On August 14, 2020 Cardax, Inc. (OTCQB:CDXI) reported its Q2 2020 results (Press release, Cardax Pharmaceuticals, AUG 14, 2020, View Source [SID1234563667]). Highlights:

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Financial Results. Net operating loss from the same quarter last year decreased from $1,049,412 in Q2 2019 to $789,032 in Q2 2020, primarily attributed to a decrease in professional fees, salaries and wages, and selling, general, and administrative expenses. Net loss in the same period increased to $1,700,342 from $1,081,694, primarily due to amortization of non-cash discounts related to outstanding convertible notes.

ZanthoSyn Sales. Cardax net revenues from ZanthoSyn, the Company’s astaxanthin dietary supplement, increased to $134,521 in Q2 2020 from $45,391 in Q2 2019, and to $277,334 in the six-months ended June 30, 2020, from $210,363 in the same period in 2019. These increases were driven primarily driven by differences in promotional incentives and ordering patterns by the Company’s largest customer, General Nutrition Corporation ("GNC"). Sell-through decreased in these periods, primarily due to COVID-19 related impacts on GNC store sales. ("Sell-through" is defined as retail sales of ZanthoSyn to GNC customers.) The Company is also exploring additional sales channels to help expand revenues.

Funding Activities. In April 2020, the Company received a $211,300 forgivable loan through the Small Business Administration’s Paycheck Protection Program under the CARES Act, which was used primarily to support employee salaries, consistent with the focus of the legislation. In May 2020, the Company raised $460,000 through the issuance of a convertible note, $250,000 of which was used to pay off an outstanding convertible note, with the balance after issuance costs used for general working capital. An additional $225,000 was raised in July and August 2020 to date through the issuance of convertible notes to existing stockholders.

Clinical Trial Grant Submission. At the invitation of a federal government agency, Cardax submitted a grant application for a proposed 400 subject, multi-center, randomized, double-blind, placebo-controlled human clinical trial in COVID-19 with one of its astaxanthin products. The Company has also filed a patent application related to this indication. The primary endpoint of the proposed clinical trial would assess the time to recovery in hospitalized COVID-19 patients aged 65 and older.

The scientific rationale for testing astaxanthin in this indication is based on its potential to boost the immune system and reduce the extreme inflammatory response and oxidative stress that may lead to severe respiratory and coagulation complications in COVID-19 patients. Furthermore, astaxanthin has demonstrated exceptional safety in rigorous animal toxicity studies, with no evidence of immunocompromise, even at high doses.

The grant application was submitted in July 2020, and the Company does not yet know if the grant will be funded or the timing or amount of a funding award, if any.

CHASE Study. In March 2020, the Company suspended recruitment of new subjects and study visits for existing subjects due to the COVID-19 pandemic and the related governmental "stay-at-home" orders. The Company expects to resume clinical trial operations when permissible and safe to proceed. The CHASE (Cardiovascular Health Astaxanthin Supplement Evaluation) study is a randomized, double-blind, placebo-controlled trial evaluating the cardiovascular health benefits of ZanthoSyn in subjects with documented cardiovascular risk factors. In a pre-specified interim look with 40 subjects, statistically significant improvements were seen in total cholesterol, LDL cholesterol, oxidized LDL cholesterol, and blood pressure, with a strong trend in reduction of the inflammatory marker, C-reactive protein, as well as triglycerides.

The Company believes that its operations, including revenues and any public or private offerings, will continue to be affected by the ongoing COVID-19 pandemic, although the extent of the impact is uncertain at this time.

"Substantial internal effort went into preparation of the recently submitted federal grant application and we look forward to further interaction with the federal agency as it goes through the review process," said David G. Watumull, Cardax CEO. "We believe that given its excellent safety profile and strong scientific rationale, our proprietary astaxanthin product should be tested for safety and efficacy in a COVID-19 clinical trial. We also continue to diligently pursue multiple other funding opportunities for our COVID-19 program as well as for other applications. We would again like to thank our shareholders, employees, contractors, advisors, and professional service providers for all of their efforts during these difficult times. Their perseverance and commitment are key to advancing our business strategy."

Please refer to the Quarterly Report on Form 10-Q filed by the Company for additional information.

On August 14, 2020 Qualigen Therapeutics, Inc. (NASDAQ: QLGN) (Qualigen or the Company) reported business highlights and financial results for the fiscal year 2021 first quarter, ended June 30, 2020 (Press release, Qualigen, AUG 14, 2020, View Source [SID1234563666]).

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Business highlights for the fiscal first quarter and recent weeks include the following:

Raised a total of $18 million in new equity financing. Under separate purchase agreements in July and August 2020, the Company raised a total of $18 million in cash (before expenses) from registered-direct placements of common stock and warrants with a single institutional investor. As of today, the Company has $16 million in cash and cash equivalents. The Company believes its cash and cash equivalents are sufficient to fund its operations into calendar 2022.
Signed exclusive license agreement with the University of Louisville for RAS interaction inhibitor drug candidates. In July 2020, Qualigen signed an exclusive worldwide license agreement with the University of Louisville (UofL) for the intellectual property covering the RAS-F family of RAS oncogene protein-protein interaction inhibitor small molecule drug candidates. The Company will evaluate these patent-pending compounds in order to identify a lead drug candidate for further development against one or more cancers.
Signed exclusive license agreement with the University of Louisville, with plans to develop AS1411 for the treatment of COVID-19. In June 2020, the Company signed an exclusive license agreement with the UofL to facilitate development of Qualigen’s AS1411 DNA aptamer as a drug candidate for the treatment of COVID-19, the disease caused by the novel coronavirus SARS-CoV-2.
Engaged NFL Hall of Famer Mike Haynes as advisor to the Company and spokesperson for the FastPack rapid diagnostic system. In July 2020, the Company engaged Pro Football Hall of Fame and College Football Hall of Fame inductee Mike Haynes as an advisor to the Company and as spokesperson for Qualigen’s FastPack rapid diagnostic system. Since receiving an elevated PSA test result using a FastPack immunoassay test at a 2008 Hall of Fame event sponsored by Qualigen and the American Urological Association, Mr. Haynes has been a prominent advocate for prostate cancer testing.
Commenced commercial shipments of its FastPack COVID-19 antibody test. In July 2020, Qualigen announced it began commercial shipments of its FastPack SARS-CoV-2 IgG diagnostic test for COVID-19 antibodies. This test has been submitted to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA), and previously the Company submitted an official notification to the FDA of its plans to exercise its right to commence sales while the EUA is pending.
Received U.S. patent Notice of Allowance for its STARS technology. In June 2020, the United States Patent and Trademark Office issued Qualigen a Notice of Allowance for a U.S. patent titled "Devices and Methods for On-Line Whole Blood Treatment" regarding the Company’s Selective Target Antigen Removal System (STARS) technology. STARS is a DNA/RNA-based treatment product candidate for the removal of viral and tumor-produced compounds from a patient’s blood.
Management Commentary

"I am pleased with the significant progress Qualigen has made since our May 2020 reverse recapitalization transaction to expand and advance our development programs," stated Michael Poirier, President and Chief Executive Officer of Qualigen. "We recently raised $18 million in capital, which we will use to advance our therapeutic pipeline of promising cancer and infectious disease drug candidates, including AS1411, ALAN and RAS-F, as well as to further our FastPack diagnostics platform."

First Quarter Financial Results

Total revenues for the three months ended June 30, 2020 were $0.9 million compared with $1.5 million for the same period in 2019. The decrease was primarily due to the COVID-19 pandemic resulting in a decrease in patient visits to physician offices, clinics and small hospitals, which reduced the number of FastPack tests performed. All revenues in both periods were derived from diagnostic products.

General and administrative expense was $2.0 million for the three months ended June 30, 2020 compared with $0.3 million for the prior-year period. The increase is largely attributable to one-time expenses related to the reverse recapitalization transaction and other public company expenses not incurred in the prior-year period.

Total R&D expense was $0.6 million for the three months ended June 30, 2020 compared with $0.7 million for the prior-year period. Higher expenses related to sponsored therapeutics research at the University of Louisville and COVID-19 antibody diagnostic test development were offset by the absence in the 2020 period of related-party research and development costs associated with a diagnostics development project with Sekisui Diagnostics, LLC which was terminated in May 2019.

Loss from operations for the three months ended June 30, 2020 increased to $2.6 million from a $0.5 million loss from operations for the prior-year period. Net loss for the three months ended June 30, 2020 was $18.6 million, or $2.12 per share, compared with a net loss of $0.6 million, or $0.11 per share, for the same period of 2019. Net loss for the three months ended June 30, 2020 included a non-cash charge of $16.2 million for the fair value of warrant liabilities.

Qualigen had cash and cash equivalents of $2.3 million as of June 30, 2020. Subsequent to the close of the quarter, in July and August 2020 the Company raised an additional $18 million in gross proceeds from registered-direct equity offerings.

Conference Call

Qualigen senior management will host a business update conference call and live audio webcast beginning at 4:30 p.m. Eastern time on August 18, 2020. Participants are encouraged to pre-register for the conference call using this link. Callers who pre-register will be given a conference passcode and unique PIN to gain immediate access to the call and bypass the live operator. Participants may register at any time, including up to and after the call start time. A webcast of the call may also be accessed at Qualigen’s Investor Relations page at Qualigen Business Update Conference Call. Those without internet access or unable to pre-register may dial in by calling 1-866-777-2509 (U.S.) or 1-412-317-5413 (International).

A replay of the webcast will be available beginning approximately one hour after the completion of the live conference call at Qualigen Business Update Conference Call. A dial-in replay of the call will be available until August 25, 2020 by calling 1-877-344-7529 (U.S.) or 1-412-317-0088 (International) and providing the passcode 10147089.

On August 14, 2020 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported its recent accomplishments and financial results for the quarter ended June 30, 2020 (Press release, Soligenix, AUG 14, 2020, View Source [SID1234563665]).

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Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "We continue to execute on our strategy with a number of positive accomplishments. Our pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial continues to demonstrate SGX301’s potential to be an important new treatment for early-stage cutaneous T-cell lymphoma (CTCL). In the double-blind, placebo controlled Cycle 1 portion of the study, a statistically significant treatment response (p=0.04) was achieved in the primary endpoint after 6 weeks of therapy. This positive treatment response continued to significantly improve with extended SGX301 treatment in the open-label treatment cycle, referred to as Cycle 2, with an additional 6 weeks of therapy (p<0.0001 compared to placebo and p<0.0001 compared to 6-weeks treatment). The optional, compassionate-use, treatment cycle (Cycle 3) and the subsequent 6-month follow-up is expected in the fourth quarter of 2020, with the majority of patients enrolled having elected to continue with this optional cycle of the study – a clear indication of their satisfaction. We also continue to advance our pivotal Phase 3 clinical trial of SGX942 (dusquetide), referred to as the DOM-INNATE (Dusquetide treatment in Oral Mucositis – by modulating INNATE Immunity) study, for the treatment of oral mucositis in patients with head and neck cancer (HNC) receiving chemoradiation therapy. Following the positive recommendation received from the independent Data Monitoring Committee (DMC) and after taking a conservative approach to assessing the potential impact of COVID-19 on the study, we have successfully enrolled 268 subjects. With enrollment completed, top-line results continue to be expected in the fourth quarter 2020."

Dr. Schaber continued, "Under our Public Health Solutions business segment, we continue to advance our work with the University of Hawaiʻi at Mānoa (UHM) and Hawaii Biotech Inc. on filovirus vaccines (protecting against viruses such as Ebola and Marburg) and the development of vaccines to potentially combat coronaviruses, including SARS-CoV-2, the cause of COVID-19. We recently announced publication of positive pre-clinical data from immunogenicity studies with CiVax (heat stable COVID-19 vaccine candidate), demonstrating immunity of both broad-spectrum antibody and cell-mediated, rapid onset immunity is possible using the CoVaccine HT adjuvant. Our heat stable ricin vaccine, RiVax, continues to be supported with a National Institute of Allergy and Infectious Disease contract award of $21.2 million. With over $11M in cash, not including our non-dilutive government funding, along with the at-the-market sales issuance agreement with B. Riley FBR, Inc. to judiciously supplement our cash runway as needed, we anticipate having sufficient capital to achieve multiple inflection points across our rare disease pipeline, including final top-line results in our SGX942 Phase 3 clinical trial in oral mucositis."

Soligenix Recent Accomplishments

On July 28, 2020, the Company announced publication of pre-clinical immunogenicity studies for its CiVax program (heat stable COVID-19 vaccine candidate), demonstrating immunity of both broad-spectrum antibody and cell-mediated, rapid onset immunity is possible using the CoVaccine adjuvant. The article, authored by collaborators at the UHM, is titled, "CoVaccine HT adjuvant potentiates robust immune responses to recombinant SARS-CoV-2 spike-S1 immunization," and has been submitted for peer-review to the journal npj Vaccines. An accelerated preprint of the manuscript has been made available here. To view this press release, please click here.
On July 20, 2020, the Company announced that it had issued an update letter from its President and Chief Executive Officer, Dr. Christopher J. Schaber, highlighting important catalysts for the second half of 2020. To view this press release and letter, please click here.
On June 24, 2020, the Company announced that it had completed patient enrollment in its Phase 3 DOM-INNATE study for SGX942 (dusquetide) in the treatment of oral mucositis in HNC patients. The study successfully enrolled 268 subjects, following positive interim analysis, which included a prospectively defined, unblinded assessment of the study’s primary efficacy endpoint by an independent DMC. To view this press release, please click here.
On June 22, 2020, the Company announced that it would join the Russell Microcap Index at the conclusion of the 2020 Russell indexes annual reconstitution, effective after the US market opens on June 29th, according to a final list of additions posted June 15th. To view this press release, please click here.
Financial Results – Quarter Ended June 30, 2020

Soligenix’s revenues for the quarter ended June 30, 2020 were $0.5 million as compared to $1.4 million for the quarter ended June 30, 2019. Revenues included payments on a contract in support of RiVax, our ricin toxin vaccine candidate, grants received to support the development of SGX943 for treatment of emerging and/or antibiotic-resistant infectious diseases, ThermoVax, our thermostabilization technology, and the assessment of SGX942 safety in juvenile animals.

Soligenix’s basic net loss was $2.8 million, or ($0.10) per share, for the quarter ended June 30, 2020, as compared to $2.1 million, or ($0.12) per share, for the quarter ended June 30, 2019. This increase in net loss was primarily the result of increased research and development spending primarily attributable to higher clinical trial site and patient fees for the pivotal Phase 3 clinical trials of SGX301 and SGX942.

Research and development expenses were $2.2 million as compared to $1.9 million for the quarters ended June 30, 2020 and 2019, respectively. The increase in research and development spending for the quarter ended June 30, 2020 was primarily attributable to the site and patient fees for the pivotal Phase 3 clinical trials of SGX301 and SGX942, compared to the same period in 2019.

General and administrative expenses were $0.8 million for both the three months ended June 30, 2020 and 2019.

As of June 30, 2020, the Company’s cash position was approximately $11.2 million.

On August 14, 2020 Oncology Venture A/S (Nasdaq First North Stockholm: OV.ST) ("OV" or the "Company") today announces that it will issue 1,893,939 shares at a price per share of SEK 1.32 to Negma Group LTD in order to comply with the Company’s existing convertible loan note agreement (Press release, Oncology Venture, AUG 14, 2020, View Source [SID1234563664]). This share issue completes the share conversions related to OV’s call of the first tranche of convertible loan notes.

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Oncology Venture announced on April 3rd, 2020, that it has called upon the first tranche of convertible loan notes in line with the terms from the financing agreement communicated on March 31st, 2020. Negma Group Ltd. has requested to convert SEK 2,500,000 of the notes into 1,893,939 shares of nominal DKK 0.05 each. This share conversion, announced today, finalizes the share issues related to the first tranche of convertible loan notes under the agreement.

OV has not utilized additional tranches under this agreement and remains in full control of any further issue of convertible loan notes.

The conversion price is fixed at SEK 1.32 per share of nominal DKK 0.05 share and has been calculated as 95% of the lowest VWAP share price of the seven consecutive trading days prior the receipt of the conversion request, excluding trading days on which the closing VWAP is lower than 90 % of the average closing VWAP over the pricing period otherwise calculated.

The registered share capital of Oncology Venture will after the conversion be nominal DKK 9,288,716.57 divided into 185,774,331 shares of nominal DKK 0.05 each.

On August 14, 2020 OncoSec Medical Incorporated (NASDAQ: ONCS) (the "Company" or "OncoSec") reported that it intends to offer and sell shares of its common stock in a public offering (Press release, OncoSec Medical, AUG 14, 2020, View Source [SID1234563663]). 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.

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The Company intends to use the net proceeds from this offering for clinical, regulatory, manufacturing and, if and when approved, potential commercial activities of its product candidates; research and development activities, including potential acquisitions and in-licensing; and other general corporate purposes.

ThinkEquity, a division of Fordham Financial Management, Inc., and Torreya Capital, LLC are acting as placement agents for the offering.

A shelf registration statement on Form S-3 (File No. 333-233447) relating to the shares of common stock to be issued in the proposed offering was filed with the Securities and Exchange Commission (SEC) and is effective. 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.

A preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC. The securities may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained from ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673, by email at [email protected]. Electronic copies of the preliminary prospectus supplement and accompanying prospectus will also be available on the SEC’s website at View Source