Aura Biosciences Reports First Quarter 2022 Financial Results and Provides Clinical Development and Operational Highlights

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.

Updated AUA/ASTRO Guideline Includes Supportive Statement for Use of Genomic Tests, Including Decipher Prostate, for Men With Localized Prostate Cancer

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.

PAVmed Provides Business Update and Preliminary First Quarter 2022 Financial Results

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.

Orca Bio to Present New Clinical Data on Orca-T at the European Hematology Association 2022 Congress

On May 12, 2022 Orca Bio, a clinical-stage biotechnology company developing purified, high-precision cell therapies for the treatment of cancer, genetic blood disorders and autoimmune diseases, reported that new clinical data on its lead investigational high-precision cell therapy, Orca-T, will be shared in an oral presentation at the hybrid European Hematology Association (EHA) (Free EHA Whitepaper) Congress from June 9-17, 2022, in Vienna, Austria (Press release, Orca Bio, MAY 12, 2022, View Source [SID1234614424]).

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Oral Session: Clinical Studies in Transplantation

Title: Orca-T, an Engineered Allograft, Results in High GVHD-Free and Relapse-Free Survival Following Myeloablative Conditioning for Hematological Malignancies
Abstract Number: S237
Date and Time: Sunday, June 12, at 11:30–12:45 CEST / 5:30AM–6:45AM EDT
Location: Hall Stolz 1-2

The presentation will highlight results from the single-center Phase 2 and multi-center Phase 1b trials of Orca-T in patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and myelodysplastic syndromes (MDS). Data included in the abstract will be updated at the time of presentation.

The oral session will take place in Vienna and will be livestreamed on the EHA (Free EHA Whitepaper) Congress platform.

About Orca-T

Orca-T is an investigational, high-precision allogeneic cell therapy derived from the stem and immune cells from either related or unrelated HLA-matched donors. Orca-T is intended to safely replace a patient’s compromised blood and immune system with that from a healthy donor. Orca-T is currently being evaluated in a Phase 3 clinical trial for the treatment of multiple hematologic malignancies and has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration.

Sierra Oncology Announces Oral Presentation of Momelotinib Pivotal Phase 3 Data at European Hematology Association Annual Meeting

On May 12, 2022 Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company on a mission to deliver transformative therapies for rare cancers, reported two abstracts have been accepted into the program for the 2022 Annual Meeting of the European Hematology Association (EHA) (Free EHA Whitepaper) (Press release, Sierra Oncology, MAY 12, 2022, View Source [SID1234614423]). An abstract presenting the full data from the pivotal phase 3 MOMENTUM study in myelofibrosis patients who are symptomatic and anemic has been selected for oral presentation. Additionally, a subset analysis from the trial evaluating safety and efficacy for patients with low platelet counts has been selected for poster presentation.

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"We are excited and honored to have the MOMENTUM data selected for an oral presentation at EHA (Free EHA Whitepaper) which demonstrates that momelotinib achieved statistically significant and clinically important efficacy across all prespecified primary and key secondary endpoints," said Barbara Klencke, MD, Chief Medical Officer of Sierra Oncology. "In addition, we are pleased to present the subset analysis in a poster presentation which indicates momelotinib may be safely administered and provide an improvement in symptoms, spleen and anemia in anemic myelofibrosis patients who present with low platelet counts. The data to be presented further expand upon the potential of momelotinib as a treatment option for myelofibrosis patients who are symptomatic and anemic."

Abstract: S195: MOMENTUM: Phase 3 Randomized Study of Momelotinib (MMB) versus Danazol (DAN) in Symptomatic and Anemic Myelofibrosis (MF) Patients Previously Treated with a JAK Inhibitor

The primary and all key secondary results, as well as safety data, from the MOMENTUM pivotal Phase 3 trial of momelotinib will be presented in an oral presentation by Srdan Verstovsek, MD, PhD, co-Principal Investigator of the study. Topline results from the study were announced in January 2022. Key data to be presented include:

Primary Endpoint of Total Symptom Score (TSS) of >50%: 25% in the MMB arm vs. 9% in the control arm (p=0.0095)
Secondary Endpoint of Transfusion Independence (TI): 31% in the MMB arm vs. 20% in the control arm (one-sided p=0.0064; non-inferiority)
Secondary Endpoint of Splenic Response Rate (SRR) >35%: 23% in the MMB arm vs. 3% in the control arm (p=0.0006)
The rate of Grade 3 or worse adverse events in the randomized treatment period was 54% in the MMB arm and 65% in the control arm. Serious treatment emergent adverse events were 35% in the MMB arm and 40% in the control arm.
Mean baseline characteristics for all patients were TSS of 27, Hemoglobin (Hgb) of 8 g/dL and platelet count of 145 x 109/L
Presentation Details

Abstract: S195
Title: MOMENTUM: Phase 3 Randomized Study of Momelotinib (MMB) versus Danazol (DAN) in Symptomatic and Anemic Myelofibrosis (MF) Patients Previously Treated with a JAK Inhibitor
Presenter: Srdan Verstovsek, MD, PhD, The University of Texas MD Anderson Cancer Center
Session Title: Treatments and Complications in MPN
Location: Hall Lehar 1-2
Date and Time: Saturday, June 11, 2022, 11:30 am – 12:45 pm CEST

Abstract: P1050: Thrombocytopenic Myelofibrosis (MF) Patients Previously Treated with a JAK Inhibitor in a Phase 3 Randomized Study of Momelotinib (MMB) versus Danazol (DAN) [MOMENTUM]

Abstract P1050 will highlight an analysis of MOMENTUM patients with baseline platelet counts of <150 x 109/L on key symptom, anemia and spleen volume endpoints at 24 weeks. Results to be presented are consistent with the overall intent-to-treat analysis set. Momelotinib was superior to danazol for symptom responses, transfusion requirements and spleen responses, and showed a trend toward improved overall survival up to Week 24 was seen with momelotinib versus danazol [95% CI = 0.490 (0.195, 1.235)].

Presentation Details

Abstract: P1050
Title: Thrombocytopenic Myelofibrosis (MF) Patients Previously Treated with a JAK Inhibitor in a Phase 3 Randomized Study of Momelotinib (MMB) versus Danazol (DAN) [MOMENTUM]
Presenter: Alessandro Vannucchi, MD, Center Research and Innovation for Myeloproliferative Neoplasms, AOU Careggi, University of Florence, Italy
Session Title: Poster Session
Date and Time: Friday, June 10, 2022, 4:30 – 5:45 pm CEST