On August 14, 2019 Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company focused on hospital acute care and gastroenterology reported second quarter 2019 financial results with net revenues of $11.6 million, up 14% over the prior year quarter (Press release, Cumberland Pharmaceuticals, AUG 14, 2019, View Source [SID1234538745]). Year-to-date net revenues were $23.5 million, up 25% from the prior year period. While the GAAP net loss for the second quarter was $(0.5) million, or $(0.04) per share, the Adjusted Earnings for the quarter were $1.6 million or $0.10 per diluted share. As of June 30, 2019, Cumberland had $108 million in total assets, including approximately $30 million in cash and marketable securities.

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QUARTER HIGHLIGHTS:

Continued a company-wide strategic review of products, partners, and organization
Increased sales team and national territories to improve support for acute-care key brands Caldolor, Vibativ and Vaprisol
Finalized Vibativ agreements with Hikma Pharmaceuticals LLC for the Middle East, R. Pharma LLC for Russia and the CIS, and Dr. Reddy’s Laboratories Ltd for India
Provided the U.S. Food and Drug Administration (FDA) with additional data in support of approval submission for a new line of methotrexate products designed for the treatment of patients with arthritis and psoriasis
Completed a submission to the FDA in support of an update to our Caldolor approval that included new geriatric, shortened infusion, pediatric, and safety data
"We continued to make progress in the second quarter towards our goal of building a company that offers long-term, sustainable growth," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "We remain in a strong financial position with a solid balance sheet and positive cash flow from operations. The momentum we’ve generated during the first half of this year has put us on a path for a very strong second half, and we remain optimistic that 2019 will be a standout year for Cumberland."

KEY DEVELOPMENTS:

Methotrexate

In January 2019, the Company received notification from the FDA that the new drug application (NDA) for our new line of methotrexate products is complete and acceptable for filing. Furthermore, the FDA has set September 2019 as the Prescription Drug User Fee (PDUFA) action date for an approval decision.

In November 2018, we submitted the NDA for approval from the FDA. These products are designed to treat adult and pediatric patients with rheumatoid arthritis, as well as adults with psoriasis. During 2019, we provided additional data to the FDA to address a number of requests arising from their review of our NDA.

Caldolor

In January 2019, the FDA approved the application for Cumberland’s next generation Caldolor product, featuring a new, patented formulation in a more convenient to use package. In April 2019, the Company began initial shipments of the product to select customers. A full launch of this next generation product is planned for late 2019.

In addition, we completed a submission to the FDA in support of an update to our Caldolor approval that included new geriatric, shortened infusion, pediatric, and safety data. Aiming to further expand the product’s label, we provided important data generated from our clinical studies regarding an optimal infusion time, additional safety information, as well as geriatric and pediatric administration. The revised label will also include a class label update on the use of NSAIDs with aspirin.

Meanwhile, we completed enrollment in our study of Caldolor in newborns with ages ranging from birth to six months of age. Once the gathering and evaluation of the study data is complete, we will provide top line results from this trial.

Cumberland Strategic Review

On March 29, 2019, we announced that we had initiated a strategic review of our brands, capabilities and international partners. This review followed our accelerated business development initiative, which delivered a series of transactions. Because of that progress, we felt that it was prudent to take a fresh look at our portfolio, partners, and organization to ensure we have the proper focus and capabilities. As a result:

We executed a License and Distribution agreement with Hong Kong WinHealth Pharma Group Co. Limited (WinHealth) for our Caldolor and Acetadote brands in China and Hong Kong. We anticipate WinHealth will provide $2 million in milestone payments and up to an estimated $290 million in revenue contribution over a ten – year period for supplies of the products following their registration in China.
We also entered into a Strategic Alliance agreement with WinHealth to explore future business opportunities that will further the mission and goals of each organization. Founded in Hangzhou, China and currently headquartered in Hong Kong, WinHealth has developed a wide breadth of capabilities including drug licensing, product development and registration, and has established a strong network of distribution and sales promotional capabilities for the Chinese market. Further, WinHealth has established partnerships with international companies that include Boehringer-Ingelheim, Janssen, Novartis, Pfizer, and Roche, generating approximately $330 million in annual sales in 2018.
In addition, WinHealth entered into an agreement with Cumberland Emerging Technologies (CET) to make a $1 million investment through the purchase of shares of CET stock. As part of that agreement, WinHealth obtained a Board position at CET and the first opportunity to license CET products for the Chinese market.
We completed the assignment and amendment of a Commercialization Agreement with Hikma Pharmaceuticals LLC (Hikma) to register and distribute Vibativ in a number of countries throughout the Middle East. Hikma is a multinational pharmaceutical company currently headquartered in London, United Kingdom. Originally founded in Amman, Jordan the company now has market representation throughout the world, with a particular focus in the Middle East and North African regions. Hikma develops, manufactures, and markets a broad range of branded and non-branded generic medicines, generating over $2 billion in gross sales during 2018.
We also completed the assignment and amendment of a Commercialization Agreement with R-Pharma JSC (R Pharma) associated with ongoing distribution of Vibativ in Russia and a number of adjacent countries in Eastern Europe. R-Pharma is one of the leading multinational pharmaceutical organizations based in Russia. Headquartered in Moscow and focusing in a wide breadth of therapeutic areas in the specialty and hospital care markets, R-Pharma generated over $1.6 billion in revenues in 2018.
Cumberland also completed the assignment and amendment of a Commercialization Agreement with Dr. Reddy’s Laboratories Limited (Dr. Reddy’s) for the registration and distribution of Vibativ in India. Dr. Reddy’s is a multinational pharmaceutical company based in Hyderabad, India. The company currently markets over 190 medications through their commercial operations in over 35 countries. Combined with their extensive network of manufacturing capabilities, Dr. Reddy’s generated over $2.2B in sales during their 2018 – 2019 fiscal year.
In addition, we also signed a new License and Distribution agreement with DB Pharm Korea Co., Ltd. (DB Pharm) for Vibativ in South Korea. DB Pharm is also currently distributing our Caldolor product in that market.
Our hospital product efforts will now be focused on our three key acute care products – Caldolor, Vibativ and Vaprisol. In order to support this acute care business, we have completed the expansion of our hospital sales division, as well as our field-based medical science team.
Lastly, we also concluded the License and Distribution agreement with Teligent Inc. for Caldolor in Canada.
FINANCIAL RESULTS:

Net Revenue: For the three months ended June 30, 2019, net revenues were $11.6 million, up 14% from $10.2 million the prior year period.

Net revenue by product for the three months ended June 30, 2019, included $3.5 million for Kristalose and $2.6 million for Vibativ. Net revenue for the Company’s other brands included $2.0 million for Ethyol, $1.1 million for Caldolor, $1.0 million for Acetadote (including the brand and Company’s Authorized Generic), and $0.8 million for our other brands.

For the six months ended June 30, 2019, net revenues were $23.5 million, up 25% from $18.8 million for the six months ended June 30, 2018.

Operating Expenses: Total operating expenses for the three months ended June 30, 2019 were $12.2 million, compared to $11.0 million during the prior year period. The primary drivers of this increase were the increase in sales, new cost of goods, and amortization expenses associated with the addition of Vibativ.

Total operating expenses for the first six months of 2019 were $24.3 million compared to $22.1 million for 2018.

Earnings: Net income (loss) for the second quarter 2019 was $(0.5) million or $(0.04) a share, compared to $(0.7) million or $(0.05) a share for the prior year period.

Adjusted Earnings for the second quarter were $1.6 million or $0.10 per diluted share, up from $0.2 million or $0.01 per diluted share for the prior year period. The definition and reconciliation of Adjusted Earnings to net income (loss) is provided in this release.

Balance Sheet: At June 30, 2019, Cumberland had $30.4 million in cash and marketable securities, including approximately $21.0 million in cash and equivalents. Total assets at June 30, 2019 were $107.5 million. Total liabilities were $53.9 million, including $20.0 million outstanding on the Company’s revolving line of credit, resulting in Total shareholder’s equity of $53.9 million.

Cumberland also has approximately $44 million in tax net operating loss carryforwards, resulting from the prior exercise of stock options.

Conference Call and Webcast

A conference call and live Internet webcast will be held on Wednesday, August 14, 2019 at 4:30 p.m. Eastern Time to discuss the Company’s second quarter 2019 financial results. To participate in the call, please dial 877-303-1298 (for U.S. callers) or 253-237-1032 (for international callers). A rebroadcast of the teleconference will be available for one week and can be accessed by dialing 855-859-2056 (for U.S. callers) or 404-537-3406 (for international callers). The Conference ID for the rebroadcast is 3198706. The live webcast and rebroadcast can be accessed via Cumberland’s website at
View Source

On August 14, 2019 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3 stage biopharmaceutical company discovering and developing novel products to treat cancer, with a focus on Myelodysplastic Syndromes (MDS), today provided a corporate update and reported financial results for the second quarter ended June 30, 2019.

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Steven M. Fruchtman, M.D., President and Chief Executive Officer, stated, "Enrollment in our global Phase 3 INSPIRE Trial with IV rigosertib in second-line, higher-risk MDS patients is progressing. Our goal is to complete enrollment by the end of 2019 and we anticipate reporting top-line data in the first half of 2020 following full enrollment and 288 death events. If the INSPIRE Trial is successful, we believe rigosertib could be the first new treatment for higher-risk MDS in more than 15 years, and based on its unique mechanism of action, has the potential to provide clinical benefit in other Ras mutated cancers."

Dr. Fruchtman continued, "In addition to advancing the INSPIRE Trial, our Special Protocol Assessment (SPA) request to the FDA for a Phase 3 combination trial of oral rigosertib plus azacitidine in first-line higher-risk MDS patients is being pursued. We also have plans to target cancers driven by mutated Ras genes. Ras-mutated cancers represent about a third of all human cancers, and a Phase 1 study of rigosertib in combination with a PD-1 inhibitor for patients with progressive K-Ras mutated non-small cell lung cancer is expected to commence in 2019 as an investigator-initiated study. We are also working toward filing an IND for a Phase 1 trial of ON 123300, our investigational, first-in-class, dual inhibitor of CDK4/6 + ARK5, which we believe has the potential to treat various cancers including refractory metastatic breast cancer."

Second Quarter 2019 and Recent Highlights

On March 25, the Company announced that it had passed the 75 percent enrollment mark in the Phase 3 INSPIRE Trial. Onconova remains focused on our primary goal of completing enrollment by the end of 2019 and expects to report top-line survival data following full enrollment and 288 death events.

• More than 140 trial sites in 24 countries across four continents are open, including 21 sites in Japan. The Company opened new clinical trial sites in already participating countries. Additional geographies, including Brazil, are being opened during the coming months to add approximately 25 more sites. This strategy is designed to support the goal of achieving full accrual to the INSPIRE Trial in 2019. The Company anticipates reporting top-line data in the first half of 2020 following full enrollment and 288 death events.
The Company entered into a license agreement with HanX Biopharmaceuticals (HanX) for the development and commercialization of rigosertib in Greater China. The agreement provides for $4 million of upfront payments to Onconova, including a $2 million cash upfront fee and an investment totaling $2 million in shares purchased at a premium to market. In addition, HanX agreed to place $2 million in escrow in local currency for rigosertib clinical development expenses in Greater China. HanX will make additional regulatory, developmental, and sales-based milestone payments to Onconova of up to $45.5 million and will pay Onconova tiered royalties up to double digits on net sales in Greater China. If approval is received, Onconova will supply rigosertib to HanX for development and commercialization. HanX also will support Onconova’s other clinical trial initiatives in Greater China.
Onconova and Mission Bio have entered into a collaboration to utilize the Mission Bio Tapestri Platform for targeted single-cell DNA analysis to study rigosertib as part of planned clinical trials. Single-cell genomics may identify mutations with far better resolution than that of traditional sequencing methods, allowing a view into each patient’s disease at a level never before achieved. Tapestri will be utilized to identify mutations, including those of the Ras pathway, to monitor a patient’s response in clinical trials, supporting the advancement of rigosertib. By adding the Tapestri Platform to its research and development program, Onconova is including the opportunity to study single cell clones in MDS and determine the sequence of genetic events and the influence of rigosertib on these events along with clinical outcomes.

In December 2018, Onconova applied to the FDA for a Special Protocol Assessment (SPA) for a Phase 3 trial of oral rigosertib in combination with azacitidine for treatment of first-line higher-risk MDS patients. The Company expects completion of the FDA’s SPA decision before the end of 2019.

Results from the Phase 2 trial were reported in December 2018 in an oral presentation at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) meeting and updated at the 2019 European Hematology Association (EHA) (Free EHA Whitepaper) Meeting.
Additional Progress for Rigosertib and Pipeline Products

ON 123300, an investigational first-in-class dual inhibitor of CDK4/6 + ARK5 with the potential to treat a variety of cancers, continues to make progress toward clinical development in the U.S. and China in partnership with HanX. HanX has conducted toxicology studies to support an IND filing in the U.S.

The collaboration with the National Cancer Institute as well as one with a Center of Excellence in Juvenile Myelomonocytic Leukemia, or JMML, for preclinical studies of rigosertib for treatment of pediatric cancer associated RASopathies are ongoing.

Onconova continues to participate in important medical and investment conferences. During the second quarter, presentations related to rigosertib development and clinical trials were made at:
• 15th Annual International Symposium on MDS/Copenhagen
• Acute Leukemia Forum/Shanghai
• BIO International Forum/Philadelphia
• European Hematology Association (EHA) (Free EHA Whitepaper)/Amsterdam
Upcoming 2019 conferences include:

RAS-Targeted Drug Discovery Summit (Boston, September 17-19)
Brazilian Association of Hematology, Hemotherapy and Cellular Therapy Congress (Rio de Janeiro, November 6-9)
The American Society of Hematology (ASH) (Free ASH Whitepaper) Conference in (Orlando, December 7-10)
Second Quarter 2019 Financial Results

Cash and cash equivalents as of June 30, 2019, totaled $5.9 million compared to $17.0 million at December 31, 2018. The Company believes that cash and cash equivalents at June 30, 2019, along with additional funds to be received from the HanX license in the third quarter, will be sufficient to fund ongoing trials and operations late into the fourth quarter of 2019. The Company was notified by Nasdaq on July 26 that Nasdaq has accepted the Company’s plan to regain compliance with the stockholders’ equity listing requirement by November 18, 2019.

Net loss was $3.6 million for the quarter ended June 30, 2019, compared to $4.3 million for the second quarter ended June 30, 2018. Research and development expenses were $3.9 million for the quarter ended June 30, 2019, and $4.1 million for the comparable period in 2018. General and administrative expenses were $1.8 million for the quarter ended June 30, 2019, and $2.1 million for the comparable period in 2018.

Conference Call and Webcast Information

The Company will host a conference call today, August 14, 2019, at 9 a.m. Eastern Time, to provide a corporate update and discuss second quarter 2019 financial results. Interested parties may access the call by dialing toll-free (855) 428-5741 from the U.S., or internationally (210) 229-8823 and using conference ID 90141175. The call will also be webcast live. Please click here to access the webcast. A replay will be available following the live webcast.

About Myelodysplastic Syndromes

Myelodysplastic syndromes (MDS) are conditions that can occur when the blood-forming cells in the bone marrow become dysfunctional and thus produce an inadequate number of circulating blood cells. It is frequently associated with the presence of blasts or leukemic cells in the marrow. This leads to low numbers of one or more types of circulating blood cells, and to the need for blood transfusions. In MDS, some of the cells in the bone marrow are abnormal (dysplastic) and may have genetic abnormalities associated with them. Different cell types can be affected, although the most common finding in MDS is a shortage of red blood cells (anemia). Patients with higher-risk MDS may progress to the development of acute leukemia.

On August 14, 2019 Scholar Rock Holding Corporation (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported financial results for the quarter ended June 30, 2019 and highlighted recent progress and upcoming milestones for its pipeline programs (Press release, Scholar Rock, AUG 14, 2019, View Source [SID1234538815]).

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"Throughout the first half of 2019, we made significant progress both clinically and financially as we advanced SRK-015 into a Phase 2 trial in SMA, SRK-181 towards the initiation of a Phase 1 trial in cancer immunotherapy in mid-2020, as well as successfully completed a follow-on offering to ensure that we are well-capitalized to support our portfolio of product candidates and overall company growth," said Nagesh Mahanthappa, Ph.D., President and CEO of Scholar Rock. "We look forward to building upon this momentum as we continue to progress our broad pipeline, with a number of important milestones at the end of this year and into 2020."

Company Highlights and Upcoming Milestones

SRK-015 Program:

Positive Final Results from the Phase 1 Clinical Trial of SRK-015 in Healthy Volunteers Presented at the Cure SMA Annual Conference. In June 2019, Scholar Rock presented positive detailed results from the Phase 1 trial of SRK-015, which consisted of data from both the single-ascending and multiple-ascending dose portions of the trial. SRK-015 was observed to be well-tolerated with no dose-limiting toxicities identified in up to the highest evaluated dose of 30 mg/kg. The pharmacologic profile showed robust engagement of latent myostatin, which was saturated and sustained up to at least Day 140 after three doses of SRK-015 given once every two weeks at 20 mg/kg or 30 mg/kg. In contrast, no meaningful change was observed in the latent myostatin biomarker concentrations in subjects who received placebo.

Preliminary Pharmacokinetic (PK) and Pharmacodynamic (PD) Data from TOPAZ Phase 2 Trial Expected by End of 2019. Patient enrollment is underway in the TOPAZ Phase 2 proof-of-concept trial to assess the safety and efficacy of SRK-015 in patients with Type 2 and Type 3 Spinal Muscular Atrophy (SMA). Approximately 55 patients are anticipated to be enrolled in the U.S., Canada, and Europe across three distinct and parallel cohorts and treated with SRK-015, either as a monotherapy or in conjunction with an approved survival motor neuron (SMN) upregulator therapy.

Scholar Rock is on track to report preliminary PK/PD data for a subset of patients in the Phase 2 TOPAZ trial by the end of 2019, which will provide initial observations on target engagement of latent myostatin in patients with Type 2 and Type 3 SMA. These preliminary PK/PD results will be followed by interim safety and efficacy results for a subset of patients with six months of treatment exposure expected in the first half of 2020 and top-line data for the full 12-month treatment period expected beginning in the fourth quarter of 2020.
Details of Scholar Rock-Developed Biomarker Assay that Quantifies Serum Latent Myostatin Published in Peer-Reviewed Journal. In July 2019, Scholar Rock published details of its immunoassay used to measure serum latent myostatin in peer-reviewed journal Society of Laboratory Automation and Screening Discovery. The publication, "A Sensitive and Selective Immunoassay for the Quantitation of Serum Latent Myostatin After In-Vivo Administration of SRK-015, a Selective Inhibitor of Myostatin Activation,"(1) highlights the ability of the immunoassay to quantify serum latent myostatin without cross-reactivity to promyostatin, mature myostatin, or closely related members of the TGFβ superfamily and the establishment of the robustness, reproducibility, and stability of the immunoassay.

Through use of this biomarker assay, robust and sustained target engagement of latent myostatin has been observed in both preclinical studies and the Phase 1 clinical trial in healthy volunteers, establishing proof-of-mechanism of Scholar Rock’s therapeutic approach of targeting the latent form of growth factors.
Identification of Second Indication for SRK-015 Planned for 2020. Scholar Rock continues to evaluate multiple potential opportunities for which SRK-015 could offer clinical benefit and is assessing additional potential clinical settings in which the selective inhibition of the activation of myostatin may offer therapeutic benefit.
SRK-181 Program:

Initiation of the Phase 1 Clinical Trial of SRK-181 in Patients with Solid Tumors Anticipated in Mid-2020. In March 2019, Scholar Rock selected SRK-181, a highly specific inhibitor of TGFβ1 activation, as the first product candidate in its TGFβ1 cancer immunotherapy program based on the strength of preclinical data and human translational insights. Scholar Rock intends to develop SRK-181 for the treatment of tumors resistant to checkpoint blockade therapies (CBTs), such as anti-PD(L)1 antibodies, and believes there is significant opportunity to expand the number of patients who can benefit from CBTs.

Scholar Rock plans to initiate a Phase 1 trial in patients with primary resistance to approved checkpoint blockade therapies in mid-2020 with initial clinical data anticipated by the end of 2021.
RGMc Program:

Nomination of a Product Candidate from the RGMc Program Planned in First Half of 2020. For its third product candidate, Scholar Rock is evaluating a number of highly specific inhibitors of repulsive guidance molecule C (RGMc) and plans to nominate an antibody in the first half of 2020. RGMc is a co-receptor of bone morphogenetic protein 6 (BMP6), a member of the TGFβ superfamily that plays an important role in iron metabolism. RGMc’s known function is localized to hepatocytes and the identification of RGMc selective-antibodies may offer the potential for liver-specific modulation of BMP6 signaling to address iron-restricted anemias.
Corporate Update:

Public Offering of Common Stock Completed in June/July 2019. Scholar Rock successfully completed a public offering of 3,450,000 shares of common stock, inclusive of the full exercise of the over-allotment option by the underwriters, raising gross proceeds of approximately $51.8 million.
Second Quarter 2019 Financial Results

For the quarter ended June 30, 2019, net loss was $12.5 million or $0.48 per share compared to a net loss of $14.7 million or $1.39 per share for the quarter ended June 30, 2018.

Research and development expense was $13.7 million for the quarter ended June 30, 2019 compared to $11.4 million for the quarter ended June 30, 2018. The increase year-over-year reflects preclinical and manufacturing costs for SRK-181 and higher personnel-related costs, partially offset by a decrease year-over-year in manufacturing costs associated with SRK-015.

General and administrative expense was $4.7 million for the quarter ended June 30, 2019 compared to $3.5 million for the quarter ended June 30, 2018. The increase year-over-year was primarily attributable to increased headcount, stock compensation, and higher operational fees associated with operating as a public company.
As of June 30, 2019, Scholar Rock had cash, cash equivalents, and marketable securities of $185.1 million, compared to $175.6 million as of December 31, 2018. The cash balance as of June 30, 2019 is inclusive of the approximately $42.2 million in net proceeds from the public offering of 3,000,000 shares of common stock and exclusive of $6.3 million in net proceeds from the underwriter’s purchase of an additional 450,000 shares of common stock that was settled in July 2019.

Cote, S. M., Jackson, J., Pirruccello-Straub, M., Carven, G. J., & Wawersik, S. (2019). A Sensitive and Selective Immunoassay for the Quantitation of Serum Latent Myostatin after In Vivo Administration of SRK-015, a Selective Inhibitor of Myostatin Activation. SLAS DISCOVERY: Advancing Life Sciences R&D.

On August 14, 2019 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation oncology therapeutics, reported its financial results for the three and six months ended June 30, 2019 (Press release, Sutro Biopharma, AUG 14, 2019, View Source [SID1234538728]).

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"During the second quarter of 2019, we presented encouraging interim safety data from our Phase 1 trial for STRO-001 at the EHA (Free EHA Whitepaper) Congress and continued to advance our pipeline of product candidates and programs," said Bill Newell, Sutro’s Chief Executive Officer. "We believe our proprietary technology allows us to rapidly and precisely create optimally designed, next-generation protein therapeutics candidates for cancer and autoimmune disorders. At Sutro, we hold ourselves to the highest standards and set ambitious goals for ourselves which we have been meeting and exceeding."

Recent Business Highlights and Developments

STRO-001 Clinical Program

Potential first-in-class and best-in-class Antibody Drug Conjugate ("ADC") directed against CD74, which is highly expressed in many B cell malignancies
Phase 1 dose-escalation, with dose expansion, clinical trial enrolling patients with multiple myeloma and non-Hodgkin lymphoma, with initial safety data presented at the EHA (Free EHA Whitepaper) Congress on June 15, 2019 and initial efficacy data expected by year end 2019
STRO-002 Clinical Program

Potential best-in-class ADC directed against folate receptor-alpha, which is highly expressed in ovarian cancer
Phase 1 dose-escalation, with dose expansion, clinical trial enrolling women with advanced ovarian and endometrial cancers, with initial safety data expected by year end 2019
BCMA ADC Clinical Program and Celgene Collaboration

Celgene received FDA clearance on its IND application for an ADC targeting B-cell maturation antigen ("BCMA") for the treatment of multiple myeloma. This is the third product candidate to originate from Sutro’s proprietary discovery and manufacturing platform to enter clinical development since early 2018, and for which Celgene has worldwide development and commercialization rights. Sutro is entitled to development and regulatory milestone payments and tiered royalties ranging from mid to high single digit percentages from Celgene for this BCMA ADC.
Existing pipeline was bolstered as Sutro gained back rights to three bispecific assets from the collaboration with Celgene. Sutro holds U.S. development and commercialization rights targeting BCMA-CD3, PD1-LAG3 and PD1-TIM3. For any products resulting from these three programs, Celgene will own ex-U.S. development and commercialization rights and will be obligated to pay Sutro development and regulatory milestone payments and tiered royalties.
Second Quarter 2019 Financial Highlights

Cash, Cash Equivalents and Marketable Securities

As of June 30, 2019, Sutro had cash, cash equivalents and marketable securities of $168.2 million, as compared to $204.5 million as of December 31, 2018, which represents net cash usage of $36.3 million during the six months ended June 30, 2019.

Revenue

Revenue was $10.5 million and $19.2 million for the three and six months ended June 30, 2019, respectively, compared to $5.7 million and $11.5 million for the same periods in 2018. The 2019 periods included collaboration revenue from Celgene, Merck and EMD Serono. On January 1, 2019, Sutro adopted Accounting Standards Update No. 2014-09 Revenue from Contracts with Customers (Accounting Standards Codification Topic 606). For more information on the impact of the adoption of the new revenue standard, see "Notes to Unaudited Interim Condensed Financial Statements" contained in Part I, Item 1 of Sutro’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 14, 2019. Future collaboration revenue from Celgene, Merck and EMD Serono, and from any future collaboration partners, will fluctuate as a result of the amount and timing of revenue recognition of upfront, milestones and other collaboration agreement payments.

Operating Expenses

Total operating expenses for the three and six months ended June 30, 2019, were $24.2 million and $47.1 million, respectively, compared to $17.8 million and $35.3 million for the same periods in 2018, including non-cash stock-based compensation of $2.5 million and $0.2 million, and depreciation and amortization expense of $1.2 million and $1.1 million, in the 2019 and 2018 second quarters, respectively. Total operating expenses for second quarter 2019 were comprised of research and development expenses of $16.1 million and general and administrative expenses of $8.1 million, with both expense types expected to increase in 2019 as Sutro’s internal product candidates advance in clinical development and additional general and administrative expenses are incurred as a public company.

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.