Athersys Reports Second Quarter 2022 Financial Results and Provides Business Update

On August 11, 2022 Athersys, Inc. (NASDAQ: ATHX) reported its financial results for the three and six months ended June 30, 2022 and provided a business update (Press release, Athersys, AUG 11, 2022, View Source [SID1234618131]).

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Second quarter 2022 Corporate and Operational Highlights:

Corporate Restructuring

Implemented a restructuring of our organization with the intention of significantly reducing expenses, conserving cash, improving focus of the Company’s activities and becoming more attractive to potential financial and strategic partners.
Reduction in workforce of up to 70% including changes to leadership team
Reduced size of Board of Directors from ten to five members while maintaining critical skills and enhancing efficiency
Suspended expensive manufacturing and process development initiatives
Initiated a process to sublet the Stow, Ohio facility
Reduced internal research function to focus resources on MASTERS-2
Made key executive appointments to pursue Athersys’ new business strategy
Engaged Ankura Consulting Group LLC and named financial expert Kasey Rosado interim Chief Financial Officer
Operations and supply-chain leader Maia Hansen named Chief Operating Officer
Exploring financing options to enable us to obtain funds to continue operations and execute reprioritized business strategy
Business Development Strategy

Participated in multiple investor conferences to build awareness, including:
Maxim Group 2022 Virtual Growth Conference
Locust Walk Stem Cell Conference
Needham Healthcare Conference
Bank of America Securities 2022 Global Healthcare Conference
H.C. Wainwright Global Healthcare Conference
Pursuing a business development strategy focused on securing regional and/or global MultiStem partners, non-dilutive funding and complementary capabilities across clinical, regulatory, commercial and manufacturing functions
Announced an August 29th webinar to provide a comprehensive review of preclinical research across multiple indications with MultiStem hosted by Dr. Willie Mays, Executive Vice President and Head of Regenerative Medicine & Neuroscience Programs, and Dr. Sarah Busch, Vice President, Regenerative Medicine & Head of Nonclinical Development; previously published preclinical data demonstrate that MultiStem holds potential in Alzheimer’s disease, multiple sclerosis, epilepsy, Parkinson’s disease, spinal cord injury, hypoxia and ischemia
Announced preclinical research by the Armed Forces Radiobiology Research Institute, a Department of Defense research laboratory under the leadership of the Uniformed Services University of the Health Sciences, showing the benefit of MultiStem in an animal model of acute radiation syndrome
Second Quarter MultiStem Clinical Trial Updates

MASTERS-2 (Phase 3 global study in ischemic stroke)

Reprioritized MASTERS-2 as development focus following restructuring
Increased enrollment rate, doubling the average number of patients enrolled per month in 2022 from prior years; enrolled more subjects in the second quarter of 2022 than during any other quarter
Expanded the network of active trial sites by adding new locations, including key stroke centers in Germany, the UK, Taiwan and Australia
Analyzed TREASURE results for potential read through to MASTERS-2 trial design
TREASURE (Phase 2/3 Japan study in ischemic stroke)

Trial did not reach statistical significance for its primary endpoint of Excellent Outcomes at 90-days, yet the long-term impact on the quality of life among treated patients was supported by topline results reported by Healios. The full data set demonstrated consistent improvement in essentially all measured functional outcomes over time through one year
Full results will be presented in a plenary session at the 14th World Stroke Congress in October
MATRICS-1 (Phase 2 study in trauma)

Collaborating with The University of Texas Health Science Center at Houston, one of the busiest Level 1 trauma centers in the U.S.
Funding provided by Medical Technology Enterprise Consortium and Memorial Hermann Foundation
Completed enrollment of the first patient cohort
Initiated dosing with product derived from Athersys’ large-scale bioreactors, providing greater scalability and efficiency
MACOVIA (Phase 2/3 study in acute respiratory distress syndrome)

Fast-track designation by the FDA
Now have data evaluating two different dosing levels of MultiStem produced by a cell factory process. Analysis of this data will help inform the design of the next phase of the trial
In order to focus resources on MASTERS-2, MACOVIA has been suspended until we receive additional financing or establish a partnership to move forward with the next phase of the study.
Management Commentary

"My first six months at Athersys have certainly been both challenging and productive," stated Dan Camardo, Chief Executive Officer of Athersys. "While the topline data from the TREASURE study evaluating MultiStem for the treatment of ischemic stroke conducted by our partner Healios in Japan did not reach statistical significance for its primary Endpoint of Excellent Outcome at 90-days, there were important and encouraging takeaways from this trial. We are particularly pleased that the study demonstrated improvement in other pre-specified measures of functional outcomes over time, supporting the long-term impact of MultiStem in ischemic stroke patients. The TREASURE trial results were positively endorsed by stroke key opinion leaders offering further encouragement as we proceed with our own MASTERS-2 study." Camardo continued, "We also implemented a restructuring of our organization with the intention of significantly reducing expenses, conserving cash, improving focus of the Company’s activities and creating a positive impact on enrollment progress in our MASTERS-2 study. We are confident that the actions taken over the last two months will better position Athersys in bringing MultiStem to market and becoming a global leader in regenerative medicine."

Second Quarter Results

Revenues increased to $2.3 million for the three months ended June 30, 2022 compared to no revenues for the three months ended June 30, 2021. Our collaboration revenues currently fluctuate from period to period based on the delivery of services under our arrangement with Healios.

Research and development expenses increased to $20.8 million for the three months ended June 30, 2022 from $17.7 million for the comparable period in 2021. The $3.1 million increase is associated with an impairment charge of $4.9 million related to assets that are no longer necessary to support future research and development and restructuring costs of $1.5 million. These increases were partially offset by decreases in clinical trial and manufacturing costs of $2.0 million, internal research supplies of $0.7 million, consulting fees of $0.4 million and decreases in other research development costs of $0.2 million. Our clinical development, clinical manufacturing and manufacturing process development expenses vary over time based on the timing and stage of clinical trials underway, manufacturing campaigns for clinical trials and manufacturing process development projects. These variations in activity level may also impact our accounts payable, accrued expenses, prepaid expenses and deposits balances from period to period. Other than external expenses for our clinical and preclinical programs, we generally do not track our research expenses by project; rather, we track such expenses by the type of cost incurred. We expect our research and development expenses to decrease in connection with our restructuring plan.

General and administrative expenses were $5.2 million for the three months ended June 30, 2022, which was higher than the $4.2 million for the comparable period in 2021. The increase is primarily related to restructuring costs of $1.2 million. We expect our general and administrative expenses to decrease in connection with our restructuring plan.

Net loss for the second quarter of 2022 was $23.6 million compared to a net loss of $22.6 million in the second quarter of 2021. The difference primarily results from the above variances.

During the six months ended months ended June 30, 2022, net cash used in operating activities was $36.6 million compared to $37.2 million in the six months ended months June 30, 2021. At June 30, 2022, we had $13.4 million in cash and cash equivalents, compared to $37.4 million at December 31, 2021.

Conference Call

Athersys will host a conference call today at 4:30 p.m. Eastern time to discuss these results and answer questions. Stockholders are encouraged to listen using this Webcast link. To participate via phone if you intend to ask a question, please pre-register for the conference call using this Call registration link. Registered stockholders will receive the toll-free number, a direct entry passcode and a registrant ID.

A replay of the event will be available on the webcast link at www.athersys.com under the investors’ section approximately two hours after the call has ended. Stockholders may also call in for on-demand listening approximately three hours after the completion of the call until 11:59 p.m. Eastern time on August 18, 2022, by dialing (888) 330-2506 or (240) 789-2712 and entering the conference code 70781.

ORIC Pharmaceuticals Reports Second Quarter 2022 Financial Results and Operational Update

On August 11, 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 June 30, 2022 (Press release, ORIC Pharmaceuticals, AUG 11, 2022, View Source [SID1234618130]).

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"We are well positioned with a highly differentiated and diverse pipeline of oncology candidates, a strong cash position and multiple, key upcoming clinical readouts," said Jacob M. Chacko, MD, chief executive officer. "As we head into the second half of 2022, we continue to execute on our programs and anticipate three initial data readouts from our three ongoing studies of ORIC-533, ORIC-114 and ORIC-944 in the first half of 2023."

Second Quarter 2022 and Other Recent Highlights

Preclinical Data Presented at AACR (Free AACR Whitepaper): In April 2022, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, ORIC disclosed new preclinical data in three poster presentations and one oral presentation from our ORIC-533 and ORIC-114 programs, as well as a newly disclosed PLK4 inhibitor program.

Anticipated Program Milestones

ORIC anticipates the following upcoming milestones:

ORIC-533 (oral CD73 inhibitor): Initial Phase 1b data in 1H 2023
ORIC-114 (brain penetrant EGFR/HER2 exon 20 inhibitor): Initial Phase 1b data in 1H2023
ORIC-944 (allosteric PRC2 inhibitor): Initial Phase 1b data in 1H 2023
Second Quarter 2022 Financial Results

Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments totaled $237.8 million as of June 30, 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 $13.8 million for the three months ended June 30, 2022, compared to $15.5 million for the same period in 2021. The decrease was primarily driven by a net decrease in external expenses of $2.4 million related to lower ORIC-101 costs due to the discontinuation of the program and lower ORIC-533 manufacturing costs, offset by higher personnel costs, including non-cash stock-based compensation of $0.3 million. For the six months ended June 30, 2022, R&D expenses were $30.7 million, compared to $27.2 million for the same period of 2021. The increase was primarily driven by a net increase of external expenses related to the advancement of ORIC-533, ORIC-114, ORIC-944 and our other product candidates as well as higher personnel costs, including non-cash stock-based compensation of $0.8 million.

G&A Expenses: General and administrative (G&A) expenses were $6.9 million for the three months ended June 30, 2022, compared to $5.5 million for the same period in 2021. For the six months ended June 30, 2022, G&A expenses were $13.3 million compared to $10.4 million for the same period of 2021. The increases were primarily due to higher personnel costs, including non-cash compensation of $0.6 million and $1.3 million for the three and six months ended June 30, 2022, as compared to the same periods in 2021, respectively.

Kinnate Biopharma Inc. Announces Second Quarter 2022 Financial Results and Recent Corporate Updates

On August 11, 2022 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a clinical-stage precision oncology company, reported financial results for the quarter ended June 30, 2022, and recent corporate updates (Press release, Kinnate Biopharma, AUG 11, 2022, View Source [SID1234618129]).

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"Kinnate is making meaningful progress with its proprietary clinical and preclinical precision oncology programs," said Nima Farzan, chief executive officer, Kinnate Biopharma Inc. "We continue to expand the global footprint of clinical trial sites for our pan-RAF inhibitor, KIN-2787, for which we expect to share initial clinical data later this year. The Kinnate Discovery Engine is actively generating new research leads, and with our financial strength, we’re well positioned to invest in breakthrough science and long-term growth of the company."

Pipeline Updates

KIN-2787, pan-RAF Inhibitor

Announced that KN-8701, a Phase 1 clinical trial to evaluate KIN-2787, was initiated in Taiwan by Kinnjiu Biopharma Inc., Kinnate’s China joint venture to develop and commercialize its most advanced kinase inhibitors in the People’s Republic of China, Hong Kong, Macau and Taiwan.
Granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration for KIN-2787 for the treatment of stage IIb-IV melanoma. An ODD is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the U.S.
Published online abstract as part of the 2022 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting proceedings on the in vitro and in vivo preclinical studies evaluating KIN-2787 in combination with binimetinib in NRAS-mutant melanoma models. (View release)
Enrolling patients in the ongoing Phase 1 dose escalation portion of KN-8701 evaluating KIN-2787 at approximately 18 active trial sites, including in the U.S., Spain, France and Australia. Initial monotherapy data is expected in the fourth quarter of 2022, and data for the binimetinib combination in the first half of 2023.
KIN-3248, FGFR Inhibitor

Presented the design and rationale of KN-4802, a Phase 1 clinical trial evaluating KIN-3248, the company’s investigational FGFR inhibitor, at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting. (View release)
Enrolling patients in the Phase 1 dose escalation portion of KN-4802, with initial clinical data for KIN-3248 expected in the second half of 2023.
Corporate Highlights

Expanded the organization to 82 full-time employees as of June 30, 2022, of which 61 were engaged in research and development activities.
The following senior leaders joined the company in the second quarter:
Robert Pelham, PhD, Vice President, Translational Medicine
Cheng Quah, MBBS, Vice President, Clinical Development
Second Quarter 2022 Financial Results

Cash and Cash Equivalents and Investments Position: As of June 30, 2022, the total of cash and cash equivalents and investments was $279.6 million, exclusive of Kinnjiu’s cash.
Research and Development Expenses: Second quarter research and development expenses for 2022 were $19.8 million, compared to $16.2 million for the same period in 2021.
General and Administrative Expenses: Second quarter general and administrative expenses for 2022 were $7.6 million, compared to $5.3 million for the same period in 2021.
Net Loss: Second quarter net loss for 2022 was $27.1 million, compared to $21.4 million for the same period in 2021.

Lineage Cell Therapeutics Reports Second Quarter 2022 Financial Results and Provides Business Update

On August 11, 2022 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported financial and operating results for the second quarter of 2022 (Press release, Lineage Cell Therapeutics, AUG 11, 2022, View Source [SID1234618128]). Lineage management will host a conference call and webcast today at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its second quarter 2022 financial and operating results and to provide a business update.

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"We are pleased with the progress on RG6501 (OpRegen) product development under our collaboration with Roche and Genentech. During the second quarter this year, we have made progress across multiple functional areas, including clinical, regulatory, and technology transfer activities," stated Brian M. Culley, Lineage CEO. "As we continue to position Lineage as a leader in regenerative medicine through the transplant of specific cell types, our focus is on completing the necessary clinical, regulatory and related activities which can create value and reduce risk across our portfolio of five cell transplant assets. In particular, our efforts have been focused on preparing for OPC1 and VAC2 regulatory interactions to enable their next phases of clinical testing in spinal cord injury and oncology, respectively. In parallel, we are advancing our auditory neuron and photoreceptor programs through preclinical development activities which are necessary to support initial clinical testing. We believe our disciplined use of capital and our increased strategic business development activities can support multiple years of growth and the achievement of important milestones in the months and years to come."

Second quarter milestones and activities included:

– RG6501 (OpRegen)

Continued execution under our collaboration with Roche and Genentech across multiple functional areas, including:
Conducting additional OpRegen manufacturing runs and supporting Chemistry Manufacturing and Controls (CMC) activities.
Continuing technology transfer activities.
Actively participating in both Joint Advisory and Joint Manufacturing Committees, forums for discussion and planning with respect to next steps in clinical development and related activities.
Continuing long-term follow-up of patients from the Phase 1/2a clinical study of OpRegen:
Enrolled patients have continued to do well, supporting multi-year durability of a treatment effect with RG6501 (OpRegen).
– OPC1

Results from a Phase 1/2a clinical study in subacute cervical spinal cord injury were published in the Journal of Neurosurgery: Spine;
OPC1 has demonstrated an excellent safety profile, and at one-year post-treatment, 96% of patients had recovered one or more levels of neurological function on at least one side of their body, and 32% of patients had recovered two or more levels of neurological function on at least one side of their body.
Preclinical testing of a new thaw and inject formulation of OPC1, manufactured via an improved and larger-scale process, has demonstrated functional recovery, improvement in gait coordination and motor performance with a reduction of the area of cavitation.
A majority of the verification and validation activities for the novel parenchymal spinal delivery (PSD) system, and its preclinical testing in support of a regulatory submission have been completed.
Preclinical activities to support upcoming regulatory interactions are near completion.
Engagement with the California Institute of Regenerative Medicine (CIRM), as well as various patient advocacy organizations and patient advocates, is underway.
– VAC2

Following technology transfer of the program from Cancer Research UK (CRUK) to Lineage and improvement of manufacturing processes, production scale was increased and accordingly the cost of goods has been reduced significantly, along with marked improvements in the purity and functionality of the manufactured material.
CRUK continues to follow patients on the Phase 1 NSCLC clinical study; Lineage has received all necessary clinical information from CRUK required to support U.S., or other, regulatory interactions.
– ANP1 & PNC1

Preclinical activities are continuing, including thought leader engagement to support future preclinical testing.
– Business Development

Broadened collaboration with Advanced BioMatrix, a division of BICO Group AB (STO: BICO), for the HyStem delivery technology to include clinical/commercial GMP (Good Manufacturing Practice) material, increasing the milestone payments and royalty percentages due to Lineage upon ABM reaching certain development milestones and/or product sales.
Continued work under our collaboration with our strategic partner, Immunomic Therapeutics ("ITI"); currently awaiting decision on next steps for ITI’s allogeneic cell-based cancer immunotherapy for the treatment of glioblastoma based on the VAC platform.
Some of the key upcoming milestones and activities anticipated by Lineage include:

– Planned interaction with FDA in Q4 2022 to discuss an OPC1 IND amendment submission to enable clinical performance and safety testing of a novel PSD system.

– A pre-IND regulatory interaction in Q4 2022 to seek feedback on a VAC2 CMC, nonclinical, and clinical package to support U.S. clinical development; pre-IND briefing package submission in Q3 2022.

– Submission of a grant application to the California Institute for Regenerative Medicine (CIRM) for the continued support of the clinical development of OPC1.

– Clinical data update from the ongoing VAC2 Phase 1 non-small cell lung cancer (NSCLC) study, pending release from CRUK.

– Preclinical activities for both the ANP1 and PNC1 programs.

– Additional OPC1 publications, including preclinical study results utilizing a new thaw and inject formulation of OPC1, manufactured via an improved and larger-scale process.

– An additional OPC1 manuscript from a Phase 1/2a clinical study in subacute cervical spinal cord injury, focused on MRI data.

– Evaluation of new partnership opportunities and/or expansion of existing collaborations.

– Continued participation in investor and partnering meetings and medical and industry conferences to broaden awareness of our mission and accomplishments.

Balance Sheet Highlights

Cash, cash equivalents, and marketable securities totaled $72 million as of June 30, 2022, which is expected to support operations through Q2 2024.

Second Quarter Operating Results

Revenues: Lineage’s revenue is generated primarily from licensing fees, royalties, collaboration revenues, and research grants. Total revenues for the three months ended June 30, 2022 were approximately $4.6 million, a net increase of $4.0 million as compared to $0.5 million for the same period in 2021. The increase was primarily related to licensing fees recognized from deferred revenues in connection with the $50.0 million upfront licensing payment received in the first quarter of 2022 from Roche.

Operating Expenses: Operating expenses are comprised of research and development ("R&D") expenses and general and administrative ("G&A") expenses. Total operating expenses for the three months ended June 30, 2022 were $8.6 million, an increase of $1.1 million as compared to $7.5 million for the same period in 2021.

R&D Expenses: R&D expenses for the three months ended June 30, 2022 were $3.3 million, a net increase of $0.4 million as compared to $2.9 million for the same period in 2021. The net increase was driven by $0.1 million in higher OpRegen related expenses to support the Roche Collaboration. Another $0.2 million and $0.1 million of the increase was related to R&D spending on the new auditory neuron and photoreceptor cell therapy programs, respectively.

G&A Expenses: G&A expenses for the three months ended June 30, 2022 were $5.3 million, a net increase of approximately $0.7 million as compared to $4.5 million for the same period in 2021. The increase was primarily attributable to $0.4 million in payroll and related benefits expense, and $0.5 million in share-based compensation, partially offset by $0.2 million in lower investor relations expense.

Loss from Operations: Loss from operations for the three months ended June 30, 2022 was $4.2 million, a decrease of $2.9 million as compared to $7.1 million for the same period in 2021.

Other Income/(Expenses), Net: Other income (expenses), net for the three months ended June 30, 2022 reflected other expense, net of ($2.5) million, compared to other income, net of $2.1 million for the same period in 2021. The net change was primarily driven by exchange rate fluctuations related to Lineage’s international subsidiaries, as well as a decrease in the value of marketable equity securities, and partially offset by the gain on extinguishment of debt from Lineage’s Paycheck Protection Program loan forgiveness recognized in the prior year’s quarter.

Net Loss Attributable to Lineage: The net loss attributable to Lineage for the three months ended June 30, 2022 was $6.8 million, or $0.04 per share (basic and diluted), compared to a net loss attributable to Lineage of $4.8 million, or $0.03 per share (basic and diluted), for the same period in 2021.

Conference Call and Webcast

Interested parties may access today’s conference call by dialing (800) 715-9871 from the U.S. and Canada and (646) 307-1952 from elsewhere outside the U.S. and Canada and should request the "Lineage Cell Therapeutics Call" or provide conference ID number 6448886. A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through August 18, 2022, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 6448886.

Alpine Immune Sciences Provides Corporate Update and Reports Second Quarter 2022 Financial Results

On August 11, 2022 Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune and inflammatory diseases, reported financial results for the second quarter ended June 30, 2022 (Press release, Alpine Immune Sciences, AUG 11, 2022, View Source [SID1234618127]).

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"We are pleased with our productive second quarter that included the presentation of encouraging clinical data across our pipeline of novel autoimmune and immuno-oncology candidates and the continued strengthening of our company with the additions of Dr. Sandler to our management team and Dr. Drapa to our board of directors," said Mitchell H. Gold, MD, Executive Chairman and Chief Executive Officer of Alpine. "Promising first-in-human data for ALPN-303, our potentially best-in-class dual BAFF/APRIL inhibitor, were presented at the 2022 European Alliance of Associations for Rheumatology (EULAR) Congress. We look forward to sharing a more detailed clinical update later in the year to be followed by multiple patient-based studies. Our lead immuno-oncology candidate, davoceticept, has demonstrated a deepening reduction in tumor volume as a monotherapy and focused expansion cohorts have been initiated. In addition, we are pleased to have had the partial clinical hold removed on the NEON-2 trial of davoceticept in combination with pembrolizumab and we plan to report initial data from this combination later this year."

Second Quarter 2022 and Recent Pipeline Updates

ALPN-303

Preliminary data from the first-in-human, phase 1 study of ALPN-303 in healthy volunteers were included in a poster presentation at the 2022 European Alliance of Associations for Rheumatology (EULAR) Congress. ALPN-303 has significantly improved potency against the B cell cytokines BAFF and APRIL, superior to related inhibitors including wild-type TACI-Fc’s. In addition, the ongoing phase 1 study demonstrates that ALPN-303 has been well tolerated to-date and has exhibited highly encouraging preliminary pharmacodynamic reductions in circulating immunoglobulins.
Initiation of up to three basket trials in hematologic, renal, and dermatologic indications and a phase 2 study in systemic lupus erythematosus (SLE) is anticipated beginning in the first half of 2023, updated from end of 2022 due, in part, to delays in enrollment in our phase 1 study related to the COVID-19 pandemic in Australia earlier this year. We plan to provide a more detailed clinical update from the phase 1 study in the third quarter of 2022 and anticipate initial clinical data from the basket trials in the second half of 2023.
Davoceticept

Davoceticept monotherapy dose escalation data (NEON-1) were presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, demonstrating tumor volume reduction in 23% of evaluable participants despite a highly heterogeneous, heavily pretreated, advanced solid tumor population. Monotherapy expansion cohorts are currently open for enrollment with a particular interest in renal cell carcinoma, given the observed preliminary activity in this setting.
FDA removed the partial clinical hold on the NEON-2 trial of davoceticept in combination with pembrolizumab after review of the Company’s Complete Response, which included a comprehensive review of the davoceticept safety database, as well as a revised investigator brochure and study protocol. Preliminary data from the NEON-2 combination trial is anticipated in the second half of 2022.
Corporate

Andrew Sandler, MD was appointed Chief Medical Officer of Alpine effective August 17, 2022. Dr. Sandler brings over 25 years of industry experience and clinical development expertise and leadership to the Alpine team. Dr. Sandler joins Alpine from Kiadis Pharma, a Sanofi Company, where he was Chief Medical Officer.
Jörn Drappa, MD, PhD, a 20-year industry veteran with extensive global clinical development leadership experience in autoimmune and inflammatory diseases, joined the Alpine Board of Directors. Dr. Drappa co-founded Viela Bio, a biotechnology company focused on the discovery, development and commercialization of treatments for autoimmune and severe inflammatory diseases, and served as its Head of R&D and Chief Medical Officer through its acquisition by Horizon Therapeutics in March 2021 for $3.1 billion.
Second Quarter 2022 Financial Results

As of June 30, 2022, Alpine’s cash, cash equivalents, and investments totaled $201.2 million. The Company recorded net losses of $18.1 million and $11.0 million for the quarters ended June 30, 2022 and 2021, respectively.

Collaboration revenue for the second quarter ended June 30, 2022 was $5.3 million compared to $7.2 million for the second quarter ended June 30, 2021. The 2022 amounts were primarily attributable to revenue recognized under the Company’s AbbVie and Horizon Agreements, while 2021 revenue recognized solely relates to the AbbVie collaboration.

Research and development expenses for the second quarter ended June 30, 2022 were $17.6 million compared to $14.6 million for the second quarter ended June 30, 2021. The increase was primarily attributable to the Company’s Synergy, NEON, and ALPN-303 studies, and increased personnel costs and direct research activities. These increases were partially offset by a decrease in contract manufacturing and process development for ALPN-303.

General and administrative expenses for the second quarter ended June 30, 2022 were $4.2 million compared to $3.3 million for the second quarter ended June 30, 2021. The increase was primarily attributable to increases in personnel costs.

The Company expects that its current cash resources will be sufficient to fund its planned operations into 2024.