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Soligenix Announces Recent Accomplishments And Second Quarter 2020 Financial Results

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.

Oncology Venture issues 1,893,939 shares to Negma Group LTD and Park Partners GP and thereby all outstanding convertible loan notes are converted

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.

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.

OncoSec Medical Incorporated Announces Proposed Public Offering of Common Stock

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.

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

AnHeart Raises $20 Million for ROS1/NTRK Inhibitor to Treat NSCLC

On August 14, 2020 AnHeart Therapeutics of Hangzhou reported that it raised over $20 million in an over-subscribed Series A+ financing round (Press release, AnHeart Therapeutics, AUG 14, 2020, View Source [SID1234563662]). The company will use the proceeds to support global Phase II trials of taletrectinib, a selective next-gen ROS1/NTRK inhibitor, along with advancing its other oncology assets. Because taletrectinib is capable of crossing the blood-brain barrier, it is expected to be effective against brain metastases in NSCLC. AnHeart will test the candidate in patients who have NSCLC with ROS1 mutations or advanced/metastatic solid tumors with NTRK mutations.

Enzon Pharmaceuticals, Inc. Adopts Tax Benefits Preservation Plan to Protect its NOL Assets and Shareholder Value

On August 14, 2020 Enzon Pharmaceuticals, Inc. (the "Company" or "Enzon") (OTC:ENZN) reported that its Board of Directors (the "Board") adopted a tax benefits preservation plan (the "Section 382 Rights Plan") designed to protect the availability of Enzon’s net operating loss carryforwards ("NOLs") under the Internal Revenue Code (the "Code") (Press release, Enzon, AUG 14, 2020, View Source [SID1234563661]).

As of December 31, 2019, Enzon had U.S. federal and state NOLs and tax credits, including approximately $101 million of U.S. federal NOLs, which may be available to offset its future taxable income. Enzon’s ability to use these NOLs would be substantially limited if it experienced an "ownership change" within the meaning of Section 382 of the Code. In general, an ownership change would occur if Enzon’s stockholders who are deemed to be owners of 5% or more of its shares under Section 382 collectively increase their aggregate ownership of Enzon’s common stock by more than 50% (measured over a three year period).

The Section 382 Rights Plan is intended to reduce the likelihood of such an ownership change at Enzon by deterring any person (or any persons acting as a group) from acquiring beneficial ownership of 4.9% or more of Enzon’s outstanding common stock or, with respect to any person (or any persons acting as a group) that as of today’s date already is a 5% stockholder, from increasing its ownership stake.

Under the Section 382 Rights Plan, the rights will initially trade with Enzon’s common stock and will generally become exercisable only if a person (or any persons acting as a group) acquires 4.9% or more of Enzon’s outstanding common stock. If the rights become exercisable, all holders of rights (other than any triggering person) will be entitled to acquire shares of common stock at a 50% discount or Enzon may exchange each right held by such holders for one share of common stock. Under the Section 382 Rights Plan, any person which currently owns 4.9% or more of Enzon’s common stock may continue to own its shares of common stock but may not acquire any additional shares without triggering the Section 382 Rights Plan.

The Section 382 Rights Plan will expire on August 13, 2021, unless earlier terminated pursuant to the terms of the Section 382 Rights Plan. Under the Section 382 Rights Plan, the Board has the discretion to exempt any transaction and to exempt any person (or group of persons) from the provisions of the Section 382 Rights Plan.

Additional information about the Section 382 Rights Plan is available on a Form 8-K filed by Enzon with the U.S. Securities and Exchange Commission.