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.

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.

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.

On August 13, 2020 Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, reported financial results for the second quarter ended June 30, 2020 and provided an update on clinical activities (Press release, NewLink Genetics, AUG 13, 2020, View Source [SID1234563600]).

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"The second quarter continued to be a busy and productive one for Lumos Pharma," commented Rick Hawkins, Chairman, CEO and President. "Most notably, the efforts of our team during this period culminated in the sale of our Priority Review Voucher in line with our expectations, further strengthening our balance sheet. With a Study May Proceed letter from the FDA in hand, we are progressing toward our goal of initiating the Phase 2b trial of LUM-201, our oral therapeutic candidate for PGHD, prior to the end of this year. In addition, we continue to engage in activities to expand our pipeline through the licensure of other rare disease assets. With our strong balance sheet and non-dilutive funds from the monetization of our PRV, we believe Lumos Pharma is well positioned to execute on our clinical and business development plans."
Corporate Update
Sale of Priority Review Voucher (PRV) – On July 27, 2020, Lumos Pharma announced that it had entered into a definitive agreement to sell its PRV to Merck, known as MSD outside the United States and Canada. The PRV was granted in conjunction with the approval by the U.S. Food and Drug Administration (FDA) of ERVEBO, a vaccine developed by the Company’s licensee, Merck, for the prevention of the Zaire Ebola virus disease.
Under the terms of the original license agreement, Lumos Pharma is entitled to retain 60% of the value of the PRV. Based upon an agreed valuation of $100 million, Merck will pay Lumos $60 million. The $60 million will be received in two non-contingent payments, $34 million anticipated in the third quarter of 2020, and $26 million in the first quarter of 2021. The transaction remains subject to customary closing conditions including anti-trust review. The non-dilutive funds from this transaction will provide additional capital to support the expansion of the Company’s pipeline through the in-licensing or acquisition of another novel therapeutic candidate for those suffering from rare diseases.
Clinical Update and COVID-19 Impact
Phase 2b trial of LUM-201 in PGHD – Lumos Pharma continues to prioritize the clinical development of LUM-201, its orally administered therapeutic candidate for a significant subset of children with PGHD. The Company continues to anticipate the initiation of its Phase 2b trial in PGHD prior to the end of 2020. This trial will evaluate three dose levels of LUM-201 in PGHD patients against a comparator arm of standard-of-care injectable growth hormone therapy. Dosing will be administered over six months, with annualized growth height velocity as the primary clinical outcome measure. The purpose of this trial will be to prospectively confirm our Predictive Enrichment Marker strategy and to identify the optimal dose of LUM-201 to be used in a registration trial.
While the coronavirus pandemic initially caused pervasive interruptions to clinical trials industrywide, clinical sites have begun to reopen, and numerous trials have restarted. A resurgence of the coronavirus pandemic may cause further

Exhibit 99.1

delays or shutdowns of clinical trials, including our own. Our Phase 2b site selection, however, spans a broad geographic base across the US and multiple other countries and includes both private clinics and academic centers, which we believe should help mitigate the impact of a resurgence of this pandemic.
Pharmacokinetic/Pharmacodynamic Study of LUM-201 in PGHD – Lumos also plans to initiate a second concurrent trial of LUM-201 in PGHD by Q1 2021. This trial is intended to further explore the effects of the mechanism of action of LUM-201 in amplifying the natural pulsatile secretion of growth hormone. The study will focus on pharmacodynamic and pharmacokinetic endpoints at two different doses in a limited number of children with PGHD, corroborating the amplified pulsatile secretion demonstrated in prior LUM-201 studies in adults. The trial will be conducted at a single specialized pediatric center with the capacity to conduct the more frequent sample acquisition and monitoring required for these types of clinical trials. This study will run in parallel with our announced Phase 2b trial with the intention that the data will be supportive in any future regulatory filings.
Pipeline Expansion – The Company continues to pursue business development opportunities to expand its rare disease portfolio. With a team possessing deep experience in the rare disease sector, we believe we are well-positioned to be successful in our pursuit of opportunities to expand our pipeline and build shareholder value.
Financial Results for the Three-Month Period Ended June 30, 2020 and Updated Cash Guidance
Cash Position: Lumos Pharma ended the quarter on June 30, 2020, with cash and cash equivalents totaling $72.7 million compared to Lumos Pharma prior to its merger with NewLink Genetics cash of $5.0 million on December 31, 2019 and pro forma cash, including NewLink Genetics, of $95.5 million on December 31, 2019. The Company expects its cash on hand will be sufficient to fund current operations through the Phase 2b LUM-201 trial read-out.
R&D Expenses: Research and development expenses for the three months ended June 30, 2020 were $2.8 million, an increase of $882,000 from $1.9 million for the same period in 2019. The increase is primarily due to an increase of $877,000 in personnel-related and stock compensation expense, an increase of $480,000 in clinical trial expense and an increase of $310,000 in supplies and other expense, offset by a decrease of $430,000 in contract manufacturing expense, and a decrease of $355,000 in legal and consulting expense.
G&A Expenses: General and administrative expenses for the three months ended June 30, 2020 were $4.1 million, an increase of $3.4 million from $714,000 for the same period in 2019. The increase was due primarily to increases of $1.2 million in personnel-related and stock compensation expense, $1.2 million due to increased operating expenses for insurance, rent, supplies and depreciation, and $969,000 in legal and consulting expense.
Net Loss: The net loss for the three months ended June 30, 2020 was $5.4 million compared to a net loss of $2.6 million for the same period in 2019.
Lumos Pharma ended Q2 2020 with 8,293,312 shares outstanding.
Conference Call and Webcast Details
The Company has scheduled a conference call and webcast for 4:30 p.m. ET today to discuss its financial results and to give an update on clinical and business development activities. There will also be a question and answer session following management’s prepared remarks.
Access to the live conference call is available five minutes prior to the start of the call by dialing (855) 469-0612 (U.S.) or (484) 756-4268 (international). The conference call will be webcast live and a link to the webcast can be accessed through the Lumos Pharma website at www.lumos-pharma.com in the "Investors & Media" section under "Events and Presentations" or through this link: View Source To ensure a timely connection, it is recommended that users register at least 10 minutes prior to the scheduled webcast. A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and using the passcode 9585725. The replay will be available for two weeks from the date of the call.

On August 13, 2020 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported the enrollment and dosing of the first patient in the amended Stage 2 of the Phase 2 clinical study of prexigebersen (BP1001), a liposomal Grb2 antisense, for the treatment of acute myeloid leukemia (AML), in combination with frontline therapy decitabine and venetoclax (Press release, Bio-Path Holdings, AUG 13, 2020, View Source [SID1234563599]).

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As previously reported, Phase 2 clinical development of prexigebersen in AML commenced with Stage 1 of the Phase 2 clinical trial, which was open label and treated de novo AML patients with a combination of prexigebersen and low dose cytarabine (LDAC). The combination of prexigebersen and LDAC was shown to be safe and more efficacious to treat this class of patients than with LDAC alone. Despite the superior combination treatment results with LDAC, the new drug decitabine was favored by oncologists. As a result, Stage 2 of the Phase 2 trial in AML dropped the combination treatment of prexigebersen and LDAC and replaced it with the combination treatment prexigebersen and decitabine. In addition, a second cohort of relapsed/refractory AML patients was added.

The recent approval of the frontline therapy venetoclax provided an opportunity for adding prexigebersen to the newly approved frontline, two-drug combination of venetoclax and decitabine for the treatment of AML patients.

Prior to finalizing plans to include prexigebersen with the frontline treatment combination of decitabine and venetoclax, the Company performed preclinical testing in AML cancer cell lines to assess prexigebersen’s increased benefit to efficacy. Preclinical testing of prexigebersen with the frontline treatment of decitabine and venetoclax demonstrated the potential to enhance efficacy of the frontline treatment combination. In the studies, four AML cancer cell lines were treated with three different combinations of decitabine, venetoclax and prexigebersen (BP1001). Decrease in AML cell viability was the primary measure of efficacy. The triple combination of decitabine, venetoclax and BP1001 showed significant improvement in efficacy in three of the four AML cell lines. Based on these results, the Company believes that adding prexigebersen to the treatment combination of decitabine and venetoclax could lead to improved efficacy in AML patients.

% Decrease in Cell Viability
AML Cell Lines BP1001 + decitabine BP1001 + decitabine + venetoclax Controla + decitabine + venetoclax
KG-1 64 90 46
MOLM-13 86 100 88
MV-4-11 67 95 79
Kasumi-1 33 50 47

a Empty liposomes control

Bio-Path’s approved amended Stage 2 for this Phase 2 clinical trial has three cohorts of patients, which the Company believes provides for several potential regulatory pathways. The first two cohorts will treat patients with the triple combination of prexigebersen, decitabine and venetoclax. The first cohort will include untreated AML patients, and the second cohort will include relapsed/refractory AML patients. Finally, the third cohort will treat relapsed/refractory AML patients who are venetoclax resistant or intolerant with the two-drug combination of prexigebersen and decitabine.

The first step in establishing the amended Stage 2 of the Phase 2 trial in AML was demonstrating the safety of treating patients with the two-drug combination of prexigebersen and decitabine, which the Company previously reported has been successfully completed. Importantly, results from patients who were previously treated with the two-drug combination of prexigebersen and decitabine prior to the amendment to Stage 2 of the Phase 2 trial in AML and who meet the criteria for enrollment in the third cohort of the amended Stage 2 of the Phase 2 trial in AML can be included in the third cohort results. This represents a beneficial head-start in the third cohort enrollment. This third cohort represents a significant, unmet opportunity in clinical treatment, as options are limited for AML patients who fail frontline therapy.

The first six evaluable patients in the amended Stage 2 of the Phase 2 trial in AML will be treated with the triple combination of prexigebersen, decitabine and venetoclax to test the safety of this treatment combination. As noted previously, the enrollment and dosing of the first patient in the amended Stage 2 of the Phase 2 clinical study has occurred. This patient is in the relapsed/refractory cohort being treated with the triple combination of prexigebersen, decitabine and venetoclax.

"Despite recent advances in the field, AML continues to be a challenging malignancy with unmet medical need as most patients unfortunately eventually succumb to their disease. The potential for prexigebersen in combination with new standard of care treatments seems particularly promising. We look forward to the execution of this trial and, hopefully, to bringing another tool to bear in the fight against this deadly disease," said Jorge Cortes, M.D., Director of the Georgia Cancer Center and Chairman of the Bio-Path Scientific Advisory Board.

"We are excited to be testing prexigebersen in this promising triple combination. Given our preclinical data, which support treating AML patients with this triple combination, we believe there is strong potential for improved outcomes for patients with AML who otherwise have limited treatment options," said Peter Nielsen, President and Chief Executive Officer of BioPath Holdings.

"We believe that this unique trial design provides us with several definable registration pathways. We believe that prexigebersen, with its promising efficacy and safety profile, has the potential to be an ideal combination candidate with frontline therapy," concluded Mr. Nielsen.

Study Design

The amended Stage 2 of this Phase 2 trial in AML is an open label Phase 2, two-stage, multicenter study of prexigebersen in combination with decitabine and venetoclax in two cohorts of patients with previously untreated AML and relapsed/resistant AML. A third cohort includes treating relapsed/refractory AML patients who are venetoclax resistant or intolerant with the two-drug combination of prexigebersen and decitabine.

The full trial design-plans have approximately 54 evaluable patients for the cohort treating relapsed/refractory AML patients with the triple combination treatment of prexigebersen, decitabine and venetoclax and the cohort treating AML patients who are venetoclax resistant or intolerant with the two-drug combination of prexigebersen and decitabine, with a review of both cohorts performed after 19 evaluable patients.

The full trial design-plans have approximately 98 evaluable patients for the cohort treating untreated AML patients with the triple combination treatment of prexigebersen, decitabine and venetoclax, with a preliminary review for the cohort performed after 19 evaluable patients and a formal interim analysis after 38 evaluable patients. The higher number of patients in the full trial design for the untreated AML patient cohort is due to the higher baseline response of the frontline therapy.

The primary endpoint for this study will be the number of patients who achieve complete remission ("CR"), which includes complete remission with incomplete hematologic recovery ("CRi"), and complete remission with partial hematology recovery ("CRh").

An interim analysis will be performed on each cohort to assess the safety and efficacy of the treatment. In the event these results exceed the primary endpoint in a number of patients that meets or exceeds statistically determined thresholds, the Company plans to seek to convert the trial into a registration trial for accelerated approval.

The study is anticipated to be conducted at ten clinical sites in the U.S., and Gail J. Roboz, M.D., will be the national coordinating Principal Investigator for the Phase 2 trial. Dr. Roboz is professor of medicine and director of the Clinical and Translational Leukemia Program at the Weill Medical College of Cornell University and the New York-Presbyterian Hospital in New York City. For more information on the Phase 2 study, visit www.clinicaltrials.gov.