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MacroGenics Provides Update on Corporate Progress and First Quarter 2020 Financial Results

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.

Acorda Reports First Quarter 2020 Financial Results and Provides Business Update

On May 5, 2020 Acorda Therapeutics, Inc. (NASDAQ: ACOR) reported its financial results for the first quarter ended March 31, 2020 (Press release, Acorda Therapeutics, MAY 5, 2020, View Source [SID1234557017]).

"As we continue navigating the unprecedented operating environment created by COVID-19, our entire team remains focused on ensuring that the Parkinson’s disease and multiple sclerosis communities have continued access to Acorda’s critical medications," said Ron Cohen, M.D., Acorda’s President and Chief Executive Officer. "I am proud of how rapidly our team has evolved our business practices and developed new ways of working that enable us to keep our Acorda associates safe, while continuing to manufacture therapies that improve the lives of patients."

Dr. Cohen continued, "Despite significant disruption in the healthcare sector during the first quarter, INBRIJA and AMPYRA sales were consistent with our expectations, which took into account typical seasonal variability. We remain confident in our full-year expectations for AMPYRA, which is an established franchise supported by ongoing prescription renewals. For INBRIJA, which is a newer product driven by growth in new prescriptions, we are withdrawing our 2020 guidance. Due to COVID-19 stay-at-home orders and a widespread decrease in physician office visits, we do not have visibility into how changes in patient behavior may impact new prescription starts over the remainder of the year."

First Quarter 2020 Business Update

In response to the COVID-19 pandemic, Acorda launched a new, remote communications program, enabling it to communicate effectively and safely with healthcare professionals and patients to provide product education, information and support. The Company also launched virtual speaker programs and product webinars with meaningful attendance, including an Inbrija patient program that had over 500 participants. In addition, Acorda launched a new digital marketing program to drive awareness and educate people with Parkinson’s about INBRIJA.

First Quarter 2020 Financial Results

For the quarter ended March 31, 2020, the Company reported INBRIJA net revenue of $4.4 million, compared to $1.3 million for the same quarter in 2019.

For the quarter ended March 31, 2020, the Company reported AMPYRA net revenue of $20.1 million compared to $40.1 million for the same quarter in 2019. In September 2018, AMPYRA lost its exclusivity and generics entered the market. Consequently, the Company expects AMPYRA revenue to continue to decline.

Research and development (R&D) expenses for the quarter ended March 31, 2020 were $7.7 million, including $0.4 million of share-based compensation compared to $16.0 million, including $0.7 million of share-based compensation for the same quarter in 2019.

Sales, general and administrative (SG&A) expenses for the quarter ended March 31, 2020 were $41.1 million, including $1.5 million of share-based compensation compared to $52.7 million, including $2.8 million of share-based compensation for the same quarter in 2019.

Change in fair value of derivative liability for the quarter ended March 31, 2020 was $26.5 million compared to $0 for the same quarter in 2019.

Benefit from income taxes for the quarter ended March 31, 2020 was $7.0 million compared to a benefit from income taxes of $0.7 million for the same quarter in 2019.

The Company reported a GAAP net loss of $6.5 million for the quarter ended March 31, 2020, or $0.14 per diluted share. GAAP net loss in the same quarter of 2019 was $47.6 million, or $1.00 per diluted share.

Non-GAAP net loss for the quarter ended March 31, 2020 was $24.4 million, or $0.51 per diluted share. Non-GAAP net loss in the same quarter of 2019 was $26.5 million, or $0.56 per diluted share. This quarterly non-GAAP net loss measure, more fully described below under "Non-GAAP Financial Measures," excludes share-based compensation charges, non-cash interest charges on our debt, changes in the fair value of acquired contingent consideration, asset impairment charges, changes in the fair value of the derivative liability, and expenses that pertain to a non-routine restructuring event. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

At March 31, 2020, the Company had cash, cash equivalents, short-term investments and restricted cash of $126.3 million compared to $168.9 million at year end 2019. Restricted cash includes $42.7 million in escrow related to the 6% semi-annual interest portion, payable in cash or stock, of the convertible note exchange completed in December 2019. If the Company elects to pay interest due in stock, the restricted cash will be released from escrow.

2020 Financial Guidance

For the full-year 2020, Acorda continues to expect AMPYRA net revenue to be $85 – $110 million, and operating expenses to be $170 – $180 million. The operating expense guidance is a non-GAAP projection that excludes restructuring costs and share-based compensation as more fully described below under "Non-GAAP Financial Measures."

As a result of declines in physician office visits due to COVID-19 stay-at-home orders, the Company is withdrawing its previously announced 2020 INBRIJA net revenue guidance. This also necessitates the withdrawal of 2020 total net product revenue. Acorda continues to expect INBRIJA peak sales to be $300 – $500 million.

Webcast and Conference Call

The Company will host a conference call today at 4:30 p.m. ET. To participate in the conference call, please dial (833) 236-2756 (domestic) or (647) 689-4181 (international) and reference the access code 7999873. The presentation will be available on the Investors section of www.acorda.com.

A replay of the call will be available from 8:30 p.m. ET on May 5, 2020 until 11:59 p.m. ET on June 5, 2020. To access the replay, please dial (800) 585-8367 (domestic) or (416) 621-4642 (international); reference code 7999873. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.

Constellation Pharmaceuticals to Participate in Two Investor Conferences

On May 5, 2020 Constellation Pharmaceuticals, Inc. (Nasdaq: CNST), a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported that the Company will participate in two upcoming virtual investor conferences. Jigar Raythatha, CEO, will present at (Press release, Constellation Pharmaceuticals, MAY 5, 2020, View Source [SID1234557016]):

The Bank of America Merrill Lynch Global Health Care Conference at 9:00 AM EDT on May 12
The RBC Capital Markets Global Healthcare Virtual Conference at 10:55 AM EDT on May 20
Live audio webcasts of Mr. Raythatha’s presentation and archives for replay will be available on the Investor Relations section of Constellation’s website at View Source The audio webcast replay will be available for 90 days following the live presentation.

New Model Shared at Digestive Disease Week (DDW) Demonstrates the Value of Cologuard® When Using Real-World Adherence Rates for Comparing Colorectal Cancer Screening Methods

On May 5, 2020 New research from Exact Sciences Corp. (NASDAQ: EXAS) reported that uses real-world-adjusted adherence rates in a colorectal cancer microsimulation, the Colorectal Cancer and Adenoma Incidence and Mortality model (CRC-AIM), to reinforce the value of Cologuard (mt-sDNA) as an effective colorectal cancer screening test (Press release, Exact Sciences, MAY 5, 2020, View Source [SID1234557015]). Cologuard offers significant advantages over the fecal immunochemical test (FIT) and real-world adherence data further highlights those advantages. Cologuard has higher sensitivity, a longer interval, and higher observed adherence rates in real-world usage. The modeling also highlights the importance of improving access to colonoscopy following a positive Cologuard or FIT test.

These results were accepted for presentation at DDW 2020 in a series of abstracts. They are now available on the DDW website.

Colorectal cancer (CRC) is the second leading cause of cancer death for men and women, in part because many cancers go undetected until later stages when treatment options are limited.1 Colorectal cancer can be prevented or detected early through screening; however, approximately 45 million Americans are not up to date with CRC screening.2

"Policymakers and other leaders often rely on modeling to make decisions about colorectal cancer screening," said Dr. Paul Limburg, Chief Medical Officer of Exact Sciences’ screening business. "Modeling that incorporates real-life patient behaviors, and the impact of those behaviors on health outcomes, is limited. This new suite of abstracts provides insight into the effect that complex and dynamic patient patterns have on colorectal cancer screening outcomes."

Included below are titles, abstract numbers, and a brief summary of each abstract accepted for presentation at DDW.

Estimating the Impact of Imperfect Adherence to Stool-based Colorectal Cancer Screening Strategies on Comparative Effectiveness using the CRC-AIM Microsimulation Model
Abstract Number: Mo1598

Real-life adherence rates for CRC screening are imperfect and can vary widely by modality, health system setting, and use of patient compliance navigation programs. Cologuard (mt-sDNA) was recently shown to have high population-level adherence in a Medicare population, which researchers theorized was attributable to its noninvasive approach, widespread accessibility, and embedded patient navigation system. Using real-world adherence rates of 70% for mt-sDNA3 and 40-50% for FIT,4 the CRC-AIM microsimulation model estimated that the use of mt-sDNA resulted in an 8.4% to 19.1% increase in life-years gained (LYG) compared with FIT for screening ages 50-75 years.

More Fecal Immunochemical Tests are Needed to Match the Clinical Benefit of Equivalent Numbers of Multitarget Stool DNA Tests: CRC-AIM Microsimulation Model Results
Abstract Number: Su1773

Patient adherence to the annual testing regimes of FIT has proven difficult to achieve in real world settings.5 Predicted outcomes of annual FIT and triennial mt-sDNA were simulated for 4 million individuals between 50 and 75. At least twice as many FIT tests are needed to match the same clinical benefit compared with mt-sDNA testing (21 vs. 9) using guideline recommended CRC screening initiation age and test interval.

Microsimulation Study of Life-Years Gained from Screening vs. Follow-up Colonoscopy using the CRC-AIM Model
Abstract Number: Sa1658

Health care providers often face a challenge ensuring patient adherence to follow-up colonoscopy after a positive stool-based test. Current reimbursement and coverage policies can trigger patient cost-sharing when patients seek necessary follow-up colonoscopy or when a screening colonoscopy turns diagnostic, depending upon health insurance benefits. In a third study leveraging the CRC-AIM model, the analysis showed that there are approximately 3-to-5 times more LYG per colonoscopy when the colonoscopy was performed as a diagnostic follow-up to a positive stool-based test rather than as a screening colonoscopy alone.

"All too often, colonoscopies following a positive stool-based test and screening colonoscopies that turn diagnostic do not receive full reimbursement from insurers, which can prevent patients from scheduling them," said Kevin Conroy, chairman and CEO. "These data show the urgent need to remove cost barriers for these colonoscopies as they have a measurable positive impact on patient lives."

Higher Impact on Clinical Outcomes from Delays in Colorectal Cancer Screening with the Fecal Immunochemical Test vs. Multitarget Stool DNA: CRC-AIM Microsimulation Model Results
Abstract Number: Tu1822

One obstacle to CRC screening is a delay in the start of screening or a lack of adherence to repeat testing. For example, screening rates among people 50 to 54 years old are only 50%, according to recent CDC data.6 The assumption in this modeling analysis was that recommended triennial mt-sDNA or annual FIT was delayed by 12, 18, or 24 months every time screening was due. The reduction in CRC-related mortality with a 12, 18, and 24-month delay for patients 50 to 75 was greater with triennial mt-sDNA (67%, 63%, and 59%, respectively) than annual FIT (65%, 59%, and 53%). The relative efficacy of mt-sDNA was better than FIT when considering these clinically realistic delayed screening adherence scenarios.

To promote transparency and the credibility of this new model, Exact Sciences has made available CRC-AIM’s formulas and parameters at View Source so other researchers and members of the modeling community can address outstanding questions related to CRC screening.

Portage makes an additional investment in Saugatuck therapeutics after achieving proof of concept

On May 5, 2020 Portage Biotech Inc. ("Portage" or the "Company") reported an update on a subsidiary company, Saugatuck Therapeutics Ltd. ("Saugatuck") (Press release, Portage Biotech, MAY 5, 2020, View Source [SID1234557014]). Portage Biotech Inc. holds an 70% equity interest in Saugatuck.

Portage is pleased to announce that initial proof of concept of the nanolipogel ("NLG") formulation has been achieved with the initial investment. This has triggered the next tranche of capital infusion of $700,000 USD. Saugatuck has been able to formulate a proprietary PD1 aptamer in the NLG formulation and have shown the formulation properly modulates PD1 signaling. In non clinical in vivo experiments, the NLG-PD1 performed favorably compared to a mouse PD1 antibody. The additional founding will support exploration of multiple PD1 based co-formulations with small molecules and other DNA aptamers.

Separately, this work has triggered a license from D5 pharma to create additional proprietary DNA aptamers for immune-oncology targets. This license sits in another Portage company, Oncomer. Oncomer supplies Saugatuck with aptamers to be formulated in the NLG platform.

Dr. Ian Walters, CEO of Saugatuck and Portage commented" Most cancers are treated with multiple agents. Our co-formulation platform leverages the ability to modulate several pathways in a single product and direct its distribution to tumors. I am excited to begin testing our next wave of combinations in animal models and prioritizing our first clinical candidate."