM patients compared with the control group of GBM patients. Diffusion is seeking a partner to continue development of TSC in GBM.

The Company completed preparations to commence enrollment in its on-ambulance Phase 2 clinical trial testing TSC for the treatment of acute stroke. Enrollment is expected to begin in the third quarter of 2019. With close cooperation of researchers at the University of California Los Angeles (UCLA) and the University of Virginia (UVA), the 160-patient trial, named PHAST-TSC (Pre-Hospital Administration of Stroke Therapy-TSC), will involve 23 hospitals across urban, suburban and rural areas in Los Angeles County and Central Virginia. Results from the trial may be available in just under two years.

The Company continued to enhance its intellectual property position during the quarter, with receipt from the European Patent Office of a Notice of Intention to Grant a patent related to the use of TSC in combination with the leading thrombolytic, tissue plasminogen activator (tPA), in the treatment of ischemic stroke. The patent claim covers administration of TSC within three or four hours of the onset of stroke symptoms in combination with tPA administered within nine to 12 hours of the onset of stroke symptoms. The European Patent Office has also granted two additional patents to Diffusion related to the uses of TSC and methods of synthesizing the compound.

"The imminent commencement of enrollment in our PHAST-TSC Phase 2 study comes after extensive preparation," said David Kalergis, chairman and chief executive officer of Diffusion. "It represents an exciting possibility to safely mitigate some of the devastating effects of a stroke through immediate, in-ambulance treatment. The Notice of Intention to Grant a patent from the European Patent Office for the use of TSC in combination with tPA – the only currently available drug for the treatment of ischemic stroke – further supports the commercial prospects of TSC.

"We were also pleased to complete a registered direct equity financing in May, at the market price, raising net proceeds of $5.6 million. These funds will largely be used to advance our clinical programs," Mr. Kalergis added.

Second Quarter Financial Results

Research and development expenses were $1.5 million for the second quarter of 2019, compared with $1.4 million for the second quarter of 2018. The increase was mainly attributable to a $0.6 million increase related to the commencement of the Phase 2 stroke trial and a $0.1 million increase in salary and manufacturing, offset by a $0.6 million decrease in expenses related to the Company’s Phase 3 GBM trial.

General and administrative expenses were $1.1 million for the second quarter of 2019, compared with $1.7 million for the second quarter of 2018. The decline was due to lower salary and wages and stock-compensation expense.

Net cash used in operating activities during the first half of 2019 was $5.3 million, compared with $5.8 million used during the prior-year period.

Diffusion had cash and cash equivalents of $8.4 million as of June 30, 2019, compared with $8.0 million at December 31, 2018. During the quarter, the Company raised $5.6 million net proceeds from an offering of 1,317,060 shares of common stock and warrants to purchase up to 1,317,060 shares of common stocks.

On August 8, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing innovative oncology therapeutics, reported the pricing of an underwritten public offering of 5,000,000 shares of its common stock at a price of $15.25 per share, with expected gross proceeds to Stemline of $76,250,000 (Press release, Stemline Therapeutics, AUG 8, 2019, View Source [SID1234538521]). Stemline has also granted the underwriters a 30-day option to purchase up to 750,000 additional shares of its common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about August 13, 2019, subject to customary closing conditions.

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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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J.P. Morgan Securities LLC and Cowen and Company, LLC are acting as joint book-running managers for the offering. Cantor Fitzgerald & Co., Ladenburg Thalmann & Co. Inc. and H.C. Wainwright & Co., LLC are acting as co-lead managers for the offering and ThinkEquity, a division of Fordham Financial Management, Inc., A.G.P./Alliance Global Partners, and Aegis Capital Corp. are acting as co-managers for the offering.

Stemline intends to use the net proceeds from this offering for (i) commercial activities of ELZONRIS (tagraxofusp; SL-401), (ii) clinical trials for additional indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), acute myeloid leukemia (AML), and potentially other diseases such as certain lymphomas; (iii) clinical development of additional pipeline candidates (felezonexor (SL-801), SL-1001, SL-901 and SL-701); (iv) research and development and regulatory activities; (v) potential acquisitions and in-licensing; and (vi) other general corporate purposes.

Stemline has filed a preliminary prospectus supplement to its shelf registration statement on Form S-3 (File No. 333-230341) with the U.S. Securities and Exchange Commission ("SEC") for the public offering of its common stock. The preliminary prospectus supplement is available on the SEC’s web site at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to these securities may also be obtained, when available, by contacting J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Telephone: (866) 803-9204, or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attn: Prospectus Department, or by email at [email protected].

The offering of these securities is being made under an effective shelf registration statement on file with the SEC. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About ELZONRIS
ELZONRIS (tagraxofusp-erzs), a CD123-directed cytotoxin, is approved by the U.S. Food and Drug Administration (FDA) and commercially available in the U.S. for the treatment of adult and pediatric patients, two years or older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). For full prescribing information in the U.S., visit www.ELZONRIS.com. In Europe, a marketing authorization application (MAA) is under review by the European Medicines Agency (EMA). ELZONRIS is also being evaluated in additional clinical trials in other indications including CMML, MF, and AML.

About BPDCN
BPDCN is an aggressive hematologic malignancy with historically poor outcomes and an area of unmet medical need. BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56, as well as other markers. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.

About CD123
CD123 is a cell surface target expressed on a wide range of myeloid tumors including BPDCN, certain myeloproliferative neoplasms (MPNs) including CMML and MF, AML (and potentially enriched in certain AML subsets), myelodysplastic syndrome (MDS), and chronic myeloid leukemia (CML). CD123 has also been reported on certain lymphoid malignancies including multiple myeloma (MM), acute lymphoid leukemia (ALL), hairy cell leukemia (HCL), Hodgkin’s lymphoma (HL), and certain Non-Hodgkin’s lymphomas (NHL). In addition, CD123 has been detected on some solid tumors as well as autoimmune disorders including cutaneous lupus and scleroderma.