On August 10, 2020 AVEO Oncology (Nasdaq: AVEO) reported financial results for the second quarter ended June 30, 2020 and provided a business update (Press release, AVEO, AUG 10, 2020, View Source [SID1234563330]).

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"The first half of 2020 was one of the most important periods in AVEO’s history to date, with the successful completion of the TIVO-3 study and the acceptance for filing and substantive review of a New Drug Application (NDA) for tivozanib as a treatment for relapsed or refractory renal cell carcinoma (RCC)," said Michael Bailey, president and chief executive officer of AVEO. "Through successful debt and equity financings, we now expect to have access to the capital to ensure a robust launch of FOTIVDA (tivozanib) into 2022 to potentially address what we believe is a significant unmet need for an effective, better tolerated drug. Currently, more than half of patients are opting to forego third or later lines of therapy, largely due to issues of tolerability and a lack of evidence-based studies in this setting.1 Supported by positive results from TIVO-3, we believe tivozanib could address these challenges and allow patients to continue their fight against cancer, and therefore has the potential to become a standard of care in this large and growing segment of the market."

Mr. Bailey added, "With TIVO-3 complete, we are now evaluating several opportunities to initiate new pivotal studies for both tivozanib and ficlatuzumab. Building on the TiNivo and DEDUCTIVE trials in RCC and hepatocellular carcinoma (HCC) respectively, we believe tivozanib’s activity, favorable safety profile, and ability to significantly reduce regulatory T cells2 all have the potential to make tivozanib a companion tyrosine kinase inhibitor of choice in these settings. In addition, the early data we have seen in the randomized head and neck cancer (HNSCC) study with ficlatuzumab combined with cetuximab (ERBITUX), which could serve as the basis for pursuing a pivotal study in this tumor type, has led us to initiate the process to evaluate securing additional clinical manufacturing capacity. Finally, we expect AV-380 to enter into a Phase 1 study

in the first quarter of 2021, if an Investigational New Drug (IND) application which we expect to file by year end 2020, is accepted by the U.S. Food and Drug Administration (FDA)."

Tivozanib Updates

Announced FDA Acceptance for Filing of an NDA for Tivozanib as a Treatment of Relapsed or Refractory RCC. In June 2020, AVEO announced that the FDA accepted for filing its NDA seeking approval for tivozanib, the Company’s next-generation vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI), as a treatment for relapsed or refractory RCC. The FDA has assigned the application standard review and a Prescription Drug User Fee Act target action date of March 31, 2021. The FDA also indicated that they do not currently plan on convening an Oncologic Drug Advisory Committee (ODAC) to discuss the application.

The NDA submission is based on AVEO’s pivotal Phase 3 study, TIVO-3, comparing tivozanib to sorafenib in 3rd and 4th line RCC. The application is also supported by three additional trials in RCC and includes safety data from over 1,000 clinical trial subjects.

Preparations Underway to Support Potential Commercial Launch of Tivozanib in the U.S. In preparation for the potential commercial launch of tivozanib in the U.S., the Company is actively engaged in the expansion of its sales, marketing, market access and medical affairs teams, as well as working to enable distribution capabilities by the end of the year. The Company also reported that the FDA has conditionally accepted "FOTIVDA" as the proprietary brand name for tivozanib in the U.S.

Presented TIVO-3 Final Overall Survival Results at ASCO (Free ASCO Whitepaper) 2020 Virtual Scientific Program. In May 2020, the Company presented data from the final overall survival (OS) analysis of the pivotal Phase 3 TIVO-3 trial at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program. The final OS hazard ratio (HR) of 0.97 was similar to those observed with prior approved VEGFR TKI vs. VEGFR TKI pivotal studies in RCC.3-6 TIVO-3 represents the first positive Phase 3 superiority study designed to help guide treatment decisions in third and fourth line RCC, a growing patient population with a high unmet medical need for effective and better tolerated therapies.

A copy of the presentation is available on the Publications & Presentations section of AVEO’s website.

Announced Advancement to the Phase 2 Portion of Phase 1b/2 DEDUCTIVE Study of Tivozanib in Combination with IMFINZI (durvalumab) in Previously Untreated HCC After No Dose-Limiting Toxicities Observed in Phase 1 Portion. In May 2020, AVEO announced that the Phase 1b/2 DEDUCTIVE clinical trial evaluating 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 HCC has progressed to the Phase 2 portion of the trial. Advancement of the study into the Phase 2 portion, for which enrollment is currently underway, was based on findings from the recently completed Phase 1 portion of the combination in which no dose limiting toxicities were observed.

Taken together with positive results from the TiNivo study, a Phase 1b/2 multicenter trial of tivozanib in combination with PD-1 inhibitor nivolumab (OPDIVO, Bristol-Myers Squibb) in first or second line metastatic RCC, AVEO is currently evaluating opportunities to initiate potential registrational immunotherapy combination studies.

Tivozanib Non-Oncology Partnership Update

$2.8 Million Development Milestone from Kyowa Kirin Co., Ltd. The Company recently announced that it earned a $2.8 million development milestone payment from partner Kyowa Kirin Co., Ltd. (Kyowa Kirin). The milestone relates to acceptance by the Japanese Pharmaceuticals and Medical Devices Agency of an IND application for 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 previously-paid 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

Based on Early Data from Randomized Phase 2 Study of Ficlatuzumab in Combination with Erbitux in Head and Neck Cancer, AVEO Currently Evaluating Phase 3 Study Opportunities. AVEO’s potent hepatocyte growth factor (HGF) inhibitory antibody, ficlatuzumab, which binds to the HGF ligand with high affinity and specificity to inhibit HGF/c-Met biological activities, is being studied in an ongoing randomizedconfirmatory Phase 2 study in combination with cetuximab, an EGFR-targeted antibody, in metastatic HNSCC. The study was designed to confirm findings from a Phase 1 study of ficlatuzumab and cetuximab where the combination was well tolerated and resulted in a disease control rate of 67%, as well as prolonged progression free and OS compared to historical controls. The Phase 2 multi-center study is being conducted under the direction of Julie E. Bauman, MD, MPH, Professor of Medicine, Chief, Division of Hematology/Oncology, Associate Director of Translational Research, University of Arizona Cancer Center. Enrollment is expected to conclude in the fourth quarter of 2020, and results from the study are expected to be presented at a scientific meeting in the first half of 2021. AVEO and its partner Biodesix are evaluating the process to secure additional clinical manufacturing of ficlatuzumab to potentially enable a Phase 3 clinical trial of ficlatuzumab for the treatment of HNSCC in 2022.

Data from Phase 1 Study of Ficlatuzumab and Cetuximab in HNSCC Published in Cancers. Data from the Phase 1 study of ficlatuzumab and cetuximab in patients with HNSCC were recently published in the journal Cancers. The combination of ficlatuzumab and cetuximab demonstrated an acceptable safety profile and showed promising antitumor activity in a refractory HNSCC patient population. A link to the publication, titled, "Phase I Study of Ficlatuzumab and Cetuximab in Cetuximab-Resistant, Recurrent/Metastatic Head and Neck Cancer", is available on the Publications & Presentations section of AVEO’s website.

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 growth differentiation factor 15 (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

Raised Gross Proceeds of $51.1M in Oversubscribed Public Offering. In June 2020, AVEO announced the closing of an oversubscribed underwritten public offering yielding aggregate gross proceeds of approximately $51.1 million, before deducting underwriting discounts and commissions and offering expenses payable by AVEO. The financing was led by investors Deerfield Management, New Enterprise Associates and Cormorant Capital.

Announced Restructuring of Existing Term Loan with Closing of New Tranched, $35 Million Debt Facility, Potentially Providing for Working Capital into 2022. The Company announced today the closing of a tranched, $35 million debt facility with Hercules Capital, Inc. and its affiliates. The new facility has a maturity of 36 months, extendable up to 48-months, and an interest-only period of 12 months, extendable up to 30 months upon the achievement of performance milestones related to the approval and commercialization of tivozanib. 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 NDA by the FDA as a treatment for RCC, and certain other terms and conditions. An additional two $5 million tranches will become available after that time – one if net product revenues of tivozanib reach $20.0 million within a specified time frame, and the other at the lender’s consent. As previously announced, the FDA has assigned AVEO’s NDA a Prescription Drug User Fee Act target action date of March 31, 2021

Second Quarter 2020 Financial Results

AVEO ended Q2 2020 with $71.4 million in cash, cash equivalents and marketable securities as compared with $47.7 million at December 31, 2019.

Total revenue was approximately $0.7 million in each of Q2 2020 and Q2 2019.

Research and development expense for Q2 2020 was $4.4 million compared with $2.6 million for Q2 2019.

General and administrative expense for Q2 2020 was $3.7 million compared with $3.0 million for Q2 2019.

Net loss for Q2 2020 was $7.3 million, or net loss of $0.42 per basic and diluted share, compared with net loss of $3.1 million for Q2 2019, or net loss of $0.20 per basic and diluted share, respectively. The net loss in Q2 2019 reflects a $2.2 million non-cash gain that was attributable to the decrease in fair value of the 2016 private placement warrant liability that principally resulted from a decrease in the stock price that occurred within the period.

Financial Guidance

AVEO believes that its as-adjusted $79.5 million in cash, cash equivalents and marketable securities as of June 30, 2020, consisting of $71.4 million in cash, cash equivalents and marketable securities at June 30, 2020 together with the $2.8 million KKC milestone and the $5.3 million in new loan funding from Hercules, along with 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 our going concern assessment. Accordingly, the Company continues to have a going concern opinion.

About Tivozanib (FOTIVDA)

Tivozanib (FOTIVDA) is an oral, once-daily, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) discovered by Kyowa Kirin and approved 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.8,9 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 relapsed or refractory 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.10 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.

AV-380 Update

On August 10, 2020 Athersys, Inc. (NASDAQ: ATHX) reported its financial results for the three months ended June 30, 2020 (Press release, Athersys, AUG 10, 2020, View Source [SID1234563329]).
Highlights of the second quarter of 2020 and recent events include:

•Initiated and advanced enrollment in the Phase 2/3 COVID-19 induced acute respiratory distress syndrome (ARDS) clinical trial (the MACOVIA study) and currently evaluating the safety, tolerability and dose levels of MultiStem cell therapy in this indication;
•Continued interactions with the Biomedical Advanced Research and Development Authority (BARDA) regarding a potential collaboration;
•HEALIOS K.K. (Healios), our Japanese partner, enrolled the first COVID-19 induced ARDS patient in its ONE-BRIDGE arm and continues to advance this study and the TREASURE stroke study, both studies expected to complete enrollment in Q4 of 2020;
•Following the authorization from the Food and Drug Administration (FDA) and the Institutional Review Board (IRB) approval, The University of Texas Health Science Center at Houston (UTHealth) submitted the protocol for the Phase 2 clinical trial evaluating MultiStem Administration for Trauma Related Inflammation and Complications (MATRICS-1) to the Human Research Protection Office (HRPO) for approval to initiate this important trial;
•Advanced our partnering discussions with companies interested in MultiStem commercialization rights in Europe and other regions;
•Participated in several events throughout the second quarter, including the Bank of America Healthcare Conference, the Alliance for Regenerative Medicine webinar, the International Society of Cell & Gene Therapy, and a CEO round table at LifeScience Leader, and participated in several media interviews and podcasts;
•Continued to advance the enrollment of the MASTERS-2 ischemic stroke study despite the impacts of COVID-19;
•New research coverage initiated by covering analysts at Bank of America and SMBC Nikko Securities;
•Advanced manufacturing technical transfer operations and bioreactor scaling to prepare for commercial readiness;
•Successfully attracted new talent and added new employees to the dedicated staff to help meet the corporate goals; including Mr. Ivor Macleod as Chief Financial Officer and Ms. Maia Hansen as Senior Vice President and Head of Operations and Supply Chain;
•Raised gross proceeds of approximately $57.6 million, before deducting the underwriting discount and offering expenses, through an underwritten public offering of 25,587,500 shares of common stock, providing additional working capital for general corporate purposes, including the initiation of the MACOVIA trial, further advancement of process development and manufacturing projects, and other key initiatives;
•Recognized net loss of $18.4 million, or $0.10 net loss per share, for the quarter ended June 30, 2020; and
•Ended the second quarter with $80.7 million of cash and cash equivalents.

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"Over the past quarter, we have made additional progress in our key clinical programs, partnering discussions and efforts regarding the establishment of key infrastructure to support our planned transition to becoming a commercial stage company. While the COVID-19 pandemic continues to have a global impact and has impacted many patients and their families, as well as disrupted operations and clinical trials for many companies, we have continued to move forward and are in the strongest financial position in the history of the Company," commented Dr. Gil Van Bokkelen, Chairman and CEO of Athersys. "We remain focused on supporting our partner Healios while it approaches completion of enrollment in both the TREASURE and ONE-BRIDGE trials in Japan, while we advance towards the establishment of new alliances in other key geographies, including Europe.

"A major focus for the Company in 2020 has been to advance our planning and preparation related to the establishment of infrastructure that will support our commercialization objectives, as well as the addition and integration of personnel and
1capabilities that will support the evolution. Despite the challenges posed by the COVID-19 pandemic, we are on track to achieve our core objectives in the second half of the year," concluded Dr. Van Bokkelen.

Second Quarter Results
Revenues were $0.1 million for the three months ended June 30, 2020 compared to $4.3 million for the three months ended June 30, 2019. The revenues in both periods were primarily generated from our collaboration with Healios related to manufacturing services performed. We expect our collaboration revenues to vary over time as we contract with Healios to perform manufacturing services and as we potentially enter into new collaborations.
Research and development expenses increased to $13.8 million for the three months ended June 30, 2020 from $11.1 million for the comparable period in 2019. The $2.7 million net increase is associated with increases in clinical trial and manufacturing process development costs of $0.8 million, research supplies of $0.5 million, stock compensation costs of $0.5 million, personnel costs of $0.3 million, outside services of $0.3 million and other research and development costs of $0.3 million. Our clinical development, clinical manufacturing and manufacturing process development expenses vary over time based on the timing and stage of clinical trials underway, manufacturing campaigns for clinical trials and manufacturing process development projects.
General and administrative expenses increased to $4.4 million for the three months ended June 30, 2020 compared to $2.9 million in the comparable period in 2019. The $1.5 million increase was primarily due to increased personnel costs, outside services, professional fees, consulting costs and stock compensation costs.
Net loss for the second quarter of 2020 was $18.4 million compared to a net loss of $9.7 million in the second quarter of 2019. The difference primarily results from the above variances.
During the six months ended June 30, 2020, net cash used in operating activities was $24.8 million compared to $17.0 million in the six months ended June 30, 2019. At June 30, 2020, we had $80.7 million in cash and cash equivalents, compared to $35.0 million at December 31, 2019.

Conference Call
Gil Van Bokkelen, Chairman and Chief Executive Officer, Ivor Macleod, Chief Financial Officer, and Karen Hunady, Director of Corporate Communications and Investor Relations will host a conference call today to review the results as follows:
Date August 10, 2020 Time 4:30 p.m. (Eastern Time) Live webcast registration www.athersys.com under the Investors section Phone registration View Source

We encourage shareholders to listen using the webcast link above. If you would like to dial in using the phone to ask a question, please register for the conference call ahead of time using the call registration link above. Once registered, you will be provided the call details and a registrant ID.

On August 10, 2020 DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biotechnology company, reported the closing of its previously announced underwritten registered public offering of 4,600,000 of its common shares, including 600,000 shares sold upon full exercise of the underwriters’ option to purchase additional shares, at a price to the public of $5.00 per share, primarily with institutional investors including several specialist biotech funds and certain existing shareholders (Press release, DiaMedica, AUG 10, 2020, View Source [SID1234563328]).

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The gross proceeds from the offering were $23.0 million, before deducting the underwriting discount and other estimated offering expenses payable by DiaMedica. Net proceeds, after the underwriting discount, but before estimated offering expenses payable by DiaMedica, were approximately $21.6 million.

As previously announced, DiaMedica intends to use the net proceeds from the offering to continue its clinical and product development activities, including the addition of a new cohort III to its REDUX Chronic Kidney Disease study to be comprised of participants with chronic kidney disease and Type II diabetes mellitus, and for other working capital and general corporate purposes.

Guggenheim Securities, LLC acted as lead book-running manager for the offering. Craig-Hallum Capital Group LLC acted as joint book-running manager and National Securities Corporation, a wholly owned subsidiary of National Holdings Corporation (NASDAQ: NHLD), acted as lead manager. Lake Street Capital Markets acted as a financial advisor to DiaMedica.

The securities described above were offered by DiaMedica pursuant to a shelf registration statement on Form S-3 (File No. 333-235775) previously filed with and declared effective by the U.S. Securities and Exchange Commission (SEC). A final prospectus supplement and accompanying prospectus relating to and describing the terms of the offering were filed with the SEC on August 7, 2020 and may be obtained by visiting the SEC’s website at www.sec.gov or by contacting Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

On August 10, 2020 Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company, reported the second quarter 2020 financial results and provided a general business update (Press release, Tocagen, AUG 10, 2020, View Source [SID1234563327]).

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"We are very happy to have concluded the reverse merger on June 15th and in that process, brought on a very well-respected group of investors, including Alger, BVF Partners, Franklin Templeton and OrbiMed to support Forte as we continue to grow the company. Our lead program, FB-401, developed in collaboration with the National Institute of Health (NIH) and the National Institute of Allergy and Infectious Diseases (NIAID), has shown great potential in the initial Phase 1/2a study in mild, moderate and severe atopic dermatitis patients, including adults and children as young as 3 years old." said Paul Wagner, Ph.D., CEO of Forte Biosciences "We look forward to further validating FB-401’s potential with the randomized trial in mild to moderate atopic dermatitis patients, including adults and children 2 years of age and older, which will be initiating shortly. There is a particular need for safe and effective atopic dermatitis therapies for children."

Second Quarter 2020 Financial Results

Merger

On June 15, 2020, Forte merged with Tocagen, a publicly traded biotechnology company, with Forte being the surviving entity. As part of the merger, each share of Forte common stock outstanding was converted into the right to receive 3.1624 shares of Tocagen common stock following a 15:1 reverse split of Tocagen’s common stock. Post-merger and post-reverse split, Forte had approximately 10.8 million shares of common stock outstanding, with prior Forte stockholders collectively owning approximately 84.7% of the combined company and prior Tocagen stockholders owning approximately 15.3%. Forte’s common stock is traded on the Nasdaq Capital Market under the ticker symbol "FBRX." Prior to the Merger, Forte was a privately-held company incorporated in Delaware.

Financing

During the second quarter of 2020, Forte raised $24 million in equity financing associated with the merger that closed on June 15, including a $4.6 million financing that closed on June 16. Forte Biosciences ended the quarter with approximately $28 million in cash which the company believes is sufficient to fund operations for at least the next 12 months. Forte had 11.2 million shares of common stock outstanding as of June 30, 2020.

Operating Results

Research and development expenses were $1.9 million and $3.3 million for the three and six months ended June 30, 2020, respectively, compared to $0.3 million and $1.2 million for the comparable periods in 2019. The increases in 2020 were primarily due to increased outsourced contract manufacturing costs and clinical development costs as we gear up to commence Phase 2 clinical trials for FB-401.

General and administrative expenses were $0.8 million and $1.4 million for the three and six months ended June 30, 2020, respectively, compared to $0.3 million and $0.6 million for the comparable periods in 2019. The increases in 2020 were primarily due to professional fees for legal, auditing, tax and business consulting services, and personnel expenses as we transitioned to being a public company.

In connection with the Merger, we recognized a charge of $32.1 million for acquired in-process research and development related to the reverse merger with Tocagen.

Additional detail on our financial results for the second quarter 2020 can be found in our Form 10-Q as filed today with the SEC. You can also find more information in the investor relations section of our website at www.fortebiorx.com.

Conference Call and Webcast Information

The Forte management will host a conference call and webcast today at 4:30 PM Eastern Time. Participants may access the call by dialing 877-300-8521 (Domestic) or 412-317-6026 (International), the conference ID number is: 10147071. The call will also be webcast and can be accessed from the investor relations section of Forte’s website at View Source or View Source A replay of the call will also be available through August 17th.

On August 10, 2020 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose of bettering the lives of people impacted by kidney disease, reported financial results for the second quarter ended June 30, 2020. As previously announced, in lieu of a financial results and business update call, Akebia management plans to host a conference call and webcast in early September to report top-line data from PRO2TECT, the second of its two global Phase 3 cardiovascular outcomes programs (Press release, Akebia, AUG 10, 2020, View Source [SID1234563326]). The two PRO2TECT studies evaluated the efficacy and safety of vadadustat, the Company’s investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of anemia due to chronic kidney disease (CKD) in adult patients not on dialysis.

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"We had an incredible quarter in terms of advancing our vadadustat clinical development program, bringing us that much closer to achieving our purpose to better the life of each person impacted by kidney disease. We reported exciting, positive top-line data from our global Phase 3 INNO2VATE program highlighting vadadustat’s potential as a new oral standard of care for treating anemia due to CKD in adult patients on dialysis, and topped off the quarter with the first regulatory approval of vadadustat in Japan," said John P. Butler, President and Chief Executive Officer of Akebia Therapeutics. "The next chapter of Akebia’s growth story is starting to unfold and as previously announced, we plan to share top-line data from PRO2TECT in early September."

Recent Business Highlights

In August, the Company announced database lock for PRO2TECT and plans to report top-line data from PRO2TECT in early September. This announcement follows Akebia’s earlier update provided in May that it had achieved the target number of major adverse cardiovascular events (MACE) for the PRO2TECT studies.

In July, the Company announced an investigator-sponsored research study by The University of Texas Health Science Center at Houston (UTHealth) in Houston, Texas, evaluating the use of vadadustat as a potential therapy to prevent and lessen the severity of acute respiratory distress syndrome (ARDS), a complication of COVID-19 infection.

In June, Mitsubishi Tanabe Pharma Corporation (MTPC), Akebia’s collaboration partner in Japan for vadadustat, obtained the first regulatory approval of vadadustat (Japan trade name: VAFSEO), as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients, by the Ministry of Health, Labour and Welfare in Japan.

In May, the Company reported positive top-line data from INNO2VATE, the first of its two global Phase 3 cardiovascular outcomes programs, which evaluated the efficacy and safety of vadadustat versus darbepoetin alfa for the treatment of anemia due to CKD in adult patients on dialysis. Vadadustat showed consistency across both efficacy and all MACE components, achieving the primary efficacy and safety endpoints, as well as the key secondary efficacy endpoint, of the studies. Please refer to Akebia’s INNO2VATE Data Announcement for the top-line data.

In May, the Company completed a public offering of its common stock raising net proceeds of $142.4 million.

In May, the Company announced that its collaboration partner, Japan Tobacco, Inc., filed a supplemental New Drug Application with the Pharmaceuticals and Medical Devices Agency (PMDA) seeking an additional indication for Riona (generic name in Japan: ferric citrate hydrate) to treat adult patients with iron deficiency anemia (IDA) in Japan.

Second Quarter Financial Results

Revenues: Total revenue was $90.1 million for the second quarter of 2020 compared to $100.8 million for the second quarter of 2019. The decline versus the prior year period was driven by lower collaboration revenue consistent with the Company completing the INNO2VATE studies and nearing completion of the PRO2TECT studies.

Collaboration revenue was $59.4 million for the second quarter of 2020 compared to $71.7 million in the second quarter of 2019.

Net product revenue for Auryxia (ferric citrate) was $30.7 million for the second quarter of 2020 compared with $29.1 million in the second quarter of 2019, an increase of 5.5 percent.

COGS: Cost of goods sold increased $136.9 million compared to the prior year period primarily due to a non-cash impairment charge of $115.5 million related to Auryxia, and higher non-cash inventory write-downs, which included $12.4 million largely related to a manufacturing quality issue related to Auryxia identified in the second quarter of 2020.

R&D Expenses: Research and development expenses were $52.8 million for the second quarter of 2020 compared to $85.7 million for the second quarter of 2019. The decline versus the prior year period was primarily driven by a decrease in costs consistent with the Company completing the INNO2VATE studies and nearing completion of the PRO2TECT studies.

SG&A Expenses: Selling, general and administrative expenses were $35.5 million for the second quarter of 2020 compared to $36.1 million for the second quarter of 2019.

Net Loss: Net loss was $175.8 million for the second quarter of 2020 compared to $58.2 million for the second quarter of 2019. The increase in net loss compared to the prior year period was due primarily to the non-cash impairment charge and higher non-cash inventory write-downs.

Cash Position: Cash, cash equivalents and available-for-sale securities as of June 30, 2020 were $295.3 million. The increase in the Company’s cash position is primarily attributable to net proceeds of $142.4 million from Akebia’s public offering of common stock, which was completed in May 2020. The Company believes that its cash runway extends beyond the expected U.S. launch of vadadustat.

"The non-cash impairment charge reflects the change in value of the Auryxia intangible asset on our balance sheet, primarily driven by the compounding impact of the 2018 decision by the Centers for Medicare and Medicaid Services (CMS) rescinding Medicare Part D coverage of Auryxia for its IDA indication and imposing a prior authorization requirement for the hyperphosphatemia indication," stated David A. Spellman, Chief Financial Officer of Akebia Therapeutics. "While we are frustrated and disappointed that a resolution has not been reached on this matter for the benefit of patients, we remain optimistic about Auryxia’s growth prospects."