On November 12, 2019 Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INSTASYL) therapeutic platform, reported its financial results for the third quarter ended September 30, 2019 and provided a business update (Press release, Phio Pharmaceuticals, NOV 12, 2019, View Source [SID1234550993]).

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"We remain focused on advancing our immuno-oncology pipeline toward meaningful value inflection points," said Dr. Gerrit Dispersyn, Phio’s President and CEO. "During the quarter, we continued to execute on our R&D objectives, in particular for our lead programs in targeted PD-1 receptor silencing, as well as leverage our unique self-delivering RNAi platform to establish additional research collaborations with leading companies and academic institutions as part of our ongoing effort to maximize the potential value of our technology. We’ve also presented several posters demonstrating the value of our platform and highlighting our pipeline progress to an audience of potential partners and future prescribers. We look forward to continuing to update the market as our programs advance."

Quarter in Review and Recent Corporate Updates

Entered into a research collaboration with the Helmholtz Zentrum München for the design and development of new targets based on Phio’s INSTASYL platform for use in cancer immunotherapies
Announced a research collaboration with Carisma Therapeutics to evaluate potential of Phio’s technology to enhance the immune function of Carisma’s chimeric antigen receptor macrophages (CAR-M) as a novel adoptive cell therapy for use in cancer treatment
Presented three posters at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2019 Annual Meeting highlighting Phio’s proprietary INTASYL technology for "weaponizing" T cells against cancer, reflecting internal work and from collaborations with Iovance Biotherapeutics and the Karolinska Institutet
Select Quarterly Financial Results

Cash Position

At September 30, 2019, the Company had cash of $8.7 million as compared with $14.9 million at December 31, 2018. The Company expects its cash and ability to raise cash through utilization of the Lincoln Park Capital equity line to provide funding for at least the next twelve months.

Research and Development Expenses

Research and development expenses for the quarter ended September 30, 2019, were $1.0 million as compared with $0.8 million for the quarter ended September 30, 2018. The increase was primarily due to an increase in consulting and outside professional service fees in support of preclinical research for the Company’s immuno-oncology programs.

General and Administrative Expenses

General and administrative expenses for the quarter ended September 30, 2019, were $1.1 million as compared with $0.7 million for the quarter ended September 30, 2018. The increase was primarily driven by an increase in payroll-related expenses and legal fees.

Net Loss

Net loss for the quarter ended September 30, 2019, was $2.1 million or $0.08 per share, compared with $1.5 million or $0.34 per share for the quarter ended September 30, 2018. The increase was primarily due to changes in operating expenses, as discussed above.

On November 12, 2019 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported the launch of Personalis’ Cancer Whole Genome Sequencing which further extends Personalis’ portfolio of comprehensive cancer genomics services designed to maximize biological insights from tumor samples (Press release, Personalis, NOV 12, 2019, View Source [SID1234551009]).

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"This new offering continues our push to provide our customers genomics solutions that enable deeper insights into patient responses to oncology therapies," said John West, CEO of Personalis. "We are uniquely poised to provide a leading cancer whole genome sequencing solution which combines Personalis’ deep technology and experience in analyzing cancer samples for biopharma oncology clinical trials and the large-scale laboratory and data systems developed for the VA MVP program, one of the largest whole genome sequencing programs in the world."

Earlier this year, Personalis was awarded a new task order under its contract with the U.S. Department of Veterans Affairs (VA) for the VA Million Veteran Program (VA MVP). This order brought the cumulative scale of orders received to date from the VA MVP to over 110,000 human genomes. Since 2013, Personalis has sequenced over 40,000 MVP samples. Personalis anticipates it will sequence the additional samples over the coming years as they are received from the VA.

"As our understanding of the complexity of underlying mechanisms of cancer grows, it is becoming increasingly important to evaluate genome-wide structural variants, and other forms of non-coding genetic variation," commented Dr. Richard Chen, CSO of Personalis. "This new service advances our position at the leading edge of cancer translational research with biopharma customers."

On November 12, 2019 Dragonfly Therapeutics, Inc. ("Dragonfly"), a biotechnology company developing novel immunotherapies that use the innate immune system to treat disease, reported that the first patient in a Phase I / II study of DF1001 at the MD Anderson Cancer Center at the University of Texas, Houston , USA , and the study by Dragonfly on DF1001 is currently recruiting patients with several types of advanced solid tumors, the human epidermal growth factor Receptor 2 (HER2) (Press release, Dragonfly Therapeutics, NOV 12, 2019, View Source [SID1234551024]).

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"DF1001 is the first candidate in our TriNKET platform to reach the clinic, marking our transition to becoming a clinical development company," said Bill Haney , co-founder and CEO of Dragonfly Therapeutics, "We are very excited about working with the MD Anderson’s immunotherapy experts as part of our study of the differential safety profile that our NK cell engages can offer against existing immuno-oncology options, and we also look forward to improving other assets in our portfolio with the same purposefulness that made us possible To further develop DF1001 for patients. "

"Clinical candidates coming from Dragonfly’s TriNKET platform have the potential for exceptional therapeutic performance," said Jean-Marie Cuillerot, Chief Medical Officer of Dragonfly Therapeutics. "We look forward to working with our MD Anderson collaboration partners on DF1001 continue to evolve for a variety of patients who are not receiving adequate treatment from currently available therapies. "

"Today is a big day for Dragonfly, founded less than four years ago. It is very exciting that the first clinical candidate of our TriNKETs pipeline has now reached the clinic, "said Tyler Jacks , director of the Koch Institute at MITand co-founder of the company. "In addition to our DF1001 program and our extensive development of drug candidates for Celgene and Merck, Dragonfly has an extensive pipeline of other internal programs that are rapidly approaching the clinic, including an internal program planned for the second quarter of 2020 for our second new program investigational. This remarkable progress and speed underline the urgency with which Dragonfly has pursued its goal of providing potential new treatment options for cancer patients. "

Dragonfly Therapeutics received an Investigational New Drug approval for its immunotherapy drug DF1001 earlier this year from the US Food and Drug Administration (FDA). The Company’s Phase I / II clinical trial is a sophisticated, open-label, non-randomized, first-in-man, multiple-dose multiple-dose study to evaluate the safety, tolerability, pharmacokinetics, and biological and clinical activity of DF1001 in patients with locally advanced or advanced disease metastatic solid tumors with HER2, with subsequent extension to selected indications.

Further study information, including eligibility criteria, is available at the following link: View Source (ClinicalTrials.gov identifier: NCT04143711).

About DF1001
DF1001 is a novel investigational drug candidate being studied in adult patients for the treatment of advanced solid HER2-positive tumors. DF1001 was discovered and developed by Dragonfly’s TriNKET platform. DF1001 has the potential to stimulate effective anti-tumor immunity in patients who are not suited for or respond to current therapies. DF1001 is the most advanced in the pipeline of TriNKET , which Dragonfly is developing to meet the unmet medical needs of patients with a variety of cancers.

About Dragonfly’s
TriNKET Platform Dragonfly’s TriNKET platform is the foundation of a portfolio of novel therapeutics that are trispecific natural killer cell activation therapies designed to enhance the natural and killer cells (NK) of the innate and adaptive Activate and redirect the immune system so that the cancer is eliminated.

On November 12, 2019 Verastem, Inc. (NASDAQ: VSTM) (the "Company") reported that it has entered into privately negotiated agreements among the Company and a limited number of investors who are accredited investors (within the meaning of Rule 501 promulgated under the Securities Act of 1933, as amended (the "Securities Act")) and/or qualified institutional buyers (as defined in Rule 144A under the Securities Act) who are holders of the Company’s existing 5.00% convertible senior notes due 2048 (the "existing notes") to exchange approximately $114.3 million aggregate principal amount of existing notes for (i) approximately $62.9 million aggregate principal amount of newly issued 5.00% convertible senior second lien notes due 2048 (the "exchange notes") and (ii) an aggregate of approximately $11.6 million in cash (such transactions, collectively, the "exchange") (Press release, Verastem, NOV 12, 2019, View Source [SID1234550941]). For each $1,000 principal amount of existing notes being exchanged, the Company will deliver to the exchanging investor $550 principal amount of exchange notes and a cash payment of $100, together with accrued and unpaid interest on the existing notes (plus, if applicable, an adjustment in lieu of issuing fractional exchange notes). The exchange is expected to close on November 14, 2019, subject to customary closing conditions. The Company will not receive any cash proceeds from the exchange.

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The exchange notes will be issued pursuant to an indenture by and between the Company and Wilmington Trust, National Association (the "indenture"). After giving effect to the issuance of the exchange notes and the exchange of the existing notes pursuant to the exchange, approximately $62.9 million aggregate principal amount of the exchange notes is expected to be issued and outstanding and approximately $35.7 million aggregate principal amount of the existing notes is expected to remain issued and outstanding.

The exchange notes will be senior secured obligations of the Company and pay interest semiannually in arrears at a rate of 5.00% per annum on May 1 and November 1 of each year, beginning on May 1, 2020. The exchange notes will mature on November 1, 2048 (the "maturity date"), unless earlier converted, redeemed or repurchased by us, and will be secured by a second lien on the assets of the Company securing indebtedness issued under its existing senior secured credit facility. The exchange notes will be convertible at the option of the holder into shares of common stock of the Company, par value $0.0001 per share ("common stock"), at any time prior to the close of business on the scheduled trading day immediately preceding the maturity date. The conversion rate for the exchange notes is 606.0606 shares of the Company’s common stock per $1,000 principal amount of the exchange notes (subject to certain adjustments), which is equivalent to an initial conversion price of approximately $1.65 per share, representing an approximately 52.8% premium to the last reported sale price of $1.08 per share of common stock on November 11, 2019, as reported on the Nasdaq Global Market.

Upon conversion of the exchange notes, holders will receive a cash payment equal to the accrued and unpaid interest on the converted exchange notes. In addition, prior to November 1, 2020, holders who convert their exchange notes (other than in connection with the exercise of the Company’s issuer conversion option) will also be entitled to an interest make-whole equal to the sum of all regularly scheduled stated interest payments, if any, due on such exchange notes on each interest payment date occurring after the conversion date for such conversion and on or before November 1, 2020.

The Company will have the right, exercisable at its option, to cause all exchange notes then outstanding to be converted automatically if the volume-weighted average price per share of the Company’s common stock equals or exceeds 121% of the conversion price for a specified period of time and certain other conditions are satisfied.

Prior to November 1, 2022, the Company will not have the right to redeem the exchange notes. On or after November 1, 2022, the Company may elect to redeem the exchange notes, in whole or in part, at a cash redemption price equal to the principal amount of the exchange notes to be redeemed, plus accrued and unpaid interest, if any.

Holders of the exchange notes will have the right, at their option, to require the Company to purchase their exchange notes (i) on November 1, 2023, November 1, 2028, November 1, 2033, November 1, 2038 and November 1, 2043, or (ii) if a "fundamental change" (as defined in the indenture) occurs, in each case, at a repurchase price equal to 100% of the principal amount of the exchange notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the applicable repurchase date.

In connection with the exchange, the Company intends to enter into an amendment to its senior secured credit agreement.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy the notes or any other securities, and shall not constitute an offer, solicitation or sale in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful.

The offer and sale of the exchange notes or the shares of common stock issuable upon their conversion have not been registered under the Securities Act or any state securities laws. The notes and such shares may not be offered or sold except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and any applicable state securities laws.

On November 12, 2019 Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH) a biopharmaceutical company focused on commercializing its novel tetracycline XERAVA (eravacycline for injection) to treat serious and life-threatening infections, reported financial results for the third quarter ended September 30, 2019 (Press release, Tetraphase, NOV 12, 2019, View Source [SID1234550959]).

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"XERAVA has now been on the market for just over a year, and during that time we have made significant progress, particularly in the third quarter, with 30% carton growth over last quarter, leading to a 23% increase in net XERAVA revenue compared with the previous quarter," said Larry Edwards, President and Chief Executive Officer of Tetraphase. "We are squarely focused on continuing to increase formulary uptake and pull-through, as we believe XERAVA is a critically important new addition to the hospital antibiotic armamentarium, and that increased formulary uptake and pull through will result in increased sales. With our recent equity offering and payoff of debt, we are now in a stronger financial position to execute on these goals."

Third Quarter and Recent Highlights

Continued to Progress Launch of XERAVA in U.S. Hospitals
The Company continues to see increased formulary uptake, with a 99% success rate for all formulary reviews to date. Tetraphase’s salesforce is now focusing on bringing XERAVA to both Tier 1 as well as Tier 2 institutions, which are the highest users of antibiotics defined by days of therapy. The reorder rate for XERAVA continues to be very strong with the reorder rates as high as 57% for all accounts and approximately 70% within the tier 1 account segment. XERAVA is available at more than 1,000 accounts and approximately 154 formulary reviews are pending or planned to take place by the end of the fourth quarter of 2019.
Completed $7M Equity Financing (Net of Fees and Expenses)
In November 2019, the Company completed a registered direct offering with a healthcare-focused institutional investor for the purchase of (i) 300,000 shares of common stock and accompanying warrants to purchase an aggregate of 300,000 shares of common stock, and (ii) pre-funded warrants to purchase up to an aggregate of 1,830,493 shares of common stock and accompanying warrants to purchase an aggregate of 1,830,493 shares of common stock. The net proceeds to the Company from the offering, after deducting the placement agent’s fees and other estimated offering expenses payable by the Company, were approximately $7.0 million. The Company intends to use the net proceeds from the offering for the commercialization of XERAVA as well as for working capital and other general corporate purposes.
Presented XERAVA Data at the Infectious Disease Society of America’s (IDSA) Infectious Disease Week (IDWeek) 2019
In October 2019, XERAVA was featured in seven poster presentations at IDWeek 2019, which was held October 2-6 in Washington, D.C. The data lend additional support for the continued use of XERAVA in the hospital setting to treat serious, life-threating multidrug resistant infections, including complicated intra-abdominal infections (cIAI).
Effected a Reverse Stock Split
In September 2019, the Company effected a 1-for-20 reverse stock split of its common stock, bringing the Company into compliance with the minimum bid price requirement for maintaining its listing on the Nasdaq Global Select Market.
Completed Payment of Debt to Solar Capital Limited
In August 2019, the Company paid off its remaining debt to Solar Capital Limited. The Company had previously entered into a loan agreement with Solar Capital in November 2018 to support the commercial launch of XERAVA and general corporate purposes. The payoff of this debt provides the Company with long term financial flexibility.
Third Quarter 2019 Financial Results

As of September 30, 2019, Tetraphase had cash and cash equivalents of $24.5 million and 2.7 million shares outstanding. Subsequent to the end of the third quarter, the Company raised an additional $7 million, net of expenses, in an equity offering. The Company expects that its cash and cash equivalents including the equity proceeds, as well as expected revenue, will be sufficient to fund operations into the third quarter of 2020.

For the third quarter of 2019, Tetraphase reported a net loss of $16.3 million, or $6.00 per share, compared to a net loss of $19.6 million, or $7.39 per share, for the same period in 2018, driven by both increased revenues and lower operating expenses.

Revenues from sales of XERAVA were $1.0 million in the third quarter of 2019. Total revenues, including License and Collaboration Revenue and Government Revenue, were $3.3 million for the third quarter of 2019, compared to $1.2 million for the same period in 2018. Total revenues for the third quarter of 2019 consisted of XERAVA product revenue of $1.0 million, a territory expansion payment from Everest Medicines of $2.0 million and government contract revenue of $0.4 million.

Research and development (R&D) expenses for the third quarter of 2019 were $5.3 million, compared to $11.7 million for the same period in 2018. This decrease was primarily due to a decrease in activity across all of our pipeline programs as compared to the prior year period.

Selling, general and administrative (SG&A) expenses for the third quarter of 2019 were $11.4 million, compared to $9.5 million for the same period in 2018. This increase in SG&A expenses for the third quarter of 2019 compared to the same prior-year period was primarily due to an increase in commercial-related expenses for XERAVA.

Conference Call and Webcast Information

Tetraphase will host a conference call today at 4:30 p.m. ET to discuss its financial results and provide an update on the Company. The call can be accessed by 844-831-4023 (U.S. and Canada) or 731-256-5215 (international) and entering conference ID number 2362909. To access the live audio webcast, visit the "Investors — Events & Presentations" section of the Tetraphase website at www.tphase.com.

A replay of the conference call will be available from 7:30 p.m. ET on Tuesday, November 12, 2019, through 7:30 p.m. ET on Tuesday, November 19, 2019 by dialing and dialing 855-859-2056 (U.S. and Canada) and 404-537-3406 for (international) callers. The conference ID number is 2362909. A replay of the webcast will be available by visiting Tetraphase’s website.

About XERAVA

XERAVA (eravacycline for injection) is a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections (cIAI) in patients 18 years of age and older. XERAVA was investigated for the treatment of cIAI as part of the Company’s IGNITE (Investigating Gram-Negative Infections Treated with Eravacycline) Phase 3 program. In the first pivotal Phase 3 trial in patients with cIAI, twice-daily intravenous (IV) XERAVA met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to ertapenem and was well-tolerated. In the second Phase 3 clinical trial in patients with cIAI, twice-daily IV XERAVA met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to meropenem and was well-tolerated. In both trials, XERAVA achieved high cure rates in patients with Gram-negative pathogens, including resistant isolates.

XERAVA Important Safety Information

XERAVA is a tetracycline class antibacterial indicated for the treatment of complicated intra‑abdominal infections in patients 18 years of age and older.

XERAVA is not indicated for the treatment of complicated urinary tract infections.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial drugs, XERAVA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

XERAVA is contraindicated for use in patients with known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs or to any of the excipients. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with XERAVA.

The use of XERAVA during tooth development (last half of pregnancy, infancy and childhood to the age of eight years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.

The use of XERAVA during the second and third trimester of pregnancy, infancy and childhood up to the age of eight years may cause reversible inhibition of bone growth.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis.

The most common adverse reactions observed in clinical trials (incidence ≥ 3%) were infusion site reactions, nausea, and vomiting.

XERAVA is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti‑anabolic action which has led to increased blood urea nitrogen, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with XERAVA. Discontinue XERAVA if any of these adverse reactions are suspected.

To report SUSPECTED ADVERSE REACTIONS, contact Tetraphase Pharmaceuticals Inc., at 1-833-7-XERAVA (1-833-793-7282) or FDA at 1‑800‑FDA-1088 or www.fda.gov/medwatch.