On August 10, 2020 Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, reported financial results for the second quarter 2020 and recent business progress (Press release, Abeona Therapeutics, AUG 10, 2020, View Source [SID1234563348]).

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"During the past several months, Abeona has delivered on our goals in clinical development, manufacturing, and regulatory affairs toward bringing urgently needed treatments to patients with RDEB and MPS III," said João Siffert, M.D., Chief Executive Officer of Abeona. "Notably, new patients have been treated in our RDEB and MPS IIIA clinical programs, and we expect additional patient enrollment across our clinical programs in the coming weeks. Concurrent with the increased clinical activities, we resumed internal manufacturing operations at our Cleveland campus in June. We have made significant advancements in process development for retrovirus and AAV manufacturing in-house, anticipated to start in late-2020 and early-2021, respectively. In addition, we recently reached general alignment with the CHMP on our proposed path toward a European marketing authorization application for ABO-102 in MPS IIIA, anticipated in 2023. Looking ahead to the potential commercial launches of EB-101 in late-2022 and ABO-102 the following year, we have also strengthened our leadership team, bringing on board a Chief Commercial Officer with significant relevant experience and expertise."

Second Quarter and Recent Highlights

EB-101 (Autologous, Gene-Corrected Cell Therapy)

A second patient was treated in Abeona’s EB-101 pivotal Phase 3 VIITAL study for recessive dystrophic epidermolysis bullosa (RDEB) after enrollment resumed in June 2020 following a pause due to the COVID-19 pandemic. Additional patients are expected to be treated in the coming weeks, with completion of enrollment in the VIITAL study expected in early-2021.
Two posters were presented at the Society for Pediatric Dermatology 45th Annual Meeting. The first poster highlighted data showing that EB-101 treatment of large RDEB wounds resulted in up to five years of durable healing, which was associated with long-term pain relief. A separate poster characterized the significant disease burden of RDEB on patients and their families.
ABO-102 and ABO-101 (AAV-based Gene Therapies)

In July 2020, Abeona held a kick-off meeting under the European Medicines Agency’s (EMA) PRIority MEdicines (PRIME) program, which included members of the Committee for Advanced Therapies (CAT) and the Committee for Medicinal Products for Human Use (CHMP) of the EMA. The Company presented its plan toward registration of ABO-102 for MPS IIIA (Sanfilippo syndrome type A), taking advantage of the PRIME designation that offers a path for accelerated assessment of promising therapies targeting unmet medical needs. Based on the PRIME meeting, along with previous input from the CHMP and the Pediatric Committee (PDCO) of the EMA, Abeona anticipates submitting a marketing authorization application for EU conditional approval of ABO-102 for MPS IIIA in 2023. The Company continues to seek guidance from the FDA on the U.S. regulatory path for ABO-102 in MPS IIIA, but acknowledges that the FDA is currently focused on matters related to COVID-19 and other life-threatening conditions, as reflected in its issued guidance in May 2020.
Total enrollment to date in the ABO-102 Transpher A study for MPS IIIA is 17 patients, including 11 patients dosed in cohort 3. Total enrollment to date in the ABO-101 Transpher B study for MPS IIIB (Sanfilippo syndrome type B) is 9 patients, including 2 patients dosed in cohort 3. Abeona anticipates completing enrollment in both the Transpher A and Transpher B studies by the end of 2020.
Updated positive interim data from the Transpher A and Transpher B studies were presented at the American Society of Gene & Cell Therapy 23rd Annual Meeting. The findings support previously reported data showing preservation of neurocognitive skills among three young patients treated in dose cohort 3 of the Transpher A study. Improvements in multiple disease-specific biomarkers, denoting clear biologic effects, and a favorable safety profile in MPS IIIA and MPS IIIB patients after treatment with ABO-102 and ABO-101, respectively, were observed in both studies.
Manufacturing Activities

In June 2020, Abeona fully resumed operations at its state-of-the-art GMP manufacturing facility in Cleveland, Ohio, manufacturing EB-101 drug product for the Phase 3 VIITAL study. The Company initiated process development at the facility that will enable production of the retrovirus used for EB-101 manufacture, allowing for increased control of the supply chain and product quality, as well as reduced costs. Abeona also resumed process development activities to enable in-house manufacturing of commercial supply of ABO-101 and ABO-102.
Corporate Update

The Company further strengthened its leadership team with the appointment of Michael Amoroso as Chief Commercial Officer, and the addition of George Migausky and Paul Mann as independent members of its Board of Directors. In addition to their Board service, Mr. Migausky serves as Chairman of the Company’s Audit Committee and Mr. Mann serves as a member of the Audit Committee.
Second Quarter Financial Results

Cash, cash equivalents and short-term investments totaled $107.9 million as of June 30, 2020, compared to $129.3 million as of December 31, 2019. Net cash used in operating activities was $9.5 million for the second quarter 2020.

Research and development (R&D) spending was $6.1 million for the second quarter of 2020 and $12.9 million for the six months ended June 30, 2020, compared to $16.3 million and $28.0 million in the comparable periods in 2019. The decrease in R&D expenses was primarily due to decreased manufacturing, clinical and non-clinical development activities arising from the effects of the COVID-19 pandemic, and cost savings associated with the decision to internally manufacture retrovirus for the EB-101 program.

General and administrative (G&A) expenses were $5.5 million for the second quarter of 2020 and $12.0 million for the six months ended June 30, 2020, compared to $5.6 million and $11.3 million in the comparable periods in 2019. The increase in G&A expenses for the six months ended June 30, 2020 was largely due to increases in salary and related costs partially offset by decreased professional fees.

Net loss was $13.0 million for the second quarter of 2020 and $61.2 million for the six months ended June 30, 2020, compared to net loss of $23.9 million and $42.5 million for the comparable periods in 2019.

Conference Call Details

Abeona Therapeutics will host a conference call and webcast tomorrow, Tuesday, August 11, 2020 at 8:30 a.m. ET, to discuss its second quarter 2020 financial results and provide an update on the company’s business. To access the call, dial 844-369-8770 (U.S. toll-free) or 862-298-0840 (international) and provide conference ID 18965539 five minutes prior to the start of the call. A live, listen-only webcast and archived replay of the call can be accessed on the Investors & Media section of Abeona’s website at www.abeonatherapeutics.com. The archived webcast replay will be available for 30 days following the call.

On August 10, 2020 Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported financial results for the second quarter ended June 30, 2020 (Press release, TapImmune, AUG 10, 2020, View Source [SID1234563347]).

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"We continue to make progress toward advancing our planned Phase 2 trial with our novel MultiTAA-specific T cell therapy in patients with acute myeloid leukemia, or AML," said Peter L. Hoang, President & CEO of Marker Therapeutics. "While the COVID-19 pandemic has impacted hospital systems globally, we have augmented our process development for our MT-401 product, continued the buildout of our manufacturing facility and added further clinical sites for our Phase 2 AML trial. With a novel cell therapy product candidate that has demonstrated the ability to induce broad and durable immune responses in earlier clinical studies, Marker remains well-positioned to provide a potential treatment option for patients suffering from this devastating disease."

PROGRAM UPDATES

Multi-Antigen Targeted (MultiTAA) T Cell Therapies

Phase 2 AML Trial Update
The Company continues to identify and add clinical trial sites in preparation for the Phase 2 AML trial initiation. The study is currently subject to a partial clinical hold on the use of a new reagent in the manufacturing process until the FDA reviews and accepts the final data and certificates of analysis for the new reagent. The alternate supplier has been delayed in providing the reagent but expects to ship the reagent to Marker in Q3. Once Marker receives the reagent and completes the required analyses for FDA, the Company will provide additional clarification around the timing of the AML trial enrollment.

USAN Council Approval of "Zelenoleucel" for MT-401
Marker recently announced that the United States Adopted Names (USAN) Council approved "zelenoleucel" as the nonproprietary (generic) name for MT-401, a MultiTAA-specific T cell product candidate for the treatment of patients with AML following allogeneic stem cell transplant in both adjuvant and active disease settings.

Pancreatic Cancer Data Presented During ASCO (Free ASCO Whitepaper)
Updated clinical results from an ongoing investigator-sponsored Phase 1 trial led by the Baylor College of Medicine, evaluating the Company’s MultiTAA-specific T cell therapy in patients with advanced or metastatic pancreatic adenocarcinoma, were presented during the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Annual Meeting. Data from a cohort of patients receiving MultiTAA-specific T cell therapy in combination with standard-of-care chemotherapy in the first-line setting (Arm A) were presented.

Out of the 13 evaluable patients (best overall response): four patients experienced objective responses, including one complete response; six patients experienced stable disease; one patient experienced a mixed response (some lesions increased in size and others decreased for a net zero change in size of tumor lesions).
Patients had durable cancer control with 9 of the 13 patients exceeding historical control of overall survival.
Evidence of epitope-spreading was observed in all responders, suggesting that the MultiTAA T cell therapy triggered the recruitment of a broader endogenous immune system response for improved anti-tumor activity.
No infusion-related reactions, cytokine release syndrome or neurotoxicity was observed.
BUSINESS UPDATES

On June 30, 2020, Marker announced that the Company executed a lease agreement to establish an in-house cGMP manufacturing facility in Houston, TX. The facility is expected to be completed by year-end and operational in 2021. Marker will continue to manufacture its MultiTAA-specific T cell therapy at the Baylor College of Medicine to support the Company-sponsored AML trial until the in-house cGMP manufacturing facility is operational.

SECOND QUARTER 2020 FINANCIAL RESULTS

Cash Position and Guidance: At June 30, 2020, Marker had cash and cash equivalents of $32.1 million. The Company believes that its existing cash and cash equivalents will fund its operating expenses and capital expenditure requirements into Q2 2021.

R&D Expenses: Research and development expenses were $4.3 million for the quarter ended June 30, 2020, compared to $3.2 million for the quarter ended June 30, 2019.

G&A Expenses: General and administrative expenses were $2.5 million for the quarter ended June 30, 2020, compared to $2.7 million for the quarter ended June 30, 2019.

Net Loss: Marker reported a net loss of $6.3 million for the quarter ended June 30, 2020, compared to a net loss of $5.6 million for the quarter ended June 30, 2019.

On August 10, 2020 Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company progressing Nano-Pulse Stimulation (NPS) technology, reported financial results for the second quarter ended June 30, 2020 (Press release, Pulse Biosciences, AUG 10, 2020, View Source [SID1234563346]).

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Recent Highlights

Completed the CellFX System GLP (good laboratory practice) preclinical study treatments to generate the data required for the planned 510(k) submission to the U.S. Food and Drug Administration (FDA) for an initial FDA clearance with a general dermatologic indication. This puts the Company on track for a 510(k) submission in the next 60-90 days
Conducted a formal Pre-Submission meeting with the FDA to establish the design for the comparative study required for a subsequent 510(k) submission to expand the indication for use of the CellFX System to include a specific indication for Sebaceous Hyperplasia. The meeting resulted in a general agreement on the study design which allows the Company to move forward with an IDE submission and a potential study start in early Q4, as planned
Submitted the CellFX System technical file to its European notified body in pursuit of the CE mark, the regulatory approval that would authorize the Company to commercialize the CellFX System in the EU. Review is currently underway with expectations for receipt of a CE mark for the CellFX System in Q1 2021
Three clinical studies demonstrating favorable results from the investigational use of NPS technology in Nodular Basal Cell Carcinoma, Sebaceous Hyperplasia and Common Warts, respectively, were presented at the virtual American Society for Laser Medicine and Surgery (ASLMS) annual conference
Strengthened balance sheet with the successful completion of a substantially oversubscribed rights offering, incurring minimal offering costs compared to a traditional public offering, delivering greater net proceeds to the Company. The $30.0 million rights offering generated $29.5 million of net proceeds, not including additional potential gross proceeds of $4.5 million through the exercise of issued warrants
Expanded its Board of Directors with the appointment of Richard van den Broek, serving as a member of the audit and the compensation committees of the Board
"We had a very productive second quarter despite the challenging circumstances persisting as a result of the COVID-19 pandemic. We have remained diligent in our efforts to create the safest work environment possible for our employees and the community and I would like to thank our entire team for their continued efforts and dedication. At the same time, we are pleased that we continue to drive progress towards our top priority of achieving regulatory approvals for the CellFX System," said Darrin Uecker, President and CEO of Pulse Biosciences. "We believe our progress on the clinical and regulatory front combined with continued engagement from the scientific community has positioned us favorably for eventual commercialization in the US, Europe and Canada. Lastly, I would like to thank our shareholders for their participation in the rights offering. Proceeds from this offering will enable us to further progress our development, clinical and commercial objectives."

Financial Update

Cash, cash equivalents and investments totaled $37.8 million as of June 30, 2020, compared to $15.9 million as of March 31, 2020. Excluding the net proceeds of the rights offering received in the three months ended June 30, cash used in the second quarter of 2020 totaled $7.9 million. This compares with $9.5 million used in the first quarter of 2020.

Operating expenses for the three months ended June 30, 2020 were $11.4 million, compared to $11.6 million for the prior year period. Second quarter 2020 operating expenses included stock-based compensation expense of $2.4 million, compared to $2.7 million in the second quarter of 2019. The decrease in operating expenses was primarily driven by reduced research and development costs which were partially offset by increases in general and administrative costs in preparation for commercialization.

Operating expenses for the six months ended June 30, 2020 were $23.3 million, compared to $22.1 million for the prior year period. Stock-based compensation expense for the six months ended June 30, 2020 was $5.0 million, compared to $5.1 million in the prior year period. The increase in operating expenses was primarily driven by the expansion of operational infrastructure including marketing and sales functions.

Net loss for the three months ended June 30, 2020 was ($11.3) million compared to ($11.4) million for the three months ended June 30, 2019. Net loss for the six months ended June 30, 2020 was ($23.2) million compared to ($21.4) million for the six months ended June 30, 2019.

Impact of COVID-19

Our operations in the second quarter of 2020 experienced minimal impacts as a result of the COVID-19 pandemic. Product development and regulatory timelines have not been materially affected at this time but due to the uncertain scope and duration of the pandemic, we cannot reasonably estimate the future impact to our operations and financial results.

Webcast and Conference Call Information

Pulse Biosciences’ management will host a conference call today, August 10, 2020 beginning at 1:30pm PT. Investors interested in listening to the conference call may do so by dialing 1-855-327-6837 for domestic callers or 1-631-891-4304 for international callers. A live and recorded webcast of the event will be available at View Source

On august 10, 2020 ChemoCentryx, Inc. (Nasdaq: CCXI) reported financial results for the second quarter ended June 30, 2020 and provided an overview of the Company’s recent corporate highlights (Press release, ChemoCentryx, AUG 10, 2020, View Source [SID1234563345]).

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"A major milestone was accomplished recently with the filing of the NDA for avacopan for the treatment of ANCA-associated vasculitis with the U.S. FDA," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "This is one more crucial step toward achieving our unwavering goal of changing the treatment paradigm for people now enduring this organ-threatening and life-endangering disease. ANCA vasculitis patients have waited too long for new therapy; it is our goal to make sure that wait is not in vain."

"We are also ever closer to realizing avacopan’s potential as a pipeline-in-a-drug with upcoming readouts in HS and C3G expected later this year. We will not stop there. The innovation seen in such new pipeline assets as CCX559, our novel orally administered checkpoint inhibitor for next generation cancer treatment, has real potential to fuel future growth and create significant value. I believe that we are poised to achieve our ultimate mission to be a fully integrated and self-sustaining enterprise that provides better therapies for previously neglected, underserved patient needs. And the $325.7 million in net proceeds from our successful June equity follow-on offering, coupled with our already healthy cash reserves, provides the capital to get us there."

Key Highlights

Filed the New Drug Application (NDA) for avacopan in the treatment of ANCA-associated vasculitis in July. The Company’s NDA submission is supported by the results of its pivotal Phase III ADVOCATE trial, which demonstrated statistical superiority in sustaining remission at 52 weeks in the avacopan group compared to the prednisone group. In the trial, the avacopan group also showed significantly lower glucocorticoid toxicity, greater improvement in kidney function and greater improvement in health-related quality of life measures compared to the prednisone group. Finally, avacopan demonstrated favorable safety results in this serious and life-threatening disease, with fewer subjects having serious adverse events in the avacopan group than in the prednisone group.

Presented additional data from the ADVOCATE trial were selected for oral plenary presentations in June at the leading European rheumatology and nephrology conferences: EULAR (European League Against Rheumatism) and ERA-EDTA (European Renal Association – European Dialysis and Transplant Association).

Presented data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) meeting in June, demonstrating that the Company’s orally administered checkpoint inhibitors led to marked inhibition of PD-1/PD-L1 interaction and signaling in vitro and potent anti-tumor effects in animal models. The Company has identified its orally administered checkpoint inhibitor, CCX559, as a candidate for next generation cancer treatment and plans to initiate clinical studies in the first half of 2021.

Completed enrollment in May 2020 of more than 400 patients in the Company’s AURORA Phase IIb clinical trial of avacopan for the treatment of the chronic disabling skin disease Hidradenitis Suppurativa (HS). Topline data from AURORA are now expected early in the fourth quarter of 2020, a modest delay caused by the resurgence of COVID-19 impacting certain sites where we have been conducting this trial.

Strengthened the balance sheet with $325.7 million in net proceeds from a successful equity follow-on offering, including full exercise of the underwriters’ option to purchase additional shares. Proceeds from the offering will be used to support the anticipated commercial launch of avacopan in ANCA vasculitis; avacopan lifecycle management, including expansion into additional indications and formulation development; and development of additional drug candidates, including CCX559.

Reported cash, cash equivalents and investments exceeded $504.6 million at June 30, 2020.
Second Quarter 2020 Financial Results

Revenue was $49.4 million for the second quarter of 2020, compared to $7.2 million for the same period in 2019. The increase in total revenue from 2019 to 2020 was primarily due to the acceleration of revenue recognition associated with the CCX140 agreement with Vifor. Following the decision to discontinue development of CCX140 in FSGS, $46.7 million of deferred revenue was recognized as contract revenue. This increase was partially offset by lower costs incurred due to the completion of the avacopan ADVOCATE Phase III pivotal trial in 2020.

Research and development expenses were $18.8 million for the second quarter of 2020, compared to $17.6 million for the same period in 2019. The increase from 2019 to 2020 was primarily attributable to the completion of patient enrollment of the avacopan AURORA Phase IIb clinical trial in patients with HS, professional fees associated with the preparation of our NDA submission for avacopan for the treatment of ANCA vasculitis and higher research and drug discovery expenses, including those tied to the advancement of CCX559, the Company’s orally administered checkpoint inhibitor. These increases were partially offset by lower expenses due to the completion of the avacopan ADVOCATE Phase III pivotal trial in 2020 and the CCX140 LUMINA-1 Phase II clinical trial in 2019.

General and administrative expenses were $10.3 million for the second quarter of 2020, compared to $5.6 million for the same period in 2019. The increase from 2019 to 2020 was primarily due to higher employee-related expenses, including those associated with our commercialization planning efforts, and higher professional fees.

Net income for the second quarter of 2020 was $20.3 million, compared to net loss of $15.2 million for the same period in 2019.

Total shares outstanding at June 30, 2020 were approximately 68.8 million shares.

Cash, cash equivalents and investments totaled $504.6 million at June 30, 2020, including the $325.7 million in net proceeds from the June 2020 equity follow-on offering of common stock.

Conference Call and Webcast

The Company will host a conference call and webcast today, August 10, 2020 at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time. To participate by telephone, please dial (877) 303-8028 (Domestic) or (760) 536-5167 (International). The conference ID number is 6246545. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.ChemoCentryx.com. The archived webcast will remain available on the Company’s website for fourteen (14) days following the conference call.

On August 10, 2020 Adaptive Biotechnologies Corporation ("Adaptive Biotechnologies") (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, reported financial results for the quarter ended June 30, 2020 (Press release, Adaptive Biotechnologies, AUG 10, 2020, View Source [SID1234563344]).

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"The current coronavirus pandemic is highlighting the critical importance of a deeper understanding of the immune response to disease broadly, making Adaptive’s technology more relevant than ever," said Chad Robins, chief executive officer and co-founder of Adaptive Biotechnologies. "In the past several months, we have demonstrated that we can read and translate the genetics of immune receptors in blood, including T-cell response at scale, which is enabling us to rapidly deliver novel, immune-driven products."

Recent Highlights

Revenue was $21.0 million for the quarter ended June 30, 2020, representing a 5% decrease from the second quarter in the prior year.
Clinical sequencing volume increased 31% to 3,136 clinical tests delivered in the second quarter of 2020 compared to the second quarter 2019.
Advanced our first immunoSEQ Dx clinical product in development for SARS-CoV-2 based on favorable results from a head-to-head study comparing Adaptive’s clinical T-cell based diagnostic test to two leading serology tests with additional publication forthcoming.
Launched a new research product, immunoSEQ T-MAP COVID, to offer vaccine developers a tool to accurately and reproducibly measure the T-cell immune response to vaccines in development and track the persistence of that response over time.
Received clearance from the U.S. Food and Drug Administration (FDA) for clonoSEQ Assay to detect and monitor minimal residual disease (MRD) in blood or bone marrow from patients with chronic lymphocytic leukemia (CLL).
Initiated two clinical validation studies for immunoSEQ Dx: ImmuneSENSE Lyme for Lyme disease, and ImmuneRACE to collect blood samples from people who have been exposed, are actively fighting or have recently recovered from COVID-19.
Strengthened balance sheet with the successful completion of underwritten public offering, raising approximately $271.7 million in net proceeds.
Second Quarter 2020 Financial Results

Revenue was $21.0 million for the quarter ended June 30, 2020, representing a 5% decrease from the second quarter in the prior year. Sequencing revenue was $8.0 million for the quarter, representing a 33% decrease from the second quarter in the prior year. Development revenue increased to $13.0 million for the quarter, representing a 27% increase from the second quarter in the prior year.

Operating expenses were $57.9 million for the second quarter of 2020, compared to $38.2 million in the second quarter of the prior year, representing an increase of 52%.

Net loss was $33.5 million for the second quarter of 2020, compared to $15.7 million for the same period in 2019.

Adjusted EBITDA (non-GAAP) was a loss of $28.5 million for the second quarter of 2020, compared to a loss of $10.9 million for the second quarter of the prior year.

Cash, cash equivalents and marketable securities was $627.8 million as of June 30, 2020. Subsequent to the quarter, Adaptive Biotechnologies raised approximately $271.7 million in net proceeds, after deducting underwriting discounts and net offering expenses payable by us, from a follow-on offering, which closed in mid-July.

2020 Financial Guidance

Adaptive Biotechnologies is not providing 2020 financial guidance due to the continued uncertainties from the impact of COVID-19.

Webcast and Conference Call Information

Adaptive Biotechnologies will host a conference call to discuss its second quarter financial results after market close on Monday, August 10, 2020 at 4:30 PM Eastern Time. The conference call can be accessed at View Source The webcast will be archived and available for replay at least 90 days after the event.