On August 7, 2020 Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE technology, reported its Q2 2020 financial results and provides a business update (Press release, Pulmatrix, AUG 7, 2020, View Source [SID1234563149]).

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"The second quarter has been marked with important progress for our strategic partnership with Sensory Cloud," said Ted Raad, Chief Executive Officer of Pulmatrix. "The recent publication of data demonstrating the ability of FEND to suppress the exhalation of respiratory droplets, which can transmit airborne infections, leaves us confident that our proprietary NasoCalm technology can be applied to provide an important new OTC hygiene option for addressing the spread of COVID-19. We look forward to an anticipated commercial launch in the fall of this year and believe the royalty stream from the commercialization of FEND, upon the commencement of sales, could be an important source of non-dilutive funding to fuel our internal development pipeline."

Mr. Raad continued, "Together with our partner Cipla, we decided to end our Phase 2 clinical study of Pulmazole for the treatment of asthma patients with ABPA. We are leveraging this pause in our development program to prepare for a new Phase 2b study of longer study duration and inclusion of efficacy endpoints that are intended to better inform and propel the program forward. While we prepare for a potential study start in 3Q 2021, we are working with Cipla to amend the Phase 2 development and commercialization agreement to include the new Phase 2b development plan and budget. In our partnership with Johnson & Johnson, we achieved a significant milestone with the MRHA approval of the PUR1800 Ph1b study, enabling us to start the study in 2H 2020."

Q2 and Recent Highlights:

●Announced partner Sensory Cloud’s progress towards the commercialization of FEND, an over the counter (OTC) nasal hygiene product that is comprised of proprietary Pulmatrix NasoCalm formulations (PUR003 and PUR006) of sodium chloride and calcium chloride salts licensed from Pulmatrix. FEND is designed to provide, among other potential benefits, an ability to suppress the exhalation of droplets of airway lining fluid, which can transmit airborne infection with an anticipated commercial launch in the fall of 2020. Pulmatrix will receive escalating royalties from worldwide revenues upon commencement of sales.

●Announced the publication of NasoCalm development data, along with data generated by Sensory Cloud, in the Quarterly Reviews of Biophysics, demonstrating a reduction in airborne particles in exhaled air over time following FEND administration. These data suggest FEND provides hygienic benefit that may augment current social distancing and hygiene measures for addressing the spread of COVID-19 and other airborne pathogens.

●Due to past enrollment delays, coupled with the impact of the COVID-19 pandemic on enrollment, Pulmatrix and Cipla ended its Phase 2 clinical study of Pulmazole for the treatment of allergic bronchopulmonary Aspergillosis (ABPA). Pulmatrix intends to initiate a new Phase 2b clinical study in 3Q 2021 with up to four months of dosing and the addition of trial efficacy endpoints, replacing the Phase 2 clinical study which focused on safety and tolerability endpoints. Top-line data is anticipated 18 months after site activation start. Due to the changes in the development of Pulmazole, Pulmatrix and Cipla are negotiating amendments to the development and commercialization agreement.

●The Medicines and Healthcare Products Regulatory and Approval Agency (MHRA) approved in July the PUR1800 Ph1b clinical trial, enabling Pulmatrix plans to begin the study in the United Kingdom during 2H 2020.

●Appointed Chris Cabell, M.D. to the Pulmatrix Board of Directors. As current Head of Research & Development and Chief Medical Officer at Arena Pharmaceuticals, with prior experience as Chief Medical and Scientific Officer at Quintiles, Dr. Cabell possesses the critical skills that will be beneficial in the strategy for Pulmatrix pipeline programs. Steven Gills, Ph.D., will step down from the Board of Directors on September 1, 2020.

●Strengthened balance sheet with gross proceeds from a registered direct offering in April and a warrant exercise transaction in July, in order to support ongoing preclinical and anticipated clinical programs for Pulmazole, PUR1800, other pipeline assets and general working capital needs.

Financials

As of June 30, 2020, Pulmatrix had $27.3 million in cash compared to $23.4 million as of December 31, 2019.

Pulmatrix generated $3.5 million of revenue in the second quarter of 2020, compared to $4.8 million in the second quarter of 2019. The revenue for the first quarter of 2020 was the result of the collaboration and licensing agreements with Cipla and JJEI, respectively.

Research and development expenses for the second quarter of 2020 and 2019 were $3.2 million. Included in the second quarter of 2020 costs were pre-clinical toxicology costs for the PUR1800 program and clinical study costs incurred for the Phase 2 Pulmazole study.

General and administrative expenses for the second quarter of 2020 were $1.5 million compared to $3.1 million in the second quarter of 2019. The decrease of $1.6 million was due to decreased spend in employment costs primarily as a result of reduced share-based compensation expense of $1.1 million in 2020, a $0.3 million milestone payment in 2019 and a $0.2 million reduction in legal and patent expense in 2020.

Net loss was $1.2 million for the first quarter of 2020 and $7.8 million for the first quarter of 2019. The net loss for both periods was due to spend on the Pulmazole study and PUR1800 manufacturing costs for the upcoming planned Phase 1b clinical study.

On August 7, 2020 Pulmatrix (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE technology, reported its Q2 2020 financial results and provides a business update (Press release, Pulmatrix, AUG 7, 2020, View Source [SID1234563148]).

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"The second quarter has been marked with important progress for our strategic partnership with Sensory Cloud," said , Chief Executive Officer of Pulmatrix. "The recent publication of data demonstrating the ability of FEND to suppress the exhalation of respiratory droplets, which can transmit airborne infections, leaves us confident that our proprietary NasoCalm technology can be applied to provide an important new OTC hygiene option for addressing the spread of COVID-19. We look forward to an anticipated commercial launch in the fall of this year and believe the royalty stream from the commercialization of FEND, upon the commencement of sales, could be an important source of non-dilutive funding to fuel our internal development pipeline."

Mr. Raad continued, "Together with our partner Cipla, we decided to end our Phase 2 clinical study of Pulmazole for the treatment of asthma patients with ABPA. We are leveraging this pause in our development program to prepare for a new Phase 2b study of longer study duration and inclusion of efficacy endpoints that are intended to better inform and propel the program forward. While we prepare for a potential study start in 3Q 2021, we are working with Cipla to amend the Phase 2 development and commercialization agreement to include the new Phase 2b development plan and budget. In our partnership with Johnson & Johnson, we achieved a significant milestone with the MRHA approval of the PUR1800 Ph1b study, enabling us to start the study in 2H 2020."

Q2 and Recent Highlights:

Announced partner Sensory Cloud’s progress towards the commercialization of FEND, an over the counter (OTC) nasal hygiene product that is comprised of proprietary Pulmatrix NasoCalm formulations (PUR003 and PUR006) of sodium chloride and calcium chloride salts licensed from Pulmatrix. FEND is designed to provide, among other potential benefits, an ability to suppress the exhalation of droplets of airway lining fluid, which can transmit airborne infection with an anticipated commercial launch in the fall of 2020. Pulmatrix will receive escalating royalties from worldwide revenues upon commencement of sales.
Announced the publication of NasoCalm development data, along with data generated by Sensory Cloud, in the Quarterly Reviews of Biophysics, demonstrating a reduction in airborne particles in exhaled air over time following FEND administration. These data suggest FEND provides hygienic benefit that may augment current social distancing and hygiene measures for addressing the spread of COVID-19 and other airborne pathogens.
Due to past enrollment delays, coupled with the impact of the COVID-19 pandemic on enrollment, Pulmatrix and Cipla ended its Phase 2 clinical study of Pulmazole for the treatment of allergic bronchopulmonary Aspergillosis (ABPA). Pulmatrix intends to initiate a new Phase 2b clinical study in 3Q 2021 with up to four months of dosing and the addition of trial efficacy endpoints, replacing the Phase 2 clinical study which focused on safety and tolerability endpoints. Top-line data is anticipated 18 months after site activation start. Due to the changes in the development of Pulmazole, Pulmatrix and Cipla are negotiating amendments to the development and commercialization agreement.
The Medicines and Healthcare Products Regulatory and Approval Agency (MHRA) approved in July the PUR1800 Ph1b clinical trial, enabling Pulmatrix plans to begin the study in the United Kingdom during 2H 2020.
Appointed Chris Cabell, M.D. to the Pulmatrix Board of Directors. As current Head of Research & Development and Chief Medical Officer at Arena Pharmaceuticals, with prior experience as Chief Medical and Scientific Officer at Quintiles, Dr. Cabell possesses the critical skills that will be beneficial in the strategy for Pulmatrix pipeline programs. Steven Gills, Ph.D., will step down from the Board of Directors on September 1, 2020.
Strengthened balance sheet with gross proceeds from a registered direct offering in April and a warrant exercise transaction in July, in order to support ongoing preclinical and anticipated clinical programs for Pulmazole, PUR1800, other pipeline assets and general working capital needs.
Financials

As of June 30, 2020, Pulmatrix had $27.3 million in cash compared to $23.4 million as of December 31, 2019.

Pulmatrix generated $3.5 million of revenue in the second quarter of 2020, compared to $4.8 million in the second quarter of 2019. The revenue for the first quarter of 2020 was the result of the collaboration and licensing agreements with Cipla and JJEI, respectively.

Research and development expenses for the second quarter of 2020 and 2019 were $3.2 million. Included in the second quarter of 2020 costs were pre-clinical toxicology costs for the PUR1800 program and clinical study costs incurred for the Phase 2 Pulmazole study.

General and administrative expenses for the second quarter of 2020 were $1.5 million compared to $3.1 million in the second quarter of 2019. The decrease of $1.6 million was due to decreased spend in employment costs primarily as a result of reduced share-based compensation expense of $1.1 million in 2020, a $0.3 million milestone payment in 2019 and a $0.2 million reduction in legal and patent expense in 2020.

Net loss was $1.2 million for the first quarter of 2020 and $7.8 million for the first quarter of 2019. The net loss for both periods was due to spend on the Pulmazole study and PUR1800 manufacturing costs for the upcoming planned Phase 1b clinical study.

On August 6, 2020 Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it has entered into a $50 million Revenue Interest Financing ("RIF") agreement with Sagard Healthcare Royalty Partners, LP ("SHRP"), a division of multi-strategy alternative asset manager Sagard Holdings (the "Agreement") (Press release, Athenex, AUG 6, 2020, View Source [SID1234573874]). The Company expects the proceeds from the financing will be used to fund the commercial launch of oral paclitaxel and encequidar (Oral Paclitaxel), ongoing pipeline development, manufacturing infrastructure, and working capital and general corporate purposes.

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The Agreement provides Athenex with $50 million of capital upon approval by the U.S. Food and Drug Administration (FDA) of Oral Paclitaxel for the treatment of metastatic breast cancer. In exchange for funding this capital, SHRP will receive a temporary mid-single digit royalty on net sales of Oral Paclitaxel. The agreement allows the RIF to be repurchased by the Company at an IRR of as low as 13%. The facility has no maturity date and no fixed amortization schedule. Further information with respect to the facility is set forth in a Form 8-K filed by Athenex with the Securities and Exchange Commission on August 6, 2020.

In addition to its Revenue Interest Financing, SHRP and certain of its co-investors have purchased by assignment $50 million of outstanding loans and undrawn commitments from funds managed by Oaktree Capital Management, L.P. ("Oaktree"), becoming lenders under Athenex’s $225 million term loan facility entered into between Oaktree and Athenex in June 2020. There is no incremental capital available to Athenex as a result of this transaction.

"We are delighted to have Sagard Healthcare Royalty Partners as another financial partner, as Athenex continues to make excellent progress towards our goal of bringing important novel cancer therapies like Oral Paclitaxel to patients," said Dr. Johnson Lau, Chairman and Chief Executive Officer of Athenex. "The recent funding arrangements will provide Athenex further flexibility and cash runway to support our commercial launch activities and ongoing pipeline development. We believe that this Revenue Interest Financing transaction is precedent setting in that it would provide $50 million of additional non-dilutive capital that co-exists with the covenant-light, 6-year $225 million senior term debt provided by Oaktree."

"Revenue Interest Financing is becoming an increasingly attractive option for innovative companies such as Athenex as they look to commercialize novel therapies. We’re excited to be providing this funding and to be partnering with Oaktree Capital Management on the loan facility," said David MacNaughtan, Head of SHRP, which recently completed a second close of its inaugural fund.

Ladenburg Thalmann & Co. Inc. and Royalty/Revenue Interest Capital Advisors LLC served as financial advisors to Athenex and Cooley LLP served as legal counsel to Athenex. Torys LLP served as legal counsel to Sagard Holdings.

On August 6, 2020 Immatics N.V. (NASDAQ: IMTX; "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell redirecting cancer immunotherapies, reported the extension of its cell therapy manufacturing collaboration with The University of Texas Health Science Center at Houston (UTHealth), in Houston, Texas (Press release, Immatics Biotechnologies, AUG 6, 2020, View Source [SID1234569554]). The continued collaboration grants Immatics access to UTHealth’s state-of-the-art cGMP manufacturing infrastructure at the Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory, enabling continued production and supply of Immatics’ specialized, cell-based product candidates for testing in multiple clinical trials. Maximum capacity of the facility is anticipated at 48 ACTengine T cell products per month. The new agreement will run until the end of 2024. Under the agreement, UTHealth will provide Immatics with exclusive access to three cGMP suites and support areas for the manufacturing of various Adoptive Cell Therapy (ACT) products. Therapeutic T cell production will be carried out by Immatics’ manufacturing personnel and will be supported by a UTHealth-Immatics joint quality team.

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Steffen Walter, Ph.D., Chief Technology Officer at Immatics, commented: "During the last five years, we have established a strong and productive partnership with UTHealth that has enabled the initiation of four ongoing clinical trials. As we remain focused on the development of our clinical pipeline, this extension of our collaboration with UTHealth will fulfill Immatics’ manufacturing needs for our early-stage ACT clinical programs for the next four years. Being able to rely on a partner with profound cell therapy expertise who is familiar with our technologies and can support cGMP cell therapy production is critical to ensuring the advancement of our clinical trials. We look forward to continuing this fruitful collaboration with the experts at UTHealth."

Fabio Triolo, D.d.R., M.Phil., Ph.D., The Clare A. Glassell Distinguished Chair and Director of the Cellular Therapy Core at UTHealth, added: "Signing the extended contract with Immatics fits into our strategy at UTHealth of supporting the development of new treatments for patients in need. We therefore look forward to continuing our collaboration and further leveraging the potential of our manufacturing capabilities."

About Immatics’ ACT Programs
ACTengine is a personalized approach in which the patient’s own T cells are genetically modified to express a novel proprietary TCR cognate to one of Immatics’ proprietary cancer targets which are then reinfused back into the patient. Immatics’ latest proprietary ACTengine manufacturing processes are designed to generate cell product candidates within a short six day manufacturing window and to deliver highly proliferative T cells, with the capability to infiltrate the patient’s tumor and function in a challenging solid tumor microenvironment. The process is designed to rapidly produce younger, better-persisting T cells capable of "serial" killing tumor cells in vitro. Immatics’ is further advancing the ACT concept beyond individualized manufacturing with its product class ACTallo which is being developed to generate "off-the-shelf" cellular therapies.

On August 6, 2020 Prothena Corporation plc (NASDAQ:PRTA), a clinical-stage company with expertise in protein dysregulation and a diverse pipeline of investigational therapeutics for neurodegenerative and rare peripheral amyloid diseases, reported financial results for the second quarter and first six months of 2020 (Press release, Prothena, AUG 6, 2020, View Source [SID1234568679]). In addition, the Company provided an update on its R&D programs.

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"We continue to expect multiple clinical data read-outs later this year across our pipeline," said Gene Kinney, Ph.D., President and Chief Executive Officer of Prothena. "New data from Part 1 of the Phase 2 prasinezumab study (PASADENA) in Parkinson’s disease, being conducted by Roche will be presented in an oral presentation next month at the Movement Disorders Society congress, and additional data from our Phase 1 study of PRX004 in ATTR amyloidosis are expected in the fourth quarter. In addition, we are making excellent progress on our early-stage pipeline targeting a range of neurological indications and look forward to sharing preclinical data from programs in our Alzheimer’s disease portfolio later this year."

Second Quarter Research and Development Updates and Upcoming Milestones

Prasinezumab (PRX002/RG7935), a potential treatment for Parkinson’s disease, is a monoclonal antibody designed to target alpha-synuclein and is the focus of the worldwide collaboration with Roche

Part 1 of the Phase 2 PASADENA study in patients with early Parkinson’s disease (N=316), being conducted by Roche, is complete. Results from Part 1 of the study have been selected as an oral Top Abstract presentation at the upcoming virtual International Congress of Parkinson’s Disease and Movement Disorders Society (MDS) on September 14, 2020.

The 52-week blinded extension of the study (Part 2 of the Phase 2 PASADENA Study) is ongoing. COVID-19 has caused some participants to miss assessments in Part 2 of the study. Mitigation efforts have been put in place to ensure patient safety, and the situation is improving in most geographies. Roche continues to monitor the situation carefully to minimize patient risk and the impact on the study.
PRX004, a potential treatment for ATTR amyloidosis, is a monoclonal antibody designed to deplete the pathogenic, non-native forms of the TTR protein

Since interim data from cohorts 1 through 5 were reported in December, patients in all 6 cohorts of the Phase 1 study of PRX004 have received the three infusions and assessments that comprised the dose-escalation portion of the study.

The long-term extension (LTE) portion of the study, which allowed for up to 15 additional infusions, experienced disruptions due to the COVID-19 pandemic. However, 6 patients in cohorts 4 and 5, and 1 patient in cohort 6 completed one post-baseline neuropathy assessment following 9 months of PRX004 administration.

The Company expects to report new data in the fourth quarter of this year from the dose-escalation and available LTE portion of the study. This timing, however, is dependent on ongoing COVID-19 restrictions at clinical study sites that can impact data collection and analyses.

The Company continues to believe that the study has advanced sufficiently to determine next steps for the program, and has begun further clinical development planning activities, expecting to disclose next steps in the fourth quarter of this year.
Discovery and Preclinical Development: Prothena is advancing an early-stage pipeline of programs for a number of potential neurological indications

The Company continues to expect to advance IND-enabling activities in 2020 for our preclinical tau program, part of a global neuroscience collaboration with Bristol-Myers Squibb.

The Company continues to expect to initiate IND-enabling activities in 2020 for our preclinical Aβ program.
Upcoming Investor Conference

Members of the senior management team will present and participate in investor meetings at the following upcoming investor conferences:

BTIG Virtual Biotechnology Conference 2020 on August 11, 2020 at 1:00PM Eastern Time
A live webcast of the presentations can be accessed through the Investors section of the Company’s website at www.prothena.com. Following the live presentations, a replay of the webcast will be available on the Company’s website for at least 90 days following the presentation date.

Second Quarter and First Six Months of 2020 Financial Results

For the second quarter and first six months of 2020, Prothena reported a net loss of $26.3 million and $49.9 million, respectively, as compared to a net loss of $15.8 million and $36.7 million for the second quarter and first six months of 2019, respectively. The second quarter and first six months of 2019 included a restructuring credit of nil and $0.1 million, respectively, which resulted from an adjustment in previously recorded employee termination benefits associated with the discontinuation of the NEOD001 program. Net loss per share for the second quarter and first six months of 2020 was $0.66 and $1.25, respectively, as compared to a net loss per share of $0.40 and $0.92 for the second quarter and first six months 2019, respectively.

Prothena reported total revenue, primarily from its collaboration with Roche, of $0.2 million and $0.3 million for the second quarter and first six months of 2020, respectively, as compared to total revenue of $0.2 million and $0.4 million for the second quarter and first six months of 2019, respectively.

Research and development (R&D) expenses totaled $17.3 million and $32.5 million for the second quarter and first six months of 2020, respectively, as compared to $9.6 million and $22.9 million for the second quarter and first six months of 2019, respectively. The increase in R&D expense for the second quarter and first six months of 2020 compared to the same periods in the prior year was primarily due to higher collaboration expense with Roche related to the prasinezumab program and higher manufacturing costs (primarily related to the tau, Aβ and PRX004 programs). R&D expenses included non-cash share-based compensation expense of $2.1 million and $4.1 million for the second quarter and first six months of 2020, respectively, as compared to $2.1 million and $4.2 million for the second quarter and first six months of 2019, respectively.

General and administrative (G&A) expenses totaled $9.7 million and $19.4 million for the second quarter and first six months of 2020, respectively, as compared to $9.1 million and $19.0 million for the second quarter and first six months of 2019, respectively. The increase in G&A expenses for the second quarter and first six months of 2020 compared to the same periods in the prior year primarily related to higher costs for our director and officer insurance premiums and higher legal and accounting fees offset in part by lower personnel costs (including share-based compensation expense). G&A expenses included non-cash share-based compensation expense of $3.6 million and $7.1 million for the second quarter and first six months of 2020, respectively, as compared to $4.2 million and $8.3 million for the second quarter and first six months of 2019, respectively.

Total non-cash share-based compensation expense was $5.7 million and $11.2 million for the second quarter and first six months of 2020, respectively, as compared to $6.3 million and $12.5 million for the second quarter and first six months of 2019, respectively.

As of June 30, 2020, Prothena had $336.6 million in cash, cash equivalents and restricted cash and no debt.

As of July 31, 2020, Prothena had approximately 39.9 million ordinary shares outstanding.

The Company continues to expect its full year 2020 net cash burn from operating and investing activities to be $75-$85 million, and expects to end the year with approximately $299 million in cash, cash equivalents and restricted cash (midpoint). The estimated full year 2020 net cash burn from operating and investing activities is primarily driven by estimated net loss of $101-$118 million, which includes an estimated $23 million of non-cash share-based compensation expense.

Inducement Grant Under NASDAQ Listing Rule 5635(C)(4)

In connection with hiring an employee, the compensation committee of the Company’s board of directors granted the individual hired by the Company an option to purchase 60,000 ordinary shares of the Company. The stock option has an exercise price per share equal to $12.76, which was the closing trading price on August 3, 2020, the date of the grant. The inducement award will vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of the date of grant and 1/48th of the underlying shares vesting monthly thereafter over 36 months. The stock option was granted pursuant to the Company’s 2020 Employment Inducement Incentive Plan, which was approved by the Company’s board of directors under Rule 5635(c)(4) of The Nasdaq Global Market for equity grants to induce new employees to enter into employment with the Company.