On August 11, 2020 Aethlon Medical, Inc. (Nasdaq: AEMD), a medical device technology company focused on developing products to diagnose and treat life and organ threatening diseases, reported financial results for its first quarter ended June 30, 2020 and provided an update on recent developments (Press release, Aethlon Medical, AUG 11, 2020, View Source [SID1234563457]).

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Company Updates

Aethlon Medical, Inc. (Company or Aethlon) is continuing the development of its proprietary Hemopurifier, which is a first in class therapeutic device designed for the single use depletion of cancer-promoting exosomes and circulating viruses. The Hemopurifier has previously been designated a Breakthrough Device by the FDA for the treatment of glycosylated viruses, including Ebola and other hemorrhagic fever viruses, and in late 2018 was additionally designated as a Breakthrough Device "…for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease….".

Aethlon is currently initiating its first clinical trial in patients with advanced and metastatic cancers. Under an Investigational Device Exemption (IDE) application approved by FDA in October 2019 this trial, termed an Early Feasibility Study (EFS – the device equivalent of a phase 1 study), in patients with advanced and/or metastatic head and neck cancer is being run at the UPMC Hillman Cancer Center in Pittsburgh, PA and has been approved by the UPMC Institutional Review Board (IRB). The EFS will enroll 10-12 subjects and will investigate the combination of the Hemopurifier with standard of care pembrolizumab (Keytruda) in the front line setting.

As previously disclosed, the FDA has approved an amendment to the Company’s open IDE for the Hemopurifier in life threatening viral infections, to allow for the treatment of patients with SARS-CoV-2/COVID-19 infection. This will allow for up to 40 of these patients to be treated under a New Feasibility Study protocol at up to 20 clinical sites in the U.S. The Company is currently recruiting sites to conduct this trial. The Company has also recently initiated treatment of one patient under an emergency use single patient pathway that allows for the use of an investigational product in patients who have essentially failed other treatment options. While the Company cannot draw any conclusions about efficacy based on a single case, the treatment has been uneventful to date.

In other news, the Company recently announced receipt, in collaboration with the University of Pittsburgh and other academic institutions, of a five year, approximately $3.5 million grant from the National Institutes of Health (NIH) entitled "Depleting exosomes to improve responses to immune therapy in head and neck squamous cell carcinoma". This grant, on which Theresa Whiteside, one of the world’s foremost authorities on exosomes in cancer, and Dr. Annette Marleau, Aethlon’s Senior Director of Research are Co-Principal Investigators, will provide support for both bench studies on exosomes in head and neck cancer using samples from the clinical trial now being initiated and will also provide some support for a follow on clinical trial.

Financial Results for the First Quarter Ended June 30, 2020

At June 30, 2020, we had a cash balance of approximately $15.7 million.

Operating expenses for the three months ended June 30, 2020 were approximately $1.4 million, compared to approximately $1.6 million for the three months ended June 30, 2019. This decrease of approximately $200,000, or 12%, in the 2020 period was due to a decrease in payroll and related expenses of approximately $170,000 and in professional fees of approximately $43,000, which was partially offset by an increase in general and administrative expenses of approximately $27,000.

The $170,000 decrease in payroll and related expenses was due to the combination of a $242,000 reduction in stock-based compensation expense and a $73,000 increase in our cash-based compensation expense. The cash-based compensation increase was in turn due to additions to our headcount and to salary increases.

The $43,000 decrease in our professional fees was primarily due to a $22,000 decrease in our legal fees and a $22,000 decrease in our accounting fees.

The $27,000 increase in general and administrative expenses was primarily due a $26,000 increase in our clinical trial expenses as we prepare for our planned clinical trials.

Other expense during the three months ended June 30, 2020 consisted of interest expense and during the three months ended June 30, 2019, consisted of interest expense and a loss on debt extinguishment. Other expense for the three months ended June 30, 2020 was approximately $1,000, compared to other expense of approximately $501,000 for the three months ended June 30, 2019.

As a result of the changes in revenues and expenses noted above, our net loss before noncontrolling interests decreased to approximately $1.4 million for the three months ended June 30, 2020, from approximately $2.1 million for the three months ended June 30, 2019.

In June 2020, we raised additional cash through the sale of 2,685,600 shares of common stock under our ATM facility at an average price of $2.70 per share of net proceeds. We did not issue any warrants in this financing. The aggregate net proceeds to us were approximately $7.3 million.

The unaudited condensed consolidated balance sheet for June 30, 2020 and the unaudited condensed consolidated statements of operations for the three month periods ended June 30, 2020 and 2019 follow at the end of this release.

Conference Call

The Company will hold a conference call today, Tuesday, June 11, 2020 at 4:30 p.m. Eastern Time to review financial results and recent corporate developments. Following management’s formal remarks, there will be a question and answer session.

Interested parties can register for the conference by navigating to View Source

Please note that registered participants will receive their dial in number upon registration.

Interested parties without internet access or unable to pre-register may dial in by calling:

PARTICIPANT DIAL IN (TOLL FREE):

1-844-836-8741

PARTICIPANT INTERNATIONAL DIAL IN:

1-412-317-5442

All callers should ask for the Aethlon Medical, Inc. conference call.

A replay of the call will be available approximately one hour after the end of the call through August 18, 2020. The replay can be accessed via Aethlon Medical’s website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada Toll Free at 1-855-669-9658. The replay conference ID number is 10147021.

On August 11, 2020 Unum Therapeutics Inc. (Nasdaq: UMRX), a biopharmaceutical company focused on developing novel, best-in-class precision kinase inhibitors for a range of patients living with cancer and other unmet medical needs, reported financial results for the second quarter ended June 30, 2020 and provided corporate updates (Press release, Unum Therapeutics, AUG 11, 2020, View Source [SID1234563456]).

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"With the recent acquisition of Kiq, Unum’s focus on PLX9486 creates an exciting opportunity as we advance development of novel precision kinase inhibitors to treat patients with cancer and a range of other diseases with limited safe and effective treatment options," said Chuck Wilson, Ph.D., President and CEO of Unum. "PLX9486 is a highly potent and selective KIT D816V inhibitor that has demonstrated promising clinical data, and we believe has significant potential to transform the management of serious diseases in many individuals. With PLX9486 as a cornerstone, we believe our team at Unum is poised to build a pipeline of best-in-class, precision kinase inhibitors."

Recent Program and Corporate Highlights

Announced completed acquisition of Kiq LLC: In July 2020, Unum announced the completed acquisition of Kiq LLC, a privately held biotechnology company focused on the discovery and development of precision kinase inhibitors. The acquisition was further financed by a private placement resulting in gross proceeds to Unum of approximately $104.4 million before deducting placement agent and other offering expenses. The private placement was led by Fairmount Funds Management LLC, with participation from Venrock Healthcare Capital Partners, BVF Partners L.P., Atlas Venture, Acorn Bioventures, Perceptive Advisor’s LLC, RTW Investments, OrbiMed, Samsara BioCapital, Logos Capital, Ally Bridge Group and Commodore Capital, as well as additional undisclosed institutional investors. Unum believes the acquisition of Kiq represents a high potential value creation opportunity for shareholders and creates a promising path forward. The Company continues to pursue strategic opportunities for its cell-based therapy programs. Unum has retained key employees across the newly integrated company and continues to attract talent to advance its precision kinase inhibitor programs.
Advancing clinical development of PLX9486: Unum is advancing clinical studies of PLX9486 in multiple indications, including Gastrointestinal Stromal Tumors (‘GIST’) and systemic mastocytosis. Published clinical data demonstrate the critical role of KIT kinase activity as a driver in both GIST and systemic mastocytosis. PLX9486 is a highly potent and selective KIT D816V inhibitor that not only addresses primary activating mutations, but also resistance and activation loop mutations.
Unum plans to initiate clinical development of PLX9486 as a monotherapy for patients with Advanced Systemic Mastocytosis (ASM) and Indolent Systemic Mastocytosis (ISM) with the goal of demonstrating a best-in-class clinical profile. Patients living with systemic mastocytosis experience a range of symptoms, including reduced life span and chronic conditions, and there are limited treatment options available. Unum expects to initiate clinical testing in ASM patients in the first half of 2021, followed by trials in ISM patients in the second half of 2021.
In addition, PLX9486 has demonstrated promising clinical activity in a Phase 1/2 trial in patients with GIST demonstrating 11 months median progression free survival in 18 GIST patients treated in a second line or later setting. Safety data from both single agent and combination trials in more than 50 patients supports further clinical development. PLX9486 is currently in Phase 2 clinical development in GIST, and Unum plans to advance the compound into additional clinical trials in the second half of 2021. Unum plans to present further details from PLX9486 studies at an upcoming medical meeting.
Second Quarter 2020 Financial Results

Collaboration Revenue: Collaboration revenue recognized during the second quarter ended June 30, 2020 of $0.5 million compared to $3.1 million in the same period of 2019. This decrease is due to the termination of a collaboration agreement in January 2020.
R&D Expenses: Research and development expenses of $5.1 million for the second quarter ended June 30, 2020 compared to $10.6 million for the same period of 2019. This decrease is primarily related to the reduction in clinical activity of Unum’s legacy clinical trials.
G&A Expenses: General and administrative expenses for the second quarter ended June 30, 2020 were $2.8 million, compared to $3.1 million for the same period of 2019. The decrease is primarily related to lower professional and consultant fees.
Net Loss: Net loss attributable to common stockholders was $7.4 million, or $0.24 per share, for the second quarter ended June 30, 2020 compared with a net loss attributable to common stockholders of $10.5 million, or $0.34 per share, for the same period of 2019.
Cash and Cash Equivalents: As of June 30, 2020, Unum had cash and cash equivalents of $21.3 million. Unum believes that its current cash and cash equivalents, including the $104.4 million received on July 9, 2020 from the Series A Preferred Stock private placement, will enable Unum to fund its operating expenses and capital expenditure requirements beyond 2022.

On August 11, 2020 Medicure Inc. ("Medicure" or the "Company") (TSXV: MPH) (OTC: MCUJF), a cardiovascular pharmaceutical company, reported its results from operations for the quarter ended June 30, 2020 (Press release, Medicure, AUG 11, 2020, View Source [SID1234563455]).

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Quarter Ended June 30, 2020 Highlights:

Net income for the quarter ended June 30, 2020 was $19,000 compared to net loss of $957,000 for the quarter ended June 30, 2019; and

Adjusted earnings before interest, taxes, depreciation and amortization (EBITDA1) for the quarter ended June 30, 2020 was $263,000 compared to adjusted EBITDA of $103,000 for the quarter ended June 30, 2019; and

Recorded total net revenue from the sale of products of $2.7 million during the quarter ended June 30, 2020 compared to $6.3 million for the quarter ended June 30, 2019;

Recorded total net revenue from the sale of AGGRASTAT of $2.6 million during the quarter ended June 30, 2020 compared to $6.2 million for the quarter ended June 30, 2019.
Financial Results

Net revenues for the three months ended June 30, 2020 were $2.7 million compared to $6.3 million for the three months ended June 30, 2019. Net revenues from AGGRASTAT for the three months ended June 30, 2020 were $2.6 million compared to $6.2 million for the three months ended June 30, 2019. ZYPITAMAGTM contributed $103,000 for the three months ended June 30, 2020 compared to $9,000 for the three months ended June 30, 2019. Additionally, SNP, which was first sold commercially during 2020, contributed $17,000, during the three months ended June 30, 2020. The Company did not earn any revenues from ReDSTM during the three months ended June 30, 2020 compared to net revenue of $51,000 for the three months ended June 30, 2019.

Net revenues for the six months ended June 30, 2020 were $5.7 million compared to $11.2 million for the six months ended June 30, 2019. Net revenues from AGGRASTAT for the six months ended June 30, 2020 were $5.3 million compared to $11.0 million for the six months ended June 30, 2019. ZYPITAMAGTM contributed $266,000 for the six months ended June 30, 2020 compared to $9,000 for the six months ended June 30, 2019. Additionally, SNP, which was first sold commercially during 2020, contributed $48,000, during the six months ended June 30, 2020. Revenues from ReDSTM for the six months ended June 30, 2020 totaled $89,000 compared to net revenue of $154,000 for the six months ended June 30, 2019.

There was a significant decrease in the volume of the AGGRASTAT sold in Q2 2020 compared to Q2 2019, due mainly to COVID-19. The Company is beginning to see increases in demand for ZYPITAMAGTM and expects growth in ZYPITAMAGTM revenues going forward. The Company continues to show strong patient market share with AGGRASTAT, however, the market share is offset by the lower discounted prices for AGGRASTAT in the first half of 2020.

Adjusted EBITDA for the three months ended June 30, 2020 was $263,000 compared to $103,000 for the three months ended June 30, 2019. The increase in adjusted EBITDA for the three months ended June 30, 2020 is the result of lower selling and research and development expenses, partially offset by lower revenues during the three months ended June 30, 2020 when compared to the same period in 2019.

Adjusted EBITDA for the six months ended June 30, 2020 was negative $1.0 million compared to negative $1.6 million for the six months ended June 30, 2019. The improvement in adjusted EBITDA for the six months ended June 30, 2020 is the result of lower selling and research and development expenses, partially offset by lower revenues during the six months ended June 30, 2020 when compared to the same period in 2019.

During the three months ended June 30, 2020, the Company recorded $325,000 in government assistance resulting from the Canada Emergency Wage Subsidy. The funding has been recorded as a reduction of the related salary expenditures with $248,000 recorded within selling expenses, $43,000 recorded within general and administrative expenses and $34,000 recorded with research and development expenses. Additionally, during the three months ended June 30, 2020, the Company recorded a recovery totaling $677,000 within research and development expenses pertaining to fees previously paid to the United States Food and Drug Administration ("FDA") for which the FDA has subsequently granted a waiver.

Net income for the three months ended June 30, 2020 was $19,000 or $0.00 per share compared to net loss of $957,000 or $0.06 per share for the three months ended June 30, 2019. The change in the net income for the three months ended June 30, 2020 is the result of lower selling and research and development expenses and a gain on foreign exchange, partially offset by lower revenues experienced during the three months ended June 30, 2020 when compared to the three months ended June 30, 2019.

Net loss for the six months ended June 30, 2020 was $1.4 million or $0.13 per share compared to $3.7 million or $0.24 per share for the six months ended June 30, 2019. The change in the net loss for the six months ended June 30, 2020 is the result of lower selling and research and development expenses and a gain on foreign exchange, partially offset by lower revenues and higher cost of goods sold, primarily from increased amortization of intangible assets, experienced during the six months ended June 30, 2020 when compared to the six months ended June 30, 2019.

At June 30, 2020, the Company had unrestricted cash totaling $11.2 million down from the $13.0 million of unrestricted cash held as of December 31, 2019. Cash flows used in operating activities for the six months ended June 30, 2020 totaled $1.8 million compared to $7.1 million for the six months ended June 30, 2019.

All amounts referenced herein are in Canadian dollars unless otherwise noted.

Notes

(1) The Company defines EBITDA as "earnings before interest, taxes, depreciation, amortization and other income or expense" and Adjusted EBITDA as "EBITDA adjusted for non-cash and non-recurring items". The terms "EBITDA" and "Adjusted EBITDA", as it relates to the three and six months ended June 30, 2020 and 2019 results prepared using IFRS, do not have any standardized meaning according to IFRS. It is therefore unlikely to be comparable to similar measures presented by other companies.

Conference Call Info:

Topic: Medicure’s Q2 2020 Results

Call date: Wednesday, August 12, 2020

Time: 7:30 AM Central Time (8:30 AM Eastern Time)

Canada toll: 1 (416) 764-8659

North American toll-free: 1 (888) 664-6392

Passcode: not required

Webcast: This conference call will be webcast live over the internet and can be accessed from the Medicure investor relations page at the following link: View Source

You may request international country-specific access information by e-mailing the Company in advance. Management will accept and answer questions related to the financial results and operations during the question-and-answer period at the end of the conference call. A recording of the call will be available following the event at the Company’s website.

On August 11, 2020 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for population sequencing and cancer, reported that it has commenced an underwritten public offering of $100 million of its common stock (Press release, Personalis, AUG 11, 2020, View Source [SID1234563451]). In addition, Personalis expects the underwriters to be granted a 30-day option to purchase up to an additional $15 million of common stock from a selling stockholder on the same terms and conditions. Personalis will not receive any proceeds from any sale of shares by the selling stockholder.

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The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering.

BofA Securities, Citigroup and Cowen are acting as joint book-running managers. BTIG, Needham & Company and Oppenheimer & Co. are acting as co-managers.

A shelf registration statement relating to the shares being sold in this offering was filed with the U.S. Securities and Exchange Commission on July 2, 2020, and was declared effective on July 10, 2020. The offering will be made only by means of a prospectus supplement and accompanying prospectus. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available for free on the SEC’s website located at View Source When available, electronic copies of the preliminary prospectus supplement and accompanying prospectus relating to the proposed public offering may be obtained from BofA Securities, Inc., Attention: Prospectus Department, NC1‐004‐03‐43, 200 North College Street, 3rd floor, Charlotte, NC 28255‐0001, or by emailing [email protected]; Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 1-800-831-9146; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: 631‐274‐2806.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On August 11, 2020 Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis to advance the science of precision health, reported Chairman and Chief Executive Officer, Kevin Hrusovsky, will participate in a virtual fireside chat discussion at the Canaccord Genuity 40th Annual Growth Conference on August 13 at 10:00 a.m., EDT. Hrusovsky will also host virtual one-on-one and group meetings with institutional investors that day (Press release, Quanterix, AUG 11, 2020, View Source [SID1234563450]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A live webcast of the conversation will be available on the investor section of the Quanterix website at View Source Replays of the webcast will be available on the Quanterix website for 90 days following the conference.