On August 8, 2018 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today reported financial results for the three and six months ended June 30, 2018 and highlighted recent corporate progress.

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Recent Corporate Progress

Pain Management Franchise

Positive Topline Results from Phase 2b Clinical Studies of HTX-011 in Total Knee Arthroplasty and Breast Augmentation. HTX-011 achieved all primary endpoints in two completed Phase 2b studies: Study 209 (local administration in total knee arthroplasty) and Study 211 (instillation or pectoral pocket nerve block in breast augmentation). In both of these studies:
HTX-011 demonstrated statistically significant reductions in both pain intensity and opioid use;
HTX-011 demonstrated a strong correlation between pain reduction and pharmacokinetics; and
HTX-011 was well tolerated.
Breakthrough Therapy Designation Granted for HTX-011. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for HTX-011 for local administration into the surgical site. Breakthrough Therapy designation is designed to expedite the development and review of drugs that are intended to treat serious conditions and for which preliminary clinical evidence indicates substantial improvement over available therapies on clinically significant endpoint(s). Breakthrough Therapy designation was granted for HTX-011 based on the results of completed Phase 2 studies and two recently completed Phase 3 studies, which showed that HTX-011 produced significant reductions in both pain intensity and the need for opioids through 72 hours post-surgery compared to placebo and bupivacaine solution, the standard of care.
In the second half of 2018, Heron expects to submit a New Drug Application (NDA) to the FDA for HTX-011.

CINV Franchise

CINV Sales. Chemotherapy-induced nausea and vomiting (CINV) franchise net product sales for the three and six months ended June 30, 2018 were $17.3 million and $28.8 million, respectively. Heron reaffirms full-year 2018 CINV franchise net product sales guidance of $60 million to $70 million, and Heron believes net product sales will be in the upper end of this range.
SUSTOL Sales. Net product sales of SUSTOL (granisetron) extended-release injection for the three and six months ended June 30, 2018 were $6.1 million and $12.4 million, respectively. The entry of generic palonosetron in the first quarter of 2018 has had, and is expected to have, a several-quarter negative impact on provider demand for SUSTOL.
CINVANTI Sales. Net product sales of CINVANTI (aprepitant) injectable emulsion for the three and six months ended June 30, 2018 were $11.2 million and $16.4 million, respectively. CINVANTI was approved by the FDA on November 9, 2017 and became commercially available in the U.S. on January 4, 2018.
"We are pleased with the progress we have made in the first half of 2018. In our pain management franchise, the results of completed Phase 2 and Phase 3 studies and the Breakthrough Therapy designation by the FDA of HTX-011 further confirm our belief in the superiority of HTX-011 over the standard of care in reducing pain intensity and opioid use across multiple diverse surgical models. In our CINV franchise, providers are continuing to realize the value of CINVANTI over other injectable NK1 receptor antagonists, and the number of oncology clinics ordering CINVANTI has increased," said Barry D. Quart, Pharm.D., Chief Executive Officer of Heron Therapeutics. "We look forward to submitting an NDA for HTX-011 to the FDA in the second half of this year and achieving full-year CINV net product sales in the upper end of our $60 million to $70 million guidance."

Financial Results

Net product sales for the three and six months ended June 30, 2018 were $17.3 million and $28.8 million, respectively, compared to $8.5 million and $12.1 million for the same periods in 2017, respectively.

Heron’s net loss for the three and six months ended June 30, 2018 was $38.7 million and $90.9 million, or $0.54 per share and $1.33 per share, respectively, compared to $42.8 million and $93.1 million, or $0.80 per share and $1.79 per share, for the same periods in 2017, respectively. Net loss for the three and six months ended June 30, 2018, included non-cash, stock-based compensation expense of $7.8 million and $15.5 million, respectively, compared to $8.2 million and $16.2 million, for the same periods in 2017, respectively.

As of June 30, 2018, Heron had cash, cash equivalents and short-term investments of $423.0 million, compared to $172.4 million as of December 31, 2017. Net cash used for operating activities for the six months ended June 30, 2018 was $122.4 million, compared to $82.6 million for the same period in 2017.

About HTX-011 for Postoperative Pain

HTX-011, which utilizes Heron’s proprietary Biochronomer drug delivery technology, is an investigational, long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the management of postoperative pain. By delivering sustained levels of both a potent anesthetic and a local anti-inflammatory agent directly to the site of tissue injury, HTX-011 was designed to deliver superior pain relief while reducing the need for systemically administered pain medications such as opioids, which carry the risk of harmful side effects, abuse and addiction. HTX-011 has been shown to reduce pain significantly better than placebo or bupivacaine alone in five diverse surgical models: hernia repair, abdominoplasty, bunionectomy, total knee arthroplasty and breast augmentation. HTX-011 was granted Fast Track designation from FDA in the fourth quarter of 2017 and Breakthrough Therapy designation in the second quarter of 2018. In the second half of 2018, Heron expects to submit a New Drug Application (NDA) to the FDA for HTX-011.

About CINVANTI (aprepitant) injectable emulsion

CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin and nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). CINVANTI is an intravenous formulation of aprepitant, a substance P/neurokinin-1 (NK1) receptor antagonist. CINVANTI is the first intravenous (IV) formulation to directly deliver aprepitant, the active ingredient in EMEND capsules. Aprepitant (including its prodrug, fosaprepitant) is the only single-agent NK1 receptor antagonist to significantly reduce nausea and vomiting in both the acute phase (0 – 24 hours after chemotherapy) and the delayed phase (24 – 120 hours after chemotherapy). CINVANTI is the only IV formulation of an NK1 receptor antagonist indicated for the prevention of acute and delayed nausea and vomiting associated with HEC and nausea and vomiting associated with MEC that is free of polysorbate 80 or any other synthetic surfactant. Pharmaceutical formulations containing polysorbate 80 have been linked to hypersensitivity reactions, including anaphylaxis and irritation of blood vessels resulting in infusion-site pain. FDA-approved dosing administration included in the United States prescribing information for CINVANTI is a 30-minute infusion.

Please see full prescribing information at www.CINVANTI.com.

About SUSTOL (granisetron) extended-release injection

SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-HT3 receptor antagonist that utilizes Heron’s Biochronomer drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL’s efficacy and safety in more than 2,000 patients with cancer. SUSTOL’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0 – 24 hours after chemotherapy) and delayed phase (24 – 120 hours after chemotherapy).

Please see full prescribing information at www.SUSTOL.com.

On August 7, 2018 ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of proprietary antibody drug conjugates (ADCs), reported that the first patient has been dosed in its Phase II clinical trial intended to support the submission of Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) (Press release, ADC Therapeutics, AUG 7, 2018, View Source [SID1234596075]). The clinical trial is evaluating the efficacy and safety of ADCT-402 (loncastuximab tesirine) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

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At the 2017 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, the Company presented interim Phase I data on ADCT-402 in 138 evaluable, heavily pre-treated lymphoma patients who had failed, or were intolerant to, any established therapy known to provide clinical benefit, with a median of three prior therapies. At the time, for the 49 response-evaluable patients in Part 1 of the study (dose escalation) with DLBCL who received ADCT-402 at doses greater than or equal to 120 μg/kg, the overall response rate (ORR) was 55 percent (27/49), with 18 patients achieving a complete response (37 percent) and 9 patients achieving a partial response (18 percent).

The primary endpoint of the Phase II, multi-center, open-label, single-arm trial is the ORR in patients treated with ADCT-402, as confirmed by central review. Secondary endpoints include assessments of duration of response, complete response rate, relapse-free survival, progression-free survival and overall survival, as well as safety, pharmacokinetics and health-related quality of life. The trial will enroll approximately 140 patients with relapsed or refractory DLBCL at multiple centers in the USA and Europe.

"We are pleased to have dosed the first patient in our registrational Phase II clinical trial evaluating ADCT-402 in patients with DLBCL who have relapsed and have refractory disease after two or more multi-agent treatment regimens. Our Phase I clinical trial of ADCT-402 in non-Hodgkin lymphoma showed significant activity in patients with DLBCL and an acceptable safety profile," said Jay Feingold, MD, PhD, Chief Medical Officer and Senior Vice President of Clinical Development at ADC Therapeutics. "Unfortunately, there is no effective treatment for patients with multiple relapsed and refractory DLBCL, so we are excited about the potential to improve outcomes in these patients with ADCT-402 in a single-arm trial. We anticipate reporting results from the Phase II trial in the third quarter of 2019 and are hopeful that the data will support our submission of a BLA to the FDA."

Alex Spira, MD, PhD, FACP, Director of Virginia Cancer Specialists Research Institute and Clinical Assistant Professor of Oncology at Johns Hopkins School of Medicine, added, "Patients with DLBCL who have relapsed or are refractory after second-line chemotherapy face a very poor prognosis. There is a

significant unmet need for an effective new treatment option for this patient population, and we believe ADCT-402 has the potential to help impact patient outcomes in this disease."

For more information about the Phase II clinical trial, please visit www.clinicaltrials.gov (identifier NCT03589469).

ADC Therapeutics also plans to initiate multiple combination studies with ADCT-402 in the fourth quarter of 2018.

About Diffuse Large B-Cell Lymphoma (DLBCL)

Non-Hodgkin lymphoma (NHL) is the seventh most common type of cancer in the U.S., and accounted for an estimated 4.3 percent of new cancer cases in 2017.1 Diffuse large B-cell lymphoma (DLBCL) accounts for nearly one-third (32.5 percent) of NHL.2 The most common initial treatment for patients with DLBCL is chemo-immunotherapy. Response to initial treatment is high, but more than half of patients do not have long-term disease control.3 The current standard of care for relapsed DLBCL is additional chemotherapy, which can be followed by stem cell transplantation (SCT). The prognosis for relapsed patients is poor, especially for those with chemotherapy-refractory disease with a short interval between remission and relapse or those who relapse after high-dose therapy and SCT. There is a significant unmet need for an effective treatment for patients with relapsed or refractory DLBCL.

About ADCT-402

ADCT-402 is an antibody drug conjugate (ADC) composed of a humanized monoclonal antibody that binds to human CD19, conjugated through a linker to a pyrrolobenzodiazepine (PBD) dimer toxin. Once bound to a CD19-expressing cell, ADCT-402 is internalized into the cell where enzymes release the PBD-based warhead. CD19 is a clinically validated target for the treatment of B-cell malignancies. The PBD-based warhead has the ability to form highly cytotoxic DNA interstrand cross-links, blocking cell division and resulting in cell death. Preliminary data from a Phase I clinical trial in relapsed or refractory B-cell non-Hodgkin lymphoma demonstrate ADCT-402 has significant activity in patients with diffuse large B-cell lymphoma (DLBCL). ADCT-402 is also being evaluated in an ongoing Phase I clinical trial in patients with relapsed or refractory B-cell lineage acute lymphoblastic leukemia (B-ALL). The U.S. Food and Drug Administration has granted orphan drug designation to ADCT-402 for the treatment of DLBCL and mantle cell lymphoma.

On August 7, 2018 Eidos Therapeutics, Inc. (Eidos) (Nasdaq:EIDX), a clinical stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin (TTR) amyloidosis (ATTR), reported its financial results for the quarter ended June 30, 2018 and provided an update on the Company’s recent achievements (Press release, Eidos Therapeutics, AUG 7, 2018, View Source [SID1234576275]).

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"With the proceeds from our IPO and Series B financing, we are well positioned to continue the momentum of developing AG10 as a disease-modifying therapy for ATTR," said Neil Kumar, PhD, chief executive officer of Eidos. "Specifically, we plan to complete our ongoing Phase 2 trial in ATTR-CM patients by the end of 2018 and initiate Phase 3 studies in ATTR-CM and ATTR-PN patients in 2019."

Recent Achievements and Upcoming Milestones

Initiated and completed enrollment in the ongoing Phase 2 trial in ATTR-CM patients.
Completed Series B preferred stock financing raising $64 million.
Completed initial public offering, with total gross proceeds of $122.2 million including exercise of underwriters’ option to purchase additional shares, from the sale of 7.2 million shares of common stock.
Complete data from Phase 1 study of AG10 in healthy volunteers to be presented at poster presentation at Heart Failure Society of America 22nd Annual Scientific Meeting (September 15-18).
Top-line results from ongoing Phase 2 study of AG10 in symptomatic ATTR-CM patients to be announced by the end of 2018.
Financial Results for the Second Quarter 2018

Cash and cash equivalents totaled $176.7 million at June 30, 2018 compared with $5.5 million at December 31, 2017, reflecting the $112.2 million of net proceeds from our initial public offering in June 2018 and $64.0 million related to the Series B preferred stock financing.

Research and development expenses were $7.4 million for the second quarter of 2018, compared to $1.3 million for the same period of 2017, an increase of $6.1 million. The increase was primarily due to increased expenses for contract consultants, contract manufacturing and other activities for AG10 clinical trials and increases in headcount and related salaries and expenses.

General and administrative expenses were $1.9 million for the second quarter of 2018 compared to $0.5 million for the same period in 2017, an increase of $1.4 million. The increase was primarily due to increased salaries and employee-related expenses and increases in professional fees and services in connection with becoming a public company.

Net loss for the quarter ended June 30, 2018 was $10.6 million or $1.38 per common share, compared to a net loss of $1.7 million or $0.49 per common share for the same period in 2017.

About AG10

AG10 is an orally-administered small molecule designed to potently stabilize tetrameric transthyretin, or TTR, thereby halting at its outset the series of molecular events that give rise to amyloidosis, or ATTR. AG10 is currently being examined in a Phase 2 clinical trial in patients with ATTR cardiomyopathy. Top-line results from this trial are expected to be reported by the end of 2018.

AG10 was designed to mimic a naturally-occurring variant of the TTR gene (T119M) that is considered a "rescue mutation" because it has been shown to prevent ATTR in individuals carrying pathogenic, or disease-causing, mutations in the TTR gene. To our knowledge, AG10 is the only TTR stabilizer in development that has been observed to mimic the "super-stabilizing" properties of this rescue mutation.

On August 7, 2018 Teneobio, Inc., a next generation multi-specific antibody therapeutics company, and Poseida Therapeutics, Inc., a San Diego-based clinical-stage company translating best-in-class gene engineering technologies into lifesaving cell therapies, reported a new research collaboration and licensing agreement to develop novel CAR-T therapies using Teneobio’s heavy chain only domain antibodies (UniDabs) (Press release, TeneoBio, AUG 7, 2018, View Source [SID1234558319]).

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Poseida will apply UniDab binders, which demonstrate significant advantages over traditional single chain variable antibody fragment (scFv) binders, to the development of its next generation CAR-T therapies.

The new collaboration follows a commercial license agreement between the companies that was announced in May of 2017. Under the terms of the new agreement, Teneobio will generate multiple UniDab product candidates using its proprietary UniRat transgenic human antibody ‘heavy-chain only’ rodent platform and its state-of-the-art sequence-based discovery engine, TeneoSeek. Poseida will have exclusive global licensing rights for the clinical development and commercialization of specific UniDabs for CAR-T therapies.

Teneobio Inc. will receive an upfront payment and is eligible to receive future research, development and regulatory milestone payments per UniDab candidate, with total potential earnings of over $250 million for CAR-T therapies developed by Poseida. Teneobio would also receive royalties on worldwide net sales of each CAR-T therapy.

"We are delighted to partner with Poseida and to help create the next generation of cell therapies," said Roland Buelow, CEO of Teneobio. "Domain antibodies have been clinically validated as excellent targeting moieties in CAR-T cells. They confer robust in vivo specificity and efficacy. They are smaller in size, have greater humanicity, and superior developability relative to standard scFv’s. The use of UniDabs as binders in CAR-T products is predicted to result in a lack of tonic signaling and lower immunogenicity, thus solving some of the problems of the first-generation, scFv-based CAR-T therapies."

Eric Ostertag, CEO of Poseida, noted, "Teneobio’s UniDab binders are an ideal match for Poseida’s novel and industry-leading CAR-T platform technologies. Poseida has demonstrated that UniDabs can be engineered to serve as binding molecules for our CAR-T therapeutics and oftentimes may function better than other binders for use in CAR-T products."

"We are pleased to expand our existing partnership with Poseida, whose cutting-edge genetic engineering tools combined with our targeting UniDab candidates will enable the development of the next generation of superior CAR-T therapies to treat cancer. We believe that UniDabs provide differentiated advantages from other targeting moieties, and that their utility and reach will extend beyond antibody therapeutics to novel transformational cell therapy treatments," added Omid Vafa, CBO of Teneobio.

On August 7, 2018 GT Biopharma Inc. (OTCQB: GTBP; Euronext Paris: GTBP) an immuno-oncology biotechnology company focused on innovative treatments based on the company’s proprietary platforms, reported that on August 2, 2018 it completed a private placement of convertible debentures for gross proceeds of $5,140,000 (Press release, GT Biopharma , AUG 7, 2018, View Source [SID1234539526]).

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”It is a testament to the potential of our immuno-oncology platforms and the promise for patients that our well informed and successful financing partners continue to support GT Biopharma as we move this company to the next level. Meeting our capital requirements is just one of many critical steps to advancing our drug development programs,” said Dr. Raymond W. Urbanski, Chairman and Chief Executive Officer of GT Biopharma.

The interest rate on the convertible debentures is 10%. The convertible debentures are convertible into the Company’s common stock, par value $0.001 per share, at an initial exercise price of $2 per share, subject to adjustment. The convertible debentures mature after one year.