On November 12, 2019 Reata Pharmaceuticals, Inc. (Nasdaq: RETA) ("Reata" or the "Company"), a clinical-stage biopharmaceutical company, reported financial results for the third quarter ended September 30, 2019, and provided an update on the Company’s business and product development programs (Press release, Reata Pharmaceuticals, NOV 12, 2019, View Source [SID1234550988]).

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Recent Company Highlights

Reported positive, topline one-year data from the pivotal CARDINAL study of bardoxolone methyl in patients with chronic kidney disease caused by Alport syndrome
Reported positive topline data from the pivotal MOXIe study of omaveloxolone in patients with Friedreich’s ataxia
Third Quarter Financial Highlights

The Company incurred total expenses of $46.8 million for the quarter ended September 30, 2019, with research and development accounting for $32.3 million. This compares to total expenses of $34.7 million for the same period of the year prior, when research and development accounted for $27.1 million. We reported a net loss of $39.7 million or $1.32 per share for the quarter ended September 30, 2019. This compares to a net loss of $30.8 million or $1.07 per share in the same period of the year prior.

The net loss for the three-month period compared to the year prior is primarily driven by an increase in expenses offset with an increase in revenue. Higher expenses were driven by an increase in research and development expenses due to clinical, manufacturing, and medical affairs activities, and an increase in personnel expenses to support growth of our development activities.

We incurred total expenses of $124.6 million for the nine month period ended September 30, 2019, with research and development accounting for $87.9 million. This compares to total expenses of $97.1 million for the same period of the year prior, when research and development accounted for $72.0 million. We reported a net loss of $103.2 million or $3.44 per share for the nine month period ended September 30, 2019. This compares to a net loss of $55.0 million or $2.03 per share in the same period of the year prior.

The increase in net loss for the nine month period ended September 30, 2019 is driven primarily by both an increase in expenses and a decrease in revenue. Higher expenses were driven by an increase in research and development expenses due to clinical, manufacturing, and medical affairs activities, and an increase in personnel expenses to support growth of our development activities. Revenue to date has primarily been related to license and collaboration agreements entered into during 2009, 2010, and 2011. Additional revenue related to variable consideration that was included in the transaction price under the KKC Agreement was recognized in the prior year period. Since we did not have a similar event in the current period, the revenue decreased by comparison.

Our cash-based operating expenses, a non-GAAP measure, were $41.2 million and $109.9 million for the three and nine months ended September 30, 2019, respectively. This compares to $31.9 million and $89.0 million for the same periods of the year prior. The increase in cash-based operating expenses for the three and nine months ended September 30, 2019, were driven by increased manufacturing and clinical activities, as well as increased personnel costs to support growth in our development activities. We expect our cash-based operating expenses to continue to increase in the future as we advance bardoxolone methyl and omaveloxolone through ongoing and future clinical trials, scale manufacturing for registrational and validation purposes, advance other product candidates into mid- and later-stage clinical trials, expand our product candidate portfolio, increase both our research and development and administrative personnel, and plan for commercialization of our product candidates.

At September 30, 2019, we had $240.1 million in cash and cash equivalents. We expect our current cash, along with our access to additional equity or debt funding, will enable us to meet our current obligations through December 31, 2020.

Non-GAAP Financial Measures

In addition to the U.S. generally accepted accounting principles (GAAP) financial highlights, this earnings release includes cash-based operating expenses, a non-GAAP financial measure, which the Company defines as total expenses excluding stock-based compensation expense and depreciation expense. A reconciliation of this non-GAAP financial measure to its most directly comparable GAAP financial measure is presented in the table below in this earnings release.

We believe that this non-GAAP financial measure, in addition to GAAP financial measures, provides a meaningful measure of our ongoing business and operating performance by allowing investors to analyze our financial results similarly to how management analyzes our financial results by viewing period expense totals more indicative of effort directly expended to advance the business and our product candidates. Non-GAAP financial measures should be considered in addition to, not in isolation or as a substitute for, GAAP financial measures. In addition, our non-GAAP financial measure may differ from similarly named measures used by other companies.

CONFERENCE CALL INFORMATION

Date: November 12, 2019
Time: 8:00 a.m. ET
Audience Dial-in (toll-free): (844) 348-3946
Audience Dial-in (international): (213) 358-0892
Conference ID: 4159656
Webcast Link: View Source

On November 12, 2019 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported financial results and corporate highlights for the third quarter of 2019 (Press release, Surface Oncology, NOV 12, 2019, View Source [SID1234550987]).

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"The Surface team’s focus on execution across the pipeline has delivered a next wave of programs on the cusp of entering clinical development and a new development candidate for our first NK cell targeted program, SRF813. We look forward to walking through our phase 1 trial plans for SRF617 and SRF388, as well as our differentiated approach towards targeting the immune checkpoint protein CD112R at our inaugural R&D day," said Jeff Goater, chief executive officer of Surface Oncology.

The R&D day will be introduced by keynote speaker and Surface Oncology scientific advisor E. John Wherry, Ph.D., director of the Penn Institute for Immunology at the University of Pennsylvania, and co-director of the Parker Institute for Cancer Immunotherapy. The event will be broadcast live at investors.surfaceoncology.com. Parties interested in attending should contact [email protected].

Recent & Upcoming Corporate Highlights:

Appointment of Ramy Ibrahim, Ph.D., to the Surface Oncology board of directors. Dr. Ibrahim is a medical oncologist currently serving as chief medical officer and vice president of clinical development at the Parker Institute for Cancer Immunotherapy. He is an acknowledged immunotherapy expert and played an important role in the development of several approved immune checkpoint inhibitor therapies such as durvalumab (Imfinzi), ipilimumab (Yervoy) and nivolumab (Opdivo).
Presentation of three scientific posters at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) conference in National Harbor, Maryland, sharing insights from the SRF617, SRF388 and SRF231 programs. These posters will be hosted on the Company’s corporate website.
A new development program, SRF813, to be discussed in detail at the Company’s R&D day. SRF813 is Surface’s first natural killer (NK) cell targeting program, focused on the recently identified immune checkpoint protein CD112R, the blockade of which promotes anti-tumor responses through both innate and adaptive arms of the immune system.
Continued progression of SRF617 (CD39) and SRF388 (IL-27) towards IND filings this year.
Continued enrollment of the ongoing phase 1b study of NZV930 (CD73), licensed to Novartis, which is evaluating combinations of NZV930 with PDR001 (anti PD-1), NIR178 (A2aR inhibitor), as well as a combination of all three therapies. Novartis is responsible for all development costs associated with NZV930. Surface Oncology is currently entitled to cumulative potential milestones in excess of $500 million, as well as tiered royalties on annual net sales by Novartis ranging from high single-digit to mid-teens percentages upon the successful commercialization of NZV930.
Financial Results:

As of September 30, 2019, cash, cash equivalents and marketable securities were $111.8 million, compared to $126.3 million on June 30, 2019.

R&D expenses were $12.9 million for the third quarter ended September 30, 2019, compared to $15.8 million for the same period in 2018. The decrease in expenditures was primarily driven by a reduction of manufacturing spend on the SRF231 (CD47) program, which was partially offset by increased spend on SRF617 and SRF388 in preparation for IND filings in the fourth quarter of 2019. R&D expenses included $0.6 million in stock-based compensation expense for the third quarter of 2019.

General and administrative (G&A) expenses were $5.0 million for the third quarter ended September 30, 2019, compared to $4.0 million for the same period in 2018. The increase in G&A expenses is primarily due to increased personnel costs and professional fees. G&A expenses included $1.0 million in stock-based compensation expense for the third quarter of 2019.

For the third quarter ended September 30, 2019, net loss was $16.9 million, or basic and diluted net loss per share attributable to common stockholders of $0.61. Net loss was $17.2 million for the same period in 2018, or a basic and diluted net loss per share attributable to common stockholders of $0.62.

Financial Outlook:

Based upon its current operating plan, which includes anticipated milestones from Novartis, Surface continues to have a projected cash runway through 2021.

On November 12, 2019 OncoSec Medical Incorporated ("OncoSec") (Nasdaq:ONCS), a company developing late-stage intratumoral cancer immunotherapies, reported outcomes from a safety and biomarker analysis on its lead product candidate, TAVO, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting (Press release, OncoSec Medical, NOV 12, 2019, View Source [SID1234550986]). Outcomes demonstrated treatment-related changes in key immune biomarkers coinciding with clinical outcomes across both KEYNOTE-695 and KEYNOTE-890 trials of TAVO in combination with KEYTRUDA (pembrolizumab).

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In the poster, which was presented on November 9, 2019, investigators noted that following TAVO administration, increased tumor infiltrating CD8+ T-cells were consistent with tumor shrinkage in anti-PD-1 antibody refractory melanoma and chemotherapy refractory metastatic triple negative breast cancer (mTNBC). The interim analysis also highlighted the systemic immune effects of TAVO, including increases in the frequencies of circulating memory T cells and reduced frequencies of circulating immuno-suppressive PMN-MDSC cells in predominately responding patients across both indications. Additionally, a broad safety analysis of over 200 patients treated with TAVO in multiple cancer indications across several clinical trials including TAVO as a monotherapy as well as in combination with KEYTRUDA was reported. There were no Grade 4 or 5 treatment-related adverse events reported and only 7.9% of patients experienced Grade 3 treatment-related adverse events across all TAVO studies, underscoring a predictable and consistently well-tolerated safety profile.

OncoSec is currently evaluating TAVO in combination with KEYTRUDA in a pivotal trial for Stage III/VI anti-PD1 checkpoint resistant metastatic melanoma and a phase 2 trial for late stage chemo-refractory metastatic TNBC, both KEYNOTE-designated studies. The immune data presented at SITC (Free SITC Whitepaper) represented those patients for whom pre- and post-treatment blood and tumor samples were obtained in these ongoing KEYNOTE studies.

"The data presented at SITC (Free SITC Whitepaper) were consistent with earlier published data showing that the well-established indicators of immune response are present in the blood and tumor tissue post-treatment and that the presence of these immune signatures continues to be associated with clinical response," said Daniel J. O’Connor, CEO of OncoSec. "Further, with more than 200 TAVO-treated patients, we clearly see that these powerful clinical responses are delivered with an excellent safety profile as both a monotherapy and importantly, in combination with anti-PD-1 therapy."

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 Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, reported third quarter 2019 financial results and business updates, which will be discussed on a conference call scheduled for Wednesday, November 13 at 10:00 a.m. ET (Press release, Abeona Therapeutics, NOV 12, 2019, View Source [SID1234550984]). Interested parties are invited to participate in the call by dialing 844-602-0380 (toll-free domestic) or 862-298-0970 (international) or via webcast at View Source

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"Abeona has made progress on our lead clinical program, EB-101, for the treatment of recessive dystrophic epidermolysis bullosa," said João Siffert, M.D., Chief Executive Officer of Abeona. "We continue to anticipate receiving CMC clearance for this pivotal trial by year-end following the recent submission of additional transport stability data for EB-101, in response to the Clinical Hold Letter received in the quarter, as well as the submission of updated clinical and comparability protocols for the VIITALTM Phase 3 study."

Dr. Siffert continued, "We were also very pleased with the publication of positive long-term data from our Phase 1/2a clinical trial, reinforcing the potential of EB-101 to safely provide durable healing for the most challenging to treat, large and painful RDEB wounds. Three years post treatment, the majority of EB-101-treated wounds remained healed and without pain. We believe that EB-101 is uniquely positioned to address the needs of the majority of RDEB patients who suffer from these types of chronic wounds and we remain dedicated to delivering this therapy to the community."

Third Quarter Financial Results:

Cash, cash equivalents and marketable securities as of September 30, 2019, were $47.9 million compared to $62.5 million as of June 30, 2019. The decrease in cash was driven primarily by the net cash used in operating activities of $18.3 million.

Research and development expenses for the third quarter ended September 30, 2019 were $10.9 million compared to $13.2 million in the same period of 2018. The decrease in R&D expense was primarily attributable to decreased clinical and development work, partially offset by increased salary and related costs from the hiring of additional clinical, regulatory, manufacturing and quality staff.

General and administrative expenses for the third quarter ended September 30, 2019 were $4.7 million compared to $5.0 million in the same period of 2018. The decrease in G&A expenses was primarily due to decreased rental, recruiting, professional fee and salary related costs.

Net loss was $0.35 per share for the third quarter of 2019 compared to $0.34 per share in the same period of 2018.

Third Quarter and Recent Highlights:

●Submitted additional transport stability data for EB-101 in response to September 17 FDA Clinical Hold Letter regarding the planned Phase 3 VIITAL study
Submitted Phase 3 VIITAL clinical trial protocol with updated PRO assessments, and submitted the retrovirus comparability protocol to FDA.
●Presentation of data from the Transpher A Study, the Company’s ongoing Phase 1/2 clinical trial evaluating ABO-102 for the treatment of MPS IIIA, and research updates from its library of novel AIMTM adeno-associated virus capsids at the 27th European Society of Gene and Cell Therapy Congress.
●Publication of positive long-term safety and efficacy data from the Phase 1/2a clinical trial of EB-101 in JCI Insight with collaborators from Stanford University School of Medicine.
●Three years after treatment with EB-101, a majority of RDEB patients had sustained wound healing, with 80% (16/20) of wounds achieving ≥50% healing, and 70% (14/20) achieving ≥75%
●Two years after treatment, only 1 of 6 untreated (17%), prospectively selected control wounds, had ≥50% healing
●50% or greater wound healing was associated with no pain (0/16) and no itch (0/16) at treated sites three years post-treatment, compared with presence of pain in 53% (20/38) and itch in 61% (23/38) of wound sites at baseline
●EB-101 was associated with long-term molecular expression of type VII collagen protein, which plays an important role in anchoring the dermal and epidermal layers of the skin
●No serious treatment-related adverse events were observed during the three-year observation period
●Retained Jefferies LLC as its financial advisor to assist with the review of strategic intiatives focused on advancing the Company’s mission and maximizing stakeholder value.