Seoul Viosys to Develop a Cancer Diagnosis Technology for Companion Animals with Violeds Technology

On August 13, 2020 Seoul Viosys (KOSDAQ: 092190), a leading compound semiconductor solution provider, reported that it has developed an advanced concept technology for early diagnosis of cancer in companion animals with its ultraviolet LED Violeds technology through clinical testing conducted by scientists at the University of Ulsan, based in South Korea (Press release, Seoul Viosys Co, AUG 13, 2020, View Source [SID1234563606]).

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According to Seoul Viosys’ research team, companion animals have a high incidence of cancer as humans, but it has difficulty in early diagnosis of cancer. So Seoul Viosys is in the process of developing a technology that can be applied not only in animals but also in human cancer diagnosis. The early cancer diagnosis method using Violeds light provides a profound study results to show significantly higher sensitivity in detecting cancer than the conventional diagnosis methods and enable to detect all incident cancers.

Seoul Viosys conducted comparative experiments with blood from healthy dogs and from cancer diseased dogs using a biomarker that can be easily collected in this clinical test. As a result, it’s confirmed that cancer diagnosis is possible by only one drop of blood. Seoul Viosys already applied for number of related patents.

Reactive Oxygen Species, ROS caused by various exogenous and endogenous factors damaged to DNA in cells and it can be pathological basis for cancer when this DNA is not repaired in a timely manner. Even though level of DNA damage on cancer cells due to oxidative stress is higher than healthy cells, the difference between the two results is small and it’s difficult to distinguish perfectly. However, Violeds technology provides the advantage that can be able to detect this delicate difference.

"Through the results of the pre-clinical testing with comet assay, an uncomplicated and sensitive technique for the detection of DNA damage at the level of the individual mononuclear cell, by research group of Ulsan University, Seoul Viosys demonstrates that Violeds technology has the performance for significantly high level of 95% sensitivity in detecting cancer for companion animals, but improvement for specificity is needed," said research team at Seoul Viosys.

"If we achieve the improved level of specificity in the future, we will be able to make a positive contribution to a quantum jump in medical technology by enabling early cancer diagnosis with about a tenth price compared to conventional test kits. Seoul Viosys also expects this technology to be used for human cancer diagnosis in the future and looks for relevant and suitable research partners to achieve significant specificity," added the team.

*Light and Violeds

Circadian rhythms as an internal clock that governs the body’s hormone levels and other biological processes such as sleep, wake, and eliminating waste from the body are based on a 24-hour cycle. It is based on natural sunlight, under which all animals and plants on the earth have evolved over 3.9 billion years, being with the beginning of the Earth 4.6 billion years ago. Seoul Viosys has recently launched air purifiers with Violeds light technology proven to sterilize various harmful bacteria and variants of coronavirus. Tracking traces of light is difficult, but if you can bend the light around the Earth, it will orbit 7.5 times per second. Also, it takes 8 minutes for light to reach Earth from the Sun, and hundreds of millions of years from distant galaxies. It is unprecedented that this light may also be used in cancer diagnosis.

BiomX Reports Second Quarter 2020 Financial Results and Provides Business Update

On August 13, 2020 BiomX Inc. (NYSE: PHGE), a clinical stage company developing natural and engineered phage therapies that target specific pathogenic bacteria, reported financial results and provided a business update for the second quarter ended June 30, 2020 (Press release, BiomX, AUG 13, 2020, View Source [SID1234563605]).

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"Following proof of concept clinical results for our phage therapy cocktail BX001 in acne-prone skin earlier this year, we continue to advance the development of multiple phage therapy candidates that have the potential to improve treatment in diverse disease areas," commented Jonathan Solomon, Chief Executive Officer of BiomX. "These candidates are designed with the ability to selectively reduce pathogenic bacterial strains without disrupting beneficial bacteria. Our BX002 program for the treatment of inflammatory bowel disease (IBD) is on track to begin clinical development in the third quarter, with the initial goal of demonstrating an ability to deliver viable phage to the lower gastrointestinal tract. We expect to report pharmacokinetics and safety data from the study by the end of 2020. This is an important step in our clinical development plans for both IBD and primary sclerosing cholangitis (PSC). The Phase 1a results are expected to inform the design of a Phase 1b/2a study aimed at evaluating the efficacy of BX002 in reduction of the target bacteria."

Recent Highlights and Key Upcoming Milestones

BX002 for the Treatment of Inflammatory Bowel Disease

BiomX has completed GMP manufacturing of phage in anticipation of a planned Phase 1a and the facility can now support multiple clinical trials simultaneously.
The first-in-human Phase 1a study of BX002 is expected to begin in the third quarter of 2020, with results expected by the end of 2020. The study is designed to provide pharmacokinetic measurements and safety data, including an assessment of delivery of viable phage to the gastrointestinal system as a key exploratory endpoint.
A Phase 1b/2a study aimed at evaluating the efficacy of BX002 in reduction of the target bacteria Klebsiella pneumoniae is expected to begin in 2021.
BX001 for the Cosmetic Market for the Appearance of Acne-Prone Skin

Following positive results from its Phase 1 cosmetic clinical study, BiomX is on track to initiate a Phase 2 cosmetic clinical study in the first quarter of 2021 with results expected in the second quarter of 2021.
BX003 for the Treatment of Primary Sclerosing Cholangitis

The Company’s program in the rare liver disease primary sclerosing cholangitis (PSC) shares the same bacterial target (Klebsiella pneumoniae) as the IBD program, BiomX plans to apply the Phase 1 study results in IBD to inform the PSC program, with the intention of progressing into Phase 2 development in 2022.
Phage Therapy for Tumor-Targeted Delivery in Cancer

BiomX is exploring phage mediated delivery of therapeutic payloads to Fusobacterium nucleatum bacteria residing in the tumors of patients with colorectal cancer. The results of a proof of concept in animal models are expected in the second quarter of 2021.
Second Quarter 2020 Financial Results

Cash balance and short-term deposits as of June 30, 2020, were $70.6 million, compared to $82.4 million as of December 31, 2019. The decrease was primarily due to net cash used in operating activities.
Research and development expenses were $4.1 million in the second quarter of 2020, compared to $2.9 million in the same period of 2019. The increase was primarily due to the manufacturing of BX001 and BX002, the Company’s product candidates for acne-prone skin and IBD/PSC, respectively.
General and administrative expenses were $2.3 million in the second quarter of 2020, compared to $1.2 million in the same period in 2019. The increase was primarily due to expenses associated with operating as a public company.
Net loss was $6.2 million in the second quarter of 2020, compared to $3.8 million in the same period of 2019.
Net cash used in operating activities was $11.4 million for the six months ended June 30, 2020, compared to $5.9 million in the same period of 2019.
Financial Expectations

Existing cash, cash equivalents and short-term deposits are expected to be sufficient to fund the Company’s current operating plan through mid-2022.
Conference Call Details

BiomX management will host a conference call and webcast today at 8:00 a.m. ET to report financial results for the second quarter of 2020 and provide business updates. To participate in the conference call, please dial 1-877-407-0724 (U.S.), 1-809-406-247 (Israel) or 1-201-389-0898 (international). A live and archived webcast of the call will be available in the Investors section of the company’s website at www.biomx.com.

About Phage

Bacteriophage, or phage, are viruses that target bacteria and are considered inert to mammalian cells. Specific phage can target and kill specific bacterial species or strains without disrupting other bacteria or the healthy microbiota. All of BiomX’s phage-based product candidates derive from its proprietary platform, which is first used to discover and validate the association and biologic rationale of specific bacterial strains with human diseases or conditions, and is then used to develop rationally-designed phage combinations ("cocktails") of naturally occurring or synthetic phage to target pathogenic bacteria. The phage cocktails contain multiple phage with complementary functions optimized through in vitro and in vivo testing.

Provectus Biopharmaceuticals Expands Sponsored Research Collaboration with University of Calgary (Canada) to Investigate Oral Administration of Rose Bengal Disodium for Cancer Treatment

On August 13, 2020 Provectus (OTCQB: PVCT) reported that the Company has expanded its sponsored research program with Aru Narendran, MD, PhD, Professor, Departments of Pediatrics, Oncology, Biochemistry & Molecular Biology, and Physiology & Pharmacology at the Cumming School of Medicine of the University of Calgary in Calgary, Alberta, Canada (Press release, Provectus Biopharmaceuticals, AUG 13, 2020, View Source [SID1234563604]).

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Under ongoing collaboration with Provectus, the Narendran research team has produced preliminary findings that show oral dosing of the Company’s current Good Manufacturing Practice (cGMP) rose bengal disodium (RBD) is effective and well tolerated in an in vivo pediatric leukemia murine model. Data from this work are currently being prepared for publication.

As part of today’s announced sponsored research expansion, the Narendran team will now investigate oral dosing of cGMP RBD in in vivo murine models for the treatment of refractory adult solid tumors that are high-risk phenotypes and have high metastatic potential. These cancer types will include head and neck, breast, pancreatic, liver, and colorectal.

The Narendran research team will also evaluate the potential prophylactic efficacy of oral cGMP RBD dosing to prevent or delay the initiation of malignancies in established in vivo murine models predisposed to developing cancer.

Provectus’ cGMP RBD is a pharmaceutical-grade drug substance produced by the Company’s quality-by-design (QbD) manufacturing process to exacting regulatory standards that avoids the formation of uncontrolled impurities currently present in commercial-grade rose bengal. The Company’s cGMP RBD manufacturing process is protected by composition of matter and manufacturing patents as well as trade secrets.

"Provectus’ prior and ongoing clinical work, which has treated more than 400 cancer patients in single-agent and combination therapy settings via intralesional administration, has established the safety, activity, mechanistic, and immunomodulatory profile of our proprietary, pharmaceutical-grade rose bengal disodium," Dominic Rodrigues, Vice Chair of the Company’s Board of Directors added. "Oral administration of a new rose bengal disodium formulation for cancer treatment is a potential novel drug product for Provectus and the logical outgrowth of the Company’s expansive medical science platform and strong clinical foundation."

About Rose Bengal Disodium

cGMP RBD is 4,5,6,7-tetrachloro-2’,4’,5’,7’-tetraiodofluorescein disodium, which is a small molecule halogenated xanthene and Provectus’ proprietary lead compound. Administered by intralesional (IL) (aka intratumoral) injection, PV-10 is the Company’s investigational autolytic immunotherapy drug product and a formulation of cGMP RBD drug substance. The Company manufactures RBD using a patented process designed to meet stringent modern global quality requirements for pharmaceuticals and pharmaceutical ingredients (cGMP).

By targeting tumor cell lysosomes, RBD treatment may yield immunogenic cell death in solid tumor cancers that results in tumor-specific reactivity in circulating T cells and a T cell mediated immune response against treatment refractory and immunologically cold tumors.1-3 Adaptive immunity can be enhanced by combining immune checkpoint blockade (CB) with RBD.4

IL PV-10 is undergoing clinical study for adult solid tumor cancers, such as relapsed and refractory cancers metastatic to the liver and metastatic melanoma. IL PV-10 is also undergoing preclinical study for relapsed and refractory pediatric solid tumor cancers (e.g., neuroblastoma, Ewing sarcoma, rhabdomyosarcoma, and osteosarcoma)5,6.

New formulations of cGMP RBD are undergoing preclinical study for relapsed and refractory pediatric blood cancers (such as acute lymphocytic leukemia and acute myelomonocytic leukemia)7,8.

Tumor Cell Lysosomes as the Seminal Drug Target

Lysosomes are the central organelles for intracellular degradation of biological materials, and nearly all types of eukaryotic cells have them. Discovered by Christian de Duve, MD in 1955, lysosomes are linked to several biological processes, including cell death and immune response. In 1959, de Duve described them as ‘suicide bags’ because their rupture causes cell death and tissue autolysis. He was awarded the Nobel Prize in 1974 for discovering and characterizing lysosomes, which are also linked to each of the three primary cell death pathways: apoptosis, autophagy, and necrosis.

Building on the Discovery, Exploration, and Characterization of Lysosomes

Cancer cells, particularly advanced cancer cells, are very dependent on effective lysosomal functioning.9 Cancer progression and metastasis are associated with lysosomal compartment changes10,11, which are closely correlated (among other things) with invasive growth, angiogenesis, and drug resistance12.

RBD selectively accumulates in the lysosomes of cancer cells upon contact, disrupting the lysosomes and causing the cells to die. Provectus1,13, external collaborators6, and other researchers14,15,16 have independently shown that RBD triggers each of the three primary cell death pathways: apoptosis, autophagy, and necrosis.

Cancer Cell Autolytic Death via RBD: RBD-induced autolytic cell death, or death by self-digestion, in Hepa1-6 murine hepatocellular carcinoma (HCC) cells can be viewed in this Provectus video of the event (ethidium homodimer 1 [ED-1] stains DNA, but is excluded from intact nuclei; lysosensor green [LSG] stains intact lysosomes; the video is provided in 30-second frames; the event has a duration of approximately one hour). Exposure to RBD triggers the disruption of lysosomes, followed by nucleus failure and autolytic cell death. Identical responses have been shown by the Company in HTB-133 human breast carcinoma (which can be viewed in this Provectus video; this event has a duration of approximately two hours) and H69Ar human multidrug-resistant small cell lung carcinoma. Cancer cell autolytic cell death was reproduced by research collaborators in neuroblastoma cells to show that lysosomes are disrupted upon exposure to RBD.5

Tumor Autolytic Death via RBD: RBD causes acute autolytic destruction of injected tumors (via autolytic cell death), mediating the release of danger-associated molecular pattern molecules (DAMPs) and tumor antigens; release of these signaling factors may initiate an immunologic cascade where local response by the innate immune system may facilitate systemic anti-tumor immunity by the adaptive immune system. The DAMP release-mediated adaptive immune response activates lymphocytes, including CD8+ T cells, CD4+ T cells, and NKT cells, based on clinical and preclinical experience in multiple tumor types. Mediated immune signaling pathways may include an effect on STING, which plays an important role in innate immunity8.

Orphan Drug Designations (ODDs)

ODD status has been granted to RBD by the U.S. Food and Drug Administration for metastatic melanoma in 2006, hepatocellular carcinoma in 2011, neuroblastoma in 2018, and ocular melanoma (including uveal melanoma) in 2019.

Intellectual Property (IP)

Provectus’ IP includes a family of US and international (a number of countries in Asia, Europe, and North America) patents that protect the process by which cGMP RBD and related halogenated xanthenes are produced, avoiding the formation of previously unknown impurities that exist in commercial-grade rose bengal in uncontrolled amounts. The requirement to control these impurities is in accordance with International Council on Harmonisation (ICH) guidelines for the manufacturing of an injectable pharmaceutical. US patent numbers are 8,530,675, 9,273,022, and 9,422,260, with expirations ranging from 2030 to 2031.

The Company’s IP also includes a family of US and international (a number of countries in Asia, Europe, and North America) patents that protect the combination of RBD and CB (e.g., anti-CTLA-4, anti-PD-1, and anti-PD-L1 agents) for the treatment of a range of solid tumor cancers. US patent numbers are 9,107,887, 9,808,524, 9,839,688, and 10,471,144, with expirations ranging from 2032 to 2035; US patent application numbers include 20200138942.

Entry into a Material Definitive Agreement

On August 13, 2020, Aclaris Therapeutics, Inc., a Delaware corporation referred to herein as we, us, our or the Company, reported that it entered into a purchase agreement, or the Purchase Agreement, with Lincoln Park Capital Fund, LLC, or Lincoln Park, which provides that, upon the terms and subject to the conditions and limitations set forth therein, we may sell to Lincoln Park up to $15,000,000 of shares of our common stock, or the Purchase Shares, from time to time over the 36-month term of the Purchase Agreement (Filing, 8-K, Aclaris Therapeutics, AUG 13, 2020, View Source [SID1234563602]). Concurrently with entering into the Purchase Agreement, we also entered into a registration rights agreement with Lincoln Park, or the Registration Rights Agreement, pursuant to which we agreed to register the sale of the shares of our common stock that may be issued to Lincoln Park under the Purchase Agreement pursuant to our existing shelf registration statement on Form S-3 or a new registration statement.

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After the Commencement Date (as defined below), on any business day selected by us, if the closing sale price of our common stock on the Nasdaq Global Select Market, or Nasdaq, is not below $0.25, we may direct Lincoln Park to purchase up to 100,000 shares of our common stock on such business day (or the purchase date), which we refer to as a Regular Purchase, provided, however, that (i) a Regular Purchase may be increased to up to 125,000 shares if the closing sale price of our common stock on Nasdaq is not below $1.50 on the applicable purchase date, (ii) a Regular Purchase may be increased to up to 200,000 shares if the closing sale price of our common stock on Nasdaq is not below $2.50 on the applicable purchase date and (iii) a Regular Purchase may be increased to up to 250,000 shares, if the closing sale price of our common stock on Nasdaq is not below $3.00 on the applicable purchase date. In each case, upon the parties’ mutual agreement, the maximum amount of any single Regular Purchase may be increased up to $2,000,000 of shares. We may direct Lincoln Park to purchase shares in Regular Purchases as often as every business day. The foregoing share amounts and per share prices will be adjusted for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction occurring after the date of the Purchase Agreement.

The purchase price per share for each such Regular Purchase will be equal to the lesser of:

·the lowest sale price for our common stock on Nasdaq on the purchase date of such shares; and

·the average of the three lowest closing sale prices for our common stock on Nasdaq during the 10 consecutive business days prior to the purchase date of such shares.

In addition, we may also direct Lincoln Park, on any business day on which we have submitted a Regular Purchase notice for the maximum amount allowed for such Regular Purchase and the closing sale price of our common stock on Nasdaq is not below $0.50, to purchase an additional amount of our common stock, which we refer to as an Accelerated Purchase, of up to the lesser of:

·three times the number of shares purchased pursuant to such Regular Purchase; and

·30% of the aggregate shares of our common stock traded on Nasdaq during all or, if certain trading volume or market price thresholds specified in the Purchase Agreement are crossed on the applicable Accelerated Purchase date, the portion of the normal trading hours on the applicable Accelerated Purchase date prior to such time that any one of such thresholds is crossed, which period of time on the applicable Accelerated Purchase date we refer to as the Accelerated Purchase Measurement Period.

The purchase price per share for each such Accelerated Purchase will be equal to 97% of the lower of:

·the volume-weighted average price of our common stock on Nasdaq during the applicable Accelerated Purchase Measurement Period on the applicable Accelerated Purchase date; and

·the closing sale price of our common stock on Nasdaq on the applicable Accelerated Purchase date.

We may also direct Lincoln Park on any business day on which an Accelerated Purchase has been completed and all of the shares to be purchased thereunder have been delivered to Lincoln Park in accordance with the Purchase Agreement, provided that the closing price of our common stock on the business day immediately preceding such business day is not below $0.50, to purchase an additional amount of our common stock, which we refer to as an Additional Accelerated Purchase, of up to the lesser of:

·three times the number of shares purchased pursuant to the applicable corresponding Regular Purchase; and

·30% of the aggregate shares of our common stock traded on Nasdaq during a certain portion of the normal trading hours on the applicable Additional Accelerated Purchase date as determined in accordance with the Purchase Agreement, which period of time on the applicable Additional Accelerated Purchase date we refer to as the Additional Accelerated Purchase Measurement Period.

We may, in our sole discretion, submit multiple Additional Accelerated Purchase notices to Lincoln Park on a single Accelerated Purchase date, provided that all prior Accelerated Purchases and Additional Accelerated Purchases (including those that have occurred earlier on the same day) have been completed and all of the shares to be purchased thereunder have been properly delivered to Lincoln Park in accordance with the Purchase Agreement.

The purchase price per share for each such Additional Accelerated Purchase will be equal to 97% of the lower of:

·the volume-weighted average price of our common stock on Nasdaq during the applicable Additional Accelerated Purchase Measurement Period on the applicable Additional Accelerated Purchase date; and

·the closing sale price of our common stock on Nasdaq on the applicable Additional Accelerated Purchase date.

In the case of Regular Purchases, Accelerated Purchases and Additional Accelerated Purchases, the purchase price per share will be equitably adjusted for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction occurring during the business days used to compute the purchase price.

Under applicable rules of Nasdaq, in no event may we issue or sell to Lincoln Park under the Purchase Agreement shares of our common stock, including the Commitment Shares described below, in excess of 8,544,555 shares, which is equal to 19.99% of the shares of our common stock outstanding immediately prior to the execution of the Purchase Agreement, or the Exchange Cap, unless (i) we obtain stockholder approval to issue shares of our common stock in excess of the Exchange Cap or (ii) the average price of all applicable sales of our common stock to Lincoln Park under the Purchase Agreement equals or exceeds $2.1912 per share (which represents the average of the official closing prices of our common stock on Nasdaq for the five trading days immediately preceding the signing of the Purchase Agreement), such that the transactions contemplated by the Purchase Agreement are exempt from the Exchange Cap limitation under applicable Nasdaq rules. In any event, the Purchase Agreement specifically provides that we may not issue or sell any shares of our common stock under the Purchase Agreement if such issuance or sale would breach any applicable rules or regulations of Nasdaq.

The Purchase Agreement contains customary representations, warranties, covenants, closing conditions and indemnification and termination provisions. Sales under the Purchase Agreement may commence only after certain conditions have been satisfied, the date on which all requisite conditions have been satisfied is referred to herein as the Commencement Date, which conditions include the delivery to Lincoln Park of a prospectus supplement covering the shares of our common stock issued or sold by us to Lincoln Park under the Purchase Agreement, approval for listing on Nasdaq Global Select Market of the shares of our common stock issued or sold by us to Lincoln Park under the Purchase Agreement, the issuance of 121,584 shares of our common stock to Lincoln Park as Commitment Shares under the Purchase Agreement, and the receipt by Lincoln Park of a customary opinion of counsel and other certificates and closing documents. The Purchase Agreement may be terminated by us at any time, at our sole discretion, without any cost or penalty. Lincoln Park has covenanted not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of our common stock. There are no limitations on use of proceeds, financial or business covenants, restrictions on future financings (other than restrictions on our ability to enter into additional "equity line" or similar transactions whereby an investor is irrevocably bound to purchase securities over a period of time from us at a price based on the market price of our common stock at the time of such purchase), rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement. We may deliver Purchase Notices under the Purchase Agreement, subject to market conditions, and in light of our capital needs from time to time and under the limitations contained in the Purchase Agreement. Any proceeds that we receive under the Purchase Agreement are expected to be used for working capital and general corporate purposes.

The issuance of the Purchase Shares and Commitment Shares have been registered pursuant to our effective shelf registration statement on Form S-3 (File No. 333-237163), or the Registration Statement, and the related base prospectus included in the Registration Statement, as supplemented by a prospectus supplement filed on August 13, 2020, or the Prospectus Supplement. A copy of the legal opinion as to the legality of the shares of our common stock subject to the Purchase Agreement is filed as Exhibit 5.1 attached hereto.

The foregoing is a summary description of certain terms of the Purchase Agreement and the Registration Rights Agreement and, by its nature, is incomplete. Copies of the Purchase Agreement and the Registration Rights Agreement are filed as Exhibits 10.1 and 10.2 attached hereto. The foregoing descriptions of the Purchase Agreement and the Registration Rights Agreement are qualified in their entirety by reference to such exhibits.

The Purchase Agreement and Registration Rights Agreement contain customary representations and warranties, covenants and indemnification provisions that the parties made to, and solely for the benefit of, each other in the context of all of the terms and conditions of such agreements and in the context of the specific relationship between the parties thereto. The provisions of the Purchase Agreement and Registration Rights Agreement, including any representations and warranties contained therein, are not for the benefit of any party other than the parties thereto and are not intended as documents for investors and the public to obtain factual information about the current state of affairs of the parties thereto. Rather, investors and the public should look to other disclosures contained in our annual, quarterly and current reports we may file with the Securities and Exchange Commission, or SEC.

The information contained in this Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the shares of our common stock discussed herein, nor shall there be any offer, solicitation or sale of the shares in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

Navidea Biopharmaceuticals Reports Second Quarter and Year-to-Date 2020 Financial Results

On August 13, 2020 Navidea Biopharmaceuticals, Inc. (NYSE American:NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported its financial results for the second quarter and year-to-date for the period ended June 30, 2020 (Press release, Navidea Biopharmaceuticals, AUG 13, 2020, View Source [SID1234563601]).

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"The past four months have been truly momentous for the company. The successful second interim look showed how valuable our diagnostic agent will be for the effective management of Rheumatoid Arthritis," said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. "The signing of the binding MOU with Jubilant is a transformational event for the future of Navidea. Partnering with the second largest radiopharmaceutical company in the United States and a global leader in pharmaceuticals is something we have worked hard to achieve for many years. Furthermore, the $25 million in growth capital pledged by a top-notch syndicate of investors has assured the company’s non-RA related growth funding for years to come."

Second Quarter 2020 Highlights and Subsequent Events

Executed a binding memorandum of understanding ("MOU") on August 9, 2020 with Jubilant Draximage Inc. dba Jubilant Radiopharma, Radiopharmaceuticals Division ("Jubilant"). The MOU outlines the terms and framework for an Exclusive License and Distribution Agreement for Navidea’s Rheumatoid Arthritis Diagnostic in the United States, Canada, Mexico, and Latin America. In connection with the MOU, Jubilant made a $1 million equity investment in exchange for a limited exclusivity period while final due diligence efforts are completed.
Signed a binding commitment letter on August 9, 2020 with Mastiff Group LLC, for a private placement financing of up to $25 million in aggregate gross proceeds of shares of Navidea’s common stock, to be priced either "at the market" or at a premium to Navidea’s closing price on the date of execution. Navidea expects to sign definitive documents for a common stock only transaction, with an investor syndicate comprised of Mastiff Group LLC, John Kim Scott, Jr. and other fundamental biotech focused investors no later than August 18, 2020, with the closing to take place within 15 business days thereafter.
Regained the commercialization and distribution rights for Lymphoseek (Tc99m tilmanocept) injection in Europe through the mutually agreed upon termination of the perpetual license agreement with SpePharm AG, a subsidiary of Norgine B.V.
Finalized the previously announced $4.2 million financing related to the judgment by the Ohio Court of Common Pleas (the "Judgment"). Navidea agreed to issue Keystone Capital Partners, LLC, up to $4.2 million of convertible preferred shares, which will be guaranteed by a portion of the proceeds of the Judgment.
Announced positive preliminary results from the Company’s second interim analysis of its ongoing NAV3-31 Phase 2b study. Analysis demonstrated that these interim data further corroborate Navidea’s hypotheses that Tc99m tilmanocept imaging can provide robust, quantitative imaging in healthy controls and in patients with active rheumatoid arthritis ("RA"), and that this imaging can provide an early indicator of treatment efficacy in patients with active RA.
Achieved full enrollment in its ongoing NAV3-31 Phase 2b study titled "Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc99m Tilmanocept Planar Imaging." All of the subjects have been enrolled in the three-arm trial, with the protocol-specified longitudinal imaging events on track.
Presented results from the Company’s first interim analysis of its ongoing NAV3-31 phase 2b clinical study, titled, A Phase 2b Study of Intravenously Administered Tc 99m Tilmanocept to Determine Differential Uptake, Reproducibility Over Time and Image Stability in Healthy Subjects and in Patients with Rheumatoid Arthritis ("RA") on Stable Treatment, at the European League Against Rheumatism ("EULAR") Congress 2020.
Continued enrollment in the Investigator Initiated Phase 2 trial being run at the Massachusetts General Hospital evaluating Tc99m tilmanocept uptake in atherosclerotic plaques of HIV-infected individuals.
Filed a provisional patent on improved synthesis of Tilmanocept.
Received a one-year extension on its NIH phase 1 Small Business Technology Transfer grant (1R41HL147640-01A1) entitled Gallium 68 Tilmanocept for PET Imaging of Atherosclerosis Plaques, due to COVID-19 related shutdown of the research facility at the University of Alabama Birmingham. The site has reopened and these preclinical studies are ongoing.
Michael Rosol, Ph.D., Chief Medical Officer for Navidea, said, "The clinical research team continues to work diligently to advance the technology in key disease areas, with an emphasis on our RA program. Our currently running Phase 2b trial in RA is proceeding well and, building upon the interim analysis results, we are preparing to discuss the upcoming Phase 3 with the FDA. We are also preparing for the start of our second Phase 2b trial comparing tilmanocept imaging to synovial tissue biopsy samples of RA patients."

Financial Results

Total revenues for the second quarter 2020 were $271,000, compared to $260,000 for the same period in 2019. Total revenues for the first half of 2020 were $427,000, compared to $302,000 for the same period in 2019. The increases were primarily due to increased grant revenue related to Small Business Innovation Research grants from the National Institutes of Health supporting Manocept development.
Research and development ("R&D") expenses for the second quarter of 2020 were $1.3 million, compared to $1.1 million in the same period in 2019. R&D expenses for the first half of 2020 were $2.3 million, compared to $1.8 million in the same period in 2019. The increases were primarily due to net increases in drug project expenses, including increased Manocept diagnostic development costs offset by decreased Manocept therapeutic development costs, coupled with increased employee compensation.
Selling, general and administrative ("SG&A") expenses for the second quarter of 2020 were $1.3 million, compared to $1.9 million in the same period in 2019. SG&A expenses for the first half of 2020 were $3.2 million, compared to $3.6 million in the same period in 2019. The decrease was primarily due to decreased legal and professional services, travel, insurance, depreciation, and investor relations costs, offset by increased employee compensation and franchise taxes.
Navidea’s net loss attributable to common stockholders for the second quarter of 2020 was $2.4 million, or $0.11 per share, compared to $2.7 million, or $0.24 per share, for the same period in 2019. Navidea’s net loss attributable to common stockholders for the first half of 2020 was $5.1 million, or $0.24 per share, compared to $5.1 million, or $0.48 per share, for the same period in 2019.
Navidea ended the second quarter of 2020 with $1.6 million in cash and investments. Since June 30, 2020, the Company has received the final $3.9 million of cash related to the February 2020 funding transactions. In addition, the Company received $1.0 million related to execution of the Jubilant MOU in August 2020.
Conference Call Details

Investors and the public are invited to dial into the earnings call through the information listed below, or participate via the audio webcast on the company website. Participants who would like to ask questions during the question and answer session will be prompted by the moderator, who will provide instructions.

Event:

Q2 2020 Earnings and Business Update Conference Call

Date:

Thursday, August 13, 2020

Time:

5:00 p.m. (EDT)

U.S. & Canada Dial-in:

877-407-0312

International Dial-in:

+1 201-389-0899

Conference ID:

13708190

Webcast Link:

View Source

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.