On February 11, 2020 Novartis reported that the US Food and Drug Administration (FDA) accepted and granted Priority Review to capmatinib’s (INC280) New Drug Application (NDA) (Press release, Novartis, FEB 11, 2020, View Source [SID1234554129]). Capmatinib is a MET inhibitor being evaluated as a treatment for first-line and previously treated patients with locally advanced or metastatic MET exon 14 skipping (METex14) mutated non-small cell lung cancer (NSCLC). If approved, capmatinib will be the first therapy to specifically target METex14 mutated advanced lung cancer, a type of lung cancer with a particularly poor prognosis2,3.

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Priority Review is granted to therapies that the FDA determines have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. This designation shortens the FDA review period following the acceptance of the NDA to six months compared to ten months under Standard Review. Novartis was previously granted Breakthrough Therapy designation for capmatinib.

There are currently no approved therapies that specifically target METex14 mutated advanced NSCLC. NSCLC accounts for approximately 85% of lung cancer diagnoses4. METex14 mutations occur in 3-4% of newly diagnosed advanced NSCLC cases5 and is a recognized oncogenic driver6,7. As part of the continued collaboration between Novartis and Foundation Medicine, Inc., companion diagnostics for capmatinib are in development for both tumor tissue and liquid biopsies to be included on FoundationOneCDx* and the forthcoming version of Foundation Medicine’s liquid biopsy platform, which is currently under review with the FDA. Foundation Medicine is a leading provider of comprehensive genomic profiling solutions for patients with advanced cancer, including NSCLC.

"We are extremely encouraged by the FDA’s Priority Review designation for capmatinib, a MET inhibitor that may be a major treatment advance for patients with this particularly aggressive form of lung cancer," said John Tsai, M.D., Head of Global Drug Development and Chief Medical Officer, Novartis. "Results of the GEOMETRY mono-1 trial clearly identify METex14 as an oncogenic driver and we are inspired to bring capmatinib, potentially the first METex14 targeted therapy, to patients and to reimagine medicine and outcomes for people with lung cancer."

The NDA submission for capmatinib is supported by results from the GEOMETRY mono-1 Phase II study, which demonstrated an overall response rate of 67.9% (95% CI, 47.6 – 84.1)1 and 40.6% (95% CI, 28.9 – 53.1)1 among treatment-naïve and previously treated patients, respectively, based on the Blinded Independent Review Committee (BIRC) assessment per RECIST v1.1. The study also demonstrated that capmatinib provided durable responses among all patients: median duration of response was 11.14 months (95% CI, 5.55 – NE) in treatment-naïve patients and 9.72 months (95% CI, 5.55 – 12.98) in previously treated patients1.

All results were based on independent assessment by the BIRC, and all tumor CT scans were evaluated in parallel by two radiologists to confirm the response1. The most common treatment-related adverse events (AE) (≥ 10% all grades) across all cohorts (N=334), were peripheral edema (42%), nausea (33%), creatinine increase (20%), vomiting (19%), fatigue (14%), decreased appetite (13%) and diarrhea (11%). The majority of the AEs were grades 1/21.

About Lung Cancer
Lung cancer is the most common cancer worldwide, accounting for 2.1 million new cases and 1.8 million deaths in 20188. There are two main types of lung cancer – small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC)9. NSCLC accounts for approximately 85% of lung cancer diagnoses, inclusive of known oncogenic mutations4. The MET exon 14 skipping mutation occurs in 3-4% of newly diagnosed advanced NSCLC cases5. There are currently no approved therapies specifically targeted to treat METex14 mutated advanced lung cancer.

About Capmatinib
Capmatinib (INC280) is an investigational, oral, potent and selective MET inhibitor licensed to Novartis by Incyte Corporation in 2009. Under the Agreement, Incyte granted Novartis worldwide exclusive development and commercialization rights to capmatinib and certain back-up compounds in all indications.

On February 10, 2020 Millendo Therapeutics, Inc. (Nasdaq: MLND), a late-stage biopharmaceutical company primarily focused on developing novel treatments for orphan endocrine diseases, reported that Christophe Arbet-Engels, MD, PhD, has joined the company as Chief Medical Officer (Press release, Millendo Therapeutics, FEB 10, 2020, View Source [SID1234554210]). The company also announced that it expects to report topline results from the Phase 2b portion of its pivotal Phase 2b/3 clinical trial for livoletide in patients with Prader-Willi syndrome (PWS), called ZEPHYR, early in the second quarter of 2020.

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"We are honored and excited to welcome Christophe to the team," said Julia C. Owens, PhD, President and Chief Executive Officer of Millendo Therapeutics. "Christophe brings to Millendo broad experience in endocrinology and guiding clinical stage therapies through registration and lifecycle management. We believe this expertise will be a significant asset with the data readout from our pivotal clinical trial for livoletide in PWS anticipated in early second quarter of this year and as we look ahead to potential commercialization of our product candidates, including livoletide for PWS."

Dr. Arbet-Engels joins Millendo from Poxel Pharmaceuticals where he was Chief Medical Officer, Executive Vice President Late Development and Medical Affairs with responsibility for all medical activities for Poxel’s portfolio, including driving portfolio strategy and execution of registration programs. Previously, he served as Vice President, Worldwide Medical, Collaborative Medical Sciences at Biogen, where Dr. Arbet-Engels built, developed and led global medical research, clinical operations, biostatistics/analytics, communication and expanded access program teams to advance the medical sciences in multiple therapeutic areas. Dr. Arbet-Engels has also held several senior leadership positions, globally and locally, in clinical development and medical affairs at pharmaceutical and biotech companies including Boehringer Ingelheim, Roche, Merck, Aventis (now Sanofi) and Ligand Pharmaceuticals where he led the clinical development and registration, launch and lifecycle management for several new medicines. Dr. Arbet-Engels has a medical degree from University of Paris Sud, a PhD in endocrinology/diabetes and metabolism from University of Paris Descartes, and a master’s degree in business administration from Rutgers University. He will be based in Millendo’s Lexington, Massachusetts office.

"This is a very exciting time to join the talented team at Millendo," Dr. Arbet-Engels added. "With the data readouts from the Phase 2b portion of the study for livoletide in PWS expected in early second quarter of 2020 and for nevanimibe in classic congenial adrenal hyperplasia (CAH) in the second half of the year, I look forward to working closely with Julia and the rest of the team to guide the company through the critical next steps for advancing Millendo’s pipeline programs through development and into commercialization."

Inducement Equity Award
On February 10, 2020, the Compensation Committee of Millendo’s Board of Directors approved, effective as of February 10, 2020, the grant of an inducement stock option to purchase 140,000 shares of the Company’s common stock to Dr. Arbet-Engels. The stock option awarded to Dr. Arbet-Engels will have an exercise price equal to the closing price per share of the Company’s common stock on February 10, 2020, and will vest and become exercisable over four years, with 25% of the shares vesting on February 10, 2021, the one-year anniversary of the vesting commencement date, and the remaining shares vesting ratably over the subsequent 36 months, subject to Dr. Arbet-Engels’ continued service with the Company as of each such date. The stock option is subject to acceleration if Dr. Arbet-Engels’ employment terminates in connection with a change in control. The stock option has a ten-year term and is subject to the terms and conditions of the stock option agreement pursuant to which the option was granted.

The stock option was granted as an inducement material to Dr. Arbet-Engels entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4).

About Livoletide
Livoletide is an unacylated ghrelin analogue in late-stage clinical development for the treatment of Prader-Willi syndrome (PWS), a rare genetic disease characterized by hyperphagia, a chronic unrelenting hunger, that leads to obesity, metabolic dysfunction, reduced quality of life and early mortality. In a previous randomized, double-blind, placebo-controlled Phase 2 clinical trial in 47 patients with PWS, administration of livoletide once daily for two weeks was associated with a clinically meaningful improvement in hyperphagia, as well as a reduction in appetite. Millendo has received both Orphan Drug Designation and Fast Track Designation for livoletide for the treatment of PWS from the U.S. Food and Drug Administration (FDA) and Orphan Drug Designation from the European Medicines Agency (EMA). For more information about Millendo’s pivotal study of livoletide (ZEPHYR) please visit www.clinicaltrials.gov (NCT03790865) or the Patients and Families portion of our website.

About Prader-Willi Syndrome
Prader-Willi syndrome (PWS) is a genetic disease caused by the lack of expression of several genes on chromosome 15, which leads to hyperphagia, intellectual disability, short stature and incomplete sexual development, among other symptoms. PWS patients are at risk of premature mortality, mainly from obesity related conditions such as cardiovascular disease, respiratory distress and from accidents. The incidence of PWS is approximately 1 in 15,000 births. The prevalence of PWS is estimated between 8,000-11,000 patients in the United States and 13,000-18,000 in Europe. Currently, there is no effective or approved treatment for hyperphagia and abnormal eating behaviors associated with PWS. Growth hormone is used for improvement in height, cognition and body composition, but has no effect on appetite and over-eating. The only way to effectively manage hyperphagia, obesity and related complications of PWS is strict control over access to food, creating significant burden for families and caregivers.

About the ZEPHYR study
The ZEPHYR study is a two-part, randomized, double-blind, placebo-controlled pivotal Phase 2b/3 study. The first part is a Phase 2b study that includes a three-month double-blind, placebo-controlled core period in which patients receive one of two doses of livoletide or placebo followed by a nine-month extension period in which all patients receive livoletide. The Phase 2b portion of the study, one of the largest global PWS studies ever conducted, has completed recruitment for patients ages 8 to 65 with over 150 patients across 39 clinical sites in the United States, Europe and Australia. Millendo continues to implement a protocol amendment globally adding an additional cohort of PWS patients ages four to seven. Sites that recruit pediatric patients will continue to actively recruit patients for this cohort. The second part is a Phase 3 study that will consist of a six-month double-blind, placebo-controlled core period in which patients will receive livoletide or placebo followed by a six-month extension period in which all patients receive livoletide. The study’s primary endpoint measures the change in food-related behaviors using the validated Hyperphagia Questionnaire for Clinical Trials (HQ-CT) during each core period. ZEPHYR is a pivotal study and the results of the Phase 2b portion of the study may be sufficient to support a new drug application (NDA) for livoletide.

On February 10, 2020 The Neuroendocrine Tumor Research Foundation (NETRF) reported $3.5 million in neuroendocrine tumor (NET) research grants to fund 12 projects around the world in pursuit of more precise treatments for this uncommon cancer affecting an estimated 171,000 Americans (Press release, NETRF, FEB 10, 2020, View Source [SID1234554209]).

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After investing $26 million in research during the past 15 years, NETRF has helped to establish the NET knowledge base needed to expand the exploration of improved treatments, according to Elyse Gellerman, NETRF Chief Executive Officer. "We can see real momentum in this new round of grants. We hope the discoveries from these projects will lead to improved treatment options for patients."

NETRF is supporting a new pioneering approach to NET immunotherapy with an Accelerator Award to Steven Libutti, MD, Rutgers Cancer Institute of New Jersey, to characterize a novel immune regulator called B7x to determine whether it has a role in shutting off the body’s immune response to fight against pancreatic NETs.

This round of funding features multiple new fronts for NETRF. To help grow the NET scientific workforce, the Foundation granted two inaugural Mentored Awards for early career researchers, one of which was funded by an educational grant from Ipsen. There were also new areas of NET inquiry. For the first time, NETRF is funding pheochromocytoma and paraganglioma research, including an evaluation of a novel radiotracer for imaging adrenal NETs.

NETRF also funded four research projects in lung NETs, an area that has not previously received the attention of other NET sites. These lung studies include:

Conducting single-cell genomic analyses to understand how lung NETs form, grow, and spread.
Mapping the cellular networks of typical and atypical lung NETs to find biomarkers that help predict a tumor’s aggressiveness.
Characterizing the molecular makeup of a newly identified, aggressive lung NET called "supra-carcinoid."
Determining the sociodemographic and geographic patterns of lung NETs in California.
"Advances in NET research have been hampered by the lack of effective laboratory disease models, and a limited understanding of the molecular and genetic profiles of NETs," said John Kanki, PhD, NETRF Director of Research. "Now that we are making strong headway along these lines, we can finally begin to drill deeper with greater specificity, to identify and explore new strategies for treating NETs."

NET tumors require the expansion of new blood vessels in order to grow and spread and two new grants explore new therapies that target developing tumor blood vessels. Researchers at Vanderbilt University will explore the potential efficacy of a combination therapy testing a drug known to affect the formation of new blood vessels (cabozantinib) together with an experimental drug called CB-839. At Columbia University Medical School, scientists will conduct preclinical laboratory experiments to test whether turning off two complementary blood vessel-forming processes together can improve therapeutic efficacy in pancreatic NETs.

NETRF also approved grants to study a potential cause of small intestinal multifocal tumors and to evaluate the role of the gut microbiome in carcinoid syndrome.

Seventy-five percent of the grants were awarded to research institutions that are new to NETRF. Seven of the 12 grants fund innovative NET research at American academic institutions, including Columbia University Medical Center, New York, NY; Dana-Farber Cancer Institute, Boston, MA; Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; University of California, San Francisco, CA; Tufts Medical Center, Boston, MA; University of Michigan, Ann Arbor, MI; and Vanderbilt University Medical Center, Nashville, TN.

Five grants fund international research at Erasmus MC, University Medical Center Rotterdam, Netherlands; Hebrew University of Jerusalem, Jerusalem, Israel; International Agency for Research on Cancer (IACR-WHO), Lyon, France; Istituto Auxologico Italiano – Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy; and Weizmann Institute of Science, Rehovot, Israel.

The NETRF grant process is a competitive and structured peer-reviewed process. The Foundation is currently accepting applications for its next grant cycle. Applications must be received by March 9, 2020.

Gellerman thanked the many individuals and foundations whose gifts to the 501(c)(3) nonprofit organization support NETRF’s research and educational activities. A generous gift from the Margie and Robert E. Petersen Foundation will fund several of the new projects. Additional support has been provided by the Goldhirsh-Yellin Foundation of Los Angeles and Advanced Accelerator Applications.

On February 10, 2020 AngioGenex, Inc. (AGGX.PK) (www.angiogenex.com) reported an exclusive agreement with Memorial Sloan Kettering Cancer Center (MSK) to license and advance a series of anti-ID compounds through the regulatory process and into human clinical trials (Press release, Angiogenex, FEB 10, 2020, View Source [SID1234554159]). The company has secured exclusive, worldwide rights to the commercial development of pharmacological treatments based on these molecules. "We are delighted that after decades of basic and translational research aimed at hitting these targets, we will finally be able to determine their benefit to patients" said the Company’s Scientific Advisory Board Chairman and MSK Member Dr. Robert Benezra.

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The scientific team, led by Dr. Benezra, has, in its recent in vitro and in vivo work identified a biological mechanism that allows certain fatal cancers of the liver, brain and breast to regenerate despite their apparent elimination by surgery, chemotherapy or radiation. Recent results indicate a fundamental mechanism, common to a significant group of cancers that allows these diseases to marshal a set of ID proteins which enable their persistent recurrence and lethality.

The anti-ID molecules that AngioGenex is developing include their lead drug AGXA, described in a recent Cell Reports paper (View Source(19)31128-3.pdf), and a new manuscript available online in BioRxiv (View Source). The drugs are intended to disrupt and ultimately disable the cellular pathways by which these intractable cancers repropagate.

The initial clinical trials will be designed to focus on certain cancers of the liver, which, at present, invariably recur and are most often fatal. MSK and AngioGenex contemplate working together to prepare and file an Investigational New Drug (IND) application with the FDA. The company expects to begin the formal process of obtaining FDA approval of its IND application during the first half of 2020. It is the company’s intention to have its IND accepted by the FDA and to begin a Phase 1 clinical trial at MSK within a year of that initial meeting.

Disclosures

Researchers at MSK, including Dr. Robert Benezra, have intellectual property interests associated with the anti-ID compounds. Dr. Robert Benezra is also a co-founder of, holds equity interests in, and serves on the board of directors and on the scientific advisory board of AngioGenex. MSK has financial interests in AngioGenex through an agreement to license intellectual property to the company.

On February 10, 2020, Sorrento Therapeutics, Inc. (the "Company") reported that it has entered into a Common Stock Purchase Agreement (the "Purchase Agreement") with Aspire Capital Fund, LLC, an Illinois limited liability company ("Aspire Capital"), pursuant to which Aspire Capital is committed to purchase up to an aggregate of $75.0 million of shares of the Company’s common stock ("Common Stock") over the 24-month term of the Purchase Agreement on the terms set forth therein (the "Offering") (Filing, 8-K, Sorrento Therapeutics, FEB 10, 2020, View Source [SID1234554139]). Upon execution of the Purchase Agreement, the Company issued and sold to Aspire Capital under the Purchase Agreement 2,991,027 shares of Common Stock at a price per share of $2.5075, for an aggregate purchase price of $7,500,000 (the "Initial Shares").

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In connection with the Offering, the Company entered into a Registration Rights Agreement with Aspire Capital (the "Registration Rights Agreement") on February 10, 2020, pursuant to which the Company agreed to file with the Securities and Exchange Commission (the "SEC") one or more registration statements (each, a "Registration Statement") as necessary to register for sale under the Securities Act of 1933, as amended (the "Securities Act"), the Initial Shares, the Commitment Shares (as defined below) and the additional shares of Common Stock that may be issued to Aspire Capital under the Purchase Agreement (such shares, collectively, the "Aspire Shares"). The Company has filed with the SEC a prospectus supplement to the Company’s effective shelf registration statement on Form S-3 (File No. 333-221443) registering all of the shares of Common Stock that may be offered to Aspire Capital from time to time.

Pursuant to the terms of the Purchase Agreement, on any business day selected by the Company, the Company has the right, but not the obligation, to direct Aspire Capital, by delivering to Aspire Capital a notice (each, a "Purchase Notice"), to purchase on such date (each, a "Purchase Date") the number of shares of Common Stock set forth in the Purchase Notice, in an amount of up to 500,000 shares of Common Stock (subject to adjustment for recapitalizations, stock splits and similar matters), for up to $2,000,000 of the Common Stock in the aggregate (unless otherwise mutually agreed by the Company and Aspire Capital), at a price per share (the "Purchase Price") equal to the lesser of (1) the lowest sale price of the Common Stock on the Purchase Date, and (2) the arithmetic average of the three lowest closing sale prices for the Common Stock during the ten consecutive business days ending on the business day immediately preceding the Purchase Date. The Company and Aspire Capital also may mutually agree to increase the number of shares that may be sold to as much as an additional 4,000,000 shares per business day.

In addition, on any business day on which the Company delivers a Purchase Notice directing Aspire Capital to purchase at least 500,000 shares of Common Stock (subject to any reorganization, recapitalization, stock dividend, stock split, reverse stock split or other similar transaction), the Company has the right, but not the obligation, to direct Aspire Capital, by delivering to Aspire Capital a volume-weighted average purchase notice (each, a "VWAP Purchase Notice"), to purchase on the next business day (each, a "VWAP Purchase Date") the number of shares of Common Stock that is equal to the percentage set forth in the VWAP Purchase Notice (which may not exceed 30%) of the trading volume of the Common Stock on the Nasdaq Capital Market on such VWAP Purchase Date, subject to a maximum number of shares of Common Stock as determined by the Company in its sole discretion. The price per share (the "VWAP Purchase Price") for any shares of Common Stock purchased under a VWAP Purchase Notice will be equal to the lesser of: (a) the closing sale price of the Common Stock on the VWAP Purchase Date, and (b) 97% of the volume-weighted average price of the Common Stock on the Nasdaq Capital Market on the VWAP Purchase Date, subject to certain exceptions.

The Purchase Price and the VWAP Purchase Price will be adjusted for any reorganization, recapitalization, stock dividend, stock split, reverse stock split or other similar transaction occurring during the period(s) used to compute the Purchase Price or the VWAP Purchase Price, as applicable. The Company may deliver multiple Purchase Notices and VWAP Purchase Notices to Aspire Capital from time to time during the term of the Purchase Agreement, so long as the most recent purchase has been completed.

The Purchase Agreement provides that the Company and Aspire Capital will not effect any sales under the Purchase Agreement on any Purchase Date on which the closing sale price of the Common Stock is less than $1.00 (which shall not be subject to adjustment for any reorganization, recapitalization, stock dividend, stock split, reverse stock split or other similar transaction). There are no trading volume requirements or restrictions under the Purchase Agreement, and the Company will control the timing and amount of sales of shares of Common Stock to Aspire Capital. Aspire Capital has no right to require any sales by the Company, but is obligated to make purchases from the Company as directed by the Company in accordance with the Purchase Agreement. There are no limitations on the use of proceeds, financial or business covenants, restrictions on future financings, rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement, other than an agreement by the Company not to issue shares for a period of 30 days following the execution of the Purchase Agreement, subject to certain exceptions. Concurrently with the execution of the Purchase Agreement, and as consideration for Aspire Capital entering into the Purchase Agreement, the Company issued to Aspire Capital 897,308 shares of Common Stock as a commitment fee (the "Commitment Shares"). The Purchase Agreement may be terminated by the Company at any time, for any reason or no reason, without any liability to the Company. Generally, Aspire Capital may terminate the Purchase Agreement at any time that an event of default exists. Pursuant to the Purchase Agreement, Aspire Capital agreed that neither it nor any of its agents, representatives or affiliates will engage in any direct or indirect short-selling or hedging of the Common Stock during the term of the Purchase Agreement. The Company expects to use any proceeds it receives under the Purchase Agreement for working capital and general corporate purposes.

The foregoing descriptions of the Purchase Agreement and the Registration Rights Agreement do not purport to be complete and are qualified in their entirety by reference to the copy of each of the Purchase Agreement and the Registration Rights Agreement, which are filed as Exhibit 10.1 and Exhibit 4.1, respectively, to this Current Report on Form 8-K and incorporated herein by reference.

The representations, warranties and covenants contained in the Purchase Agreement and the Registration Rights Agreement were made solely for the benefit of the parties to the Purchase Agreement and the Registration Rights Agreement, and may be subject to limitations agreed upon by the contracting parties. Accordingly, the Purchase Agreement and the Registration Rights Agreement are incorporated herein by reference only to provide investors with information regarding the terms of the Purchase Agreement and the Registration Rights Agreement, respectively, and not to provide investors with any other factual information regarding the Company or its business, and should be read in conjunction with the disclosures in the Company’s periodic reports and other filings with the SEC.