On May 8, 2023 Aravive, Inc. (Nasdaq: ARAV, "the Company"), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, reported it will host a virtual Key Opinion Leader (KOL) event on its late-stage oncology asset, batiraxcept, on Wednesday, May 24, 2023 at 1:00pm ET (Press release, Aravive, MAY 8, 2023, View Source [SID1234631128]).

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The event will feature oncology experts Katherine Fuh, MD, PhD (UCSF Division of Gynecologic Oncology), who will discuss batiraxcept as a potential treatment for ovarian cancer, and Katy Beckermann, MD, PhD (Vanderbilt-Ingram Cancer Center; Vanderbilt University Medical Center), who will provide an overview of batiraxcept as a promising treatment for kidney cancer.

The Aravive leadership team will provide a company update and overview of the commercial opportunity and future directions. Batiraxcept has been granted Fast Track Designation by the U.S. FDA for both clear cell renal cell carcinoma and platinum-resistant ovarian cancer and Orphan Drug Designation for pancreatic ductal adenocarcinoma. Batiraxcept has been granted Orphan Drug Designation by the European Commission for platinum-resistant recurrent ovarian cancer.

A live question and answer session will follow the formal presentations. To register for the event, please click here.

About Katy Beckermann, MD, PhD
Dr. Beckermann is a clinical researcher focused on kidney cancer and inspired by the dramatic responses with immunotherapy agents targeting T cells to harvest the power of the immune system and fight cancer. She aspires to take excellent care of patients forced to deal with the horrific diagnosis of cancer by asking the "why" questions that will advance understanding and improve their therapy. She is national principal investigator (PI) for four clinical trials including two Investigator-Sponsored Trials (IST), and she is site PI on a number of industry-sponsored clinical trials in kidney cancer. She has salary support through the Kidney Cancer Clinical Consortium Department of Defense (DoD) grant as well as a Co-I and sub-PI on collaborative DoD and RO1 focused on kidney cancer research projects. She also has funding as PI on a translational correlative project through BMS, Arsenal Bio, and Pionyr. The goal of her research is to care for patients with kidney cancer by advancing novel therapeutics through clinical trials and identifying predictive biomarkers of response to improve patient selection and reduce both clinical and financial toxicity.

About Katherine Fuh, MD, PhD
Dr. Fuh is a board-certified gynecologic oncologist and has clinical expertise in the management and treatment of gynecologic cancers such as advanced stage ovarian and uterine cancers. She returned to UCSF in 2022 after spending 9 years at Washington University in St. Louis. She serves on national committees for clinical trials and translational research including Translational Co-Chair for the Uterine Corpus Committee for the NRG Clinical Trials Group. She is the international PI for GOG-3059/ENGOT OV-66 which is a Phase 3, randomized, double-blind, placebo-controlled/paclitaxel study in combination with batiraxcept, an AXL inhibitor, for platinum-resistant, high-grade serous ovarian, fallopian-tube, and Peritoneal Cancer. She is the principal investigator on multiple grants from various federal and foundation sources. She is committed to developing better treatments for women with gynecologic cancers.

On May 8, 2023 Akoya Biosciences, Inc. (Nasdaq: AKYA) ("Akoya"), The Spatial Biology Company, reported its financial results for the first quarter ending March 31, 2023 (Press release, Akoya Biosciences, MAY 8, 2023, View Source [SID1234631127]).

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"Akoya started the year strong, highlighted by record quarterly revenue and our 1000th spatial instrument placement in April, the largest installed base in the rapidly growing spatial biology industry," said Brian McKelligon, Chief Executive Officer, Akoya Biosciences. "We continue to see robust growth and rising interest in our platforms across the discovery, translational, and clinical markets, as well as strong traction with our new product offerings. Our targeted investments in product development, commercial expansion, and business infrastructure have positioned us well to continue to drive long-term growth, while moving towards business profitability."

First Quarter 2023 Financial Highlights

Total revenue was $21.4 million in the first quarter of 2023, compared to $16.9 million in the prior year period; an increase of 26.6%.
Product revenue (which includes instruments, reagents, and software) was $15.5 million in the first quarter of 2023, compared to $13.3 million in the prior year period; an increase of 16.5%.
Instrument revenue was $9.6 million, compared to $8.5 million; an increase of 12.9%.
Reagent revenue was $5.7 million, compared to $4.6 million; an increase of 23.9%.
Service and other revenue totaled $5.9 million in the first quarter of 2023, compared to $3.6 million in the prior year period; an increase of 63.9%.
Gross profit was $12.3 million and gross profit margin was 57.4% in the first quarter of 2023.
58 instruments were sold in the first quarter of 2023; 19 PhenoCyclers, 39 PhenoImagers (which includes Fusion and HT); compared to 51 instruments sold in the prior year period (14 PhenoCyclers, 37 PhenoImagers).
Instrument installed base of 992 as of March 31, 2023 (273 PhenoCyclers, 719 PhenoImagers); compared to an installed base of 748 in the prior year period (196 PhenoCyclers, 552 PhenoImagers); an increase of 33%.
Combined-unit PhenoCycler-Fusion installed base of 128 as of March 31, 2023; compared to 23 in the prior year period.
$60.2 million of cash and cash equivalents as of March 31, 2023, with $11.3 million in additional debt capacity.
First Quarter 2023 Business Highlights

As of March 31, 2023, there have been 860 total publications featuring Akoya’s platforms; 62% growth from 530 total publications as of March 31, 2022.
Akoya shipped its 1000th instrument in April, a major milestone for the company and the largest installed base in the spatial biology industry.
At the 2023 American Association of Cancer Research (AACR) (Free AACR Whitepaper) conference held from April 16-19, Akoya launched two new commercial product offerings, including the high-plex modular PhenoCode Discovery Panels on the PhenoCycler-Fusion platform, to further increase speed and simplicity of the workflow, and the partnered Enable Medicine Cloud Platform, for enhanced and rapid data analysis of high-plex images, with the potential to improve outcomes in both clinical and research settings.
Johnny Ek appointed as new Chief Financial Officer, who brings more than 20 years of financial leadership experience across the diagnostics and life sciences tools industries, and Joe Driscoll has retired after more than four successful years as Chief Financial Officer.
Jennifer Kamocsay appointed as Akoya’s first General Counsel, who brings over a decade of experience as a corporate and M&A attorney, to oversee all company legal activities and provide strategic guidance and corporate governance oversight.
2023 Financial Outlook

The Company, based on its current plans and initiatives, continues to expect full year 2023 revenue guidance range of $95-98 million.

Webcast and Conference Call Details

Akoya will host a conference call today, May 8, 2023, at 5:00 p.m. Eastern Time to discuss its first quarter 2023 financial results. Investors interested in listening to the conference call are required to register online. A live webcast of the conference call will be available on the "Investors" section of the Company’s website at View Source The webcast will be archived on the website following the completion of the call for three months.

On May 8, 2023 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, 2023 and provided business highlights (Press release, Akebia, MAY 8, 2023, View Source [SID1234631126]).

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"Approval of Vafseo (vadadustat) by the European Commission is a significant milestone for us and for dialysis patients in Europe with anemia due to chronic kidney disease," said John P. Butler, Chief Executive Officer of Akebia. "This is an important step as we continue to deliver on our commitment to better the lives of people with kidney disease. Now we are working to complete a partnership to launch Vafseo in Europe, and we are eager to conclude our appeal process with the FDA."

In April, the European Commission granted marketing authorization for Vafseo (vadadustat), for the treatment of symptomatic anemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis. Akebia plans to select a partner to commercialize Vafseo in Europe. Vadadustat is now approved in 32 countries. Akebia also expects a regulatory opinion on vadadustat in the United Kingdom, Switzerland and Australia over the course of this year.

In the U.S., Akebia has continued to engage with the Office of New Drugs on its Formal Dispute Resolution regarding vadadustat. Dr. Stein, the deciding authority on the appeal, indicated he has completed his internal discussions, and the company expects a response within the next 30 days.

Akebia also recently reported positive top-line results from FO2CUS, a study evaluating the efficacy and safety of vadadustat in hemodialysis patients who were converted from a long-acting erythropoiesis-stimulating agent (ESA) to three times weekly oral vadadustat dosing for the maintenance treatment of anemia. The data demonstrated that vadadustat met the primary and secondary efficacy endpoints and was non-inferior to an ESA in the treatment of anemia due to chronic kidney disease in patients on hemodialysis when used three times a week at the time of dialysis and with a comparable safety profile to the current standard of care.

"Our team has been diligent in efforts to manage spend and sustain a reduction in operating costs," said David A. Spellman, Chief Financial Officer of Akebia. "Auryxia revenue was impacted by a $5 million reduction in the volume of channel inventory from year end. We believe quarterly fluctuations in our revenue will continue, which do not impact revenue guidance of $175-$180 million. Our team is delivering operating expense savings, with an almost 50% reduction versus the first quarter of 2022, and almost 30% reduction from the fourth quarter of 2022. We continue to execute strategic decisions to enable us to operate with cash on hand and Auryxia revenue for at least the next twelve months."

Financial Results

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Revenues: Total revenue was $40.1 million in the first quarter of 2023 compared to $61.7 million for the first quarter of 2022.

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Net product revenue was $34.8 million in the first quarter of 2023 compared to $41.4 million in the first quarter of 2022, a 15.9% decrease; and compared with $49.7 million in the fourth quarter of 2022, a 30.0% decrease. The decrease compared to the first quarter of 2022 was primarily due to a reduction in inventory of Auryxia by certain customers, as well as a decline in volume, partially offset by higher net price per tablet. The decrease compared to the fourth quarter of 2022 is primarily due to the previously discussed year-end inventory build up by a customer at the end of 2022, which has now been reduced significantly.

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License, collaboration, and other revenue was $5.3 million for the first quarter of 2023 compared to $20.3 million for the first quarter of 2022. The decrease was primarily related to a reduction in revenue from the termination of the U.S. and international collaboration agreements between Akebia and Otsuka in the second quarter of 2022.

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COGS: Cost of goods sold was $19.5 million for the first quarter of 2023 compared to $31.3 million for the first quarter of 2022. The decrease was primarily due to lower excess and obsolescence reserves associated with Auryxia, lower manufacturing costs associated with the supply of Vafseo to Mitsubishi Tanabe Pharma Corporation for commercial sale in Japan, and lower freight costs as a result of a lower volume of shipments. The company continues to carry a non-cash intangible amortization charge of $9.0 million per quarter through the fourth quarter of 2024.

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R&D Expenses: Research and development expenses were $19.7 million for the first quarter of 2023 compared to $43.8 million for the first quarter of 2022. The decrease was primarily due to decreased headcount related costs as a result of the April 2022 reduction in force, decreased outsourced contract services, decreased clinical trial costs, and development expenses related to vadadustat.

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SG&A Expenses: Selling, general and administrative expenses were $25.2 million for the first quarter of 2023 compared to $44.3 million for the first quarter of 2022. The decrease was primarily due to decreased headcount related costs as a result of the 2022 reductions in force and lower marketing expenses following receipt of the complete response letter for vadadustat from the U.S. Food and Drug Administration (FDA).

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Net Loss: Net loss was $26.2 million for the first quarter of 2023 compared to $62.4 million for the first quarter of 2022. The decrease in net loss was due primarily to lower cost of goods sold and lower operating expenses, partially offset by lower revenues.

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Cash Position: Cash and cash equivalents as of March 31, 2023 were approximately $57.0 million. Akebia believes that its cash resources will be sufficient to fund its current operating plan for at least the next twelve months. Akebia’s objective is to fund its current operating plan with existing cash resources and cash from operations for at least the next twelve months. Future decisions by the FDA or other regulatory agencies related to the potential regulatory approval of vadadustat, or Akebia’s ability to generate additional value from vadadustat through partnerships or other transactions may potentially further extend our cash runway, but are not currently reflected in the operating plan. Akebia also plans to continue to work on initiatives to extend its revenues from Auryxia beyond anticipated loss of exclusivity in March 2025.

Conference Call

Akebia will host a conference call on Monday, May 8 at 8:30 a.m. ET to discuss its financial results and recent business highlights. To access the call, please register by clicking on this Registration Link, and then you will be provided with dial in details. To avoid delays, we encourage dialing into the conference call fifteen minutes ahead of the scheduled start time.

A live webcast of the conference call will be available via the Investors section of Akebia’s website at View Source." target="_blank" title="View Source." rel="nofollow">View Source An online archive of the webcast can be accessed via the Investors section of Akebia’s website at View Source approximately two hours after the event.

On May 8, 2023 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported its financial results for the first quarter of 2023 and provided a corporate update (Press release, Aclaris Therapeutics, MAY 8, 2023, View Source [SID1234631125]).

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"The first quarter of 2023 represented another period of continued progress advancing our clinical stage development programs toward important data milestones," stated Doug Manion, M.D., Chief Executive Officer of Aclaris. "As we continue to move toward data catalysts for zunsemetinib in rheumatoid arthritis and psoriatic arthritis as well as ATI-1777 in atopic dermatitis, we also are making positive progress towards bringing our next potentially broadly applicable candidate, ATI-2138, into its first proof of concept trial in ulcerative colitis."

Continued Dr. Manion, "Regarding our proof-of-concept trial of zunsemetinib in hidradenitis suppurativa, which we reported in March, while we did not see positive efficacy results in this particularly challenging disease, we were able to strengthen our safety database and demonstrate mechanistically that our potentially first-in-class MK2 inhibitor performed as expected."

Research and Development Highlights:

Clinical Development Programs:

Zunsemetinib, an investigational oral small molecule MK2 inhibitor:
Currently being developed as a potential treatment for immuno-inflammatory diseases

Rheumatoid Arthritis (ATI-450-RA-202): This Phase 2b dose ranging trial to investigate the efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses (20 mg and 50 mg twice daily) of zunsemetinib in combination with methotrexate in subjects with moderate to severe rheumatoid arthritis (RA) is ongoing. Based on the continued positive enrollment momentum, Aclaris is narrowing its timing guidance for topline data to the fourth quarter of 2023.

Psoriatic Arthritis (ATI-450-PsA-201): This Phase 2a trial to investigate the efficacy, safety, tolerability, PK and PD of zunsemetinib (50 mg twice daily) in subjects with moderate to severe psoriatic arthritis (PsA) is ongoing. Based on a slower than anticipated study start up in Europe, the trial enrollment has taken longer than expected. Based on current enrollment trends and momentum, particularly in Poland, Aclaris now expects topline data in the first half of 2024, rather than year end 2023.
ATI-1777, an investigational topical "soft" Janus kinase (JAK) 1/3 inhibitor:
Currently being developing as a potential treatment for mild to severe atopic dermatitis (AD)

Atopic Dermatitis (ATI-1777-AD-202): This Phase 2b trial to determine the efficacy, safety, tolerability, and PK of multiple doses and application regimens of ATI-1777 in subjects with mild to severe AD is ongoing. In April 2023, Aclaris modified the protocol to expand the inclusion criteria for the trial to enroll patients with milder disease to broaden the drug’s target indication potential and to further aide enrollment which was challenged by an unexpected milder winter season. As a result, Aclaris currently projects topline data in the second half of 2023, rather than mid-year 2023.
ATI-2138, an investigational oral covalent ITK/JAK3 inhibitor:
Currently being developed as a potential treatment for T cell-mediated autoimmune diseases

Aclaris has selected ulcerative colitis as the intended first clinical development target for ATI-2138. Aclaris is also exploring additional indications that are relevant to the mechanism of action.

Healthy Volunteers (ATI-2138-PKPD-102): This Phase 1 MAD (multiple ascending dose) trial to investigate the safety, tolerability, PK and PD of ATI-2138 in healthy volunteers is ongoing. Aclaris continues to expect topline data in the second half of 2023.
Preclinical Development Program

ATI-2231, an investigational oral MK2 inhibitor compound:
Currently being explored as a potential treatment for pancreatic cancer and metastatic breast cancer as well as in preventing bone loss in patients with metastatic breast cancer

Second MK2 inhibitor generated from Aclaris’ proprietary KINect drug discovery platform and designed to have a long plasma half-life.

Aclaris expects clinical development activities to be initiated in 2023, which is expected to advance as a collaboration with an academic third party.
Financial Highlights:

Liquidity and Capital Resources

As of March 31, 2023, Aclaris had aggregate cash, cash equivalents and marketable securities of $204.4 million compared to $229.8 million as of December 31, 2022.

Additionally, in March 2023, Aclaris issued a placement notice to sell approximately 3.4 million shares under its ATM facility for aggregate net proceeds of $26.7 million. This transaction closed in April 2023.

Aclaris continues to anticipate that its cash, cash equivalents and marketable securities as of March 31, 2023 in combination with the $26.7 million in net proceeds from sales under the ATM facility subsequent to quarter end, will be sufficient to fund its operations through the end of 2025, without giving effect to any potential business development transactions or additional financing activities.

Financial Results

First Quarter 2023

Net loss was $28.2 million for the first quarter of 2023 compared to $18.8 million for the first quarter of 2022.
Total revenue was $2.5 million for the first quarter of 2023 compared to $1.5 million for the first quarter of 2022. The increase was driven by higher licensing revenue primarily from royalties earned on out-licensed intellectual property in the first quarter of 2023.
Research and development (R&D) expenses were $22.6 million for the quarter ended March 31, 2023 compared to $14.3 million for the prior year period.
The $8.3 million increase was primarily the result of higher:
Zunsemetinib development expenses related to drug candidate manufacturing and costs associated with clinical activities for a Phase 2b trial for RA.
ATI-1777 development expenses related to costs associated with a Phase 2b clinical trial for AD.
ATI-2138 development expenses, including costs associated with a Phase 1 MAD trial and other preclinical activities.
Compensation-related expenses due to an increase in headcount.
General and administrative (G&A) expenses were $8.8 million for the quarter ended March 31, 2023 compared to $6.1 million for the prior year period. The increase was primarily due to an increase in compensation-related expenses due to an increase in headcount.
Licensing expenses were $1.1 million for the quarter ended March 31, 2023 resulting from separate third-party contractual obligations related to the non-exclusive patent license agreement with Lilly. There were no licensing expenses for the quarter ended March 31, 2022.
Revaluation of contingent consideration resulted in a $0.8 million credit for the quarter ended March 31, 2023 compared to a credit of $1.2 million for the prior year period.
Conference Call and Webcast

As previously disclosed on May 2, 2023, management will host a conference call and webcast, with an accompanying slide presentation, at 8:00 AM ET today to provide a corporate update. To access the live webcast of the call and the accompanying slide presentation, please visit the "Events" page of the "Investors" section of Aclaris’ website, www.aclaristx.com. The webcast will be archived for at least 30 days on the Aclaris website.

On May 8, 2023 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that it has entered into a joint development agreement with Bliss Biopharmaceutical (Hangzhou) Co., Ltd. (Headquarters: Zhejiang Province, China, "BlissBio"), for BB-1701, an antibody-drug conjugate (ADC) with option rights for a strategic collaboration (Press release, Eisai, MAY 7, 2023, View Source [SID1234631139]).

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BB-1701 is an ADC that is composed of Eisai’s in-house developed anticancer agent eribulin, and anti-HER2 antibody using a linker, and is expected to have anti-tumor effects on breast, lung and other solid tumors that express HER2. The linker-payload, which uses eribulin as a payload, is a proprietary technology platform developed by Eisai’s U.S. research base Exton Site, and Eisai is investigating the possibilities of using this platform to link to various antibodies. Under a license agreement signed by the two companies in 2018, Eisai has granted BlissBio global exclusive development rights for several ADCs to use eribulin as the payload. Based on the status of the Phase I/II clinical trials of BB-1701 currently being conducted by BlissBio, the both companies have decided to co-develop this drug.

Under the terms of the joint development agreement, Eisai will make upfront and development milestone payments to BlissBio, conduct a Phase II clinical trial in breast cancer, and obtain option rights to develop and commercialize BB-1701 globally, excluding Greater China (China, Hong Kong, Macau, Taiwan). If Eisai exercises the option rights, an additional upfront payment will be made to BlissBio, as well as development and regulatory milestone payments, sales milestone payments and a certain amount of royalties on sales revenue of BB-1701 after the launch. If all development, regulatory and sales milestones are achieved, up to a total of $2 billion USD will be paid.

"BB-1701 is characterized by its payload of eribulin, which is a product of our modern synthetic organic chemistry that has already made contributions to patients with breast cancer and soft tissue sarcoma," said Dr. Takashi Owa, Chief Scientific Officer, Senior Vice President, Eisai Co., Ltd. "Our collaboration with BlissBio will accelerate the development of BB-1701 with the goal of bringing a new treatment option to patients globally."