On March 10, 2022 Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), a commercial-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure Hepatitis Delta Virus (HDV) and other serious diseases, reported financial results for fourth quarter and full year 2021 and provided a business update (Press release, Eiger Biopharmaceuticals, MAR 10, 2022, View Source [SID1234609938]).

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"We expect 2022 to be a transformational year for Eiger with topline data planned from two Phase 3 studies," said David Cory, President and CEO of Eiger. "The Phase 3 TOGETHER study of Peginterferon Lambda for COVID-19 is expected to readout later this month and the Phase 3 D-LIVR study of Lonafarnib for HDV is planned to readout by end of year. We look forward to reporting results from these potentially registration enabling studies as well as progress across our other late-stage pipeline programs with multiple catalysts this year."

Program Highlights

Lonafarnib: Oral Prenylation Inhibitor for HDV

D-LIVR Phase 3 multi-center, global study
Two Lonafarnib-based regimens, both with potential for registration
Lonafarnib oral and Lonafarnib / peginterferon alfa combination
Fully enrolled N=407, with topline data planned by end of 2022
D-LIVR study design includes conservative powering assumptions, modeling response rates well below what was demonstrated in Phase 2
Ukraine and Russia Update
Ukraine:
Eiger continues to closely assess this evolving situation, prioritizing patient care and patient monitoring to ensure continuity in the study
Eiger believes the study remains more than adequately powered to demonstrate statistical significance over placebo even if these patients discontinue from study
Russia:
To date, no interruption to patient visits, safety monitoring, or drug supply; contingency plans in place to ensure continuity of drug supply, sample storage and analysis to preserve integrity of results
Peginterferon Lambda: Well-tolerated Interferon for HDV

LIMT-2 Phase 3 multi-center, global study
Peginterferon Lambda monotherapy for registration
Enrolling patients, targeting N=150
Peginterferon Lambda and Lonafarnib Combination for HDV

LIFT-2 Phase 2 study at National Institutes of Health
Initiating 1H22, targeting N=30
Potential to be interferon of choice in HDV combination therapies
Peginterferon Lambda for Non-hospitalized COVID-19 Infection

Novel mechanism of action, agnostic to variants and mutations
TOGETHER Phase 3 study fully enrolled, N>1,800
Includes unvaccinated and vaccinated patients across multiple variants
Topline data planned in March 2022
Avexitide for Rare Metabolic Disorders

Granted Breakthrough Therapy Designation for Congenital Hyperinsulinism (HI)
Granted Rare Pediatric Disease Designation for HI; PRV eligible
Phase 3 ready in 2022
Zokinvy for Progeria and Processing-Deficient Progeroid Laminopathies

Successful U.S. commercial launch
Approximately 80% of identified U.S. patients converted to commercial supply
EMA review of MAA
CHMP opinion expected in first half of 2022
Corporate

Cash, cash equivalents and investments of $106.1 million to begin 2022 expected to fund planned operations through Q3 2023
Fourth Quarter and Full Year 2021 Financial Results

Cash, cash equivalents, and total investments as of December 31, 2021 totaled $106.1 million compared to $128.8 million on December 31, 2020.

Net product sales of Zokinvy were $3.4 million for fourth quarter 2021, as compared to $3.0 million for third quarter 2021. The increase reflects shipment of product under a reimbursed early access program approved in France, partially offset by fewer shipments to the U.S. specialty pharmacy due to timing of patient refills. The Company commercially launched Zokinvy in the U.S. in January 2021 and reported full year 2021 net sales of $12.1 million.

Cost of Sales was $0.1 million and $0.7 million for fourth quarter and full year 2021, respectively, and related to certain manufacturing, shipping, and distribution costs associated with Zokinvy that were incurred after FDA approval.

Research and Development expenses were $18.2 million and $64.4 million for fourth quarter and full year 2021, respectively, as compared to $12.5 million and $41.6 million for the same periods in 2020. The increases in fourth quarter and full year 2021 expenses were primarily due to contract manufacturing and clinical trial related expenses for increased clinical development activities and personnel related expenses, including stock-based compensation, due to an increase in headcount.

Selling, General and Administrative expenses were $6.0 million and $23.9 million for fourth quarter and full year 2021, respectively, as compared to $5.4 million and $20.6 million for the same periods in 2020. The increases in fourth quarter and full year 2021 were primarily due to an increase in personnel related expenses attributed to an increase in headcount and an increase in outside services, including consulting and advisory services to support the growth of the Company.

Total operating expenses include non-cash expenses of $2.8 million and $10.7 million for fourth quarter and full year 2021, respectively, as compared to $2.1 million and $7.8 million for the same periods in 2020.

The Company reported net losses of $21.8 million, or $0.64 per share, and $33.9 million, or $1.00 per share, for fourth quarter and full year 2021, respectively, as compared to $18.8 million, or $0.58 per share, and $65.1 million, or $2.31 per share, for the same periods in 2020.

As of December 31, 2021, the company had 34.6 million of common shares outstanding.

CONFERENCE CALL
At 4:30 PM Eastern Time today, March 10, 2022, Eiger will host a conference call to discuss its financial results and provide a business update. The live and replayed webcast of the call will be available through the company’s website at www.eigerbio.com. To participate in the live call by phone, dial (844) 743-2495 (U.S.) or (661) 378-9529 (International) and enter conference ID 4338659. The webcast will be archived and available for replay for at least 90 days after the event.

On March 10, 2022 AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, reported its fourth quarter and full year 2021 financial results (Press release, AcelRx Pharmaceuticals, MAR 10, 2022, View Source [SID1234609937]).

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"We are executing on our strategy to expand and diversify our product portfolio by acquiring commercial-ready, or late-stage development-ready assets that address what we consider as unmet market needs for medically supervised settings. In particular, we are currently focused on the development and ultimate approval of our newly secured pre-filled syringes and Niyad (nafamostat) product candidates which could potentially provide multiple value creating catalysts for our shareholders in the near-term," said Vince Angotti, Chief Executive Officer of AcelRx. Mr. Angotti continued, "In addition, we have taken deliberate actions to adapt to the evolving healthcare environment as many medical procedures resulting in moderate-to-severe pain that were previously performed in surgical centers or hospitals have now been shifted to procedural suites, allowing us the opportunity to introduce DSUVIA into these settings. We have thus shifted our commercial resources, beginning in the third quarter, to focus on this new customer base, resulting in solid growth in DSUVIA unit sales in the fourth quarter 2021."

FY 2021 and Recent Highlights

AcelRx entered into a license agreement with Laboratoire Aguettant (Aguettant) providing AcelRx with two innovative pre-filled syringe product candidates for the U.S. The expected market opportunity for these two product candidates exceeds $100 million, and AcelRx currently plans to file New Drug Applications for both in 2022.

A second license transaction with Aguettant was completed establishing Aguettant as the commercial partner for DZUVEO in Europe with an expected launch in the third quarter of 2022. AcelRx is entitled to receive up to approximately $55 million in combined up-front and sales-based milestone payments.

AcelRx announced the closing of its acquisition of Lowell Therapeutics, Inc. (Lowell) in January 2022 in a transaction for consideration of approximately $32.5 million plus net cash acquired and certain other adjustments, and which includes up to approximately $26.0 million of contingent consideration payable in cash or stock at AcelRx’s option, upon the achievement of regulatory and sales-based milestones. Niyad (nafamostat) is the lead product, with a targeted indication of anticoagulation of the extracorporeal circuit, and which has received Breakthrough Device Designation from the FDA, as well as an ICD-10 procedural code from CMS which allows for reimbursement. Annual peak sales potential for Niyad is expected to exceed $200 million.

Since January 2021, six articles on DSUVIA were published reporting the benefits of administering DSUVIA in place of IV opioids, including reducing perioperative opioid use, rapid recovery times, efficacy and safety among a wide range of demographics and the overall advantages of sublingual delivery. Of note, one of these articles was a commentary published in Military Medicine, identifying DSUVIA as the next evolution in battlefield pain management. An additional study of DSUVIA for painful cosmetic procedures has been accepted for publication by the American Journal of Cosmetic Surgery and another study on the use of DSUVIA during general anesthesia for lengthy plastic surgery procedures has been submitted for publication.

As of December 31, 2021, AcelRx has achieved 725 approvals compared to our initial target of 615. As of February 28, 2022, AcelRx has achieved 813 formulary approvals for DSUVIA.

In February 2022, AcelRx was notified that it had met all requirements set by the U.S. Food and Drug Administration (FDA) with regards to the FDA Warning Letter regarding certain DSUVIA promotional materials, dated February 11, 2021, and a Closeout Letter is expected in Q1 2022.
Financial Information

The cash, cash equivalents and short-term investments balance was $51.6 million as of December 31, 2021.

8,960 units of DSUVIA were sold in the fourth quarter of 2021, compared to 3,710 units in the third quarter of 2021; however, the Company has recognized only $2 thousand in net revenues in the fourth quarter 2021 as a result of a $0.3 million reserve for potential returns related to a certain wholesale customer that purchased product for the Department of Defense (DoD) in 2020. The DoD has purchased exclusively from a secondary wholesale customer instead of their primary wholesaler, and therefore the Company has recorded a reserve in the event this product is not ultimately sold to the DoD.

Unit sales growth in the first two months of Q1 2022, compared to the first two months of Q4 2021 is 63%.

Combined R&D and SG&A expenses for the fourth quarter of 2021 totaled $6.9 million compared to $8.7 million for the fourth quarter of 2020. Excluding non-cash depreciation and stock-based compensation expense, these amounts were $5.6 million for the fourth quarter of 2021, compared to $7.5 million for the fourth quarter of 2020. R&D and SG&A expenses for the year ended December 31, 2021 totaled $35.0 million compared $40.3 million for the year ended December 31, 2020. Excluding non-cash depreciation and stock-based compensation expense, these figures were $29.7 million for the year ended December 31, 2021, compared to $35.4 million for the year ended December 31, 2020. The decrease in combined R&D and SG&A expenses in the fourth quarter and year ended 2021 was primarily due to reductions in personnel-related costs, including travel expense, partially offset by increased Catalent manufacturing-related DSUVIA development expenses.

Net loss for the fourth quarter of 2021 was $7.9 million, or $0.06 per basic and diluted share, compared to $8.9 million, or $0.10 per basic and diluted share, for the fourth quarter of 2020. Net loss for the year ended December 31, 2021 was $35.1 million, or $0.29 per basic and diluted share, compared to $40.4 million, or $0.47 per basic and diluted share, for the year ended December 31, 2020.
2022 Guidance

The Company’s 2022 year-end goals include the submission of two NDAs for its pre-filled syringe product candidates, pending outcome of FDA feedback that is expected in the second quarter, and the manufacturing of initial lots of nafamostat. Quarterly combined R&D and SG&A expense is expected to be approximately $9-$10 million (and $8-$9 million excluding stock compensation and depreciation). Annual debt service is expected to approximate $10 million as the Company continues to pay down amounts outstanding under its senior debt facility that matures in June 2023. Annual capital expenditures are expected to approximate $2 million attributed mainly to the final validation of the automated packaging line at AcelRx’s contract manufacturer.

2022 financial guidance is based on the Company’s current expectations and are forward-looking statements. Actual results could differ materially depending on market conditions and the factors set forth under Forward-Looking Statements below.

Webcast and Conference Call Information
As previously announced, AcelRx will host a live webcast Thursday, March 10th at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss these financial results and provide other corporate updates. The webcast is accessible by visiting the Investors page of AcelRx’s website at View Source and clicking on the webcast link. The webcast will be accompanied by a slide presentation. Investors who wish to participate in the conference call may do so by dialing (866) 361-2335 for domestic callers, (855) 669-9657 for Canadian callers or (412) 902-4204 for international callers. A webcast replay will be available on the AcelRx website for 90 days following the call by visiting the Investor page of AcelRx’s website at View Source.

About DSUVIA (sufentanil sublingual tablet), 30 mcg
DSUVIA, to be marketed as DZUVEO in Europe, is indicated for use in adults in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route of administration and to eliminate dosing errors associated with intravenous (IV) administration of opioid analgesics. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Commission approved DZUVEO for marketing in Europe and it will be commercialized by AcelRx’s European partner, Aguettant.

For more information, including important safety information and black box warning for DSUVIA, please visit www.DSUVIA.com.

About nafamostat Nafamostat is a broad spectrum, synthetic serine protease inhibitor with anticoagulant, anti-inflammatory and potential anti-viral activities. Niyad is a lyophilized formulation of nafamostat and is currently being studied under an investigational device exemption, or IDE, as an anticoagulant for the extracorporeal circuit. Niyad has received Breakthrough Device Designation Status from the FDA. LTX-608 is a proprietary nafamostat formulation for direct IV infusion that we plan to potentially develop as a COVID anti-viral treatment, as well as for the treatment of disseminated intravascular coagulation (DIC), acute respiratory distress syndrome (ARDS), and acute pancreatitis.

On March 10, 2022 Myeloid Therapeutics, Inc. ("Myeloid"), a clinical stage mRNA-immunotherapy company developing novel therapies for cancer and autoimmune diseases, reported that company management will present a corporate overview at Oppenheimer’s 32nd Annual Healthcare Conference and will participate in one-on-one meetings with investors (Press release, Myeloid Therapeutics, MAR 10, 2022, View Source [SID1234609936]). The conference is being held in a virtual format, March 15-17, 2022.

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On March 10, 2022 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, reported updates and financial results for the fourth quarter and full year ended December 31, 2021 (Press release, Poseida Therapeutics, MAR 10, 2022, View Source [SID1234609935]).

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"We continued to demonstrate strong progress on our key priorities in the fourth quarter even as the pandemic impacted all parts of our industry. In the fourth quarter, we announced our first strategic collaboration with Takeda in gene therapy as well as the FDA IND clearance for P-MUC1C-ALLO1, our allogeneic CAR-T program in solid tumor indications," said Mark Gergen, Chief Executive Officer of Poseida. "We are highly focused on our key priorities for 2022, including initial clinical data for both the P-BCMA-ALLO1 and P-MUC1C-ALLO1 programs expected in the second half of the year, additional data on P-PSMA-101 in prostate cancer, and continuing progress in our gene therapy programs as we work toward applying our technologies to redefining cell and gene therapy."

Program Highlights

BCMA Program
P-BCMA-ALLO1 is the Company’s first allogeneic CAR-T program, currently being evaluated in patients with relapsed/refractory multiple myeloma (R/R MM) with initial clinical data expected in the second half of 2022. The planned shift in operational focus to allogeneic CAR-T was announced in the fourth quarter, as the Company began winding down the autologous BCMA program, P-BCMA-101.

The Company reported interim results from its Phase 1 clinical trial of P-BCMA-101 for the treatment of R/R MM at the 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December. The results shown highlight that P-BCMA-101, a non-viral transposon-based autologous CAR-T, was well tolerated and demonstrated strong anti-tumor activity in advanced, late line R/R MM patients. The Company also highlighted findings from some of the novel dosing regimens explored during the trial, including the combination with rituxan, which demonstrated an ability to improve response rates, eliminate antibodies, and show an increase in both progression free survival and overall survival in that cohort. The full results of the ASH (Free ASH Whitepaper) update can be found on the Company’s website.

PSMA Program
P-PSMA-101 is an autologous CAR-T product candidate being developed to treat patients with metastatic castrate-resistant prostate cancer (mCRPC) currently in an ongoing Phase 1 dose escalation trial.

In February, the Company presented interim data at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU). The results presented showed notable responses even at the lowest doses in heavily pre-treated patients with mCRPC, including one patient who demonstrated evidence of near complete tumor elimination as evidenced by PSMA PET and other measures. The full ASCO (Free ASCO Whitepaper) GU presentation can be found on the Company’s website.

MUC1-C Program
P-MUC1C-ALLO1 is an allogeneic CAR-T product candidate with the potential to treat a wide range of solid tumors derived from epithelial cells, including breast and ovarian cancers. The Phase 1 clinical trial of P-MUC1C-ALLO1 is proceeding following IND clearance in the fourth quarter of 2021, and an update on the program is expected in the second half of 2022.

Liver-Directed Gene Therapy Programs
P-OTC-101 is the Company’s first liver-directed gene therapy program for the in vivo treatment of urea cycle disease caused by congenital mutations in the ornithine transcarbamylase (OTC) gene, a condition characterized by high unmet medical need.

The Company shared an update on the program during the R&D Day held in February 2022, including the presentation of data showing that use of a non-viral nanoparticle delivery system utilizing piggyBac AAV plus lipid nanoparticle potentially enables curative outcomes in a mouse model of severe OTC. The Company is currently evaluating the P-OTC-101 program to determine the best path forward and will update expected timing on program advancement once that evaluation is complete.

P-FVIII-101 is a liver-directed gene therapy currently partnered with Takeda Pharmaceuticals USA, Inc. (Takeda) and in development for the in vivo treatment of Hemophilia A. P-FVIII-101 utilizes piggyBac gene modification delivered via lipid nanoparticle and has demonstrated stable and sustained Factor VIII expression in animal models. Data from preclinical studies were shared during the R&D Day and showed that the biodegradable nanoparticle in combination with super piggyBac may overcome the limitations of AAV-based systems, with the following potential benefits: larger cargo capacity than AAV delivery alone, the ability to re-dose patients, the ability to treat pediatric patients, and fewer safety concerns.

Platforms and Emerging Technologies
The Company also reviewed its core platform technologies and introduced emerging technology programs at the R&D Day. These emerging programs highlight the Company’s continuing focus on innovation and include: (i) emerging preclinical work demonstrating the Company’s ability to include T cell receptors (TCRs), in addition to CARs in cell therapies; (ii) early preclinical data on a version of Site-Specific piggyBac gene insertion for site-directed DNA integration; and (iii) a CAR 3.0, an approach that utilizes genetically engineered hematopoietic stem cells to treat certain cancer indications. The full presentation is currently available for a limited period of time on the Company’s website.

For these and other discovery programs, the Company may seek partnerships or collaborations to move those applications forward.

Organizational Updates
The Company announced today that Kerry Ingalls, the Company’s Chief Operating Officer (COO), intends to retire effective May 13, 2022 and will continue in a strategic advisory role with the Company through September 2022. As previously announced, effective February 1, 2022, Mark Gergen, the Company’s President and former Chief Business Officer (CBO), assumed the role of Chief Executive Officer (CEO) and Eric Ostertag, the Company’s founder and former CEO, assumed the role of Executive Chairman of the board of directors. In February 2022, the Company announced the appointment of Brent Warner as President, Gene Therapy, to lead the Company’s gene therapy efforts including management of the collaboration with Takeda.

Financial Results for the Fourth Quarter and Full Year 2021

Revenues
Revenues were $31.2 million for both the fourth quarter and the full year ended December 31, 2021 consisting of revenue earned from the collaboration and license agreement with Takeda entered into in the fourth quarter of 2021, compared to no revenue for the same periods in 2020.

Research and Development Expenses
Research and development expenses were $39.1 million for the fourth quarter ended December 31, 2021, compared to $27.9 million for the same period in 2020. For the full year ended December 31, 2021, research and development expenses were $136.7 million, compared to $103.5 million for the same period in 2020. The increase was primarily related to an increase in personnel expenses due to an increase in headcount and an increase in stock-based compensation expense, an increase in external costs related to preclinical programs due to an increased number of early stage programs, an increase in external costs related to clinical stage programs including the enrollment and manufacturing for the P-BCMA-101 clinical trial and increased enrollment of the Phase 1 P-PSMA-101 trial, and an increase in internal costs related to facilities and other expenses primarily due to the increased activities in the pilot plant.

General and Administrative Expenses
General and administrative expenses were $9.6 million for the fourth quarter ended December 31, 2021, compared to $7.5 million for the same period in 2020. General and administrative expenses were $35.9 million for the full year ended December 31, 2021, compared to $23.0 million for the same period in 2020. The increase was primarily related to an increase in personnel expenses due to an increase in headcount combined with an increase in stock-based compensation expense, and increases in insurance costs and professional fees.

Net Income (Loss)
Net income was $1.5 million for the fourth quarter ended December 31, 2021 compared to net loss of $36.1 million for the same period in 2020. Net income for the fourth quarter was primarily driven by the revenue from the Company’s Takeda collaboration and the write-off of CIRM liability related to the P-BCMA-101 grant award. For the full year ended December 31, 2021, net loss was and $125.0 million compared to net loss of $129.8 million in 2020.

Cash Position
As of December 31, 2021, cash and cash equivalents balance was $206.3 million, which does not include net proceeds of $28.3 million from the restructuring of the Company’s debt arrangement, pursuant to that certain loan and security agreement with Oxford Finance LLC, that closed in the first quarter of 2022.

On March 10, 2022 ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported that the Company will be presenting at the virtual Oppenheimer 32nd Annual Healthcare Conference on Thursday, March 17, 2022 at 2:40 p.m. Eastern Time (Press release, ESSA, MAR 10, 2022, View Source [SID1234609934]).

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David. R. Parkinson, President and Chief Executive Officer of ESSA Pharma, will participate in and host one-on-one meetings. Peter Virsik, ESSA’s Chief Operating Officer, and David S. Wood, ESSA’s Chief Financial Officer, will also be participating in the one-on-one meetings.