On March 27, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin and eye cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported to its website results from a survey performed by the Collaborative Ocular Oncology Group (COOG) for the purpose of providing a current practices survey for clinicians regarding management of patients diagnosed with uveal melanoma and other ocular tumors during the COVID-19 pandemic (Press release, Castle Biosciences, MAR 27, 2020, View Source [SID1234555952]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Collaborative Ocular Oncology Group (COOG) represents most major ocular oncology centers in North America who manage patients with uveal melanoma and other ocular tumors. Twenty-three of twenty-five COOG members were able to complete the survey.

The COOG conducted an on-line survey study between March 25-26, 2020, in order to survey current management practices for patients with a range of eye tumors, including uveal melanoma, high risk choroidal nevus, retinoblastoma, intraocular metastasis, vitreoretinal lymphoma, benign intraocular tumors, conjunctival melanoma, conjunctival squamous cell carcinoma/ocular surface squamous neoplasia (OSSN), and conjunctival lymphoma.

"Telemedicine is of limited value in patients with active intraocular cancers, due to the need for specialized ophthalmic imaging, whereas it may be of more benefit in patients with treated inactive tumors, and those with ocular surface conjunctival tumors, in which the patient can take photos of the eye with their smartphone," said J. William Harbour, M.D., the Mark J. Daily Endowed Professor of Ophthalmology, Vice Chairman for Translational Research, and Director of Ocular Oncology at Bascom Palmer Eye Institute, Associate Director for Basic Research at Sylvester Comprehensive Cancer Center, and chair of the COOG. "Given these challenges, we conducted a survey of COOG investigators across North America to obtain a snapshot of current practices during the COVID-19 pandemic. Currently, most ocular oncology experts continue to promptly see new patients with eye cancers, such as uveal melanoma, retinoblastoma, intraocular metastasis and vitreoretinal lymphoma. In contrast, many experts would delay by at least a few weeks the return of established eye cancer patients who have been treated and are stable, and those with benign or low-grade tumors."

Summary results are attached, and detailed results are available on the Castle Biosciences DecisionDx-UM page: View Source The attached results were prepared by the COOG, and Castle Biosciences makes no representation or warranty as to their accuracy or completeness.

About DecisionDx-UM

DecisionDx-UM is a 15-gene expression profiling (GEP) test that uses an individual patient’s tumor biology to predict individual risk of metastasis. DecisionDx-UM is considered to be standard of care in the management of uveal melanoma in the majority of ocular oncology practices in the United States. Since 2009, the American Joint Committee on Cancer (AJCC; v7 and v8) Staging Manual for UM has specifically identified the GEP test as a prognostic factor that is recommended for collection as a part of clinical care. Further, the National Comprehensive Cancer Network (NCCN) guidelines for uveal melanoma include the DecisionDx-UM test result as a prognostic method for determining risk of metastasis and recommended differential surveillance regimens based on a Class 1A, 1B, and 2 result. DecisionDx-UM is the only prognostic test for uveal melanoma that has been validated in prospective, multi-center studies and it has been shown to be a superior predictor of metastasis compared to other prognostic factors such as chromosome 3 status, mutational status, AJCC stage, and cell type.

It is estimated that nearly 8 in 10 patients diagnosed with uveal melanoma in the U.S. receive the DecisionDx-UM test as part of their initial diagnostic workup. More information about the test and disease can be found at www.MyUvealMelanoma.com.

On March 27, 2020 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported financial results for the year ended December 31, 2019 and provided a corporate update (Press release, Altimmune, MAR 27, 2020, View Source [SID1234555951]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"2019 was a productive year for the Company with the acquisition of ALT-801, a supplemental award for the development of NasoShield from BARDA, and the advancement of ALT-702 as a preclinical program," said Vipin K. Garg, Ph.D., President and Chief Executive Officer. "However, we all find ourselves in a very different world in 2020 with the COVID-19 global pandemic causing substantial disruption to many of our lives."

Dr. Garg continued, "We face an unprecedented time, which will require companies, organizations, academic institutions, and governments to come together as a united front against this pandemic. At Altimmune, we believe we can leverage our intranasal vaccine technology platform and experience with both influenza and anthrax to rapidly develop a COVID-19 vaccine candidate. Our entire Company is working tirelessly to address this crisis as we progress our vaccine candidate for COVID-19 towards the initiation of a Phase 1 clinical trial as early as Q3 of this year. We believe our vaccine platform has the potential to offer specific and substantial benefits to address a pandemic situation, and we will continue to press forward in our effort to address this challenge."

Corporate Update and 2019 Highlights

2020 Activity:

Initiated development of "AdCOVID", our single-dose intranasal COVID-19 vaccine candidate

Utilizing our proprietary intranasal vaccine technology, the Company began development of AdCOVID, a vaccine candidate to protect against COVID-19. We believe, our vaccine technology is particularly well positioned to respond to pandemic respiratory infections as it combines intranasal dosing, a broad, rapid immune response and room temperature stability with avoidance of cold chain shipping requirements, making it easier to distribute across communities. The Company designed and created the vaccine candidate in February and plans to begin animal testing in Q2 2020. The Company is engaged in discussions with a number of organizations who are addressing this crisis, including The United States Medical Countermeasures Task Force, The World Health Organization, academia, and other institutions engaged in the effort.
Announced positive results for ALT-702 in a preclinical model of colorectal cancer

ALT-702 met a key preclinical milestone with the demonstration of systemic antitumor activity in a preclinical model of colorectal cancer following its local injection into solid tumors. ALT-702 is a depot-forming immune stimulant candidate designed to safely activate tumor immunity. In these studies, regression of both treated and non-treated tumors was observed following combination treatment with ALT-702 and a CTLA-4 immune checkpoint inhibitor, with overall survival in the combination group markedly better than either agent alone. These findings highlight the potential benefits of ALT-702 in both local and metastatic disease and support continued development activities.
2019 Activity:

Acquired Spitfire Pharma, Inc. with NASH Candidate ALT-801

The Company acquired Spitfire Pharma, Inc. including the product candidate ALT-801, a potent GLP-1/Glucagon receptor dual agonist for the treatment of non-alcoholic steatohepatitis (NASH). ALT-801 is a peptide-based therapeutic candidate with balanced agonist activity on the GLP-1 and glucagon receptors and a differentiated PK profile to improve tolerability. ALT-801 is designed to treat obesity, the basic underlying cause of NASH, the most severe form of non-alcoholic fatty liver disease (NAFLD). The Company is preparing for a Phase 1 clinical trial anticipated to begin in 2020.
Awarded $3.7 million BARDA funding for NasoShield Phase 1b trial

In Q3, the Company modified its existing anthrax vaccine development contract with the Biomedical Advanced Research and Development Authority (BARDA), resulting in $3.7 million of additional funding. The supplemental funding will support the initiation and conduct of a Phase 1b clinical trial of NasoShield in 2020 to evaluate alternative methods of intranasal dosing in humans. NasoShield is being developed as a single-dose, intranasal post-exposure anthrax vaccine, and is the only anthrax product candidate supported by BARDA. We believe it offers potentially transformational improvements over the current two and three dose vaccines. The NasoShield program is funded through a contract with BARDA (HHSO100201600008C), with a total potential value of $133.7 million if all options in the contact are exercised.
Financial Results for the Year Ended December 31, 2019

At December 31, 2019, the Company had cash, cash equivalents and short-term investments of $37.3 million.
Revenue was $5.8 million for the year ended December 31, 2019 compared to $10.3 million in the prior year. The change was due to a decrease in billings under the Company’s U.S. government contracts due to timing of manufacturing and clinical trials for the NasoShield program and the 2018 completion of the primary activities under the SparVax-L contract.
Research and development expenses were $17.8 million for the year ended December 31, 2019 compared to $18.5 million in the prior year period. The decrease was attributable to lower manufacturing and clinical trial costs on existing programs offset by IPR&D expense recognized in conjunction with the acquisition of Spitfire Pharma, Inc.
General and administrative expenses were $8.5 million for the year ended December 31, 2019 compared to $9.8 million in the prior year period. The decrease was attributable to lower compensation, professional services and legal costs; offset by an increase in insurance premiums.
Impairment charges were $1.0 million for the year ended December 31, 2019 compared to $24.9 million for the prior year. Impairment in both years was due primarily to the SparVax-L program as the development contract with NIAID ended in Q3 2019, with no further funding identified. As disclosed by BARDA, U.S. government funding for anthrax will now focus on post-exposure vaccines that offer transformational improvements over a two-dose vaccine. Since SparVax-L was being developed as a two-dose vaccine candidate and our NasoShield program fits the government’s funding profile with active funding, additional development of SparVax-L is not expected.
Other income (expense) was $0.9 million for the year ended December 31, 2019 compared to ($2.5) million in the prior year. The 2019 activity is attributable to interest income earned on cash and investments while the 2018 expense was primarily due to changes in the fair value of the Company’s warrant liability, including loss on exchange.
Net loss attributed to common stockholders for the year ended December 31, 2019 was $20.97 million, or ($1.60) per share, compared to $42.48 million in the prior year, or ($15.16) per share. The difference in net loss is primarily attributable to the $24.9 million impairment recognized in 2018.
Conference Call Information

Altimmune will host a conference call to discuss the company’s year end results and other business information.

Date: Friday, March 27, 2020
Time: 8:30 am Eastern Time
Domestic: 877-423-9813
International: 201-689-8573
Conference ID: 13701071
Webcast: View Source
Following the conclusion of the call, the webcast will be available for replay on the Investor Relations page of the Company’s website at www.altimmune.com. The company has used, and intends to continue to use, the investor relations portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD.

On March 27, 2020 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported financial results for the year ended December 31, 2019 (Press release, Can-Fite BioPharma, MAR 27, 2020, View Source [SID1234555950]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Clinical Developments and Corporate Highlights Include:

Piclidenoson as Potential Treatment for Coronavirus – Piclidenoson’s anti-rheumatic and anti-viral effects, combined with its excellent safety profile, make it a potential candidate for the treatment of coronavirus. Can-Fite recently submitted Piclidenoson to the Institutional Review Board at Rabin Medical Center for a compassionate use program to treat coronavirus patients. If approved, the compassionate use program will be led by Dr. Dror Diker, M.D., Head of Internal Medicine D at the Rabin Medical Center. Concurrently, through a collaborative research agreement with the Lewis Katz School of Medicine at Temple University in Philadelphia, Can-Fite is conducting studies on the anti-viral activity of Piclidenoson on the coronavirus. The anti-viral effect of Piclidenoson is protected by US patent US7589075. Rheumatoid arthritis drugs are now being evaluated for the treatment of coronavirus in global studies, and China recently approved the use of Roche’s Actemra, a rheumatoid arthritis drug, to treat coronavirus.

Namodenoson Phase II NASH Data Expected in April 2020 – Can-Fite completed enrollment of 60 patients with NAFLD (non-alcoholic fatty liver disease) with or without NASH (non-alcoholic steatohepatitis), and plans to announce topline results during April 2020. The end points of this study include serum ALT levels, percentage change in liver fat, as measured by PDFF (proton density fat fraction), weight loss and additional serum parameters.

Namodenoson is Headed into Pivotal Phase III Liver Cancer Study – Following a successful End-of-Phase II Meeting with the U.S. Food and Drug Administration (FDA) regarding Namodenoson in the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer, the FDA agreed with Can-Fite’s proposed pivotal Phase III trial design to support a New Drug Application submission and approval. The Phase III study protocol and registration plan have also been submitted to the European Medicines Agency (EMA). Namodenoson is currently being used to treat liver cancer patients in a compassionate use program in Israel, which has enrolled seven patients. In addition, two patients who were enrolled in the Company’s former Phase II study, who responded well to the drug, are continuing treatment. Those two advanced liver cancer patients have reached an overall survival of over 2.5 years while being treated with Namodenoson.

Piclidenoson Phase III Rheumatoid Arthritis and Psoriasis Studies Complete 50% Enrollment; Interim Data for Rheumatoid Arthritis Expected Q4 2020 – Can-Fite continues to enroll patients in its Phase IIII study for psoriasis. An interim analysis is being implemented for the rheumatoid arthritis study. Data will be monitored by an independent data monitoring committee (IDMC) which will have un-blinded access to the data in Q3 2020, with an announcement of interim results expected in Q4 2020.

Developing Cannabinoid-based Drug Candidates – During 2019, Can-Fite signed an agreement with Univo Pharmaceuticals (TASE:UNVO), a medical cannabis company, to identify and co-develop specific formulations of cannabis components for the treatment of diseases in which there is an overexpression of A3AR, Can-Fite’s target. Based on its recent scientific findings, Can-Fite has filed patents for the use of cannabinoid-based drugs to treat cancer, autoimmune, inflammatory and metabolic diseases. The Company’s most recent research revealed that cannabis-derived CBD enriched fractions inhibit fat cell expansion and have beneficial effects against liver cancer.

Cash Infusion of $11 Million from Distribution Deals and Equity Raise – During 2019, Can-Fite raised a total of $9.2 million through equity offerings, and received upfront payments from distribution agreements for its drugs in specific territories and indications in the amount of $1.75 million. The upfront payments from distributors were part of agreements that totaled $10 million plus royalties based on the achievement of milestones. Following the end of 2019, Can-Fite received an additional cash infusion of $8.4 million through a combination of $5 million raised through an equity offering and $3.4 million through cash exercises of warrants.

"We are focused on delivering our advanced stage drug candidates to meet the immediate medical needs of patients who lack safe and effective treatments to life threatening conditions. This includes Piclidenoson for the treatment of coronavirus and Namodenoson for advanced liver cancer," stated Can-Fite CEO Pnina Fishman. "In 2019, we achieved very significant progress in our Phase III trials of Piclidenoson and are now over 50% complete with patient enrollment. In 2020, we are well positioned for achieving milestones which we believe may generate more non-dilutive funding for Can-Fite through new global distribution agreements, as well as trigger milestone payments from our current agreements."

Financial Results

Revenues for the year ended December 31, 2019 were $2.0 million, a decrease of $1.8 million, or 47.3%, compared to $3.8 million for the year ended December 31, 2018. The decrease in revenue was mainly due to the recognition of a $2 million advance payment received in August 2018 under the License, Collaboration and Distribution Agreement with CMS Medical.

Research and development expenses for the year ended December 31, 2019 were $10.9 million, an increase of $4.9 million, or 81.6%, compared to $6 million for the year ended December 31, 2018. Research and developments expenses for the year ended 2019 comprised primarily of expenses associated with the Phase II studies for Namodenoson and Phase III studies of Piclidenoson. The increase is primarily due to increased costs associated with the initiation of the Phase III clinical trial of Piclidenoson for the treatment of rheumatoid arthritis. We expect that the research and development expenses will increase through 2020 and beyond.

General and administrative expenses were $3.0 million for the year ended December 31, 2019 a decrease of $0.1 million, or 3.1%, compared to $3.1 million for the year ended December 31, 2018. The decrease is primarily due to decrease in investor relations expense and a decrease in salary and related expenses which was partly offset by an increase in insurance expenses. We expect that general and administrative expenses will remain at the same level through 2020.

Financial income, net for the year ended December 31, 2019 were $2.4 million compared to financial expenses, net of $1.1 million in the same period in 2018. The decrease in financial expense, net was mainly due to decrease in a loss from short-term investment revaluation and increase in income from changes in fair value of warrants liability exercisable into shares.

Net loss for the year ended December 31, 2019 was $9.5 million compared with a net loss of $6.6 million for the year ended December 31, 2018. The increase in net loss for the year ended December 31, 2019 was primarily attributable to decrease in revenues in 2019 and an increase in research and development expenses which were partly offset by an increase in finance income, net.

As of December 31, 2019, Can-Fite had cash and cash equivalents of $2.7 million as compared to $3.6 million at December 31, 2018. The decrease in cash during the year ended December 31, 2019 is due to increase in net cash provided by financing activity which was offset by an increase in net cash used in operating activity. In February 2020, Can-Fite raised $5 million in a registered direct offering, and in January and March 2019 the Company received approximately $3.4 million through warrant exercises.

More detailed information can be found in the Company’s Annual Report on Form 20-F for the fiscal year ended December 31, 2019, a copy of which has been filed with the Securities and Exchange Commission (SEC). The Annual Report, which contains the Company’s audited consolidated financial statements, can be accessed on the SEC’s website at View Source as well as via the Company’s investor relations website at View Source The Company will deliver a hard copy of its Annual Report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request to Can-Fite Investor Relations at 10 Bareket Street, Kiryat Matalon, Petah-Tikva 4951778, Israel or by phone at +972-3-9241114.

On March 27, 2020 CStone Pharmaceuticals ("CStone" or the "Company", HKEX: 2616) reported that the Company has submitted a New Drug Application (NDA) to the Taiwan Food and Drug Administration (TFDA) for avapritinib, a precision therapy being developed for the treatment of gastrointestinal stromal tumor (GIST), and had received priority review designation from the TFDA on March 9, 2020 (Press release, CStone Pharmaceauticals, MAR 27, 2020, View Source [SID1234555949]). This NDA is for the indication of adult patients with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations. Discovered by CStone’s partner, Blueprint Medicines, avapritinib is the second drug candidate for which CStone has submitted an NDA.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Within just one year, CStone has submitted NDAs for two first-in-class targeted-therapies, demonstrating our commitment to addressing urgent clinical needs and the Company’s rapid transformation toward commercialization," said Dr. Frank Jiang, Chairman and CEO of CStone. "GIST is a rare tumor type, and PDGFRA D842V mutant GIST is resistant to currently approved therapies in Greater China. In addition to Taiwan, we plan to submit an NDA for the same indication in Mainland China in the first half of this year with the goal of benefitting more patients suffering from this devastating condition."

"Avapritinib is an investigational, orally available, potent, and selective inhibitor of KIT and PDGFRA. In January this year, avapritinib received an approval from the U.S. FDA for the treatment of adults with unresectable or metastatic PDGFRA exon 18 mutant GIST and became the first and only U.S. FDA-approved targeted therapy for this indication," said Dr. Jason Yang, Chief Medical Officer of CStone. "Clinical data submitted to the TFDA show unprecedented antitumor activity of avapritinib in advanced GIST patients with a PDGFRA exon 18 mutation, including PDGFRA D842V mutations, with an overall response rate (ORR) of 84% and most adverse events reported as Grade 1 or 2. In addition, the median duration of response (DOR) was not reached and 61% of these patients had a DOR ≥6 months. "

GIST is the most common mesenchymal tumor of the GI tract, and it is most prevalent in patients aged 50 to 80. Around 90% of all GIST cases are associated with dysregulated cell growth due to mutations in KIT and PDGFRA tyrosine kinases. As GIST patients do not respond well to chemotherapy and radiotherapy, current treatment for advanced GIST is primarily based on sequential treatment with tyrosine kinase inhibitors (TKIs). However, GIST patients harboring PDGFRA D842V mutations are not sensitive to existing approved TKIs in Greater China, with studies showing an ORR of 0%, a median progression-free survival of just three to five months, and a median overall survival of about 15 months1. Similarly, these approved therapies have shown limited effects against other rare PDGFRA exon 18 mutations.

CStone Pharmaceuticals and Blueprint Medicines have an exclusive collaboration and license agreement for the development and commercialization of avapritinib and certain other drug candidates in Mainland China, Hong Kong, Macau and Taiwan. Blueprint Medicines retains development and commercial rights for these licensed products in the rest of the world.

About Avapritinib

Avapritinib is an investigational, selective and potent inhibitor of KIT and PDGFRA mutant kinases. It is a type 1 inhibitor that works by directly binding to the active kinase conformation from which mutant KIT and PDGFRA signal. Avapritinib has demonstrated inhibition of a broad range of KIT and PDGFRA mutations associated with GIST, including potent clinical activity against activation loop mutations that are associated with resistance to currently approved therapies in Greater China.

Blueprint Medicines is pursuing a broad clinical development program for avapritinib across multiple lines of GIST treatment, as well as for advanced, smoldering and indolent systemic mastocytosis.

Avapritinib is a kinase inhibitor approved by the U.S. FDA under the brand name AYVAKIT for the treatment of adults with unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations.

Avapritinib is not approved for the treatment of any other indication in the U.S. or for the treatment of any indication by the TFDA in Taiwan, by the National Medical Products Administration in China or by any other health authority in any other jurisdiction.

On March 27, 2020, Vaccinex, Inc. (the "Company") reported that it has entered into an Open Market Sale AgreementSM (the "Sale Agreement") with Jefferies LLC ("Jefferies"), under which the Company may issue and sell shares of its common stock, par value $0.0001 per share (the "Common Stock"), from time to time for an aggregate sales price of up to $11,500,000 through Jefferies as sales agent (the "ATM Offering") (Filing, 8-K, Vaccinex, MAR 27, 2020, View Source [SID1234555948]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Sales of the Common Stock, if any, under the Sale Agreement will be made by any method that is deemed to be an "at the market" offering as defined in Rule 415(a)(4) of the Securities Act of 1933, as amended (the "Securities Act"), including but not limited to sales made directly on or through the Nasdaq Capital Market or any other existing trading market for the Common Stock. Subject to the terms and conditions of the Sale Agreement, Jefferies will use its commercially reasonable efforts to sell the Common Stock from time to time, as the sales agent, based upon the Company’s instructions.

The Company has no obligation to sell Common Stock pursuant to the Sale Agreement and may at any time suspend offers under the Sale Agreement or terminate the Sale Agreement.

The Company has provided Jefferies with customary indemnification rights and Jefferies will be entitled to a commission at a fixed commission rate in an amount equal to 3.0% of the gross proceeds for each sale of the Common Stock.

This description of the Sale Agreement does not purport to be complete and is qualified in its entirety by reference to the Sale Agreement, which is attached hereto as Exhibit 10.1 and incorporated by reference herein.

The Common Stock to be sold under the Sale Agreement, if any, will be issued and sold pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-236416), previously filed with the Securities and Exchange Commission ("SEC") on February 13, 2020 and declared effective by the SEC on March 11, 2020 (the "Registration Statement"). On March 27, 2020, the Company filed a prospectus supplement with the SEC in connection with the offer and sale of the Common Stock pursuant to the Sale Agreement. This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the Common Stock under the Sale Agreement nor shall there be any sale of the Common Stock in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.