TTNP Titan Pharmaceuticals Inc.

0.29
-0.01  -2%
Previous Close 0.3
Open 0.3
52 Week Low 0.142
52 Week High 1.4
Market Cap $28,095,446
Shares 95,660,355
Float 95,380,960
Enterprise Value $25,127,710
Volume 3,572,663
Av. Daily Volume 15,644,011
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Drug Pipeline

Drug Stage Notes
Ropinirole implant
Parkinson's disease
Phase 1/2
Phase 1/2
Phase 1/2 treatment has commenced - noted October 11, 2017. DSMB recommended trial to continue - July 2, 2018 but further enrollment has been postponed due to lack of resources.
Probuphine
Opioid dependence
Approved
Approved
CRL issued April 30, 2013. Approved May 26 2016

Latest News

  1. SAN FRANCISCO, June 24, 2020 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) ("Titan" or the "Company") today announced that it has entered into a co-promotion partnership with Indegene Inc. to establish multichannel digital marketing programs throughout the United States and expand the capabilities for the engagement of health care providers ("HCPs") who are eligible to prescribe Titan's Probuphine® (buprenorphine) implant.

    Indegene is a leading healthcare solutions company with a unique blend of life sciences domain expertise and state-of-the-art technology capabilities that will complement and help accelerate the build out of the current commercial operations at Titan. Under the terms of the renewable four-year agreement, Indegene's sophisticated multichannel marketing tools, predictive analytics, webinars and social media campaigns will be used along with its dedicated tele-representatives to help expand the universe of Probuphine Risk Evaluation and Mitigation Strategy ("REMS")-certified HCPs and enable further expansion of maintenance treatment with Probuphine for eligible Opioid Use Disorder ("OUD") patients. Titan will continue its ongoing commercial efforts with its field sales and medical liaison personnel who will also provide support to Indegene as needed. Titan will be responsible for all training of HCPs, administration of the REMS program and regulatory affairs.

    "This partnership with Indegene further strengthens and expands our Probuphine commercial operations, especially with the COVID-19-related restrictions that have limited in-person HCP outreach capabilities," said Titan's President and CEO, Sunil Bhonsle. "Indegene brings a wealth of business expertise and experience in the digital arena working globally with large and small pharmaceutical companies that is invaluable in today's changing environment. This partnership accelerates the expansion of our capabilities to potentially achieve our goals and enable access to Probuphine for eligible patients suffering from OUD, especially at a time when a six-month maintenance treatment option could be very important in minimizing frequent direct contact."

    Please see Probuphine Full Indication and Important Safety Information and Boxed Warning below, and link below to Full Prescribing Information.

    "We are looking forward to partnering with Titan using our proven AI-driven Next Generation Commercialization Platform," said Gaurav Kapoor, Executive Vice President of Indegene Inc. "This partnership comes at a meaningful time, when the COVID-19 pandemic is exacerbating the opioid crisis while limiting direct engagement with the HCPs that treat OUD patients. I believe the 'new normal' model in pharma commercial operations will start relying just as much on digital programs with remote representatives, as field representatives providing face-to-face interaction. We at Indegene are making significant investments to be at the forefront of this transition and are excited to see Titan embrace this innovative approach."

    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 inner 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.

    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 implants 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
    • Sleep Apnea. Call your doctor right away if you or someone close to you notices:  Observed episodes of stopped breathing or abnormal breathing patterns during sleep

    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.

    Common risks with the minor surgical procedure:  Itching, pain, irritation, redness, swelling, bleeding, or bruising at the insertion or removal site. Scarring around the insertion site. 

    Please read Full Prescribing Information, including BOXED WARNING regarding IMPLANT MIGRATION, PROTRUSION, EXPULSION and NERVE DAMAGE ASSOCIATED WITH INSERTION AND REMOVAL.

    Titan encourages you to report negative side effects of prescription drugs to the FDA. You can visit www.fda.gov/safety/medwatch/ or call 1-800-FDA-1088.

    About Indegene, Inc.

    Indegene is a leading global healthcare solutions company that enables healthcare organizations address complex challenges to improve health and business outcomes. Indegene helps drive effectiveness and efficiency while bringing pharma products to market through modern commercial and medical operations by combining deep medical understanding, modern technology, and flexible engagement models.  Indegene has a global footprint with offices in North America, Europe, China and India.

    About Titan Pharmaceuticals

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a commercial stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The Company's lead product is Probuphine® (buprenorphine) implant, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid dependence. Approved by the U.S. Food and Drug Administration in May 2016, Probuphine is the first and only commercialized treatment of opioid dependence to provide continuous, around-the-clock blood levels of buprenorphine for six months following a single procedure. The ProNeura technology also has the potential to be used in developing products for treating other chronic conditions such as Parkinson's disease and hypothyroidism, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the commercialization of Probuphine; the regulatory approval process; Titan's ability to access capital; the development, testing, production and marketing of our drug candidates; patent and intellectual property matters; and strategic agreements and relationships.  We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    CONTACTS:

    Sunil Bhonsle

    President & CEO

    (650) 244-4990

    Stephen Kilmer

    Investor Relations

    (650) 989-2215

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/titan-pharmaceuticals-and-indegene-enter-into-probuphine-co-promotion-partnership-301082645.html

    SOURCE Titan Pharmaceuticals, Inc.

    View Full Article Hide Full Article
  2. SOUTH SAN FRANCISCO, Calif., June 16, 2020 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) ("Titan" or the "Company") today announced that it has initiated a fully-virtual Probuphine® (buprenorphine) implant Risk Evaluation and Mitigation Strategy ("REMS") training and certification program for qualified health care providers ("HCPs") who treat patients with Opioid Use Disorder ("OUD").

    The U.S. Food and Drug Administration ("FDA") has approved the virtual REMS training program for use during the COVID-19 pandemic to support the safety of HCPs, their staff and the training personnel. The program is now available to qualified HCPs at treatment centers across the U.S.

    "We are grateful for the FDA's expeditious review and approval of our fully-virtual REMS training program, which enables us to continue to certify HCPs to prescribe and administer Probuphine during this critical time when rates of opioid-related morbidity and mortality are significantly increasing," said Titan's Executive Vice President and Chief Scientific Officer, Dr. Kate Beebe DeVarney. "We believe that the ability to continue certifying HCPs amidst the pandemic will facilitate access to our six-month maintenance treatment option for eligible patients with OUD who are now at increased risk for infection, relapse, and overdose due to the COVID-19 health crisis."

    Please see Probuphine Full Indication and Important Safety Information and Boxed Warning below, and link below to Full Prescribing Information.

    "A few days ago, I had the honor of becoming Titan's first HCP to receive fully-virtual training on prescribing, inserting, and removing Probuphine," said Dr. Christopher Ray, of Phoenix, Arizona. "Titan's virtual, REMS training is so well-planned, organized and thorough in every detail that I feel comfortable prescribing Probuphine treatment to eligible OUD patients receiving buprenorphine maintenance therapy, particularly given the COVID-19 pandemic-related restrictions that limit the frequency of face-to-face interaction with patients. I would recommend this virtual Probuphine REMS training to any qualified HCP providing long-term buprenorphine maintenance treatment for OUD."

    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 inner 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.

    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 implants 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
    • Sleep Apnea. Call your doctor right away if you or someone close to you notices:  Observed episodes of stopped breathing or abnormal breathing patterns during sleep

    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.

    Common risks with the minor surgical procedure:  Itching, pain, irritation, redness, swelling, bleeding, or bruising at the insertion or removal site. Scarring around the insertion site. 

    Please read Full Prescribing Information, including BOXED WARNING regarding IMPLANT MIGRATION, PROTRUSION, EXPULSION and NERVE DAMAGE ASSOCIATED WITH INSERTION AND REMOVAL.

    Titan encourages you to report negative side effects of prescription drugs to the FDA. You can visit www.fda.gov/safety/medwatch/ or call 1-800-FDA-1088.

    About Titan Pharmaceuticals

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a commercial stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The Company's lead product is Probuphine® (buprenorphine) implant, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid dependence. Approved by the U.S. Food and Drug Administration in May 2016, Probuphine is the first and only commercialized treatment of opioid dependence to provide continuous, around-the-clock blood levels of buprenorphine for six months following a single procedure. The ProNeura technology also has the potential to be used in developing products for treating other chronic conditions such as Parkinson's disease and hypothyroidism, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the commercialization of Probuphine; the regulatory approval process; Titan's ability to access capital; the development, testing, production and marketing of our drug candidates; patent and intellectual property matters; and strategic agreements and relationships.  We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    CONTACTS:

    Sunil Bhonsle

    President & CEO

    (650) 244-4990

    Stephen Kilmer

    Investor Relations

    (650) 989-2215

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/titan-pharmaceuticals-launches-virtual-rems-training-for-probuphine-health-care-providers-301077482.html

    SOURCE Titan Pharmaceuticals, Inc.

    View Full Article Hide Full Article
  3. SOUTH SAN FRANCISCO, Calif., May 15, 2020 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) ("Titan" or the "Company") today reported financial results for the first quarter ended March 31, 2020 and provided an update on its business.

    First Quarter 2020 Highlights

    • In January 2020, Titan completed an offering resulting in net cash proceeds of approximately $1.9 million.
    • Since January 1, 2020, the Company received proceeds of approximately $6.7 million as a result of the exercise of previously issued common stock purchase warrants.

    COVID-19 Impact and Adjusted Probuphine Commercial Strategy

    Titan's commercial operations expansion has continued throughout the past several months, with additions to its sales and medical liaison teams, including support from additional marketing and medical access staff, that now provide coverage for all 50 states and Puerto Rico. Unfortunately, the emergence of the COVID-19 pandemic during the latter half of the first quarter and the resulting restrictions on travel and social distancing rules that have minimized personal physician/patient interaction, except in emergencies, has hindered the effectiveness of the commercial team. In order to try and mitigate the impact of the ongoing public heath crisis, Titan has undertaken a number of key activities during this period, including:

    • Preparatory work using digital communication techniques to establish relationships with new health care providers ("HCPs") and their staff;
    • Providing virtual communication tools for HCPs to use with their patients and to highlight the potential benefits of Probuphine as a treatment modality in the increasing telemedicine environment; and
    • Establishing a social media presence in select geographies to increase awareness of Probuphine and enhance its share of voice in the medication assisted treatment space.

    "Our first quarter of 2020 financial results were affected by the COVID-19 pandemic, and we have had to make several adjustments to our commercial tactics to best position Titan in the current environment," said Titan's President and CEO, Sunil Bhonsle. "We have been working in a virtual environment and have focused our efforts on using digital communication tools to establish strong relationships with the medical community as well as inform patients of Probuphine's long acting treatment option, which may be well-suited for telemedicine. In addition, our Medical Affairs team continues to develop a virtual process for providing training to health care providers, which, if approved by the FDA, could be a very valuable tool for Titan and health care providers alike."

    Probuphine is indicated for the maintenance treatment of OUD in eligible patients.

    Please see Full Indication and Important Safety Information below, and link below to Full Prescribing Information.

    "The board has been very supportive of the team's initiative in the face of these new challenges, and I am very pleased with our progress," said Titan's Executive Chairman, Dr. Marc Rubin. "The unfortunate reality is that patients suffering from OUD are now facing more challenges to getting proper treatment during this pandemic, and we are working hard to ensure we can support their needs, as well as the needs of their health care providers."

    First Quarter 2020 Financial Results

    For the three months ended March 31, 2020, Titan reported approximately $1.3 million in revenue, which reflects approximately $0.2 million in product sales and approximately $1.1 million related to the Company's National Institute on Drug Abuse ("NIDA") grant. This compared with revenues of approximately $0.9 million in the same period in 2019, which was comprised of $0.3 million in product sales, $0.3 million related to the amortization of deferred revenue related to the sale to Molteni of the European intellectual property rights to Probuphine and $0.3 million related to the NIDA grant.

    Total operating expenses for the first quarter of 2020 were approximately $5.6 million, compared with approximately $5.2 million from the same quarter in 2019, 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 the quarter ended March 31, 2020 were approximately $2.3 million, compared with approximately $1.8 million for the same three month period in 2019. SG&A expenses for the 2020 first quarter were approximately $3.1 million, essentially unchanged from the same quarter a year ago. Costs of goods sold for the first quarter of 2020 were approximately $0.2 million, compared with approximately $0.3 million in the 2019 first quarter.

    Net other expense, consisting primarily of interest expense, non-cash losses on changes in the fair value of warrants and costs attributable to the issuance of warrants was approximately $1.4 million in the first quarter of 2020, compared with net other expense of approximately $0.2 million in the first quarter of 2019.

    Net loss applicable to common stockholders in the first quarter of 2020 was approximately $5.6 million, or approximately $0.07 per share, compared with a net loss applicable to common stockholders of approximately $4.5 million, or approximately $0.34 per share, in the same quarter in 2019.

    As of March 31, 2020, Titan had cash and cash equivalents of approximately $8.0 million, which the Company believes, together with proceeds from a Paycheck Protection Program loan and the subsequent exercise of warrants, are sufficient to fund planned operations through the third quarter of 2020.

    Conference Call Details

    Titan management will host a conference call today at 12:00 p.m. ET / 9:00 a.m. PT to review these financial results and discuss business developments in the period. The conference call will be hosted by Sunil Bhonsle, President and CEO; Kate Beebe DeVarney, Ph.D., Executive Vice President and Chief Scientific 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 3367973. 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 inner 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 implants 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
    • Sleep Apnea. Call your doctor right away if you or someone close to you notices:  Observed episodes of stopped breathing or abnormal breathing patterns during sleep

    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.

    Common risks with the minor surgical procedure:  Itching, pain, irritation, redness, swelling, bleeding, or bruising at the insertion or removal site. Scarring around the insertion site. 

    Please read Full Prescribing Information, including BOXED WARNING regarding IMPLANT MIGRATION, PROTRUSION, EXPULSION and NERVE DAMAGE ASSOCIATED WITH INSERTION AND REMOVAL.

    Titan encourages you to report negative side effects of prescription drugs to the FDA. You can visit www.fda.gov/safety/medwatch/ or call 1-800-FDA-1088.

    About Titan Pharmaceuticals

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a commercial stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The Company's lead product is Probuphine® (buprenorphine) implant, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid dependence. Approved by the U.S. Food and Drug Administration in May 2016, Probuphine is the first and only commercialized treatment of opioid dependence to provide continuous, around-the-clock blood levels of buprenorphine for six months following a single procedure. The ProNeura technology also has the potential to be used in developing products for treating other chronic conditions such as Parkinson's disease and hypothyroidism, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the commercialization of Probuphine; the regulatory approval process; Titan's ability to access capital; the development, testing, production and marketing of our drug candidates; patent and intellectual property matters; and strategic agreements and relationships.  We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    CONTACTS:

    Sunil Bhonsle
    President & CEO
    (650) 244-4990

    Stephen Kilmer
    Investor Relations
    (650) 989-2215

    TITAN PHARMACEUTICALS, INC.

    CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (in thousands, except per share amount)

    (unaudited)





    Three Months Ended





    March 31,





    2020


    2019

    Revenue:






    License revenue


    $                        -


    $                      313


    Product revenue


    210


    317


    Grant revenue


    1,126


    315



    Total revenue


    1,336


    945








    Operating expense:






    Cost of goods sold


    171


    304


    Research and development


    2,277


    1,844


    Selling, general and administrative


    3,114


    3,082



    Total operating expense


    5,562


    5,230

    Loss from operations


    (4,226)


    (4,285)










    Other expense, net


    (1,358)


    (232)








    Net loss and comprehensive loss


    $                 (5,584)


    $                 (4,517)








    Basic and diluted net loss per common share


    $                   (0.07)


    $                   (0.34)








    Weighted average shares used in computing basic and diluted net loss per common share


    82,641


    13,217

     

    CONDENSED BALANCE SHEETS

    (in thousands)

    (unaudited)












    March 31,


    December 31,





    2020


    2019

    Assets






    Cash and cash equivalents


    $                   8,038


    $                   5,223


    Receivables


    1,551


    993


    Inventory


    1,064


    998


    Prepaid expenses and other current assets


    1,493


    1,094



    Total current assets


    12,146


    8,308


    Furniture and equipment, net


    780


    817


    Operating lease right-of-use asset


    336


    397



    Total assets


    $                 13,262


    $                   9,522

    Liabilities and Stockholders' Equity 






    Current liabilities


    $                   4,410


    $                   3,600


    Operating lease liability, non-current


    76


    150


    Long-term debt


    3,500


    4,019


    Warrant liability


    -


    320


    Stockholders' equity 


    5,276


    1,433



    Total liabilities and stockholders' equity

    $                 13,262


    $                   9,522

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/titan-pharmaceuticals-reports-first-quarter-2020-financial-results-301059905.html

    SOURCE Titan Pharmaceuticals, Inc.

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  4. SOUTH SAN FRANCISCO, Calif., May 11, 2020 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) today announced that its first quarter 2020 financial results will be released on Friday, May 15, 2020.

    Titan will host a live conference call to discuss the financial results and provide a general business review the same day, May 15, 2020, at 9:00 a.m. PT / 12:00 p.m. ET. The call will be hosted by Sunil Bhonsle, president and CEO; Kate Beebe DeVarney, Ph.D., executive vice president and chief scientific officer; Brian Crowley, vice president of finance; and Marc Rubin, M.D., executive chairman. A summary of the first quarter financial results and other highlights will be included in a press release to be issued prior to the call.

    The live webcast and a replay of the call may be accessed by visiting http://www.titanpharm.com/news/events. The call can also be accessed by dialing 1-888-317-6003 (or 1-412-317-6061 from outside the U.S.) ten minutes prior to the start time, and providing passcode 3367973.

    About Titan Pharmaceuticals

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a commercial stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The company's lead product is Probuphine® (buprenorphine) implant, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid dependence. Approved by the U.S. Food and Drug Administration in May 2016, Probuphine is the first and only commercialized treatment of opioid dependence to provide continuous, around-the-clock blood levels of buprenorphine for six months following a single procedure. The ProNeura technology also has the potential to be used in developing products for treating other chronic conditions such as Parkinson's disease and hypothyroidism, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the commercialization of Probuphine; the regulatory approval process; Titan's ability to access capital; the development, testing, production and marketing of our drug candidates; patent and intellectual property matters; and strategic agreements and relationships. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    CONTACTS:

    Sunil Bhonsle
    President & CEO
    (650) 244-4990

    Stephen Kilmer
    Investor Relations
    (650) 989-2215

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/titan-pharmaceuticals-to-report-first-quarter-2020-financial-results-on-may-15-2020-301056815.html

    SOURCE Titan Pharmaceuticals, Inc.

    View Full Article Hide Full Article
  5. SOUTH SAN FRANCISCO, Calif., March 30, 2020 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) ("Titan" or the "Company") today reported financial results for the fourth quarter and full year ended December 31, 2019 and provided an update on its business.

    Full Year 2019 Business Highlights

    • In early 2019, Titan reported completion of the initial activities planned for the reacquisition of Probuphine® (buprenorphine) implant, Titan's novel six-month maintenance treatment for opioid use disorder ("OUD") in eligible patients, from its former licensee. This included the recruitment and onboarding of a small number of highly qualified commercial and medical affairs personnel to reengage with health care providers who had previously treated patients with Probuphine, providing retraining and medical liaison assistance where needed, and assuring the medical community of the continued supply of the product with the goal to stabilize Probuphine usage.
    • A key objective for Titan in the first half of 2019 was to improve the overall commercial services provided to the health care providers and patients through streamlining the product distribution and third party payor reimbursement process. This was accomplished through the following steps that were completed by August 2019:
      • Entering into an agreement with AppianRx to establish a new 'hub' that provides a full suite of patient and healthcare provider support services related to Probuphine, including an improved product ordering system and performing REMS required verification steps, and initial assessment of third party payor benefits available to the patient.
      • Establishing specialty pharmacy distribution and services agreements for Probuphine with a number of well recognized companies, including AllianceRx Walgreens Prime, Accredo® specialty pharmacy (a subsidiary of Express Scripts), CVS Caremark (a subsidiary of CVS Health) and Southside Specialty Pharmacy, with the goal to improve third party payor access and improve product distribution.
    • Also in the first half of 2019, Titan and Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A. ("Molteni"), Titan's Probuphine partner for Europe and certain other territories, worked closely to meet with the Committee for Medicinal Products for Human Use of the European Medicines Agency and address all their questions regarding Sixmo®-buprenorphine (the brand name for Probuphine implant in the European Union) which led to the adoption of a positive opinion recommending the granting of a marketing authorization. Those efforts culminated in the European Commission approving Sixmo in June 2019 for substitution treatment for opioid dependence in clinically stable adult patients who require no more than 8 mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment.
    • While Titan successfully established the infrastructure to support Probuphine and began to stabilize revenues, it became clear that it was also necessary to expand the sales outreach to grow the business. Accordingly, in the second half of 2019 Titan completed two financing transactions (August and October 2019) that provided total net proceeds of approximately $9.9 million, after which the Company began the process to expand the sales and commercial team.
    • Also, in the second half of 2019, the National Institutes of Health's National Institute on Drug Abuse ("NIDA") approved approximately $6.1 million in second-year funding for Titan's non-clinical development of a ProNeura™ based six-month implantable formulation of Nalmefene, an opioid antagonist, intended for the prevention of relapse to opioid addiction, following opioid detoxification.

    Year-to-Date 2020 Business Highlights

    • In January 2020, Titan completed an offering resulting in net cash proceeds of approximately $1.9 million.
    • In January 2020, Titan signed an agreement for Probuphine to be included on the Federal Supply Schedule, providing U.S. veterans and other federal government agencies with access to Titan's novel six-month maintenance treatment for OUD in eligible patients.
    • Since January 1, 2020, the Company has received proceeds of approximately $6.2 million as a result of the exercise of previously issued common stock purchase warrants.

    "Throughout 2019, we focused on initiatives to successfully transition to a commercial-stage company," said Titan's President and CEO, Sunil Bhonsle. "I am very pleased with our team's progress during 2019, which, among other things, includes executing arrangements with multiple top tier specialty pharmacy companies, establishing a new patient services 'hub,' and obtaining insurance coverage from a broad range of third party payors – all of which served to broaden product access for healthcare providers and patients. While we primarily focused on stabilizing our product revenue during the transition, our goal during the remainder of 2020 is to focus on executing our sales growth initiatives in the U.S. and extending the commercial reach of Probuphine to eligible patients suffering from OUD."

    Probuphine is indicated for the maintenance treatment of OUD in eligible patients. Please see Full Prescribing Information including Boxed Warning below.

    "An important 2019 milestone for Titan was the European Commission's approval of Sixmo, Probuphine's brand name in the EU," said Titan's Executive Chairman, Dr. Marc Rubin. "Our EU commercialization partner, Molteni, is located in Italy, one of the countries hit hardest by the global COVID-19 pandemic. While the launch of Sixmo may be delayed as a result, we are confident that Molteni is poised to aggressively roll-out the product across Europe once the situation allows."

    Dr. Rubin continued, "As the developments involving the COVID-19 pandemic continue to evolve, we are monitoring and implementing recommendations from local, national and global health organizations. Titan's top priorities are the health and safety of our employees, customers and the communities in which we live and work. To that end, we have put proactive, precautionary measures in place, such as sheltering in place and working from home, freezing all non-essential travel, and we have pivoted to virtual sales and business meetings only, with the goal of keeping everyone safe. At the same time, we remain deeply committed to continuing to execute additional components of our growth plan throughout 2020. These include initiatives to increase awareness and adoption of Probuphine, advance our Nalmefene program toward the clinic, and explore opportunities for the use of our ProNeura platform technology in additional important medical applications. Everyone at Titan is working remotely and being productive. We sincerely hope that all of our stakeholders will be safe and healthy as well."

    Fourth Quarter 2019 Financial Results

    For the three months ended December 31, 2019, Titan reported approximately $1.2 million in revenue, which reflect approximately $0.2 million in product sales and approximately $1.0 million related to the Company's NIDA grant. This compared with revenues of approximately $1.2 million in the same period in 2018, which was comprised of $0.2 million in product sales, $0.3 million related to the amortization of deferred revenue related to the sale to Molteni of the European intellectual property rights to Probuphine and $0.7 million related to the NIDA grant.

    Total operating expenses for the fourth quarter of 2019 were approximately $5.0 million, compared with approximately $4.5 million from 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 quarter ended December 31, 2019 and the same quarter in 2018 were approximately $1.9 million. SG&A expenses for the 2019 fourth quarter were approximately $2.6 million, compared with approximately $2.4 million in the same quarter a year ago. Costs of goods sold for the fourth quarter of 2019 were approximately $0.6 million, compared with approximately $0.3 million in the 2018 fourth quarter.

    Net other expense, consisting primarily of interest expense, was approximately $0.1 million in the fourth quarter of 2019, compared with net other expense of approximately $0.2 million in the fourth quarter of 2018.

    Net loss applicable to common stockholders in the fourth quarter of 2019 was approximately $4.0 million, or approximately $0.08 per share, compared with a net loss applicable to common stockholders of approximately $3.5 million, or approximately $0.29 per share, in the same quarter in 2018.

    Full Year 2019 Financial Results

    Total revenues for the full year ended December 31, 2019 were approximately $3.6 million, reflecting approximately $0.3 million in license revenue, approximately $1.0 million from sales of Probuphine and approximately $2.3 million related to Titan's NIDA grant. This compares to total revenues of approximately $6.6 million in 2018 which included approximately $5.4 million in license revenue, approximately $0.5 million from sales of Probuphine and approximately $0.7 million related to Titan's NIDA grant. The approximately $3.0 million decrease resulted primarily from non-recurring license revenue in 2018  of approximately $3.2 million in upfront and milestone payments from Molteni, and approximately $2.1 million related to reacquiring the rights to Probuphine from our former licensee which was partially offset by increases in  product revenue of approximately $0.5 million, and grant revenues of approximately $1.6 million in 2019 and approximately $0.3 million of license revenue which represented the remaining amortization of the Molteni upfront payment in 2019.

    Total operating expenses in 2019 were approximately $20.5 million, compared with approximately $14.9 million in 2018, and consisted primarily of R&D and SG&A expenses. R&D expenses for the year ended December 31, 2019 were approximately $7.3 million compared to approximately $7.5 million in 2018. The decrease in R&D costs was primarily associated with decreases in employee-related expenses and other research and development expenses, partially offset by increased activities related to the NIDA grant and an increase in our contract manufacturing costs. SG&A expenses for 2019 were approximately $11.9 million, compared to approximately $6.9 million in 2018. The increase in SG&A expenses was primarily due to higher sales and marketing expenses related to establishing the infrastructure to streamline the Probuphine ordering and distribution network and the increased expenses associated with expanding Titan's Probuphine commercial activities.

    Net other income for the year ended December 31, 2019 was approximately $0.4 million, compared to net other expense of approximately $0.8 million in 2018. Net other income in 2019 was primarily due to non-cash gain on changes in the fair value of warrants. Net other expense in 2018 was primarily due to interest expense on the Company's debt.

    Net loss applicable to common stockholders for 2019 was approximately $16.5 million, or $0.72 per share, compared with net loss applicable to common stockholders of approximately $9.3 million, or $1.64 per share, for 2018.

    As at December 31, 2019, Titan had cash and cash equivalents of approximately $5.2 million, which the Company believes, together with the net cash proceeds of approximately $8.0 million received from the January 2020 offering and exercises of warrants in the first quarter of 2020, are sufficient to fund planned operations into the fourth quarter of 2020.

    Conference Call Details

    Titan management will host a conference call today at 4:30 p.m. ET / 1:30 p.m. PT to review these financial results and discuss business developments in the period. The conference call will be hosted by Sunil Bhonsle, President and CEO; Kate Beebe DeVarney, Ph.D., Executive Vice President and Chief Scientific Officer; 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 2248161. 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 inner 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 implants 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
    • Sleep Apnea. Call your doctor right away if you or someone close to you notices:  Observed episodes of stopped breathing or abnormal breathing patterns during sleep

    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.

    Common risks with the minor surgical procedure:  Itching, pain, irritation, redness, swelling, bleeding, or bruising at the insertion or removal site. Scarring around the insertion site. 

    Please read Full Prescribing Information, including BOXED WARNING regarding IMPLANT MIGRATION, PROTRUSION, EXPULSION and NERVE DAMAGE ASSOCIATED WITH INSERTION AND REMOVAL.

    Titan encourages you to report negative side effects of prescription drugs to the FDA. You can visit www.fda.gov/safety/medwatch/ or call 1-800-FDA-1088.

    About Titan Pharmaceuticals

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a commercial stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The Company's lead product is Probuphine® (buprenorphine) implant, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid dependence. Approved by the U.S. Food and Drug Administration in May 2016, Probuphine is the first and only commercialized treatment of opioid dependence to provide continuous, around-the-clock blood levels of buprenorphine for six months following a single procedure. The ProNeura technology also has the potential to be used in developing products for treating other chronic conditions such as Parkinson's disease and hypothyroidism, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the commercialization of Probuphine; the regulatory approval process; Titan's ability to access capital; the development, testing, production and marketing of our drug candidates; patent and intellectual property matters; and strategic agreements and relationships.  We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    CONTACTS:

    Sunil Bhonsle
    President & CEO
    (650) 244-4990

    Stephen Kilmer
    Investor Relations
    (650) 989-2215

    TITAN PHARMACEUTICALS, INC.

    CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (in thousands, except per share amount*)

    (unaudited)





    Three Months Ended
    December 31,


    Year Ended
    December 31,




    2019


    2018


    2019


    2018

    Revenue:









    License revenue

    $                  2


    $                313


    $                315


    $             5,376


    Product revenue

    195


    217


    1,006


    535


    Grant revenue

    1,020


    707


    2,290


    707



    Total revenue

    1,217


    1,237


    3,611


    6,618











    Operating expense:









    Cost of goods sold

    550


    290


    1,288


    538


    Research and development

    1,872


    1,855


    7,242


    7,478


    Selling, general and administrative

    2,589


    2,358


    11,925


    6,866



    Total operating expense

    5,011


    4,503


    20,455


    14,882

    Loss from operations

    (3,794)


    (3,266)


    (16,844)


    (8,264)













    Other income (expense), net

    (147)


    (238)


    386


    (759)











    Net loss and comprehensive loss

    $           (3,941)


    $           (3,504)


    $         (16,458)


    $           (9,023)

    Deemed dividend on trigger of down round provision

    -


    -


    -


    (285)

    Net loss attributable to common stockholders

    $           (3,941)


    $           (3,504)


    $         (16,458)


    $           (9,308)











    Basic net loss per share

    $             (0.08)


    $             (0.29)


    $             (0.72)


    $             (1.64)











    Diluted net loss per share

    $             (0.08)


    $             (0.29)


    $             (0.72)


    $             (1.66)











    Weighted average shares used in computing basic net loss per share

    49,206


    11,960


    22,957


    5,688











    Weighted average shares used in computing diluted net loss per share

    49,206


    11,960


    22,957


    5,688


    * Adjusted to reflect the impact of the 1:6 reverse split effective January 24, 2019.

     

    CONDENSED BALANCE SHEETS

    (in thousands)

    (unaudited)














    December 31,


    December 31,






    2019


    2018









    Assets







    Cash and cash equivalents



    $             5,223


    $             9,295


    Restricted cash



    -


    361


    Receivables



    993


    1,737


    Inventory



    998


    1,262


    Contract assets



    -


    99


    Prepaid expenses and other current assets



    1,094


    547



    Total current assets



    8,308


    13,301


    Property and equipment, net



    817


    794


    Operating lease right-of-use asset



    397


    -



    Total assets



    $             9,522


    $           14,095

    Liabilities and Stockholders' Equity 







    Current liabilities



    $             3,600


    $             3,452


    Long-term debt



    4,019


    3,787


    Warrant liability



    320


    -


    Derivative liability



    -


    25


    Operating lease liability, non-current



    150


    -


    Stockholders' equity 



    1,433


    6,831



    Total liabilities and stockholders' equity 



    $             9,522


    $           14,095

     

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    SOURCE Titan Pharmaceuticals, Inc.

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