On May 6, 2020 Constellation Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported its first-quarter 2020 financial results (Press release, Constellation Pharmaceuticals, MAY 6, 2020, View Source [SID1234557083]).

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"In the face of the serious public health and economic impacts of the COVID-19 pandemic, we at Constellation remain focused on our mission of addressing unmet medical needs in cancer and hematological diseases," said Jigar Raythatha, president and chief executive officer of Constellation Pharmaceuticals. "We are continuing to make progress on each of our development programs and are steadily advancing toward our goal of becoming a fully integrated hematology / oncology company with a sustainable product pipeline.

"Our vision is to transform the standard of care in myelofibrosis with CPI-0610. Encouraging preliminary data on CPI-0610 suggest possible disease-modifying effects, including improvement in bone marrow fibrosis, hemoglobin increases, and conversion of transfusion dependence to transfusion independence, as well as spleen volume reductions and symptom improvement – both in combination with ruxolitinib and as a monotherapy.

"We are also working to create novel treatments for patients in other therapeutic areas," Mr. Raythatha concluded. "We believe that our EZH2-inhibitor franchise of CPI-1205 and CPI-0209 provides potential opportunities to treat a wide range of oncology patients, and we aim to achieve important milestones with each of these molecules this year."

Program Updates

CPI-0610

On May 14, we expect three abstracts to publish in association with the European Hematology Association (EHA) (Free EHA Whitepaper). We will provide an update with 12-week data from 29 JAK-inhibitor-naïve (first-line) patients, 24-week data from 15 JAK-inhibitor-naïve patients, and 24-week data from 48 JAK-inhibitor-experienced (second-line) patients.

Data will include preliminary evidence of disease modification, including bone marrow fibrosis, hemoglobin changes, and conversion from transfusion dependence to transfusion independence, in addition to spleen and symptom improvement.

In mid-June, we expect to present a further update in conjunction with the EHA (Free EHA Whitepaper) meeting, including 12-week data from approximately 50 first-line patients, and 24-week data from 25-30 first-line patients and 70-80 second-line patients.

We aim to start a global clinical trial for CPI-0610 in the first-line setting during the second half of 2020.

We continue to plan to meet with the FDA in mid-2020 to discuss the future development of CPI-0610.
EZH2

The ProSTAR trial is fully enrolled and we plan to determine next steps for CPI-1205 after taking a mid-year data cut. As we previously discussed, our plans for any potential Phase 3 program for CPI-1205 will depend on our assessment of these data on duration of effect, as well as other considerations.

The Phase 1 clinical trial for CPI-0209 is proceeding as planned, and we expect to determine a recommended Phase 2 dose in the second half of 2020. Once we have established the Phase 2 dose we plan to start a broad-based expansion study in solid tumors.
Impact of COVID-19

Execution of ongoing clinical trials. Patient safety remains paramount in the execution of our clinical trials. In the face of the COVID-19 pandemic, we continue to treat patients in our MANIFEST, ProSTAR, and CPI-0209 clinical trials.

Patient enrollment in MANIFEST began to slow toward the end of first quarter of 2020. Prior to the pandemic, we had met or exceeded our internal enrollment goal for MANIFEST, and we continue to assess what impact the pandemic could have on our MANIFEST trial timeline. Similarly, while we have had incidences of incomplete data collection to date, we are utilizing provisions of the protocol and recent regulatory guidance that provide potential flexibility in the time and place of data collection, and we will continue to monitor the situation. We expect to provide a data update at EHA (Free EHA Whitepaper) similar to our plans prior to the COVID-19 outbreak.

To date, we have not seen a significant impact of COVID-19 on clinical trials for CPI-1205 or CPI-0209. The ProSTAR trial for CPI-1205 is proceeding, and we continue to expect to do a data cut in mid-2020 and to provide an update shortly thereafter. Our CPI-0209 Phase 1 trial continues as planned before the COVID-19 outbreak and we continue to expect to determine a recommended Phase 2 dose in the second half of 2020.
CPI-0610 Phase 3 clinical trial. Conditions at clinical trial sites caused by COVID-19 may impact the timing of the start of our Phase 3 clinical trial for CPI-0610. However, we still aim to begin this trial in the second half of 2020.

Manufacturing. We have experienced some disruption in our supply chain due to COVID-19. However, supply chain disruptions have not impacted our overall timelines for conducting clinical trials to date, and we continue to manufacture batches for our ongoing clinical trials.
Milestones

The Company anticipates achieving the following milestones during 2020:

CPI-0610 – Provide MANIFEST program update at EHA (Free EHA Whitepaper) in June

CPI-0610 – Initiate Phase 3 clinical trial in second half of 2020

CPI-0610 – Provide additional MANIFEST program update by end of year

CPI-1205 – Provide ProSTAR program update and determine next steps mid-year

CPI-0209 – Provide program update, including recommended Phase 2 dose, by end of year

First Quarter 2020 Financial Results

Cash, cash equivalents, and marketable securities as of March 31, 2020, were $358.8 million, a decrease of 6.5% compared to December 31, 2019, primarily due to operating expenses.

Research and development (R&D) expenses increased 28.1% year over year to $20.1 million in the first quarter of 2020, mainly due to increased clinical trial expenses.

General and administrative (G&A) expenses grew 33.4% year over year to $5.9 million in the first quarter of 2020, primarily due to building out the organization of the company.

The net loss attributed to common shareholders increased 31.0% year over year to $25.4 million for the first quarter of 2020, mainly due to increased R&D and G&A expenses. The net loss per share attributable to common shareholders decreased 18.7% to $0.61 per share due to an increase in shares outstanding as a result of the private placement in October 2019 and the public offering in December 2019, offset in part by the increased net loss.
Financial Guidance

Constellation expects that its current cash, cash equivalents, and marketable securities will enable it to fund operations into the second half of 2022.

Conference Call

Constellation will host a conference call at 8:00 AM EDT on May 6, 2020, to discuss its clinical programs and financial results. The event will be webcast live and can be accessed on the Investor Relations section of Constellation’s website at View Source To participate in the live question-and-answer session, please dial (877) 473-2077 (domestic) or (661) 378-9662 (international) and refer to conference ID 4372778.

On May 6, 2020 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycles) technology, reported that management will present at the Bank of America 2020 Health Care Conference on Thursday, May 14, 2020 at 3:00 p.m. ET (Press release, Bicycle Therapeutics, MAY 6, 2020, View Source [SID1234557082]). The conference will be held in a virtual meeting format.

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A live webcast of the presentation will be accessible in the Investors & Media section of Bicycle’s website at www.bicycletherapeutics.com. An archived replay of the webcast will be available for 60 days following the presentation date.

On May 6, 2020 Bristol Myers Squibb (NYSE: BMY) reported that the U.S. Food and Drug Administration (FDA) has extended the action date by three months for the biologics license application (BLA) for lisocabtagene maraleucel (liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy for the treatment of adults with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies (Press release, Bristol-Myers Squibb, MAY 6, 2020, View Source [SID1234557081]). The new Prescription Drug User Fee Act (PDUFA) action date set by the FDA is November 16, 2020.

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Subsequent to the submission and acceptance of the BLA and upon FDA request, the company submitted additional information to the FDA, which was deemed to constitute a major amendment to the application and will require additional time for FDA review. The company will work closely with the FDA to support the continued review of the BLA for liso-cel and is committed to bringing this therapy to patients.

For Holders of Contingent Value Rights (CVR), Ticker BMY-RT

U.S. FDA approval of liso-cel by December 31, 2020 is one of the required remaining milestones of the Contingent Value Rights issued upon the close of the Celgene acquisition in the fourth quarter of 2019. The other is U.S. FDA approval of Idecabtagene Vicleucel (ide-cel) by March 31, 2021.

The company is committed to working with FDA to progress both applications and achieve the remaining regulatory milestones required by the CVR.

About Lisocabtagene Maraleucel (liso-cel)

Liso-cel is an investigational chimeric antigen receptor (CAR) T-cell therapy designed to target CD19, which is a surface glycoprotein expressed during normal B-cell development and maintained following malignant transformation of B cells. Liso-cel aims to target CD19-expressing cells through a CAR construct that includes an anti-CD19 single-chain variable fragment (scFv) targeting domain for antigen specificity, a transmembrane domain, a 4-1BB costimulatory domain hypothesized to increase T-cell proliferation and persistence, and a CD3-zeta T-cell activation domain. The defined composition of CAR-positive viable T-cells (consisting of CD8 and CD4 components) in liso-cel may reduce product variability; however, the clinical significance of defined composition is unknown.

Bristol Myers Squibb: Advancing Cancer Research

At Bristol Myers Squibb, patients are at the center of everything we do. The goal of our cancer research is to increase patients’ quality of life, long-term survival and make cure a possibility. We harness our deep scientific experience, cutting-edge technologies and discovery platforms to discover, develop and deliver novel treatments for patients.

Building upon our transformative work and legacy in hematology and Immuno-Oncology that has changed survival expectations for many cancers, our researchers are advancing a deep and diverse pipeline across multiple modalities. In the field of immune cell therapy, this includes registrational CAR T cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. We are developing cancer treatments directed at key biological pathways using our protein homeostasis platform, a research capability that has been the basis of our approved therapies for multiple myeloma and several promising compounds in early- to mid-stage development. Our scientists are targeting different immune system pathways to address interactions between tumors, the microenvironment and the immune system to further expand upon the progress we have made and help more patients respond to treatment. Combining these approaches is key to delivering new options for the treatment of cancer and addressing the growing issue of resistance to immunotherapy. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients.

On May 6, 2020 LabCorp (NYSE: LH) reported that members of the executive management team will participate in a virtual fireside chat at the Bank of America Securities 2020 Health Care Conference on Wednesday, May 13, at 10:20 a.m. ET (Press release, LabCorp, MAY 6, 2020, View Source [SID1234557080]).

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A live audio webcast of the presentation will be available via the company website at www.LabCorp.com and archived for replay.

On May 6, 2020 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported financial results for the first quarter ended March 31, 2020 and provided a corporate update (Press release, Jounce Therapeutics, MAY 6, 2020, View Source [SID1234557079]).

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"The start to 2020 has been marked by unprecedented times as the impact of the ongoing COVID-19 pandemic has been felt globally. Through this challenging environment, Jounce remains committed to driving our novel science forward as we work hard to bring long-lasting benefit to cancer patients with critical unmet needs and I am proud of our team’s strength and commitment during this time," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "Though both the enrollment of the EMERGE Phase 2 trial and initiation of the SELECT Phase 2 trial have been modestly impacted by COVID-19, we are dedicated to the continued advancement of vopratelimab while simultaneously keeping the safety of our patients, employees and clinical collaborators at the forefront of our work. We look forward to executing on our milestones as we work diligently to progress our pipeline of clinical and preclinical programs."

Pipeline Update:
Clinical Programs: Vopratelimab and JTX-4014
Jounce currently expects a modest delay of approximately 2 to 3 months to both EMERGE interim analysis and initiation of the SELECT clinical trial due to COVID-19.

Phase 2 EMERGE trial interim analysis data: EMERGE trial enrollment of patients with non-small cell lung cancer (NSCLC) who have progressed on or after both a platinum-based regimen and a PD-1 or PD-L1 inhibitor is expected to be complete mid-year 2020, and per protocol, will include at least 18 weeks of clinical plus biomarker data from all evaluable patients. The interim analysis will be conducted approximately 6 months after the last patient is enrolled and as such has shifted into early 2021.
Phase 2 SELECT trial initiation: Preparations continue for the initiation of the randomized SELECT trial to evaluate vopratelimab in combination with JTX-4014, a PD-1 inhibitor, versus JTX-4014 alone, in PD-1 inhibitor naive TISvopra biomarker selected patients in second line NSCLC. Jounce expects to enroll approximately 75 patients, outside the U.S. Despite the approximate 2 to 3 month delay to initiate the trial due to COVID-19, Jounce still expects to report clinical data in 2021.
Identified TISvopra predictive biomarker for Phase 2 SELECT trial: In February 2020, Jounce presented new data identifying the predictive biomarker associated with vopratelimab patient selection, known as TISvopra, a baseline RNA signature with a threshold optimized for the prediction of the emergence of ICOS hi CD4 T cells which is expected to predict for both vopratelimab and PD-1 activity.
Pre-Clinical Program: JTX-1811

Announced CCR8 as the JTX-1811 target: CCR8 is a chemokine receptor enriched on intra-tumoral T regulatory cells. CCR8 was one of Jounce’s top choices of T regulatory targets stemming from its systematic interrogation of the tumor microenvironment using its discovery engine. JTX-1811, the next potential first-in-class development program, is a monoclonal antibody designed to selectively deplete immuno-suppressive T regulatory cells. When JTX-1811 binds to CCR8, it targets the T regulatory cells for depletion by enhanced antibody-dependent cellular cytotoxicity. Jounce will present new preclinical data at the second portion of the virtual 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting being held June 22-24 and expects to file an Investigational New Drug (IND) application in the first half of 2021.
Corporate Update:

COVID-19 and Jounce operations: Amid the ongoing COVID-19 pandemic, Jounce has taken key precautions in line with guidance from public health officials to ensure the health and safety of its employees, patients enrolled in clinical trials, investigators and clinical collaborators. Critical research lab work continues on site, while non-laboratory employees are working remotely.
First Quarter 2020 Financial Results:

Cash position: As of March 31, 2020, cash, cash equivalents and investments were $148.6 million, compared to $170.4 million as of December 31, 2019. The decrease in cash, cash equivalents and investments was primarily due to operating expenses incurred during the period.
License and collaboration revenue: We did not recognize any license and collaboration revenue in the first quarter of 2020. License and collaboration revenue recognized during the first quarter of 2019 was comprised solely of non-cash revenue recognition related to the original strategic collaboration with Celgene which ended in July 2019.
Research and development expenses: Research and development expenses were $19.6 million for the first quarter of 2020, compared to $17.3 million for the same period in 2019. The increase in research and development expenses was primarily due to increased external clinical and regulatory costs associated with the EMERGE and SELECT clinical trials and increased employee compensation costs, partially offset by decreased IND-enabling expenses.
General and administrative expenses: General and administrative expenses were $7.5 million for the first quarter of 2020, compared to $7.2 million for the same period in 2019. The increase in general and administrative expenses was primarily due to increased professional service fees.
Net loss: Net loss was $26.4 million for the first quarter of 2020, resulting in basic and diluted net loss per share of $0.78. Net loss was $12.4 million for the same period in 2019, resulting in a basic and diluted net loss per share of $0.38. The increase in net loss and net loss per share was primarily attributable to a decrease in license and collaboration revenue and an increase in operating expenses.
Financial Guidance:
Based on its current operating and development plans, Jounce continues to expect gross cash burn on operating expenses and capital expenditures for the full year 2020 to be approximately $80.0 million to $95.0 million.

Given the strength of its balance sheet, Jounce expects its existing cash, cash equivalents and investments to be sufficient to enable the funding of its operating expenses and capital expenditure requirements through the end of 2021.

Conference Call and Webcast Information:
Jounce Therapeutics will host a live conference call and webcast today at 8:00 a.m. ET. To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 4044098. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of Jounce’s website at www.jouncetx.com. The webcast will be archived and made available for replay on Jounce’s website approximately two hours after the call and will be available for 30 days.