On August 14, 2019 Nuvo Pharmaceuticals Inc. (Nuvo or the Company) (TSX:NRI;OTCQX:NRIFF), a Canadian focused, healthcare company with global reach and a diversified portfolio of commercial products, reported its financial and operational results for the three and six months ended June 30, 2019 (Press release, Nuvo Pharmaceuticals, AUG 14, 2019, View Source [SID1234538750]). For further details on the results, please refer to Nuvo’s Management, Discussion and Analysis (MD&A) and Condensed Consolidated Interim Financial Statements which are available on the Company’s website (www.nuvopharmaceuticals.com). All figures are in Canadian dollars, unless otherwise noted.

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"During the second quarter, our operating segments continued to perform in line with our expectations and our second quarter financial results reinforce the increase in scale the Aralez Transaction has made to our business," said Jesse Ledger, Nuvo’s President & CEO. "While the Vimovo news during the quarter was disappointing, we have made cost-saving adjustments to our operations and our underlying business and financial performance is expected to benefit from these changes moving forward."

Second Quarter Financial Summary

Adjusted total revenue(1) was $19.1 million for the three months ended June 30, 2019 compared to $6.0 million for the three months ended June 30, 2018.

Adjusted EBITDA(1) was $5.7 million for the three months ended June 30, 2019 compared to $2.0 million for the three months ended June 30, 2018.

Gross profit on total revenue was $9.6 million or 58% for the three months ended June 30, 2019 compared to a gross profit of $3.5 million or 60% for the three months ended June 30, 2018.

Cash and short-term investments were $14.7 million as at June 30, 2019 compared to $28.1 million as at December 31, 2018. The decrease was primarily related to the settlement of transaction costs and indebtedness acquired by Nuvo upon close of the Aralez Transaction.
(1)

Non-International Financial Reporting Standards (IFRS) financial measure defined by the Company below.

Second Quarter and 2019 Business Update

Canadian prescriptions of Blexten increased 64% to 105,407 for the three months ended June 30, 2019 compared to 64,404 for the three months ended June 30, 2018.

Canadian prescriptions of Cambia increased 30% to 19,500 for the three months ended June 30, 2019 compared to 15,036 for the three months ended June 30, 2018.

On April 2, 2019, the Company announced the Marketing Authorization Application for Pennsaid 2% had been accepted for review by the Austrian Agency for Health and Food Safety (AGES) acting as the reference member state for Austria, Italy, Greece and Portugal. It is anticipated that a review decision will be made in early 2020.

On May 3, 2019, the Suvexx registration dossier passed screening with Health Canada and is now under formal review. The Company anticipates a review decision from Health Canada during the first half of 2020.

On May 15, 2019, the Company announced the United States Court of Appeals for the Federal Circuit (the Court of Appeals) had reversed the decision by the United States District Court for the District of New Jersey (the District Court) that had upheld the validity of U.S. Patent Nos. 6,926,907 (the ‘907 patent) and 8,557,285 (the ‘285 patent). On July 30, 2019, the Court of Appeals rejected the Company’s en banc request to have the Court of Appeals reconsider its decision. On June 26, 2019, the Company amended its financing agreement with Deerfield Management Company, L.P. (Deerfield), to provide, among other things, for a payment deferral of a portion of mandatory minimum quarterly prepayments should Vimovo U.S. market exclusivity be lost due to a generic entry.

On June 17, 2019, the Company announced that in the second half of 2019, it will start to realize on synergies resulting from organizational changes and its acquisition of Aralez Canada that will reduce its operating expenses by approximately $7.0 million annually.
Second Quarter 2019 Financial Results

Total revenue is comprised of product sales, license revenue and contract revenue. Total revenue was $16.6 million for the three months ended June 30, 2019 compared to $5.9 million for the three months ended June 30, 2018. The significant increase in total revenue for the current quarter was the result of the timing of the Aralez Transaction. Total revenue for the six months ended June 30, 2019 was $31.1 million compared to $10.3 million for the comparative six-month period.

Adjusted total revenue increased to $19.1 million for the three months ended June 30, 2019 compared to $6.0 million for the three months ended June 30, 2018. The $13.1 million increase in adjusted total revenue in the current quarter was primarily related to the timing of the Aralez Transaction, which provided an incremental $9.7 million of total revenue contributed from the Commercial Business segment and $4.7 million attributable to the Vimovo royalties related to the U.S. and ex-U.S. territories, partially offset by a $1.2 million decrease in Production and Service revenue. Adjusted total revenue increased to $36.2 million for the six months ended June 30, 2019 compared to $10.6 for the six months ended June 30, 2018.

Adjusted EBITDA increased to $5.7 million for the three months ended June 30, 2019 compared to $2.0 million for the three months ended June 30, 2018. The increase in adjusted EBITDA for the current quarter was primarily attributable to the increase in gross profit as a result of the Aralez Transaction, partially offset by an increase in sales and marketing and general and administrative (G&A) expenses, including $1.0 million of one-time restructuring expenses. Adjusted EBITDA increased to $10.9 million for the six months ended June 30, 2019 compared to $2.7 million for the six months ended June 30, 2018.

Gross profit on total revenue was $9.6 million or 58% for the three months ended June 30, 2019 compared to a gross profit of $3.5 million or 60% for the three months ended June 30, 2018. The increase in gross profit for the current quarter was primarily attributable to an increase in gross margin on product sales and an increase in license revenue due to the timing of the Aralez Transaction. Gross profit on total revenue was $18.7 million or 60% for the six months ended June 30, 2019 compared to a gross profit of $6.1 million or 59% for the six months ended June 30, 2018.

Non-IFRS Financial Measures
The Company discloses non-IFRS measures (such as adjusted total revenue, adjusted EBITDA and adjusted EBITDA per share) that do not have standardized meanings prescribed by IFRS. The Company believes that shareholders, investment analysts and other readers find such measures helpful in understanding the Company’s financial performance and in interpreting the effect of the Aralez Transaction and the Deerfield Financing on the Company. Non-IFRS financial measures do not have any standardized meaning prescribed by IFRS and may not have been calculated in the same way as similarly named financial measures presented by other companies.

Adjusted Total Revenue
The Company defines adjusted total revenue as total revenue, plus amounts billed to customers for existing contract assets, less revenue recognized upon recognition of a contract asset. Management believes adjusted total revenue is a useful supplemental measure from which to determine the Company’s ability to generate cash from its customer contracts that is used to fund its operations.

The following is a summary of how adjusted total revenue is calculated:

Adjusted EBITDA
EBITDA refers to net income (loss) determined in accordance with IFRS, before depreciation and amortization, net interest expense (income) and income tax expense (recovery). The Company defines adjusted EBITDA as net income before net interest expense (income), depreciation and amortization and income tax expense (recovery) (EBITDA), plus amounts billed to customers for existing contract assets, inventory step-up expense, stock-based compensation expense, Other Expenses, less revenue recognized upon recognition of a contract asset and other income. Management believes adjusted EBITDA is a useful supplemental measure from which to determine the Company’s ability to generate cash available for working capital, capital expenditures, debt repayments, interest expense and income taxes.

The following is a summary of how EBITDA and adjusted EBITDA are calculated:

Management to Host Conference Call/Webcast
Management will host a conference call to discuss the results today (Wednesday, August 14, 2019) at 8:30 a.m. ET. To participate in the conference call, please dial 1 888 390 0546 or 416 764 8688. Please call in 15 minutes prior to the call to secure a line. You will be put on hold until the conference call begins.

A taped replay of the conference call will be available two hours after the live conference call and will be accessible until midnight on August 21, 2019 by calling 1 888 390 0541 or 416 764 8677 playback passcode 509912#.

A live audio webcast of the conference call will be available through www.nuvopharmaceuticals.com. Please connect at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to hear the webcast.

On August 14, 2019 ESSA Pharma Inc. ("ESSA", or the "Company") (TSX-V: EPI,NASDAQ: EPIX), a pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, provided a corporate update and reported financial results for the fiscal third quarter ended June 30, 2019 (Press release, ESSA, AUG 14, 2019, View Source [SID1234538749]). All references to "$" in this release refer to United States dollars, unless otherwise indicated.

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"The last quarter marked another significant period in our ongoing transformation process for Essa from both corporate and clinical standpoints. During the quarter, we worked diligently on the work required to complete the acquisition of Realm Therapeutics with the transaction closing on July 31st. The acquisition of Realm and its cash balance put Essa in a strong financial position to allow us to commence the Phase 1 clinical study of EPI-7386," stated David Parkinson, MD, President and CEO of ESSA. "We are progressing with IND-enabling studies on EPI-7386 and on track to file an IND with the FDA in the first calendar quarter of 2020. We look forward to presenting further in vitro and in vivo study results of EPI-7386 in the coming months at medical conferences."

Recent Company Highlights

On July 31, 2019, the Company completed the acquisition of Realm Therapeutics plc ("Realm") pursuant to a scheme of arrangement under Part 26 of the U.K. Companies Act 2006 (the "Acquisition"). Under the terms of the Acquisition, ESSA acquired all of the issued and outstanding shares of Realm, and Realm shareholders received a total of 6,718,150 common shares of the Company.
On May 4, 2019 at the 2019 American Urological Association Meeting, an oral poster presentation presented a deeper preclinical characterization of EPI-7386. The poster showed that pre-clinical studies demonstrate that EPI-7386 (i) displays similar in vitro IC50 potency compared to the lutamide class of antiandrogens in an in vitro androgen receptor (AR) inhibition assay; (ii) shows in vitro activity in several enzalutamide-resistant prostate cancer cell models in which enzalutamide is resistant; (iii) exhibits a favorable metabolic profile across three preclinical animal species (which suggests that EPI-7386 will have high exposure and a long half-life in humans) (iv) provides similar antitumor activity to enzalutamide in the enzalutamide-sensitive LNCaP prostate cancer xenograft model, and (v) provides superior antitumor activity to enzalutamide, as a single agent or in combination with enzalutamide, in the enzalutamide emerging-resistant VCaP prostate cancer xenograft model, specifically showing AR inhibition with both an N-terminal domain inhibitor (EPI-7386) and a ligand binding domain inhibitor (enzalutamide), induces deeper and more consistent anti-tumor responses in the enzalutamide emerging-resistant VCaP xenograft model.
EPI-7386 was selected for a poster presentation at the European Society for Medical Oncology ("ESMO") 2019 Congress to be held September 27-October 1, 2019 in Barcelona, Spain.
Summary Financial Results

Net Income (Loss). ESSA recorded a net loss of $3.3 million ($0.52 loss per common share based on 6,383,737 weighted average common shares outstanding) for the quarter ended June 30, 2019, compared to a net loss of $2.9 million ($0.50 loss per common share based on 5,776,098 weighted average common shares outstanding) for the quarter ended June 30, 2018.

Research and Development ("R&D") expenditures. R&D expenditures for the quarter ended June 30, 2019 were $1.95 million compared to $0.99 million for the quarter ended June 30, 2018. The increase in R&D expenditures for the quarter were primarily related to ESSA’s efforts in preparing an Investigational New Drug application for its recently-nominated clinical candidate, EPI-7386. Costs in the comparative period included preclinical research related to the Company’s next-generation aniten compounds.

General and administration ("G&A") expenditures. G&A expenditures for the quarter ended June 30, 2019 were $1.2 million compared to $1.6 million for the quarter ended June 30, 2018. The decrease is the result of a reduction in professional fees, primarily due to Acquisition-related professional fees being recorded as deferred costs for the period, as well as decreases in rent expense and share-based payments.
Liquidity and Outstanding Share Capital
Cash on hand at June 30, 2019, was $4.9 million, with working capital of $0.3 million, reflecting the aggregate gross proceeds of the completed January 2018 financing, which totaled $26 million, less operating expenses in the intervening period.

As of June 30, 2019, the Company had 7,963,628 common shares issued and outstanding.

In addition, as of June 30, 2019 there were 473,688 common shares issuable upon the exercise of warrants and broker warrants at a weighted-average exercise price of $34.36 per ESSA common share and 1,154,711 ESSA common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $4.58 per common share.

On August 14, 2019 Western Oncolytics (WO), a privately held biotechnology company focused on the discovery and development of next generation oncolytic vaccinia virus immunotherapies reported that it has appointed Helena H. Chaye, Ph.D., J.D. to the position of chief executive officer (Press release, Western Oncolytics, AUG 14, 2019, View Source [SID1234538748]). Dr. Chaye most recently served as chief business officer for SillaJen, Inc., an oncolytic virus therapy company, and brings over 20 years of experience in business development, intellectual property management, corporate affairs and operations to Western Oncolytics.

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"Helena is an excellent, key and timely addition to our management team as we continue to build our company’s foundation ahead of moving into clinical development. Her depth of experience on the operations and business side for a company developing cancer immunotherapies will be invaluable," said Stephen H. Thorne, Ph.D., WO’s founder and chief scientific officer. "We also look forward to tapping into the global network that Helena has developed and believe that her contributions will enable us to move our new generation of optimized, multi-mechanistic cancer immunotherapies to the clinic more quickly."

"I am excited for the opportunity to join Western Oncolytics given the tremendous potential of WO’s technology and look forward to contributing to the company’s mission to create the best-in-class immuno-oncology platform," stated Dr. Chaye. "Among other tremendous progress by the WO team, I was pleased to see the SBIR (Small Business Innovation Research) Grant awarded to WO by the U.S. government and believe this to be greatly validating to our technology and therapeutic approach."

Dr. Chaye served in recent years at SillaJen Biotherapeutics, most recently as chief business officer after having been part of the Strategic Planning and Development team at SillaJen. She was one of the early executives of Jennerex, which was acquired by SillaJen in 2014, and made significant contributions to the early development of the company’s oncolytic virus therapy and the growth of Jennerex during the years 2006 to 2012. At the time of her departure in 2012, Dr. Chaye was vice president of corporate affairs and intellectual property after having held many leadership positions that included business development, human resources and technology operations. She has held business development and IP management positions at DNAtrix, MediGene, Canadian Genetic Diseases Network and has worked as a consultant to start-up companies based in the U.S. and in Korea. Dr. Chaye received her Ph.D. in Genetics from the University of British Columbia and her J.D. from Dalhousie University.

On August 14, 2019 Henry Ford Cancer Institute is first-in-the-world reported to enroll a patient in the GBM AGILE Trial (Adaptive Global Innovative Learning Environment) – a novel trial design and architecture made possible by an international collaboration of experts in the care of patients with glioblastoma and the design of clinical trials (Press release, The Henry Ford Cancer Institute, AUG 14, 2019, View Source [SID1234538747]). Led by the trial sponsor Global Coalition for Adaptive Research (GCAR), GBM AGILE is a seamless Phase II (Efficacy and Safety) / Phase III (Confirmatory) trial aimed at identifying the most effective therapies for patients with glioblastoma, the most aggressive form of brain cancer.

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A next-generation clinical trial program and the first-ever adaptive platform trial for brain cancer, GBM AGILE is a move away from the traditional, one-size-fits-all approach to clinical trials – a major step forward for Precision Medicine.

"We are launching an era of unprecedented collaboration and advancement in glioblastoma treatment," said Steven Kalkanis, M.D., chairman of the Department of Neurosurgery at Henry Ford Health System and medical director of the Henry Ford Cancer Institute. "Current treatments have been refined – including surgery, radiation and chemotherapy – but in the era of molecular medicine, dramatic leaps in outcomes through immunotherapy or targeted therapies are yet to be fully realized. With GBM AGILE, those dramatic leaps in outcomes will be more attainable, and at a faster pace, than ever before."

Traditional clinical trials take three-to-seven years to produce results, cannot be modified once started, and study only one treatment against the standard of care. GBM AGILE is uniquely designed as a long-standing platform with the ability to test multiple therapies concurrently against a common control (or standard of care). This enables more patients on trial to get access to experimental therapies. Another innovation of GBM AGILE is adaptive randomization, which means it is continuously updated with the latest information. As information accrues, the trial defines subsets of patients more likely to benefit from therapy. Patients are more likely to receive promising therapies at a faster and less costly rate.

"Progress in the treatment of patients with malignant brain tumors has been slow," said Tom Mikkelsen, M.D. of the Henry Ford Cancer Institute and medical director of the Precision Medicine Program and Clinical Trials Office at Henry Ford Health System. "The efficiency, speed and learning of GBM AGILE is intended to allow rapid discovery of better and better treatments for patients with glioblastoma. The era of data-driven innovation has arrived, and it’s being applied to the most difficult problems in cancer therapy."

GBM AGILE was first conceived in 2015 by an international group of more than 130 clinicians, researchers, biostatisticians, imagers, pathologists, patient advocates, and leaders from government and industry known as the "GBM Knowledge Network." It came together in response to a worldwide effort known as The Cancer Genome Atlas (TCGA), which was launched in 2006 by the National Cancer Institute (NCI) and the National Human Genome Research Institute (NHGRI). The organizations led a nationally-coordinated effort to perform a 10-year, deep-dive into the molecular basis of certain kinds of cancers. One of the first types of tumors studied in the landmark precision medicine effort was glioblastoma. Henry Ford was a major TCGA contributor, nearly 25% of all the gliomas studied over the course of the initiative having been donated by Henry Ford’s Hermelin Brain Tumor Center.

Former Vice President Joe Biden has been an outspoken supporter of GBM AGILE and attended the GBM AGILE launch event in November 2015. Biden’s son, Beau Biden, passed away from glioblastoma in May 2015 at the age of 46. Beau had been diagnosed in 2013 and was treated with surgery, chemotherapy, and radiation. He suffered a recurrence in the spring of 2015, at which time his condition deteriorated rapidly. Biden acknowledged the potential of GBM AGILE to offer unparalleled hope for many patients who had previously waited several years to benefit from advances in brain cancer research.

Henry Ford enrolled GBM AGILE’s first patient in collaboration with GCAR, an international partnership that comprises some of the world’s foremost clinical, translational, and basic science investigators. Through this collaboration and open exchange of ideas, the ultimate beneficiary—the patient—is supported in the fight against rare and deadly diseases.

"This is an important milestone for GBM AGILE and all those involved in this effort, most importantly, the patients, who desperately need new treatment options. We value the dedication of Dr. Tom Mikkelsen and the team at Henry Ford Cancer Institute to make this trial available to their patients and are eager to continue to work with our other committed study sites and investigators to make this trial available to patients across the United States this year, and internationally in 2020," said Dr. Meredith Buxton, Chief Operating Officer of GCAR.

Glioblastoma is one of the deadliest diseases on the planet. When treated with surgery, radiation and chemotherapy, patients have a median life expectancy of 11-15 months. The disease most commonly affects men ages 60 or older, although it can develop at any age in both men and women. The NCI estimates that 22,850 adults were diagnosed with brain and other nervous system cancers in 2015. It also estimates that in the same year, more than 15,000 of those diagnoses resulted in death.

On August 14, 2019 Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) reported financial results for the second quarter ended June 30, 2019 and provided an update on its business (Press release, Titan Pharmaceuticals, AUG 14, 2019, View Source [SID1234538746]).

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Second Quarter 2019 and Recent Business Highlights

In May 2019, Titan announced a product purchase and supply agreement for Probuphine (buprenorphine) with Accredo specialty pharmacy, a subsidiary of Express Scripts.
In June 2019, Titan announced a pharmacy services agreement for Probuphine with Southside Specialty Pharmacy.
In June 2019, Titan and Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A. ("Molteni") announced that the European Commission approved Sixmo-buprenorphine, the brand name for Probuphine implant in the European Union ("EU").
In July 2019, Titan announced a specialty product distribution agreement for Probuphine with CVS Caremark, a subsidiary of CVS Health.
In August 2019, Titan completed a $2.1 million offering resulting in net proceeds of approximately $1.8 million.
"During the second quarter, we continued to build on the foundation required to transition from a small product development company to a successful commercial enterprise. We now have a new user-friendly hub for processing Probuphine prescriptions and product orders, as well as a wider and more streamlined distribution network to support the commercialization of the product, all of which are essential for achieving commercial success," said Titan’s President and CEO, Sunil Bhonsle. "The global footprint of Probuphine expanded when Titan and our partner, Molteni, achieved a major milestone in June with the approval in the EU of Sixmo. We hope to see operational and commercial synergies as we continue supporting Molteni in preparation for Sixmo’s progressive launch across the world’s second largest market for buprenorphine-based products, and look forward to initiating product shipments to Molteni by the end of this year."

Probuphine is indicated for the maintenance treatment of opioid dependence in eligible patients. Please see full indication below.

Titan’s Executive Chairman, Dr. Marc Rubin, commented, "In addition to obtaining regulatory approval in a third major market, we are working hard to continue building our commercial capabilities. We are seeing an increase in Probuphine prescribers which we believe, when combined with our improved capabilities, will translate to product growth. Moving forward, with sufficient resources, we can expect to see this progress to be increasingly reflected in our financial results."

Second Quarter 2019 Financial Results

For the three months ended June 30, 2019, Titan reported approximately $0.5 million in revenues, which reflect approximately $0.3 million in product revenues and $0.2 million of grant revenues. This compared with revenues of approximately $2.7 million in the same period in 2018, which were primarily related to license revenues from the sale of European intellectual property rights to Molteni; and the return of the Braeburn license and earned royalties.

Total operating expenses for the second quarter of 2019 were approximately $5.4 million, compared with approximately $3.3 million in the same quarter in 2018, and consisted primarily of research and development ("R&D") and selling, general and administrative ("SG&A") expenses and costs of goods sold, inclusive of distribution expenses.

R&D expenses for both the quarters ended June 30, 2019 and June 30, 2018 were approximately $1.9 million. SG&A expenses for the 2019 second quarter were approximately $3.2 million, compared with approximately $1.4 million in the same quarter a year ago. The increase in SG&A expenses for the three months ended June 30, 2019 was primarily due to expenses associated with the commercialization of Probuphine, which included increases in employee related expenses of approximately $0.8 million, consulting and professional fees of approximately $0.5 million, other outside services of approximately $0.3 million, travel related expenses of approximately $0.2 million and facilities related expenses of approximately $0.1 million. Costs of goods sold, which reflects product costs and other distribution expenses associated with sales of Probuphine, were approximately $0.2 million for the second quarter of 2019, compared with cost of goods sold of approximately $70,000 for the three months ended June 30, 2018.

Net other expense was approximately $0.3 million for the three month period ended June 30, 2019, compared with net other expense of approximately $0.2 million in the same quarter a year ago. The increase was primarily attributable to loss on debt extinguishment associated with the conversion of the Molteni convertible loan.

Net loss applicable to common shareholders in the second quarter of 2019 was approximately $5.2 million, or approximately $0.38 per share, compared with a net loss applicable to common shareholders of approximately $0.9 million, or approximately $0.25 per share, in the same quarter in 2018.

As of June 30, 2019, Titan had cash and cash equivalents of approximately $2.3 million. Titan believes that its cash and cash equivalents as of June 30, 2019, along with the approximately $1.8 million of net proceeds from the registered direct offering and concurrent private placement completed in August 2019, will be sufficient to fund its operation through October 2019.

Conference Call Details

Titan management will host a conference call today at 4:30 p.m. EDT to review these financial results and discuss business developments in the period. The conference call will be hosted by Sunil Bhonsle, President and CEO; Dane Hallberg, Executive Vice President and Chief Commercial Officer; Brian Crowley, Vice President of Finance; and Marc Rubin, M.D., Executive Chairman.

The live conference call may be accessed by dialing 1-888-317-6003 (U.S.) or 1-412-317-6061 (international) and providing passcode 9110840. The call will also be broadcast live and archived on Titan’s website at www.titanpharm.com/news/events.

About Probuphine

Probuphine is the only subdermal implant designed to deliver buprenorphine continuously for six months following insertion.

Probuphine was developed using ProNeura, the continuous drug delivery system developed by Titan that consists of a small, solid implant made from a mixture of ethylene-vinyl acetate and a drug substance. The resulting construct is a solid matrix that is placed subdermally, normally in the upper arm, in an outpatient office procedure and removed in a similar manner at the end of the treatment period. The U.S. Food and Drug Administration ("FDA") approved Probuphine in May 2016, and it is the first and only buprenorphine implant available for the maintenance treatment of opioid addiction in eligible patients.

IMPORTANT SAFETY INFORMATION INCLUDING INDICATION AND BOXED WARNING

INDICATION

PROBUPHINE is an implant that contains the medicine buprenorphine. PROBUPHINE is used to treat certain adults who are addicted to (dependent on) opioid drugs (either prescription or illegal). PROBUPHINE is indicated for the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses (doses no more than 8 mg per day) of a buprenorphine-containing product.

PROBUPHINE is part of a complete treatment program that also includes counseling and behavioral therapy.

It is not known if PROBUPHINE is safe or effective in children less than 16 years of age.

IMPORTANT SAFETY INFORMATION

WARNING: COMPLICATIONS FROM INSERTION AND REMOVAL OF PROBUPHINE
See Full Prescribing Information for complete Boxed Warning

Serious complications may happen from insertion and removal of PROBUPHINE, including:

Nerve or blood vessel injury in your arm
Movement of implant (migration). PROBUPHINE or pieces of it can move into blood vessels, possibly to your lung, and could lead to death
Implant sticks out of the skin (protrusion)
Implant comes out by itself (expulsion)
Call your healthcare provider right away if:

PROBUPHINE sticks out of the skin or comes out by itself
You have bleeding or symptoms of infection at the site after insertion or removal, including excessive or worsening itching, pain, irritation, redness, or swelling
You have numbness or weakness in your arm after the insertion or removal procedure
You have weakness or numbness in your arm, or shortness of breath
If the implant comes out by itself, keep it away from others, especially children, as it may cause severe difficulty in breathing and possibly death.

Because of the risk of complications of, migration, protrusion, expulsion and nerve injury with insertion and removal of PROBUPHINE, it is only available through a restricted program called the PROBUPHINE REMS Program. Healthcare providers who prescribe and/or insert PROBUPHINE must be certified with the program by enrolling and completing live training.

PROBUPHINE is not available in retail pharmacies
PROBUPHINE must be inserted or removed only in the facility of the certified prescriber
Implants may be difficult to locate if inserted too deeply, if you manipulate them, or if you gain significant weight after insertion. Your healthcare provider may do special procedures or tests, or refer you to a surgical specialist to remove the implants if they are difficult to locate.

The medicine in PROBUPHINE can cause serious and life-threatening problems, especially if you take or use certain other medicines or drugs. Call your healthcare provider right away or get emergency help if you:

Feel faint or dizzy, have mental changes such as confusion, slower breathing than you normally have, severe sleepiness, blurred vision, problems with coordination, slurred speech, cannot think well or clearly, high body temperature, slowed reflexes, feel agitated, stiff muscles or have trouble walking.

These can be signs of an overdose or other serious problems.

Coma or death can happen if you take anxiety medicines or benzodiazepines, sleeping pills, tranquilizers, or sedatives, antidepressants, or antihistamines, or drink alcohol during treatment with PROBUPHINE. Tell your healthcare provider if you are taking any of these medicines or if you drink alcohol.

Who should not use PROBUPHINE?

Do not use PROBUPHINE if you are allergic to buprenorphine or any of its ingredients, this includes buprenorphine hydrochloride and the inactive ingredient ethylene vinyl acetate or EVA.

PROBUPHINE may not be right for you. Before starting PROBUPHINE tell your doctor about all of your medical conditions, including:

Trouble breathing or lung problems, an enlarged prostate gland (men), a head injury or brain problem, problems urinating, a curve in your spine that affects your breathing, liver problems, gallbladder or adrenal gland problems, Addison’s disease, low thyroid hormone levels (hypothyroidism), a history of alcoholism, a history of keloid formation, connective tissue disease (such as scleroderma), or history of MRSA infections, mental problems such as hallucinations, an allergy to numbing medicines or medicines used to clean your skin, are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

What should I avoid while being treated with PROBUPHINE?

Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how this medication affects you
You should not drink alcohol during treatment. You should not take anxiety medicines or benzodiazepines, sleeping pills, tranquilizers, or sedatives that are not prescribed to you during treatment with PROBUPHINE, as this can lead to slowed breathing, drowsiness, delayed reaction time, loss of consciousness or even death
What are the possible side effects of PROBUPHINE?

PROBUPHINE can cause serious side effects, including:

Infection at the insertion or removal site. Infection may happen at the implant site during insertion or removal. Do not try to remove PROBUPHINE yourself
Opioid withdrawal. If PROBUPHINE comes out of your arm or if you stop treatment, tell your doctor right away as you can have symptoms of shaking, sweating more than normal, feeling hot or cold more than normal, runny nose, watery eyes, goose bumps, diarrhea, vomiting and muscle aches
Physical dependency
Liver problems. Call your doctor right away if you notice signs of liver problems that may include your skin or the white part of your eyes turning yellow (jaundice)
Allergic reaction. If you get a rash, hives, itching, swelling of your face, or wheezing, low blood pressure, dizziness or decrease in consciousness
Decrease in blood pressure. You may feel dizzy when you get up from sitting or lying down
Tell your healthcare provider if you develop any of the symptoms listed.

Common side effects of PROBUPHINE include: Headache, nausea, toothache, constipation, depression, vomiting, back pain, mouth and throat pain.