On November 8, 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 nine months ended September 30, 2019 (Press release, Sutro Biopharma, NOV 8, 2019, View Source [SID1234550763]).

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"In late October 2019, we presented encouraging interim safety data from our Phase 1 trial for STRO-002 at the AACR (Free AACR Whitepaper)-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference, as we further advance our pipeline of product candidates and programs," said Bill Newell, Sutro’s Chief Executive Officer. "STRO-002 is our second proprietary ADC in clinical trials, and one of four ADC clinical product candidates from our platform in the past three years, including those of our collaborators. We believe our proprietary technology allows us to rapidly and precisely create optimally designed, next-generation protein therapeutics candidates for cancer and autoimmune disorders."

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 in June 2019. Safety data with several additional patients was released in an abstract in association with the American Society of Hematology (ASH) (Free ASH Whitepaper) Conference on November 6, 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 presented at the AACR (Free AACR Whitepaper)-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference on October 29, 2019.
STRO-002 was well tolerated in patients with advanced relapsed and refractory ovarian cancer and demonstrated preliminary evidence of anti-tumor activity.
No ocular toxicity has been observed in the trial to date.
Potent anti-tumor activity was seen in preclinical endometrial cancer models.
BCMA ADC Clinical Program

Celgene received FDA clearance on its IND application CC- 99712 targeting B-cell maturation antigen ("BCMA") for the treatment of multiple myeloma in the second quarter of 2019. 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.
Bispecific ADC Clinical Development Candidate

In the third quarter of 2019, Merck KGaA, Darmstadt, Germany designated an undisclosed bispecific ADC as a clinical development candidate with approval to advance to IND-enabling studies, which triggered a financial milestone to be received by Sutro. As part of the agreement, Sutro will manufacture the ADC for the early clinical supply of the candidate and is eligible for further milestones and royalties. Merck KGaA, Darmstadt, Germany will be responsible for drug product, clinical development and commercialization of this clinical development candidate.
Third Quarter 2019 Financial Highlights

Cash, Cash Equivalents and Marketable Securities

As of September 30, 2019, Sutro had cash, cash equivalents and marketable securities of $150.4 million, as compared to $204.5 million as of December 31, 2018, which represents net cash usage of $17.8 million and $54.1 million during the three and nine months ended September 30, 2019, respectively.

Revenue

Revenue was $12.3 million and $31.4 million for the three and nine months ended September 30, 2019, respectively, compared to $7.8 million and $19.3 million for the same periods in 2018. 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 November 7, 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 nine months ended September 30, 2019, were $25.0 million and $72.1 million, respectively, compared to $18.0 million and $53.3 million for the same periods in 2018, including non-cash stock-based compensation of $2.9 million and $0.3 million, and depreciation and amortization expense of $1.2 million and $1.1 million, in the 2019 and 2018 third quarters, respectively. Total operating expenses for third quarter 2019 were comprised of research and development expenses of $16.9 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 November 8, 2019 Alkermes plc (Nasdaq: ALKS) reported new data from the company’s ARTISTRY clinical development program related to ALKS 4230 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 34th Annual Meeting in National Harbor, MD (Press release, Alkermes, NOV 8, 2019, View Source [SID1234550779]). ALKS 4230 is an investigational, engineered fusion protein designed to selectively expand tumor-killing immune cells while avoiding the IL-2-induced activation of immunosuppressive cells by preferentially binding to the intermediate-affinity interleukin-2 (IL-2) receptor complex. The company presented preliminary clinical data from ARTISTRY-1, the ongoing phase 1/2 study investigating ALKS 4230 administered intravenously, as well as study design details and preliminary safety data from ARTISTRY-2, the ongoing phase 1/2 study investigating ALKS 4230 administered subcutaneously. Both studies are evaluating ALKS 4230 as a monotherapy and in combination with pembrolizumab (KEYTRUDA). The posters presented by the company at SITC (Free SITC Whitepaper) and a corporate presentation related to the ALKS 4230 program are available on the Investors section of www.alkermes.com.

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"The early signs of clinical efficacy and safety that we have seen so far with ALKS 4230 as both monotherapy and in combination with pembrolizumab are encouraging, and have been observed in multiple solid tumor types, including in PD-(L)1 inhibitor unapproved indications," said Craig Hopkinson, M.D., Chief Medical Officer and Senior Vice President of Medicines Development and Medical Affairs at Alkermes. "In addition to the preliminary data from ARTISTRY-1, we are making progress in ARTISTRY-2 and are now enrolling the next set of cohorts that will evaluate once-weekly and once-every-three-week dosing regimens. We look forward to presenting data from ARTISTRY-2 at a future medical meeting."

"Despite the introduction of immunotherapies and other innovations in the field of oncology, there remains a high unmet need for new treatments, as many patients are not eligible to receive certain medications such as checkpoint inhibitors, or don’t respond well to such medications," said Ulka N. Vaishampayan, M.D., Professor of Oncology at Wayne State University and Director of the Phase I Program at the Karmanos Cancer Institute. "The emerging data from the ARTISTRY clinical program are encouraging, with ALKS 4230 demonstrating initial signs of clinical benefit and a safety profile that is generally consistent with what is expected with cytokine therapy. Importantly, no evidence of vascular leak syndrome, which is the most significant limitation to currently available IL-2 therapy, has been observed as of October 31st."

The following preliminary safety and efficacy findings from the ARTISTRY-1 monotherapy and combination therapy cohorts are as of Aug. 2, 2019, unless otherwise noted:

Data presented from the ongoing monotherapy dose-escalation stage of ARTISTRY-1 included five completed cohorts, spanning a dose range of 0.1 µg/kg/day to 6 µg/kg/day:

A total of 36 patients with refractory advanced solid tumors were treated.
Consistent with earlier non-clinical findings, treatment with ALKS 4230 selectively expanded natural killer (NK) and CD8+ T cells and had negligible, non-dose-dependent effects on regulatory T cells (Tregs).
ALKS 4230 3 µg/kg/day dose was selected for initial evaluation in combination with pembrolizumab, based on the cell expansion and tolerability profile seen at this dose.
ALKS 4230 6 µg/kg/day dose was identified as the monotherapy recommended phase 2 dose (RP2D) for intravenous administration. Data from this dose demonstrated our targeted tolerability profile, along with the targeted lymphocyte cell expansion without corresponding IL-2-induced Treg activation.
At doses of 3 µg/kg/day and 6 µg/kg/day of ALKS 4230, 8 of 14 patients with evaluable initial scans had stable disease.
This includes one patient in the 6 µg/kg/day group with heavily pretreated pancreatic adenocarcinoma who received monotherapy ALKS 4230 for 10 months, with stable disease maintained for approximately 6 months. Following progressive disease, this patient rolled over to combination therapy with pembrolizumab for 4.5 months.
The most frequently reported adverse events (AEs), regardless of relationship to ALKS 4230, were fever and chills, which are anticipated effects of cytokine administration. No Grade 4 or 5 treatment-related AEs were reported, and no signs of vascular leak syndrome were observed at any dose.
The maximum tolerated dose of monotherapy intravenous ALKS 4230 has not been determined and dose escalation is ongoing.
Data presented from the combination stage of ARTISTRY-1 focused on the cohort of PD-(L)1 inhibitor unapproved tumor types and one monotherapy rollover patient. These patients received the ALKS 4230 3 µg/kg/day dose in combination with pembrolizumab:

26 patients (n=1 monotherapy rollover, n=25 PD-(L)1 inhibitor unapproved tumor types) were treated in the cohort.
12 of the 18 patients with evaluable scans achieved stable disease or better, including:
One patient with ovarian cancer had a confirmed partial response at Cycle 6 and demonstrated complete normalization of her CA-125 (tumor marker) levels at Cycle 4, which continued in the normal range: 282 U/mL (screening) to 12.6 U/mL (Cycle 10). As of Oct. 31, 2019, this patient remains on therapy.
One patient with triple negative breast cancer showed a >50% reduction in target lesion size at Cycle 8. As is common with checkpoint inhibitor treatment, small new lesions developed for this patient at Cycle 2. The decrease in her target lesions and in these small new lesions qualified her for an immune-partial response (iPR) based on iRECIST (Response Evaluation Criteria in Solid Tumors) criteria. As of Oct. 31, 2019, this patient remains on therapy.
The most frequently reported adverse events (AEs), regardless of relationship to ALKS 4230 were fever and chills. No Grade 4 or 5 treatment-related AEs were reported, and no signs of vascular leak syndrome were observed.
In addition to data from ARTISTRY-1, the company also presented a trials-in-progress poster on ARTISTRY-2. The study’s initial dose escalation cohort (n=7) has been completed at the once-weekly 0.3 mg subcutaneous dose of ALKS 4230. Initial signals of tolerability were observed, and no patient discontinued treatment due to AEs.

As of Oct. 31, 2019, 6 of 7 patients from the first cohort remained on therapy. Enrollment in the next two dose escalation cohorts, to evaluate ALKS 4230 0.6 mg once-weekly and ALKS 4230 1.0 mg once-every-three-weeks, is ongoing. The company plans to present data from ARTISTRY-2 at a future medical meeting.

About ALKS 4230
ALKS 4230 is a novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to selectively expand tumor-killing immune cells while avoiding the IL-2-induced activation of immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex. The selectivity of ALKS 4230 is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

About the ARTISTRY Clinical Development Program
ARTISTRY is an Alkermes-sponsored clinical development program evaluating ALKS 4230 in patients with advanced solid tumors. ARTISTRY-1 is an ongoing phase 1/2 study in which ALKS 4230 is administered as an intravenous infusion daily for five consecutive days. ARTISTRY-1 has three distinct stages: an ongoing monotherapy dose-escalation stage, a recently initiated monotherapy expansion stage, and an ongoing combination therapy stage with the PD-1 inhibitor KEYTRUDA (pembrolizumab) in patients with select advanced solid tumors.

ARTISTRY-2 is an ongoing phase 1/2 study of ALKS 4230 administered subcutaneously as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors. ARTISTRY-2 is designed to explore the safety, tolerability and efficacy of ALKS 4230 administered subcutaneously and assess once-weekly and once-every-three-week dosing schedules.

On November 8, 2019 Precision BioSciences presented the corporate presentation (Presentation, Precision Biosciences, NOV 8, 2019, View Source [SID1234550929]).

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On November 8, 2019, Corvus Pharmaceuticals, Inc. (the "Company") reported that it entered into an exchange agreement (the "Exchange Agreement") with entities affiliated with Biotechnology Value Fund, L.P. (the "Exchanging Stockholders"), pursuant to which the Company exchanged an aggregate of 10044135 shares of the Company’s common stock, par value $0.0001 per share (the "Common Stock"), owned by the Exchanging Stockholders for warrants (the "Exchange Warrants") to purchase an aggregate of 1,458,000 shares of common stock (subject to adjustment in the event of stock splits, recapitalizations and other similar events affecting common stock), with an exercise price of $0.0001 per share (Filing, 8-K, Corvus Pharmaceuticals, NOV 8, 2019, View Source [SID1234550945]). The Exchange Warrants will expire ten years from the date of issuance. The Exchange Warrants are exercisable at any time prior to expiration except that the Exchange Warrants cannot be exercised by the Exchanging Stockholders if, after giving effect thereto, the Exchanging Stockholders would beneficially own more than 9.99% of Common Stock, subject to certain exceptions. The holders of the Exchange Warrants will not have the right to vote on any matter except to the extent required by Delaware law. The Exchange Warrants were issued without registration under the Securities Act of 1933, as amended (the "Securities Act"), in reliance on the exemption from registration contained in Section 3(a)(9) of the Securities Act.

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The description of the Exchange Agreement and the Exchange Warrant are not complete and are qualified in their entirety by reference to the Exchange Agreement and the form of Exchange Warrant, which are filed as Exhibit 10.1 and Exhibit 4.1, respectively, to this Current Report on Form 8-K and incorporated herein by reference. The representations, warranties and covenants made by the Company in the Exchange Agreement and the Exchange Warrant were made solely for the benefit of the parties to the Exchange Agreement and the Exchange Warrant, as applicable, including, in some cases, for the purpose of allocating risk among the parties thereto, and should not be deemed to be a representation, warranty or covenant to investors. Moreover, such representations, warranties or covenants were made as of an earlier date. Accordingly, such representations, warranties and covenants should not be relied on as accurately representing the current state of our affairs.

On November 8, 2019 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), an immunology company developing treatments that harness the patient’s innate immune system to fight disease, reported its financial results for the third quarter ended September 30, 2019 and is providing a business update (Press release, INmune Bio, NOV 8, 2019, View Source [SID1234551121]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Q3 2019 and Recent Highlights:

·Launched NeuLiv(TM) program for the treatment of NASH
.Presented data related to lead compound XPro1595 at the Society for Neuroscience’s annual meeting
·Announced a potential link between obesity and Alzheimer’s Disease at the Society for Neuroscience 49th annual meeting: Dr. Malú Tansey’s new data was highlighted at the corresponding press conference
·Announced USPTO Allowance of Key Patent Covering the Company’s DN-TNF Platform Technology for Treating Cancer
·Presented XPro1595 for Treating Neuroinflammation in Alzheimer’s Disease at 2019 Alzheimer’s Association International Conference (AAIC) Satellite Symposium
·Invited to present at industry meetings in the US and EU including Targeting Innate Immunity Congress, Inflammasome Therapeutics Summit and Markets&Markets Next Gen Immuno-Oncology Congress
"During the quarter we advanced our existing programs and expanded our pipeline of therapies reprograming the innate immune system to fight disease," stated RJ Tesi, M.D., Chief Executive Officer of INmune Bio. "For our existing pipeline, we are looking to the up-coming Phase II trials for INB03 and Phase 1 trials of INKmune(TM) in Cancer and XPro1595 for Alzheimer’s Disease. Also, we expanded our pipeline with the launch of our NeuLiv(TM) program for the treatment of NASH which we expect to start a Phase 2a trial next year. Looking ahead, the team at INmune Bio is focused on executing against our upcoming milestones to maximize shareholder value."

Upcoming Milestones:

·4Q19 – First patient enrolled XPro1595 Alzheimer’s Disease trial
·1H20 – Initiate INB03 Phase II cancer trial
·2H20 – Initiate NeuLiv(TM) Phase IIa trial in NASH
·2H20 – First patient enrolled INKmune(TM) cancer trial
·2H20 – Phase I data on Alzheimer’s Disease XPro1595 AD data
·Financial Results for the Third Quarter Ended September 30, 2019:
Net loss attributable to common stockholders for the third quarter ended September 30, 2019 was $3.1 million, compared to $1.5 million for the quarter ended September 30, 2018.

Research and development expense totaled approximately $1.2 million for the third quarter ended September 30, 2019, compared with approximately $0.7 million for the quarter ended September 30, 2018. Research and development expenses increased during the three months ended September 30, 2019 as a result of the further advancement of our drug platforms.

General and administrative expense was approximately $1.9 million in the quarter ended September 30, 2019, compared to approximately $0.9 million in the quarter ended September 30, 2018. The $1.0 million increase in general and administrative expense is largely due to costs associated with being a public company.

At September 30, 2019, the Company had cash and cash equivalents of approximately $7.4 million with no debt. During October 2019, the Company received $0.4 million of cash proceeds from Australia pursuant to a research and development tax credit.

As of November 8, 2019, the Company had 10.8 million common and 13.9 million fully diluted shares outstanding.