On November 9, 2020 AVEO Oncology (Nasdaq: AVEO) reported financial results for the third quarter ended September 30, 2020 and provided a business update (Press release, AVEO, NOV 9, 2020, View Source [SID1234570441]).

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"In advance of the Food and Drug Administration’s (FDA) March 31, 2021 Prescription Drug User Fee Act (PDUFA) target action date for our tivozanib New Drug Application, we are actively building out AVEO’s U.S. commercial infrastructure to support the FDA-pending U.S. launch of tivozanib in relapsed or refractory renal cell carcinoma (RCC)," said Michael Bailey, president and chief executive officer of AVEO. "Market data suggests that a significant and growing demand exists for effective and better tolerated treatment options for these patients. These data also suggest that roughly half of patients currently forego treatment in the third- and fourth-line of treatment.1 We believe tivozanib has the potential to help address some of these challenges and provide patients with a new option for continuing their fight against cancer."

Mr. Bailey added, "Beyond our ongoing development of tivozanib as a potential monotherapy treatment, we are continuing our work in the immunotherapy combination setting as a key area of focus, given tivozanib’s tolerability profile and effects on reducing regulatory T-cells2 to potentially enhance activity of the immune system. In addition, we further enhanced our pipeline by regaining full global rights to our second late-stage asset, ficlatuzumab, and have secured additional manufacturing capacity to enable a potential registrational Phase 3 trial in head and neck squamous cell cancer (HNSCC) in 2022. Finally, we remain on track to file an Investigational New Drug (IND) application by the end of the year for AV-380 for the treatment of cancer cachexia, with a potential Phase 1 study in the first quarter of 2021, following the IND safe to proceed letter."

Tivozanib Updates

Announced Publication of Results from Phase 1b/2 TiNivo Study of Tivozanib in Combination with OPDIVO (nivolumab) in RCC in Annals of Oncology. In November 2020, AVEO announced that previously reported results from the Phase 1b/2 TiNivo study of oral (PO) tivozanib (FOTIVDA), AVEO’s next-generation vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor (TKI) drug candidate, in combination with intravenous (IV) nivolumab (OPDIVO, Bristol-Myers Squibb), an immune checkpoint, or PD-1, inhibitor, for the treatment of advanced RCC, were published in Annals of Oncology. The article, titled "TiNivo: Safety and Efficacy of Tivozanib-Nivolumab Combination Therapy in Patients with Metastatic Renal Cell Carcinoma", is available online first via this link.

AVEO is also studying tivozanib in combination with IMFINZI (durvalumab), AstraZeneca’s human monoclonal antibody directed against programmed death-ligand 1 (PD-L1), in patients with first-line metastatic hepatocellular carcinoma (HCC) in the Phase 1b/2 DEDUCTIVE clinical trial, which is currently in Phase 2.
Published Final Overall Survival Results from Phase 3 TIVO-3 Study of Tivozanib in RCC in European Urology. In September 2020, AVEO announced that final overall survival (OS) results from its pivotal Phase 3 TIVO-3 study comparing tivozanib to sorafenib in third- and fourth-line RCC were published in the journal European Urology. The article, titled "Final Overall Survival Results from a Phase 3 Study to Compare Tivozanib to Sorafenib as Third- or Fourth-line Therapy in Subjects with Metastatic Renal Cell Carcinoma," is available online via this link.
Preparations Ongoing to Support Commercial Launch of Tivozanib in the U.S. Following the PDUFA Date (March 31, 2021). In preparation for the potential commercial launch of tivozanib in the U.S., the Company continues to expand its sales, marketing, market access and medical affairs teams, and is working to put in place its U.S. distribution capabilities by the end of the year. In connection with these preparations, in October 2020, AVEO announced the appointment of David W. Crist as vice president of sales. Mr. Crist, who brings to AVEO over twenty years of oncology sales experience in both launch-stage and late-stage companies, will be responsible for building out AVEO’s sales force in anticipation of the potential marketing approval and launch of tivozanib in the U.S.
Tivozanib Non-Oncology Partnership Update

$2.8 Million Development Milestone from Kyowa Kirin Co., Ltd. In August 2020, the Company announced that it earned a $2.8 million development milestone payment from partner Kyowa Kirin. The milestone relates to acceptance by the Japanese Pharmaceuticals and Medical Devices Agency of an IND application for a new formulation of tivozanib in a non-oncology indication being developed by Kyowa Kirin.

Under the terms of AVEO’s agreement with Kyowa Kirin, in addition to the 2019 upfront payment of $25 million to AVEO, waiver of AVEO’s obligation to make an $18 million milestone payment upon AVEO gaining U.S. marketing approval of tivozanib for RCC, and the $2.8 million IND development milestone, Kyowa Kirin has also agreed to pay AVEO up to an additional $388 million in potential milestone payments upon the successful achievement of certain development, regulatory, and commercial objectives in non-oncology indications of tivozanib. Kyowa Kirin will also be obligated to make tiered royalty payments on the net sales of a product for these indications, ranging from a high single-digit to low double-digit percent.
Ficlatuzumab Update

Regained Full Global Rights to Ficlatuzumab. In September 2020, AVEO regained full global rights to ficlatuzumab, the Company’s potent hepatocyte growth factor (HGF) inhibitor antibody which binds to the HGF ligand with high affinity and specificity to inhibit HGF/c-Met biological activities. The Company announced plans to fund the clinical manufacture of ficlatuzumab to enable a potential registrational Phase 3 clinical trial in HNSCC, as well as additional potential development in Phase 2 studies in pancreatic cancer and acute myeloid leukemia. Ficlatuzumab is being studied in an ongoing randomized confirmatory Phase 2 study in combination with cetuximab, an EGFR-targeted antibody, in metastatic HNSCC, which is expected to conclude enrollment in the fourth quarter of 2020, with results from the study expected in the middle of 2021. In that timeframe, the Company plans to provide an update on its pivotal program for ficlatuzumab.
AV-380 Update

Company on Track for IND Application Submission by Year-end, with Phase 1 Clinical Study Planned for the First Quarter of 2021. AVEO plans to submit an IND application to the FDA for AV-380, its first-in-class, potent, humanized inhibitory antibody targeting GDF15, for the treatment of cancer cachexia by year-end. Cachexia, a common complication in patients with advanced cancer and other chronic diseases, is a complex metabolic syndrome characterized by malnutrition and severe involuntary weight loss due to the loss of muscle and fat tissue, as well as the clinical manifestation of anemia, inflammation and suppression of immune functions. Preparations for a Phase 1 trial are currently underway.
Corporate Updates

Announced Restructuring of Existing Term Loan with Closing of New Tranched, $35 Million Debt Facility, Potentially Providing for Working Capital into 2022. In August 2020, The Company announced the closing of a tranched, $35 million debt facility with Hercules Capital, Inc. and its affiliates. Under the terms of the agreement, the initial tranche of $15 million fully refinanced AVEO’s existing Hercules term loan facility, which had an outstanding principal amount of approximately $9.7 million, providing net new proceeds of $5.3 million. A second $10 million tranche is contingent upon the approval of the tivozanib New Drug Application by the FDA as a treatment for RCC, and certain other terms and conditions. An additional two $5 million tranches would potentially become available after that time – one if net product revenues of tivozanib reach $20.0 million within a specified time frame, and the other upon the lender’s consent.
A current summary of the Company’s activities and corporate updates is available in AVEO’s corporate presentation available on the investor relations portion of the Company’s website at investor.aveooncology.com.

Third Quarter 2020 Financial Results

AVEO ended Q3 2020 with $68.8 million in cash, cash equivalents and marketable securities as compared with $47.7 million at December 31, 2019.
Total revenue was approximately $3.6 million for Q3 2020 compared with $25.7 million for Q3 2019. The third quarter of 2019 included the $25.0 million upfront payment pursuant to AVEO’s agreement with Kyowa Kirin for non-oncology indications of tivozanib.
Research and development expense for Q3 2020 was $5.9 million compared with $4.0 million for Q3 2019.
General and administrative expense for Q3 2020 was $5.8 million compared with $2.9 million for Q3 2019.
Net loss for Q3 2020 was $8.4 million, or net loss of $0.33 per basic and diluted share, compared with net income of $16.4 million for Q3 2019, or net income of $1.02 per basic and diluted share, respectively.
Financial Guidance

AVEO believes that its $68.8 million in cash, cash equivalents and marketable securities as of September 30, 2020, along with anticipated partnership cost sharing reimbursements, royalties from EUSA’s FOTIVDA sales and, if the pending marketing application for FOTIVDA is approved by the FDA, resulting product revenues upon commercial launch and the potential additional $20 million in credit under the Hercules loan, would allow the Company to fund planned operations into 2022.

In accordance with Accounting Standards Update No. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Accounting Standards Codification Subtopic 205-40), cash flows that are contingent on FDA approval, such as product revenues, cannot be reflected in the going concern assessment. As a result, Hercules loan funding contingent on such approval and revenue is also excluded from the Company’s going concern assessment. Accordingly, the Company continues to have a going concern opinion.

About Tivozanib (FOTIVDA)

Tivozanib is an oral, once-daily, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) discovered by Kyowa Kirin and approved as FOTIVDA for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union and other countries in the EUSA territory. It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.3,4 Tivozanib is being studied in the TIVO-3 trial, which is supporting a regulatory submission of tivozanib in the U.S. seeking marketing approval as a treatment for adult patients with relapsed or refractory advanced RCC. Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models2 and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC.5 Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, colorectal, ovarian and breast cancers. Tivozanib is also being studied by partner Kyowa Kirin in non-oncology indications.

On November 9, 2020 Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in cell therapy to treat cancer, reported data from the dose escalation cohorts of its Phase 1 SURPASS trial using ADP-A2M4CD8 in a poster at the Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) ("SITC") Conference (Press release, Adaptimmune, NOV 9, 2020, View Source [SID1234570434]).

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In these cohorts of heavily pre-treated patients with advanced cancers (n=6), three were treated with target doses of 1 billion SPEAR T-cells, and three with target doses of 5 billion. Most adverse events were consistent with those typically experienced by cancer patients undergoing cytotoxic chemotherapy or cancer immunotherapy.

"We have seen responses in two out of six patients treated in the safety cohorts of the SURPASS trial as well as antitumor activity in five of them. The responses and antitumor activity we have seen with our next-generation ADP-A2M4CD8 SPEAR T-cells, across a range of solid tumors, support our belief that this is a highly active product," said Ad Rawcliffe, Adaptimmune’s Chief Executive Officer. "Based on these data, we will initiate the Phase 2 trial in gastroesophageal cancers in the first half of 2021 and look forward to identifying additional indications to take into late-stage development."

There were two confirmed partial responses (PRs): one in a patient with esophagogastric junction (EGJ) cancer, previously reported, and one in a patient with head and neck cancer, reported as unconfirmed in May. The four other patients had best overall responses of stable disease (SD). Overall, five out of six patients treated had initial tumor shrinkage.

In vitro translational data using the manufactured products from patients in the SURPASS trial indicate that co-expression of the CD8α co-receptor on CD4+ ADP-A2M4 SPEAR T-cells enables them to kill MAGE-A4 expressing target cells with equal potency as CD8+ SPEAR T-cells targeting MAGE-A4. These data, combined with the responses and antitumor activity observed at low doses, indicate that ADP-A2M4D8 may be a more potent product than the first-generation ADP-A2M4 SPEAR T-cells.

Best Overall Response (BOR) and maximum changes from baseline in target lesions in Cohorts 1 and 2

Indication Dose x 109 BOR Tumor reduction
Head and neck 4.6 PR -63.16%
EGJ 1.2 PR -51.52%
EGJ 1.0 SD -34.07%
Ovarian 1.1 SD -16.13%
Esophageal 6.0 SD -13.37%
MRCLS 5.7 SD +1.35%

As of data cut-off: October 1, 2020

At SITC (Free SITC Whitepaper), Adaptimmune also presented a poster entitled "Inhibition of AKT signaling during expansion of TCR-engineered T-cells from patient leukocyte material generates SPEAR T-cells with enhanced functional potential in vitro." These preclinical data indicate that AKT inhibition during the manufacture of SPEAR T-cells results in a more consistent expansion and phenotype of the final product. This process is currently being used for manufacture of ADP-A2M4CD8 for the SURPASS trial.

The Company also presented two posters summarizing data for the two completed Phase 1 trials with ADP-A2M10 (a previously terminated program)

On November 9, 2020 Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, reported financial results for the third quarter 2020 and recent business progress (Press release, Abeona Therapeutics, NOV 9, 2020, View Source [SID1234570433]).

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"Abeona remains committed to pursuing the development of our portfolio of advanced and early stage programs toward providing our novel gene and cell therapies to patients who currently have no approved treatment options," said Michael Amoroso, Chief Operating Officer of Abeona. "In particular, we are continuing to propel our clinical programs in recessive dystrophic epidermolysis bullosa (RDEB) and Sanfilippo syndrome type A (MPS IIIA) and type B (MPS IIIB) to drive Abeona’s long-term growth and unlock shareholder value."

Third Quarter and Recent Highlights

Corporate and Business Development Updates

In August 2020, Abeona entered into definitive agreements with Taysha Gene Therapies to license its rights to ABO-202, an AAV-based gene therapy for CLN1 disease (also known as infantile Batten disease). As part of the transaction, Abeona received initial cash proceeds of $7.0 million in October 2020. Abeona is also eligible to receive up to $56.0 million upon the achievement of certain clinical, regulatory and sales milestones, plus royalty-based payments based on net sales.
In October 2020, Abeona entered into a license agreement with Taysha Gene Therapies with respect to certain intellectual property rights, materials, and know-how relating to a potential AAV-based gene therapy for Rett syndrome. In connection with the agreement, Abeona received a one-time upfront payment of $3.0 million and is eligible to receive up to $56.5 million upon the achievement of certain clinical, regulatory and sales milestones, plus royalty-based payments based on net sales.
In October 2020, Michael Amoroso, Senior Vice President and Chief Commercial Officer at Abeona, was promoted to Chief Operating Officer. In this newly created role, Mr. Amoroso’s responsibilities are broadened to include oversight and leadership of all operations.
Abeona continues to work with Jefferies LLC as its financial advisor in the review of strategic options focused on advancing the Company’s mission and maximizing stakeholder value.
EB-101 (Autologous, Gene-Corrected Cell Therapy)

Patient enrollment is ongoing for Abeona’s EB-101 pivotal Phase 3 VIITAL study for RDEB. The Company currently anticipates completing enrollment in the VIITAL study in the first half of 2021, depending upon the impact from the COVID-19 pandemic, including travel restrictions and safety concerns.
ABO-102 and ABO-101 (AAV-based Gene Therapies)

Target enrollment in the ABO-102 Transpher A study for MPS IIIA (15 to 22 patients) has been achieved. To date, 18 patients have been dosed in the Transpher A study, including 12 patients dosed in cohort 3. Abeona intends to continue enrolling patients into the study through the first quarter of 2021 given the lack of treatment options for MPS IIIA and encouraging efficacy and safety data from cohort 3.
In the ABO-101 Transpher B study for MPS IIIB, 11 patients have been dosed to date, including 4 patients dosed in cohort 3. The Company anticipates completing target enrollment in the Transpher B study (15 to 20 patients) in the first quarter of 2021.
In the third quarter, Abeona presented its plan toward registration of ABO-102 for MPS IIIA (Sanfilippo syndrome type A) during a kick-off meeting under the European Medicines Agency’s (EMA) PRIority MEdicines (PRIME) program that offers a path for accelerated assessment of promising therapies targeting unmet medical needs. Based on the meeting, along with previous input from the Committee for Medicinal Products for Human Use and the Pediatric Committee of the EMA, Abeona anticipates submitting a marketing authorization application for EU conditional approval of ABO-102 for MPS IIIA after completion of two-year follow-up of the last patient treated in the Transpher A study. Regarding the U.S. regulatory path for ABO-102 in MPS IIIA, Abeona plans to request a meeting with the FDA to take place in the first quarter of 2021, depending on FDA’s availability.
Manufacturing Activities

Process development at the Company’s GMP manufacturing facility in Cleveland, Ohio is ongoing that will enable production of the retrovirus used for EB-101 manufactured at the facility, allowing for increased control of the supply chain and product quality, as well as reduced costs. In addition, Abeona continues process development activities to enable in-house manufacturing of commercial supply of ABO-102 and ABO-101.
Third Quarter Financial Results

Cash, cash equivalents, receivables and short-term investments totaled $103.9 million as of September 30, 2020, compared to $129.3 million as of December 31, 2019. Accounts receivable were $7.0 million at September 30, 2020, which was paid by the customer in October 2020. Net cash used in operating activities was $10.7 million for the third quarter of 2020.

License and other revenues for the third quarter of 2020 were $7.0 million, comprised of initial proceeds from the ABO-202 transaction, compared to zero revenues in the year-ago quarter.

Research and development (R&D) expenses were $8.0 million for the third quarter of 2020 and $20.9 million for the nine months ended September 30, 2020, compared to $10.9 million and $39.0 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 $4.4 million for the third quarter of 2020 and $16.4 million for the nine months ended September 30, 2020, compared to $4.7 million and $16.0 million in the comparable periods in 2019. The decrease in G&A expenses in the third quarter of 2020 was primarily due to decreased salary and related costs. The increase in G&A expenses in the nine months ended September 30, 2020 was primarily from severance costs associated with management changes, partially offset by decreased professional fees.

Net loss was $7.2 million for the third quarter of 2020 and $68.4 million for the nine months ended September 30, 2020, compared to net loss of $17.4 million and $59.9 million for the comparable periods in 2019. The increase in net loss for the nine months ended September 30, 2020 includes the non-cash impairment charge of $32.9 million related to the termination of the license agreement with REGENXBIO.

Conference Call Details

Abeona Therapeutics will host a conference call and webcast tomorrow, Tuesday, November 10, 2020 at 8:30 a.m. ET, to discuss its third quarter 2020 financial results and business update. To access the call, dial 844-369-8770 (U.S. toll-free) or 862-298-0840 (international) 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 November 9, 2020 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, and Roivant Sciences, a global biopharmaceutical company, reported that they have entered into a licensing and strategic collaboration agreement to develop and commercialize novel ICE molecules in oncology (Press release, Affimed, NOV 9, 2020, View Source [SID1234570420]).

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The collaboration grants Roivant a license to the preclinical molecule AFM32. The collaboration will also leverage Affimed’s proprietary Redirected Optimized Cell Killing (ROCK) platform to generate ICE molecules against targets not included in Affimed’s current pipeline.

Under the terms of the agreement, Affimed will receive $60 million in upfront consideration, comprised of $40 million in cash and pre-paid R&D funding, and $20 million of newly issued shares in Roivant. Affimed could receive further short-term proceeds in the form of option fees contingent on the commencement of additional programs contemplated under the agreement. The company is eligible to receive up to an additional $2 billion in milestones over time upon achievement of specified development, regulatory and commercial milestones, as well as tiered royalties on net sales.

Pursuant to the agreement, Affimed will be primarily responsible for driving the discovery and research phases of molecule development through filing of the IND. Roivant will be responsible for clinical development and commercialization worldwide, and Affimed retains an option for co-promotion.

"This partnership represents an important milestone as it further validates our platform and scientific expertise in the selection of promising targets to develop ICE molecules in oncology indications where patients are underserved by existing therapies," said Dr. Adi Hoess, Affimed’s Chief Executive Officer. "Partnering with Roivant, an innovative trailblazer in biopharmaceutical development, is another step towards accelerating the growth of our current and future pipeline."

"We are extremely pleased to have entered into this agreement with Affimed given their leadership position in the science of innate immunity and extensive expertise in the preclinical development of bispecifics," commented Dr. Roger Sidhu, Chief Medical Officer and Head of R&D at Roivant. "We look forward to working together to deliver meaningful therapies to patients."

About the ROCK Platform

Affimed’s proprietary, fit-for-purpose ROCK platform technology generates diverse, tetravalent, bispecific antibodies known as innate cell engagers (ICE) which can be customized to target specific binding domains on hematologic and solid tumor cells. Affimed’s ROCK -generated ICE use a distinct, dual mechanism of action that activates CD16A on natural killer cells and macrophages and binds to specific antigens on tumor cells, restoring the body’s innate ability to overcome tumor invasion and destroy tumor cells.

On November 9, 2020 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported financial results and business highlights for the third quarter of 2020 (Press release, CASI Pharmaceuticals, NOV 9, 2020, View Source [SID1234570419]).

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Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, "We are pleased to report that EVOMELA revenues for Q3 were $4.2 million. For the full year 2020 revenue, we expect to exceed $14 million, performing better than we had previously forecasted. We are thrilled with the progress we are seeing across our hematology oncology product portfolio. With our recently announced partnership with BioInvent, we gained exclusive Greater China development and commercialization rights to BI-1206, a first-in-class anti-FcyRIIB monoclonal antibody. BI-1206 has broad potential clinical applications across multiple tumor types in many first line indications and in refractory settings, which we look forward to exploring."

Dr. He continued, "With respect to our commercial asset CNCT-19 (CD19 CAR-T), our partner Juventas is making good progress with their current Phase 1 trials in B-NHL and B-ALL, and is expecting to initiate registration trials by the end of 2020. We expect to initiate our Phase 1 study for CID-103 (anti-CD38 monoclonal antibody) in the EU during the first quarter of 2021. We will continue to execute on a number of key milestones across our broad portfolio in the quarters ahead. In parallel, our team will continue tactically evaluating additional strategic opportunities that complement our growing portfolio."

Third Quarter 2020 Financial Results

Revenues consisted primarily of product sales of EVOMELA that launched in August of 2019. Revenues were $4.2 million for the three months ended September 30, 2020 compared to $2.7 million for the three months ended September 30, 2019.
Costs of revenues were $1.8 million for the three months ended September 30, 2020 compared to $2.6 million for the three months ended September 30, 2019. The decrease in cost of revenues is a result of the transfer to a new manufacturer, resulting in a considerable decrease in the unit cost of inventories of EVOMELA.
Research and development expenses for the three months ended September 30, 2020 were $2.8 million, compared with $1.8 million for the three months ended September 30, 2019. The increases in R&D expenses are primarily due to increases in 2020 R&D expenses incurred related to the development of CID-103, and costs associated with the EVOMELA post marketing study.
General and administrative expenses for the three months ended September 30, 2020 were $5.3 million, compared with $8.0 million for the three months ended September 30, 2019. The decrease in general and administrative expenses was primarily because the 2019 period included costs related to sales and marketing efforts to prepare for the August 2019 launch of EVOMELA, as well as lower professional fees and travel costs incurred during the 2020 period.
Selling and marketing expenses for the three months ended September 30, 2020 were $2.1 million, compared with $975,000 for the three months ended September 30, 2019. The increase is due to selling costs related to commercial sales of EVOMELA that began in August of 2019.
Acquired in-process R&D expenses for the three months ended September 30, 2020 was $10.9 million, compared to $0 million for the three months ended September 30, 2019. Expense of $0.6 million relates to 2020 milestone fees paid to Pharmathen due to the first submission to the National Medical Products Administration in China for Octreotide which was achieved during 2020 and $10.3 million relates to milestone fees paid to Juventas.
Net loss for the third quarter of 2020 was $16.8 million compared to $9.7 million for the same period in 2019.
As of September 30, 2020, the Company had cash and cash equivalents of $74.6 million compared to $44.9 million as of June 30, 2020. As reported, the Company consummated an underwritten public offering in July 2020 generating gross proceeds of approximately $43.7 million.
Further information regarding the Company, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, can be found at www.casipharmaceuticals.com.

Conference Call

The Company will host a conference call reviewing the third quarter highlights today at 4:30 p.m. ET. The conference call can be accessed by dialing (833) 647-4459 (U.S.), (800) 870-0181 (China), (400) 682-8629 (China, domestic), (580) 86567 (Hong Kong) to listen to the live conference call. The conference ID number for the live call is 8835514.

This call will be recorded and available for replay by dialing (855) 589-2056 (U.S.) or (404)-537-3406 (international) and enter 8835514 to access the replay.