On May 1, 2019 Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) reported financial and operational results for the first quarter ended March 31, 2019 (Press release, Vanda Pharmaceuticals, MAY 1, 2019, View Source [SID1234535516]).

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"During the first quarter, Vanda made significant advances towards its commercial and research goals. Patients on treatment with Hetlioz continue to increase steadily, driven by broader awareness and recognition of Non-24. We are preparing for a possible launch later this year in jet lag disorder, an indication that has the potential to drive significant growth for our Hetlioz franchise. Tradipitant clinical development is advancing for three indications, atopic dermatitis, gastroparesis and motion sickness," said Mihael H. Polymeropoulos, M.D., Vanda’s President and CEO. "We believe that Vanda is well positioned for significant growth in the coming quarters and years given its strong commercial and clinical development pipeline and its exceptional people."

Key Financial Highlights:

Total net product sales from HETLIOZ and Fanapt were $47.7 million in the first quarter of 2019, a 10% decrease compared to $53.0 million in the fourth quarter of 2018 and a 9% increase compared to $43.6 million in the first quarter of 2018.
HETLIOZ net product sales were $29.0 million in the first quarter of 2019, an 11% decrease compared to $32.4 million in the fourth quarter of 2018 and a 14% increase compared to $25.4 million in the first quarter of 2018. In the first quarter of 2019, HETLIOZ units sold to patients declined by 2% compared to the fourth quarter of 2018.
Fanapt net product sales were $18.8 million in the first quarter of 2019, a 9% decrease compared to $20.6 million in the fourth quarter of 2018 and a 3% increase compared to $18.2 million in the first quarter of 2018. In the first quarter of 2019, Fanapt prescriptions, as reported by IQVIA, declined by 5% compared to the fourth quarter of 2018.
Cash, cash equivalents and marketable securities (Cash) were $267.8 million as of March 31, 2019, representing an increase to Cash of $10.5 million and $19.0 million as compared to December 31, 2018 and March 31, 2018, respectively.
Key Research and Development Highlights:

Tradipitant – Clinical Development

Vanda plans to meet with the U.S. Food and Drug Administration (the FDA) in the second quarter of 2019 to further define and confirm the path towards approval of tradipitant in the treatment of patients with gastroparesis.
Vanda plans to initiate a Phase III clinical study of tradipitant in gastroparesis in the second quarter of 2019.
Enrollment in the Phase III clinical study (EPIONE) of tradipitant in atopic dermatitis is ongoing. Results are expected in the first half of 2020. A second Phase III clinical study is expected to begin in the first quarter of 2020.
In January 2019, Vanda initiated a Phase II clinical study of tradipitant in motion sickness. Study results are expected in the third quarter of 2019.
HETLIOZ (tasimelteon)

The HETLIOZ supplemental New Drug Application (sNDA) for the treatment of jet lag disorder is under review by the FDA with a Prescription Drug User Fee Act target action date of August 16, 2019.
Vanda expects to meet with the FDA in the third quarter of 2019 to confirm the regulatory path forward for HETLIOZ in the treatment of patients with SMS and expects to file an sNDA in the third quarter of 2019.
Vanda plans in the third quarter of 2019 to initiate a Phase II clinical study of HETLIOZ in delayed sleep phase disorder (DSPD) in patients who have a mutation in the CRY1 gene, which is believed to be causative in a subset of patients with DSPD.
Fanapt (iloperidone)

Enrollment is ongoing in a pharmacokinetic study for the once-a-month long acting injectable (LAI) formulation of Fanapt.
A randomized study of Fanapt in bipolar disorder is planned to begin in 2019.
VTR-297 (histone deactetylase (HDAC) inhibitor)

Enrollment is ongoing in a Phase I clinical study (1101) of VTR-297 in hematologic malignancies.
Tradipitant – Partial Clinical Hold and FDA Dispute

In April 2018, Vanda submitted a protocol amendment to the FDA, proposing a 52-week open-label extension (OLE) period for patients who had completed the tradipitant Phase II clinical study (2301) in gastroparesis. In May 2018, based on feedback from the FDA, Vanda amended the protocol limiting the duration of treatment in the 2301 study to a total of three months, while continuing to seek further dialogue with the FDA on extending the study duration to 52-weeks. As a part of this negotiation process, in September 2018, Vanda submitted a new follow-on 52-week OLE protocol to the FDA (2302) for patients who had completed the 2301 study. While waiting for further feedback, no patients were ever enrolled in any study beyond 12 weeks. In December 2018, the FDA imposed a partial clinical hold (PCH) on two of Vanda’s proposed clinical studies of tradipitant, stating that Vanda is required first to conduct additional chronic toxicity studies in canines, monkeys or minipigs before allowing patients access in any clinical protocol beyond 12 weeks. The original PCH was not based on any safety or efficacy data related to tradipitant. Rather, the FDA informed Vanda that these additional toxicity studies are required by a guidance document.

In February 2019, Vanda filed a lawsuit against the FDA in the United States District Court for the District of Columbia (DC District Court), challenging the FDA’s legal authority to issue the PCH, and seeking an order to set it aside. On February 14, 2019, the FDA filed a Motion for Voluntary Remand to the Agency and for a Stay of the Case. On March 14, 2019, the DC District Court granted the FDA’s request for voluntary remand and returned the matter to the FDA for further consideration. On April 26, 2019, the FDA provided its remand response, in which it indicated that, after re-evaluation, it believes a partial clinical hold continues to be appropriate. After reviewing the FDA’s remand response, Vanda continues to believe that additional chronic toxicity studies are unjustified, and that Vanda has provided the FDA with sufficient information regarding the safety of tradipitant to justify the continued study of tradipitant in patients beyond 12 weeks, in accordance with applicable law and FDA regulations. On April 29, 2019, Vanda and the FDA filed a Joint Motion for Extension of Time to Propose a Scheduling Order for this matter. On April 30, 2019, the DC District Court granted the motion, thereby extending the deadline until May 3, 2019 for the FDA and Vanda to file proposals regarding a scheduling order. Vanda intends to continue vigorously pursuing its interests in the matter.

Vanda does not expect the PCH to have any impact on its ongoing clinical studies in atopic dermatitis and motion sickness, each of which is under 12 weeks in duration, or its planned 12-week Phase III study in gastroparesis, none of which are subject to the PCH. Nor does Vanda expect the PCH to impact the potential timing of a New Drug Application (NDA) filing. If the matter has not been fully resolved prior to the date on which Vanda is ready to file the first NDA for tradipitant, then Vanda may choose to file with the safety data it has available at that time. Vanda may pursue additional studies of durations in excess of 12 weeks in countries where the conduct of such studies may be permitted (or it may choose to file for approval of a limited indication). If the FDA determines that Vanda’s NDA does not contain safety data sufficient for approval, it may not accept the NDA for filing. Vanda will continue to reassess the situation as events unfold.

Non-GAAP Financial Results

Non-GAAP net income was $3.0 million for the first quarter of 2019, or $0.06 per share, compared to a Non-GAAP net income of $6.6 million, or $0.14 per share, for the first quarter of 2018.

Vanda provides Non-GAAP financial information, which it believes can enhance an overall understanding of its financial performance when considered together with GAAP figures. Refer to the sections of this press release entitled "Non-GAAP Financial Information" and "Reconciliation of GAAP to Non-GAAP Financial Information" for more detailed information regarding Non-GAAP financial information.

2019 Financial Guidance

Vanda reiterates its prior 2019 financial guidance and expects to achieve the following financial objectives in 2019:

Full Year 2019

Financial Objectives

Full Year 2019

Guidance

Combined net product sales
from both HETLIOZ and
Fanapt

$215 to $225 million

HETLIOZ net product sales

$137 to $143 million

Fanapt net product sales

$78 to $82 million

Year-end 2019 Cash

Greater than $260 million

Conference Call

Vanda has scheduled a conference call for today, Wednesday, May 1, 2019, at 4:30 PM ET. During the call, Vanda’s management will discuss the first quarter 2019 financial results and other corporate activities. Investors can call 1-866-688-9426 (domestic) or 1-409-216-0816 (international) and use passcode 6195579. A replay of the call will be available on Wednesday, May 1, 2019, beginning at 7:00 PM ET and will be accessible until Wednesday, May 8, 2019, at 11:59 PM ET. The replay call-in number is 1-855-859-2056 for domestic callers and 1-404-537-3406 for international callers. The passcode number is 6195579.

The conference call will be broadcast simultaneously on Vanda’s website, www.vandapharma.com. Investors should click on the Investor Relations tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda’s website for a period of 30 days.

Non-GAAP Financial Information

Vanda believes that the Non-GAAP financial information provided in this press release can assist investors in understanding and assessing the ongoing economics of Vanda’s business and reflect how it manages the business internally and sets operational goals. Vanda’s "Non-GAAP Selling, general and administrative expenses" and "Non-GAAP Research and development expenses" exclude stock-based compensation. Vanda’s "Non-GAAP Net income (loss)," "Non-GAAP Net income (loss) per share" and "Non-GAAP Operating expenses excluding Cost of goods sold" exclude stock-based compensation and intangible asset amortization.

Vanda believes that excluding the impact of these items better reflects the recurring economic characteristics of its business, as well as Vanda’s use of financial resources and its long-term performance.

These Non-GAAP financial measures, as presented, may not be comparable to similarly titled measures reported by other companies since not all companies may calculate these measures in an identical manner and, therefore, they are not necessarily an accurate measure of comparison between companies.

The presentation of these Non-GAAP financial measures is not intended to be considered in isolation or as a substitute for guidance prepared in accordance with GAAP. The principal limitation of these Non-GAAP financial measures is that they exclude significant elements that are required by GAAP to be recorded in Vanda’s financial statements. In addition, they are subject to inherent limitations as they reflect the exercise of judgments by management in determining these Non-GAAP financial measures. In order to compensate for these limitations, Vanda presents its Non-GAAP financial guidance in connection with its GAAP guidance. Investors are encouraged to review the reconciliation of our Non-GAAP financial measures to their most directly comparable GAAP financial measure.

On May 1, 2019 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), reported financial results and provided a business update for the three months ended March 31, 2019 (Press release, Lexicon Pharmaceuticals, MAY 1, 2019, View Source;2019.htm [SID1234535650]).

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"XERMELO net sales grew more than 20% in the first quarter of 2019 versus the same period in 2018. We advanced the telotristat ethyl Phase 2 program for biliary tract cancer, with the first patient dosed, and we continued making progress in advancing LX9211, a candidate for neuropathic pain," said Lonnel Coats, Lexicon’s president and chief executive officer. "We are pleased with the recent approval of Zynquista in type 1 diabetes in Europe, which represents the second product originating from our own laboratories to be approved in a major region in a span of only 26 months. In the U.S., we and our collaborator, Sanofi, will be working with the FDA to better understand sotagliflozin’s potential pathway to approval in type 1 diabetes. Lastly, we look forward to topline results from the first of several Phase 3 studies of sotagliflozin in type 2 diabetes. We will provide updates on our progress throughout the year."

First Quarter Product and Pipeline Highlights

XERMELO (telotristat ethyl)

XERMELO U.S. net sales were $6.7 million in the first quarter of 2019.

The first patient was dosed in the Telotristat Ethyl for Advanced Biliary Tract Cancer, or TELE-ABC, study, a Phase 2a clinical study of telotristat ethyl in patients with biliary tract cancer.

Data from a patient-reported survey demonstrating improvement in carcinoid syndrome symptoms after initiation of XERMELO therapy in the real world were presented at the 16th Annual European Neuroendocrine Tumor Society Conference (ENETS).

Zynquista (sotagliflozin)

The U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) for sotagliflozin for the treatment of adults with type 1 diabetes in combination with insulin in March. The CRL followed the Endocrinologic and Metabolic Drugs Advisory Committee’s eight to eight vote in January on the question of whether the overall benefits of sotagliflozin outweighed the risks to support approval.

In March, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on the Marketing Authorization of Zynquista in both a 200-mg and 400-mg dose for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes (T1D) mellitus with a body mass index (BMI) ≥ 27 kg/m2, who have failed to achieve adequate glycemic control despite optimal insulin therapy. Subsequent to quarter-end, Zynquista received formal approval in the European Union in accordance with the CHMP opinion.

First Quarter 2019 Financial Highlights

Revenues: Revenues for the three months ended March 31, 2019 decreased to $9.2 million from $25.4 million for the corresponding period in 2018, primarily due to lower revenues recognized from our collaboration and license agreement with Sanofi, partially offset by a milestone payment from Ipsen and an increase in net product revenues. Net product revenues for the three months ended March 31, 2019 included $6.7 million from net sales of XERMELO in the U.S., up 24% from the corresponding period in 2018.

Cost of Sales: Cost of sales related to sales of XERMELO for the three months ended March 31, 2019 and 2018 was $0.6 million and $0.5 million, respectively.

Research and Development (R&D) Expenses: Research and development expenses for the three months ended March 31, 2019 decreased to $12.0 million from $47.7 million for the corresponding period in 2018, primarily due to lower external clinical development costs relating to sotagliflozin.

Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the three months ended March 31, 2019 decreased to $14.1 million from $14.9 million for the corresponding period in 2018, primarily due to decreased marketing costs, partially offset by higher salaries and benefits related to increased headcount.

Net Loss: Net loss for the three months ended March 31, 2019 was $21.8 million, or $0.21 per share, compared to a net loss of $41.8 million, or $0.40 per share, in the corresponding period in 2018. For the three months ended March 31, 2019 and 2018, net loss included non-cash, stock-based compensation expense of $3.4 million and $3.1 million, respectively.

Cash and Investments: As of March 31, 2019, Lexicon had $133.1 million in cash and investments, as compared to $160.1 million as of December 31, 2018.

Anticipated Near-Term Milestones

June, September 2019 – Presentation of new analyses from pivotal studies of sotagliflozin in type 1 diabetes at the annual ADA and EASD meetings

2H 2019 – Topline Phase 1b data for LX9211

2019 – Topline results from core Phase 3 studies for sotagliflozin in type 2 diabetes

2019 – Completion of patient enrollment of the initial safety cohort in the Phase 2 study for telotristat ethyl in biliary tract cancer

Conference Call and Webcast Information

Lexicon management will hold a live conference call and webcast today at 8:00 am EDT / 7:00 am CDT to review its financial and operating results and to provide a general business update. The dial-in number for the conference call is 888-645-5785 (U.S./Canada) or 970-300-1531 (international). The conference ID for all callers is 8663398. The live webcast and replay may be accessed by visiting Lexicon’s website at www.lexpharma.com/investors. An archived version of the webcast will be available on the website for 14 days.

About XERMELO (telotristat ethyl)

Discovered using Lexicon’s unique approach to gene science, XERMELO (telotristat ethyl) is the first and only approved oral therapy for carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSAs. XERMELO targets tryptophan hydroxylase, an enzyme that mediates the excess serotonin production within metastatic neuroendocrine tumor (mNET) cells. Lexicon has built the in-house capability and infrastructure to launch and market XERMELO in the U.S., where it retains all commercialization rights. Lexicon also retains rights to market XERMELO in Japan. Lexicon has established a license and collaboration agreement with Ipsen to commercialize XERMELO in Europe and other countries outside of U.S. and Japan.

XERMELO was approved by the U.S. Food and Drug Administration on February 28, 2017 and by the European Commission on September 19, 2017 for the treatment of carcinoid syndrome diarrhea in combination with SSA therapy in adults inadequately controlled by SSA therapy. Carcinoid syndrome is a rare condition that occurs in patients living with metastatic NETs (mNETs) and is characterized by frequent and debilitating diarrhea. XERMELO targets the overproduction of serotonin inside mNET cells, providing an additional treatment option for patients suffering from carcinoid syndrome diarrhea.

XERMELO (telotristat ethyl) Important Safety Information

Warnings and Precautions: XERMELO may cause constipation, which can be serious. Monitor for signs and symptoms of constipation and/or severe, persistent, or worsening abdominal pain in patients taking XERMELO. Discontinue XERMELO if severe constipation or severe, persistent, or worsening abdominal pain develops.

Adverse Reactions: The most common adverse reactions (≥5%) include nausea, headache, increased gamma-glutamyl-transferase, depression, flatulence, decreased appetite, peripheral edema, and pyrexia.

Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 substrates, as XERMELO may decrease their systemic exposure. If combination treatment with XERMELO and short-acting octreotide is needed, administer short-acting octreotide at least 30 minutes after administering XERMELO.

For more information about XERMELO, see Full Prescribing Information at www.xermelo.com.

About Zynquista (sotagliflozin)

Discovered using Lexicon’s unique approach to gene science, sotagliflozin is an investigational oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney.

Lexicon entered into a collaboration and license agreement with Sanofi in November 2015 under which Lexicon granted Sanofi an exclusive, worldwide (excluding Japan), royalty-bearing right and license to develop, manufacture and commercialize sotagliflozin. Lexicon is responsible for all clinical development activities relating to type 1 diabetes and has exercised an exclusive option to co-promote and have a significant role, in collaboration with Sanofi, in the commercialization of sotagliflozin for the treatment of type 1 diabetes in the U.S. Sanofi is responsible for all clinical development and commercialization of sotagliflozin for the treatment of type 2 diabetes worldwide (excluding Japan) and is solely responsible for the commercialization of sotagliflozin for the treatment of type 1 diabetes outside the U.S. (excluding Japan). Zynquista has been approved in the European Union for use as an adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes and a body mass index ≥ 27 kg/m2, who could not achieve adequate glycemic control despite optimal insulin therapy. Sotagliflozin has not yet been approved for use in any other jurisdiction.

On May 1, 2019 Tmunity Therapeutics, Inc., a private clinical-stage biotherapeutics company focused on saving and improving lives by delivering the full potential of next-generation T cell immunotherapy, reported it has entered into an exclusive licensing and research collaboration with the University of California San Francisco (UCSF) aimed at advancing novel engineered T Cell Receptor (TCR) therapies for rare and currently incurable pediatric conditions with high mortality rates (Press release, Tmunity Therapeutics, MAY 1, 2019, View Source [SID1234535501]). Initially, research will focus on Diffuse Intrinsic Pontine Glioma (DIPG), a rare and highly aggressive brain stem tumor.

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As part of the research collaboration, Tmunity will work with one of the world’s leading experts in the field of neuro-oncology gene therapy, Hideho Okada, MD, PhD, a physician-scientist and professor of neurological surgery at UCSF who studies immunotherapeutic strategies aimed at malignant brain tumors. Dr. Okada has discovered and engineered a TCR that binds to and is selective for the H3.3K27M neoantigen. Recent studies have shown that the K27M mutation in the H3.3 histone is observed in more than 70 percent of DIPGs, and that gliomas harboring this mutation are associated with a poor prognosis and survival rate. In animal studies, Dr. Okada found that T cells transfected with the engineered TCR and infused into a mouse model of H3.3K27M-positive glioma harboring the K27M mutation in H3.3 had anti-tumor activity and limited toxicity in treated animals.

"This collaboration with UCSF embodies our commitment to advance novel T cell therapies into the clinic faster. Sadly, children who are diagnosed with DIPG currently have very few therapeutic options and there has been little progress in improving treatments and overall survival rates for DIPG over the last few decades," said Usman "Oz" Azam, MD, President, Chief Executive Officer and Chairperson of the Board of Tmunity. "We look forward to working with Dr. Okada and his research team to help advance this exciting discovery of a novel TCR therapy that could be a potential breakthrough in the treatment of this devastating pediatric disease, and perhaps other gliomas."

Approximately 300 children in the U.S. are diagnosed with DIPG each year, with most diagnoses occurring between five and nine years of age. Children with DIPG have a median overall survival of nine to 10 months using currently available treatments that mainly manage symptoms and complications associated with the disease.

"We are excited to join forces with Tmunity to further study the potential of our TCR T cell as a therapy for DIPG," said Dr. Okada. "The expertise Tmunity brings in clinical development, regulatory and manufacturing is invaluable as our pre-clinical research suggests that our discovery may show promise as a therapeutic approach in pediatric patients with DIPG."

The exclusive collaboration between Tmunity and UCSF brings together leading technologies and expertise from both groups to accelerate the clinical development of this novel T cell therapy. Under the terms of the agreement, Tmunity will work closely with Dr. Okada’s laboratory with the intention of moving quickly into IND-enabling studies and into the clinic. Tmunity will be responsible for leading the development, manufacturing and commercialization of the H3.3K27M TCR T cell therapy. The negotiations were led by the Technology Management team in the UCSF Innovation Ventures office, which leads the university’s business development, technology licensing, and efforts to translate cutting-edge science into therapies and products that directly benefit patients worldwide.

On May 1, 2019 Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, reported that the Company will release its first quarter 2019 financial results after the market closes on Wednesday, May 8, 2019 (Press release, Sangamo Therapeutics, MAY 1, 2019, View Source [SID1234535517]). The press release will be followed by a conference call at 5:00 p.m. ET, which will be open to the public via telephone and webcast. During the conference call, the Company will review its financial results and provide a business update.

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The conference call dial-in numbers are (877) 377-7553 for domestic callers and (678) 894-3968 for international callers. The conference ID number for the call is 7577586. Participants may access the live webcast via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. A conference call replay will be available for one week following the conference call. The conference call replay numbers for domestic and international callers are (855) 859-2056 and (404) 537-3406, respectively. The conference ID number for the replay is 7577586.

On May 1, 2019 Gossamer Bio, Inc. (Nasdaq:GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported that Sheila Gujrathi, M.D., Chief Executive Officer and Co-Founder, will participate in a fireside chat at the Bank of America Merrill Lynch Health Care Conference on Tuesday, May 14 at 1:00 p.m. PT (Press release, Gossamer Bio, MAY 1, 2019, View Source [SID1234535502]).

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A live webcast of the fireside chat will be available on the "Events and Presentations" page in the "Investors" section of the company’s website at View Source A replay of the webcast will be archived on the company’s website for 90 days following the presentation.