On November 12, 2019 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) reported financial results for the third quarter ended September 30, 2019 and provided a business update (Press release, Adamis Pharmaceuticals, NOV 12, 2019, View Source [SID1234550985]).

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Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated, "Since the full launch in July, Sandoz has implemented several initiatives that we expect will increase sales of SYMJEPITM. We believe the Sandoz team is now targeting allergists and primary care physicians with their retail launch. A new website was launched in the third quarter that provides patients and physicians with product information, instructions for use and provides links to order demonstrator devices and to have SYMJEPI shipped to patients’ homes through PillPack, an Amazon company."

"While we are eager for sales of SYMJEPI to grow, we are also looking forward to a final decision by the FDA on ZIMHITM, our naloxone injection product candidate. If approved, we believe our company will be very well positioned for growth in 2020 as we plan to play an important role in combating the ongoing public health crisis of opioid overdose."

Product Updates

SYMJEPI (epinephrine) Injection

During the third quarter, Adamis’ commercial partner, Sandoz, announced the full launch of our SYMJEPI epinephrine injection product, making both the 0.3mg and 0.15mg doses available in local pharmacies across the U.S. Sandoz increased and continues to expand its commercial initiatives and we expect those efforts to begin translating into a steeper sales growth during the fourth quarter.

In addition to the U.S., Adamis continues to seek opportunities to market SYMJEPI into other territories and on October 1, 2019, the company announced it had entered into an exclusive distribution and commercialization agreement with Emerge Health to seek registration and commercialize SYMJEPI in Australia and New Zealand.

ZIMHI (naloxone) Injection

Since Adamis’ November 4, 2019 update, the U.S. Food and Drug Administration ("FDA") continues to review the company’s New Drug Application (NDA) for its ZIMHI high-dose naloxone product candidate, and as of the date of this press release the company has not received any notice of action from the FDA. The company believes that if approved, ZIMHI could be an important part of the solution to this growing health crisis of opioid overdose. The company believes that discussions with potential partners for ZIMHI have sufficiently progressed and that while no assurances are possible, the company expects to be able to announce a commercial partner soon after receiving clearance from the FDA.

Drug Outsourcing Facility

During the third quarter of 2019, the company’s wholly owned drug outsourcing facility, US Compounding (USC), continued to grow its revenues by approximately 19% in the third quarter compared to the same quarter last year and approximately 25% year-to-date versus the same nine months of 2018. USC’s increase in revenues was due to the increase in sales of USC’s sterile pharmaceutical formulations resulting in part from an increase in production capacity in order to meet product demand and from marketing personnel efforts.

Third Quarter 2019 Financial Results

Revenues increased approximately 54%, from $3.8 million to $5.9 million, for the three months ended September 30, 2018 and 2019, respectively. Revenues increased by approximately 52%, from $10.9 million to $16.6 million for the first nine months of 2018 compared to the same period in 2019. The increase was primarily attributable to growth in sales of USC’s sterile pharmaceutical products and revenue relating to SYMJEPI.

Selling, general and administrative expenses ("SG&A") decreased approximately 19%, from $6.5 million to $5.3 million for the three months ended September 30, 2018 and 2019, respectively. The decrease in SG&A expenses was primarily due to decreases in wages and benefits.

Research and development expenses ("R&D") decreased approximately 15%, from $3.9 million to $3.3 million for the third quarter of 2018 compared to the same period in 2019. The decrease was primarily due to a decrease in development costs of our product candidates. We anticipate that R&D expenses will continue to decrease in the fourth quarter of 2019.

Cash and equivalents at the end of the third quarter was approximately $12.1 million.

Targeted Near-Term Milestones

•Increasing sales of SYMJEPI in the U.S.
•FDA approval and commercial partner for ZIMHI
•Additional commercial partners for SYMJEPI outside of the U.S.
•Increasing sales and margins at US Compounding

Conference Call

Adamis will host a conference call and live webcast today, November 12, 2019 at 2:00 pm PDT (5:00 pm EDT) to discuss its financial and operating results for the third quarter 2019, as well as provide an update on business developments and activities.

US Dial-in (Toll Free): 1-800-458-4121

TOLL/International Dial-In: 1-323-794-2093

Conference ID: 1103072

Webcast: View Source

If you are unable to participate in the call live, a telephone playback will be available after approximately 5:00 pm PDT on November 12, 2019. To listen to the replay, call toll free 1-844-512-2921 within the U.S. or 1-412-317-6671 internationally (toll) and enter PIN number 1103072.

On November 12, 2019 bluebird bio, Inc. (Nasdaq: BLUE) and Forty Seven, Inc. (Nasdaq:FTSV) reported that they have entered into a research collaboration to pursue clinical proof-of-concept for Forty Seven’s novel antibody-based conditioning regimen, FSI-174 (anti-cKIT antibody) plus magrolimab (anti-CD47 antibody), with bluebird’s ex vivo lentiviral vector hematopoietic stem cell (LVV HSC) gene therapy platform (Press release, bluebird bio, NOV 12, 2019, View Source [SID1234551003]). This collaboration will focus on a conditioning approach aimed to deliver reduced toxicity and will initially target diseases that have the potential to be corrected with transplantation of autologous gene-modified blood-forming stem cells. If successful, the new conditioning regimen could allow for more patients to undergo gene therapy.

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Autologous hematopoietic stem cell transplantation (HSCT) and most ex vivo LVV HSC gene therapies require that a patient’s own stem cells first be depleted from the bone marrow to facilitate the engraftment of the new (or gene-modified) HSCs through a process called conditioning. Conditioning is performed using chemotherapy or radiation, which can place patients at risk for infection and require hospitalization until bone marrow cells have recovered. In addition, conventional conditioning can place patients at risk for secondary malignancy and infertility. As a result, the overall toxicity profile of current conditioning regimens limits the types of patients who are eligible for gene therapy. It is hoped that novel antibody based conditioning regimens could avoid these toxicities.

"We are excited about this collaboration, combining our industry-leading LVV HSC gene therapy platform with Forty Seven’s novel antibody-based conditioning regimen," said Philip Gregory, chief scientific officer, bluebird bio. "We believe that, if successful, this novel conditioning modality could not only increase the number of patients and physicians who may consider gene therapy but also improve the overall risk benefit profile for stem cell-based gene therapy, as well as potentially reduce time and costs associated with hospital visits."

"Forty Seven is advancing the pioneering work on CD47 and cKIT from our scientific founder, Irv Weissman’s lab. We have shown that antibody blockade of CD47 can synergize with other antibodies targeting cancer to promote tumor engulfment. Based on this experience, coupled with the results of preclinical studies, we are eager to explore this dual-antibody approach for the potential treatment of non-malignant diseases," says Jens Peter Volkmer, M.D., Founder and Vice President of Research and Development at Forty Seven.

Forty Seven’s President and Chief Executive Officer, Mark McCamish, M.D., Ph.D., commented, "bluebird is a leading gene therapy company and we are excited to collaborate with them. Stem cell transplantation is potentially curative for a variety of blood diseases, including genetic blood disorders like sickle cell disease and beta-thalassemia. If successful, we believe our chemo- and radiation-free, all-antibody approach could expand transplantation beyond genetic blood disorders to a range of indications for which current transplantation approaches are suboptimal. In 2020, we plan to evaluate FSI-174 in healthy volunteers, before initiating a combination study of Forty Seven’s novel all-antibody conditioning regimen and bluebird’s gene therapy product."

Under the terms of the agreement, bluebird bio will provide its ex vivo LVV HSC gene therapy platform and Forty Seven will contribute its innovative antibody-based conditioning regimen for the collaboration.

About FSI-174 and Magrolimab
FSI-174 is a humanized monoclonal antibody targeting cKIT, which is a receptor that is highly expressed on hematopoietic stem cells. Magrolimab is a humanized monoclonal antibody targeting CD47, which is a "don’t eat me" signal to macrophages and is expressed on all cells. Magrolimab is currently being investigated in Phase 2 clinical trials to treat cancer and has established clinical efficacy in four indications, including myelodysplastic syndrome, acute myeloid leukemia, diffuse large B cell lymphoma and follicular lymphoma, with a favorable safety profile in over 350 patients treated, including some patients treated continuously for over two years. When combined, FSI-174 sends a positive signal to macrophages to target blood forming stem cells for removal and magrolimab disengages inhibitory signals that block phagocytosis. Combination of these antibodies has shown efficient removal of blood forming stem cells, allowing for transplantation in pre-clinical models.

On November 12, 2019 Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company, reported financial results for the third quarter and nine months ended September 30, 2019, and provided a corporate update (Press release, Lipocine, NOV 12, 2019, View Source [SID1234551019]).

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Third Quarter and Recent Corporate Highlights

TLANDO, our oral testosterone replacement therapy ("TRT") product, received a Complete Response Letter ("CRL") from the United Stated Food and Drug Administration ("FDA") on November 8, 2019
First patient has been dosed in LiFT ("Liver Fat intervention with oral Testosterone") Phase 2 clinical study of LPCN 1144 in confirmed pre-cirrhotic non-alcoholic steatohepatitis ("NASH") subjects.
The LiFT Phase 2 clinical study is a prospective, multi-center, randomized, double-blind, placebo-controlled multiple-arm study in biopsy-confirmed male NASH subjects with grade F2/F3 fibrosis and a NAFLD Activity Score ("NAS") ≥ 4 with a 36-week treatment period.
Top-line primary end point liver fat reduction data are currently expected in mid-2020, as measured by MRI-PDFF at 12 weeks, followed by 36-week biopsy data.
Data from a clinical trial of LPCN 1144 in non-alcoholic fatty liver disease ("NAFLD") were selected for presentation at The Liver Meeting 2019, held November 8th – 12th in Boston, MA.
Lipocine’s abstract was selected by the Scientific Program Committee of the American Association for the Study of Liver Disease ("AASLD") as a Poster of Distinction for presentation.
Four abstracts (two oral presentations and two poster presentation on TLANDO) were presented at the 20th Annual Fall Meeting of the Sexual Medicine Society of North America ("SMSNA"), October 24-27th in Nashville, TN.
The U.S. District Court of Delaware has set a trial date for Lipocine’s patent infringement lawsuit against Clarus’s JATENZO drug product relating to six of Lipocine’s U.S. patents.
Trial is set to begin August 24, 2020 at which time Lipocine plans to seek a permanent injunction for Clarus’s infringement.
"During the third quarter, we continued to advance our pipeline, with important milestones achieved," said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine. "We are excited to continue enrolling subjects in the ongoing LPCN 1144 LiFT clinical study and look forward to participating in the TLANDO Post Action meeting with FDA to discuss a potential path forward for the approval of TLANDO while reserving our right to request for formal dispute resolution," said Dr. Mahesh Patel.

Third Quarter Ended September 30, 2019 Financial Results

Lipocine reported a net loss of $3.1 million, or ($0.12) per diluted share, for the quarter ended September 30, 2019, compared with a net loss of $2.5 million, or ($0.12) per diluted share, in the quarter ended September 30, 2018.

License revenue was $165,000 during the three months ended September 30, 2019 compared to no license revenue being recognized during the three months ended September 30, 2018. License revenue in 2019 relates to royalty payments received from Spriaso, LLC ("Spriaso") under a licensing agreement in the cough and cold field.

Research and development expenses were $1.7 million for the quarter ended September 30, 2019, compared with $1.4 million for the quarter ended September 30, 2018. The increase in research and development expenses was primarily due to increases in outside service costs related to the ramping up of the LPCN 1144 LiFT Phase 2 clinical study and increases in other research and development costs, offset by decreased contract research organization and outside consulting costs for TLANDO in connection with the completion of the ABPM study and filing of the NDA and a decrease in personnel costs. The decrease in personnel costs primarily relate to decreased stock compensation expense which resulted from the reversal of stock-based compensation expense recorded for the expected vesting of restricted stock units upon the approval of TLANDO (previously estimated to vest in the fourth quarter of 2019). The decrease in stock-based compensation expense was offset by increased salaries and other personnel expenses.

General and administrative expenses were $1.4 million for the quarter ended September 30, 2019, compared with $0.9 million for the quarter ended September 30, 2018. The increase in general and administrative was primarily due to an increase in legal fees mainly due to the lawsuit filed against Clarus for patent infringement and increases in other general and administrative expenses, offset by a decrease in personnel costs attributable to the reversal of stock-based compensation expense recorded for the expected vesting of restricted stock units upon the approval of TLANDO (previously estimated to vest in the fourth quarter of 2019).

As of September 30, 2019, the Company had unrestricted cash, cash equivalents and marketable securities aggregating $11.5 million, compared to $15.3 million at December 31, 2018. Additionally, as of September 30, 2019 and December 31, 2018 the Company had $5.0 million of restricted cash, which is required to be maintained as cash collateral under the Loan and Security Agreement with Silicon Valley Bank until TLANDO is approved by the FDA.

Nine Months Ended September 30, 2019 Financial Results

Lipocine reported a net loss of $9.7 million, or ($0.40) per diluted share, for the nine months ended September 30, 2019, compared with a net loss of $8.4 million, or ($0.40) per diluted share, in the nine months ended September 30, 2018.

License revenue was $165,000 during the nine months ended September 30, 2019 compared to license revenue of $428,000 during the three months ended September 30, 2018. License revenue in both 2019 and 2018 relates to royalty payments received from Spriaso under a licensing agreement in the cough and cold field.

Research and development expenses were $5.6 million for the nine months ended September 30, 2019, compared with $4.3 million for the nine months ended September 30, 2018. The increase in research and development expenses was primarily due to increases in the following costs: contract research organization and outside consulting costs for TLANDO in connection with completion of the ABPM study and the filing of the NDA, increased manufacturing costs for TLANDO, increased outside service costs related to the second quarter initiation of the LPCN 1144 LiFT Phase 2 clinical study, increased outside contract research organization costs related to TLANDO XR (LPCN 1111), increases in miscellaneous other research and development expenses and increased personnel costs. These cost increases were offset by a decrease in personnel costs attributable primarily to the reversal of stock-based compensation expense recorded for the expected vesting of restricted stock units upon the approval of TLANDO (previously estimated to vest in the fourth quarter of 2019) and decreased contract manufacturing costs for LPCN 1107.

General and administrative expenses were $4.0 million for the quarter ended September 30, 2019, compared with $4.3 million for the quarter ended September 30, 2018. The decrease in general and administrative was primarily due to decreased personnel costs, including decreased salaries and benefits due to the elimination of our commercial sales and marketing team in 2018, a decrease in severance compensation, and a net decrease in stock-based compensation mainly due to reversal of stock-based compensation expense recorded for the expected vesting of restricted stock units upon the approval of TLANDO (previously estimated to vest in the fourth quarter of 2019) and increases in other general and administrative expenses. These decreases in personnel costs and other general and administrative expenses were offset by increases in legal fees mainly due to the lawsuit filed against Clarus for patent infringement and increases in corporate insurance.

On November 12, 2019 Vaxart, Inc., a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, reported financial results for the third quarter ended September 30, 2019 and provided a corporate update (Press release, Aviragen Therapeutics, NOV 12, 2019, View Source [SID1234551034]).

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"The positive topline results from the Phase 1b clinical trial were a major milestone for the norovirus program," said Wouter Latour, M.D., chief executive officer of Vaxart. "The vaccine was well tolerated and elicited robust mucosal responses in 90 – 93% of subjects for the new norovirus GII component, and 78 – 86% for the norovirus GI component. This data suggests that our oral norovirus vaccine is likely to provide mucosal immunity in the intestine, the actual site of norovirus infection. We believe this is the optimal approach to protect against norovirus disease and puts Vaxart in a unique position to develop an effective oral vaccine targeting an estimated $3+ billion US market."

The CDC estimates that norovirus causes $60 billion in global healthcare related costs annually.

Vaxart plans to focus its efforts and resources on progressing the clinical development of its oral tableted bivalent norovirus vaccine. The Company will also continue the development of its first therapeutic vaccine targeting cervical cancer and dysplasia caused by Human Papilloma Virus (HPV), and explore opportunities to apply its VAASTTM oral vaccine platform for indications such as influenza and RSV.

Recent Corporate Highlights:

Vaxart’s Tableted Oral Bivalent Norovirus Vaccine Meets Primary and Secondary Endpoints in Phase 1b Study

The study met all primary endpoints for safety and demonstrated robust immunogenicity, with response rates of 90 – 93% for norovirus GII.4 and 78 – 86% for norovirus GI.1 as measured by IgA Antibody Secreting Cells (ASC), a key marker for mucosal immunity and a potential correlate of protection for norovirus disease.

Manufacturing of Norovirus GI.1 and GII.4 vaccines is proceeding as planned at Lonza and the initiation of the Phase 2 Bivalent Norovirus study is on target for 2020.

Research collaboration with Janssen’s Universal Influenza Vaccine Program is proceeding with results expected in 2020.

Priced an underwritten public offering which closed in September. As of September 30, 2019, the aggregate gross proceeds were $9.0 million.

Vaxart presented a corporate overview and update to investors and strategic partners at the H.C. Wainwright 21st Annual Global Investment Conference, in New York City.

Scientific meeting presentations:

IDWeek – Washington, DC, Presentation Title: Oral Norovirus Vaccination in Humans Induces Plasmablast B Cell Expansion and Follicular T Cell Activation Comparable to Natural Infection

7th International Calicivirus Conference – Sydney, Australia, Presentation Title: Oral Vaccine to Prevent Norovirus Infection Induces Mucosal Homing Plasmablasts and T Follicular Cells in Humans

10th International Vaccines for Enteric Diseases Conference (VED 2019) – Lausanne, Switzerland, Presentation Title: Progress on the Development of an Oral, Bivalent Norovirus Vaccine

In mid-November, Vaxart will be hosting a Key Opinion Leader Meeting in New York City on the Health Economics of Norovirus.

Financial Results for the Three Months Ended September 30, 2019

Vaxart reported a net loss of $5.3 million for the third quarter of 2019 compared to $6.5 million for the third quarter of 2018. The principal reason for the decrease was a reduction in research and development expenditure.

Vaxart ended the quarter with cash and cash equivalents of $19.6 million compared to $16.3 million at June 30, 2019. The increase was primarily due to the $8.1 million net proceeds from equity financing, mostly from the underwritten offering in September 2019, partially offset by cash used in operations.

Revenue for the quarter was $454,000 compared to $281,000 in the third quarter of 2018. The increase was mostly due to non-cash royalty revenue related to the sale of future royalties.

Research and development expenses were $3.7 million for the quarter compared to $4.4 million for the third quarter of 2018. The decrease was mainly due to the absence of clinical trials costs for teslexivir and a reduction in amortization of intangibles, partially offset by higher clinical trial and manufacturing costs incurred in the Company’s norovirus program.

General and administrative expenses were $1.5 million for the quarter compared to $1.7 million for the third quarter of 2018. The decrease was mainly due to lower audit and accounting costs.

On November 12, 2019 Scholar Rock (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 third quarter ended September 30, 2019 and highlighted recent progress and upcoming milestones for its pipeline programs (Press release, Scholar Rock, NOV 12, 2019, View Source [SID1234551110]).

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"The third quarter of 2019 has been a time of focused execution as we continue to advance our growing pipeline. Notably, we have been able to accelerate the development of SRK-181 and are now planning to initiate a Phase 1 dose escalation and proof-of-concept trial in patients with solid tumors in the first quarter of 2020, a testament to the strength of our team and scientific progress," said Nagesh Mahanthappa, Ph.D., President and CEO of Scholar Rock. "As we wrap up the year and look towards 2020 and beyond, we are well positioned to work towards a number of important milestones across our pipeline, including read-outs from the TOPAZ Phase 2 trial for SRK-015 and the initiation of our Phase 1 trial for SRK-181, that will further elucidate the potential of our product candidates in improving the lives of patients suffering from serious diseases."

Company Highlights and Upcoming Milestones

SRK-015 Program:

Preclinical and Phase 1 SRK-015 Healthy Volunteer Data Presented at World Muscle Society Congress. In October 2019, Scholar Rock presented data for SRK-015, a highly selective inhibitor of myostatin activation, that further enforce the therapeutic rationale for the advancement of SRK-015 into the TOPAZ Phase 2 clinical trial. Preclinical studies demonstrated improved muscle strength following the administration of a mouse analog of SRK-015 (muSRK-015P) in mouse models of early and late stage restoration of SMN, the protein that is deficient in the genetic disease SMA. Multi-fold increases in serum latent myostatin levels following treatment with muSRK-015P were shown across animal species in mice, rats, and cynomolgus monkeys. In the Phase 1 clinical trial in adult healthy volunteers, SRK -015 was well-tolerated, had a well-behaved pharmacokinetic (PK) profile, and demonstrated robust and sustained target engagement.

Scholar Rock is on track to report preliminary PK and pharmacodynamic (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.

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:

Accelerated Initiation of Phase 1 Dose Escalation and Proof-of-Concept Clinical Trial of SRK-181 in Patients with Solid Tumors to the First Quarter of 2020. Scholar Rock intends to develop SRK-181, an isoform-selective inhibitor of TGFβ1 activation as a cancer immunotherapy in combination with anti-PD(L)1 antibodies. The company now plans to initiate a Phase 1 trial in the first quarter of 2020, in patients with locally advanced or metastatic solid tumors that exhibit primary resistance to anti-PD(L)1 antibodies. The two-part trial will consist of a dose escalation portion as both a single-agent and SRK-181 in combination with an approved anti-PD(L)1 antibody, as well as a dose expansion portion consisting of multiple tumor-specific cohorts evaluating SRK-181 in combination with an approved anti-PD(L)1 antibody.
RGMc Program:

Nomination of a Product Candidate from the RGMc Program Planned in 2020. Scholar Rock is evaluating a number of highly specific inhibitors of repulsive guidance molecule C (RGMc) and plans to nominate an antibody as its third product candidate in 2020. 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.
Third Quarter 2019 Financial Results

For the quarter ended September 30, 2019, net loss was $16.1 million or $0.55 per share compared to a net loss of $10.8 million or $0.44 per share for the quarter ended September 30, 2018.

Revenue was $4.8 million for the quarter ended September 30, 2019 and was related to the Gilead Collaboration Agreement that was executed in December 2018.
Research and development expense was $15.7 million for the quarter ended September 30, 2019 compared to $8.1 million for the quarter ended September 30, 2018. The increase year-over-year primarily reflects preclinical and manufacturing costs for SRK-181, clinical development costs associated with SRK-015, and higher personnel-related costs.

General and administrative expense was $6.2 million for the quarter ended September 30, 2019 compared to $3.2 million for the quarter ended September 30, 2018. The increase year-over-year was primarily attributable to increased headcount, stock compensation, separation-related expense, and professional services.
As of September 30, 2019, Scholar Rock had cash, cash equivalents, and marketable securities of $176.1 million, compared to $175.6 million as of December 31, 2018.