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Akebia Therapeutics Reports First Quarter 2022 Financial Results and Business Update

On May 9, 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 first quarter ended March 31, 2022 and provided business updates (Press release, Akebia, MAY 9, 2022, View Source [SID1234613926]).

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"While we were surprised and disappointed by the vadadustat Complete Response Letter we received from the FDA in March, our team has responded aggressively by working to strengthen and secure the company financially, with an aim of allowing us to continue to deliver on our purpose to better the lives of people impacted by kidney disease. We plan to focus on Auryxia commercial success while exploring our earlier stage assets and pursuing other value creating business opportunities," said John Butler, Chief Executive Officer of Akebia. "The past six months of Auryxia net sales have been the strongest ever. This is a testament to the strength of our commercial team, which has delivered, even as COVID-19 disproportionately impacted the patients we serve. As we emerge from the pandemic, we believe Auryxia revenue is positioned to continue to grow and provide a solid basis for ongoing financial support for the company."

Akebia has outlined three pillars of its refined strategic focus:

Drive Auryxia revenue and identify cash management opportunities with the objective to enable Akebia to manage the company with existing cash resources and ongoing cash from operations;
Support our partners selling and seeking regulatory approval for vadadustat globally, including potential EMA approval and European launch; and evaluate options for potential U.S. approval; and,
Thoughtfully invest in our pipeline of internal assets and assess other strategic growth opportunities.
Akebia refined its strategic focus following receipt on March 29, 2022 of a Complete Response Letter (CRL) from the U.S. Food & Drug Administration (FDA) for Akebia’s New Drug Application for vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor for the treatment of anemia due to chronic kidney disease. Akebia plans to request an end of review meeting with the FDA within ninety days of receipt of the CRL. Akebia plans to evaluate and determine potential next steps for vadadustat in the U.S. following the end of review meeting with the FDA. In the meantime, the company is focused on its path forward without a U.S. approval for vadadustat.

Financial Results

Revenues: Total revenue was $61.7 million for the first quarter of 2022 compared to $52.3 million for the first quarter of 2021.
Net product revenue was $41.4 million for the first quarter of 2022 compared with $30.4 million for the first quarter of 2021, an increase of 36%.
Collaboration revenue was $20.3 million for the first quarter of 2022 compared to $21.9 million for the first quarter of 2021. The decrease in the period compared to the same period in 2021 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.
Revenue Guidance: Akebia is providing net product revenue guidance for Auryxia of $165 – $170 million for fiscal year 2022. Guidance assumes, among other things, continued stabilization of the phosphate binder market and continued improvement of net realized price per tablet.
COGS: Cost of goods sold was $31.3 million for the first quarter of 2022 compared to $34.6 million in the first quarter 2021. In 2022, cost of goods sold consisted of costs associated with the manufacturing of Auryxia and supply of Vafseo to MTPC for commercial sale in Japan. Additionally, $5.3 million was related to excess and obsolescence reserves associated with Auryxia partially offset by a $0.8 million reduction to the liability for excess purchase commitments, and $9.0 million related to amortization of intangibles.

R&D Expenses: Research and development expenses were $43.8 million for the first quarter of 2022 compared to $40.6 million for the first quarter of 2021. The increase compared to the prior year period was primarily due to increased headcount compared to the first quarter 2021.

SG&A Expenses: Selling, general and administrative expenses were $44.3 million for the first quarter of 2022 compared to $41.3 million for the first quarter of 2021 due to higher marketing expenses in anticipation of the potential approval of vadadustat.

Net Loss: Net loss was $62.4 million for the first quarter of 2022 compared to $69.6 million for the first quarter of 2021.

Cash Position: Cash and cash equivalents as of March 31, 2022, were $174.6 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 operating plan includes assumptions pertaining to cost avoidance measures and the reduction of overhead costs resulting from the planned amendment of certain contractual arrangements, including with certain supply and collaboration partners, and the reduction of certain infrastructure costs. The outcome of these measures, such as the potential amendment of certain contractual arrangements with supply and collaboration partners, are outside of Akebia’s control.

Restructuring: On April 4, 2022, the Board of Directors of Akebia approved a reduction in workforce of approximately 42% across all areas of Akebia (47% inclusive of the majority of open positions) following the receipt of the CRL. On May 5, 2022, Akebia implemented a further reduction in workforce consisting of several members of management. In connection with the restructuring, the company estimates that it will incur restructuring charges of approximately $16.5 million in the aggregate, primarily related to one-time termination benefits and contractual termination benefits including severance, non-cash stock-based compensation expense, healthcare and related benefits primarily in the second quarter of 2022. Akebia expects that the reduction in force will result in an approximate range of $60-65 million reduction in cash required for operating activities through the end of 2023.
"There has been significant effort made since our CRL in March to streamline our operations with a goal of funding operations from the cash flows of Auryxia as well as funds from our collaboration partners," said David A. Spellman, Chief Financial Officer of Akebia. "There is still work to do, and we are focused on delivering increased revenue and greater cost savings. If we are successful in implementing cost avoidance measures, we believe we will have cash flows to support the business through at least the next twelve months and do not anticipate a near-term requirement to further finance the company to execute our operating plan."

Conference Call
Akebia will host a conference call on Monday, May 9, 2022 at 4:30 p.m. Eastern Time to discuss its first quarter financial results and provide business updates. To listen to the conference call on May 9, please dial (877) 458-0977 (domestic) or (484) 653-6724 (international) using conference ID number 1273066. 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 15, 2022. To access the replay, dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and reference conference ID number 1273066. An online archive of the conference call can be accessed via the Investors section of Akebia’s website at View Source

ORIC Pharmaceuticals Reports First Quarter 2022 Financial Results and Operational Update

On May 9, 2022 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported financial results and operational updates for the quarter ended March 31, 2022 (Press release, ORIC Pharmaceuticals, MAY 9, 2022, View Source [SID1234613925]).

"We continue to make steady progress in advancing our pipeline of novel oncology candidates," said Jacob M. Chacko, MD, chief executive officer, "We expect to report initial data from our three ongoing studies in the first half of 2023, which includes our Phase 1b single agent trials for ORIC-533, our orally bioavailable CD73 inhibitor, ORIC-114, our brain penetrant EGFR/HER2 inhibitor, and ORIC-944, our embryonic ectoderm development (EED) inhibitor."

First Quarter 2022 and Other Recent Highlights

Preclinical Data Presented at AACR (Free AACR Whitepaper): In April 2022, ORIC disclosed new preclinical data in three poster presentations and one oral presentation at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

ORIC-533: Oral Small Molecule CD73 Inhibitor

ORIC-533 is a highly potent, orally bioavailable small molecule inhibitor of CD73 that has demonstrated more potent adenosine inhibition in preclinical studies compared to an antibody approach and other small molecule inhibitors of the adenosine pathway. In preclinical studies, ORIC-533 overcame immune suppression and triggered significant lysis and cell death of multiple myeloma cells in an assay comprised of autologous bone marrow microenvironment. A Phase 1b trial with ORIC-533 as a single agent in multiple myeloma is enrolling patients, and the company expects to report initial Phase 1b data from this trial in the first half of 2023.

ORIC-114: EGFR/HER2 Inhibitor

ORIC-114 is a brain penetrant, orally bioavailable, irreversible inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations. In preclinical studies, ORIC-114 achieved tumor regressions in an EGFR exon 20 NSCLC model with superior efficacy relative to CLN-081 and demonstrated greater anti-tumor activity compared to mobocertinib (TAK-788) in an intracranial NSCLC model. A Phase 1b trial with ORIC-114 as a

single agent is enrolling patients with advanced solid tumors with EGFR or HER2 exon 20 alterations or HER2 amplification and allows for patients with CNS metastases that are either treated or untreated but asymptomatic. The company expects to report initial Phase 1b data from this trial in the first half of 2023.

ORIC-944: PRC2 Inhibitor

ORIC-944 is a potent and selective allosteric inhibitor of polycomb repressive complex 2 (PRC2) that targets its regulatory embryonic ectoderm development (EED) subunit and has demonstrated single agent efficacy in multiple enzalutamide-resistant prostate cancer models in preclinical studies. A Phase 1b trial with ORIC-944 as a single agent is enrolling patients with metastatic prostate cancer, and the company expects to report initial Phase 1b data from this trial in the first half of 2023.

PLK4 Inhibitor Program

In March, the company announced a small molecule therapeutic program intended to address a mechanism of innate resistance found in a subset of breast cancers, specifically a synthetic lethal interaction of polo-like kinase 4 (PLK4) inhibition in tumors bearing a TRIM37 DNA amplification. ORIC discovered novel, potent, orally bioavailable small molecule inhibitors of PLK4 that are highly selective and achieved strong anti-tumor activity of TRIM37 high xenograft tumors, with corresponding pharmacodynamic effects and no body weight loss. The PLK4 inhibitor program is currently in lead optimization.

Anticipated Program Milestones

ORIC anticipates the following upcoming milestones:

•ORIC-533: Initial Phase 1b data in 1H 2023
•ORIC-114: Initial Phase 1b data in 1H 2023
•ORIC-944: Initial Phase 1b data in 1H 2023

First Quarter 2022 Financial Results

Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments totaled $256.2 million as of March 31, 2022, which the company expects will fund its current operating plan into the second half of 2024.

R&D Expenses: Research and development (R&D) expenses were $16.8 million for the three months ended March 31, 2022, compared to $11.7 million for the same period in 2021, an increase of $5.1 million. The increase was primarily driven by an increase in external expenses related to the advancement of ORIC-533, ORIC-114, ORIC-944 and our other product candidates of $4.6 million, offset by a decrease in ORIC-101 costs of $0.7 million due to the discontinuation of the program in the first quarter of 2022. Higher internal expenses related to higher personnel costs, including additional non-cash stock-based compensation of $0.5 million, also contributed to the increase in research and development expenses.

G&A Expenses: General and administrative (G&A) expenses were $6.4 million for the three months ended March 31, 2022, compared to $4.9 million for the same period in 2021, an increase of $1.6 million. The increase was primarily due to higher personnel costs, including additional non-cash stock-based compensation of $0.7 million.

Inhibrx Reports First Quarter 2022 Financial Results and Recent Corporate Highlights

On May 9, 2022 Inhibrx, Inc. (Nasdaq: INBX), a biotechnology company with four clinical programs in development and a strong emerging pipeline, reported financial results for the first quarter of 2022 and provided an update on recent corporate highlights (Press release, Inhibrx, MAY 9, 2022, View Source [SID1234613924]).

Recent Corporate Highlights

On February 22, 2022, Inhibrx announced that it had entered into an amendment to its Loan and Security Agreement with Oxford Finance LLC. The amendment provides for the funding of an additional $130.0 million in gross proceeds, $40.0 million of which was funded upon execution of the amendment on February 18, 2022, with the remaining $90.0 million to be funded in three separate tranches upon future milestone events.
On March 3, 2022, Inhibrx announced that the FDA granted orphan-drug designation for INBRX-101 for the treatment of alpha-1 antitrypsin deficiency, or AATD.
On April 5, 2022, Inhibrx announced that it will be presenting late-breaking data from INBRX-101 at the American Thoracic Society 2022 Conference taking place May 13-18, 2022.
On April 25, 2022, Inhibrx announced the formation of a Scientific Advisory Board, comprised of the top global experts in AATD, for INBRX-101.
Financial Results

Cash and Cash Equivalents. As of March 31, 2022, Inhibrx had cash and cash equivalents of $143.5 million, compared to $131.3 million as of December 31, 2021.
R&D Expense. Research and development expenses were $24.9 million during the first quarter of 2022, compared to $16.4 million during the first quarter of 2021. This overall increase was primarily due to an increase in work performed by Inhibrx’s contract development and manufacturing organization partners for the formulation and manufacturing of certain of its therapeutic candidates, as well as an increase in clinical trial expenses based on the initiation of a potentially registration-enabling Phase 2 trial in conventional chondrosarcoma and the progression of ongoing Phase 1 trials. Additionally, personnel-related costs increased during the first quarter of 2022 as compared to the same period in the prior year as a result of the continued expansion of Inhibrx.
G&A Expense. General and administrative expenses were $5.1 million during the first quarter of 2022, compared to $3.0 million during the first quarter of 2021. This overall increase was primarily driven by an increase of approximately $1.4 million in additional personnel-related costs, as well as marketing research expenses related to the initiation of our potential commercialization efforts for INBRX-101 and INBRX-109.
Net Loss. Net loss was $31.3 million during the first quarter of 2022, or $0.80 per share, compared to $19.3 million during the first quarter of 2021, or $0.51 per share.
About the Inhibrx sdAb Platform
Inhibrx utilizes diverse methods of protein engineering in the construction of therapeutic candidates that can address the specific requirements of complex target and disease biology. A key tool for this effort is the Inhibrx proprietary sdAb platform, which enables the development of therapeutic candidates with attributes superior to other monoclonal antibody and fusion protein approaches. This platform allows the combination of multiple binding units in a single molecule, enabling the creation of therapeutic candidates with defined valency or multiple specificities that can achieve enhanced cell signaling or conditional activation. An additional benefit of this platform is that these optimized, multi-functional entities can be manufactured using the established processes that are commonly used to produce therapeutic proteins.

Neoleukin Therapeutics Announces First Quarter 2022 Financial Results and Corporate Update

On May 9, 2022 Neoleukin Therapeutics, Inc., "Neoleukin" (NASDAQ:NLTX), a biopharmaceutical company utilizing sophisticated computational methods to design de novo protein therapeutics, reported financial results for the quarter ending March 31, 2022 and provided a corporate update (Press release, Neoleukin Therapeutics, MAY 9, 2022, View Source [SID1234613923]).

"During the first quarter of 2022 our dedicated team at Neoleukin has been focused on execution of our NL-201 Phase 1 clinical trial, evaluating multiple schedules during dose escalation in patients with relapsed and refractory solid tumors," said Jonathan Drachman, M.D., Chief Executive Officer of Neoleukin. "We anticipate reporting interim data from this trial during the second half of 2022; we also expect to initiate testing of NL-201 in combination with pembrolizumab around mid-year. Our scientists continue preclinical evaluation of NL-201 in novel regimens and additional indications as well as advancing our de novo protein technology and early-stage research programs."
NL-201 Update
Neoleukin is conducting a clinical trial of intravenous NL-201 in patients with advanced solid tumors. It is currently enrolling patients at sites in Australia, the United States, and Canada, evaluating two different schedules and multiple dose levels in order to determine a recommended Phase 2 dose and schedule. Neoleukin anticipates disclosing interim data during the second half of 2022.
In January, Neoleukin announced a clinical trial collaboration and supply agreement with Merck (known as MSD outside the United States and Canada) to evaluate NL-201 plus pembrolizumab as part of Neoleukin’s ongoing Phase 1 trial in patients with advanced solid tumors. This additional arm of the ongoing clinical trial is expected to begin enrollment mid-year 2022.
In April 2022, Neoleukin announced the presentation of preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, highlighting the potential for NL-201 to treat non-Hodgkin lymphoma as well as synergistic antitumor activity when NL-201 is combined with radiation therapy, including significant inhibition of tumor growth and increased survival in preclinical models.
Based on encouraging preclinical activity, Neoleukin announced plans to initiate a separate clinical trial to evaluate NL-201 in patients with hematologic malignancies. The timing for enrolling patients in this trial will be determined based on data we receive from our ongoing solid tumor Phase 1 trial relating to safety and optimal dosing schedules.

Executive Appointment
In March 2022, Neoleukin announced the appointment of Donna M. Cochener as General Counsel, Senior Vice President, Legal. Ms. Cochener joins Neoleukin after serving as Senior Vice President, Deputy General Counsel at HomeStreet, Inc., the parent company of HomeStreet Bank. Prior to her position with HomeStreet, Ms. Cochener was a partner at Davis Wright Tremaine, LLP in Seattle, and worked as an associate at the Seattle offices of Heller Ehrman, LLP, Riddell Williams, P.S. and Perkins Coie, LLP.
Summary of Financial Results
Cash Position: Cash and cash equivalents totaled $128.1 million as of March 31, 2022, compared to $142.5 million as of December 31, 2021.
Based upon current internal infrastructure and pipeline initiatives, Neoleukin believes it has sufficient cash to fund operations through 2023.
R&D Expenses: Research and development expenses for the quarter ended March 31, 2022 increased to $10.7 million from $9.7 million for the quarter ended March 31, 2021. The increase was primarily due to increased clinical trial expenses related to our lead product candidate, NL-201, and costs incurred in connection with the advancement of other Neoleukin technologies. The increase was partially offset by higher costs incurred during the three months ended March 31, 2021 in connection with the build-out of our headquarters and laboratory space in Seattle, Washington, as well as development costs associated with our NL-CVX1 program which was suspended in June 2021.
G&A Expenses: General and administrative expenses for the quarter ended March 31, 2022 decreased to $4.7 million from $5.2 million for the quarter ended March 31, 2021. The decrease was primarily attributable to decreases in personnel-related and facility-related costs.
Net Loss: Net loss for the quarter ended March 31, 2022 was $15.4 million compared to a net loss of $14.9 million for the quarter ended March 31, 2021.
About NL-201
NL-201 is a de novo agonist of the IL-2 and IL-15 receptors, designed to expand cancer-fighting CD8 T cells and natural killer (NK) cells without any bias toward cells expressing the alpha receptor subunit (CD25). Previously presented preclinical data has demonstrated the ability of NL-201 to stimulate and expand CD8+ and NK cells at low doses with minimal impact on immunosuppressive regulatory T cells. Furthermore, NL-201 has demonstrated both monotherapy and combination activity across a wide range of preclinical syngeneic tumor models.

OPKO Health Reports 2022 First Quarter Business Highlights and Financial Results

On May 9, 2022 OPKO Health, Inc. (NASDAQ: OPK) reported business highlights and financial results for the three months ended March 31, 2022 (Press release, Opko Health, MAY 9, 2022, View Source [SID1234613922]).

Business Highlights

Business highlights for the first quarter of 2022 and subsequent weeks include the following:

Acquired ModeX Therapeutics, Inc. (ModeX), gains proprietary immunotherapy technology, new executives and Directors. ModeX is a privately held biotechnology company focused on developing innovative multi-specific immune therapies for cancer and infectious diseases. In connection with the acquisition, Dr. Elias Zerhouni joins OPKO as President and Vice Chairman of the Board of Directors, Dr. Gary Nabel joins as Chief Innovation Officer and a member of OPKO’s Board of Directors, and Alexis Borisy joins OPKO’s Board. OPKO acquired ModeX for $300 million in OPKO common stock.

Completed sale of GeneDx LLC (formerly GeneDx, Inc.) to Sema4 Holdings Corp. (Sema4). Sema4 acquired GeneDx for an upfront payment of $150 million in cash, subject to adjustments, plus 80 million shares of Sema4 Class A common stock, with up to an additional $150 million in revenue-based milestones over the next two years (payable in cash or Sema4 shares at Sema4’s discretion). Based on the closing price of Sema4’s Class A common stock on April 29, 2022, the date the transaction closed, the total upfront consideration is approximately $322 million and the total aggregate consideration including potential milestones is approximately $472 million.

Pfizer launched NGENLA (Somatrogon) injection in Germany, Japan and additional markets. NGENLA was granted marketing authorization by the Ministry of Health, Labour and Welfare in Japan and by the European Commission in January and February of this year, respectively. With the achievement of these milestones, OPKO earned an aggregate of $85 million in milestone payments. NGENLA is a once-weekly injection to treat pediatric patients with growth disturbance due to insufficient secretion of growth hormone. NGENLA provides pediatric patients, their caregivers and healthcare providers with a new treatment option for growth hormone deficiency that reduces the frequency of required injections from once-daily to once-weekly. Pfizer is OPKO’s global commercial partner for Somatrogon.

Vifor Fresenius Medical Care Renal Pharma (VFMCRP) launched RAYALDEE in Germany, and subsequently in Switzerland. VFMCRP initiated the commercial launch of RAYALDEE (extended-release calcifediol) in Germany, the first launch of RAYALDEE outside the U.S. VFMCRP is OPKO’s commercial partner for RAYALDEE in Europe and selected markets outside the U.S. VFMCRP has received marketing authorizations for RAYALDEE in 11 European countries and expects to launch the product in additional markets.
First Quarter Financial Results

Diagnostics: Revenue from services in the first quarter of 2022 was $286.6 million compared with $507.0 million in the prior-year period, with the decrease primarily due to lower COVID-19 testing volume and related reimbursement, partially offset by an improvement in genomic test reimbursement and an increase in clinical and genomic test volumes. BioReference processed approximately 2.0 million COVID-19 PCR tests in the first quarter of 2022 versus 4.1 million in the first quarter of 2021. Total costs and expenses were $330.1 million in the first quarter of 2022 compared with $439.9 million in the first quarter of 2021, resulting in an operating loss of $43.5 million compared with operating income of $67.0 million in the 2021 period. Operating income decreased primarily due to a decline in the volume of COVID-19 tests.

Pharmaceuticals: Revenue from products in the first quarter of 2022 increased to $36.6 million from $33.9 million in the first quarter of 2021, with the increase primarily attributable to accelerating growth of OPKO’s international pharmaceutical businesses. Revenue from sales of RAYALDEE in the first quarter of 2022 was $5.1 million compared with $5.8 million in the prior-year period. Revenue from the transfer of intellectual property was $6.0 million in the first quarter of 2022 compared with $4.3 million in the 2021 period. During the first quarter of 2022, OPKO recognized a $3.0 million sales milestone from VFMCRP triggered by the first commercial sales in Europe. Total costs and expenses were $60.7 million in the first quarter of 2022 compared with $57.4 million in the prior-year period. The increase was driven by the amortization of NGENLA, which received approval in Europe and Japan during the first quarter of 2022, offset by a reduction in inventory reserve, legal expenses and selling expenses related to RAYALDEE. In addition, research and development expenses decreased reflecting reduced spending on the NGENLA development program. The operating loss was $18.1 million in the first quarter of 2022 compared with an operating loss of $19.2 million in the first quarter of 2021.

Consolidated: Consolidated total revenues for the first quarter of 2022 were $329.2 million compared with $545.2 million for the comparable period of 2021. Operating loss for the first quarter of 2022 was $72.4 million compared with operating income of $38.5 million for the 2021 quarter. Net loss for the first quarter of 2022 was $55.4 million, or $0.08 per share, compared with net income of $31.1 million, or $0.05 per diluted share, for the 2021 quarter.

Cash and equivalents: Cash and cash equivalents were $102.3 million as of March 31, 2022. In addition, OPKO has $64.8 million available under its line of credit with JP Morgan. Subsequent to the close of the quarter, OPKO received $150 million gross proceeds from the sale of GeneDx to Sema4. Also, OPKO expects to receive $85 million in milestone payments from Pfizer during the second quarter of 2022.
CONFERENCE CALL & WEBCAST INFORMATION

OPKO’s senior management will provide a business update, discuss first quarter financial results and the ModeX acquisition, and answer questions during a conference call and live audio webcast today beginning at 4:30 p.m. Eastern time. Participants are encouraged to pre-register for the conference call using this link. Callers who pre-register will be given a unique PIN to gain immediate access to the call and bypass the live operator. Those unable to pre-register may participate by dialing (866) 777-2509 (U.S.) or (412) 317-5413 (International). A webcast of the call may also be accessed at OPKO’s Investor Relations page and here.

A telephone replay will be available until May 16, 2022 by dialing (877) 344-7529 (U.S.) or (412) 317-0088 (International) and providing the passcode 6587528. A webcast replay will be available beginning approximately one hour after the completion of the live conference call here.