On May 7, 2020 Nektar Therapeutics (Nasdaq: NKTR) reported financial results for the first quarter ended March 31, 2020 (Press release, Nektar Therapeutics, MAY 7, 2020, View Source [SID1234557287]).

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Cash and investments in marketable securities at March 31, 2020 were approximately $1.5 billion as compared to $1.6 billion at December 31, 2019.

"Amid the challenges of the evolving COVID-19 pandemic, our Nektar team made significant progress to advance our various clinical studies for our immuno-oncology pipeline while also prioritizing the safety of the patients we serve, our employees and the physicians and staff in our clinical trial network," said Howard W. Robin, President and CEO of Nektar. "For our ongoing studies in oncology, we are working with our global study sites to ensure that patients continue to receive uninterrupted access to study treatment and that we preserve the integrity and conduct of our trials. Many of our clinical trial timelines remain intact; however, at this time, we currently expect that enrollment and study starts managed by our partners will likely be delayed from three to six months. From an operational perspective, Nektar’s strong financial position coupled with decisive mitigation actions to address the potential impact to our business, provides a solid foundation for Nektar as we navigate this unprecedented time."

Summary of Q1 2020 Financial Results

Revenue in the first quarter of 2020 was $50.6 million as compared to $28.2 million in the first quarter of 2019. The increase was due primarily to the recognition of a $25.0 million milestone payment from Bristol-Myers Squibb related to the initiation of the registrational trial of bempegaldesleukin plus Opdivo in muscle-invasive bladder cancer.

Total operating costs and expenses in the first quarter of 2020 were $184.2 million as compared to $148.9 million in the first quarter of 2019. Total operating costs and expenses increased primarily as a result of impairment of assets and other costs for NKTR-181, partially offset by a decrease in R&D.

During the first quarter of 2020, Nektar reported $45.2 million in impairment charges and additional costs related to the discontinuation of the NKTR-181 program, which was announced in January 2020. This includes $19.7 million for the impairment of advance payments to contract manufacturers for commercial batches of NKTR-181, and $25.5 million of additional costs, primarily for non-cancellable commitments to contract manufacturers and certain severance costs.

R&D expense in the first quarter of 2020 was $109.0 million as compared to $118.5 million for the first quarter of 2019. The decrease was due primarily to pre-commercial manufacturing costs for NKTR-181 incurred during the three months ended March 31, 2019.

G&A expense was $26.2 million in the first quarter of 2020 as compared to $25.0 million in the first quarter of 2019.

Net loss for the first quarter of 2020 was $138.7 million or $0.78 basic and diluted loss per share as compared to a net loss of $119.6 million or $0.69 basic and diluted loss per share in the first quarter of 2019. The loss per share for the first quarter of 2020 includes $0.25 loss per share for the impairment charges and additional costs related to the discontinuation of the NKTR-181 program.

COVID-19 Business Update and Review

Nektar remains committed to advancing its mission of bringing forth novel therapies for the treatment of cancer and autoimmune disorders. The company continues to closely monitor the evolving situation with COVID-19 to prepare for and minimize the potential impact to the business as a result of the COVID-19 pandemic.

Nektar-Sponsored Clinical Trials:

●Nektar has numerous clinical trials underway in cancer treatment facilities across the globe that are continuing to proceed. Over the past several months, Nektar deployed a strategy to allow continued enrollment and new study site initiations at facilities that have demonstrated operational readiness and are equipped to provide superior care and uninterrupted access to study treatment and patient services. For all ongoing clinical trials, Nektar is working closely with clinical trial sites to understand their needs during this time. The company is utilizing remote monitoring when possible to oversee study conduct. Nektar has adopted processes to allow for telemedicine and closer access to patient care where and when appropriate so it can continue all data collection processes and support patient safety. Nektar continues to monitor the evolving situation and the impact of COVID-19 for all of its clinical trials.

●Nektar also continues to monitor and support patients by leveraging alternative methods for maintaining clinical trial integrity, and to properly record patient event data that may be related to the COVID-19 pandemic, incorporating recent direction and flexibility provided by the United States Food and Drug Administration and other regulatory authorities.

●The majority of Nektar-run clinical studies in oncology have not experienced any significant delays. Nektar cautions that the evolving landscape could impact these statements and could still delay late-stage studies or enrollment of new patients into clinical trials in the future. Nektar currently believes that it could experience delays of approximately three months with respect to previously-provided timelines for earlier stage Nektar-run studies, such as the PROPEL study, where the initiation of planned new investigator sites in Europe was delayed due to the COVID-19 pandemic.

Nektar Manufacturing and Supply:

●At this time, Nektar does not anticipate any supply interruptions for manufacturing, including its preparations for scale-up of commercial supply of bempegaldesleukin, which are underway. The company has sufficient clinical trial material on hand to treat all patients in the studies for bempegaldesleukin, NKTR-262, NKTR-255 and NKTR-358, which are either underway or planned to start in 2020. Nektar and its manufacturing partners are continuing to regularly assess the situation.

Partner-Sponsored Clinical Trials:

●For Nektar’s pharmaceutical partners, management practices around ongoing and planned clinical trial activities have varied during the COVID-19 situation. Based upon Nektar’s current assessment of activities of its pharmaceutical partners, at this time, Nektar currently expects adjustments of timelines for projected study endpoints, study enrollment rate and study starts of between three to six months. However, this is subject to change as the situation is evolving and will depend upon how long COVID-19 precautionary measures remain in place.

First Quarter 2020 and Recent Business Highlights:

●In February 2020, Nektar announced the publication of preclinical bempegaldesleukin data in two manuscripts in Nature Communications showing how bempegaldesleukin works synergistically with multiple immune-based therapies to enhance T-cell-mediated tumor control.

●In January 2020, Nektar and Bristol-Myers Squibb announced a new joint development plan that expands the ongoing registrational program for bempegaldesleukin plus Opdivo (nivolumab) from three ongoing registrational trials in first-line metastatic melanoma, first-line cisplatin-ineligible metastatic urothelial cancer and first-line metastatic renal cell carcinoma (RCC) to include two additional registrational trials in adjuvant melanoma and muscle-invasive bladder cancer. In addition, a Phase 1/2 study will be initiated to evaluate bempegaldesleukin plus nivolumab in combination with axitinib in first-line RCC in order to support a future registrational trial. Bristol-Myers Squibb will also independently conduct and fund a Phase 1/2 study in first-line non-small-cell lung cancer with bempegaldesleukin and nivolumab.

Conference Call to Discuss First Quarter 2020 Financial Results

Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time, Thursday, May 7, 2020.

This press release and a live audio-only Webcast of the conference call can be accessed through a link that is posted on the home page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through June 1, 2020.

To access the conference call, follow these instructions:
Dial: (877) 881-2183 (U.S.); (970) 315-0453 (international)
Passcode: 8288857 (Nektar Therapeutics is the host)

In the event that any non-GAAP financial measure is discussed on the conference call that is not described in the press release, or explained on the conference call, related information will be made available on the Investors page at the Nektar website as soon as practical after the conclusion of the conference call.

On May 7, 2020 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported financial results and a corporate update for the first quarter ended March 31, 2020 (Press release, Mirati, MAY 7, 2020, View Source [SID1234557286]).

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"Despite the challenges many are facing related to the COVID-19 pandemic, we have continued to advance all of our clinical and preclinical programs. MRTX849, our selective KRAS G12C inhibitor program, is progressing according to plan including enrollment in the registration-enabling arm of the KRYSTAL Phase 1/2 clinical trial in patients with non-small cell lung cancer (NSCLC) receiving 2nd or 3rd line therapy. We have initiated combination trials of MRTX849 with pembrolizumab, cetuximab and TNO155," said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer at Mirati Therapeutics. "Today, we are also pleased to report updated overall survival (OS) data for our sitravatinib program. Our on-going Phase 2 trial of sitravatinib in combination with nivolumab (MRTX-500), continues to demonstrate durable efficacy. Preliminary median OS of 18.1 months was observed for the subset of patients who received the combination as their 2nd or 3rd line of therapy, which is the same profile of patients currently enrolling in SAPPHIRE, our global, randomized Phase 3 clinical trial. We look forward to presenting additional data from the MRTX-500 trial at a future medical conference."

RECENT CORPORATE UPDATES:

MRTX849 (KRAS G12C Inhibitor)

Enrollment is ongoing in the KRYSTAL clinical trial including the following arms: single-agent MRTX849 Phase 2 registrational arm as 2nd or 3rd line therapy in NSCLC as well as the combinations of MRTX849 with a PD-1 (pembrolizumab) in NSCLC and with an EGFR inhibitor (cetuximab) in colorectal cancer (CRC).

Began enrolling patients in the combination trial of MRTX849 with Novartis’ SHP2 inhibitor, TNO155, in 2nd or 3rd line NSCLC and CRC.

On March 17th, the Journal of Internal Medicine published a paper online "Targeting KRAS G12C mutant cancer with a mutation‐specific inhibitor" lead author on the manuscript was James G. Christensen, Ph.D., Executive Vice President and Chief Scientific Officer at Mirati Therapeutics.

On April 6th, the Journal of Medicinal Chemistry published a paper online, "Identification of the Clinical Development Candidate MRTX849, a Covalent KRAS G12C Inhibitor for the Treatment of Cancer" senior author on the manuscript was Matthew Marx, Ph.D., Vice President of Drug Discovery at Mirati Therapeutics.

Sitravatinib

Announcing updated preliminary data from MRTX-500, the Phase 2 clinical trial evaluating sitravatinib and nivolumab (OPDIVO) in NSCLC patients who have documented disease progression on or after treatment with a checkpoint inhibitor (anti-PD-1/PD-L1 inhibitor). Patients in the prior clinical benefit (PCB) cohort experienced PCB on a checkpoint inhibitor as part of their last treatment regimen prior to enrollment. PCB is defined as either complete response (CR), partial response (PR) or stable disease (SD) for ≥12 weeks. The PCB cohort had been fully enrolled with 87 patients.

As of the data cut-off of January 30, 2020:

Preliminary median OS of 15.6 months for the PCB cohort (n=87).

Preliminary median OS of 18.1 months for the subset of PCB patients who received the combination as either 2nd or 3rd line of therapy after progressing on treatment with a checkpoint inhibitor (n=73), which is a patient cohort consistent with the inclusion criteria for the ongoing SAPPHIRE Phase 3 clinical trial.

The combination has been well-tolerated and most adverse events (AEs) were Grade 1 or 2 and were similar to data presented previously.

Operational Updates
Ended the first quarter 2020 with $695.4 million in cash, cash equivalents, and short-term investments.

Financial Results for the First Quarter 2020

License and collaboration revenues earned for manufacturing and supply services under the Collaboration and License Agreement between the Company and BeiGene, Ltd. ("BeiGene"), dated January 7, 2018, were $0.3 million for the first quarter of 2020 and $1.2 million for the same period in 2019.

Research and development expenses for the first quarter of 2020 were $71.7 million, compared to $34.2 million for the same period in 2019. The increase in research and development expenses is due to an increase in expense associated with the development of MRTX849 and sitravatinib, as well as an increase in salaries and related expense, including an increase in share-based compensation expense. The Company recognized research and development-related share-based compensation expenses of $11.8 million during the first quarter of 2020, compared to $5.2 million for the same period in 2019.

General and administrative expenses for the first quarter of 2020 were $18.0 million, compared to $9.8 million for the same period in 2019. The increase is due primarily to an increase in share-based compensation expense and, to a lesser extent, an increase in employee-related expense, professional services expense and facilities and insurance expense. The Company recognized general and administrative-related share-based compensation expenses of $9.7 million during the first quarter of 2020, compared to $6.0 million for the same period in 2019.

Net loss for the first quarter of 2020 was $86.7 million, or $2.02 per share basic and diluted, compared to net loss of $40.9 million, or $1.17 per share basic and diluted for the same period in 2019.

Cash, cash equivalents, and short-term investments were $695.4 million at March 31, 2020, compared to $415.1 million at December 31, 2019. In January 2020, we completed a public offering of common stock that provided net cash proceeds of $324.0 million.

About MRTX849

MRTX849 is an investigational, orally available small molecule that is designed to potently and selectively inhibit a form of KRAS which harbors a substitution mutation (G12C). KRAS G12C mutations are present in approximately 14% of non-small cell lung cancer (NSCLC) adenocarcinoma patients, 4% of colorectal cancer patients, and subsets of other types of cancer. Tumors characterized by KRAS G12C mutations are commonly associated with poor prognosis and resistance to therapy, and patients with these mutations have few treatment options. MRTX849 is being evaluated in a Phase 1/2 trial treating patients with molecularly identified, KRAS G12C-positive advanced solid tumors and in the first quarter of 2020, enrollment began in the registration enabling cohort in monotherapy NSCLC, colorectal cancer and pancreatic cancer.

About Sitravatinib

Sitravatinib is an investigational spectrum-selective kinase inhibitor that potently inhibits receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, Mer), split family receptors (VEGFR2, KIT) and RET. Sitravatinib is being evaluated in combination with nivolumab (OPDIVO), an anti-PD-1 checkpoint inhibitor, in patients whose cancers have progressed despite treatment with a checkpoint inhibitor. Sitravatinib’s potent inhibition of TAM and split family RTKs may overcome resistance to checkpoint inhibitor therapy through targeted reversal of an immunosuppressive tumor microenvironment, enhancing antigen-specific T cell response and expanding dendritic cell-dependent antigen presentation. Sitravatinib is being evaluated in multiple clinical trials to treat patients who are refractory to prior immune checkpoint inhibitor therapy, including the ongoing potentially registration-enabling Phase 3 trial of sitravatinib in combinations with a checkpoint inhibitor in non-small cell lung cancer (NSCLC). In addition, sitravatinib in combinations with checkpoint inhibitors are being evaluated in selected checkpoint inhibitor naïve patients.

On May 7, 2020 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the first quarter ended March 31, 2020 (Press release, Puma Biotechnology, MAY 7, 2020, View Source [SID1234557285]). Unless otherwise stated, all comparisons are for the first quarter of 2020 compared to the first quarter of 2019.

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Product revenue, net consists entirely of sales revenue from NERLYNX, Puma’s first commercial product. Net product revenue in the first quarter of 2020 was $48.6 million, compared to net product revenue of $45.6 million in the first quarter of 2019.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss of $16.9 million, or $0.43 per share, for the first quarter of 2020, compared to a net loss of $10.1 million, or $0.26 per share, for the first quarter of 2019.

Non-GAAP adjusted net loss was $8.0 million, or $0.20 per share, for the first quarter of 2020, compared to non-GAAP adjusted net income of $8.1 million, or $0.21 per basic share and $0.20 per diluted share, for the first quarter of 2019. Non-GAAP adjusted net income (loss) excludes stock-based compensation expense. For a reconciliation of GAAP net loss to non-GAAP adjusted net income (loss) and GAAP net loss per share to non-GAAP adjusted net income (loss) per share, please see the financial tables at the end of this news release.

Net cash used in operating activities for the first quarter of 2020 was $11.5 million, compared to $16.1 million used in the first quarter of 2019. At March 31, 2020, Puma had cash, cash equivalents and marketable securities of $100.6 million, compared to cash, cash equivalents and marketable securities of $111.6 million at December 31, 2019.

"We remain focused on providing a significant impact to cancer patients in need. The earlier-than-expected approval of the sNDA of NERLYNX in combination with capecitabine to treat adult patients with HER2-positive metastatic breast cancer who have received two or more prior anti HER2-based regimens in the metastatic setting is an important step toward this goal," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "Our global partners also are working hard to bring the drug to market in their respective territories, thereby increasing global access to NERLYNX. Earlier today, we announced that our licensing partner CANbridge Pharmaceuticals received marketing approval of NERLYNX in mainland China. In addition, we are closely monitoring the changing COVID-19 situation. We are pleased to announce that we maintain a significant stock of NERLYNX and do not anticipate any disruption of supply to existing or new patients."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) conducting a pre-NDA meeting with the FDA to discuss accelerated approval of neratinib in HER2 mutated hormone receptor positive breast cancer and HER2 mutated cervical cancer in the first quarter of 2021; (ii) reporting Phase II data from the HER-positive breast and cervical cancer cohort from the SUMMIT trial of neratinib in patients with HER2 mutations in the fourth quarter of 2020; (iii) reporting additional data from the Phase II CONTROL trial in the fourth quarter of 2020; and (iv) receiving regulatory decisions for an extended adjuvant HER2-positive early stage breast cancer indication in additional countries."

Revenue

Total revenue consists of net product revenue from sales of NERLYNX, Puma’s first commercial product, license revenue and royalty revenue. For the first quarter of 2020, total revenue was $51.2 million, of which $48.6 million was net product revenue, $2.0 million was license revenue from a Puma sub-licensee and $0.6 million was royalty revenue. This compares to total revenue of $99.1 million in the first quarter of 2019, of which $45.6 million was net product revenue and $53.5 million was license revenue from Puma’s sub-licensees.

Operating Costs and Expenses

Total operating costs and expenses were $65.5 million for the first quarter of 2020, compared to $89.2 million for the first quarter of 2019.

Cost of Sales

Cost of sales was $9.1 million for the first quarter of 2020, compared to $8.0 million for the first quarter of 2019.

Selling, General and Administrative Expenses

Selling, general and administrative expenses were $30.9 million for the first quarter of 2020, compared to selling, general and administrative expenses of $45.5 million for the first quarter of 2019. The $14.6 million decrease resulted primarily from decreases in professional fees and expenses of approximately $8.7 million, stock-based compensation expense of approximately $5.2 million, payroll and payroll-related expenses of approximately $0.6 million, and travel and meetings of approximately $0.3 million. These decreases were partially offset by an increase in training expenses and compliance fees of approximately $0.2 million.

Research and Development Expenses

Research and development expenses were $25.5 million for the first quarter of 2020, compared to $35.7 million for the first quarter of 2019. The $10.2 million decrease resulted primarily from decreases in clinical trial expense of approximately $4.9 million, stock-based compensation expense of approximately $4.0 million, and consultant and contractors expenses of approximately $1.4 million.

Total Other Income (Expenses)

Total other expenses were $2.6 million for the first quarter of 2020, compared to total other expenses of $20.0 million for the first quarter of 2019. The $17.4 million decrease resulted primarily from decreases in legal verdict expense of approximately $16.3 million and interest expense of approximately $1.5 million. These decreases were partially offset by a decrease in interest income of approximately $0.5 million.

Conference Call

Puma Biotechnology will host a conference call to report its first quarter 2020 financial results and provide an update on the Company’s business and outlook at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, May 7, 2020. The call may be accessed by dialing 1-866-548-4713 (domestic) or 1-323-794-2093 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available shortly after completion of the call and will be archived on Puma’s website for 90 days.

On May 7, 2020 Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on commercializing its novel tetracycline XERAVA to treat serious and life-threatening infections, reported financial results for the first quarter ended March 31, 2020 (Press release, Tetraphase, MAY 7, 2020, View Source [SID1234557284]).

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"In the first quarter, we announced a merger agreement with AcelRx Pharmaceuticals, Inc., an essential step forward for Tetraphase and more importantly, for XERAVA and the patients with serious life threatening infections in need of this treatment," said Larry Edwards, President and Chief Executive Officer of Tetraphase. "In the midst of the ongoing COVID-19 pandemic and the continued rise of antibiotic resistance, our conviction in providing patients with different antibiotic treatment options is stronger than ever, and we believe that together with AcelRx we will be able to more effectively bring XERAVA to patients in healthcare institutions. With an approximate 20% growth in XERAVA net sales in the first quarter compared to the fourth quarter of 2019, we look forward to seeing continued success from the combined Tetraphase and AcelRx teams following the planned close of the acquisition this quarter."

First Quarter and Recent Highlights

Entered into Definitive Merger Agreement with AcelRx Pharmaceuticals, Inc.
In March 2020, the Company announced the execution of a definitive merger agreement pursuant to which AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) would acquire Tetraphase in a stock for stock transaction. Under the terms of the agreement, Tetraphase stockholders will receive, for each share of Tetraphase common stock, 0.6303 of a share of AcelRx common stock, valued at approximately $14.4 million as of the close of trading on March 13, 2020, and one contingent value right (CVR), which would entitle the holders to receive aggregate payments of up to $12.5 million for the achievement of future XERAVA net sales milestones starting in 2021. The transaction was unanimously approved by both the AcelRx and Tetraphase boards of directors and is expected to close in the second quarter of 2020. Concurrently with signing the merger agreement, Tetraphase and AcelRx entered into a co-promotion agreement to market and promote XERAVA for the treatment of complicated intra-abdominal infections (cIAI) and DSUVIA for the treatment of acute pain in medically supervised settings.

Continued to Progress Launch of XERAVA in U.S. Hospitals With High Antibiotic Usage
The Company continues to see increased formulary uptake, with a 99% success rate for all formulary reviews to date and $1.8 million in XERAVA net sales for the first quarter of 2020, an increase of approximately 20% over the fourth quarter of 2019. Tetraphase’s salesforce is focusing on bringing XERAVA to targeted institutions, which are the highest users of antibiotics defined by days of therapy. The reorder rate for XERAVA continues to be strong, with reorder rates as high as 65% for all accounts and approximately 77% within the Tier 1 account segment. XERAVA is on formulary or available at more than 1,239 accounts. XERAVA continues to outperform all recent IV antibiotic launches anywhere from 3 to 10 fold in patient days of therapy (PDOTs).

Completed Equity Financing Totaling Net Proceeds of $15.9 Million
In January 2020, the Company completed a private placement with Armistice Capital, LLC, a healthcare-focused institutional investor, priced at-the-market, that generated gross proceeds of approximately $10 million. In addition, the Company concurrently completed a registered direct offering with certain healthcare-focused institutional investors, priced at-the-market, that generated gross proceeds of approximately $7.5 million. The net proceeds from the concurrent January 2020 private placement and registered direct offering were approximately $15.9 million. The Company issued warrants in connection with each financing.

First Quarter 2020 Financial Results

As of March 31, 2020, Tetraphase had cash and cash equivalents of $26.1 million and 7.3 million shares outstanding.

For the first quarter of 2020, Tetraphase reported a net loss of $12.1 million, or $1.31 per share, compared to a net loss of $19.5 million, or $7.25 per share, for the same period in 2019, driven by increased product revenues, lower operating expenses and an increase in the weighted-average number of shares outstanding.

Total revenues were $1.8 million for the first quarter of 2020, all of which was from sales of XERAVA, compared to $1.3 million for the same period in 2019, of which $0.3 million was from sales of XERAVA and $0.9 million was government contract revenue.

Research and development (R&D) expenses for the first quarter of 2020 were $1.9 million, compared to $6.7 million for the same period in 2019. The decrease in R&D expenses was driven by the completion of XERAVA development and our corporate reorganization in June 2019, which included the cessation of development of our pipeline candidates.

Selling, general and administrative (SG&A) expenses for the first quarter of 2020 were $10.7 million, compared to $13.3 million for the same period in 2019. The decrease was driven by our 2019 corporate reorganization as well as tight expense control during Q1 2020, offset by increased expenses related to the AcelRX merger transaction announced in March 2020.

About XERAVATM

XERAVA (eravacycline for injection) is a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections (cIAI) in patients 18 years of age and older. XERAVA was investigated for the treatment of cIAI as part of the Company’s IGNITE (Investigating Gram-Negative Infections Treated with Eravacycline) Phase 3 program. In the first pivotal Phase 3 trial in patients with cIAI, twice-daily intravenous (IV) XERAVA met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to ertapenem and was well-tolerated. In the second Phase 3 clinical trial in patients with cIAI, twice-daily IV XERAVA met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to meropenem and was well-tolerated. In both trials, XERAVA achieved high cure rates in patients with Gram-negative pathogens, including resistant isolates.

XERAVATM Important Safety Information

XERAVA is a tetracycline class antibacterial indicated for the treatment of complicated intra‑abdominal infections in patients 18 years of age and older.

XERAVA is not indicated for the treatment of complicated urinary tract infections.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial drugs, XERAVA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

XERAVA is contraindicated for use in patients with known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs or to any of the excipients. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with XERAVA.

The use of XERAVA during tooth development (last half of pregnancy, infancy and childhood to the age of eight years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.

The use of XERAVA during the second and third trimester of pregnancy, infancy and childhood up to the age of eight years may cause reversible inhibition of bone growth.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis.

The most common adverse reactions observed in clinical trials (incidence ≥ 3%) were infusion site reactions, nausea, and vomiting.

XERAVA is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti‑anabolic action which has led to increased blood urea nitrogen, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with XERAVA. Discontinue XERAVA if any of these adverse reactions are suspected.

On May 7, 2020 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported financial results for the first quarter 2020 (Press release, Y-mAbs Therapeutics, MAY 7, 2020, View Source [SID1234557283]).

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"We are very pleased with our first quarter 2020 financial results, especially seen in conjunction with the completion of our naxitamab BLA submission to the FDA and the notable progress we’ve made on our rolling BLA submission for omburtamab, as well as the continued commercial ramp-up for the potential launch of both compounds. After the balance sheet date, we entered into an exclusive licensing agreement with MSK and MIT for the SADA technology, which we believe may be a potential game changer in therapeutic and diagnostic use of Liquid RadiationTM," stated Thomas Gad, Founder, Chairman, President and Head of Business Development and Strategy.

Dr. Claus Moller, Chief Executive Officer, continued, "We have worked hard to complete the submission of the naxitamab BLA in March, and were excited to see the application go in. The omburtamab BLA application process is well underway, and after our recent pre-BLA meeting with the FDA, we have made good progress on that submission. We expect to start submitting a rolling BLA in May, with anticipated completion in June."

First Quarter 2020 and Recent Corporate Developments

·Subsequent to the end of the first quarter, on April 24, 2020, Y-mAbs announced the appointment of Laura J. Hamill to its Board of Directors.

·Also, subsequent to the end of the first quarter, on April 15, 2020, Y-mAbs announced that it has entered into an agreement with Memorial Sloan Kettering Cancer Center and the Massachusetts Institute of Technology for a worldwide exclusive license and research collaboration for the SADA technology, a concept we refer to as Liquid RadiationTM.

·After the close of the first quarter, on April 1, 2020, Y-mAbs announced that the Company completed the submission of its rolling BLA submission to the FDA for naxitamab on March 31, 2020.

·On February 26, 2020, Y-mAbs announced a Pre-BLA meeting with the FDA for omburtamab.

Financial Results

Y-mAbs reported a net loss for the first quarter of 2020 of $26.2 million, or $0.66 per basic and diluted share, compared to a net loss of $15.9 million, or $0.47 per basic and diluted share, reported for the first quarter of 2019.

Operating Expenses

Research and Development

Research and development expenses were $18.6 million for the quarter ended March 31, 2020, compared to $12.5 million for the quarter ended March 31, 2019, an increase of $6.1 million. The increase in research and development expenses primarily reflects the following:

·$2.8 million increase in outsourced research and supplies to support the expansion of our product development activities;
·$2.1 million increase in personnel costs; and
·$0.9 million increase in outsourced manufacturing for our two lead product candidates, naxitamab and omburtamab.

General and Administration

General and administrative expenses were $8.1 million for the quarter ended March 31, 2020, compared to $3.7 million for the quarter ended March 31, 2019, an increase of $4.4 million. Such increase in general and administrative expenses primarily reflects the following:

·$1.6 million increase in personnel costs; and
·$1.6 million increase in commercial infrastructure costs.

Cash and Cash Equivalents

The Company had approximately $185.8 million in cash and cash equivalents as of March 31, 2020, compared to $207.1 million as of December 31, 2019. The decrease of $21.4 million was primarily attributable to the increased costs of operation as the Company completed its BLA submission for naxitamab and prepared the upcoming submission of the rolling BLA for omburtamab, as wells as build-up of the Company’s commercial infrastructure, and increased personnel costs related to thesse activities.

Webcast and Conference Call

The Company will host a conference call on Friday, May 8, 2020 at 9 am eastern time. To participate in the call, please dial 855-327-6838 (domestic) or 604-235-2082 (international) and reference the access code 10009507. A webcast will be available at: View Source