On February 27, 2020 Apexigen, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, reported that Xiaodong Yang, M.D., Ph.D., President and Chief Executive Officer, will present at the following upcoming investor conferences (Press release, Apexigen, FEB 27, 2020, View Source [SID1234554949]):

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Cowen’s 40th Annual Healthcare Conference
Tuesday, March 3, 2020 at 11:30 am ET in Boston, MA

Solebury Trout’s Spring 2020 Private Company Showcase
Thursday, April 2, 2020 in New York, NY

On February 27, 2020 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 that Bill Newell, Chief Executive Officer, will present at the Cowen and Company 40th Annual Health Care Conference on Wednesday, March 4, at 9:20 a.m. EST at the Marriott Copley Place in Boston (Press release, Sutro Biopharma, FEB 27, 2020, View Source [SID1234554871]).

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A live webcast of the presentation will be accessible through the Events and Presentations page of the Investor Relations section of the company’s website at www.sutrobio.com. A replay of the webcast will be available for approximately 30 days following the event.

On February 27, 2020 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") reported that an interim analysis of an ongoing Phase 1b study of resiniferatoxin (RTX) administered via epidural route in patients with intractable cancer pain has generated positive data (Press release, Sorrento Therapeutics, FEB 27, 2020, View Source [SID1234554898]). The study is completing enrollment of an additional 25 ug expansion dose cohort. Based on full study results a dose will be selected for RTX to proceed to Phase 3 pivotal trials in patients with advanced cancer pain.

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Safety in the higher dose cohort is expected to be supportive for testing RTX epidural administration in other advanced non-cancer disease related unmet clinical needs (with a choice of starting dose at 15 or 25 ug depending on the indication considered).

Results as planned in the original study (to 15 ug) are being presented at the American Academy of Pain Medicine Annual Meeting on February 27, 2020.

The Phase 1b open-label study was used for dose escalation to assess the safety and preliminary efficacy of a single epidural administration of resiniferatoxin for the treatment of intractable pain due to cancer. Initial expectations for safety and efficacy have been met for the Phase 1b study, though optimal dose selection will follow assessment of the additional dose group in which 25 ug is also being evaluated. Thus far, after Institutional Review Board approval was obtained, and with oversight by an independent data monitoring committee, data is available from 14 subjects with intractable cancer-related pain who received a single epidural injection of RTX from 0.4 to 15 ug.

Safety Outcomes

No dose limiting toxicities or notable adverse events unrelated to progression of underlying disease were encountered for any of the subjects. The most common treatment-related adverse event was transient post-procedural pain: 7 of 14 subjects (50%) reported moderate severity. Two additional treatment-related adverse events of moderate severity were back pain and increase in blood pressure in a patient. All events resolved in less than two days following drug administration.

Efficacy Outcomes

The ongoing trial will follow subjects for at least 84 days. The lower doses of 0.4, 1.0, 2.0, 4.0 ug did not demonstrate notable pain relief, but permitted dose escalation to the next designated dose level based on how well the drug was tolerated.

Three patients had marked pain relief starting shortly after initial administration that were still observed weeks after treatment: 1 of 3 subjects who received 8 ug (a 58-year-old woman with gastrointestinal stromal cancer with severe lower back pain reported a decrease in numerical pain rating scale (NPRS) scores from >6/10 to 2/10), and 2 of 3 subjects who received 15 ug (a 62-year-old man with rectal cancer noted significant improvement in pain, physical strength, mood, and appetite with NPRS scores reduced from 7-8/10 to 3/10; and a 57-year-old man with multiple myeloma and severe pain in his back, hips, and lower extremities subsequently reported mild pain in the target areas after RTX injection). Improvement in pain and mobility within 24 hours of dosing in the three responders at the higher dose levels of RTX suggests the clinical potential of the drug for intractable cancer pain.

Sorrento intends to present the detailed results of the completed study upon completion of the additional expansion cohort later this year. A pivotal Phase 3 trial is being planned using epidural RTX for severe pain states associated with advanced disease.

"We are encouraged by the benefits of using RTX to treat intractable pain in patients with metastatic cancer," said Associate Professor of Anesthesia, Srdjan S. Nedeljkovic, M.D. from the Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women’s Hospital at Harvard Medical School. "Even in patients with high levels of pain, RTX given via an epidural injection has been found to reduce pain intensity without having any long-term adverse safety consequences. The addition of RTX to existing cancer pain therapies represents a positive step forward in improving the care of patients with intractable cancer pain and offers the hope of enhancing the overall quality of life experienced by this population."

For access to the scientific presentation (AAPM poster) please visit
View Source

About Resiniferatoxin (RTX)

A thousand times "hotter" than pure capsaicin (16 Billion Scoville units versus 16M), and with a high affinity for afferent pain nerves, resiniferatoxin binds to TRPV1 receptors and selectively ablates the nerve endings responsible for pain signals experienced by patients1. Delivered peripherally (into the joint space) the transient nerve ending ablation effect can have profound clinical benefits lasting for months to years (as shown in canine studies2).

RTX-001 is a multicenter, open-label dose escalation Phase 1b study to assess the safety and define the maximally tolerated dose of resiniferatoxin administered via the epidural route for the reduction of moderate to severe pain signal intensity associated with advanced cancer. The Phase 1b study is a dose-escalation protocol in which cohorts of patients receive increasing doses of resiniferatoxin until the maximum tolerated dose is achieved. The primary objective of the study is to evaluate the safety of resiniferatoxin and identify the recommended Phase 3 dose. The secondary objective is to assess the preliminary efficacy of resiniferatoxin measured by assessing changes in the intensity of pain using the NPRS score, a widely used proprietary validated pain scale.

RTX is not approved for clinical use by regulatory authorities. Safety and efficacy have not been established.

On February 27, 2020 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, reported financial results and business highlights for the fourth quarter and full year ended December 31, 2019 (Press release, Tocagen, FEB 27, 2020, View Source [SID1234554914]).

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"Following our extensive review of strategic alternatives, we are excited about the recently announced merger between Tocagen and Forte Biosciences. The proposed merger will create a dermatology company with established clinical proof of concept for their lead asset and an anticipated cash runway to reach a data readout in mid-2021 for its planned randomized Phase 2 trial in patients with atopic dermatitis," said Marty J. Duvall, Chief Executive Officer of Tocagen. "We believe that the proposed merger with Forte has the potential to deliver immediate and long-term value and the Forte leadership team has our full support."

Fourth Quarter 2019 Financial Results

Research and Development (R&D) Expenses: R&D expenses were $7.6 million for the quarter ended December 31, 2019, compared to $15.6 million for the quarter ended December 31, 2018. The reduction in R&D expenses was primarily driven by a reduction in manufacturing and clinical development costs due to the completion of our Toca 5 trial in September 2019.

General and Administrative (G&A) Expenses: G&A expenses were $3.1 million for the quarter ended December 31, 2019, compared to $3.5 million for the quarter ended December 31, 2018. The decrease in G&A expenses was primarily due to lower personnel related costs.

Net Loss: Net loss was $10.6 million, or $0.44 per common share (basic and diluted), for the quarter ended December 31, 2019, compared to a net loss of $19.6 million, or $0.96 per common share (basic and diluted), for the quarter ended December 31, 2018. The 2019 calculation is based on 23.9 million average common shares outstanding for the fourth quarter of 2019, compared to 20.5 million average common shares outstanding for the fourth quarter of 2018.

2019 Twelve-Month Results

License Revenue: License revenue was less than $0.1 million for the 12 months ended December 31, 2019, compared to $18.0 million for the 12 months ended December 31, 2018. The 2018 revenue was associated with a $16.0 million upfront payment and a $2.0 million development milestone earned upon

completion of enrollment in the Toca 5 clinical study, both recognized under Tocagen’s license agreement with ApolloBio.

R&D Expenses: R&D expenses were $45.3 million for the 12 months ended December 31, 2019, compared to $51.1 million for the 12 months ended December 31, 2018. The decrease in R&D expenses primarily reflects decreased costs in clinical development and manufacturing related to the wind down and suspension of the Company’s research and development activities.

G&A Expenses: G&A expenses were $16.2 million for the 12 months ended December 31, 2019, compared to $12.8 million for the 12 months ended December 31, 2018, with the increase primarily driven by commercial readiness activities incurred in the first half of 2019 in anticipation of a potential commercial launch following the completion of our Phase III clinical trial. In September 2019, upon missing our primary endpoint in our Toca 5 clinical trial, all commercial readiness activities were discontinued.

Net Loss: Net loss was $63.5 million, or $2.69 per common share (basic and diluted), for the 12 months ended December 31, 2019, compared to a net loss of $49.0 million, or $2.44 per common share (basic and diluted), for the 12 months ended December 31, 2018. The 2019 calculation is based on 23.6 million average common shares outstanding for the 12 months ended December 31, 2019, compared to 20.1 million average common shares outstanding for the prior year.

Cash Position

Cash, cash equivalents and marketable securities were $21.8 million at December 31, 2019 compared to $96.1 million at December 31, 2018.

On February 27, 2020 Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA), reported that it will participate at the following upcoming investor conferences in March 2020 (Press release, Vanda Pharmaceuticals, FEB 27, 2020, View Source [SID1234554933]):

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The Cowen and Company 40th Annual Health Care Conference in Boston on Tuesday, March 3, 2020. A corporate presentation is scheduled for 8:40 a.m. Eastern Time.

The Barclays Global Healthcare Conference in Miami on Wednesday, March 11, 2020. A corporate presentation is scheduled for 11:45 a.m. Eastern Time.

The corporate presentations given at the Cowen and Barclays conferences will be available live on Vanda’s corporate website, where they also will be archived for 30 days. To access the presentations, go to Vanda’s website at www.vandapharma.com and click on the Presentations tab on the Investor Relations page. Please connect to the website several minutes prior to the start of the live presentations.