On May 12, 2022 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that the Chinese Society of Clinical Oncology (CSCO), the most prominent medical society for oncology in China, has added multiple XPOVIO (selinexor) regimens for the treatment of relapsed/refractory multiple myeloma (R/R MM) and relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) to its 2022 Guidelines for the Diagnosis and Treatment of Hematologic Malignancies and 2022 Guidelines for the Diagnosis and Treatment of Lymphomas (CSCO Guidelines) (Press release, Antengene, MAY 12, 2022, View Source [SID1234614430]).

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The 2022 CSCO Guidelines incorporate a total of four selinexor combination therapy regimens for relapsed myeloma. In addition, the guidelines also recommend the use of selinexor for the treatment of patients with ≥ twice relapsed/progressed DLBCL. As the gold standard guiding Chinese oncologists in their clinical practice, the CSCO Guidelines are one of the most recognized and widely adopted set of practice guidelines in China.

Multiple Myeloma

Guideline for the treatment of relapsed myeloma

Evidence

Recommendation

selinexor plus bortezomib plus dexamethasone*

Class 1

Level I

selinexor plus pomalidomide plus dexamethasone

Class 2

Level II

selinexor plus daratumumab plus dexamethasone*

Class 2

Level II

selinexor plus carfilzomib plus dexamethasone*

Class 2

Level II

*newly included regimen

Incorporation of selinexor into the CSCO guidelines for R/R MM referenced data from the STORM and STOMP trials.

Prof. Wenming Chen, at Beijing Chao-Yang Hospital of Capital Medical University, said, "The continued development of novel therapies is key to improving treatment outcomes for patients with MM. Selinexor, the world’s first oral selective XPO1 inhibitor, was granted an approval in China last year, and multiple selinexor regimens have been incorporated into practice guidelines by a number of leading medical societies/organizations. The recent recommendations of selinexor by the updated CSCO Guidelines for the Diagnosis and Treatment of Hematologic Malignancies indicates strong recognition of selinexor’s safety and efficacy and is another validation of the robust clinical data supporting the wide clinical adoption of selinexor as a much-needed new treatment option. I hope more patients will soon benefit from this novel therapeutic."

Lymphoma

Guideline for the treatment of ≥ twice relapsed/progressed diffuse large B-cell lymphoma

Evidence

Recommendation

Selinexor monotherapy for third-line and subsequent therapy

Class 2A

Level II

Incorporation of selinexor into the CSCO guidelines for R/R DLBCL referenced data from the SADAL trial, the U.S. Food and Drug Administration’s (FDA) approval and the National Cancer Care Network’s (NCCN) guideline recommendations for selinexor in patients with R/R DLBCL.

Prof. Weili Zhao, at Ruijin Hospital of Shanghai Jiaotong University School of Medicine, commented, "Primary and secondary drug resistance and intolerance to standard of care therapies in a large portion of DLBCL patients pose a major clinical challenge, limiting the treatment outcomes and survival benefit for patients and resulting in the urgent need for a novel therapy with a new mechanism of action. Selinexor, a small molecule targeted therapy utilizing an innovative mechanism, is approved in the U.S. for the treatment of MM and DLBCL and has received regulatory approvals in various indications in a growing number of countries around the world. This inclusion of selinexor in the CSCO 2022 Guidelines for the Diagnosis and Treatment of Lymphomas presents a new treatment strategy for patients with ≥ twice relapsed/progressed DLBCL, and an important tool for clinicians seeking to change the current standard practices in DLBCL."

About XPOVIO (selinexor)

Selinexor is the first and only oral XPO1 inhibitor approved by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory multiple myeloma (R/R MM) and relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL). By blocking the nuclear export protein XPO1, selinexor can promote the intranuclear accumulation and activation of tumor suppressor proteins and growth regulating proteins, and down-regulate the levels of multiple oncogenic proteins. Due to its novel mechanism of action, selinexor is being evaluated for use in multiple combination regimens to improve treatment efficacy.

Antengene secured approval of selinexor in China in December 2021 for R/R MM and plans to launch the product in the second quarter of 2022. Antengene has also secured approval for selinexor in South Korea for use in R/R MM and R/R DLBCL in July 2021, in Singapore for use in R/R MM and R/R DLBCL and in Australia for use in R/R MM in March 2022. Antengene is conducting 10 clinical studies in mainland China (3 are being jointly conducted by Antengene and Karyopharm Therapeutics Inc. [Nasdaq:KPTI]) for relapsed/refractory hematological malignancies and advanced solid tumors.

On May 12, 2022 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing first-in-class allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapies for cancer, reported financial results and operational highlights for the first quarter ended March 31, 2022 (Press release, Adicet Bio, MAY 12, 2022, View Source [SID1234614428]).

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"We made steady progress with the clinical development of our lead asset ADI-001 during the first quarter of 2022 and look forward to reporting updated clinical data from our Phase 1 study of ADI-001 in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June," said Chen Schor, President and Chief Executive Officer at Adicet Bio. "We are also pleased with the progress of several additional pre-clinical pipeline programs and expect to share more information about our growing pipeline in the near future."

First Quarter 2022 and Recent Operational Highlights:

Presented ADI-001 Preclinical Data at ISCT. In May, Adicet announced data from a preclinical evaluation of ADI-001 at the International Society for Cell and Gene Therapy (ISCT) Annual Meeting highlighting potential advantages of the non-gene-edited approach for its investigational allogeneic gamma delta CAR T cell therapy targeting CD20 for B cell malignancies.
Granted Fast Track Designation. In April, Adicet announced that the U.S. Food and Drug Administration granted Fast Track Designation to ADI-001 for the potential treatment of relapsed or refractory B-cell Non-Hodgkin’s lymphoma (NHL).
Additional ADI-001 Phase 1 study data to be presented at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting. In April, Adicet announced that Sattva S. Neelapu, M.D., from The University of Texas MD Anderson Cancer Center will deliver an oral presentation titled, "A phase 1 study of ADI-001: Anti-CD20 CAR-engineered allogeneic gamma delta (γδ) t cells in adults with B-cell malignancies" at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) during a Clinical Science Symposium entitled "Beating Bad Blood: The Power of Immunotherapy in Hematologic Malignancies" from 8:00am to 9:30am CDT on June 6, 2022.
Publication of ADI-001 preclinical data in Clinical and Translational Immunology. In February, Clinical and Translational Immunology published data highlighting the key properties of ADI-001, the Company’s investigational therapy targeting CD20 for the potential treatment of B-cell NHL. These preclinical findings highlight the anti-tumor mechanism of ADI-001’s profile by maintaining the TCR gamma repertoire, preserving the adaptive targeting potential enabling tumor recognition and killing, as well as maintaining innate targeting activity. In vitro analysis showed faster kinetics compared to alpha beta T cells expressing the same CD20 CAR, whereas in vivo analysis demonstrated potent inhibition of tumor growth with activated innate and adaptive pathways contributing to the efficacy profile.
Regeneron licensed the exclusive, worldwide rights to ADI-002. In January, Regeneron Pharmaceuticals, Inc. (Regeneron) exercised its option to license the exclusive, worldwide rights to ADI-002, an allogeneic gamma delta CAR T cell therapy directed against Glypican-3. In conjunction with the exercise of the option, Regeneron paid an exercise fee of $20.0 million to Adicet and the Company completed the transfer of the associated license rights to Regeneron by March 31, 2022.
Financial Results for First Quarter 2022:

Research and Development (R&D) Expenses: R&D expenses were $13.5 million for the three months ended March 31, 2022, compared to $11.8 million during the same period in 2021. The $1.7 million increase is primarily driven by a $0.6 million increase in payroll and personnel expenses resulting from an increase in overall headcount, a $0.4 million increase in lab supplies and consumables expenses and $0.4 million increase in contract manufacturing organization and other externally sponsored R&D expense. In addition, there was a $0.4 million increase in facility and other expenses. This was partially offset by a $0.2 million decrease in contract research organization expense related to initial setup fees for the Company’s Phase 1 trial. Payroll and personnel expenses for the three months ended March 31, 2022 includes $1.7 million of non-cash stock-based compensation expense, compared to $1.6 million during the same period in 2021.
General and Administrative (G&A) Expenses: G&A expenses were $6.8 million for the three months ended March 31, 2022, compared to $5.6 million during the same period in 2021. The $1.2 million increase is primarily driven by a $1.5 million increase in payroll and personnel fees, which was partially offset by a $0.3 million decrease in professional service fees. Payroll and personnel expenses for the three months ended March 31, 2022 includes $2.6 million of non-cash stock-based compensation expense, compared to $1.5 million during the same period in 2021.
Net Income/Loss: Net income attributable to common shareholders for the three months ended March 31, 2022 was $4.6 million, or a net income per basic share of $0.12 and per diluted share of $0.10, which includes non-cash stock-based compensation expense of $4.4 million. Net loss attributable to common shareholders was $21.3 million during the same period in 2021, or a net loss of $0.82 per basic and diluted share, including non-cash stock-based compensation expense of $3.0 million.
Cash Position: Cash and cash equivalents were $277.9 million as of March 31, 2022, compared to $277.5 as of December 31, 2021. The Company expects that current cash and cash equivalents as of March 31, 2022 will be sufficient to fund its operating expenses into the second half of 2024.

On May 12, 2022 Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, reported financial results for the first quarter ended March 31, 2022, and provided clinical development and operational highlights (Press release, Aura Biosciences, MAY 12, 2022, View Source [SID1234614427]).

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"We continue to advance the AU-011 overall development program and look forward to several upcoming clinical milestones, in the second half of this year," said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura. "We remain on track with our Phase 2 suprachoroidal study in early stage choroidal melanoma and plan to finalize a decision on the route of administration and initiate our pivotal program before the end of the year. Beyond primary choroidal melanoma, we continue to build our ocular oncology franchise and we are on track to file an Investigational New Drug application for choroidal metastases, with pre-clinical data presented at ARVO last week. Lastly, we will be initiating our Phase 1 trial in non-muscle invasive bladder cancer, with multiple clinical sites in the US. While we remain focused on preparing for our pivotal trial in choroidal melanoma, we are also excited by the prospect of leveraging our VDC therapies across multiple oncology indications and providing new treatment options for patients with life threatening cancers."

Recent Pipeline Developments

AU-011 is being developed for the treatment of early-stage choroidal melanoma (CM), a life-threatening rare disease with no approved drugs. Orphan Drug Designation was recently granted to AU-011 by the European Commission for the treatment of uveal melanoma (includes CM). AU-011 was previously granted Orphan Drug and Fast Track Designations for this indication by the U.S. Food and Drug Administration (FDA). Aura plans to select the route of administration and treatment regimen to initiate the pivotal program in CM in the second half of 2022.

Beyond primary CM, we continue to build our ocular oncology franchise with choroidal metastases being the second potential ocular indication.

Abstract highlighting AU-011’s efficacy as a single agent and as a combination therapy with checkpoint inhibitors has been selected for publication at the upcoming 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The abstract, titled "A novel virus-like drug conjugate (VDC) in combination with immune checkpoint inhibitors for the treatment of primary tumors and distant metastasis" will be published as part of the Session titled "Developmental Therapeutics – Immunotherapy" and will be available on the ASCO (Free ASCO Whitepaper) website on Thursday, May 26, 2022, at 5:00 pm. ET.

Preclinical data highlighting AU-011 anti-tumor activity was presented at the 2022 Association of Research in Vision and Ophthalmology (ARVO) Annual Meeting. Preclinical results highlighted AU-011’s targeted cytotoxicity in tumor cells derived from the most common cancer types known to metastasize to the choroid in the eye. AU-011 showed dose dependent activity in vivo using cognate tumor models. These results support further evaluation of AU-011 as a potential treatment for choroidal metastases, the most common type of intraocular malignancy in adults. Aura plans to file an Investigational New Drug (IND) application with the FDA in the second half of 2022 for choroidal metastases.

Leveraging the broad tumor targeting capabilities of the VDC platform, Aura is planning to pursue clinical development of AU-011 in non-muscle invasive bladder cancer (NMIBC).

The AU-011 mechanism of action supports the opportunity for use as a first-line treatment of NMIBC, an area of high unmet need with no approved targeted therapies. The planned Phase 1 trial will evaluate the safety and early proof of mechanism, exploring distribution, local necrosis and evidence of immune activation. Aura expects to initiate the trial in the second half of 2022 with initial Phase 1 data in 2023.

Aura is investigating additional potential indications for AU-011.

Preclinical data highlighting the ability to target a broad number of tumor types was presented as part of the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The data that was presented at the AACR (Free AACR Whitepaper) annual meeting support AU-011’s potential to target associated heparan-sulfate proteoglycans that are overexpressed on the tumor cell surface. Activity was observed in every tumor type tested, indicating that there are numerous solid tumors that AU-011 can target and potentially treat, particularly those derived from neural or epithelial lineages. The AACR (Free AACR Whitepaper) annual meeting was held April 8-13, 2022 in New Orleans, LA.
First Quarter 2022 Financial Results

As of March 31, 2022, Aura had cash and cash equivalents and marketable securities totaling $133.3 million. Aura believes its current cash and cash equivalents and marketable securities are sufficient to fund its operations into 2024.
Research and development expenses increased to $8.3 million for the three months ended March 31, 2022 from $4.2 million for the three months ended March 31, 2021, primarily due to ongoing manufacturing and development costs for AU-011 and higher personnel expenses from growing headcount.
General and administrative expenses increased to $4.5 million for the three months ended March 31, 2022 from $1.7 million for the three months ended March 31, 2021. General and administrative expenses include $1.0 million and $0.1 million of stock-based compensation for the three months ended March 31, 2022 and 2021, respectively. The increase was primarily driven by personnel expenses, as well as increases in general corporate expenses related to operating as a public company.
Net loss for the three months ended March 31, 2022 was $12.8 million compared to $5.9 million for the three months ended March 31, 2021.

On May 12, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported that an updated clinical guideline from the American Urological Association (AUA) and the American Society for Radiation Oncology (ASTRO) includes a new statement that is favorable for genomic testing, including the Decipher Prostate genomic classifier, to help guide care for men with localized prostate cancer (Press release, Veracyte, MAY 12, 2022, View Source [SID1234614426]). The guideline authors specifically cite extensive evidence, including from multiple phase 3 randomized clinical trials, which have previously demonstrated that the Decipher Prostate genomic risk score is strongly associated with important prostate cancer-specific and oncologic outcomes.

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The updated guideline, which appears on the AUA website and online in The Journal of Urology, states that clinicians may selectively use tissue-based genomic biomarkers when added risk-stratification may alter clinical decision-making. The guideline specifically says, "Of note, accumulating evidence has indicated that GC [genomic classifier] scores, specifically Decipher, derived from biopsy specimens do correlate with cancer outcomes."

"We are extremely pleased that this updated guideline recognizes the important role that genomic testing can play in determining treatment approaches for men with localized prostate cancer," said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology. "Notably, the guideline authors point to extensive data from multicenter, prospectively collected, phase 3 randomized trials that demonstrate association of Decipher Prostate test results with risk of distant metastasis and prostate-cancer-specific mortality. These include studies of patients on active surveillance to men with high-risk prostate cancer. We believe our test can give physicians and patients the clarity and confidence they need to select appropriate treatment approaches."

Veracyte will be sharing information about the Decipher Prostate genomic test at Booth #1563 of the 2022 AUA Annual Meeting, which is taking place May 13-16 in New Orleans.

About Decipher Prostate

The Decipher Prostate genomic classifier is a 22-gene, whole-transcriptome-developed genomic test designed to help inform treatment decisions for men with localized prostate cancer at initial diagnosis and after surgical removal of the prostate. The test reports the Decipher Score, which prognosticates a patient’s risk of metastasis within five years and provides risk estimates of prostate cancer-specific outcomes. Decipher Prostate can help guide physicians to better select the appropriate therapy for a specific patient, which in turn can result in improved patient outcomes.

On May 12, 2022 PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the "Company" or "PAVmed"), a diversified commercial-stage medical technology company, operating in the medical device, diagnostics, and digital health sectors, reported a business update for the Company and its subsidiaries, Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid") and Veris Health Inc. ("Veris"), and presented preliminary financial results for the three months ended March 31, 2022 (Press release, PAVmed, MAY 12, 2022, View Source [SID1234614425]).

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Conference Call and Webcast

A conference call and webcast for today’s business update and first quarter 2022 financial results will take place at 4:30 PM EDT. To access the conference call, listeners should dial 800-458-4121 toll-free in the U.S., and international listeners should dial 856-344-9290, and ask to join the "PAVmed Inc. Business Update Conference Call". The conference call will be available live via a webcast and for replay at the investor relations section of the Company’s website at View Source Following the conclusion of the conference call, a replay will be available for one week and can be accessed by dialing 844-512-2921 toll-free in the U.S. or 412-317-6671 from outside the U.S., followed by the PIN number: 7771455.

Business Update Highlights

"I am delighted to report that PAVmed is making excellent progress on all fronts and that we continue to lay a solid foundation for our long-term growth strategy," said Lishan Aklog, M.D., PAVmed’s Chairman and Chief Executive Officer. "Our combined team has grown to over one hundred employees and is singularly focused on growing the PAVmed enterprise while enhancing long-term shareholder value. Our balance sheet remains strong, providing us with the resources to execute this strategy. Given the current market volatility we are particularly focused on deploying our capital as efficiently and effectively as possible to accomplish our strategic goals while preserving and extending our cash runway."

Highlights from the first quarter and recent weeks include:

The American College of Gastroenterology ("ACG") updated its clinical guideline for the diagnosis and management of esophageal precancer, endorsing, for the first time, nonendoscopic biomarker screening to detect precancer and prevent highly lethal esophageal cancer, providing support for esophageal precancer screening utilizing Lucid’s EsoGuard DNA Test on samples collected with its EsoCheck Cell Collection Device, the only such nonendoscopic biomarker screening test available.
Lucid processed 533 commercial EsoGuard tests in the first quarter of 2022, which represents a 76% increase sequentially from the fourth quarter of 2021 and a nearly 500% increase annually from the first quarter of 2021. The Company continued to expand its sales infrastructure consistent with its year-end goals.
Lucid completed the first stage of its Lucid Test Center program and subsequently launched the second stage of the program and plans to open test centers in nine additional states this year. The Company hired an experienced Director of Clinical Services to oversee the expansion.
LucidDx Labs Inc. ("LucidDx Labs"), a wholly owned subsidiary of Lucid, acquired the assets necessary to operate its own CLIA-certified, CAP-accredited clinical laboratory and hired an experienced VP of Laboratory Operations. It also upgraded it revenue cycle management provider which for the first time will begin billing and processing claims directly on behalf of Lucid.
LucidDx Labs entered into Lucid’s first commercial payer agreement—a participating provider agreement with MediNcrease Health Plans, LLC, a national, directly-contracted, multi-specialty PPO provider network with over 8 million lives covered through its clients and payers.
Veris expanded its team to include a Chief Commercial Officer and four data scientists and engineers.
Veris software development is progressing well with three interconnected software platforms to facilitate on schedule to launch with connected devices in late 2022. Veris implantable smart device development progressing along two paths, a monitoring device separate from port and a fully integrated monitoring port.
The first round of CarpX product improvements from limited commercial release have been completed; cadaver training has recommenced; and clinical cases are being scheduled. The next generation device with integrated ultrasound imaging is progressing well.
NextFlo pre-DV testing showed good regulation but currently paused for root cause analysis and exploration of possible redesigns to improve repeatability, before restarting pre-FDA submission testing.
PortIO first-in-human study is progressing with three new sites approved in Colombia, South America and will begin enrolling next month.
EsoCure development progressing well with favorable head-to-head histopathologic performance compared to market leading esophageal ablation device.
Preliminary Financial Results

For the three months ended March 31, 2022, EsoGuard related revenues were $0.2 million. Operating expenses were approximately $19.3 million, which include stock-based compensation expenses of $4.8 million. GAAP net loss attributable to shareholders was approximately $16.9 million, or $(0.20) per common share.
As shown below and for the purpose of illustrating the effect of stock-based compensation and other non-cash income and expenses on the Company’s financial results, the Company’s preliminary non-GAAP adjusted loss for the three months ended March 31, 2022, was approximately $11.7 million or $(0.14) per common share.
PAVmed had cash and cash equivalents of $64.7 million as of March 31, 2022, compared with $77.3 million as of December 31, 2021. Not included in these cash balances is approximately $24.5 million in net proceeds from issuing a senior secured convertible note to an institutional investor in April 2022.
The unaudited financial results for the three months ended March 31, 2022, are expected to be filed with the SEC on Form 10-Q on May 16, 2022 and will then be available at www.pavmed.com or www.sec.gov.

PAVmed Non-GAAP Measures

To supplement our unaudited financial results presented in accordance with U.S. generally accepted accounting principles (GAAP), management provides certain non-GAAP financial measures of the Company’s financial results. These non-GAAP financial measures include net loss before interest, taxes, depreciation, and amortization (EBITDA) and non-GAAP adjusted loss, which further adjusts EBITDA for stock-based compensation expense, loss on the issuance or modification of convertible securities, the periodic change in fair value of convertible securities, and loss on debt extinguishment. The foregoing non-GAAP financial measures of EBITDA and non-GAAP adjusted loss are not recognized terms under U.S. GAAP.

Non-GAAP financial measures are presented with the intent of providing greater transparency to information used by us in our financial performance analysis and operational decision-making. We believe these non-GAAP financial measures provide meaningful information to assist investors, shareholders, and other readers of our unaudited financial statements in making comparisons to our historical financial results and analyzing the underlying performance of our results of operations. These non-GAAP financial measures are not intended to be, and should not be, a substitute for, considered superior to, considered separately from or as an alternative to, the most directly comparable GAAP financial measures.

Non-GAAP financial measures are provided to enhance readers’ overall understanding of our current financial results and to provide further information for comparative purposes. Management believes the non-GAAP financial measures provide useful information to management and investors by isolating certain expenses, gains and losses that may not be indicative of our core operating results and business outlook. Specifically, the non-GAAP financial measures include non-GAAP adjusted loss and its presentation is intended to help the reader understand the effect of the loss on the issuance or modification of convertible securities, the periodic change in fair value of convertible securities, the loss on debt extinguishment and the corresponding accounting for non-cash charges on financial performance. In addition, management believes non-GAAP financial measures enhance the comparability of results against prior periods.

Lucid Diagnostics (Nasdaq: LUCD) Preliminary Financial Results

For the three months ended March 31, 2022, EsoGuard related revenues were $0.2 million. Operating expenses were approximately $11.9 million, which include stock-based compensation expenses of $3.8 million. GAAP net loss attributable to common stockholders was approximately $12.3 million, or $(0.35) per common share.
As shown below and for the purpose of illustrating the effect of stock-based compensation and other non-cash income and expenses on the Company’s financial results, the Company’s preliminary non-GAAP adjusted loss for the three months ended March 31, 2022, was approximately $8.2 million or $(0.23) per common share.
Lucid had cash and cash equivalents of $47.9 million as of March 31, 2022, compared to $53.7 as of December 31, 2021.
On March 28, 2022, the Company entered into a Common Stock Purchase Agreement (the "Purchase Agreement") with CF Principal Investments LLC ("Cantor"), an affiliate of Cantor Fitzgerald, relating to a committed equity facility (the "Facility"). Pursuant to the Purchase Agreement, the Company has the right to sell to Cantor up to $50.0 million of its common shares (the "Shares"), subject to certain conditions and limitations set forth in the Purchase Agreement. While there are distinct differences, the Facility is structured similarly to a traditional at-the-market equity facility, insofar as it allows the Company to raise primary equity capital on a periodic basis at a price related to the current market price.
Sales of the Shares to Cantor under the Purchase Agreement, and the timing of any sales, will be determined by the Company from time to time at its sole discretion and will depend on a variety of factors, including, among other things, market conditions, the trading price of the Shares and determinations by the Company regarding the use of proceeds of such Shares. Upon the satisfaction of the conditions to Cantor’s obligation to purchase Shares, the Company will have the right, from time to time during the 36-month period after the commencement of the Facility, to direct Cantor to purchase up to a maximum number of Shares on any trading day. The purchase price of the Shares will be 96% of the volume-weighted average price of the Shares on such trading day.
The unaudited financial results for the three months ended March 31, 2022, will be filed with the SEC on Form 10-Q in the coming days and will be available at www.luciddx.com or www.sec.gov.
Lucid Non-GAAP Measures

To supplement our unaudited financial results presented in accordance with U.S. generally accepted accounting principles (GAAP), management provides certain non-GAAP financial measures of the Company’s financial results. These non-GAAP financial measures include net loss before interest, taxes, depreciation, and amortization (EBITDA), and non-GAAP adjusted loss, which further adjusts EBITDA for stock-based compensation expense and other non-cash income and expenses, if any. The foregoing non-GAAP financial measures of EBITDA and non-GAAP adjusted loss are not recognized terms under U.S. GAAP.
Non-GAAP financial measures are presented with the intent of providing greater transparency to the information used by us in our financial performance analysis and operational decision-making. We believe these non-GAAP financial measures provide meaningful information to assist investors, shareholders, and other readers of our unaudited financial statements in making comparisons to our historical financial results and analyzing the underlying performance of our results of operations. These non-GAAP financial measures are not intended to be, and should not be, a substitute for, considered superior to, considered separately from or as an alternative to, the most directly comparable GAAP financial measures.
Non-GAAP financial measures are provided to enhance readers’ overall understanding of our current financial results and to provide further information for comparative purposes. Management believes the non-GAAP financial measures provide useful information to management and investors by isolating certain expenses, gains, and losses that may not be indicative of our core operating results and business outlook. Specifically, the non-GAAP financial measures include non-GAAP adjusted loss, and its presentation is intended to help the reader understand the effect of the loss on the issuance or modification of convertible securities, the periodic change in fair value of convertible securities, the loss on debt extinguishment, and the corresponding accounting for non-cash charges on financial performance. In addition, management believes non-GAAP financial measures enhance the comparability of results against prior periods.