On May 5, 2020 Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results for the quarter ended March 31, 2020, and provided an update on the Company’s clinical development programs and regulatory and commercial outlook for the rest of the year (Press release, Clovis Oncology, MAY 5, 2020, View Source [SID1234557022]).

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"We are pleased with our sales growth in the first quarter and believe that Rubraca is well-positioned as an oncology treatment option in the COVID-19 era," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "While we may see some impact on near-term revenues as oncology practices and patients adjust to the impact of this virus in the U.S. and Europe, it is obvious that cancer patients will continue to be diagnosed and treated given the evident risks in not actively managing their disease. We believe that Rubraca has significant advantages as a maintenance option in an environment in which physicians are trying to reduce patient visits to their clinics. Rubraca is an oral agent and is both delivered directly to and taken at home. Unlike observation, which on average requires a return to immunosuppressive chemotherapy after approximately five months, Rubraca has proven to extend progression-free survival by independent assessment on average nearly fourteen months. And finally, Rubraca only requires monthly routine monitoring. In addition to seeking to establish Rubraca as the maintenance treatment option of choice in recurrent ovarian cancer, we also look forward to the potential launch in the United States of Rubraca in BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer."

First Quarter 2020 Financial Results

Clovis reported product revenue for Rubraca of $42.6 million for the first quarter of 2020, which included U.S. product revenue of $39.3 million and ex-U.S. product revenue of $3.3 million. This compares to product revenue for Rubraca of $33.1 million for the first quarter of 2019, which included U.S. product revenue of $31.9 million and ex-U.S. product revenue of $1.2 million. This represents a 29 percent increase year over year and 8 percent increase sequentially compared to Q4 2019 product revenue of $39.3 million. U.S. product revenues were up nine percent over the $36.1 million reported in Q4 2019 and ex-U.S. product revenue increased two percent from $3.2 million reported in Q4 2019.

Clovis had $228.4 million in cash, cash equivalents and available-for-sale securities as of March 31, 2020.

In January 2020, the Company repurchased $123.4 million aggregate principal amount of its 4.50% convertible senior notes due 2024 that were initially issued in August 2019. In April 2020, the Company exchanged approximately $36.05 million in aggregate principal amount of its 4.50% convertible senior notes due 2024 for approximately $32.77 million in aggregate principal of 2021 notes. In May 2020, a holder of the 4.50% convertible senior notes due 2024 converted $24.3 million par value of notes into approximately 3.3 million shares of common stock per the standard terms of the indenture. Following these transactions, approximately $64.42 million aggregate principal amount of these 2021 notes remain outstanding and approximately $150.63 million aggregate principal amount of these 2024 notes remain outstanding. Additionally, the Company has $300 million aggregate principal amount outstanding of its 1.25% convertible senior notes due 2025. As a result of the transactions noted above, the Company has reduced its total outstanding convertible debt by $145.1 million in outstanding principal amount from December 31, 2019 through May 5, 2020.

As of March 31, 2020, the Company had drawn approximately $50 million under the TPG ATHENA clinical trial financing and had up to $125 million available to draw under the agreement to fund the expenses of the ATHENA trial through Q3 2022.

Based on the Company’s anticipated revenues, spending, available financing sources and existing cash, cash equivalents and available-for-sale securities, the Company believes it has sufficient cash, cash equivalents and available-for-sale securities to fund its operating plan into the second half of 2021. This does not include any cash repayment that may be required to pay off (unless refinanced earlier) the remaining $64.42 million aggregate principal amount of the 2.50% convertible notes, at their maturity in September 2021. While we have not yet seen a material impact on our revenues, the effects of COVID-19 on future sales are difficult to assess or predict.

Net cash used in operating activities was $82.5 million for the first quarter of 2020, compared with $98.5 million for the first quarter of 2019. Borrowings under the TPG ATHENA financing provided $15.6 million in Q1 2020, reducing net cash utilized in operating activities to $66.9 million in Q1 2020. Net cash used in operating activities for Q1 2020 included product supply costs of $12.4 million. We expect product supply costs will be significantly reduced from this first quarter level for the remainder of 2020 and at least the first half of 2021.

Clovis reported a net loss for the first quarter of 2020 of $99.3 million, or ($1.39) per share, compared to the net loss for the first quarter of 2019 which was $86.4 million, or ($1.63) per share. Net loss for the first quarter of 2020 included share-based compensation expense of $13.0 million, compared to $13.6 million for the first quarter of 2019.

Research and development expenses totaled $68.2 million for the first quarter of 2020, compared to $62.0 million for the first quarter of 2019. Research and development expenses increased during the three months ended March 31, 2020 compared to the same period in the prior year primarily due to higher research and development costs for Rubraca. We expect research and development expenses to be lower in the full year 2021 compared to full year 2020.

Selling, general and administrative expenses totaled $42.6 million for the first quarter of 2020, compared to $47.8 million for the comparable period in 2019. Selling, general and administrative expenses decreased during the three months ended March 31, 2020 compared to the same period in the prior year primarily due to decreased commercialization expenses for Rubraca in the U.S. and Europe. We expect savings in selling, general and administrative expenses as a result of the COVID-19 situation globally.

European Launch of Rubraca in Ovarian Cancer

In January 2019, the European Commission granted a variation to the marketing authorization for Rubraca to include the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Following successful reimbursement negotiations, Clovis has launched Rubraca in each of Germany, United Kingdom, Italy, France and Spain, and over time expects to launch in additional smaller European markets.

U.S. Supplemental New Drug Application for Rubraca in BRCA1/2-mutant Metastatic Castration-resistant Prostate Cancer (mCRPC)

In January 2020, Clovis announced that the FDA accepted the Company’s supplemental New Drug Application (sNDA) for Rubraca as a monotherapy treatment of adult patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer and granted priority review status to the application with a Prescription Drug User Fee Act (PDUFA) date of May 15, 2020. The sNDA filing, submitted in November 2019, was based on data from the TRITON clinical program in advanced prostate cancer. The Company is actively preparing for the launch of Rubraca in prostate cancer in the U.S. to commence upon receipt of FDA approval. Given the ongoing quarantine in the U.S., this product launch will be among the first virtual-only launches in oncology.

Lucitanib Combination Studies Underway

Two Clovis-sponsored early Phase 1b/2 lucitanib combination studies are currently underway: LIO-1, evaluating lucitanib and nivolumab in combination in advanced solid tumors (Phase 1b) and gynecologic cancers (Phase 2); and lucitanib in combination with rucaparib in advanced solid tumors (Phase 1b) and ovarian cancer (Phase 2) as an arm of the SEASTAR study. Clovis anticipates submitting abstracts for presentations at medical meetings in the Fall of 2020.

Conference Call Details

Clovis will hold a conference call to discuss Q1 2020 results this afternoon, May 5, at 4:30pm ET. The conference call will be simultaneously webcast on the Clovis Oncology web site www.clovisoncology.com, and archived for future review. Dial-in numbers for the conference call are as follows: US participants (866) 393-4306, International participants (734) 385-2616, conference ID: 1140127.

About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. Studies open for enrollment or under consideration include ovarian, prostate, breast, gastroesophageal, pancreatic, and lung cancers. Clovis holds worldwide rights for Rubraca.

In the United States, Rubraca is approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Rubraca is also approved in the United States for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca.

In Europe, Rubraca is approved for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. Rubraca is also approved in Europe for the treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

Rubraca is an unlicensed medical product outside of the U.S. and Europe.

About Lucitanib

Lucitanib is an oral, potent inhibitor of the tyrosine kinase activity of vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDGFRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR1-3). Emerging clinical data support the combination of angiogenesis inhibitors and immunotherapy to increase effectiveness in multiple cancer indications. Angiogenic factors, such as vascular endothelial growth factor (VEGF), are frequently up-regulated in tumors and create an immunosuppressive tumor microenvironment. Use of antiangiogenic drugs reverses this immunosuppression and can augment response to immunotherapy.

Lucitanib is an unlicensed medical product.

About FAP-2286

FAP-2286 is a preclinical candidate discovered by 3B Pharmaceuticals under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein alpha (FAP). FAP is highly expressed in many epithelial cancers, including more than 90 percent of breast, lung, colorectal and pancreatic carcinomas. Clovis is planning to submit an investigational new drug application (IND) for FAP-2286 in the second half of 2020. Clovis will conduct the global clinical trials and holds U.S. and global rights, excluding Europe.

FAP-2286 is an unlicensed medical product.

On May 5, 2020 Cerus Corporation (Nasdaq: CERS) reported financial results for the first quarter ended March 31, 2020 (Press release, Cerus, MAY 5, 2020, View Source [SID1234557021]).

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Recent developments and highlights include:

Total first quarter 2020 revenue of $24.6 million
Quarterly product revenue of $18.6 million, a 6% increase compared to the prior year quarter
Global demand for INTERCEPT kits grew during the first quarter with the calculated number of treatable platelet doses up 14% compared to the same period in 2019
Government contract revenue of $6.0 million
Reaffirming 2020 full year product revenue guidance range of $89 million to $93 million representing an approximately 20% to 25% increase over 2019 reported product revenue.
Strengthened balance sheet with a $63.3 million public offering of common stock. At March 31, 2020, the Company had cash, cash equivalents and short-term investments of $133.1 million.
Announced strategic organizational changes to align teams around key commercial growth and product portfolio pipeline development targets.
Formed a collaborative research group with the aim of optimizing the characteristics and dosing of convalescent plasma as a potential therapy for COVID-19 patients.
Further strengthened the Company’s collaboration with the Biomedical Advanced Research and Development Authority (BARDA) with an incremental $14 million available under the contract.
"First quarter product revenue of $18.6 million exceeded our internal expectations despite the tumultuous macro environment created by the global COVID-19 pandemic. The emergence of SARS-CoV-2 has highlighted the need for comprehensive preparedness planning for healthcare systems and the corresponding obligation to safeguard the blood supply chain. The INTERCEPT Blood System has played a critical role for many blood centers by reducing the risk of transfusion transmitted infections," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. "In the face of this crisis, I am proud of the actions taken by the Cerus employees designed to make sure that the blood centers and hospitals have access to INTERCEPT Blood System, even in the regions hardest hit by the pandemic."

"It is unclear as to the extent and duration that the COVID-19 impact will have on the global transfusion medicine industry and on healthcare in general, but given the critical need for blood and blood components, we are cautiously optimistic about the health of our business and our ability to further our mission to make INTERCEPT the standard of care," continued Greenman.

Revenue

Product revenue during the first quarter of 2020 was $18.6 million, compared to $17.5 million during the same period in 2019. Revenue growth during the quarter benefited from increased demand for INTERCEPT platelet kit sales in the U.S., offset partially by the year-over-year product mix shift in France and a decrease in kit sales in the Middle East due to the timing of distributor orders.

Government contract revenue from the Company’s BARDA agreement was $6.0 million during the first quarter of 2020, compared to $4.5 million during the same period in 2019, as a result of increasing INTERCEPT red blood cell development activities. With the recently announced amendment, the total potential value of the current BARDA agreement is now $214 million with $50 million recognized as revenue to date.

BARDA is part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. The development of the INTERCEPT red blood cell program has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600009C.

Gross Margins

Gross margins on product revenue during the first quarter of 2020 were 55%, compared to 52% for the first quarter of 2019. Gross margins during the quarter benefited from continued economies of scale and resulting lower per unit costs, driven by increased manufacturing production to meet existing and expected future growth in demand for INTERCEPT.

Operating Expenses

Total operating expenses for the first quarter 2020 were $31.7 million compared to $29.6 million for the same period the prior year.

Selling, general, and administrative (SG&A) expenses for the first quarter of 2020 totaled $15.9 million, compared to $16.2 million for the first quarter of 2019. The year-over-year decline was primarily due to lower marketing and travel related expenses, both driven in part by the COVID-19 pandemic.

Research and development (R&D) expenses for the first quarter of 2020 were $15.8 million, compared to $13.4 million for the first quarter of 2019. The increase in year-over-year R&D expenses were primarily due to increased costs associated with initiatives for expanded INTERCEPT platelet label claims and costs for our red blood cell program, namely activities under our BARDA agreement.

Net Loss

Net loss for the first quarter of 2020 was $16.5 million, or $0.10 per diluted share, compared to a net loss of $18.8 million, or $0.14 per diluted share, for the first quarter of 2019.

Cash, Cash Equivalents and Investments

At March 31, 2020, the Company had cash, cash equivalents and short-term investments of $133.1 million, compared to $85.7 million at December 31, 2019.

At March 31, 2020, the Company had approximately $39.5 million in outstanding term loan debt compared to $39.4 million at December 31, 2019.

2020 Product Revenue Guidance

The Company expects 2020 product revenue to be in the range of $89 million to $93 million, unchanged from the prior guidance originally provided on January 13, 2020. The guidance range represents approximately 20% to 25% growth compared to 2019 reported product revenue.

QUARTERLY CONFERENCE CALL

The Company will host a conference call and webcast at 4:30 P.M. EDT this afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To access the live webcast, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on the Company’s website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 8484403. The replay will be available approximately three hours after the call through May 19, 2020.

On May 5, 2020 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that it has commenced an underwritten public offering, subject to market and other conditions, to issue and sell shares of its common stock (Press release, Kura Oncology, MAY 5, 2020, View Source [SID1234557020]). In connection with the offering, Kura expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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SVB Leerink, Cowen and Credit Suisse are acting as joint bookrunning managers in the offering.

The securities described above are being offered by Kura pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was previously filed by Kura with the Securities and Exchange Commission (the "SEC") and that was declared effective on August 28, 2019. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available for free on the SEC’s website located at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from: SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6218, or by email at [email protected]; Cowen and Company, LLC c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected], or by phone at (833) 297-2926; or Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, Eleven Madison Avenue, 3rd Floor, New York, NY 10010, or by telephone at (800) 221-1037, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On May 5, 2020 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) reported financial results for the first quarter ended March 31, 2020 and provided an update on clinical and corporate developments (Press release, Deciphera Pharmaceuticals, MAY 5, 2020, View Source [SID1234557019]).

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"Work is underway across the company as we prepare for the potential approval and launch of ripretinib later this year," said Steve Hoerter, President and Chief Executive Officer of Deciphera. "We continue to make progress against our planned 2020 company milestones, including advancing our broad clinical-stage pipeline and completing enrollment in the ongoing, pivotal Phase 3 INTRIGUE study of ripretinib in second-line GIST."

Mr. Hoerter continued, "In these unprecedented times, we remain steadfast in our mission to bring important new medicines to patients for the treatment of cancer. Our employees have done a tremendous job adapting to the COVID-19 related challenges we are facing as a company, and as an industry, to carry out this mission. We are continuing to actively evaluate the potential impact of the pandemic on our business and proactively explore and implement mitigation measures."

COVID-19 Business Update

Deciphera is continuously assessing and adapting its business operations in an effort to mitigate interruption from the COVID-19 pandemic on its clinical programs, research efforts and other business activities and to ensure the well-being of its employees, as well as the physicians and patients participating in its clinical studies. At this stage of the COVID-19 pandemic, the operating environment remains fluid and uncertain. The full impact on the Company and its business is not known at this time, and the Company’s outlook assumes the COVID-19 impact on its business will be shorter-term over the next few months and not prolonged.

Clinical Trials and Research and Development Efforts

The Company is monitoring risks associated with potential interruptions to its clinical studies and is in frequent communication with clinical study sites and contract research organizations to address the individual circumstances at each site. At this stage, Deciphera can confirm previously announced milestone timing guidance:
Deciphera continues to believe that it will be able to achieve full enrollment in its Phase 3 INTRIGUE study in second-line gastrointestinal stromal tumor (GIST) patients in the second half of 2020.
The Company also continues to believe it will be able to present updated clinical data, select a recommended Phase 2 dose and open the expansion cohort for its DCC-3014 program in tenosynovial giant cell tumor patients in the second half of 2020. The Company also continues to expect to present updated clinical data from its rebastinib program in the second half of 2020.
The Company is continuing its discovery research, preclinical efforts and early development activities, and expects to file an IND for DCC-3116, its ULK kinase inhibitor, in the second half of 2020.
Drug Supply

Deciphera has commercial drug supply sufficient to support the potential launch of ripretinib in fourth-line GIST. Based on current inventories and supply plans, the Company does not anticipate any COVID-19-related supply interruptions to its clinical programs at this time.
Commercial Activities

In preparation for a potential launch of ripretinib, the Company has been preparing for the possible need to launch and promote using a virtual interaction model, if necessary.
Recent Program Highlights

Ripretinib
Today announced that two posters containing results from the Company’s pivotal Phase 3 INVICTUS study will be featured at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held May 29-31, 2020 in a virtual format. The posters will be made available on-demand via the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program beginning on Friday, May 29, 2020 at 8:00 AM ET. Titles of the poster presentations can be found below:
"Quality of life (QoL) and self-reported function with ripretinib in ≥4th-line therapy for patients with gastrointestinal stromal tumors (GIST): Analyses from INVICTUS"
"Safety profile of ripretinib, including impact of alopecia and palmar-plantar erythrodysesthesia syndrome (PPES) on patient reported outcomes (PROs), in ≥4th-line advanced gastrointestinal stromal tumors (GIST): Analyses from INVICTUS"
Today announced that a poster containing health economics and outcomes research regarding what constitutes meaningful change for patients in gastrointestinal-related cancer will be featured at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Annual Meeting, being held May 18-20, 2020 in a virtual format in a poster session on Tuesday, May 19, 2020 at 3:30-7:00 PM ET. The title of the poster presentation can be found below and a copy of the abstract can be found online here.
"Thresholds for meaningful change for the EQ-5D VAS and EORTC QLQ-C30 physical and role functioning scale in gastrointestinal-related cancer"
As previously announced, the New Drug Application (NDA) seeking approval for ripretinib for the treatment of patients with advanced GIST who have received prior treatment with imatinib, sunitinib, and regorafenib, is currently under Priority Review by the U.S. Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) target action date of August 13, 2020. The NDA is being reviewed by the FDA under the Oncology Center of Excellence Real-Time Oncology Review pilot program. Commercial preparations are currently underway to support the potential approval and launch of ripretinib.
Rebastinib
Today announced that the endometrial and ovarian cancer cohorts in Part 2 of the Phase 1b/2 study of rebastinib in combination with paclitaxel advanced into the second stage of the Simon two-stage design based on achievement of more than 4 responses in each cohort.
A poster containing data from the endometrial cancer cohort in Part 2 of the Company’s ongoing Phase 1b/2 study of rebastinib in combination with paclitaxel will be presented at the ASCO (Free ASCO Whitepaper) Annual Meeting. The poster will be made available on-demand via the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program beginning on Friday, May 29 at 8:00 AM ET. The title of the poster presentation can be found below:
"An open-label, multicenter, phase 1b/2 study of rebastinib in combination with paclitaxel in a dose expansion cohort to assess safety and preliminary efficacy in patients with advanced or metastatic endometrial cancer"
Additional updates announced today from the Company’s rebastinib program include:
The addition of a carcinosarcoma cohort in Part 2 of the Phase 1b/2 study of rebastinib in combination with paclitaxel based on the clinical activity observed in Part 1 of the study.
In the Phase 1b/2 study of rebastinib in combination with carboplatin, Part 2 of the study is continuing to enroll patients with breast cancer, ovarian cancer, and mesothelioma at the recommended Phase 2 dose of 50 mg twice daily (BID), which was reduced from 100 mg BID based on the observed frequency of muscular weakness in preliminary data from the ongoing Part 2 portion of the study.
First Quarter 2020 Financial Results

Cash Position: As of March 31, 2020, cash, cash equivalents and marketable securities were $691.5 million, compared to $579.6 million as of December 31, 2019. The increase was primarily due to the Company’s follow-on public offering in February 2020 that raised net proceeds of $188.4 million. Deciphera expects its current cash, cash equivalents and marketable securities will enable the Company to fund its operating and capital expenditures into the second half of 2022.
R&D Expenses: Research and development expenses for the first quarter of 2020 were $51.4 million, compared to $35.8 million for the same period in 2019. The increase was primarily due to personnel costs, clinical trial costs related to ripretinib, DCC-3014, and rebastinib, and preclinical costs related to DCC-3116. Non-cash stock-based compensation was $3.3 million and $1.7 million for the first quarters of 2020 and 2019, respectively.
SG&A Expenses: Selling, general and administrative expenses for the first quarter of 2020 were $23.9 million, compared to $13.2 million for the same period in 2019. The increase was primarily a result of personnel costs as well as external spend associated with commercial readiness, increased expenses incurred in connection with our new headquarters that commenced in October 2019, and technology related costs to support the growth of the business. Non-cash stock-based compensation was $3.7 million and $4.5 million for the first quarters of 2020 and 2019, respectively.
Net Loss: For the first quarter of 2020, Deciphera reported a net loss of $72.8 million, or $1.36 per share, compared with a net loss of $47.4 million, or $1.25 per share, for the same period in 2019. The increase in net loss was primarily related to increases in R&D and SG&A expenses, as discussed above.
Conference Call and Webcast

Deciphera will host a conference call and webcast to discuss this announcement today, May 5, 2020 at 4:30 PM ET. To access the live call by phone please dial (866) 930-5479 (domestic) or (409) 216-0603 (international); the conference ID is 5381739. A live audio webcast of the event may also be accessed through the "Investors" section of Deciphera’s website at www.deciphera.com. A replay of the webcast will be available for 30 days following the event.

On May 5, 2020 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported financial results for the quarter ended March 31, 2020 (Press release, MacroGenics, MAY 5, 2020, View Source [SID1234557018]).

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"We are encouraged by the progress and clinical activity that we continue to observe across our broad portfolio of seven antibody-based product candidates, and we anticipate presenting clinical data from all these molecules this year. In the near-term, we look forward to sharing the initial data from our Phase 1 studies of MGD013 and MGC018 at ASCO (Free ASCO Whitepaper) and our plans for further development of these promising candidates," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "While we expect some near-term impact on clinical trial site initiation and patient enrollment due to the unprecedented challenges posed by the COVID-19 pandemic, we have not changed our guidance for the timing of anticipated 2020 clinical data read-outs or regulatory events."

Recent and Anticipated Presentation of Clinical Data

At the recent American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting I held April 27-28, an academic collaborator presented data during a plenary session suggesting that TP53 mutational status in patients with acute myeloid leukemia (AML) correlated with an immune-infiltrated tumor microenvironment that was associated with response to flotetuzumab, an investigational, bispecific CD123 x CD3 DART molecule.

At the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in May, MacroGenics plans to present the following clinical data:

An oral presentation covering dose escalation and select expansion cohorts from the ongoing Phase 1 study of MGD013, an investigational, bispecific PD-1 x LAG-3 DART molecule;

A poster presentation covering initial dose escalation data from the ongoing Phase 1/2 study of MGC018, an investigational antibody-drug conjugate targeting B7-H3; and

A poster presentation covering results stratified by chemotherapy from the Phase 3 SOPHIA study of chemotherapy plus margetuximab, an investigational, Fc-engineered, anti-HER2 monoclonal antibody, compared to chemotherapy plus trastuzumab in patients with HER2-positive metastatic breast cancer.

MacroGenics also anticipates the presentation of the following clinical data in the second half of 2020:

Final overall survival (OS) analysis for the Phase 3 SOPHIA study of margetuximab;

Initial data from the Phase 2/3 MAHOGANY study of margetuximab plus checkpoint blockade in patients with advanced gastric cancer;

Data from the Phase 1 dose escalation study of MGD019, an investigational, bispecific, PD-1 x CTLA-4 DART molecule;

Additional data on flotetuzumab in AML patients who are refractory to induction treatment (primary induction failure); and

Incyte expects to present data from its study of retifanlimab (formerly known as MGA012 or INCMGA0012) in patients with anal cancer, which is now fully enrolled, and is one of three ongoing potentially registration-enabling monotherapy studies. Retifanlimab is an investigational anti-PD-1 monoclonal antibody invented by MacroGenics and licensed to Incyte.
Regulatory Interactions and Events

MacroGenics anticipates a Prescription Drug User Fee Act (PDUFA) target action date in December 2020 for margetuximab in combination with chemotherapy as a treatment for patients with metastatic HER2-positive breast cancer. The Food and Drug Administration (FDA) has indicated its plan to schedule an Oncologic Drugs Advisory Committee (ODAC) meeting in the second half of 2020.

MacroGenics will meet with the FDA this quarter to gain feedback on the planned registration path in the U.S. for flotetuzumab for the treatment of patients with AML who are refractory to induction treatment (primary induction failure).
Clinical Trial Updates and Status

In consideration of current global and domestic COVID-19 pandemic, the planned Phase 2 study initiation of enoblituzumab will be delayed. Enoblituzumab is an investigational, Fc-engineered, anti-B7-H3 monoclonal antibody which is being studied in combination with checkpoint blockade for the treatment of patients with advanced head and neck cancer. The Company expects to provide updates on the timing for initiating the study in the second half of 2020.

MacroGenics has stopped enrollment in an ex-U.S. Phase 1/2 study combining flotetuzumab with retifanlimab in patients with relapsed or refractory AML. The decision was not due to any safety finding or lack of activity, and the Company plans to resume the study in the U.S. in the future.

MacroGenics continues to open clinical sites globally to enroll patients in the Phase 2/3 MAHOGANY study evaluating the combination of margetuximab and retifanlimab as a front-line treatment for advanced gastric and gastroesophageal junction cancer. Zai Lab, MacroGenics’ regional partner in Greater China, has stated that it expects sites in its territory to enroll patients starting in the second half of 2020.

MacroGenics and Zai Lab, its regional partner in Greater China, are continuing to broadly explore the development of MGD013 across multiple indications. MGD013 is being studied both as a monotherapy and in combination with other pipeline assets. Zai Lab has initiated combination studies with niraparib, a PARP inhibitor, and brivanib, a dual target tyrosine kinase inhibitor of the VEGF and FGF receptors, for the study of advanced gastric cancer and hepatocellular carcinoma, respectively.
First Quarter 2020 Financial Results

Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2020, were $170.8 million, compared to $215.8 million as of December 31, 2019.

Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $13.7 million for the quarter ended March 31, 2020, compared to $9.7 million for the quarter ended March 31, 2019. This increase was primarily due to revenue recognized for manufacturing services under the Clinical Supply Agreements with Incyte and Zai Lab, as well as milestone payments under the Zai Lab Agreement for clinical trial initiations in Greater China.

R&D Expenses: Research and development expenses were $48.9 million for the quarter ended March 31, 2020, compared to $47.1 million for the quarter ended March 31, 2019. This increase was primarily due to an increase in development and clinical trial costs for multiple programs.

G&A Expenses: General and administrative expenses were $10.2 million for the quarter ended March 31, 2020, compared to $10.2 million for the quarter ended March 31, 2019.

Net Loss: Net loss was $44.7 million for the quarter ended March 31, 2020, compared to net loss of $45.0 million for the quarter ended March 31, 2019.

Shares Outstanding: Shares outstanding as of March 31, 2020 were 49,131,150.

Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities as of March 31, 2020, combined with anticipated and potential collaboration payments, should enable it to fund its operations into 2022, assuming the Company’s programs and collaborations advance as currently contemplated.
Conference Call Information

MacroGenics will host a conference call today at 4:30 p.m. ET to discuss financial results for the quarter ended March 31, 2020 and provide a corporate update. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) ten minutes prior to the start of the call and provide the Conference ID: 2993147.

The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.