SELLAS Life Sciences Provides Business Update and Reports Second Quarter 2020 Financial Results

On August 13, 2020 SELLAS Life Sciences Group, Inc. (Nasdaq:SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported financial results for the quarter ended June 30, 2020 (Press release, Sellas Life Sciences, AUG 13, 2020, View Source [SID1234563598]).

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"We are pleased that our ongoing studies for galinpepimut-S (GPS) – our Phase 3 REGAL study in patients with acute myeloid leukemia (AML) who have achieved complete remission after second-line anti-leukemic therapy (CR2), our Phase 1/2 basket study of GPS in combination with Merck’s pembrolizumab (KEYTRUDA), and the Phase 1 investigator-sponsored clinical trial (IST) of GPS in combination with Bristol-Myers Squibb’s anti-PD-1 therapy, nivolumab (Opdivo), in patients with malignant pleural mesothelioma (MPM) – are all proceeding on track despite these challenging times," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "During the second quarter of 2020, we established the independent Data Monitoring Committee (DMC) for the REGAL study comprised of esteemed members of the medical, scientific and biostatistical communities as well as a Steering Committee for the study."

Dr. Stergiou added, "We are also pleased to have strengthened our balance sheet with the closing of our private placement financing in early August, as the proceeds will be used to continue to progress our GPS program."

Second Quarter 2020 Pipeline Highlights

Galinpepimut-S (GPS) Program
In May 2020, SELLAS announced the formation of the Independent Data Monitoring Committee (DMC) for its pivotal Phase 3 REGAL clinical trial in AML CR2 patients. The DMC, comprised of an independent group of medical, scientific and biostatistics experts, is responsible for reviewing and evaluating patient safety and efficacy data for the REGAL study. The DMC currently consists of four members: Moshe Talpaz, M.D., Associate Director of Translational Research and Associate Chief of the Division of Hematology/Oncology at the University of Michigan Comprehensive Cancer Center and Chair of the DMC; Thomas Fleming, Ph.D., Professor and former department chair of the University of Washington Department of Biostatistics, Member of the Fred Hutchinson Cancer Research Center, former Director of the Statistical Center for HIV/AIDS Prevention Trial Network, NIAID, Special Government Employee for the FDA, and for more than 25 years, a regular member of several FDA Advisory Committees; Miguel-Angel Perales, M.D., Chief, Adult Bone Marrow Transplant Service at Memorial Sloan Kettering Cancer Center (MSKCC); and Stephane de Botton, M.D., Head of the Hematology Department at the Gustave Roussy Cancer Campus in Paris, France.
In April 2020, the Company announced the formation of the Steering Committee for the REGAL study. The Steering Committee currently consists of three members: Dr. Hagop Kantarjian, MD, Professor and Chair of the Department of Leukemia at The University of Texas MD Anderson Cancer Center, and Principal Investigator at MD Anderson for the REGAL study and Chair of the REGAL Steering Committee; Dr. Javier Pinilla-Ibarz, MD, PhD, Director of Immunotherapy for Malignant Hematology at the H. Lee Moffitt Cancer Center and member of the SELLAS Scientific Advisory Board; and Dr. Moshe Yair Levy, MD, Director of Hematologic Malignancies at the Texas Oncology – Baylor Charles A. Sammons Cancer Center.
Initial data readout from the MPM IST is expected by the end of 2020; initial data from the Phase 1/2 basket study is expected in the first half of 2021; and the planned interim safety and futility analysis in the REGAL study is expected to occur by the end of 2021.
Recent Corporate Highlights

In July 2020, SELLAS announced a private placement priced at-the-market of 2,744,078 shares of its common stock and accompanying warrants to purchase an aggregate of up to 2,744,078 shares of common stock, at a combined purchase price of $3.335 per share and accompanying warrant, to certain institutional and accredited investors, with gross proceeds to the Company of approximately $9.2 million before deducting the placement agent fee and related offering expenses.
Second Quarter 2020 Financial Results

R&D Expenses: Research and development expenses were $2.3 million for the second quarter of 2020, as compared to $1.4 million for the second quarter of 2019. Research and development expenses for the first half of 2020 were $4.1 million, as compared to $3.2 million for the same period in 2019. The increases in research and development expenses during the second quarter and first half of 2020 compared to the same periods in 2019 were primarily due to clinical trial expenses incurred for the REGAL study commencing in 2020.

G&A Expense: General and administrative expenses were $2.0 million for the second quarter of 2020, as compared to $2.6 million for the second quarter of 2019. General and administrative expenses for the first half of 2020 were $4.2 million, as compared to $5.1 million for the same period in 2019. The decreases during the second quarter and first half of 2020 compared to the same periods in 2019 were primarily due a reduction in legal fees and personnel related expenses.

Net Loss: Net loss attributable to common stockholders was $4.4 million for the second quarter of 2020, or a basic and diluted loss per share attributable to common stockholders of $0.66, as compared to a net loss attributable to common stockholders of $4.1 million for the second quarter of 2019, or a basic and diluted loss per share attributable to common stockholders of $6.33. Net loss attributable to common stockholders was $8.6 million for the first half of 2020, or a basic and diluted loss per share attributable to common stockholders of $1.32, as compared to a net loss attributable to common stockholders of $9.1 million for the first half of 2019, or a basic and diluted loss per share attributable to common stockholders of $16.56.

Cash Position: As of June 30, 2020, cash and cash equivalents totaled approximately $3.3 million. Following the end of the quarter, on August 4, 2020, the Company received gross proceeds of approximately $9.2 million from the Company’s sale, through a private placement priced at-the-market, of shares of common stock and accompanying common stock warrants to purchase shares of common stock.

VolitionRx Limited Announces Second Quarter 2020 Financial Results and Business Update

On August 13, 2020 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported financial results and a business update for the second quarter ended June 30, 2020 (Press release, VolitionRX, AUG 13, 2020, View Source [SID1234563597]). Volition management will host a conference call tomorrow, August 14 at 8:30 a.m. U.S. Eastern Time to discuss these results. Conference call details may be found below.

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An interview with Cameron Reynolds, President and Chief Executive Officer.
An interview with Cameron Reynolds, President and Chief Executive Officer.
Cameron Reynolds, President and Chief Executive Officer of Volition, upon releasing these results commented, "During the second quarter, given the persistence of the COVID-19 pandemic, we focused on two key areas to try and mitigate the effects of lockdowns and allow us to keep moving towards our first commercial products utilizing our cutting edge Nu.Q platform. Firstly, we significantly strengthened our balance sheet to ensure we have sufficient capital to work on our many programs concurrently, and launch products where possible during the pandemic. Secondly, we have increased the flexibility of our supply chain of key components and are moving towards producing our key components in house. Cancer remains our core disease focus, however, we have discovered that our technology potentially has applications beyond just cancer, for example with COVID-19."

View Source

An interview with Cameron Reynolds, President and Chief Executive Officer.

Mr. Reynolds added, "I am proud of the way our team has adapted to the different world we find ourselves in and kept on working at full speed, their fantastic efforts have put us in an excellent position as we move towards the launch of our first products expected later this year and early next year."

Company Highlights

Financial

Cash and cash equivalents as of June 30, 2020 totalled approximately $21.3 million compared with $12 million the previous quarter.
Raised $13.8 million in gross proceeds in an underwritten public offering.
Periodically sold shares of our common stock pursuant to our previously disclosed "At The Market" equity offering program, or "ATM", under our existing registration statement along with our Rule 10b5-1 plan. Through the end of the second quarter of 2020 we had raised approximately $1.7 million in gross proceeds under the ATM.
During July and the first week of August we raised an additional approximately $4.7 million in gross proceeds through the ATM.
Volition was added to both the Russell 3000 and Russell Microcap Indexes in June.
Product Production Facility

Submitted an offer to purchase a neighboring facility in Belgium known as "Silver One". We expect this facility to be the production hub of all of our products and components, to both secure our own supply at a lower cost, and to drive reagent revenue building on our purchase of Octamer GmbH (now called Volition Germany) earlier this year.
Clinical – COVID-19

The preliminary study results reported in May demonstrated the Area Under the Curve (AUC) for a single Nu.Q assay was 98.7% PCR positive versus control subjects, with 100% sensitivity at 94% specificity. A second Nu.Q assay also showed promising results with an AUC of 86.2%.
To date we have now tested two independent cohorts of COVID-19 positive patients with quantitative nucleosome immunoassays and found that nucleosomes were highly elevated in plasma of severe COVID-19 patients relative to healthy control subjects and importantly, that both histone 3.1 variant and citrullinated nucleosomes increased with disease severity.
Given that the highest levels of nucleosomes were found in patients requiring artificial ventilation or extracorporeal oxygenation, we believe that nucleosomes could serve as a guiding biomarker for disease severity in COVID-19 positive patients.
These data imply that Nu.Q could have strong prognostic potential, and so we are now focused on the completion of larger longitudinal studies that would be needed to support a potential COVID-19 product launch.
Our collaborators have submitted this data for peer-review and we look forward to its publication.
We have filed a novel patent for this application and plan to utilise results of these trials and other ongoing studies to further our aim of developing a clinically useful product to help in the battle against the COVID-19 global pandemic and potentially other diseases such as influenza and pneumonia.
Clinical- Veterinary

In a proof of concept study conducted by Texas A&M University, a single Nu.Q Vet assay detected almost 70% of both Canine Hemangiosarcoma and Canine Lymphoma with AUCs of 84.5% and 83.1% cancer versus healthy, respectively, at a specificity of 90%. These two cancers alone represent almost a third of all canine cancers.
Based on the results of this study, we plan to move forward with other Nu.Q Vet assays in our pipeline, and with the larger range of cohorts and trials that we have collected and planned.
The first Nu.Q Vet products expected to be launched late in 2020 are likely to be for blood and lymphoma remission monitoring and we then aim to target additional uses (such as remission monitoring for other cancers and for diagnosis itself) in 2021.
Assay Development and Clinical Studies (Cancer)

We exceeded our target of 12 assays being finalized by the end of the second quarter with respect to our fully-automated magnetic bead-based chemiluminescent format. To date, 13 assays have been developed and are being tested in our clinical research programs. We plan to reach a total of 20 by the end of 2020.
In various ways our "Marquee trials" have now been affected by the continued pandemic either by slower or paused collection, or a host of other supply chain or travel and communication issues. We believe we have successfully managed those areas under our direct control (such as assay development and running samples – both on track with our milestones) but many issues are not within our control.
We have now successfully completed 8 assays on subsets of both of our National Taiwan University studies – colorectal and lung cancers – and are working on data analysis. We expect over this coming quarter to run an additional number of assays and to submit the data at upcoming conferences.
Epigenetic Toolbox

We have developed and are seeking patents on our novel Nu.Q Capture-based epigenetic tools. We are using these tools to expand diagnostic developments that focus on circulating DNA fragment analysis, leading to a broader and potentially more powerful investigation of the epigenetic status of a patient’s circulating chromosome fragments. We have made significant progress with this work and will continue to publicise data as it is completed in the coming quarters.
Publications

The second quarter was the best quarter ever from a publications point of view.
We had three abstracts published at ASCO (Free ASCO Whitepaper), the American Society for Clinical Oncology, including data in both lung and blood cancers.
We have received acceptance for oral presentation of two abstracts at the Veterinary Cancer Society Meeting in October this year.
A Nu.Q Vet paper regarding pre-analytics has been submitted for peer review and accepted for publication.
Three papers have been submitted by collaborators using our Nu.Q technology, for lung disease, for complications during pregnancy and for COVID-19, yet again showing the wide adaptability of our platform.
We have other papers in process, including a pre-analytics paper for humans that we expect to submit over the next couple of months, and two papers from the Nu.Q Capture program on mass spectrometry and also sequencing.
Upcoming Milestones

Volition expects to achieve the following milestones during 2020 and beyond:

We will focus on driving revenue in the coming quarters, where possible during the pandemic, in 4 key areas:
Our four potential triage tests (3 cancers and COVID-19);
Nu.Q Vet products;
Reagent sales; and
Licensing of our technology for others to commercialize.
Continue to advance our previously announced large-scale colorectal and lung cancer trials in Europe, Asia and the U.S.
Commission and complete longitudinal studies for COVID-19.
Publish several abstracts and peer reviewed scientific papers with clinical results as well as showing the robustness and utility of our Nu.Q platform.
Advance the development of Nu.Q Capture
Announce patient data demonstrating the wide utility of our epigenetic toolbox.
Complete the purchase and fit out of "Silver One", to serve as our manufacturing hub and service lab in Belgium.
Mr. Reynolds concluded, "We are extremely proud of the accomplishments we have achieved thus far. I thank the dedicated Volition team for their tireless efforts especially given the challenging circumstances we all face during the COVID-19 pandemic. I, along with the rest of the Board and indeed the whole company, look forward to sharing the results of key studies over the coming year."

For further details please contact [email protected]

VolitionRx Limited Second Quarter 2020 Earnings

and Business Update Conference Call Date: Friday, August 14, 2020

Cameron Reynolds, President and Chief Executive Officer of Volition, will host the call along with David Vanston, Chief Financial Officer and Scott Powell, Executive Vice President, Investor Relations.

A live audio webcast of the conference call will also be available on the investor relations page of Volition’s corporate website at View Source In addition, a telephone replay of the call will be available until August 28, 2020. The replay dial-in numbers are 1-844-512-2921 (toll-free) in the U.S. and Canada and 1-412-317-6671 (toll) internationally. Please use replay pin number 13707978.

Histogen Reports Second Quarter 2020 Earnings and Provides Business Update

On August 13, 2020 Histogen Inc. (NASDAQ: HSTO), a clinical-stage therapeutics company focused on developing potential first-in-class restorative therapeutics that ignite the body’s natural process to repair and maintain healthy biological function, reported financial results for the second quarter ended June 30, 2020 and provided an update on its clinical pipeline and other corporate developments (Press release, Conatus Pharmaceuticals, AUG 13, 2020, View Source [SID1234563596]).

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Key Second Quarter 2020 Highlights and Subsequent Updates

Filed Investigational Device Exemption (IDE) for HST-002. In April, Histogen filed an IDE application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial of HST-002 as a dermal filler for the treatment of moderate to severe nasolabial folds. If the application is approved, Histogen plans to initiate the clinical trial in fourth quarter of 2020.

Closed Reverse Merger with Conatus. In May, Histogen closed the reverse merger transaction with Conatus. The transaction included approximately $13.0 million in cash resources, which when combined with existing resources, is expected to fund Histogen’s current operating plan into the second quarter of 2021. The combined company changed its name from Conatus Pharmaceuticals Inc. to Histogen Inc. and began trading on the Nasdaq Capital Market under the ticker symbol "HSTO" on May 27, 2020.
Appointed Susan A. Knudson as Chief Financial Officer. In May, Ms. Knudson joined Histogen as its Executive Vice President and Chief Financial Officer. With over 20 years of experience in the biopharmaceutical industry, she brings a wealth of financial and corporate strategy expertise to Histogen. Ms. Knudson most recently served as Chief Financial Officer at Pfenex Inc. and prior to Pfenex, she held the position of Chief Financial Officer of Neothetics, Inc.

Completed Enrollment for HST-001 Phase 1a/2b trial for Androgenic Alopecia in Men with Topline Data Expected in the fourth quarter 2020. Histogen announced that it initiated the trial in June, completed enrollment in July and expects to report topline results in the fourth quarter of 2020.

Entered into Common Stock Purchase Agreement for Up to $10 Million. In July, Histogen entered into a common stock purchase agreement for up to $10 million with Lincoln Park Capital Fund, LLC. Upon execution of the purchase agreement, Lincoln Park made an initial purchase of $1.0 million of common stock.
"Throughout the second quarter of this year, we focused on transforming Histogen into a leading restorative therapeutics development company through the completion of the reverse merger, obtaining a NASDAQ listing, strengthening the executive team and advancing our innovative therapeutics pipeline," said Richard W. Pascoe, Histogen’s President and Chief Executive Officer. "In the remaining months of 2020, we will focus on achieving a number of near-term clinical and regulatory value-inflection points, such as filing an IND for our HST-003 program focused on knee cartilage repair, initiating a Phase 1 trial for HST-002 for the treatment of moderate to severe nasolabial folds and reporting topline results from our HST-001 Phase 1a/2b trial for androgenic alopecia in men. Moreover, I want to take this opportunity to commend the entire Histogen team for their tireless efforts, in the midst of a global pandemic, to position the company for success in 2020 and beyond."

Expected Second Half 2020 Milestones

Submit HST-003 IND for the regeneration of cartilage in the knee
Initiate HST-002 Phase 1 trial for the treatment of moderate to severe nasolabial folds, if IDE is approved
Report topline data for HST-001 Phase 1a/2b trial for androgenic alopecia in men
Financial Highlights for the Second Quarter 2020

Revenues for the three months ended June 30, 2020 and 2019 were $0.1 million and $1.4 million, respectively. The year-over-year decrease of $1.3 million was primarily due to a decrease in the fulfillment of supply orders of CCM to Allergan and one additional customer.

Cost of revenues for the three months ended June 30, 2020 and 2019, were $0 million and $0.5 million, respectively. The decrease of $0.5 million for the three months ended June 30, 2020 as compared to the three months ended June 30, 2019 was due to a decrease in fulfillment of supply orders of CCM to Allergan and one additional customer.

For both the three months ended June 30, 2020 and 2019, we recognized costs of professional services of $0.1 million related to our Allergan License Agreements.

In-process research and development expenses for the three months ended June 30, 2020 and 2019 were $7.1 million and $2.3 million, respectively. In the three months ended June 30, 2020, we incurred $7.1 million for in-process research and development acquired in connection with the reverse merger with Conatus and in the three months ended June 30, 2019, we incurred $2.3 million for in-process research and development related to the acquisition of HST-003 and HST-004 from PUR Biologics LLC.

Research and development expenses for the three months ended June 30, 2020 and 2019 were $1.4 million and $1.0 million, respectively. The increase of $0.4 million for the three months ended June 30, 2020 was primarily due to an increase in development costs for our product candidates.

General and administrative expenses for both the three months ended June 30, 2020 and 2019 were $1.6 million. The three months ended June 30, 2019 included success-based fees of approximately $0.8 million related to $7.5 million of license revenue received in the three months ended June 30, 2019 for which there was no comparable expense incurred in the three months ended June 30, 2020. This decrease for the three months ended June 30, 2020 was offset by increases in personnel related expenses, legal and accounting fees in the three months ended June 30, 2020.

Cash and cash equivalents as of June 30, 2020 were $10.4 million. Histogen believes that its existing cash and cash equivalents and cash inflow from operations will be sufficient to meet Histogen’s anticipated cash needs into the second quarter of 2021.

Caladrius Biosciences Provides Corporate Update and Reports 2020 Second Quarter Financial Results

On August 13, 2020 Caladrius Biosciences, Inc. (Nasdaq: CLBS) ("Caladrius" or the "Company"), a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse, not manage, disease, reported financial results for the three and six months ended June 30, 2020 (Press release, Caladrius Biosciences, AUG 13, 2020, View Source [SID1234563595]).

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Product Development and Financing Highlights

CLBS119 clinical trial targeting the repair of COVID-19 induced lung damage to be initiated in 3Q 2020

Caladrius is committed to helping patients and communities combat the public health crisis of COVID-19 by leveraging its proprietary CD34+ cell technology to potentially repair COVID-19 induced lung damage. Experience to date indicates that a large portion of COVID-19 survivors who required ventilatory support will suffer long-term, debilitating lung damage.1 Scientists learned in the aftermath of the first SARS epidemic that the coronavirus targets cells that express CD34.2 Depletion of that cell population generally is thought to be connected to the lung’s inability to repair itself.2 Early reports from the COVID-19 pandemic indicate that the endothelial cells that line the microvasculature of the lung are targeted by the virus and that the destruction of the lung microcirculation may be a critical factor in the inability of the lung to repair itself even after the virus has been eliminated.3 Clinical trials and preclinical models have shown that CD34+ cells act in a restorative and regenerative capacity in multiple organs, including models of severe lung inflammation.4 Research has also shown that a deficiency in vascular CD34+ cells can result in a predisposition to injury in the lungs.5 Based on this accumulated evidence, Caladrius is excited to launch the pilot study of CLBS119 to evaluate its autologous CD34+ cell therapy for the repair of COVID-19 induced lung damage in patients who have suffered respiratory failure. The trial is planned to initiate by late August with the first patient expected to be treated in September.

CLBS12 development in Japan continues to yield promising results

The Company’s open-label, registration-eligible study in Japan of CLBS12, its SAKIGAKE-designated product candidate for the treatment of critical limb ischemia ("CLI"), a disease with no currently available approved therapy6 and a higher mortality rate than all cancers except that of lung cancer,7 has shown positive results to date. The Buerger’s Disease cohort has concluded with 4 out of 7 (57%) patients achieving a positive outcome, an outstandingly positive result for these patients who normally see continued progression leading to amputation. Despite the global impact of COVID-19, which has caused the deceleration of clinical trial enrollment globally, the Company remains encouraged by the patient pre-screening pipeline that has been identified and targets to complete trial enrollment by the end of 2020 and report top line data for the full study in late 2021 or early 2022. Based on the data from the concluded Buerger’s Disease cohort and the data to date in the no-option CLI cohort, the Company maintains its expectation of the study’s ultimate success.

CLBS16 to be studied in Phase 2b trial for the treatment of coronary microvascular dysfunction

Caladrius recently completed and announced the results of its ESCaPE-CMD Phase 2 study of CLBS16 for the treatment of coronary microvascular dysfunction ("CMD"), a disease that continues to be underdiagnosed and potentially afflicts millions annually – a vast majority of whom are female – with no current treatment options. Data from the Phase 2 trial showed highly statistically significant improvement in coronary flow reserve correlating with symptom relief for patients with CMD after a single intracoronary injection of CLBS16. The Company is committed to raising awareness of this growing women’s health crisis as it initiates a rigorous Phase 2b clinical trial of CLBS16 with the first patient expected to be enrolled by late 2020. The double-blind, randomized, placebo-controlled trial will evaluate the efficacy and safety of delivering autologous CD34+ cells (CLBS16) in subjects with coronary microvascular dysfunction and without obstructive coronary artery disease.

CLBS14 remains poised to enter a single confirmatory phase 3 clinical trial

The Company’s Phase 3 protocol for its RMAT-designated product candidate, CLBS14, for the treatment of no-option refractory angina ("NORDA") remains ready to initiate pending sufficient funding to run the program to completion. Based on an abundance of very strong data from previous Phase 1, 2, and 3 studies, Caladrius remains confident in the potential for clinical success once the program is executed.

Caladrius secures almost $30 million in new capital year-to-date and extends cash runway through the end of 2021

In April 2020, Caladrius generated $10.9 million in non-dilutive funding through the sale of a portion of its qualified New Jersey net operating losses. Throughout the remainder of the second quarter, the Company executed two registered direct offerings priced at the market under Nasdaq rules raising an additional aggregate $9.3 million. In July 2020, Caladrius raised $2.0 million in a private placement priced at the market under Nasdaq rules. In addition, Caladrius opportunistically raised $8.3 million through its Common Stock At-the-Market Sales Agreement with H.C. Wainwright & Co. year-to-date.

"Despite COVID-19’s unprecedented global impact, we continue to deliver on a number of key initiatives that we believe position the Company for success in the quarters ahead," stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius. "To date in 2020, we successfully raised enough capital to extend our cash runway through the end of 2021, continued activities in support of our existing and newly initiated clinical programs and strengthened our Board with the previously announced addition of Dr. Michael Davidson."

"We are excited about what lies ahead through the balance of 2020 and into 2021 with a number of key milestones expected, including the commencement of our pilot study of CLBS119 in COVID-19 induced lung damage, the completion of enrollment in our Phase 2 study of CLBS12 for critical limb ischemia and the initiation of our Phase 2b study of CLBS16 in coronary microvascular dysfunction," concluded Dr. Mazzo.

Second Quarter 2020 Financial Highlights

Research and development expenses for the second quarter of 2020 were $1.8 million, a 39% decrease compared with $3.0 million for the second quarter of 2019. Research and development in both periods focused on the advancement of our ischemic repair platform. More specifically, R&D expense comprised (i) costs associated with investigational new drug application and planning for commencement of a pilot study of CLBS119, (ii) execution expenses for our ongoing registration-eligible study for CLBS12 in critical limb ischemia in Japan, and (iii) expenses for both the completion of our ESCaPE-CMD clinical study for CLBS16 in coronary microvascular dysfunction and planning for the follow on Phase 2b study.

General and administrative expenses for the second quarter of 2020 were $2.5 million, compared with $2.4 million for the second quarter of 2019.

Overall, net income was $6.6 million for the second quarter of 2020, which included a $10.9 million income tax benefit from the sale of qualified New Jersey net operating losses, compared to a net loss of $5.1 million for the second quarter of 2019.

Balance Sheet Highlights

As of June 30, 2020, Caladrius had cash, cash equivalents and marketable securities of $34.9 million. Based on existing programs and projections, the Company remains confident that its current cash balances will fund its operations through 2021.

Conference Call

Caladrius management will host a conference call for investors beginning at 4:30 p.m. ET on Thursday, August 13, 2020 to discuss the financial results, provide a business update and answer questions.

Shareholders and other interested parties may participate in the conference call by dialing 866-595-8403 (domestic) or 706-758-9979 (international) and referencing conference ID number 2093833. The conference call will also be webcast live under the Investors section on the Company’s website at www.caladrius.com.

For those unable to participate in the live conference call, a replay will be accessible approximately two hours after its completion through August 20, 2020, by dialing 855-859-2056 (domestic) or 404-537-3406 (international) and referencing conference ID number 2093833. A webcast audio recording of the call will also be archived for 90 days under the Investors section of the Company’s website at www.caladrius.com.

Myriad Genetics Appoints Paul J. Diaz as President and Chief Executive Officer and a Member of the Board of Directors

On August 13, 2020 Myriad Genetics, Inc. (NASDAQ: MYGN, "Myriad" or the "Company"), a global leader in molecular diagnostics and precision medicine, reported the appointment of Paul J. Diaz as President and Chief Executive Officer, effective August 13, 2020 (Press release, Myriad Genetics, AUG 13, 2020, View Source [SID1234563594]). He will also serve on the Company’s Board of Directors. Mr. Diaz brings to Myriad Genetics more than three decades of executive leadership and business transformation experience in healthcare across a variety of healthcare segments.

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"Paul is an exceptional leader and executive with extraordinary passion, vision, experience, and operational skills," said S. Louise Phanstiel, Chair of Myriad’s Board of Directors. "His focus on building high performing teams, and instilling a culture that empowers people to deliver high quality patient care, distinctive customer service and innovation, will be important to supporting Myriad’s mission and growth. We are excited to have Paul assume the leadership of Myriad Genetics and chart the course to realize the Company’s full potential. We look forward to officially introducing Paul during our fourth quarter earnings call. Myriad is dedicated to providing vital information to physicians, patients and their families that enables them to make better decisions about their health and treatment planning. Paul’s personal dedication, throughout his career, to patients and their care will be critical in advancing Myriad’s vision of being a trusted advisor transforming patients’ lives worldwide with pioneering molecular diagnostics."

"I am very excited to join the talented management team and Board of Directors of Myriad Genetics, an organization dedicated to helping patients and physicians identify the risk of developing disease and accurately diagnosing disease and disease progression," commented Paul. "Our goal is to empower patients, as consumers, and their physicians and our payer partners with the information and data to help guide their treatment decisions, to improve clinical outcomes and lower healthcare costs. I am equally excited about Myriad’s potential for innovation and growth. The Company has a tremendous opportunity to transform its business, and strategically position itself for sustainable, profitable growth. We will look to leverage the company’s culture of innovation and revitalize our approach to the commercializing of its products and customer service levels."

Mr. Diaz served as the President and Chief Executive Officer and Executive Director and Director of Kindred Healthcare, Inc. for over ten years, where he led the growth, revitalization and diversification of the business that positioned Kindred as the largest provider of post-acute health care services in the United States. Most recently, Mr. Diaz was a Partner at Cressey & Company LP, a private equity firm focusing on healthcare services and HCIT companies. Mr. Diaz is an experienced director and operating executive, having served as an executive and board member of multiple public and private companies. He currently serves on the board of DaVita, Inc. (NYSE: DVA) and is a member of the Board of Trustees of Johns Hopkins Medicine. Mr. Diaz graduated from The American University with a B.S. in Business Administration and with a J.D. from The Georgetown University Law Center.

Heidrick & Struggles led the search process for Myriad.