On August 6, 2018 Applied DNA Sciences, Inc. (NASDAQ: APDN), reported it plans to release financial results for its fiscal 2018 third quarter ended June 30, 2018 after market close on Monday, August 13, 2018 (Press release, Applied DNA Sciences, AUG 6, 2018, View Source [SID1234529278]). In conjunction with the release, the Company has scheduled a conference call at 4:30 p.m. Eastern Time that will also be broadcast live over the Internet.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

What: Applied DNA’s Fiscal 2018 Third Quarter Financial Results Conference Call

When: Monday, August 13, 2018, at 4:30 p.m. Eastern Time

Where: Via phone by dialing +1 844-887-9402 or +1 412-317-6798 and ask for the Applied DNA call; via webcast.

A telephonic replay of the conference call will be available for one day and may be accessed by calling +1 877-344-7529 or +1 412-317-0088 with the passcode 10122259. The webcast will be archived in the Investors section of the company’s website.

These projects are following the typical preclinical biotherapeutic path of proving efficacy at small scale prior to securing larger production appropriate for clinical trials and deployment.

Most DNA-based therapeutic products, both approved and in development, rely on legacy science of plasmid and viral vector production methods that are time-consuming, carry the risks of bacterial toxins and triggering complications or unintended consequences. Several recent clinical trials have been halted by FDA due to unintended consequences of plasmid-derived DNA. As an alternative, Polymerase Chain Reaction (PCR), is a well-proven technique of DNA amplification first introduced in the 1980’s as an investigative tool in research and diagnostic laboratories. Applied DNA’s patented large-scale PCR production capability is a breakthrough for therapeutic applications as it has already demonstrated that PCR product can be made available very cleanly and at the scale required for population-scale diagnostics.

The most significant Applied DNA milestones recently achieved in this field come from work with multiple companies worldwide to qualify PCR-based linear DNA expression constructs for therapeutic applications. From these collaborative efforts, we have shown that linear DNA is effective in expression of genes in vivo.

These forms are in direct contradistinction to Applied DNA’s DNA tags for supply chains, which are too small to express proteins, have no means of entering cells or tissues, and contain none of the control elements necessary to do so.

This accomplishment is among the first times a linear DNA expression amplicon produced by PCR has demonstrated expression in vivo.

In all cases, companies in our pipeline have been driven to Applied DNA’s market position as an alternative to the current science of plasmid-produced DNA to gain PCR-based linear DNA vectors inherently superior to plasmid and viral vectors in several important aspects:

Bacteria-free: Absence of bacterial plasmid contaminants or sequences of prokaryotic origin such as genes for antibiotic resistance,
Speed: Shorter lead times (days) from vector design to large scale production,
Custom design turnaround time: custom modifications in sequence during the PCR process to enable experimentation comparisons on therapeutic performance, and,
On-site Production: patented platform for large scale production supports the feasibility of DNA production closer and tailored to the point of care to support the concept of personalized medicine.
"The milestones achieved to-date are a result of a multi-year business plan beginning with the acquisition of Vandalia Research assets three years ago. Now attracting new business at an accelerating rate and showing results that go toe-to-toe with legacy plasmid production is a major milestone for the viability of PCR-produced DNA for use in therapeutics," said Dr. James Hayward, president and CEO of Applied DNA. "We will continue to work with companies developing therapeutics to expand the processes necessary to grow this business alongside our mainstay tagging business."

On August 6, 2018 CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and development company specializing in oncology, reported financial results for the quarter ended June 30, 2018, and provided an overview of recent accomplishments and plans for its research and development programs (Press release, CytRx, AUG 6, 2018, View Source [SID1234528834]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"To date, 2018 has been marked by several important achievements, most notably the launch of Centurion BioPharma Corporation, which is focused on personalized medicine in advancing our albumin binding ultra high potency LADR (Linker Activated Drug Release) drug candidates and platform technology, and the filing of a provisional patent application covering our breakthrough companion diagnostic to be used alongside the LADR assets," said Eric Curtis, CytRx’s President and Chief Operating Officer. "We are extremely excited about the opportunity these innovative assets can offer to the oncology field and we are diligently working to secure a strategic partnership to advance them further."

"On the corporate and financial front, we have been executing on several key initiatives, including increasing our participation at institutional investor conferences, substantially reducing our cash burn rate, and strengthening our balance sheet. These efforts, combined with our addition to the Russell Microcap Index, leave us well positioned to achieve our corporate objectives for the remainder of 2018," concluded Mr. Curtis.

Second Quarter 2018 and Recent Highlights
Centurion BioPharma Corporation
Breakthrough Personalized Medicine Companion Diagnostic Filed for Albumin-Binding LADR Drug Candidates. In July 2018, Centurion filed a provisional patent application with the U.S. Patent and Trademark Office covering its unique albumin companion diagnostic (ACDx) for use alongside its albumin binding ultra-high potency LADR drug candidates. The goal of ACDx is to identify patients with cancer who are most likely to benefit from the treatment with the Company’s lead assets, LADR-7, LADR-8, LADR-9 and LADR-10 and any albumin-binding drugs the Company may generate in the future.
Launched Centurion BioPharma Corporation. In June 2018, Centurion BioPharma Corporation, a private wholly owned subsidiary, was launched by CytRx to focus on the advancement of the LADRTM drug candidates and technology platform. The subsidiary may develop novel drug candidates on its own while out-licensing other assets for larger patient populations. Eric L. Curtis serves as Centurion BioPharma’s President and Chief Executive Officer.
CytRx Corporation
Paid Off Hercules Long-Term Loan Facility. In August 2018, CytRx announced that it made the final scheduled payment under a long-term loan facility agreement with Hercules Technology Growth Capital, Inc. and Hercules Technology III, L.P. As of August 1, 2018, the Hercules loan was paid in full, which extinguished all of CytRx’s outstanding debt.
Expiration of the Majority of Its Outstanding Warrants. In July 2018, CytRx announced the expiration of warrants for approximately 3.2 million shares of its common stock. CytRx believes the expiration of these warrants, the majority of which were associated with a public offering in December 2016, eliminates overhang and provides additional common share float stability.
Aldoxorubicin Included in New NantCell Inc. Triple Negative Breast Cancer Clinical Trial. In June 2018, CytRx highlighted that aldoxorubicin licensee NantCell, Inc. had dosed the first patient in the Phase 1b portion of a Phase 1b/2 clinical trial for patients with triple negative breast cancer. This new trial represents the third NantCell study evaluating aldoxorubicin combined with immunotherapy or high affinity natural killer cell therapy in high unmet need cancer indications.
Added to the Russell Microcap Index. In June 2018, CytRx announced that it had been added to the Russell Microcap Index, effective upon the market open on Monday, June 25, 2018. The Russell indexes are broadly referenced as benchmarks by active investment strategists and institutional investors for index funds. CytRx’s inclusion in the index highlights the growth CytRx has made as a company.
Aldoxorubicin Reviewed in Future Oncology. In June 2018, CytRx highlighted data on licensee NantCell Inc’s aldoxorubicin, which was published in the peer-reviewed journal Future Oncology. The paper, published June 5, 2018, is entitled "Aldoxorubicin therapy for the treatment of patients with advanced soft tissue sarcoma" and can be accessed online here. The paper discusses the albumin-binding mechanism of action, pharmacokinetics, preclinical studies, clinical trial data and the safety profile of aldoxorubicin. It also discusses the potential relevance in the future treatment of patients with sarcoma, or who have other anthracycline sensitive tumor types, while avoiding cardiotoxicity.
Aldoxorubicin Data Presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Annual Meeting. In June 2018, CytRx highlighted NantCell Inc’s aldoxorubicin abstract selected for poster presentation at the ASCO (Free ASCO Whitepaper) 2018 Annual Meeting. The presented data showed that aldoxorubicin, alone or in combination with ifosfamide, lacks cardiotoxicity with doxorubicin equivalent doses beyond 1000 mg/m2. The data, obtained from two clinical trials of aldoxorubicin, contributes to the growing body of evidence showing that aldoxorubicin may be able to improve antitumor activity without typical doxorubicin-associated cardiac toxicity.
Eric L. Curtis named as President and Chief Operating Officer. In May 2018, CytRx announced the appointment of Eric L. Curtis as President and Chief Operating Officer. Mr. Curtis is a seasoned professional with 25 years of experience in both oncology and orphan diseases, including development and commercialization of approved drugs Votrient, Doxil, Velcade, Benlysta and Tykerb. CytRx has been utilizing Mr. Curtis’s extensive life science leadership to further the LADRTM development program by working to secure a strategic alliance for Centurion BioPharma Corporation.
Presented Statistically Significant Breakthrough LADR Drug Candidate Data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2018 Annual Meeting. In April 2018, CytRx presented three posters highlighting breakthrough data relating to its LADR drug candidates at the AACR (Free AACR Whitepaper) 2018 Annual Meeting in Chicago. The posters describe the positive scientific findings that led to the Company’s decision to select auristatin E (AE) derivatives LADR-7 and LADR-8, and maytansine derivatives LADR-9 and LADR-10, as the LADR candidates eligible to advance toward IND-enabling studies. The compounds demonstrated excellent, long-term antitumor activity across a wide range of human solid tumor cancer types, including lung, breast, ovarian, head and neck, renal cell, and melanoma. PDF copies of the presented posters (abstracts #1657, #2661, and #3703) can be accessed here.
Participated in Three Institutional Investor Conferences. Over the past quarter, CytRx participated in three institutional investor conferences, including the Singular Research Summer Solstice 2018 Conference in New York City, the OneMed NYC Oncology Investor Conference 2018 in New York City and the 8th Annual LD Micro Invitational Conference in Bel-Air, California. At each conference, CytRx executive management made a formal presentation and had one-on-one meetings with institutional investors.

Second Quarter 2018 Financial Results

During this quarter CytRx substantially reduced its monthly cash burn rate, and expects to continue to manage its cash effectively.
CytRx reported cash and cash equivalents of $36.4 million as of June 30, 2018.

Net loss for the quarter ended June 30, 2018, was $3.0 million, or $(0.10) per share, compared with a net loss of $14.4 million, or $(0.60) per share, for the comparative 2017 period, a reduction of $11.4 million, or approximately 79 percent. During the second quarter of 2018, the Company recognized a non-cash gain of $0.1 million on the fair value adjustment of warrant derivative liabilities related to warrants issued in 2016, compared to a non-cash loss of $4.3 million during the second quarter of 2017 related to these now expired warrants.

Research and development (R&D) expenses were $0.8 million for the second quarter of 2018, which represents primarily $0.6 million of expenses for the development of the albumin companion diagnostic (ACDx) and $0.2 million of non-cash expenses. In the second quarter of 2017, R&D expenses of $6.2 million included $4.3 million related to our aldoxorubicin program and $0.9 million for non-cash expenses.
General and administrative (G&A) expenses were $1.7 million for the second quarter of 2018, compared with $3.1 million for the second quarter of 2017, including non-cash stock-compensation expense of $0.4 million for the second quarter of 2018 and $0.5 million for the second quarter of 2017. G&A expenses decreased by approximately 46 percent primarily due to a decrease in professional fees.
Conference Call and Webcast
CytRx will be hosting a conference call and webcast today beginning at 11:00 am Eastern Time (8:00 am Pacific Time). To access the conference call, dial (+1)844-358-6753 (U.S. and Canada) or (+1)216-562-0397 (international callers) and enter the conference ID number: 5991089. A live and archived webcast will be available in the News and Events/Events Calendar section of the Company’s website, www.cytrx.com. A replay of the call and webcast will begin approximately two hours after the live call has ended. To access the replay, dial (+1)855-859-2056 (U.S. and Canada) or (+1)404-537-3406 (international callers) and enter the conference ID number: 5991089.

On August 6, 2018 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported the completion of an underwritten public offering of 10,454,546 shares of its common stock, including 1,363,636 shares sold pursuant to the exercise in full of the underwriters’ option to purchase additional shares (Press release, BioCryst Pharmaceuticalsa, AUG 6, 2018, View Source [SID1234528782]). The gross proceeds from this offering to BioCryst, including from the shares sold pursuant to the underwriters’ option to purchase additional shares, were approximately $57.5 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by BioCryst. BioCryst expects to use the net proceeds of this offering for general corporate purposes, which may include, but are not limited to, funding worldwide development, manufacturing, regulatory and commercial activities for the prophylactic and acute BCX7353 programs, focusing primarily on the United States, European Union and Japan; the advancement of development activities of our fibrodysplasia ossificans progressiva ("FOP") and other preclinical rare disease program; post-approval commitments for RAPIVAB/ALPIVAB; and capital expenditures and general working capital needs.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

J.P. Morgan and Jefferies acted as joint book-running managers for the offering. JMP Securities acted as lead manager for the offering.

A shelf registration statement on Form S-3 relating to the shares of common stock described above has been previously filed with and declared effective by the U.S. Securities and Exchange Commission ("SEC"). This press release does not constitute an offer to sell, or the solicitation of an offer to buy, these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale is not permitted.

This offering was made by means of a prospectus supplement and related prospectus. A prospectus supplement relating to the offering has been filed with the SEC and is available on its website at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone: 1-866-803-9204 or from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by email at [email protected].

On August 6, 2018 Protagonist Therapeutics, Inc. (Nasdaq:PTGX), a biopharmaceutical company leveraging its proprietary technology platform to discover and develop novel peptide-based drugs, reported that it has signed a securities purchase agreement with investors including BVF Partners L.P. and their affiliates for the sale of 2,750,000 shares of common stock for gross proceeds of $22 million (Press release, Protagonist, AUG 6, 2018, View Source;p=RssLanding&cat=news&id=2362104 [SID1234528667]). The investors also received five-year warrants to purchase 1,375,000 shares of common stock at $10.00 per share and 1,375,000 shares of common stock at $15.00 per share. The transaction is expected to close on Aug. 8, 2018.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Proceeds from the financing will be used to advance development of drug candidate PTG-100

On August 6, 2018 Editas Medicine, Inc. (NASDAQ: EDIT), a leading genome editing company, reported financial results for the second quarter ended June 30, 2018, and provided an update on recent achievements and upcoming events (Press release, Editas Medicine, AUG 6, 2018, View Source;p=RssLanding&cat=news&id=2362273 [SID1234528651]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"During the second quarter, we continued to drive towards our first IND and to advance our broader pipeline of transformative CRISPR medicines," said Katrine Bosley, President and Chief Executive Officer of Editas Medicine. "Our lead candidate, EDIT-101 to treat the genetic disease LCA10, is poised to be the first in vivo CRISPR medicine in human trials with an anticipated IND filing in October. Our broader pipeline of ocular and engineered cell medicines is advancing as well."

Recent Achievements and Outlook

Allergan Pharmaceuticals International Limited (Allergan) exercises option to develop and commercialize EDIT-101 globally and Editas exercises option to co-develop and equally share profits and losses in the United States. Editas and Allergan announced today that Allergan has exercised its option for EDIT-101 and Allergan has paid an option exercise fee of $15 million, which will be recorded in the third quarter. In addition, Editas is eligible to receive a $25 million milestone payment from Allergan upon clearance of an IND application for EDIT-101.

EDIT-101 advancing towards clinical trials with NIH filing submitted in July and IND filing anticipated in October 2018. Editas submitted the requisite data package for human gene transfer clinical protocol registration to the United States National Institutes of Health (NIH) for potential review by the Recombinant DNA Advisory Committee. Editas plans to file an IND application for EDIT-101 with the United States Food and Drug Administration in October 2018. In addition, the Company presented new pre-clinical data on EDIT-101 at the American Society of Gene & Cell Therapy 21st Annual Meeting (ASGCT Meeting) demonstrating that EDIT-101 was well tolerated in a study of non-human primates (NHPs). Therapeutically relevant levels of editing were achieved in NHPs regardless of pre-existing or induced immunity to Staphylococcus aureus Cas9.

Broader ocular pipeline moving forward. Editas is pursuing product candidates for Usher Syndrome type 2A (USH2A) and recurrent ocular Herpes Simplex Virus type 1 (HSV-1). At the ASGCT (Free ASGCT Whitepaper) Meeting, Editas and collaborators from Massachusetts Eye and Ear presented in vitro data demonstrating that deletion of exon 13 in the human USH2A gene using CRISPR/Cas9 can restore cilia formation, providing the basis for a potential medicine. Editas also presented pre-clinical in vivo proof-of-concept data in a rabbit model for its recurrent ocular HSV-1 program at the Association for Research in Vision and Ophthalmology 2018 Annual Meeting.

Designing novel medicines for Sickle Cell Disease and Beta-Thalassemia. Editas reported data at the ASGCT (Free ASGCT Whitepaper) Meeting demonstrating that lead molecules targeting the beta-globin locus drove the upregulation of fetal hemoglobin in human mobilized peripheral blood stem cells. This was achieved by editing a novel genomic site that has potential to result in a best-in-class medicine. Editas expects to present additional data on this program in the second half of 2018.

Improving efficacy of engineered T cell medicines to treat cancer with CRISPR-based gene editing. In May, Editas expanded its collaboration with Juno Therapeutics, Inc., a Celgene company (Celgene), to develop and commercialize engineered T cell medicines for cancer. The recently expanded collaboration now encompasses four programs, including checkpoint inhibitors, tumor microenvironment, T cell receptor locus editing, and an undisclosed program.

Strong balance sheet to advance Company through multiple value inflection points. The Company held cash, cash equivalents, and marketable securities of $344.1 million as of June 30, 2018, providing at least 24 months of funding for operating expenses and capital expenditures without any assumption of future cash received from milestones or additional financings.

Upcoming Events

Editas will participate in the following investor conferences:

Citi 13th Annual Biotech Conference, Gene Editing Panel, September 5, 1:15 p.m. ET, Boston;
Morgan Stanley 16th Annual Global Healthcare Conference, Fireside Chat, September 12, 4:50 p.m. ET, New York City;
Jefferies Gene Therapy Summit, September 27, New York City; and
Chardan 2nd Annual Genetic Medicines Conference, October 9, New York City.
Editas will also participate in the following scientific and medical conferences:

26th Annual Congress of the European Society of Gene & Cell Therapy, October 16-19, Lausanne.

Second Quarter 2018 Financial Results

Cash, cash equivalents, and marketable securities at June 30, 2018, were $344.1 million, compared to $329.1 million at December 31, 2017.

For the second quarter ended June 30, 2018, net loss attributable to common stockholders was $38.7 million, or $0.82 per share, compared to $26.4 million, or $0.65 per share, for the same period in 2017.

Collaboration and other research and development revenues were $7.4 million for the quarter ended June 30, 2018, compared to $3.1 million for the same period in 2017. The $4.3 million increase was primarily attributable to $3.9 million in revenue recognized pursuant to a license agreement with Beam Therapeutics Inc. and a $2.8 million increase in revenue recognized pursuant to our collaboration agreement with Celgene, partially offset by a $2.4 million decrease in revenue recognized pursuant to our strategic alliance with Allergan.
Research and development expenses were $32.7 million for the quarter ended June 30, 2018, compared to $17.3 million for the same period in 2017. The $15.4 million increase was primarily attributable to $9.6 million in increased sublicensing and success payment expenses resulting from $12.5 million in research funding payments related to our sponsored research agreement with the Broad Institute which were partially offset by a decrease in sublicensing fees, $3.1 million in increased process and platform development expenses, $1.4 million in increased employee related expenses, $0.9 million in increased stock-based compensation expenses, and $0.4 million in increased facility-related expenses.
General and administrative expenses were $14.3 million for the quarter ended June 30, 2018, compared to $11.9 million for the same period in 2017. The $2.4 million increase was attributable to $1.1 million in increased stock-based compensation expenses, $0.7 million in increased employee related expenses, and $0.7 million in increased professional service expenses, partially offset by $0.2 million in decreased intellectual property and patent related fees.

Conference Call

The Editas management team will host a conference call and webcast today, August 6, 2018, at 5:00pm ET. To access the call, please dial 844-348-3801 (domestic) or 213-358-0955 (international) and provide the passcode 4379216. A live webcast of the call will be available on the Investors & Media section of the Editas Medicine website at www.editasmedicine.com and a replay will be available approximately two hours after its completion.