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Akebia Therapeutics Announces Third Quarter 2018 Financial Results

On November 8, 2018 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company focused on delivering innovative therapies to patients with kidney disease through the biology of hypoxia-inducible factor (HIF), reported financial results for the third quarter ended September 30, 2018 (Press release, Akebia, NOV 8, 2018, View Source [SID1234531054]).

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"In the third quarter, we continued to drive our vadadustat Phase 3 development program, while working diligently to close our proposed merger transaction with Keryx Biopharmaceuticals by the end of 2018. The combination is expected to create a fully-integrated kidney disease therapeutics company, with a strengthened financial profile, positioned to deliver substantial long-term value to shareholders," said John P. Butler, President and Chief Executive Officer of Akebia Therapeutics. "In addition, we look forward to the Phase 3 clinical trial readouts in Japan from our collaboration partner, Mitsubishi Tanabe Pharma Corporation, expected next year. This will be the first time Phase 3 data has been reported for our product candidate, vadadustat, which is an important milestone."

Third Quarter 2018 and Recent Corporate Highlights

Merger Integration Planning:

Following the definitive merger agreement with Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) announced June 28, 2018, Akebia has been actively engaged in integration planning and expects to close the transaction by the end of 2018;
The combination offers potential operating and product portfolio synergies and the opportunity to create significant value and accelerate the growth potential beyond what either company would achieve separately;
The combined company will have an expanded and highly complementary nephrology portfolio, with Auryxia (ferric citrate), a U.S. Food and Drug Administration (FDA)-approved product in two indications with significant growth opportunity, and vadadustat, an investigational late-stage hypoxia-inducible factor prolyl hydroxylase inhibitor, which has the potential to provide a new oral standard of care to patients with anemia due to chronic kidney disease (CKD);
The combined company will have an established renal development, manufacturing and commercial organization, positioning it as a partner of choice for the renal community and for companies developing renal products; and
The combined company plans to leverage its leadership’s extensive expertise in the commercial renal market with the goal of maximizing sales of Auryxia while driving launch momentum for vadadustat in the United States, subject to FDA approval.
Clinical Development:

Akebia continued to enroll subjects in its Phase 3 INNO2VATE program, with top-line results expected in the first quarter of 2020, subject to the accrual of major adverse cardiovascular events (MACE). U.S. enrollment in the Phase 3 INNO2VATE Conversion study completed last quarter, as announced in Akebia’s second quarter 2018 earnings press release;
Akebia continued to enroll subjects in its Phase 3 PRO2TECT program, with top-line results anticipated in mid-2020, subject to the accrual of MACE; and
Akebia received a recommendation from the Independent Data Monitoring Committee, which held another meeting in the quarter, for Akebia’s global Phase 3 PRO2TECT and INNO2VATE programs to continue without modification.
Other Business:

This past quarter, Akebia appointed Cynthia Smith to its Board of Directors. With more than 20 years of broad leadership experience within the healthcare industry, including serving as a Chief Commercial Officer, Cynthia brings expertise that is particularly relevant to Akebia as it prepares for the commercialization of vadadustat, subject to regulatory approval, and works to maximize the value of Auryxia, subject to the consummation of Akebia’s merger with Keryx Biopharmaceuticals.
Financial Results

Akebia reported a net loss of $26.0 million, or ($0.46) per share, for the third quarter of 2018 as compared to a net loss for the third quarter of 2017 of $23.1 million or ($0.49) per share.

Collaboration revenue was $53.2 million for the third quarter of 2018 compared to $41.3 million for the third quarter of 2017. Collaboration revenue recognized in the third quarter of 2018 related primarily to revenue recognized under both the U.S. collaboration agreement with Otsuka Pharmaceutical Co. Ltd., or Otsuka, and the collaboration agreement with Otsuka related to Europe, China and certain other regions, or the Otsuka International Agreement. Collaboration revenue recognized in the third quarter of 2017 also related to the Otsuka U.S. Agreement and the Otsuka International Agreement, which were consummated in December 2016 and April 2017, respectively.

Research and development expenses were $70.6 million for the third quarter of 2018 compared to $58.7 million for the third quarter of 2017. The increase was primarily attributable to external costs related to the global PRO2TECT and INNO2VATE Phase 3 programs. Research and development expenses were further increased by headcount and compensation-related costs.

General and administrative expenses were $10.4 million for the third quarter of 2018 compared to $6.7 million for the third quarter of 2017. The increase was primarily attributable to an increase in legal and other professional fees related to our proposed merger with Keryx Biopharmaceuticals, and an increase in costs to support the company’s research and development programs, including headcount and compensation-related costs.

Akebia ended the third quarter of 2018 with cash, cash equivalents and available for sale securities of $390.1 million. The company also generally receives cost-share funding from its collaboration agreements with Otsuka on a prepaid quarterly basis. Akebia expects its existing cash resources, including the prepaid quarterly committed cost-share funding from its collaborators, to fund its current operating plan through the first quarter of 2020.

Synthetic Biologics Reports Third Quarter 2018 Operational Highlights and Financial Results

On November 8, 2018 Synthetic Biologics, Inc. (NYSE American: SYN), a late-stage clinical company developing therapeutics designed to preserve the microbiome to protect and restore the health of patients, reported financial results for the three and nine months ended September 30, 2018 (Press release, Synthetic Biologics, NOV 8, 2018, View Source [SID1234531053]).

"During the third quarter, we remained sharply focused on the advancement of our portfolio of microbiome-focused assets," stated Steven A. Shallcross, Interim Chief Executive Officer and Chief Financial Officer. "We were pleased to report the expansion of our relationship with Cedars-Sinai Medical Center and announced a research agreement to co-fund an investigator-sponsored Phase 2b clinical study of SYN-010, our modified-release formulation of lovastatin lactone designed to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C). In addition to fortifying the well-established clinical data set for SYN-010, we believe results from this study will determine the optimal dose of SYN-010 for future registration studies. During the third quarter we also held an End of Phase 2 meeting with the FDA to define a clear and achievable pathway forward for SYN-004, our first-in-class therapeutic intervention designed to protect the gut microbiome from antibiotic-mediated dysbiosis. We also announced that we are evaluating opportunities that may further unlock the potential of SYN-004 through the pursuit of a second more focused indication in a specialty patient population with multiple potential disease endpoints associated with IV beta-lactam-induced gut microbiome damage, such as allogeneic hematopoietic cell transplant (HCT) recipients. This dual approach may enable us to continue the clinical advancement of SYN-004 in a cost-effective manner while targeting an area of clear unmet need and expanding upon the established data set to further validate SYN-004’s use in the broader indication for the prevention of CDI."

Mr. Shallcross continued, "While remaining keenly focused on the execution of our clinical development activities, we also significantly strengthened our balance sheet by raising gross proceeds of approximately $18.6 million from the closing of a public offering of common stock and Series B convertible preferred stock, as well as net proceeds of approximately $11.8 million from the utilization of our "at-the-market" facility through October. As a result of these activities, our current cash position to date is approximately $32 million and should provide ample runway to allow the Company to continue its operations into 2020 as we continue to focus on the achievement of key clinical development milestones for our two-lead assets."

Clinical Development and Operational Update

Entered into agreement with Cedars-Sinai Medical Center (CSMC) in Q3 2018 to co-fund an investigator-sponsored Phase 2b clinical study of SYN-010 to evaluate SYN-010 dose response and inform Phase 3 clinical development:

The Phase 2b clinical study will be conducted out of the Pimentel Laboratory at CSMC and is expected to be comprised of a 12-week, placebo-controlled, double-blind, randomized clinical trial to evaluate two dose strengths of oral SYN-010 (21 mg and 42 mg) in approximately 150 patients diagnosed with IBS-C,

Anticipate dosing first patient in the Phase 2b investigator-sponsored clinical study during Q4 2018, contingent upon approval of the clinical study protocol by the Cedars-Sinai Medical Center Institutional Review Board,

Anticipate data readout from the Phase 2b investigator-sponsored clinical study during 2H 2019;

Held End-of-Phase 2 meeting with the FDA to solidify the remaining elements of the SYN-004 (ribaxamase) Phase 3 clinical trial in Q3 2018;

Clarified market/partner needs and identified potential additional indications for SYN-004 in specialty patient populations such as allogeneic hematopoietic cell transplant patients in 3Q 2018;

Plan to initiate clinical trial(s) (2H 2019), which may include a broad Phase 3 clinical trial and/or Phase 1/2 clinical trial(s) in a specialty population leading to a subsequent Phase 3 clinical trial;

Identified three potential clinical indications for SYN-020 (intestinal alkaline phosphatase) in areas of unmet medical need including, enterocolitis associated with radiation therapy, enterocolitis associated with checkpoint inhibitor therapy for cancer, and microscopic colitis in 3Q 2018,

Anticipated IND filing during Q4 2019;

Strengthened balance sheet by raising gross proceeds of approximately $18.6 million from the closing of a public offering of common stock and Series B convertible preferred stock in support of the continued advancement of our microbiome-focused clinical programs in Q4 2018.
Quarter Ended September 30, 2018 Financial Results

General and administrative expenses decreased by 12% to $1.5 million for the three months ended September 30, 2018, from $1.7 million for the three months ended September 30, 2017. This decrease is primarily the result of lower salary expense, stock compensation, and related benefits costs incurred during the three months ended September 30, 2018 as compared to the three months ended September 30, 2017 due to the resignation of the prior Chief Executive Officer, along with the reduction of travel and consulting expense, offset by higher registration, investor relations and legal costs. The charge related to stock-based compensation expense was $186,000 for the three months ended September 30, 2018, compared to $583,000 the three months ended September 30, 2017.

Research and development expenses decreased by 32% to $2.8 million for the three months ended September 30, 2018, from $4.1 million for the three months ended September 30, 2017. This decrease is primarily the result of lower SYN-004 (ribaxamase) and SYN-010 program costs for the three months ended September 30, 2018 since no clinical trials were ongoing during the quarter. The research and development costs incurred during the quarter were primarily related to planning for future Phase 3 (SYN-004) and Phase 2b/3(SYN-010) clinical programs as we sought to secure the financial resources necessary for the advancement of these clinical trials. The charge related to stock-based compensation expense was $289,000 for the three months ended September 30, 2018, compared to $317,000 for the three months ended September 30, 2017.

Other income was $631,000 for the three months ended September 30, 2018, compared to other expense of $5.1 million for the three months ended September 30, 2017. Other income for the three months ended September 30, 2018 is primarily comprised of non-cash income of $626,000 from the change in fair value of warrants. The decrease in the fair value of the warrants was due to the decrease in our stock price from the prior quarter.

Cash and cash equivalents as of September 30, 2018 totaled $9.5 million, a decrease of $7.6 million from December 31, 2017, which does not reflect the proceeds from the sale of our securities during October 2018. During October 2018, we raised gross proceeds of approximately $18.6 million from the closing of a public offering of common stock and Series B Preferred Stock and received net proceeds of approximately $5.8 million from sales of our Common Stock in "at-the-market" equity offerings.

Conference Call

Synthetic Biologics will hold a conference call today, Thursday, November 8, 2018, at 4:30 p.m. (EST). The dial-in information for the call is as follows, U.S. toll free: +1 888-347-5280 or International: +1 412-902-4280. Participants are asked to dial in 15 minutes before the start of the call to register. The call will also be webcast over the Internet at View Source." target="_blank" title="View Source." rel="nofollow">View Source An archive of the call will be available for replay at the same URL, View Source, for 90 days after the call.

Alder BioPharmaceuticals® to Present at Two Upcoming November Investor Conferences

On November 8, 2018 Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, reported that it will webcast a business overview and update by Bob Azelby, Alder’s president and chief executive officer, at each of the following upcoming healthcare conferences (Press release, Alder Biopharmaceuticals, NOV 8, 2018, View Source [SID1234531052]):

Credit Suisse 27th Annual Healthcare Conference at 4:00 p.m. MT on Wednesday, November 14, 2018 in Scottsdale, AZ.
Piper Jaffray 30th Annual Healthcare Conference at 12:00 p.m. ET on Wednesday, November 28, 2018 in New York, NY.
A live audio webcast of each event can be accessed on the Events & Presentations page of the Investors section of Alder’s website at View Source, or by following the link below in your web browser. An archived replay of the webcast will be available on Alder’s website for at least 30 days after each live event concludes.

Aurinia Reports Third Quarter Financial Results, Clinical Highlights and Corporate Development

On November 8, 2018 Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) ("Aurinia" or the "Company") reported that it has released its financial results for the third quarter ended September 30, 2018. Amounts, unless specified otherwise, are expressed in U.S. dollars (Press release, Aurinia Pharmaceuticals, NOV 8, 2018, View Source [SID1234531051]).

"We achieved a significant milestone in September with the completion of enrollment for the AURORA Phase III trial ahead of schedule. Our target enrollment of 324 patients was surpassed due to high patient demand with 358 LN patients randomized in sites across 27 countries." said Richard M. Glickman, Aurinia’s CEO and Chairman of the Board. "I continue to be impressed by our clinical team which has delivered on our important milestones, and to that end, I am pleased to announce enrollment for the phase II dry eye trial will be completed in the next couple of days, and we expect top-line data in January 2019."

Clinical Highlights

Our Phase III clinical trial ("AURORA") to evaluate voclosporin for the treatment of lupus nephritis ("LN"), which we initiated in May of 2017, completed enrollment in September 2018. We expect top-line data to be available in late 2019.
A significant percentage of patients who have completed the AURORA trial are rolling over into the AURORA 2 blinded extension study ("AURORA 2") from the AURORA Phase III clinical trial. The purpose of AURORA 2 is to assess the long-term benefit/risk of voclosporin in patients with LN; however, this study is not a requirement for potential regulatory approval for voclosporin.
We initiated a Phase II head-to-head tolerability study of voclosporin ophthalmic solution ("VOS") versus Restasis (cyclosporine ophthalmic emulsion) 0.05% for the treatment of Dry Eye Syndrome ("DES") in July 2018, and full enrollment is anticipated imminently. This four-week study of approximately 90 patients is expected to complete by the end of 2018 with data available in January 2019. We believe calcineurin inhibitors ("CNIs") are a mainstay of treatment for DES, and the goal of this program is to develop a best-in-class treatment option.
We also initiated a Phase II proof-of-concept study in focal segmental glomerulosclerosis ("FSGS") in June 2018 and are currently in the process of enrolling patients. This is an open-label study of 20 treatment naïve patients diagnosed with primary FSGS.
Corporate Development

Aurinia also announced today that Richard M. Glickman, the Company’s Chairman and Chief Executive Officer, intends to retire from his position once a suitable replacement is identified and appointed. The Board of Directors will retain a search firm and initiate a search for his successor.

"Richard is a gifted entrepreneur who has established Aurinia as a leading biotech company and shepherded it to its next phase of growth. On behalf of the Board of Directors, I want to thank him for his inspired leadership and significant contribution to both the Company and patient community since Aurinia’s inception in 2012," said George M. Milne Jr, Ph.D., Independent Director and Chairman of the Governance Committee. "Under his direction, the Company has delivered on all its key milestones and evolved into a patient-centric, late-stage clinical company with investigational drugs addressing multiple indications across the global immunology market."

"Two years ago – a critical time in the company’s growth – my decision to come out of retirement to join Aurinia as CEO was fueled by my absolute belief in the potential for voclosporin to transform the lupus nephritis treatment landscape," said Dr. Glickman. "I’m incredibly proud of Aurinia’s progress over the last 21 months, and I know this is the optimal time to bring in a new CEO who will build on our clinical success as we approach commercialization. My commitment to the Company and the patients it serves is steadfast, and I plan to remain a resource to the Board and management team as it enters its next chapter."

Financial Liquidity at September 30, 2018

At September 30, 2018, we had cash, cash equivalents and short term investments of $138.9 million compared to $150.2 million at June 30, 2018 and $173.5 million at December 31, 2017. Net cash used in operating activities was $11.3 million for the third quarter ended September 30, 2018 compared to $8.5 million for the third quarter ended September 30, 2017.

We believe that our cash position is sufficient to fund our existing LN program including the AURORA clinical trial, conduct our current studies in FSGS and DES, complete the work required for the NDA submission to the FDA, and fund operations into 2020.

Financial Results for the Three and Nine Months Ended September 30, 2018

We reported a consolidated net loss of $18.3 million or $0.21 per common share for the three months ended September 30, 2018, as compared to a consolidated net loss of $13.1 million or $0.16 per common share for the three months ended September 30, 2017.

The increase in the loss for the three months ended September 30, 2018 compared to the same period in 2017 was primarily due to the non-cash change of $5.2 million in the estimated fair value of derivative warrant liabilities. The three months ended September 30, 2018 reflected a $4.8 million increase in the estimated fair value of derivative warrant liabilities compared to a reduction of $355,000 in the estimated fair value of derivative warrant liabilities for the three months ended September 30, 2017. The change in the revaluation of the derivative warrant liabilities is primarily driven by the change in our share price at each period end. An increase in our share price results in an increase in the estimated fair value of derivative warrant liabilities and vice versa. The derivative warrant liabilities will ultimately be eliminated on the exercise or forfeiture of the warrants and will not result in any cash outlay by the Company.

The net loss before the non-cash change in estimated fair value of derivative warrant liabilities was $13.5 million for the three months ended September 30, 2018 compared to $13.5 million for the same period in 2017.

For the nine months ended September 30, 2018, the consolidated net loss was $49.5 million or $0.59 per common share compared to a consolidated net loss of $67.5 million or $0.91 per common share for the comparable period in 2017. For the nine months ended September 30, 2018 we recorded an increase of $9.4 million in the estimated fair value of derivative warrant liabilities compared to $32.9 million for the comparable period in 2017.

The net loss before the non-cash change in estimated fair value of derivative warrant liabilities was $40.1 million for the nine months ended September 30, 2018 compared to $34.5 million for the same period in 2017. The increased loss was primarily due to higher research and development expenses.

Research and development expenses increased to $11.2 million for the three months ended September 30, 2018, compared to $10.8 million for the three months ended September 30, 2017. We incurred research and development expenses of $30.5 million for the nine months ended September 30, 2018, as compared to $25.2 million for the same period in 2017. The increased research and development expenses reflected costs associated with the commencements of AURORA 2 and the FSGS and DES studies.

Corporate, administration and business development expenses increased to $2.9 million for the three months ended September 30, 2018, compared to $2.7 million for the same period in 2017. We incurred corporate, administration and business development expenses of $10.2 million for the nine months ended September 30, 2018 compared to $9.0 million for the comparable period in 2017. The increase was due primarily to higher non-cash stock compensation expense in 2018 compared to the same periods in 2017.

This press release should be read in conjunction with our unaudited interim condensed consolidated financial statements and the MD&A for the third quarter ended September 30, 2018 which are accessible on Aurinia’s website at www.auriniapharma.com, on SEDAR at www.sedar.com or on EDGAR at www.sec.gov/edgar.

Aurinia will host a conference call and webcast to discuss third quarter 2018 financial results today, Thursday, November 8, 2018 at 4:30 p.m. ET. This event can be accessed on the investor section of the Aurinia website at www.aurinia.com.

TETRAPHASE PHARMACEUTICALS REPORTS THIRD QUARTER 2018 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE

On November 8, 2018 Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on developing and commercializing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, reported financial results for the quarter ended September 30, 2018 and provided a corporate update (Press release, Tetraphase, NOV 8, 2018, View Source [SID1234531050]).

"During the third quarter of 2018, we reached our most significant milestones as a company to date – the regulatory approvals of XERAVA for the treatment of complicated intra-abdominal infections (cIAI) in both the U.S. and Europe, followed by the commercial launch of XERAVA in the U.S. in October. We are thrilled to have accomplished these extraordinary achievements and to have made this important new antibiotic treatment available to patients in need. XERAVA is now available for use in hospitals and healthcare institutions for the treatment of a range of patients with empiric and confirmed cIAI infections," said Chief Executive Officer, Guy Macdonald.

Mr. Macdonald added, "We are also pleased to have entered into a loan agreement for up to $75 million, the first $30 million tranche of which extends our cash runway into the second quarter of 2020 and provides us with additional flexibility to support a strong launch of XERAVA in the U.S. Beyond XERAVA, we look forward to milestones for our earlier-stage programs, including completion of our Phase 1 multiple ascending-dose study for oral TP-271, in development to target respiratory infections, and initiation of a bronchopulmonary disposition study for TP-6076, targeted against Acinetobacter baumannii and other MDR pathogens. As a commercial company with a focus on delivering XERAVA to patients in need, we are also continuing our pipeline efforts to develop additional antibiotic options to fight MDR infections."

Key Upcoming Milestones

Commence Phase 1 bronchopulmonary disposition study for TP-6076 – 1Q 2019
Complete Phase 1 multiple ascending-dose study for oral TP-271 – 2Q 2019
Begin phased launch of XERAVA in Europe – 1H 2019
Third Quarter and Recent Highlights

AnnouncedCommercial Launch of XERAVA for cIAI Following the U.S. Food and Drug Administration (FDA) Approval in August
The Company commercially launched XERAVA in the U.S. in October 2018. XERAVA is now available for use in hospitals and healthcare institutions for the treatment of a range of patients with empiric and confirmed cIAI infections. The salesforce will be focusing on institutions responsible for treating patients in 90% of the Gram-negative marketplace.

XERAVA’s launch followed FDA approval of XERAVA in August for the treatment of cIAI in patients 18 years of age and older. Supporting XERAVA’s approval were results from two Phase 3 clinical studies that showed the therapy was well-tolerated and achieved high clinical cure rates in patients with cIAI, thus demonstrating statistical non-inferiority to two widely used carbapenems – ertapenem and meropenem.

Received Marketing Authorization from the European Commission (EC) for XERAVA in the European Union (EU)
In September, the EC adopted the July 2018 positive opinion issued by the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) to grant marketing authorization for XERAVA for the treatment of cIAI in adults in all EU member states as well as Iceland, Liechtenstein and Norway. Following this approval, the Company is on track for a phased European launch of XERAVA, beginning with Germany and the UK in the first half of 2019.

Presented XERAVA and TP-6076 Data at the Infectious Disease Society of America’s (IDSA) 2018 IDWeek
In October, the Company presented data related to XERAVA and TP-6076 at IDSA’s IDWeek. Among the data presented were results from a post-hoc analysis of XERAVA Phase 3 data, which showed high clinical cure rates and microbiological eradication with XERAVA among patients with cIAI and concurrent bacteremia. Data from a Phase 1 randomized, placebo-controlled, double-blind, multiple-ascending-dose study demonstrating positive safety, tolerability and pharmacokinetic results for the Company’s novel, fully synthetic tetracycline, TP-6076 were also presented.

Presented XERAVA Data at the American College of Clinical Pharmacy (ACCP) 2018 Global Conference
In October, the Company announced positive data from a post-hoc analysis of two Phase 3 trials of XERAVA in higher risk populations – obese patients and those with altered renal function. Similar clinical cure rates were observed for XERAVA across all classifications of renal function, further supporting that the drug is an effective empiric treatment for cIAI comparable to carbapenems which may provide an alternative to antibiotics that require dosing modification in patients with altered renal function. XERAVA was also effective in treating patients with cIAI regardless of body mass index when dosed 1mg/kg IV every 12 hours, based on total body weight when compared to carbapenems.

Entered into Loan and Security Agreement with Solar Capital Limited
In November 2018, the Company entered into a loan agreement with Solar Capital Limited providing us up to $75 million with $30 million funded at closing, to be used to support the commercial launch of XERAVA and general corporate purposes. Armentum Partners acted as advisor to the Company on the transaction.
Third Quarter 2018 Financial Results
As of September 30, 2018, Tetraphase’s cash and cash equivalents were $97 million, and there were approximately 53.5 million shares outstanding. The Company expects that its cash and cash equivalents, including the initial funding of $30 million from the debt facility, as well as expected revenue from its U.S. government awards and commercial sales of XERAVA in the U.S. and Europe, will be sufficient to fund operations into the second quarter of 2020.

Revenues during the third quarter of 2018 were $1.2 million compared to $4.1 million for the same period in 2017. Revenues for each period consisted of contract and grant revenue under the Company’s U.S. government awards for the development of Tetraphase compounds. The decrease was primarily due to the timing of activities under these awards.

Research and development (R&D) expenses for the third quarter of 2018 were $11.7 million compared to $28.8 million for the same period in 2017. The decrease in R&D expenses was primarily due to the completion of the IGNITE Phase 3 clinical studies for XERAVA.

Sales, general and administrative expenses for the third quarter of 2018 were $9.5 million compared to $5.6 million for the same period in 2017. This increase was primarily due to commercialization expenses to support the U.S. launch of XERAVA.

For the third quarter of 2018, Tetraphase reported a net loss of $19.6 million, or a loss of $0.37 per share, compared to a net loss of $30.0 million, or a loss of $0.63 per share, for the same period in 2017.

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 dialing 844-831-4023 (U.S. and Canada) or 731-256-5215 (international) and entering conference ID number 3997765. To access the live audio webcast, or the subsequent archived recording, 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 Thursday, November 8, 2018, through 7:30 p.m. ET on Thursday, November 15, 2018 and by dialing 855-859-2056 (U.S. and Canada) and 404-537-3406 for (international) callers. The conference ID number is 3997765. A replay of the webcast is available by visiting Tetraphase’s website for 90 days.

About XERAVATM

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. It is approved for use in the U.S. and Europe. 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) eravacycline 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 eravacycline 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.

XERAVATM 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 or to tetracycline-class antibacterial drugs. 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 8 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 8 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.