On May 13, 2021 Humanigen, Inc. (Nasdaq: HGEN) ("Humanigen"), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab, reported financial results for the first quarter ending March 31, 2021 and provided a regulatory update on lenzilumab (Press release, Humanigen, MAY 13, 2021, View Source [SID1234579922]).

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"We are encouraged by the achievements Humanigen has made since the beginning of 2021 and by our progress on the emergency use authorization application," stated Cameron Durrant, MD, MBA, Chief Executive Officer, Humanigen. "We successfully completed our Phase 3 study of lenzilumab, referred to as LIVE-AIR, for the treatment of newly hospitalized and hypoxic COVID-19 patients. Trial results showed that patients who received lenzilumab and other treatments, including steroids and/or remdesivir, had a 54% greater relative likelihood of survival without the need for IMV compared with patients receiving placebo and other treatments. We believe this statistically significant result, along with data regarding additional endpoints and further analysis from the study, support the submission of applications for emergency use authorization to the U.S. Food and Drug Administration and conditional marketing authorization in the United Kingdom and the European Union. As is typical with COVID-19 study results, a pre-print of the LIVE-AIR study was published on-line. Positive results from the Phase 1b study of lenzilumab in combination with CAR-T gave further encouragement to our therapeutic approach to breaking the linkage between efficacy and toxicity in CAR-T, and we are designing a Phase 2 study of lenzilumab combined with all commercially available CD19 CAR-T therapies in diffuse large B-cell lymphoma patients."

Highlights from the First Quarter of 2021 Include:

Clinical – Lenzilumab in COVID-19

The Phase 3 results from the LIVE-AIR study were announced, demonstrating that lenzilumab improves survival without the need for mechanical ventilation in hospitalized, hypoxic patients with COVID-19.
Results from the LIVE-AIR Phase 3 study were published in MedRxiv, (View Source) showing additional analysis from the trial, including patients treated with remdesivir and/or steroids, and a second analysis which showed patients under 85 years of age with C-reactive protein ("CRP"), a widely-utilized inflammatory marker, less than 150 mg/L, derived the greatest benefit of treatment with lenzilumab.
With the report of positive top-line results from the LIVE-AIR study in March 2021, the company met the first of two specified milestones under the South Korea license agreement with KPM Tech Co., Ltd. and its affiliate, Telcon RF Pharmaceutical, Inc., and received $6.0 million (or $4.5 million net of withholding taxes and other fees and royalties) in the second quarter of 2021.
In preparation for potential launch under emergency use authorization ("EUA") and conditional marketing authorization ("CMA"), Humanigen entered into several supply agreements with contract manufacturing organizations ("CMOs") to supply bulk drug, fill/finish, and commercial packaging.
Clinical – CAR-T and Oncology

The positive data from the Phase 1 study of ifabotuzumab in glioblastoma multiforme was presented at the AACR (Free AACR Whitepaper) Annual Meeting 2021.
The CAR-T Phase 1b study results in diffuse large B-cell lymphoma("DLBCL") with lenzilumab were announced, showing 100% Objective Response Rate ("ORR") and no severe cytokine release syndrome or severe neurotoxicity at the recommended dose.
With the positive Phase 1b results, the company terminated its clinical collaboration agreement with Kite, a Gilead Company, and announced plans to initiate a Phase 2 study with all commercially available CD19 CAR-T therapies for DLBCL patients.
Corporate

Dr. Adrian Kilcoyne was appointed to the newly created role of Chief Medical Officer.
Entered into a loan facility with Hercules Capital which will provide the company up to $80 million of secured debt financing.
The company launched a public offering of common stock which closed after quarter-end, resulting in net proceeds to Humanigen of $94.1 million.
Two patents were issued for the use of lenzilumab, expanding the company’s anti-GM-CSF patent portfolio.
Lenzilumab Regulatory Update

The company recently held a meeting with FDA to discuss the filing of an EUA for lenzilumab for hospitalized, hypoxic COVID-19 patients, where topline data from the LIVE-AIR study were reviewed, along with the timeline for submission of additional clinical and manufacturing data for lenzilumab. The company plans to submit an EUA application at the end of May 2021. The company has also been in discussion with the Medicines and Healthcare Products Regulatory Agency ("MHRA") for the use of lenzilumab in COVID-19 patients in the United Kingdom and plans to initiate a rolling CMA submission before the end of the second quarter of 2021. The company also plans to submit for CMA to the European Medicines Agency ("EMA") for the use of lenzilumab in the European Union. Further, the company is reviewing the possibility of similar submissions for approval or compassionate use in other territories or countries worldwide.

The company intends to submit a Biologics License Application ("BLA") to FDA in 2022, for the use of lenzilumab in hospitalized, hypoxic COVID-19 patients. Since BLAs typically require more than one study, the company is currently evaluating the extent to which ACTIV-5/BET-B may serve as a basis for a BLA-confirmatory study for lenzilumab.

First Quarter Ended March 31, 2021 Financial Results

Net loss for the three months ended March 31, 2021 was $65.6 million or $1.25 per share as compared to $2.5 million or $0.11 per share for the three months ended March 31, 2020. The increase in net loss for the first quarter 2021 as compared to the first quarter 2020 was largely due to an increase in total expenses, mainly Research and Development expense ("R&D") of $59.2 million from $0.7 million for the three months ended March 31, 2020 to $59.9 million for the three months ended March 31, 2021. The increase in R&D is primarily due to an increase of $51.4 million of expense in lenzilumab manufacturing costs and $7.5 million for clinical trial expenses related to the LIVE-AIR study, both of which began after the first quarter of 2020. The costs incurred for the production of lenzilumab will continue to be included in R&D until lenzilumab is authorized or approved for commercial use, at which point the amounts expended for production will be classified as inventory.

Cash and Cash Equivalents

Net cash used in operating activities, net of balance sheet changes, was $35.8 million for the three months ended March 31, 2021. During the three months ended March 31, 2021, the company raised net proceeds of $36.1 million from the sale of shares of common stock under its At-the-Market offering program. The company drew the first tranche of $25.0 million under its credit facility with Hercules Capital, providing net proceeds of $24.4 million. As of March 31, 2021, the company had cash and cash equivalents of $92.9 million. The company also completed a public offering in the second quarter of 2021 with net proceeds of $94.1 million. The proforma balance of cash and cash equivalents at March 31, 2021 with the proceeds from the public offering is $187.0 million. The company expects to continue to use its funds on development and manufacturing of lenzilumab in anticipation of its potential commercialization under EUA or other conditional marketing authorizations. In the second quarter of 2021 the company anticipates the amount of spending on lenzilumab production will be at least the same level as the first quarter of 2021. If an EUA or CMA for lenzilumab is not received by mid-2021, the company will seek to decrease or eliminate spending on the production of lenzilumab for commercial use.

On May 13, 2021 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported corporate updates and financial results for the first quarter ended March 31, 2021 (Press release, CymaBay Therapeutics, MAY 13, 2021, View Source [SID1234579921]).

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In May 2021, CymaBay strengthened its management team with the additions of Dr. Dennis Kim as Chief Medical Officer and Lewis Stuart as Chief Commercial Officer. CymaBay also continued to make significant progress conducting the development program for seladelpar in primary biliary cholangitis (PBC). With clinical sites activated in North America and Europe, patient recruitment is underway in RESPONSE, a global Phase 3 registrational study evaluating seladelpar in patients with PBC. In addition, CymaBay continued to conduct enrollment activities for ASSURE, an open-label, long-term study of seladelpar in patients with PBC intended to collect additional safety data to support registration.

Sujal Shah, President and CEO of CymaBay, stated, "I’m excited to announce the addition of two key executives to our management team, Dr. Dennis Kim as Chief Medical Officer and Lewis Stuart as Chief Commercial Officer. Dennis and Lewis are both experienced biopharma industry executives who will further complement our team and provide leadership in our growing clinical and commercial organizations. We also continued to make progress with RESPONSE, our registrational study designed to evaluate the efficacy and safety of seladelpar in patients with PBC. In addition to our core focus in PBC, we are excited about other early-stage pipeline candidates, with more updates to share in the coming months."

Recent Corporate Highlights

Hired Dr. Dennis Kim as Chief Medical Officer. Dr. Kim is a physician-scientist trained in endocrinology who brings significant clinical development and executive experience in emerging biotech environments from companies such as Amylin, Orexigen and Zafgen. Dr. Kim is well suited to articulate the science, medicine, and opportunities of our programs to broad audiences including medical experts, investigators, patient groups, investors, and analysts. Dr. Kim will lead all clinical-related functions including development, clinical operations, biometrics, and medical affairs.

Hired Lewis Stuart as Chief Commercial Officer, an executive who brings a diverse set of experiences launching products in both the pharmaceutical and molecular diagnostics healthcare sectors. Mr. Stuart brings more than 25 years of experience leading the marketing, sales, market access, and other commercial functions at successful biotech companies and has launched new therapies in women’s health, oncology, metabolic, and rare diseases. Mr. Stuart will lead all aspects of CymaBay’s commercial operations, including marketing and sales.
Appointed Thomas Wiggans to the Board. Mr. Wiggans is a biopharma industry veteran, who brings extensive experience and insight having previously served as CEO and leading companies such as Dermira, Peplin, and Connectics from development through commercialization.
Appointed Janet Dorling to the Board. Ms. Dorling is a senior commercial executive at Gilead, who previously served as Chief Commercial Officer at CymaBay and Achaogen and held prior executive and senior leadership positions in the commercial organization at Roche/Genentech.
Conducted enrollment activities for RESPONSE, a 52-week, placebo-controlled, randomized, global, Phase 3 registrational study evaluating the safety and efficacy of seladelpar in patients with PBC. This study is targeting enrollment of 180 patients who have an inadequate response to, or intolerance to, ursodeoxycholic acid, in a 2:1 randomization to oral, once daily seladelpar 10 mg or placebo. The primary outcome measure is the responder rate at 52 weeks. A responder is defined as a patient who achieves an alkaline phosphatase level < 1.67 times the upper limit of normal with at least a 15% decrease from baseline and has a normal level of total bilirubin. Additional key outcomes of efficacy will compare the rate of normalization of alkaline phosphatase at 52 weeks and the level of pruritus at 6-months for patients with moderate to severe pruritus at baseline assessed by a numerical rating scale recorded with an electronic diary.
Conducted enrollment activities for ASSURE, an open-label, long-term study of seladelpar in patients with PBC intended to collect additional long-term safety data to support registration.
Initiated enrollment in a Phase 2a proof-of-pharmacology study to evaluate the potential for MBX-2982, a GPR119 agonist, to prevent hypoglycemia in patients with type 1 diabetes (T1D). The study is being conducted by the AdventHealth Translational Research Institute (TRI) in Orlando, Florida and fully funded by The Leona M. and Harry B. Helmsley Charitable Trust with CymaBay retaining full rights to MBX-2982.
Continued executing a single and multiple ascending dose pharmacokinetic study of CB-0406 in healthy subjects to establish its pharmacokinetics, safety, and maximum tolerated dose. CB-0406 is a non-agonist ligand of PPARg that attenuates the expression of inflammatory genes.

Held $125.5 million in cash, cash equivalents and short-term investments as of March 31, 2021. We believe that cash and investments are sufficient to fund CymaBay’s current operating plan into mid-2022.

Due to the ongoing effects of the global coronavirus pandemic, CymaBay continues to conduct its operations remotely for all employees, which has allowed business activities to continue as seamlessly as possible. CymaBay continues to closely monitor pandemic developments and their associated risks to the business, including the conduct of its clinical development of seladelpar, and will continue to take actions to mitigate them where possible. Further, all CymaBay’s actions will continue to be guided by a commitment to ensuring the health and safety of its employees as well as patients enrolled in its clinical studies.
First Quarter Ended March 31, 2021 Financial Results

Research and development expenses for the three months ended March 31, 2021 and 2020 were $12.4 million and $9.5 million, respectively. Research and development expenses in the three months ended March 31, 2021 were higher than the corresponding periods in 2020 primarily due to an increase in clinical trial activities following our resumption of clinical development of seladelpar in PBC in late 2020. In particular, cost increases were primarily driven by the enrollment activities associated with RESPONSE and ASSURE, our two new global late-stage clinical trials in PBC. In the three months ended March 31, 2020, costs incurred were primarily associated with the termination and shutdown of our Phase 3 PBC, Phase 2b NASH, and Phase 2 PSC clinical trials, and other studies, after the seladelpar development program was placed on hold from November 2019 through July 2020.

General and administrative expenses for the three months ended March 31, 2021 and 2020 were $5.2 million and $4.4 million, respectively. General and administrative expenses in the three months ended March 31, 2021 were higher than the corresponding period in 2020 due to higher employee compensation associated with the hiring of additional personnel upon resumption of development of seladelpar in the second half of 2020.

Net loss for the three months ended March 31, 2021 and 2020 was $17.6 million and $13.1 million, or ($0.25) and ($0.19) per diluted share, respectively. Net loss was higher largely due to increases in clinical operating expenses which were incurred following the resumption of our clinical development of seladelpar in PBC during the second half of 2020. We expect our operating expenses to increase in 2021 as we continue to execute on our clinical development plans.
Conference Call Details

CymaBay will host a conference call today at 4:30 p.m. ET to discuss first quarter 2021 financial results and provide a business update. To access the live conference call, please dial 877-407-0784 from the U.S. and Canada, or 201-689-8560 internationally, Conference ID# 13718350. To access the live and subsequently archived webcast of the conference call, go to the Investors section of the company’s website at View Source

On May 13, 2021 Bolt Biotherapeutics, Inc. (NASDAQ: BOLT) a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, reported financial results for the first quarter ended March 31, 2021 and provided an update on recent business highlights (Press release, Bolt Biotherapeutics, MAY 13, 2021, View Source [SID1234579920]).

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"Our successful IPO in the first quarter of 2021 places us in a position of strength to deliver on value-creating milestones in 2021 and 2022. We continue to advance our Phase 1/2 trial for our lead candidate, BDC-1001, for the treatment of patients with HER2-expressing solid tumors. We look forward to completing the monotherapy dose escalation and initiating the monotherapy Phase 2 dose expansion cohorts as well as the evaluation of combining BDC-1001 with an anti-PD-1 antibody later in 2021," said Randall C. Schatzman, Ph.D., Chief Executive Officer of Bolt. "Beyond BDC-1001, we continue to advance our pipeline and are on track to initiate clinical trials for CEA-targeted ISAC BDC-2034 in 2022 and we expect to designate our third clinical candidate later this year."

Recent Business Highlights and Anticipated Milestones

Cash, cash equivalents, and marketable securities were $302.9 million as of March 31, 2021, which is expected to fund operations into 2023 – Bolt is well positioned to continue to drive growth across the company and advance the pipeline through key milestones, with cash to fund operations into 2023.

Completed upsized Initial Public Offering in February 2021 – In February 2021, Bolt completed its Initial Public Offering (IPO) of 13,225,000 shares of common stock, inclusive of the full exercise by the underwriters of their option to purchase 1,725,000 shares, at a public offering price of $20.00 per share. Gross proceeds from the IPO were approximately $264.5 million and net proceeds from the offering, after deducting underwriting discounts, commissions and offering expenses, were approximately $242.0 million.

Presented on the HER2-targeting Boltbody ISAC BDC-1001 in the "New Drugs on the Horizon" symposium and in a trial-in-progress poster in April at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting

At AACR (Free AACR Whitepaper)’s New Drugs on the Horizon symposium, Bolt’s Chief Scientific Officer David Dornan, Ph.D. presented key data-driven decisions made during the development of Bolt’s lead program, BDC-1001, a novel HER2-targeting ISAC. Dr. Dornan’s presentation included a discussion of immunosuppression mediated by various cells in the tumor microenvironment (TME), as well as the tumor-supportive nature of antigen presenting cells (APCs) in the TME in preclinical models. Reawakening these immunosuppressed APCs can result in a productive and durable anti-tumor immune response, as evidenced by BDC-1001 achieving complete tumor regression in preclinical tumor models.
A Trial in Progress poster was also presented at AACR (Free AACR Whitepaper) by Manish R. Sharma, M.D. of START Midwest, a principal investigator in Bolt’s ongoing BDC-1001 Phase 1/2 trial. The poster detailed the design of the four-part study evaluating BDC-1001 administered intravenously with or without an immune checkpoint inhibitor targeting PD-1 in up to 390 patients with HER2-expressing or HER2-amplified advanced or metastatic solid tumors. The dose escalation parts will evaluate sequential doses of BDC-1001 as a monotherapy or in combination with a PD-1 checkpoint inhibitor in a 3+3 design, with the ability to backfill up to a total of 15 patients in each dose cohort. The dose expansion parts will evaluate the recommended Phase 2 dose as monotherapy or in combination with a PD-1 checkpoint inhibitor in four cohorts of patients. Bolt expects to provide a further update on the trial sometime in the second half of 2021.
Upcoming Events

At the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, Manish R. Sharma, M.D. of START Midwest, a principal investigator in Bolt’s ongoing BDC-1001 Phase 1/2 trial will present a poster entitled "Preliminary results from a Phase 1/2 study of BDC-1001, a novel HER2 targeting TLR7/8 immune-stimulating antibody conjugate (ISAC), in patients (pts) with advanced HER2-expressing solid tumors." This poster will provide more details on the initial 20 patients treated with BDC-1001, as of the initial data cutoff date of January 29, 2021.
First Quarter 2021 Financial Results

Cash Position – Cash, cash equivalents, and marketable securities were $302.9 million as of March 31, 2021, compared to $22.8 million as of December 31, 2020. Bolt expects its cash balance to fund operations into 2023.

Research and Development (R&D) Expenses – R&D expenses were $14.1 million for the quarter ended March 31, 2021, compared to $6.8 million for the same quarter in 2020. The increase in R&D spending in the comparative periods was due primarily to increased manufacturing of BDC-1001 and BDC-2034 (CEA-targeting Boltbody ISAC program), increased personnel-related expenses due to additional hiring and increased facility-related expenses and outside services.

General and Administrative (G&A) Expenses – G&A expenses were $4.3 million for the quarter ended March 31, 2021, compared to $2.1 million for the same quarter in 2020. The increase in G&A spending in the comparative periods was due primarily to increased personnel-related expenses due to additional hiring and increased accounting and legal fees associated with the Company’s Initial Public Offering which was completed in February 2021.

Loss from Operations – Loss from operations was $24.5 million for the quarter ended March 31, 2021 compared to $8.6 million for the same quarter in 2020.

On May 13, 2021 Inhibrx, Inc. (Nasdaq: INBX), a biotechnology company with four clinical programs in development, reported financial results for the first quarter of 2021 (Press release, Inhibrx, MAY 13, 2021, View Source [SID1234579919]).

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"This past quarter, we continued to make significant progress advancing our clinical programs and are on track to deliver data from all four programs later this year," said the Company’s Chief Executive Officer, Mark Lappe. "April 2021 marked 11 years of Inhibrx dedicated to developing novel, best-in-class therapeutics for the treatment of cancer and rare diseases, and we remain strongly encouraged that we will deliver on our mission."

Financial Results

Cash and Cash Equivalents. As of March 31, 2021, Inhibrx had cash and cash equivalents of $108.0 million, compared to $128.7 million as of December 31, 2020.
R&D Expense. Research and development expenses were $16.4 million during the first quarter of 2021, compared to $17.0 million during the first quarter of 2020. This overall decrease was primarily due to the timing of work performed by Inhibrx’s contract development and manufacturing organization partners for the formulation and manufacturing of certain of its therapeutic candidates, offset in part by an increase in headcount and personnel-related costs due to the continued expansion of its organization.
G&A Expense. General and administrative expenses were $3.0 million during the first quarter of 2021, compared to $1.5 million during the first quarter of 2020. This increase was primarily due to an increase in personnel-related costs and other expenses associated with operating as a public company.
Net Loss. Net loss was $19.3 million during the first quarter of 2021, or $0.51 per share, compared to $20.1 million during the first quarter of 2020, or $1.11 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.

On May 13, 2021 Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported financial results for the first quarter ended March 31, 2021 (Press release, Alpine Immune Sciences, MAY 13, 2021, View Source [SID1234579918]).

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"The first quarter of this year has been highly productive as we continue to make strong progress across our pipeline. We look forward to sharing the first clinical data update on NEON-1, a Phase 1 dose escalation and expansion study of ALPN-202 monotherapy, at the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting," said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine. "In addition, we continue our focus on the imminent global Phase 2 study of ALPN-101 in systemic lupus erythematosus, targeted to initiate around the middle of the year."

First Quarter 2021 and Recent Updates

ALPN-202: Conditional CD28 costimulator and dual checkpoint inhibitor
In April 2021, at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting I, Dr. Mark Voskoboynik from Nucleus Network and The Alfred Hospital in Melbourne, Australia, presented a Trials in Progress poster describing the ongoing first-in-human, Phase 1 clinical trial involving monotherapy with ALPN-202, the company’s lead oncology program.
In April 2021, Alpine announced an upcoming clinical data presentation on NEON-1 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting scheduled to take place June 4, 2021.
Research
In April 2021, at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting I, Alpine researchers demonstrated the use of directed evolution to engineer novel variant immunoglobulin domain (vIgD) Fc fusion proteins that enable tumor antigen-dependent CD28 costimulation.
General Corporate
Promotion of Remy Durand, Ph.D. to Chief Business Officer: Dr. Durand joined Alpine Immune Sciences in 2018 as Vice President, Business Development and Corporate Strategy, and has played a leading role in building the company’s partnerships with AbbVie and Adaptimmune, and has represented the company at investor meetings and conferences.
Appointed Pamela Holland, Ph.D. as Senior Vice President, Research: Dr. Holland is an experienced cancer biologist with a proven track record of successfully discovering and progressing multiple preclinical therapeutics into clinical development, most recently at Surface Oncology and Amgen.
First Quarter 2021 Financial Results

As of March 31, 2021, we had cash, cash equivalents, restricted cash, and investments totaling $115.4 million. Net cash used in operating activities for the quarter ended March 31, 2021 was $16.0 million compared to net cash used in operating activities of $9.7 million for the quarter ended March 31, 2020. We recorded net losses of $10.6 million and $5.5 million for the quarters ended March 31, 2021 and 2020, respectively.

Collaboration revenue for the quarter ended March 31, 2021 was $3.2 million and related to our agreement with AbbVie, compared to $1.1 million related to our agreement with Adaptimmune for the quarter ended March 31, 2020.

Research and development expenses for the quarter ended March 31, 2021 were $10.4 million compared to $4.9 million for the quarter ended March 31, 2020. The increase was primarily attributable to increases in contract manufacturing and process development of our product candidates, clinical trial activities, and personnel-related expenses.

General and administrative expenses for the quarter ended March 31, 2021 were $3.3 million compared to $1.8 million for the quarter ended March 31, 2020. The increase was primarily attributable to increases in professional and legal services, personnel-related expenses, and insurance and facility costs to support the growth and expansion of our business.

Alpine expects that its current cash resources, combined with the potential $75 million in pre-option exercise milestones payable under its option and license agreement with AbbVie, for the development and commercialization of ALPN-101, are sufficient to fund Alpine’s planned operations through 2023.