On March 1, 2022 Elevation Oncology, Inc. (Nasdaq: ELEV), a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, reported that Shawn M. Leland, PharmD, RPh, Elevation Oncology’s Founder and Chief Executive Officer, will participate in the following investor conferences in March (Press release, Elevation Oncology, MAR 1, 2022, View Source [SID1234609311]):

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Cowen 42nd Annual Health Care Conference
Date: Tuesday, March 8
Panel Title: Tumor Agnostic Development
Panel Time: 12:50 p.m. ET

Oppenheimer 32nd Annual Healthcare Conference
Date: Wednesday, March 16
Presentation Time: 12:40 p.m. ET

A live webcast and replay of these events will be available on the Events page of the Company’s Investor Relations website at View Source

On March 1, 2022 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, reported that company management will participate in a panel discussion and one-on-one investor meetings at Cowen’s 42nd Annual Healthcare Conference taking place virtually March 7-9, 2022 (Press release, Cardiff Oncology, MAR 1, 2022, View Source [SID1234609310]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Details on the panel can be found below.

A replay of the panel discussion will be available by visiting the "Events" section of the Cardiff Oncology website and will be archived for 30 days after the conference’s conclusion.

On March 1, 2022 Bold Therapeutics, a clinical-stage biopharmaceutical company, reported that they have successfully completed the Phase 1b (dose-escalation) portion of its seamless adaptive oncology trial of BOLD-100 in combination with FOLFOX in the treatment of advanced gastrointestinal cancers (colorectal, pancreatic, gastric and bile duct) (Press release, Bold Therapeutics, MAR 1, 2022, View Source [SID1234609309]).

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Bold Therapeutics Successfully Completes Phase 1b Trial and Advances into Global Phase 2 Trial of BOLD-100 in the Treatment of Advanced GI Cancers
Bold Therapeutics Successfully Completes Phase 1b Trial and Advances into Global Phase 2 Trial of BOLD-100 in the Treatment of Advanced GI Cancers
BOLD-100 is a first-in-class ruthenium-based small molecule therapeutic that (1) alters the unfolded protein response (UPR) through selective GRP78 inhibition; and (2) induces reactive oxygen species (ROS) which causes DNA damage and cell cycle arrest. Collectively, these effects result in cell death in both sensitive and resistant solid and liquid cancers and in combination with a wide range of existing anti-cancer therapies. The FDA previously granted BOLD-100 Orphan Drug Designations (ODDs) in both Gastric and Pancreatic cancers, and Bold Therapeutics anticipates leveraging clinical data from the Phase 1b portion of its trial for one or more Breakthrough Therapy Designations (BTDs) in 2022.

The Phase 1b data – which Bold Therapeutics anticipates presenting at an upcoming cancer conference – indicate that (1) BOLD-100 can be safely combined with FOLFOX chemotherapy at a dose of 625 mg / m2 (the highest dose level tested), with no new Grade 3 or 4 treatment-emergent adverse events; and (2) patients can safely remain on treatment for an extended number of treatment cycles. Based on this strong safety and tolerability profile, the Study Steering Committee unanimously endorsed proceeding immediately into the Phase 2 (dose-expansion) portion of the study.

"Completing our Phase 1b trial with a strong safety profile for BOLD-100 is a significant achievement for Bold Therapeutics – and while it is too early to say anything definitive, preliminary efficacy data is undoubtedly encouraging," said Jim Pankovich, EVP, Clinical Development. "Despite substantial headwinds from the ongoing COVID-19 pandemic, we were nevertheless able to successfully enroll and treat patients at our six clinical sites in Canada, and I wish to recognize the patients for their contribution to this study as well as the persistent and resilient efforts of our investigators."

The Phase 2 (dose-expansion) portion of the seamless adaptive trial of BOLD-100 will enroll 80 additional patients at 13 investigational sites worldwide: 6 sites in Canada; 2 sites in the U.S.; and 5 sites in South Korea. Interim and complete Phase 2 data is expected by year-end 2022 and late 2023, respectively.

"As BOLD-100 advances into Phase 2, Bold Therapeutics crosses another significant value inflection point," stated Glenn Walthall, Chairman of the Board of Bold Therapeutics. "As Bold Therapeutics’ largest institutional investor, we are encouraged with the results that we’ve seen thus far and optimistic that BOLD-100 may significantly improve outcomes in these difficult-to-treat cancers that are often refractory to conventional treatment options. Consistent with preclinical observations, a number of patients in the study who had previously failed on FOLFOX alone suddenly responded when BOLD-100 was added to the treatment regimen – a result that can only be described as remarkable."

Bold Therapeutics executed a regional option agreement with an undisclosed biopharmaceutical company in South Korea in 2020 and is actively seeking development partners in other territories. Bold Therapeutics is also seeking investors for a data-driven institutional Series B round to be closed later in 2022, likely concurrent with interim Phase 2 results.

"I am exceptionally proud of the agile and industrious Bold Therapeutics team without whom this success would not be possible," added E. Russell McAllister, CEO of Bold Therapeutics. "Through innovative programs like NRC-IRAP, the Canadian government has provided Bold Therapeutics with substantial support in advancing our scientific understanding of BOLD-100 that not only allowed us to advance in the treatment of gastrointestinal cancer indications, but also opened up promising areas for future development. As a result, they share this win with us. The strong results from this Phase 1b trial and the overall accumulation of data on BOLD-100 continue to excite support for the development of this innovative therapeutic for patients with a wide range of advanced cancers."

On March 1, 2022 Dragonfly Therapeutics, Inc. ("Dragonfly") reported the achievement of a Phase 1 clinical development milestone for the DF6002/BMS-9896415 IL-12 program (Press release, Dragonfly Therapeutics, MAR 1, 2022, View Source [SID1234609308]). DF6002/BMS-9896415 is a monovalent IL-12 immunoglobulin Fc fusion protein proposed to achieve strong anti-tumor efficacy by establishing an inflammatory tumor microenvironment necessary for productive anti-tumor responses.

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Dragonfly received investigational new drug approval for DF6002 from the U.S. Food and Drug Administration in May 2020, and its Phase 1/2 clinical trial for patients with advanced solid tumors began in July 2020. Bristol Myers Squibb (NYSE:BMY) signed an exclusive worldwide license agreement with Dragonfly Therapeutics for its IL-12 investigational immunotherapy program, including its extended half-life cytokine DF6002, in August 2020. Bristol Myers Squibb intends to advance the research and development of DF6002 in oncology and hematology.

Bristol Myers Squibb is responsible for the development and any subsequent commercialization of DF6002/BMS-9896415 and its related products worldwide, including strategic decisions, regulatory responsibilities, funding, and manufacturing. Dragonfly is eligible to receive additional performance-based development, regulatory and commercial milestone payments. Dragonfly will receive up to 24% royalties on worldwide net sales.

"We are very encouraged by the progress being made on the DF6002/BMS-9896415 program and with Bristol Myers Squibb, whose broad range of oncology agents will help to accelerate the development of DF6002, the most advanced cytokine in Dragonfly’s pipeline," said Bill Haney, Co-founder and CEO of Dragonfly Therapeutics. "We remain confident that the talent, experience and commitment to science-driven innovation of the Bristol Myers Squibb team will enable DF6002/BMS-9896415 to discover novel, life-saving solutions for patients."

"We are pleased to see results in the clinic bearing out the original hypothesis that DF6002/BMS-9896415 offers a remarkably differentiated profile from other cytokine programs," said Rupert Vessey, M.A., B.M., B.Ch., F.R.C.P., D.Phil., Executive Vice President, Research & Early Development, Bristol Myers Squibb. "We look forward to our continued work with Dragonfly to further guide the program’s clinical data at this pivotal point in its development, as we continue to deliver on our commitment to serve more patients with cancer."

About DF6002
DF6002, an extended half-life IL12 cytokine, is an investigational immunotherapy being evaluated in adult patients for the treatment of advanced solid tumors. DF6002 has the potential to stimulate effective anti-tumor immunity in patients who are not eligible or not adequately responding to current therapies. DF6002 is the most advanced in a pipeline of cytokines developed by Dragonfly to address the high unmet need in patients with advanced cancer.

The Phase 1/2 clinical trial for DF6002/BMS-986415 is a first-in-human open-label, dose-escalation study with a consecutive parallel-group efficacy expansion study, designed to determine the safety, tolerability, PK, pharmacodynamics, and preliminary anti-tumor activity of DF6002 as monotherapy and in combination with nivolumab. Additional information about the trial, including eligibility criteria, can be found at: View Source (ClinicalTrials.gov Identifier: NCT04423029).

On March 1, 2022 – Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, reported financial results for the fourth quarter and full-year ended December 31, 2021 and recent business updates related to pre-commercialization activities ahead of a potential first-in-class U.S. launch for vadadustat, Akebia’s investigational oral therapeutic for the treatment of anemia due to chronic kidney disease (CKD) (Press release, Akebia, MAR 1, 2022, View Source [SID1234609307]). Vadadustat is currently under review by the U.S. Food and Drug Administration (FDA) with a scheduled Prescription Drug User Fee Act (PDUFA) date of March 29, 2022.

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"The PDUFA date for vadadustat is fast approaching. We recognize how transformational the potential approval would be for Akebia and, true to our purpose as a company, our team continues to work tirelessly to deliver a new oral therapeutic option for the patients we serve," said John P. Butler, Chief Executive Officer of Akebia. "We are prepared for what we believe will be a significant catalyst for the company marked by launching a potential first-in-class oral therapeutic for people living with anemia due to CKD, subject to regulatory approval."

Last month Akebia and Vifor Pharma Group (Vifor Pharma) amended and restated the terms of their license agreement, which provides important access to up to 60% of U.S. dialysis patients through existing Vifor Pharma relationships, supporting a successful commercial launch of vadadustat, if approved. Vifor Pharma completed a $20 million equity investment in Akebia, and will pay Akebia a $25 million upfront payment and contribute an initial $40 million in refundable working capital to partially fund launch supply. The companies also defined profit share economics of potential vadadustat revenue.

"Many of our on-going pre-commercialization activities, including amending the terms of our relationship with Vifor Pharma, are aimed at ensuring patient access for vadadustat," said Dell Faulkingham, Chief Commercial Officer of Akebia. "If approved, we will immediately initiate the process to secure reimbursement for vadadustat under the Transitional Drug Add-on Payment Adjustment (TDAPA) period for dialysis organizations, which we expect will take approximately six months. We believe TDAPA designation for vadadustat will be an important driver for adoption within U.S. dialysis organizations, if approved."

Akebia continues to optimize its sales, marketing, and payor strategies to support Auryxia (ferric citrate). Akebia ended 2021 with notable Auryxia net product revenue growth and the strongest quarter of net product revenue to date while the phosphate binder market declined by 8.1% year-over-year in the U.S., due in part to the impact of COVID-19 on kidney disease patients. Akebia achieved $142.2 million in net product revenue in 2021 due to improved commercial contracts and payor mix.

"Both the 2021 and our expected 2022 Auryxia revenue growth is due to our team’s commitment to patients and healthcare providers, even against the backdrop of the COVID-19 pandemic," added Dell Faulkingham. "Our renal focused field team has proven its ability to successfully engage with the kidney community and thoughtfully outline our value proposition. This expertise establishes a strong foundation from which to launch vadadustat, if approved."

Fourth Quarter and Full-Year 2021 Financial Results

Revenues: Total revenue was $59.6 million for the fourth quarter of 2021 compared to $56.7 million for the fourth quarter of 2020, and $213.6 million for the full-year 2021 compared to $295.3 million for the full-year 2020.

Collaboration revenue was $17.5 million for the fourth quarter of 2021 compared to $22.1 million for the fourth quarter of 2020, and $71.4 million for the full-year 2021 compared with $166.4 million for the full-year 2020. The decrease in both periods compared to the same periods in 2020 was primarily due to lower collaboration revenue from Otsuka Pharmaceuticals Co. Ltd (Otsuka) driven by lower development costs incurred subject to cost share provisions under both the Otsuka collaboration agreement for the U.S. and the Otsuka collaboration agreement for certain territories outside the U.S. as Akebia successfully completed the INNO2VATE and PRO2TECT global Phase 3 clinical programs in 2020 and is currently engaged in close-out activities with respect to the programs.
Net product revenue was $42.1 million for the fourth quarter of 2021 compared with $34.6 million for the fourth quarter of 2020, an increase of approximately 22 percent. Net product revenue was $142.2 million for the full-year 2021 compared to $128.9 million for the full-year 2020, an increase of approximately 10 percent.
COGS: Cost of goods sold was $50.4 million for the fourth quarter of 2021 compared to $63.2 million for the fourth quarter of 2020. Cost of goods sold was $153.4 million for the full-year 2021, compared with $295.9 million for the full-year 2020. Cost of goods sold includes a non-cash charge related to excess purchase commitments of $18.0 million and $33.4 million, for the fourth quarter and full year 2021, respectively.

R&D Expenses: Research and development expenses were $29.6 million for the fourth quarter of 2021 compared to $37.6 million for the fourth quarter of 2020, and $147.9 million for the full-year 2021 compared to $218.5 million for the full-year 2020. Fourth quarter 2021 expenses included a one-time credit of $8.6 million representing a reimbursement from Vifor Pharma following the sale of the Priority Review Voucher (PRV), which proceeds were subsequently paid to Otsuka as reimbursement for their contribution to purchase the PRV.

SG&A Expenses: Selling, general and administrative expenses were $44.8 million for the fourth quarter of 2021 compared to $40.3 million for the fourth quarter of 2020, and $174.2 million for the full-year 2021 compared to $153.9 million for the full-year 2020. The increase for the full year 2021 was primarily due to higher marketing expenses, increased headcount-related costs, and one-time legal costs.

Net Loss: Net loss was $70.7 million for the fourth quarter of 2021 compared to $87.0 million for the fourth quarter of 2020, and $282.8 million for the full-year 2021 compared to $383.5 million for the full-year 2020. The decrease in net loss for the full-year 2021 compared to the prior year was due primarily to higher product revenues, lower cost of goods sold and lower operating expenses, partially offset by lower collaboration revenue.

Cash Position: Cash and cash equivalents as of December 31, 2021 were $149.8 million. Akebia believes that its cash resources will be sufficient to fund its current operating plan through at least the next twelve months. Akebia’s base operating plan assumes a timely regulatory approval of vadadustat for the treatment of anemia due to CKD in dialysis dependent patients, as well as milestones and product revenues as an important source of funding of our cash runway.