On February 6, 2020, Moleculin Biotech, Inc. (the "Company") repored that it has entered into subscription agreements (each a "Subscription Agreement") with certain institutional investors (the "Investors") for the sale by the Company of up to 7,500,000 shares of Company’s common stock, $0.001 par value per share ("Common Stock") and warrants to purchase 5,625,000 shares of Common Stock (each a "Warrant") at a combined public offering price of $0.80 per share and related warrant (Filing, 8-K, Moleculin, FEB 6, 2020, View Source [SID1234553978]).

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The Warrants will be exercisable six months from the date of issuance at a price of $1.05 per share, and will expire five years from the date they are first exercisable. The shares of Common Stock are being offered together with the Warrants, but the securities will be issued separately and will be separately transferable.

The closing of the offering is expected to take place on February 10, 2020, subject to the satisfaction of customary closing conditions. The Company estimates that the net proceeds from the sale of the securities will be approximately $5.4 million after deducting the placement agent fees and estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for planned clinical trials, preclinical programs, for other research and development activities and for general corporate purposes.

The securities are being offered and sold pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-219434), which became effective on August 21, 2017.

On February 6, 2020, the Company also entered into a placement agent agreement (the "Placement Agent Agreement") with Oppenheimer & Co. Inc. ("Oppenheimer"), pursuant to which Oppenheimer agreed to serve as exclusive placement agent for the issuance and sale of the securities. The Company has agreed to pay Oppenheimer an aggregate fee equal to 7.0% of the gross proceeds received by the Company from the sale of the securities in the offering.

Pursuant to the Placement Agent Agreement, the Company also agreed to grant issue to Oppenheimer warrants to purchase up to 7% of the aggregate number of shares of Common Stock sold in the offering (the "Oppenheimer Warrant"). The exercise price of the Oppenheimer Warrant will be equal to the greater of the $0.80 combined public offering price per share and related Warrant and the closing price of the Common Stock on the day prior to closing of the offering (or the day of the closing, if such closing occurs after 4:00 p.m. ET). The Oppenheimer Warrant has been deemed underwriting compensation by the Financial Industry Regulatory Authority, Inc. ("FINRA") and therefore shall not be sold, transferred, assigned, pledged, or hypothecated, or be the subject of any hedging, short sale, derivative, put or call transaction that would result in the effective economic disposition of the securities by any person for a period of 180 days immediately following the date of effectiveness or commencement of sales of the offering, pursuant to Rule 5110(g)(1) of FINRA’s Rules. The Company will also reimburse Oppenheimer for its expenses up to $125,000.

The Company and its executive officers and directors agreed to a 60-day and 90-day, respectively, "lock-up" with respect to shares of Common Stock and other securities beneficially owned, including securities that are convertible into, or exchangeable or exercisable for, shares of Common Stock. Subject to certain exceptions, during the lock-up period, the Company and its executive officers and directors may not offer, sell, pledge or otherwise dispose of the foregoing securities without the prior written consent of Oppenheimer.

The Placement Agent Agreement contains customary representations, warranties and covenants by the Company, customary conditions to closing, indemnification obligations of the Company and the Placement Agent, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties and termination provisions. The representations, warranties and covenants contained in the Placement Agent Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement, and may be subject to limitations agreed upon by the contracting parties.

On February 6, 2020 Lunaphore Technologies SA, a Swiss life-sciences company developing innovative next-generation equipment for cancer research and tissue diagnostics, reported the first closing of its Series C funding, amounting to CHF 23M (Press release, Lunaphore Technologies, FEB 6, 2020, View Source [SID1234553977]). The round was led by the Japanese strategic investor PHC Holdings Corporation (hereafter, PHCHD), a global healthcare company that owns Epredia, a leading provider of comprehensive solutions for precision cancer diagnostics.

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The closing of the oversubscribed round was finalized on January 15, 2020. Existing investors including Redalpine Venture Partners, OCCIDENT and Alpana Ventures have also participated in this financing round.

"We are thrilled by the confidence placed in Lunaphore by our existing investors as well as the new ones in this financing round. The interest of global players in healthcare, like PHCHD demonstrates the relevance and added value of Lunaphore’s technology and confirms its high potential to transform the field of tissue analytics" said Ata Tuna Ciftlik, Lunaphore’s CEO, and added "We’re one step closer to fulfilling our vision of enabling highly sophisticated new-generation tissue analytics tests with our unique automation capabilities. The expertise and rapidly expanding network of the PHC Group and the specialist knowledge of the anatomical pathology field at Epredia will both help us gain scale and speed in this process".

Lunaphore will invest the proceeds of Series C funding in market and product expansion. This includes a US market entry, the ramp up of activities in Europe and the development of next generation of instruments.

"We are delighted that PHCHD has invested in one of the most exciting players in tissue staining" said James Post, President of Epredia, a PHC Group portfolio company. "We believe that their technology has the potential to help revolutionize tissue analytics and greatly improve the workflow for pathologists and immuno-oncology researchers. We look forward to working together with Lunaphore to further develop their highly innovative solutions and bring them to market to help further enhance cancer research and diagnostics." Mr. Post has joined Lunaphore’s Board of Directors as part of the transaction.

"This investment is a strong strategic fit for PHCHD, as we look to invest further in our diagnostics business," explained Michael Kloss, President and CEO of PHCHD. "Lunaphore’s tissue staining products complement the portfolio we currently have in Epredia and we believe there is a strong opportunity for growth in their business."

Epredia was created in June 2019 following the acquisition of Thermo Fisher Scientific’s Anatomical Pathology business by PHC Holdings Corporation. Epredia’s portfolio includes microscope slides, instruments and consumables and they are committed to providing high quality products and services to enhance precision cancer diagnostics.

On February 6, 2020 Intabio, a developer of instrumentation systems for biotherapeutic precision analysis and quality assessment throughout bioproduction, reported a Series B investment of $18 million (Press release, Intabio, FEB 6, 2020, View Source [SID1234553976]). The financing round was led by Northpond Ventures, with additional funds coming from Genoa Ventures and Vertical Venture Partners. In a testament to Intabio’s steady progress, the step-up valuation financing round was fully subscribed by existing investors. The funds will be used to build Intabio’s commercial team and prepare for launch of its Blaze platform.

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"We believe Intabio is in a strong position to accelerate biotherapeutic development by enabling expanded quality monitoring throughout the drug development process," said Michael P. Rubin, M.D., Ph.D., Northpond’s Founder and CEO. "The Intabio team achieved an impressive string of milestones during 2019 and we remain enthusiastic about the company’s future as they progress toward commercialization of their first products."

Intabio’s Blaze platform performs a comprehensive analysis of biopharmaceutical product quality with blazing speed, offering 100-fold higher throughput over traditional methods. Testing of beta systems by major Biopharma groups is scheduled to begin in the second quarter of 2020, with full commercial introduction slate for late 2020.

"We are grateful to receive such steady, enthusiastic support from our investors," said Intabio’s CEO and co-founder, Lena Wu, Ph.D. "We built a strong foundation for our company in 2019, including the issuance of three patents, publication of a seminal paper, launch of our Technical Evaluation Service, and presentation of the first Blaze study by a Biopharma customer. This infusion of capital will fuel the commercial launch of the Blaze system which is eagerly anticipated by customers."

On February 6, 2020 Valo Therapeutics Limited (Valo Tx), an immuno-oncology company developing tumour antigen-coated oncolytic viruses as therapeutic vaccines, reported that it had received additional funding, triggered by positive pre-clinical data, to progress its PeptiCRAd platform into first-in-human clinical trials (Press release, Valo Therapeutics, FEB 6, 2020, View Source [SID1234553975]). The in-vivo data demonstrated a synergistic improvement in tumour clearance when checkpoint inhibitors were combined with Valo Tx’s platform.

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Dr Michael Stein, CEO of Valo Tx, commented, "With our latest funding from existing investors, of EUR1.1m, we’ve now raised a total of over EUR 10m, which will enable us to further validate our platform to develop antigen-coated oncolytic viruses as therapeutic vaccines. This funding gives us a strong financial basis to progress the GMP manufacture of our lead oncolytic adenovirus using PeptiCRAd into clinical trials in Q1 2021. Our first clinical trial will target melanoma, lung cancer and triple negative breast cancer. To help translate our exceptional science into effective treatments for patients with cancer, we plan to complete a Series A by summer 2020."

PeptiCRAd (Peptide-coated Conditionally Replicating Adenovirus) is an innovative way of combining the best features of two clinically proven cancer immunotherapy approaches, an oncolytic adenovirus and a peptide vaccine. PeptiCRAd uses immunogenic viruses as active carriers of tumour-specific peptides to direct the immune system to specifically target and kill cancer cells.

Valo’s EUR 10m funding comprises the recent EUR 1.1m from existing investors, a non-dilutive loan from The Finnish Funding Agency for Innovation (Business Finland, previously Tekes), and seed capital from private investors.

On February 6, 2020 BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, reported quarterly revenues of $4.225 billion for the first fiscal quarter ended December 31, 2019 (Press release, BD Pharmaceutical Systems, FEB 6, 2020, View Source [SID1234553974]). This represents an increase of 1.6 percent as reported over the prior-year period, or 2.5 percent on a currency-neutral basis.

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BD also announced today that it is continuing to work with the U.S. Federal Drug Administration (FDA) on its software remediation plan for the Alaris System, which will require additional regulatory filings beyond what the company previously anticipated. The company expects to submit its comprehensive regulatory filing in the fourth quarter of fiscal year 2020. In the interim, the company will partner with the FDA and existing customers to ensure continued access to the Alaris System under medical necessity. As a result, the company is lowering its full fiscal year revenue and adjusted diluted earnings per share guidance.

"In the first quarter, the BD team delivered solid results, in line with our expectations," said Tom Polen, CEO and president. "As we look ahead to the balance of the fiscal year, we are focused on the resolution of the Alaris pump matter. We stand behind the safety of the Alaris System, which is used in the care of 70 percent of patients undergoing infusion therapy. Now, we need to take the necessary steps to meet the FDA’s expectations with respect to the Alaris System. We are committed to doing what is right for customers, patients and shareholders. You can expect that our purpose and values will always be at the core of who we are and how we work to resolve this situation moving forward."

First Quarter Fiscal 2020 Operating Results
As reported, diluted earnings per share for the first quarter were $0.87, compared with $2.05 in the prior-year period. This represents a decrease of 57.6 percent, and is primarily due to the gain on the sale of the Advanced Bioprocessing business in the prior-year period. Adjusted diluted earnings per share were $2.65, compared with $2.70 in the prior-year period. This represents a decrease in adjusted diluted earnings per share of 1.9 percent, or 0.4 percent on a currency-neutral basis.

Segment Results
In the BD Medical segment, as reported, worldwide revenues for the quarter of $2.090 billion decreased 2.1 percent from the prior-year period, or 1.1 percent on a currency-neutral basis. As anticipated, the segment’s results reflect growth in the Pharmaceutical Systems unit that was offset by declines in the Medication Management Solutions and Diabetes Care units and revenues in the Medication Delivery Solutions unit that were about flat when compared to the prior year.

In the BD Life Sciences segment, as reported, worldwide revenues for the quarter of $1.123 billion increased 6.4 percent over the prior-year period, or 7.4 percent on a currency-neutral basis. Revenue growth was driven by performance in the Biosciences and Diagnostic Systems units. BD Life Sciences’ growth was aided by flu-related revenues in the Diagnostic Systems unit as a result of a stronger flu season in comparison to the prior year.

In the BD Interventional segment, as reported, worldwide revenues for the quarter of $1.012 billion increased 4.4 percent over the prior-year period, or 5.0 percent on a currency-neutral basis. Revenue growth was driven by performance across the Surgery, Urology and Critical Care and Peripheral Intervention units.

Geographic Results
As reported, first quarter revenues in the U.S. of $2.430 billion increased 1.8 percent over the prior-year period. Growth in the U.S. was driven by performance in the Life Sciences and Interventional segments, partially offset by a decline in the Medical segment, as anticipated.

As reported, revenues outside of the U.S. of $1.795 billion increased 1.2 percent over the prior-year period, or 3.4 percent on a currency-neutral basis. International revenue growth was driven by performance in China and the Asia Pacific region.

Fiscal 2020 Outlook for Full Year
The company is lowering its full fiscal year 2020 revenue and adjusted diluted earnings per share guidance to reflect the impact of the remediation effort and anticipated loss of sales of the Alaris infusion system.

The company now expects full fiscal year 2020 revenues to increase 1.5 to 2.5 percent as reported, or 2.5 to 3.5 percent on a currency-neutral basis.

The company now expects full fiscal year 2020 adjusted diluted earnings per share to be between $11.90 and $12.10. This represents growth of approximately 4.0 to 5.5 percent on a currency-neutral basis over fiscal 2019 adjusted diluted earnings per share of $11.68, or growth of approximately 2.0 to 3.5 percent including the estimated unfavorable impact of foreign currency. Adjusted diluted earnings per share guidance includes an adverse impact of approximately 500 basis points related to the expiration of the Gore royalty.

Adjusted diluted earnings per share for fiscal 2020 excludes potential charges or gains that may be recorded during the fiscal year, such as, among other things, the non-cash amortization of intangible assets, acquisition-related charges, and certain tax matters. BD does not attempt to provide reconciliations of forward-looking non-GAAP earnings guidance to the comparable GAAP measure because the impact and timing of these potential charges or gains is inherently uncertain and difficult to predict and is unavailable without unreasonable efforts. In addition, the company believes such reconciliations would imply a degree of precision and certainty that could be confusing to investors. Such items could have a substantial impact on GAAP measures of BD’s financial performance.

Conference Call Information
A conference call regarding BD’s first quarter results will be broadcast live on BD’s website, www.bd.com/investors, along with related slides, at 8:00 a.m. (ET) Thursday, February 6, 2020. The conference call will be available for replay on BD’s website, www.bd.com/investors, or at 1-800-585-8367 (domestic) and 1-404-537-3406 (international) through the close of business on Thursday, February 13, 2020, confirmation number 6886458.