On May 9, 2019 FibroGen, Inc. (NASDAQ: FGEN) reported financial results for the first quarter of 2019 and provided an update on the company’s recent developments (Press release, FibroGen, MAY 9, 2019, View Source [SID1234536134]).

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"The first quarter of 2019 saw critical execution across multiple programs. With respect to the global roxadustat anemia platform, we received positive topline results from analyses of pooled MACE and MACE+ data from our Phase 3 trials evaluating roxadustat as a treatment for dialysis and non-dialysis CKD patients. We and our partners continue to prepare for NDA submission to the FDA in the third quarter, with the EMA MAA submission to follow," said Thomas B. Neff, Chief Executive Officer. "In our anti-CTGF antibody program, we completed the analysis of the first year of treatment with pamrevlumab, our anti-CTGF antibody, for the 21 non-ambulatory subjects in a Phase 2 trial with favorable results in lung and cardiac functions and muscle strength from our administrative analysis suggesting promise for a new treatment option for DMD patients."

Recent Developments and Highlights

Roxadustat for Anemia in Chronic Kidney Disease (CKD) in the U.S. and EU

In the pooled analyses of around 4,000 dialysis patients, the upper bound of the 95% confidence interval (CI) was below the pre-specified non-inferiority margin for the time to first MACE+ analyses. Based on the MACE safety analyses of this population, we believe there is no clinically meaningful difference in risk of MACE between roxadustat and epoetin alfa.

In the pooled analyses of about 1,500 incident dialysis patients roxadustat demonstrated superiority to epoetin alfa in the time to first MACE+ in this subpopulation. In the MACE analysis, there is a trend toward reduced risk for patients on roxadustat, compared to epoetin alfa.

In the non-dialysis pool of approximately 4,300 patients, non-inferiority was demonstrated for roxadustat compared to placebo in the time to first MACE+, based on the upper bound of the 95% CI being below the pre-specified non-inferiority margin. We believe there is no clinically meaningful difference in risk of MACE between roxadustat and placebo.

•

Multiple MACE and MACE+ analyses in non-dialysis from the roxadustat global Phase 3 program are being performed in intent-to-treat (ITT) analyses that demonstrated comparability of roxadustat to placebo. ITT is among the several statistical methods that we will discuss with the FDA. In these ITT analyses, roxadustat was comparable based on a commonly applied non-inferiority margin of 1.3.

Additional positive efficacy results from pooled analyses were observed in the areas of:

rate of kidney function decline, as measured by eGFR, as compared to placebo

quality of life, as measured by standard endpoints, as compared to placebo

efficacy in the presence of inflammation, as compared to epoetin alfa

FibroGen and AstraZeneca will begin discussions with the U.S. Food and Drug Administration (FDA) to prepare for regulatory submission of our New Drug Application (NDA), which is anticipated in September/October 2019, with the MAA for submission to the European Medicines Agency (EMA) to follow.

Roxadustat for Anemia in CKD in China

Completed clinical site inspections by the China Food and Drug Inspection division of the National Medical Products Administration (NMPA) for Phase 3 study evaluating roxadustat for treatment of anemia in non-dialysis-dependent CKD patients.

Anticipate NMPA approval decision on roxadustat for treatment of anemia in non-dialysis-dependent CKD mid-year 2019.

Roxadustat for Anemia in Myelodysplastic Syndromes (MDS)

Completed enrollment of the open-label portion of our global multi-center Phase 3 study in transfusion-dependent, lower risk MDS patients.

Initiated patient dosing in the double-blind, placebo-controlled portion of this Phase 3 study.

Open-label portion of China Phase 2/3 MDS study is ongoing.

Pamrevlumab for Duchenne Muscular Dystrophy (DMD)

Received Orphan Drug Designation from the FDA for treatment of Duchenne muscular dystrophy.

Administrative analysis of the first year treatment in 21 non-ambulatory DMD patients shows favorable results in lung function, cardiac function, and muscle strength.

Pamrevlumab for Idiopathic Pulmonary Fibrosis (IPF)

On track to initiate a randomized, double-blind, placebo-controlled Phase 3 clinical trial with a primary endpoint of change in forced vital capacity (FVC) from baseline in approximately 500 patients in Q2 2019.

Pamrevlumab for Pancreatic Cancer

On track to initiate a randomized, double-blind, placebo-controlled Phase 3 study evaluating pamrevlumab in combination with gemcitabine and nab-paclitaxel as a neoadjuvant therapy versus placebo in combination with gemcitabine and nab-paclitaxel for unresectable locally advanced pancreatic cancer (LAPC) in approximately 260 patients in Q2 2019.

Corporate and Financial

Net loss for the first quarter of 2019 was $45.4 million, or $0.53 net loss per basic and diluted share, compared to a net loss of $41.4 million, or $0.53 net loss per basic and diluted share one year ago.

At March 31, 2019, FibroGen had $712.7 million in cash, restricted time deposits, cash equivalents, investments, and receivables, compared to $747.2 million at year-end 2018.

Conference Call and Webcast Details

FibroGen will host a conference call and webcast today, Thursday, May 9, 2019, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss financial results and provide a business update. A live audio webcast of the call may be accessed in the investor section of the company’s website, www.fibrogen.com. To participate in the conference call by telephone, please dial 1 (888) 771-4371 (U.S. and Canada) or 1 (847) 585-4405 (international), reference the FibroGen first quarter 2019 financial results conference call, and use passcode 48545313. A replay of the webcast will be available shortly after the call for a period of two weeks. To access the replay, please dial (888) 843-7419 (domestic) or (630) 652-3042 (international), and use passcode 48545313#.

About Roxadustat

Roxadustat (FG-4592), discovered by FibroGen, is a first-in-class, orally administered small molecule currently approved in China for the treatment of anemia in CKD patients on dialysis. Roxadustat is a HIF-PH inhibitor that promotes erythropoiesis through increasing endogenous production of erythropoietin, improving iron regulation, and overcoming the negative impact of inflammation on hemoglobin syntheses and red blood cell production by downregulating hepcidin. Administration of roxadustat has been shown to induce coordinated erythropoiesis, increasing red blood cell count while maintaining plasma erythropoietin levels within or near normal physiologic range in multiple subpopulations of CKD patients, including in the presence of inflammation and without a need for supplemental intravenous iron.

Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, the Commonwealth of Independent States, the Middle East, and South Africa. AstraZeneca and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in the U.S., China, and other markets in the Americas and in Australia/New Zealand as well as Southeast Asia.

About Pamrevlumab

Pamrevlumab is a first-in-class antibody developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. Pamrevlumab is advancing towards Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and pancreatic cancer, has been granted Orphan Drug Designation (ODD) in each of these indications. Pamrevlumab has also received Fast Track designation from the U.S. Food and Drug Administration for the treatment of patients with IPF and for patients with locally advanced unresectable pancreatic cancer, and is currently in a Phase 2 trial for Duchenne muscular dystrophy (DMD). Across all trials, pamrevlumab has consistently demonstrated a good safety and tolerability profile to date. For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.

On May 9, 2019 Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company focused on the development of PEDMARKTM (a unique formulation of sodium thiosulfate (STS)) for the prevention of platinum-induced ototoxicity in pediatric patients, reported its business update and financial results for the first quarter ended March 31, 2019 (Press release, Fennec Pharmaceuticals, MAY 9, 2019, View Source [SID1234536133]).

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"We were very pleased with the production transition of PEDMARKTM API to the new commercial drug substance manufacturing site during the first quarter." said Rosty Raykov, chief executive officer of Fennec. "The strength of our cash balance is of utmost importance to us while we remain on track to complete our submission of the NDA for PEDMARKTM in late 2019 to early 2020. We look forward to providing further updates on our progress."

Financial Results for the First Quarter 2019

·Cash Position – Cash and cash equivalents were $20.2 million as of March 31, 2019. The reduction in cash balance over the quarter ended March 31, 2019, is the result of cash used for operating activities including the manufacturing and regulatory expenses associated with the regulatory submissions of PEDMARKTM.
·R&D Expenses – Research and development (R&D) expenses were $1.7 million for the three months ended March 31, 2019, compared to $0.7 million for the same period in 2018. The increase in R&D expenses for the comparative three months, is primarily due to activities associated with the regulatory approvals of PEDMARKTM.
·G&A Expenses – General and administrative (G&A) expenses were $1.0 million for the three months ended March 31, 2019, compared to $1.1 million same period in 2018.
·Net Loss – Net loss was $2.6 million and $1.6 million for the three months ended March 31, 2019 and 2018, respectively.
·Financial Guidance – The Company believes its cash and cash equivalents on hand as of March 31, 2019 will be sufficient to fund the Company’s planned commercial launch of PEDMARKTM in the second half of 2020.

Financial Update

The selected financial data presented below is derived from our unaudited condensed consolidated financial statements which were prepared in accordance with U.S. generally accepted accounting principles. The complete interim unaudited consolidated financial statements for the period ended March 31, 2019 and management’s discussion and analysis of financial condition and results of operations will be available via www.sec.gov and www.sedar.com. All values are presented in thousands unless otherwise noted.

Forward looking statements

Except for historical information described in this press release, all other statements are forward-looking. Forward-looking statements are subject to certain risks and uncertainties inherent in the Company’s business that could cause actual results to vary, including such risks that regulatory and guideline developments may change, scientific data may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, protection offered by the Company’s patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Company’s products will not be as large as expected, the Company’s products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to fund further development and clinical studies, the Company may not meet its future capital requirements in different countries and municipalities, and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2018. Fennec Pharmaceuticals, Inc. disclaims any obligation to update these forward-looking statements except as required by law.

For a more detailed discussion of related risk factors, please refer to our public filings available at www.sec.gov and www.sedar.com.

About PEDMARK (Sodium Thiosulfate (STS))

Cisplatin and other platinum compounds are essential chemotherapeutic components for many pediatric malignancies. Unfortunately, platinum-based therapies cause ototoxicity in many patients, and are particularly harmful to the survivors of pediatric cancer.

In the U.S. and Europe there is estimated that over 10,000 children may receive platinum-based chemotherapy. The incidence of hearing loss in these children depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids. There is currently no established preventive agent for this hearing loss and only expensive, technically difficult and sub-optimal cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement.

STS has been studied by cooperative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, The Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. Both studies are completed. The COG ACCL0431 protocol enrolled one of five childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.

On May 9, 2019 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported first quarter 2019 financial results (Press release, CytomX Therapeutics, MAY 9, 2019, View Source/news-releases/news-release-details/cytomx-therapeutics-announces-first-quarter-2019-financial" target="_blank" title="View Source/news-releases/news-release-details/cytomx-therapeutics-announces-first-quarter-2019-financial" rel="nofollow">View Source [SID1234536132]).

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As of March 31, 2019, CytomX had cash, cash equivalents and short-term investments of $396.6 million.

"We continued to make excellent progress developing our differentiated technology platform and lead product candidates during the first quarter," said Sean McCarthy, D.Phil., president, chief executive officer and chairman of CytomX Therapeutics. "Early clinical data from our PROCLAIM CX-072 and PROCLAIM-CX-2009 programs continued to emerge, pointing the way to next steps for these unique assets. Taken together, the developing clinical profiles for CX-072 and CX-2009 validate that the Probody platform has potential to give rise to best in class and first-in-class product candidates for the treatment of cancer. We look forward to providing additional details regarding the advancement of our pipeline as we progress through 2019."

Business Highlights and Recent Developments

PROCLAIM-CX-072 (PD-L1 Probody Therapeutic) Clinical Program

CX-072 is a Probody therapeutic targeting PD-L1, a clinically and commercially validated anti-cancer target.
CytomX has previously presented Phase 1 clinical data from PROCLAIM-CX-072 evaluating the safety and activity of CX-072 as monotherapy and in combination with YERVOY (ipilimumab).
• The PROCLAIM-CX-072 Monotherapy dose escalation phase is complete (Parts A and A2). Of 24 efficacy evaluable patients, all with generally weakly immunogenic tumors, and treated with doses greater than or equal to 3 mg/kg of CX-072, 12 (50%) demonstrated tumor shrinkage including four partial responses (one confirmed, 2 unconfirmed, one confirmation pending) as of the February 6, 2019 data cutoff. CX-072 as monotherapy was generally well tolerated. A maximum tolerated dose (MTD) for CX-072 monotherapy was not reached.
• The PROCLAIM-CX-072 combination dose escalation of CX-072 with ipilimumab (Part B1) is complete with the MTD defined as 3 mg/kg of ipilimumab and 10 mg/kg of CX-072. Of 19 patients evaluable for efficacy, four (21%) patients experienced confirmed responses as of the February 6, 2019 data cutoff including one complete response. Among 27 patients treated with CX-072 in combination with ipilimumab at 3 mg/kg or above, the combination was generally well tolerated. Seven (26%) patients reported a Grade 3/4 treatment-related adverse event (TRAE) and 3 (11%) patients reported a Grade 3/4 immune-related adverse event (irAE). These data compare well to historical controls and strongly support the further clinical advancement of this combination.
Updated clinical data from monotherapy expansion cohorts (Part D) of the PROCLAIM-CX-072 program, evaluating the safety and efficacy of CX-072 in multiple tumor types at 10mg/kg, will be presented in a poster and as part of the Poster Discussion Session on Saturday, June 1 at the 2019 Annual Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
• Abstract 2513 – CX-072, a PD-L1 Probody Therapeutic, as Monotherapy in Patients with Advanced Solid Tumors: Preliminary Results of PROCLAIM-CX-072
Next steps in the further advancement of CX-072 are under development.
PROCLAIM-CX-2009 (CD166 Probody Drug Conjugate) Clinical Program

CX-2009 is a first in class Probody drug conjugate (PDC) that targets CD166, a novel antigen that is broadly and highly expressed in many types of cancer.
During the first quarter, CytomX presented preliminary clinical findings from PROCLAIM-CX-2009 studying CX-2009 as monotherapy in a subset of CD166 expressing cancer types, including certain patients selected for high level CD166 expression (Parts A and A2).
• As of a February 26, 2019 data snapshot, 71 patients at all doses tested were evaluable for efficacy. For patients who received ≥4 mg/kg of CX-2009 and had at least one post-baseline, on-study tumor assessment, 15/39 (38%) achieved tumor shrinkage, including seven unconfirmed partial responses observed in breast cancer, ovarian cancer and head and neck cancer. 29/39 patients (74%) achieved stable disease or better at the time of the first on-treatment scan.
• CX-2009 was generally well tolerated. The MTD was not reached at the highest dose level tested of 10 mg/kg. The most common TRAEs were grade 1 and 2 and included nausea (32%), fatigue (24%) and decreased appetite (23%). The most common grade 3/4 TRAE was keratitis (8%).
Next steps in the further advancement of CX-2009 are under development.
CX-2029 (CD71 Probody Drug Conjugate) Clinical Program

CD71, also known as the Transferrin Receptor, is a highly efficient cellular mechanism for the internalization of antibody drug conjugates in preclinical models.
Given the widespread expression of CD71 on normal tissues, however, it is widely considered to be an undruggable target for clinical purposes using conventional antibody drug conjugate technology.
CytomX discovered and is developing, in collaboration with AbbVie, CX-2029, a CD71-directed Probody Drug Conjugate which has the potential to turn CD71 into a druggable target.
CytomX continues to enroll patients in PROCLAIM-CX-2029, a Phase 1/2 clinical trial evaluating CX-2029 as monotherapy in patients with solid tumors or lymphomas.
BMS-986249 (CTLA-4 Probody Therapeutic) Clinical Program

Bristol-Myers Squibb (BMS), continues enrollment in a Phase 1/2 clinical trial evaluating BMS-986249 alone and in combination with OPDIVO (nivolumab) in solid tumors that are advanced and have spread.
Technology Acquisition from Agensys, Inc.

In January, CytomX announced the acquisition of drug conjugate linker-toxin and CD3-based bispecific technologies from Agensys, Inc., an affiliate of Astellas Pharma Inc. CytomX aims to utilize this technology in the ongoing discovery and development of novel Probody therapeutic candidates.
Appointment of New Director

In April, CytomX announced the appointment of Elaine V. Jones, Ph.D. to the Board of Directors, effective May 1, 2019.
First Quarter 2019 Financial Results

Cash, cash equivalents and short-term investments totaled $396.6 million as of March 31, 2019, compared to $436.1 million as of December 31, 2018.

Revenue was $29.5 million for the three months ended March 31, 2019, compared to $14.2 million for the three months ended March 31, 2018. The increase in revenue of $15.3 million for the current period compared to the corresponding period in 2018 was primarily due to the accelerated recognition of revenue of $17.4 million related to the cessation of research on certain targets under the BMS Agreement in 2019.

Research and development expenses increased by $13.9 million during the three months ended March 31, 2019 compared to the corresponding period in 2018. The increase was attributable to a $5.0 million charge for acquired technical know-how related to drug conjugate linker-toxin and CD3-based bispecific technologies during the current period, an increase of $2.5 million expenses related to laboratory contracts and services and laboratory supplies and equipment, an increase of $2.1 million clinical related expenses resulting from increased clinical trial activities and an increase of $3.4 million in personnel-related expenses due to an increase in headcount.

General and administrative expenses increased by $2.3 million during the three months ended March 31, 2019 compared to the corresponding period in 2018. The increase was attributable to increased personnel-related expense due to an increase in headcount, and increased consulting and professional services primarily due to an increase in tax and accounting compliance activities.

Teleconference Scheduled Today at 5:00 p.m. ET
Conference Call/Webcast Information

CytomX management will host a conference call today at 5:00 p.m. ET. Interested parties may access the live audio webcast of the teleconference through the "Investor & News" section of CytomX’s website at View Source or by dialing 1-877-809-6037 (U.S. and Canada) or 1-615-247-0221 (International) and using the passcode 9496795. An archive of the webcast will be available on the CytomX website from May 9, 2019, until May 16, 2019.

On May 9, 2019 Melinta Therapeutics, Inc. (NASDAQ: MLNT), a commercial-stage company, developing and commercializing novel antibiotics to treat serious bacterial infections, reported financial results and provided a business update for the first quarter ended March 31, 2019 (Press release, Cempra, MAY 9, 2019, View Source [SID1234536131]).

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"During the first quarter of 2019, we continued to execute against a number of strategic initiatives to help streamline operations and strengthen Melinta’s balance sheet, while continuing to advance our commercial plans and sales efforts," said John H. Johnson, chief executive officer of Melinta. "We also recently filed a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) for Baxdela (delafloxacin) for the treatment of community-acquired bacterial pneumonia (CABP). We believe that the potential market opportunity for CABP is substantial and that, if approved, Baxdela may play a significant role in the treatment of this life-threatening illness. We remain confident in the strength of our long-term strategy to position Melinta for future success as the largest branded antibiotics-focused company and are committed to meeting the growing global threat of antibiotic resistance."

"We are pleased with our swift execution of cost-cutting initiatives during the first quarter of 2019, which significantly drove down our operating expenses both on a year-over-year and quarter-over-quarter basis," said Peter Milligan, chief financial officer of Melinta. "We believe that we have the ability to sustain this disciplined approach to stewardship of financial resources, which is critical for long-term shareholder value."

First Quarter 2019 Financial Results
Melinta reported revenue of $14.1 million for the first quarter of 2019. Revenue from product sales was $11.8 million, flat with the first quarter of 2018. Strong performance by Vabomere (meropenem and vaborbactam) and Minocin (minocycline) for Injection were offset by softer sales of Baxdela and Orbactiv (oritavancin).

Cost of goods sold ("COGS") was $7.4 million and $7.7 million, respectively, for the first quarter of 2019 and the first quarter of 2018, of which $4.1 million and $4.7 million was comprised of non-cash amortization of intangible assets.
Research and development ("R&D") expenses were $5.4 million for the first quarter of 2019, compared to $16.1 million for the same period in 2018. R&D expenses decreased primarily as a result of the completion of the Company’s Phase III study for Baxdela in CABP as well as winding down its early research and discovery programs, which was completed at the end of March 2019. Selling, general and administrative ("SG&A") expenses were $25.9 million for the first quarter of 2019, compared to $34.6 million for the same period in 2018. SG&A expenses decreased primarily as a result of the cost-cutting measures the Company initiated in the fourth quarter of 2018.
Net loss was $26.5 million, or $2.34 per share, for the first quarter of 2019, compared to a net loss of $29.4 million, or $4.76 per share, for the first quarter of 2018. Net loss per share year-over-year reflects changes in share count as a result of the one-for-five reverse stock split effective on February 22, 2019.

The Company ended the quarter with $116.9 million of cash and cash equivalents, which included the $75 million disbursement under the convertible loan facility with Vatera in February 2019.

2019 Guidance
In light of the first quarter results, and to provide the Company with additional time to evaluate the impact of its new strategic commercial initiatives, the Company will update 2019 financial guidance as part of its second quarter 2019 earnings communications. Previous revenue guidance should no longer be relied upon.

Portfolio Updates

sNDA submission to FDA for Baxdela for treatment of CABP in adult patients in April 2019; awaiting official acceptance and PDUFA date from the FDA

Clinical study for a new formulation of Orbactiv scheduled to commence in the second half of 2019, targeted to reduce infusion time from three hours to one hour

Presentation of portfolio data, including results from real-world registry studies of Vabomere, Orbactiv and Minocin for Injection at the Making a Difference in Infectious Diseases (MAD-ID) 2019 Annual Meeting held from May 8-11, 2019 in Orlando, Florida

Business Highlights

Recent execution of several new strategic commercial initiatives, including the engagement of a contract sales organization to sell Baxdela in the retail setting

Implementation of operating cost-reduction initiatives, delivering significant cost savings in 2019

Upcoming Potential Catalysts

European Commission approval decision for delafloxacin (to be marketed under the brand name Quofenix) for acute bacterial skin and skin structure infections (ABSSSI)

Country approvals for Baxdela in South America and Central America

Latin America commercialization agreement execution for Vabomere, Orbactiv and Minocin for Injection

FDA approval for Baxdela for the treatment of CABP in adults

Conference Call and Webcast
Melinta’s earnings conference call for the first quarter of 2019 will be broadcast at 4:30 p.m. ET on May 9, 2019. Investors wishing to participate in the call should dial: 877-377-7553 and international investors should dial: 253-237-1151, using the conference ID# 5233509. A live webcast of the call will be available online from the Investor Relations section of the company website at www.melinta.com and will be archived there for 30 days. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID# 5233509.

On May 9, 2019 Caladrius Biosciences, Inc. (Nasdaq: CLBS) ("Caladrius" or the "Company"), a late-stage therapeutics development biopharmaceutical company pioneering advancements of cell therapies in select cardiovascular and autoimmune diseases, reported financial results for the three months ended March 31, 2019 and provides highlights of progress within the development pipeline (Press release, Caladrius Biosciences, MAY 9, 2019, View Source [SID1234536130]).

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"I am pleased with the pace of our accomplishments so far in 2019 as we continue to enroll subjects in both our ESCaPE-CMD study in the U.S. for CLBS14-CMD and our CLI study in Japan for CLBS12," stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius. "The preliminary data for both studies are very promising and we expect to report top-line results for ESCaPE-CMD by the end of 2019 and for CLBS12 in the first half of 2020. In addition, we continue to work closely with the U.S Food and Drug Administration on the protocol design for our no-option refractory disabling angina ("NORDA") program and have targeted initiation of that Phase 3 study before the end of 2019."

"We look forward to building on the momentum we have created in advancing our clinical development pipeline and reporting on a number of important, value-creating milestones throughout the balance of this year," concluded Dr. Mazzo.

First Quarter Financial Highlights

Research and development expenses for the first quarter of 2019 were $2.0 million, a 10% decrease compared with $2.3 million for the first quarter of 2018. Research and development in both periods focused on the advancement of our ischemic repair platform and related to (i) expenses associated with our ongoing Phase 2 study of CLBS12 in critical limb ischemia development program in Japan, (ii) expense associated with our ongoing Phase 1b/2a study for CLBS14-CMD in coronary microvascular dysfunction, and (iii) expenses associated with the planning of our CLBS14-NORDA program in refractory angina.

General and administrative expenses, which focus on general corporate related activities, were $2.6 million for the first quarter of 2019, a 12% decrease compared with $2.9 million for the first quarter of 2018.

The net loss for the first quarter of 2019 was $4.4 million, or $0.44 per share, compared with $5.0 million, or $0.52 per share, for the first quarter of 2018.

Balance Sheet Highlights

As of March 31, 2019, Caladrius had cash, cash equivalents and marketable securities of $38.4 million. Based on existing programs and projections, the Company remains confident that its cash balances will allow it to fund its current business plan through the second quarter of 2020.

Conference Call

Caladrius’ management will host a conference call beginning at 4:30 p.m. ET on Thursday, May 9, 2019 to discuss the financial results, provide a company update and answer questions.

Shareholders and other interested parties may participate on the conference call by dialing (866) 595-8403 (domestic) or (706) 758-9979 (international), using the conference ID number: 2576003. The conference call will also be webcast live and can be accessed from the Company’s website at www.caladrius.com/investors/news-events.

For those unable to participate in the live conference call or webcast, an audio recording will be available for replay approximately two hours after the conclusion of the call until 11:59 p.m. ET on May 16, 2019. To access the audio replay, dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and provide conference ID number: 2576003.

A webcast replay of the conference call will remain available on the Company’s website for 90 days.