On May 7, 2020 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, reported its financial results for the first quarter of 2020 and provided research and development (R&D) and business highlights (Press release, Aclaris Therapeutics, MAY 7, 2020, View Source [SID1234557260]).

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"In the first quarter, we borrowed $11 million from Silicon Valley Bank enabling us to extend our cash runway, and started enrolling subjects with moderate-to-severe rheumatoid arthritis in our Phase 2a trial of ATI-450. As a result of the COVID-19 pandemic and as a precautionary measure, we temporarily paused subject enrollment in this trial. At this time, we have decided to resume enrollment at one clinical trial site. We will continue to monitor the COVID-19 pandemic and engage additional clinical trial sites, as appropriate, based on our assessment of the impact on our trial. I’m proud of our team’s focus, dedication and resilience while navigating through the unique challenges that the COVID-19 pandemic has created," said Dr. Neal Walker, President and CEO of Aclaris.

R&D Highlights:
The global outbreak of COVID-19 continues to rapidly evolve and has caused and may continue to cause Aclaris to experience disruptions that could impact the timing of its regulatory and research and development activities listed below.

ATI-450:
ATI-450 is an investigational oral small molecule MK2 inhibitor.
ATI-450-RA-201: A Phase 2a trial to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ATI-450 in subjects with moderate-to-severe rheumatoid arthritis.
Aclaris started subject enrollment in the first quarter of 2020. Due to the COVID-19 pandemic, Aclaris temporarily paused enrollment of subjects in the trial. At this time, Aclaris has decided to resume enrolling subjects at one clinical trial site. The initiation of additional clinical trial sites will be determined on an ongoing basis as the COVID-19 pandemic evolves.
Aclaris previously anticipated reporting data from this trial in the second half of 2020; however, Aclaris expects that the data may be delayed and will provide an update, at a later date, regarding the timing of reporting data from this trial.
ATI-450-PKPD-101: This Phase 1 single and multiple ascending dose (SAD/MAD) trial evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of orally administered ATI-450 in 77 healthy subjects.
Final data from this trial demonstrated that ATI-450:
resulted in marked inhibition of TNFα, IL1β, IL8, and IL6;
was generally well-tolerated at all doses tested in the trial. The most common adverse events (reported by 2 or more subjects who received ATI-450) observed during the trial were dizziness, headache, upper respiratory tract infection, constipation, abdominal pain, and nausea;
had dose-proportional pharmacokinetics (PK) with a terminal half-life of 9-12 hours in the MAD cohort; and
had no meaningful food effect or drug-drug interaction with methotrexate.
Aclaris is also planning to initiate a Phase 2a clinical trial of ATI-450 in an additional immuno-inflammatory indication.

ATI-1777:
ATI-1777 is an investigational topical soft-Janus Kinase (JAK) inhibitor compound.
Aclaris expects to submit an IND for ATI-1777 for the treatment of atopic dermatitis in mid-2020.
If the IND is allowed, Aclaris expects to initiate a Phase 1/2 clinical trial in subjects with atopic dermatitis in the second half of 2020 evaluating ATI-1777 as a potential topical treatment for moderate-to-severe atopic dermatitis.

ATI-2138:
ATI-2138 is an investigational oral ITK/TXK/JAK3 (ITJ) inhibitor compound that Aclaris is developing as a potential treatment for psoriasis and/or inflammatory bowel disease.
Aclaris expects to submit an IND for ATI-2138 in the fourth quarter of 2020 or the first quarter of 2021.
Business Development Highlights:

Aclaris continues to pursue strategic alternatives, including seeking partners for:
A-101 45% Topical Solution: to obtain regulatory approval and commercialize A-101 45% Topical Solution, an investigational compound, as a potential treatment for common warts (verruca vulgaris);
ATI-501 & ATI-502: to further develop, obtain regulatory approval and commercialize ATI-501 (oral) and ATI-502 (topical), investigational JAK 1/3 inhibitor compounds, as potential treatments for alopecia; and
ESKATA: to commercialize ESKATA (hydrogen peroxide) topical solution, 40% (w/w).
Financial Highlights:
Liquidity and Capital Resources

As of March 31, 2020, Aclaris had aggregate cash, cash equivalents and restricted cash and marketable securities of $79.0 million compared to $75.0 million as of December 31, 2019. For the quarter ended March 31, 2020, net cash used in operating activities was $6.8 million, which includes $5.2 million received from Allergan Sales, LLC on behalf of EPI Health, LLC for sales of RHOFADE (oxymetazoline hydrochloride) cream, 1%. On March 30, 2020, Aclaris entered into a loan and security agreement with Silicon Valley Bank pursuant to which Aclaris borrowed $11.0 million. As of March 31, 2020, Aclaris had approximately 41.8 million shares of common stock outstanding.

Aclaris anticipates that its cash, cash equivalents and marketable securities as of March 31, 2020, will be sufficient to fund its operations into the first quarter of 2022, without giving effect to any potential business development transactions or financing activities.

First Quarter 2020 Financial Results

The accompanying consolidated statements of operations and selected consolidated balance sheet data have been recast for all periods presented to reflect the assets, liabilities, revenue and expenses related to Aclaris’ commercial products as discontinued operations. The accompanying financial statement data are generally presented in conformity with Aclaris’ historical format. Aclaris believes this format provides comparability with its previously filed financial statements.
Net loss was $15.6 million for the first quarter of 2020, compared to $37.6 million for the first quarter of 2019. Total costs and expenses from continuing operations for the first quarter of 2020 were $16.9 million, compared to $28.3 million for the first quarter of 2019.
Total costs and expenses in the first quarter of 2020 included non-cash stock-based compensation expense of $3.5 million, compared to $4.3 million in the prior year period.
R&D expenses were $9.4 million for the quarter ended March 31, 2020, compared to $19.6 million for the prior year period.
The quarter-over-quarter decrease of $10.2 million was primarily the result of the substantial completion of Aclaris’ various Phase 2 clinical trials of ATI-501 and ATI-502 and two pivotal Phase 3 clinical trials of A-101 45% Topical Solution in 2019, and the corresponding reduction in personnel costs to support these programs.
These reductions were offset by a $1.8 million non-cash charge for the change in the fair value of contingent consideration that was recorded in the first quarter of 2020.
General and administrative expenses were $6.2 million for the first quarter of 2020, compared to $7.5 million for the first quarter of 2019. The decrease was primarily the result of lower personnel and stock-based compensation related costs due to lower headcount.
Loss from continuing operations was $15.3 million for the first quarter of 2020 compared to $27.3 million for the first quarter of 2019, while our loss from discontinued operations was $0.3 million for the first quarter of 2020 compared to $10.3 million for the first quarter of 2019.

On May 7, 2020 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, financial results for the three-month period ended March 31, 2020 (Press release, Spectrum Pharmaceuticals, MAY 7, 2020, View Source [SID1234557259]).

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"The progress in our development pipeline speaks to the investigator interest and the commitment of our team during these unprecedented times," said Joe Turgeon, President and CEO, Spectrum Pharmaceuticals. "The PDUFA date for ROLONTIS remains October 24, 2020 and our updated poziotinib strategy is well under way. We continue to drive the business forward and remain focused on achieving our milestones this year."

Pipeline Updates

ROLONTIS (eflapegrastim), a novel long-acting G-CSF

FDA is actively reviewing the BLA for ROLONTIS for the treatment of chemotherapy-induced neutropenia. The PDUFA target action date for the ROLONTIS BLA is October 24, 2020.
Company-sponsored study evaluating the administration of ROLONTIS on the same day as chemotherapy, dosed its first patient. The trial will evaluate the duration of severe neutropenia when administered at three different time points on the same day following standard chemotherapy in patients with early stage breast cancer.
Poziotinib, an irreversible tyrosine kinase inhibitor targeting EGFR and HER2 mutations

Spectrum presented additional results for Cohort 1 from its Phase 2 clinical trial, ZENITH20, evaluating poziotinib in previously treated non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations at a plenary session of the virtual American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting on April 27, 2020. The podium presentation included additional safety and efficacy data. Although the results for Cohort 1 did not meet the primary endpoint, as previously announced, poziotinib demonstrated a 68.7% disease control rate.
Spectrum provided an update on its ZENITH20 trial evaluating poziotinib in NSCLC patients with EGFR and HER2 exon 20 insertion mutations. The protocol has been amended to explore additional dosing regimens and the earlier use of corticosteroids in an effort to increase drug compliance.
Cohort 2 of the ZENITH20 trial enrolling previously treated HER2 NSCLC patients is fully accrued as previously announced and is expected to have topline results released in mid-2020. Cohort 3 of the ZENITH20 trial enrolling first-line EGFR NSCLC patients is now fully enrolled and is expected to have topline results in the second half of 2020. Either cohort has the potential to support a future NDA submission.
Three-Month Period Ended March 31, 2020 (All numbers are from Continuing Operations and are approximate)

GAAP Results

Spectrum recorded a net loss of $40.6 million, or $0.36 loss per basic and diluted share, in the three-month period ended March 31, 2020, compared to net loss of $39.8 million, or $0.36 loss per basic and diluted share, in the comparable period in 2019. Total research and development expenses were $16.0 million in the quarter, as compared to $21.9 million in the same period in 2019. Selling, general and administrative expenses were $14.8 million in the quarter, compared to $16.0 million in the same period in 2019.

The company ended the quarter with cash, cash equivalents, and marketable securities of $177.8 million.

Non-GAAP Results

Spectrum recorded a non-GAAP net loss of $25.0 million, or $0.22 per basic and diluted share, in the three-month period ended March 31, 2020, compared to a non-GAAP net loss of $29.2 million, or $0.27 per basic and diluted share, in the comparable period in 2019. Non-GAAP research and development expenses were $14.6 million, as compared to $20.4 million in the same period of 2019. Non-GAAP selling, general and administrative expenses were $10.8 million, as compared to $10.7 million in the same period in 2019.

Conference Call and Webcast

Spectrum’s management will host a webcast and conference call today, May 7, 2020, at 4:30 p.m. ET / 1:30 p.m. PT to discuss the financial results and provide a corporate update. The live call may be accessed by dialing (877) 837-3910 for domestic callers and (973) 796-5077 for international callers and entering the conference ID#: 8470139. A live webcast of the call will be available from the Investor Relations section of the company’s website at View Source and will be archived there shortly after the live event.

On May 7, 2020 IMV Inc. ("IMV" or the "Company") (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of cancer immunotherapies and vaccines to fight against infectious diseases including COVID-19, reported that it has completed its previously announced non-brokered private placement (the "Private Placement") of 8,770,005 units of the Company (each, a "Unit") at Cdn$2.86 per Unit for gross proceeds of approximately Cdn$25.1 million (Press release, IMV, MAY 7, 2020, View Source [SID1234557258]). The size of the Private Placement has increased by approximately Cdn$2.8 million following our earlier announcement on April 30, 2020.

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Each Unit consists of one common share of the Company ("Common Share") and 0.35 of one common share purchase warrant (each whole common share purchase warrant, a "Warrant"). Each Warrant entitles its holder to purchase one Common Share at an exercise price of Cdn$3.72 per share and is exercisable until May 7, 2022.

The private placement is being co-led by Fonds de Solidarité FTQ, an existing investor, and Lumira Ventures, a new investor in the Company, along with participation by Altium Capital, also a new investor in IMV, together with incumbent investors.

The Company intends to use the net proceeds from the Private Placement for the clinical development of its lead candidate, DPX-Survivac, currently being assessed in advanced ovarian cancer, as well as in multiple clinical studies in combination with Merck’s Keytruda. The balance of the net proceeds will be used for general corporate purposes, including funding research and development, preclinical and clinical expenses, and corporate costs.

All securities issued pursuant to the Private Placement will be subject to a four month and one day hold period in Canada in accordance with applicable securities laws.

Fred Ors, President and CEO of IMV commented, "We are pleased to welcome both Lumira Ventures and Altium Capital as new investors and thank Fonds de Solidarité FTQ for their leadership in this round of financing. We greatly appreciate the confidence shown in the Company. We look forward to further advancing our existing clinical pipeline and leveraging our unique and proprietary delivery platform against other selected targets including COVID-19."

"Since 1989, the Fonds de Solidarité FTQ has supported the life sciences sector with direct investments in companies and in specialized funds which invest in Québec. More than ever, it is important to proactively support our portfolio companies like IMV that give hope to patients in particular and society in general, whether it be for the fight against cancer or COVID-19," said Didier Leconte, Vice-President for Investments, Life Sciences and Funds of Funds, at the Fonds de Solidarité FTQ.

"We believe that an effective immunotherapy treatment must be capable of eliciting rapid, robust, and long-lasting responses and we have been impressed with the ability of the DPX platform to produce clinical evidence of such type of immune responses. We are happy to support IMV in advancing such a differentiated immunotherapy approach to potentially provide a much needed new treatment ption for women with advanced ovarian cancer." said Daniel Hétu, Managing director at Lumira Ventures.

On May 7, 2020 Applied DNA Sciences, Inc. (NASDAQ: APDN), reported that it plans to release financial results for its fiscal 2020 second quarter ended March 31, 2020 after market close on Thursday, May 14, 2020 (Press release, Applied DNA Sciences, MAY 7, 2020, View Source [SID1234557256]). In conjunction with the release, the Company has scheduled a conference call at 4:30 p.m. Eastern Time that will also be broadcast live over the Internet.

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What: Applied DNA’s Fiscal 2020 Second Quarter Financial Results Conference Call

When: Thursday, May 14, 2020, at 4:30 p.m. Eastern Time

Where: Via phone by dialing +1-844-887-9402 or +1-412-317-6798 and ask to join the Applied DNA call; via webcast.

A telephonic replay of the conference call will be available for one week beginning one hour after the end of the live conference call. Replay can be accessed by calling 1-877-344-7529 or +1-412-317-0088 with the passcode 10141899. The webcast will be archived within the ‘Events and Presentations’ portion of the ‘Investors’ page to the company’s website.

On May 7, 2020 Bio-Techne Corporation (NASDAQ:TECH) reported a major publication in the Journal of Prostate Cancer and Prostatic Diseases entitled, Clinical Utility of the exosome based ExoDx Prostate (IntelliScore) EPI test in men presenting for initial Biopsy with a PSA 2-10ng/mL (link available here) (Press release, Bio-Techne, MAY 7, 2020, View Source [SID1234557255]). Principal investigators Dr. Ronald Tutrone, Medical Director of Chesapeake Urology, and Dr. James McKiernan, Professor of Urology at Columbia University, demonstrated the ExoDx Prostate test, or EPI, delivered improved patient outcomes over standard of care in a real-world clinical setting that included 72 urologists, 24 sites and more than 1000 patients. The study is the first ever prospective, multi-center, randomized prostate biomarker trial with a blinded control arm conducted in a clinical utility setting, The study was a collaboration between the largest urology practice in Maryland, Chesapeake Urology, and CareFirst Blue Cross Blue Shield of Maryland.

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The EPI test is a urine-based genomic test that helps inform the prostate biopsy decision. This liquid biopsy test recently received coverage for the VA Healthcare system under the General Services Administration (GSA) award, received a positive coverage decision from Medicare, and is included in the National Comprehensive Cancer Network (NCCN) guidelines for early detection in men for both initial and repeat biopsy. It is performed by Exosome Diagnostics, a Bio-Techne brand, in its CLIA, ISO, and NY certified and CAP-accredited laboratory located in Waltham, Massachusetts. The EPI test is a risk assessment tool that assists physicians and their patients with determining if a prostate biopsy is needed when presented with an ambiguous PSA test result, thereby reducing complications from unnecessary and invasive procedures.

Key findings from the study include:

When implementing the ExoDx Prostate test in a real-world clinical setting, patients demonstrated improved compliance with the physician’s recommendation to defer prostate biopsy when the test was negative and go through with a biopsy when the test was positive.
Twenty-three percent of patients deferred a biopsy due to the EPI test based on the physician-patient shared decision questionnaire.
In the standard of care setting, many high-grade prostate cancers are missed because not all high-risk men go through with a biopsy.
Due to improved compliance to proceed to biopsy, physicians detected 30% more cases of clinically significant, or high-grade prostate cancer compared to the standard of care control arm.
These findings can have significant implications for both clinical and economic outcomes. According to Dr. Ronald Tutrone, "From a clinical perspective, deferring biopsy can help a patient avoid the undesirable complications from a biopsy, such as pain, hematuria, infection and potentially hospitalization. Many patients are frightened to undergo biopsy procedure; however, introducing an EPI result not only improved compliance to proceed to biopsy, but detected more clinically significant cancers that might have been missed under the standard of care paradigm."

"This study has important implications from an economic perspective," commented Chuck Kummeth, President and Chief Executive Officer of Bio-Techne. "Avoiding unnecessary biopsy procedures represents an estimated savings to the healthcare system of $1,400-$4,000 per patient, in addition to added costs treating complications. There are economic consequences to missing high grade prostate cancer as well. Risk stratification tools such as the ExoDx Prostate test provide the right intervention for the right patient at the right time. Publication of this study in a leading urology journal confirms our convictions that the ExoDx Prostate test provides strong clinical utility and economic value to patients, the medical community and private payors."

A nationwide webinar is scheduled for May 21, 2020 to review the study findings in detail. More information can be found on the Exosome Diagnostics website at View Source