On May 10, 2021 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported operating results for the first quarter ended March 31, 2021 (Press release, Sesen Bio, MAY 10, 2021, View Source [SID1234579604]). The Company’s Biologics License Application (BLA) for the Company’s lead program, Vicineum, is currently under Priority Review with the Food and Drug Administration (FDA) for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with a target Prescription Drug User Fee Act (PDUFA) date of August 18, 2021.

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"We are very pleased with the tremendous progress we continue to make in our four biggest global markets: the US, Europe, the Middle East and North Africa region and China," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "In the US, we continue to work with the FDA as we approach our target PDUFA date, and we are making substantial progress toward launch readiness. We are laser focused on bringing a product to market that we believe will improve patient outcomes while reducing overall healthcare costs to patients globally, and we expect to continue to make progress around the world in the coming months."

US and OUS Regulatory Update

US:

In February 2021, Sesen Bio received notice from the FDA that the BLA for Vicineum was accepted for filing. Along with the acceptance, the Company was granted Priority Review with a target PDUFA date of August 18, 2021 for a decision on the BLA. The FDA also stated that an advisory committee meeting was not currently planned to discuss the BLA.
Europe:

On March 25, 2021, the Company was notified by the European Medicines Agency (EMA) that the Company’s Marketing Authorization Application (MAA) for Vysyneum was found to be valid and that the review procedure had officially started. Sesen Bio submitted the MAA on March 5, 2021, and the Company remains on-track for potential approval of Vysyneum in the EU in early 2022.
On March 31, 2021, the Company received notice from the Committee for Medicinal Products for Human Use (CHMP) of the EMA that the CHMP has conditionally accepted the proprietary brand name Vysyneum for the Company’s product candidate, oportuzumab monatox, in the EU. The Company believes Vysyneum is a brand name with strong marketing potential given its identical pronunciation to the US proprietary brand name Vicineum. Final approval of the Vysyneum brand name is conditional on EMA product approval.
China:

The Investigational New Drug (IND) application for Vicineum for the treatment of BCG-unresponsive NMIBC submitted to the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) was approved on March 19, 2021 ahead of the original timeline of April 2021. This approval triggers a $3M milestone payment to the Company, and authorizes Qilu Pharmaceutical, the Company’s partner in China, to conduct the proposed clinical trial to assess the efficacy and safety of Vicineum in China, at the sole cost of Qilu Pharmaceutical. Assuming a successful trial, Qilu Pharmaceutical anticipates submission of the product market application for Vicineum in 2022, with potential approval in China expected in 2023.
Middle East and North Africa (MENA):

The Company continues to work closely with its partner, Hikma Pharmaceuticals, to submit marketing authorization applications for Vicineum in 2021 in four key markets in the region: the Kingdom of Saudi Arabia, Jordan, Morocco and Egypt. These four markets represent a significant opportunity in the MENA region, as Saudi Arabia, Jordan and Morocco have some of the most advanced healthcare systems in the region while Egypt is the second largest economy in Africa. The Company anticipates the first wave of potential country approvals for Vicineum in the MENA region as early as 2022.
Commercial Update

The Company continues to build its commercial organization with key leadership appointments and a partnership with a leading contract sales organization (CSO), Syneos Health, as it prepares for the anticipated commercial launch of Vicineum in the US in 3Q 2021. Sesen Bio has begun to hire key commercial roles and has entered into a partnership with Syneos Health who will provide speed and logistical support in the hiring and deployment of the sales force. The sales force will include 35 sales representatives across four regions to target approximately 2,000 high prescribers of BCG.
First Quarter 2021 Financial Results

Cash Position: Cash, cash equivalents and restricted cash were $110 million as of March 31, 2021, compared to $55.4 million as of December 31, 2020.
R&D Expenses: Research and development expenses for the first quarter of 2021 were $6.1 million compared to $8.9 million for the same period in 2020. The decrease of $2.8 million was due to decreased costs associated with technology transfer and manufacturing ($4.4 million) and lower clinical trial expense as a result of the Company’s Phase 3 VISTA trial winding down ($0.1 million). This was partially offset by increases in professional services in support of the MAA submission to the EMA ($0.9 million), license milestone fees ($0.6 million) and employee-related compensation ($0.2 million).
G&A Expenses: General and administrative expenses for the first quarter of 2021 were $5.3 million compared to $3.4 million for the same period in 2020. The increase of $1.9 million was due primarily to increases in legal fees ($0.7 million), employee-related compensation driven by increased headcount as part of the commercial build ($0.7 million), professional services ($0.3 million), and other increases ($0.2 million).
Net Loss: Net loss was $55.5 million, or $0.35 per share, for the first quarter of 2021, compared to net income of $41.6 million, or $0.31 per basic share and $0.31 per diluted share, for the first quarter of 2020. The change from net income to net loss was attributable primarily to differences in the non-cash change in the fair value of contingent consideration that is recognized in earnings (or loss) for each respective period.
Conference Call and Webcast Information
Members of the Sesen Bio management team will host a conference call and webcast today at 8:00 AM ET to provide a corporate update and review the Company’s financial results. To participate in the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) and refer to conference ID 6229838. The webcast can be accessed in the Investor Relations section of the Company’s website at www.sesenbio.com. The replay of the webcast will be available in the investor section of the Company’s website at www.sesenbio.com for 60 days following the call.

About Vicineum
Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently in the follow-up stage of a Phase 3 registration trial in the US for the treatment of BCG-unresponsive NMIBC. In February 2021, the FDA accepted for filing the Company’s BLA for Vicineum for the treatment of BCG-unresponsive NMIBC and granted the application Priority Review with a target PDUFA date of August 18, 2021. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. For this reason, the activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

On May 10, 2021 BWXT Medical Ltd. (BWXT Medical) reported that it has entered into a new long-term, mutually exclusive agreement to manufacture TheraSphere Y-90 Glass Microspheres for Boston Scientific, a leading global medical device company (Press release, BWXT Medical, MAY 10, 2021, View Source [SID1234579625]).

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Developed for the treatment of patients with hepatocellular carcinoma (HCC), TheraSphere treatment is comprised of millions of glass microspheres containing radioactive Yttrium-90, which are delivered directly to liver tumors via catheter and result in minimal exposure to surrounding healthy tissue.

BWXT Medical is a subsidiary of BWX Technologies, Inc. (NYSE: BWXT) and a global supplier of medical isotopes and radiopharmaceuticals.

Under the terms of the agreement, BWXT Medical will invest to automate the production process at its Ottawa, Canada facility, and thereby significantly increase capacity and dependability to support a growing global demand for TheraSphere.

"We congratulate Boston Scientific on its recent receipt of FDA PMA approval of TheraSphere, which expands patient access to this unique technology," said Martyn Coombs, president of BWXT Medical. "We share the aspiration of making a significant difference in the lives of people suffering with cancer, and we look forward to continuing to build a strong supply chain foundation for future growth."

On May 10, 2021 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics designed to selectively engage and modulate targeted T cells within the patient’s body, reported that interim clinical data, including a confirmed partial response (PR), from its ongoing Phase 1a/1b monotherapy study of CUE-101 as second-line treatment for patients with HPV+ R/M HNSCC (Press release, Cue Biopharma, MAY 10, 2021, View Source [SID1234608280]). To date, CUE-101 has demonstrated a favorable tolerability profile in a monotherapy dose escalation trial and continues to generate encouraging emerging data pertaining to its pharmacokinetic (PK) and pharmacodynamic (PD) profiles, as well as clinical anti-tumor activity.

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"We are very excited by the partial response observed in this patient, since it demonstrates single-agent activity of CUE-101, so rarely seen in mono-immunotherapy treatments," said Ken Pienta, M.D., acting chief medical officer of Cue Biopharma. "Based on recent clinical observations, we have delivered CUE-101 to patients at tolerated doses, achieving a confirmed PR as well as stable disease (SD) in several patients while still in the dose escalation portion of the trial. This provides evidence that CUE-101 is an active agent with promising potential for HPV+ HNSCC patients. This is bolstered by the supporting pharmacodynamic data in which we have observed activation of disease-specific T cells and NK cells in the blood of our treated patients. We look forward to initiating the expansion phase of the Phase 1 trial which may provide a potential path forward for a registration-directed clinical trial for CUE-101 as a monotherapy for HPV+ R/M HNSCC."

Key interim analysis of patient data from the ongoing open-label Phase 1a/1b study include:

Confirmed PR in one patient and SD in five patients, all confirmed by RECIST criteria, in the dose escalation phase of the study to date, providing early signs of potential single-agent activity of CUE-101.
Demonstrated evidence of both tumor-specific CD8+ T cell expansion as well as dose-dependent increases in NK cells in patients.
Observed immune cell infiltration and tumor cell necrosis in patient tumor biopsies after CUE-101 treatment, supporting CUE-101’s mechanism of action at engaging and modulating targeted T cells within the patient’s body.
Dose-proportional PK profile and comparable drug exposure levels in patients receiving repeated dosing cycles, consistent with a lack of drug-clearing anti-drug antibodies.
No maximum tolerated dose (MTD) observed in patients dosed with up to 8 mg/kg of CUE-101.
Dan Passeri, chief executive officer of Cue Biopharma added, "Receiving early confirmation of clinical activity of CUE-101 as a monotherapy in this challenging patient population is an important validation of the potential of the CUE-101 program for oncology, as well as for our follow-on programs such as CUE-102, from the IL2-based CUE-100 series. This confirmed PR provides valuable proof of concept of the Immuno-STAT platform to activate and expand disease specific T cells and NK cells as a method to treat other cancers. We anticipate a number of important milestones throughout this year with the potential of further data to inform CUE-101’s clinical application. These milestones include, the potential selection of a recommended Phase 2 dose of CUE-101 by mid-2021 for further development as a single-agent treatment for HPV+ 2L+ head and neck squamous cell carcinoma; our plans to report initial Phase 1 results from the combination study of CUE-101 with pembrolizumab in the second half of 2021; and our plans to initiate a Phase 2 neoadjuvant study to evaluate the effects of CUE-101 on the tumor microenvironment, which is also expected to start in the second half of 2021."

Conference Call
Cue Biopharma will discuss these new data points during its first quarter business update call and webcast on May 17 at 4:30 p.m. ET. Please check the Events page of the Investor and Media section of the Company’s website at www.cuebiopharma.com for details. A live and archived version of the webcast will be available for 30 days after the call.

About the CUE-101 Clinical Trial
The trial (NCT03978689) is a multi-center, first-in-human, open-label Phase 1 dose escalation and expansion study evaluating the safety, anti-tumor effect and immunogenicity of CUE-101 as a monotherapy in second-line patients with confirmed HPV16-driven recurrent/metastatic HNSCC and HLA-A*02:01 serotype. Based on translational data from the trial, a maximum tolerated dose (MTD) or recommended Phase 2 dose will be determined. The company has expanded the study to evaluate CUE-101 in combination with KEYTRUDA (pembrolizumab) as first-line treatment in patients with HPV16-driven recurrent/metastatic HNSCC.

About the CUE-100 Series
The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-MHC (pMHC) molecules along with rationally engineered IL-2 molecules. This singular biologic is anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing the potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies.

About Immuno-STAT
The company’s Immuno-STAT (Selective Targeting and Alteration of T cells) biologics are designed for targeted modulation of disease-associated T cells in the areas of immuno-oncology and autoimmune disease. Each of our biologic drugs is designed using our proprietary scaffold comprising: 1) a pMHC to provide selectivity through interaction with the T cell receptor (TCR), and 2) a unique co-stimulatory signaling molecule to modulate the activity of the target T cells.

The simultaneous engagement of co-regulatory molecules and pMHC binding mimics the signals delivered by antigen presenting cells (APCs) to T cells during a natural immune response. This design enables Immuno-STAT biologics to engage with the T cell population of interest, resulting in selective T cell modulation. Because our drug candidates are delivered directly in the patient’s body (in vivo), they are fundamentally different from other T cell therapeutic approaches that require the patients’ T cells to be extracted, modified outside the body (ex vivo), and reinfused.

On May 10, 2021 Medigene AG (Medigene, FSE: MDG1, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, today presents new data on components of its preclinical programs targeting the development of future T cell receptor-modified T cell (TCR-T) therapies against solid cancers at the 18th Annual Meeting of the Association for Cancer Immunotherapy (CIMT) (Free CIMT Whitepaper) taking place on 10-12 May 2021 (Press release, MediGene, MAY 10, 2021, View Source [SID1234579498]). The three eTalk presentations can be found on Medigene’s website: View Source

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Component 1: Proprietary new T cell receptors (TCRs) targeting novel tumor-specific antigens that are potential solid cancer TCR-T therapy target candidates

Identifying novel tumor-specific antigens (TSAs) as targets for T cells is a vital goal in the development of effective and safe cancer immunotherapies. As Medigene has recently disclosed, ten novel tumor-specific peptides stemming from non-coding regions of the genome of tumor cells have been identified that can be recognized by TCRs. These "immunogenic" peptides were present in tumors from several patients with solid cancers of different origin (including ovarian, breast, and lung cancer), but were not detected in healthy tissues in work performed in collaboration with the University of Montréal.

To date, Medigene has isolated more than 20 TCRs of T cell clones that recognize these novel TSAs and have the potential to become next-generation TCR-T therapy candidates. Their functional and safety characterization is ongoing, as presented in the current eTalk.

Component 2: Medigene’s inducible TCR (iM-TCR) – A fine control system to switch TCR-T cells on and off

The iM-TCR system could allow physicians to avoid unwanted side effects of TCR-T therapy or to fine-tune an ongoing immune reaction. This is part of Medigene’s work on the safety and functionality of engineered T cells for adoptive transfer into patients.

The iM-TCR system controls the level of expression of an introduced TCR on the surface of T cells, thereby governing the amount of functional activity of the TCR-T cells on the cell surface. In the presence of the appropriate drug the TCRs which contain the iM-TCR signature are brought onto the T cell surface; without the drug, they are down-regulated from the surface and new TCRs are only replaced upon new specific drug induction. The presence or absence of the drug therefore determines the level of activity of the TCR-T cells, potentially giving clinicians the possibility of switching on and switching off TCR-T activity as required.

Medigene’s scientists show in the eTalk that iM-TCR-expressing cells can be tightly controlled by the dose and timing of drug-induced expression, allowing fine control of TCR-T cell activity.

Component 3: TCR-4 + PD1-41BB switch receptor – Enhanced killing of solid tumor specimens

Solid tumors grow stealthily, hiding from the immune system and evading T cell attacks, using mechanisms such as the expression of the checkpoint molecule PD-L1 on their surface. Medigene has developed the PD1-41BB switch receptor, turning the tumors’ off-signal sent by PD-L1 into an activation signal for its TCR-T cells.

In the eTalk Medigene’s scientists illustrate that adding the PD1-41BB receptor to TCR-T cells enhances their metabolic fitness and their killing of tumor cells, as demonstrated using TCR-4, Medigene’s lead TCR candidate against solid tumors. TCR-4 is a non-mutated TCR isolated from a healthy donor that, in the context of HLA-A2, specifically recognizes a peptide stemming from the PRAME protein. TCR-T cells expressing only TCR-4 have already demonstrated potent preclinical in vitro and in vivo efficacy. Adding the PD1-41BB switch receptor further improves cell killing functions and metabolic fitness of the TCR-Ts without inducing off-target toxicities.

Prof. Dolores Schendel, Chief Executive Officer and Chief Scientific Officer at Medigene: "Our high-throughput functional T cell screening platform efficiently identifies T cells and their TCRs against a wide variety of potential target antigens. The identification of novel TSAs from non-coding regions of the genome adds to the range of cancer antigens that Medigene can use as targets for these immunotherapies. We can also limit the risk of off-tumor reactivity of tumor-specific TCR-T cells through tight control of TCR surface expression using our iM-TCR system. Importantly, we believe tools such as our PD1-41BB switch receptor will allow our TCR-T cells to overcome tumor evasion from immune attacks without giving rise to potential side effects as seen, for example, when using systemic PD-1/-L1 blocking agents.

We are excited that the phenomenal progress of our technology programs is advancing our TCR-T therapies towards solid cancer indications. Our approaches could improve clinical safety and efficacy in TCR-T therapies against Medigene’s unique tumor-specific targets."

On May 10, 2021 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 first quarter ended March 31, 2021 and highlighted recent corporate milestones (Press release, Akebia, MAY 10, 2021, View Source [SID1234579542]). The Company will host a conference call today, Monday, May 10, 2021, at 9:00 a.m. Eastern Time.

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"Akebia is off to a great start in 2021, building positive momentum with solid execution on strategic priorities that set the stage for an exciting year. Most importantly, we submitted the vadadustat NDA to the FDA, a significant milestone for Akebia and our partner, Otsuka Pharmaceutical Co. Ltd. We are also very proud that the New England Journal of Medicine recently published the results from both INNO2VATE and PRO2TECT, the global Phase 3 programs for vadadustat. We believe these publications reinforce the scientific rigor and quality of the vadadustat clinical development program, and we are pleased with early feedback from the medical community," stated John P. Butler, Chief Executive Officer of Akebia. "We believe this progress positions us well to continue advancing vadadustat with the goal of bringing this novel therapeutic to patients as quickly as possible, subject to regulatory approval. We remain confident in the clarity and quality of our data, and we look forward to engaging with the FDA on our NDA. In addition, we are working with Otsuka on the preparation of a Marketing Authorization Application (MAA) for vadadustat for submission to the European Medicines Agency (EMA), expected this year."

Recent Business Highlights:

In April, the New England Journal of Medicine (NEJM) published the results of Akebia’s global Phase 3 program for vadadustat, which consisted of two programs that evaluated the efficacy and safety of vadadustat versus darbepoetin alfa for the treatment of anemia due to CKD in adult patients on dialysis (INNO2VATE) and not on dialysis (PRO2TECT).
In March, Akebia submitted an NDA to the FDA for vadadustat for the treatment of anemia due to CKD in both adult patients on dialysis and adult patients not on dialysis.
In February, Akebia completed a non-dilutive transaction with an entity managed by HealthCare Royalty Management, LLC (HCR), to monetize the Company’s rights to receive royalties and sales milestones on vadadustat net sales under its collaboration agreement with Mitsubishi Tanabe Pharma Corporation (MTPC), with an upfront payment of $45 million.
In February, Akebia announced that LeAnne M. Zumwalt joined Akebia’s Board of Directors. Ms. Zumwalt recently served as Group Vice President, Government Affairs at DaVita Inc.
In February, Akebia launched its Medical Engagement Hub, an online resource dedicated to scientific education and connecting U.S. healthcare professionals with Akebia Medical Affairs.
In January, the University of Texas Health Science Center at Houston (UTHealth) in Houston, Texas, announced that it had received $5.1 million in government funding for its study 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. This investigator-sponsored research study is currently underway and actively enrolling patients.
First Quarter Financial Results

Revenues: Total revenue was $52.3 million for the first quarter of 2021 compared to $88.5 million for the first quarter of 2020. The decrease compared to the same period in 2020 was primarily due to lower collaboration revenue consistent with the Company successfully completing the INNO2VATE and PRO2TECT global Phase 3 clinical programs.
Collaboration revenue was $21.9 million for the first quarter of 2021 compared to $59.3 million for the first quarter of 2020.
Net product revenue was $30.4 million for the first quarter of 2021 compared with $29.2 million for the first quarter of 2020, an increase of 4 percent.
COGS: Cost of goods sold was $34.6 million for the first quarter of 2021 compared to $27.7 million for the first quarter of 2020. The increase was driven by higher non-cash purchase accounting adjustments as a result of the merger with Keryx, and a $5.1 million non-cash charge to inventory reserves related to a previously disclosed manufacturing quality issue related to Auryxia (ferric citrate), partially offset by an $8.9 million non-cash gain due to a reduction to the liability for excess purchase commitments primarily as a result of the Company having successfully modified certain supply agreements.
R&D Expenses: Research and development expenses were $40.6 million for the first quarter of 2021 compared to $81.2 million for the first quarter of 2020. The decrease compared to the same period in 2020 was primarily due to the completion of the INNO2VATE and PRO2TECT global Phase 3 clinical programs.
SG&A Expenses: Selling, general and administrative expenses were $41.3 million for the first quarter of 2021 compared to $38.0 million for the first quarter of 2020.
Net Loss: Net loss was $69.6 million for the first quarter of 2021 compared to $60.7 million for the first quarter of 2020. The increase in net loss compared to the prior year period was due primarily to lower collaboration revenue and higher cost of goods sold, partially offset by lower operating expenses.
Cash Position: Cash, cash equivalents and available-for-sale securities as of March 31, 2021 were $272.8 million. The Company expects its cash resources to fund its current operating plan beyond the expected U.S. launch of vadadustat, assuming timely regulatory approval and the receipt of associated regulatory milestones.
"Despite the ongoing impact of COVID-19 on dialysis patients, we are encouraged by Auryxia’s revenue growth in the first quarter of 2021 when compared to the prior year’s period. We believe this performance highlights Auryxia’s favorable product profile and the critical nature of this therapy, as well as our team’s ability to execute at a high level," stated David A. Spellman, Chief Financial Officer of Akebia. "While we remain cautious due to COVID-19, together with our continued commercial efforts, we believe that Auryxia’s positioning will drive product revenue growth for the year."

Conference Call

Akebia will host a conference call at 9:00 a.m. Eastern Time today, Monday, May 10, to discuss its first quarter financial results and recent business highlights. To listen to the conference call, please dial (877) 458-0977 (domestic) or (484) 653-6724 (international) using conference ID number 6250159. The call will also be webcast LIVE and can be accessed via the Investors section of the Company’s website at View Source

A replay of the conference call will be available two hours after the completion of the call through May 16, 2021. To access the replay, dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and reference conference ID number 6250159. An online archive of the conference call can be accessed via the Investors section of the Company’s website at View Source