On August 14, 2018 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to the development and delivery of high quality, cost-effective pharmaceutical products and innovative therapeutics to patients in the U.S., China and throughout the world, reported financial results for the second quarter and six months ended June 30, 2018 and provided a review of recent accomplishments and anticipated upcoming milestones (Press release, CASI Pharmaceuticals, AUG 14, 2018, View Source [SID1234528921]).

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Ken K. Ren, Ph.D., CASI’s Chief Executive Officer, commented, "Our financial results for the second quarter of 2018 are in line with our expectations. We have made tremendous progress since the start of 2018 and remain committed to working with the relevant regulatory authorities and our strategic partners in the U.S. and in China to provide high quality, life-saving medications to patients. We will continue to advance our current product portfolio while evaluating additional opportunities to add further medicines to our pipeline."

Second Quarter and Recent Business Highlights

China FDA (CFDA) import drug registration priority review of EVOMELA in progress – On April 26, 2018, the Center for Drug Evaluation (CDE) of the China FDA held a Clinical Advisory Committee (the "Advisory Committee") meeting to review the EVOMELA application. CASI has recently received a series of standard questions from the CFDA related to EVOMELA drug product production which usually reflect the final stage of CFDA assessment before approval based on the Import Drug Approval registration pathway. CASI is working with Spectrum Pharmaceuticals and its vendors from whom EVOMELA is in-licensed to address the questions and submit the requested documents.

Preparation continues for EVOMELA’s commercial launch in China – CASI is building an in-house marketing and sales team with key members in place. The team is led by Thomas Zhang who has a 20-year track record of commercialization of multiple anti-cancer drugs in China for companies such as Roche and Johnson & Johnson.

CFDA review in progress for MARQIBO and ZEVALIN – CASI continues to work with the CFDA on advancing MARQIBO’s import drug clinical trial application and anticipates that the regulatory agency will complete its review within the next four to six months. The import drug clinical trial application for ZEVALIN is also in process with CFDA. The ZEVALIN antibody kit and the radioactive Yttrium-90 component of the application require separate submissions of which both are currently under technical review by the CDE of CFDA and the quality confirmatory testing by National Institute for Food and Drug Control (NIFDC) of CFDA as part of the regulatory review process.

Company enters into strategic manufacturing agreement – In June 2018, CASI entered into a strategic and long-term contracting manufacturing agreement for the manufacturing of entecavir and cilostazol. The partnership will support CASI’s plan to market and sell both products in China, U.S. and worldwide markets. Entecavir and cilostazol are part of the 29 abbreviated new drug applications (ANDAs) that were acquired from Sandoz in January 2018.

CASI added to Russell 2000, 3000 and Microcap Indexes – In July 2018, CASI announced that the company has been added to the Russell 2000, 3000 and Microcap Indexes.

Second Quarter and First Half 2018 Financial Results

Cash Position: As of June 30, 2018, CASI had cash and cash equivalents of $66.2 million compared to $49.9 million as of March 31, 2018. This increase primarily reflects the remaining gross proceeds of $20.7 million received in April 2018 related to CASI’s $50 million private placement announced in March 2018, partially offset by costs related to operating expenses during the quarter.

R&D Expenses: Research and development (R&D) expenses for the three and six months ended June 30, 2018, were $1.7 million and $3.4 million, respectively, compared to $1.7 million and $2.8 million for the same periods in 2017. The increase in R&D expenses primarily reflects personnel costs associated with the technology transfer activities and regulatory support associated with the recently acquired ANDA portfolio, offset by a decrease in costs related to the timing of the CFDA regulatory process of CASI’s in-licensed U.S. FDA approved assets from Spectrum Pharmaceuticals.

G&A Expenses: General and administrative (G&A) expenses for the three and six months ended June 30, 2018, were $4.0 million and $5.3 million, respectively, compared to $0.7 million and $1.3 million for the same periods in 2017. The increase in G&A over the prior year is primarily attributed to non-cash stock-based compensation expense for the stock options issued to the Company’s Executive Chairman and an increase in salary, benefits and recruitment expense in China, largely related to sales and marketing efforts to prepare for the anticipated launch of the Company’s first commercial product in China, as well as other G&A functions. There were also increased costs associated with business development related to exploratory acquisition activities, investor and public relations activities, and an increase in legal and other professional services fees during the 2018 period. G&A expenses include non-cash stock-based compensation of $1.5 million and $1.6 million for the three and six months ended June 30, 2018, respectively, compared to $0.1 million and $0.2 million in the respective periods in 2017.

Net Loss: The Company reported a net loss attributable to common shareholders for the three and six months ended June 30, 2018 of ($5.9) million, or ($0.07) per share, and ($9.5) million, or ($0.12) per share, respectively, compared to ($2.4) million, or ($0.04) per share, and ($4.1) million, or ($0.07) per share for the same periods in 2017. The larger net loss is primarily due to the non-cash stock-based compensation expense for stock options issued to the Company’s Executive Chairman, costs associated with the technology transfer activities and regulatory support for our ANDA portfolio, the write-off of approximately $0.7 million in January 2018 due to acquired in-process R&D primarily related to ANDAs not approved by the FDA, and increased costs associated with G&A functions, including employment costs for sales and marketing efforts, increased business development and investor relations activities, as well as other professional service fees.

Further information regarding the Company, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, can be found at www.casipharmaceuticals.com.

On August 14, 2018 Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody drug conjugates (ADCs) based on its Dolaflexin and other proprietary platforms, reported financial results and a business update for the second quarter ended June 30, 2018 (Press release, Mersana Therapeutics, AUG 14, 2018, View Source [SID1234529009]).

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"Our top priority is to resolve the partial clinical hold placed on our novel drug candidate XMT-1522 for HER2 expressing cancers, and to continue advancing XMT-1536 for solid tumors expressing NaPi2b," said Anna Protopapas, President and CEO of Mersana Therapeutics. "We have submitted our response to the FDA this week and are optimistic that, based on communications with the FDA, we are aligned on a path to lifting the hold."

Clinical Program Status of XMT-1522

As reported on July 19, 2018, the U.S. Food and Drug Administration (FDA) placed the Phase 1 study of XMT-1522 on partial clinical hold following a report to the FDA of a Grade 5 Serious Adverse Event (patient death) in dose level 7 of the XMT-1522 Phase 1 trial. The company continues to dose patients who had started treatment prior to the hold and continue to participate in the trial consistent with the protocol.

Clinical Update on XMT-1536

XMT-1536 is a first-in-class Dolaflexin ADC targeting NaPi2b, which is broadly expressed in epithelial ovarian cancer and non-squamous non-small cell lung cancer, as well as several other rare tumor types. The company continues to dose patients in its Phase 1 dose escalation study. Upon completing the dose escalation phase and selecting a recommended phase 2 dose (RP2D), the company will move into expansion studies in defined patient populations.

Other Recent Highlights and Updates

Further data on our Clinical Programs

·Presented interim dose escalation data on XMT-1522 in select cancers at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. These data showed that as of April 21, 2018, 22 patients had completed the dose limiting toxicity (DLT) evaluation period across 6 dose levels. As of that date, the treatment was well-tolerated, with most adverse events (AEs) for those patients being low grade and manageable; the most common treatment-related AEs were fatigue, nausea, vomiting,

anemia, and transient elevations of AST and ALT. As of the date of the ASCO (Free ASCO Whitepaper) disclosure, six patients had been dosed at dose level 7 (28.3 mg/m2), but only three had completed the first evaluation period. Of the thirteen patients enrolled at doses of 16 mg/m2 or greater at that time, including the three from dose level 7, eleven had stable disease (SD) or better, including one confirmed partial response (PR).

Discovery & Platform Progress

·The company has progressed its research on new payloads, platforms and new molecules and plans to present preclinical data at a major scientific meeting in the fourth quarter of 2018.

Upcoming 2018 Events

·The company will give a corporate presentation on August 15, 2018, at the 2018 Wedbush PacGrow Healthcare Conference in New York City.

·The company will give a corporate presentation at the H.C. Wainwright Healthcare Conference in New York City from September 4 to 6, 2018

·The company will give a corporate presentation on September 6, 2018, at the Baird Healthcare Conference in New York City

·The company will be presenting preclinical data on XMT-1536 at the IASLC World Conference on Lung Cancer in Toronto on September 25, 2018. Data will be presented demonstrating preferential expression of NaPi2b in lung adenocarcinoma, as determined using a new immunohistochemical reagent developed by the company, that can be used to detect NaPi2b expression in tissue samples.

Financial Results

·Cash, cash equivalents and marketable securities as of June 30, 2018, were $96.5 million, compared to $125.2 million as of December 31, 2017. The company expects that its cash, cash equivalents and marketable securities will enable it to fund its operating plan for at least the next twelve months.

·Collaboration revenue for the second quarter 2018 was approximately $4.2 million, compared to $3.7 million for the same period in 2017, primarily due to a $1.5 million milestone achieved during the three months ended June 30, 2018.

·Research and development expenses for the second quarter 2018 were approximately $12.6 million, compared to $10.6 million for the same period in 2017, driven primarily by an increase in employee-related costs due to increased headcount and clinical and in regulatory expenses due to the progress of XMT-1522 and XMT-1536.

· General and administrative expenses for the second quarter 2018 were approximately $4.2 million, compared to $2.2 million for the same period in 2017, driven primarily by increased employee-related expenses due to increase in headcount and increased consulting and professional fees.

· Net loss for the second quarter 2018 was $12.4 million, or $0.54 per share, compared to a net loss of $8.9 million, or $6.33 per share, for the same period in 2017. Weighted average common shares outstanding for the quarter ended June 30, 2018 were 22,966,314 and 1,412,308 for the quarter ended June 30, 2017.

Conference Call

Mersana Therapeutics will host a conference call and webcast at 8:00 am ET on August 15 to report financial results for the second quarter 2018 and provide certain business updates. To access the call, please dial 877-303-9226 (domestic) or 409-981-0870 (international) and provide the Conference ID 2895337. A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com.

About Dolaflexin

The Dolaflexin platform is designed to increase the efficacy, safety, and tolerability of ADCs by overcoming key limitations of existing technologies based on direct conjugation of a payload molecule to an antibody. Dolaflexin consists of Fleximer, a biodegradable, highly biocompatible, water soluble polymer, to which are attached multiple molecules of Mersana’s proprietary auristatin drug payload using a linker specifically optimized for use with Mersana’s polymer. The high water-solubility of the Fleximer polymer compensates for the low solubility of the payload, surrounding the payload and protecting it from aggregation and maintaining stability in circulation. Multiple molecules of this Dolaflexin polymer-drug conjugate can then be attached to an antibody of choice, which significantly increases the payload capacity of the resulting ADC. This approach differs from most other ADC technologies that conjugate the payload directly to the antibody. Using its Dolaflexin platform, Mersana has been able to generate ADCs with a very high Drug-to-Antibody Ratio (DAR), between 12 to 15, while maintaining desirable pharmacokinetics and drug-like properties in animal models. This represents a three to four-fold increase in DAR relative to traditional ADC approaches. The Dolaflexin platform also incorporates DolaLock technology, an engineered controlled bystander effect. AF-HPA, the initial auristatin drug release product, is freely cell permeable and has bystander-killing capabilities. Intra-tumor metabolism then facilitates the conversion of AF-HPA to AF, which is non-cell permeable, highly potent, and "locked" into the tumor. This enhancement improves both the efficacy and tolerability of Mersana’s ADC candidates.

On August 14, 2018 Aradigm Corporation (NASDAQ: ARDM) (the "Company") reported financial results for the second quarter and six months ended June 30, 2018 (Press release, Aradigm, AUG 14, 2018, View Source [SID1234529247]).

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Second Quarter 2018 Financial Results

The Company recorded $256,000 in revenue in the second quarter of 2018 compared with $7.7 million in revenue in the second quarter of 2017. The Company recognized $96,000 in contract revenue – related party, $95,000 in government contract revenue and $65,000 in government grant revenue for the second quarter of 2018, as compared to $7.5 million in contract revenue – related party, $196,000 in government contract revenue and $7,000 in government grant revenue for the second quarter of 2017.

Total operating expenses for the second quarter of 2018 were $3.0 million, compared with total operating expenses of $5.7 million for the second quarter of 2017. The decrease in research and development expenses of $2.1 million was due to a decrease in spend in support of the Linhaliq regulatory process towards US and EU approvals for market authorization and lower employee-related expenses due to a reduction in headcount. The decrease in general and administrative expenses of $0.5 million was primarily related to lower legal expenses, lower expenses for Board of Director fees and lower employee-related expenses due to a reduction in headcount.

Net loss for the second quarter of 2018 was $3.8 million or $(0.25) per share, compared with a net income of $1.0 million or $0.07 per share in the second quarter of 2017. For the quarter ended June 30, 2018, the shift to a net loss from net income resulted primarily from a decrease in revenue of $7.4 million and a decrease in operating expenses of $2.7 million.

Liquidity and Capital Resources and Related Matters

As of June 30, 2018, the Company reported cash and cash equivalents of $2.1 million.

In January, Aradigm received a Complete Response Letter (CRL) from the FDA regarding the New Drug Application (NDA) for Linhaliq as a treatment for non-cystic fibrosis bronchiectasis NCFBE patients with chronic lung infections with Pseudomonas aeruginosa (P. aeruginosa).

The CRL states that the FDA has determined that it cannot approve the NDA in its present form and provides specific reasons for this action along with recommendations needed for resubmission; the areas of concern include clinical data, human factor validation study and product quality. We remain confident in the efficacy, safety and quality of Linhaliq (now named Apulmiq for the FDA) and are formally interacting with the FDA to discuss the topics covered in the CRL with the goal of developing plans to move towards resubmission of the Linhaliq NDA as soon as possible. We are committed to continuing to work on obtaining regulatory approval of Linhaliq in the US for NCFBE patients who suffer from this very severe disease which carries a burden of high morbidity and mortality with no treatment options.

The Aradigm Board of Directors approved temporary measures on February 9, 2018 intended to preserve the Company’s cash resources.

During the quarter ended June 30, 2018 Aradigm raised $4.0 million through the issuance of bridge notes and obtained commitments for additional monthly funding through September of 2018 totaling approximately $3.0 million. This $3.0 million along with the cash balance of $2.1 million will be sufficient to fund operations through the third quarter of 2018.

Aradigm is pursuing potential alternatives to resolve our cash position in the short term as well as developing strategic options that would provide for our long term viability. We feel it is very important to bring Linhaliq to commercialization in as many countries as possible to allow patients suffering from (NCFBE) to receive the benefits of Linhaliq. Patients, patient advocacy groups and key opinion leaders have expressed support for regulatory approval of Linhaliq as we work towards this goal. The MAA was filed on March 8, 2018 followed by the EMA validation of the MAA. The EMA review of the MAA for Linhaliq will be according to standard timelines, with an opinion of the Committee for Medicinal Products for Human Use (CHMP) expected within 210 days from the formal procedural start date of March 29, 2018. The time needed by us to respond to EMA questions during the MAA review will trigger formal clock-stops of the procedure and may add several months to the nominal 210 day duration, until the final CHMP opinion will be issued.

About Non-Cystic Fibrosis Bronchiectasis

NCFBE is a severe, chronic and rare disease characterized by abnormal dilatation of the bronchi and bronchioles, frequently associated with chronic lung infections. It is often a consequence of a vicious cycle of inflammation, recurrent lung infections, and bronchial wall damage. NCFBE represents an unmet medical need with high morbidity and mortality that affects more than 150,000 people in the US. and over 200,000 people in Europe. There is currently no drug approved for the treatment of this condition.

On August 13, 2018 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the MD Anderson Cancer Center, reported its financial results for the second quarter ended June 30, 2018 (Press release, Moleculin, AUG 13, 2018, View Source [SID1234528825]). Additionally, the Company announced potential upcoming milestones and recent corporate developments.

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Management Discussion

Walter Klemp, Chairman and CEO of Moleculin, said, "During the second quarter, and the first half of 2018, we continued to make measurable progress in achieving important milestones in our three core disruptive technologies and six oncology drug candidates. We are successfully executing our strategic plan to advance our innovative cancer treatment solutions through the regulatory process and work our way toward accelerated FDA approvals by focusing on significant unmet needs. Our recent accomplishments include:

receiving Polish National Office approval to begin our second Phase I/II clinical trial in Poland to study Annamycin for treatment of relapsed or refractory acute myeloid leukemia ("AML");
qualified a second and a third U.S. Annamycin clinical site with a fourth, we believe, to come in the near term;
commencing treatment for the first patient enrolled in the Annamycin U.S. Clinical trial at The University Hospitals Cleveland Medical Center, which includes the Seidman Cancer Center and the Cleveland Clinic;
announcing the opening of enrollment for a physician-sponsored clinical trial of WP1066 for the treatment of glioblastoma and brain metastases in adults;
initiating operations in Australia to benefit from potential rebates of up to 43.5% of qualified R&D expenditures and speed up preclinical development;
commencing preclinical toxicology testing of WP1732, a fully water-soluble STAT3 inhibitor we believe, based on preclinical testing, has the potential to be a breakthrough discovery for rare and difficult to treat cancers through our new subsidiary in Australia; and
submitting a request to Polish authorities for clinical trial authorization ("CTA") for our STAT3 inhibitor, WP1220, for the treatment of Cutaneous T-Cell Lymphoma ("CTCL") which, if approved, will give us our third drug in clinic.
In our mission to develop breakthrough treatments for rare and difficult cancers, we have developed unique attributes in certain compounds that we believe will: inhibit STAT3 – a prevalent indicator in many cancers; avoid heart damage, eliminate multi-drug resistance with little to no cardiotoxicity; and inhibit metabolic activity by blocking the energy supply cancer cells require and inducing immune system function to target unique and highly metastatic tumors. We believe our three highly differentiated technologies have the potential to effectively attack high profile acute cancer states, ranging from AML; brain tumors; deadly forms of skin cancer; to pancreatic cancer. We currently have two oncology drugs in clinical trials, Annamycin and WP1066, a physician-sponsored trial, with the possibility of two others commencing clinical trials in 2019. This is only possible because of the tireless dedication and the hard work of all our associates at Moleculin. They have driven the momentum that we’ve achieved to this point while remaining fiscally responsible in our development process. We are highly focused on leveraging our successes to potentially change the treatment for cancer and excited about the opportunities ahead."

"With total R&D and total operating expense of $4.2 million and $5.5 million in the quarter, respectively, it should be noted that we had some one-time R&D charges in the quarter. Specifically, we expensed approximately $2.3 million related to the production of additional drug product for our Annamycin clinical trials, including product for the expansion beyond the currently planned Phase I/II clinical trial, and the initiation of pre-clinical work on WP1732 in Australia. We believe that the latter will generate Australian income tax credits next calendar year for which cash should be received by our Australian subsidiary in 2019. Furthermore, we incurred $1 million in R&D expense related to finalizing the acquisition of the license to the non-skin rights of the WP1066 portfolio," stated Jonathan P. Foster, executive vice president and chief financial officer of Moleculin. He continued, "We expect our R&D expense to be lower going forward on a quarterly basis extending our cash on hand into the second quarter of 2019."

Moleculin Seeks Approval from Polish Regulatory Agency for Skin Cancer Clinical Trial – August 9, 2018, the Company announced its submission of a request to Polish authorities for a CTA for its STAT3 inhibitor, WP1220, for the treatment of CTCL which, if approved, will give the Company its third drug in clinic. Published research supports the belief that Cutaneous T-Cell Lymphoma, a deadly form of skin cancer, may be highly dependent on the upregulation of the activated form of STAT3. The Company believes WP1220 may be ideally suited as a topical agent to inhibit STAT3 and therefore could potentially become a valuable new drug for the treatment of CTCL. A request for CTA in Poland is the equivalent of a request for Investigational New Drug status in the U.S.

Moleculin Announces Enrollment Opens for Brain Tumor Trial of WP1066 – July 31, 2018, the Company announced enrollment opened for a physician-sponsored clinical trial of WP1066 for the treatment of glioblastoma and brain metastases in adults. This is the first investigator-initiated trial of WP1066, an important milestone. The goal of this clinical research study is to find the highest tolerable dose of WP1066 that can be given to patients with recurrent (has returned after treatment) cancerous brain tumors or melanoma that has spread to the brain. The safety of this drug will also be studied. WP1066 is designed to target the STAT3 pathway in cancer cells, which independent research has shown allows these cells to survive and proliferate, increases new blood vessels to the tumor, causes the cancer cells to move throughout the body and brain, and reduces the ability of the immune system to effectively combat tumor development. In addition, the Company believes that WP1066 may also have the potential to stimulate a natural anti-tumor immune response.

Moleculin Expects to Meet FDA IND Filing Requirements for its Pancreatic Cancer Drug Candidate with Development Work in Australia – July 18, 2018, the Company announced it began preclinical toxicology testing of its WP1732, a fully water-soluble STAT3 inhibitor with the potential to be a breakthrough discovery for rare and difficult to treat cancers through its new subsidiary in Australia. By utilizing its subsidiary in Australia and the attractive R&D tax credits it offers, it can accelerate the preclinical work of WP1732 and maintain a strong cash balance. The Company believes this will allow it to complete its IND-enabling work and meet FDA submission requirements before year-end, which should allow it to complete the IND filing during 2019, while also reducing the Company’s total cost of development.

Moleculin Expands Operations to Australia; Taps R&D Incentive Program Capped at $20,000,000 AUD Turnover – July 11, 2018, the Company announced it had formed Moleculin Australia Pty. Ltd., a wholly-owned subsidiary to oversee preclinical development in Australia. For companies like Moleculin with less than $20,000,000 AUD group turnover, it can amount to a rebate of up to 43.5% of qualified R&D expenditures. The Australian subsidiary provides a great opportunity to speed up preclinical development and reduce the overall cost of continued drug development efforts.

Moleculin Selected for the Russell Microcap Index – June 26, 2018, the Company announced it was selected to be added to the Russell Microcap Index effective after the U.S. market opened on June 25, 2018, when the Russell Investments reconstituted its comprehensive set of U.S. and global equity indexes. Membership in the Russell Microcap Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes.

Moleculin Announces $2.3 Million Registered Direct Offering Priced At-the-Market – June 21, 2018, the Company announced that it entered into a definitive agreement with institutional investors for a registered direct offering of securities with gross proceeds of approximately $2.3 million, which was completed on June 22, 2018.

Moleculin Receives Approval for Leukemia Clinical Trial – June 20, 2018, the Company announced it received Polish National Office approval to begin its second Phase I/II clinical trial to study Annamycin for the treatment of relapsed or refractory AML. Consent from the Polish National Office was the final step required to allow recruitment of patients for this important trial.

Moleculin Targets accelerated FDA approval of WP1732; Pursues Development for Ocular Tumors – June 12, 2018, the Company announced that it entered into an agreement with the Jagiellonian University in Krakow, Poland, for the development of its STAT3 inhibitor, WP1732, for the treatment of ocular tumors. The Company believes the water-soluble nature of WP1732 could make it an ideal candidate for targeting these unique and highly metastatic tumors.

Moleculin’s Breakthrough Discovery of a New Molecule for Cancer Treatment Advances to Development Agreement with the University of Iowa – June 06, 2018, the Company announced that it entered into an agreement with The University of Iowa Pharmaceuticals for the development of a formulation for WP1732. The Company believes WP1732 represents a major expansion of its STAT3 inhibition capability by providing a highly soluble alternative that is ideally suited for IV administration. This agreement marks the beginning of creating a preclinical package to submit to the FDA in order to request Investigational New Drug status.

Moleculin Invited to Present to International BioForum 2018 Conference – May 24, 2018, the Company announced that its CEO, Walter Klemp, was asked to address the 2018 BioForum Conference in Łódź, Poland regarding the Polish-American Innovation Bridge: Bringing validated innovations from USA to Poland.

Moleculin to Begin Clinical Trials at UMC Southwest Cancer Center – May 16, 2018, the Company announced that a second U.S. site, located in Lubbock, Texas, has qualified for its clinical trial to study Annamycin for the treatment of relapsed or refractory AML. UMC Southwest Cancer Center qualified as the second U.S. site for Moleculin’s clinical trial of Annamycin. Dr. Sanjay Awasthi, Division Chief of Hematology/Oncology at Texas Tech University will serve as the site’s Principal Investigator.

Moleculin Announces Engagement with Voisin Consulting Life Sciences to Expand Annamycin Clinical Trial – May 03, 2018, the Company announced it has engaged Voisin Consulting Life Sciences ("VCLS"), as an additional regulatory consulting firm and contract research organization to prepare for expansion of its clinical trial to study Annamycin for the treatment of relapsed or refractory AML. VCLS headquartered in Paris, France will evaluate Australia and selected Western European countries for the potential expansion of clinical sites for the Company’s AML clinical trial.

Moleculin Announces New Data for Immuno-Stimulating Drug to be Presented at International Conference – April 26, 2018, the Company announced Dr. Waldemar Priebe, Chair of the Company’s Scientific Advisory Board, has been selected to present findings on Moleculin’s STAT3 inhibitor and immune-stimulating agent, WP1066, at the Global Academic Programs ("GAP") 2018 in Stockholm, Sweden from May 15 to 17, 2018. The annual GAP Conference provides a forum for faculty from MD Anderson and its Sister Institutions to develop collaborations and exchange research results and ideas. The GAP 2018 Conference is being sponsored by a prestigious list of major pharmaceutical companies, including Roche, Bayer, Bristol-Meyers Squibb, AstraZeneca, Novartis, Merck, and Pfizer.

Moleculin Enters Agreement with BSP Pharmaceuticals for its Leukemia Drug Candidate – April 24, 2018, the Company announced it entered into an agreement with BSP Pharmaceuticals S.p.A to expand production capacity for Annamycin. BSP Pharmaceuticals S.p.A., based in Latina, Italy will begin preparations for commercial scale production of the Annamycin drug product. BSP has a solid track record for supplying liposomal formulations to large pharmaceutical companies.

Moleculin Announces Patients Treated in FDA Approved Phase I/II Annamycin Clinical Trial – April 04, 2018, the Company announced that patients have successfully begun treatment in its U.S. Phase I/II clinical trial of Annamycin for the treatment of relapsed or refractory AML. The first patient enrolled in Moleculin’s Annamycin clinical trial was treated at The University Hospitals Cleveland Medical Center Seidman Cancer Center on March 28, 2018.

Financial Results for the Second Quarter Ended June 30, 2018

Research and Development Expense. Research and development ("R&D") expense was $4.2 million and $0.5 million for the three months ended June 30, 2018 and 2017, respectively. The increase of approximately $3.7 million mainly represents an increase of approximately: $2.3 million associated with producing additional drug product for the Company’s Annamycin clinical trials and with pre-clinical work on WP1732 in anticipation of filing an IND in 2019, $1.0 million accrued expense related to the HPI Option Repurchase Payment, $0.2 million related to an increase in R&D associated headcount costs; and $0.2 million related to various other expenses.

General and Administrative Expense. General and administrative expense was $1.2 million and $0.8 million for the three months ended June 30, 2018 and 2017, respectively. The increase of approximately $0.4 million was mainly attributable to the increase in headcount and associated payroll costs of $0.3 million, and $0.1 million of stock-based compensation. Such increases are due to the increased corporate activity as the Company enters clinical trials and increases its pre-clinical work on WP1732.

Net Loss. The net loss for the three months ended June 30, 2018 was $5.1 million, which included non-cash income of $0.3 million on the gain in fair value of the Company’s warrant liability, which was offset by noncash charges for $0.3 million related to stock-based compensation and other stock-based expenses.

Liquidity and Capital Resources

As of June 30, 2018, the Company had $11.7 million in cash and cash equivalents. On June 22, 2018, the Company completed the sale to institutional investors for a registered direct offering of securities for the sale of 1,092,636 shares of the Company’s common stock, at a purchase price of $2.105 per share. Concurrently with the sale of the common shares, the Company also sold warrants to the investors 710,212 shares of common stock. The Company sold the common shares and warrants for aggregate gross proceeds of approximately $2.3 million. Subject to certain beneficial ownership limitations, the warrants will be initially exercisable on the six-month anniversary of the issuance date at an exercise price equal to $2.02 per share of common stock, subject to adjustments as provided under the terms of the warrants. The warrants are exercisable for five years from the initial exercise date. The closing of the sales of these securities under the agreement occurred on June 22, 2018. The Company believes that its existing cash and cash equivalents as of June 30, 2018 will be sufficient to fund its planned operations into the second quarter of 2019. Such plans are subject to change depending on clinical enrollment progress and use of drug product.

On August 13, 2018 Atossa Genetics Inc. (NASDAQ: ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, reported second quarter ended June 30, 2018 financial results and provided an update on recent company developments (Press release, Atossa Genetics, AUG 13, 2018, View Source [SID1234528826]).

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Steve Quay, President and CEO commented, "We have made tremendous progress with our clinical programs. We opened enrollment in two phase 2 clinical studies: one study using our proprietary topical Endoxifen for breast density reduction, and another study using our proprietary oral Endoxifen for reducing breast cancer tumor cell activity in the "window of opportunity" between diagnosis of breast cancer and surgery. We also completed dosing and patient visits in our phase 1 study of topical Endoxifen in men. Our intraductal microcatheter immunoOncology pre-clinical program was launched and we contracted with an additional manufacturer for Endoxifen. We have had a very busy and productive first six months of 2018 as we continue the momentum in the advancement of our clinical programs. We are looking forward to announcing preliminary results from our phase 1 study of topical Endoxifen in men by September 30, 2018," added Dr. Quay.

Recent Corporate Developments

Atossa’s important recent developments include the following:

August 2018 – Contracted with a US-based additional manufacturer of Endoxifen.
July 2018 – Announced intraductal microcatheter immunoOncology pre-clinical program.
July 2018 – Opened enrollment in phase 2 study of oral Endoxifen to treat breast cancer.
June 2018 – Opened phase 2 study of topical Endoxifen to treat mammographic breast density.
June 2018 – Completed all dosing and clinical visits in its phase 1 study of topical Endoxifen in men.
June 2018 – Appointed two additional prominent industry executives from Pfizer and the Belgium-based Flemish Institute of Biotechnology to strategic advisory board.
May 2018 – Announced $13.4 million in gross proceeds from rights offering.
May 2018 – Formed strategic advisory board to accelerate growth with prominent former pharmaceutical executives from Pfizer and Boehringer Ingelheim.
April 2018 – Received a positive interim safety review on the Phase 1 study of topical Endoxifen in men.
Q2 2018 Financial Results

For the three and six months ended June 30, 2018 and 2017, we had no revenue and no associated cost of revenue.

Total operating expenses were approximately $4.1 million and $6.0 million for the three and six months ended June 30, 2018, respectively, consisting of general and administrative (G&A) expenses of approximately $2.7 million and $4.1 million, respectively; and research and development (R&D) expenses of approximately $1.5 million and $1.9 million, respectively. For the previous year, total operating expenses were approximately $1.9 million and $3.6 million for the three and six months ended June 30, 2017, respectively, consisting of G&A expense of approximately $1.1 million and $2.2 million, respectively, and R&D expenses of $0.8 million and $1.4 million, respectively.