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INmune Bio, Inc. Reports Third Quarter 2019 Financial Results and Provides Shareholder Update

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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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.

Entry into a Material Definitive Agreement.

On November 8, 2019, UroGen Pharma Ltd. (the "Company") reported that it has entered into a license agreement (the "License Agreement") with Agenus Inc. ("Agenus"), pursuant to which Agenus granted to the Company an exclusive, worldwide (not including Argentina, Brazil, Chile, Colombia, Peru, Venezuela and their respective territories and possessions), royalty-bearing, sublicenseable license under Agenus’s intellectual property rights to develop, make, use, sell, import, and otherwise commercialize products incorporating a proprietary antibody of Agenus known as AGEN1884 for the treatment of cancers of the urinary tract via intravesical delivery (Filing, 8-K, UroGen Pharma, NOV 8, 2019, View Source [SID1234551040]). AGEN1884 is an anti-CTLA-4 antagonist that is currently being evaluated by Agenus as a monotherapy in PD-1 refractory patients and in combination with Agenus’ anti-PD-1 antibody in solid tumors. Initially, the Company plans to develop AGEN1884 in combination with UGN-201 for the treatment of high-grade non-muscle invasive bladder cancer.

Pursuant to the License Agreement, the Company paid Agenus an upfront fee of $10.0 million and has agreed to pay Agenus up to $115.0 million upon achieving certain clinical development and regulatory milestones, up to $85.0 million upon achieving certain commercial milestones, and royalties on net sales of licensed products in the 14%-20% range. The Company will be responsible for all development and commercialization activities. Under the terms of the License Agreement, Agenus has agreed to use commercially reasonable efforts to supply AGEN1884 to the Company for use in preclinical studies or clinical trials.

Unless earlier terminated in accordance with the terms of the License Agreement, the License Agreement will expire on a product-by-product and country-by-country basis at the later of (a) the expiration of the last to expire valid claim of a licensed patent right that covers the licensed product in such country or (b) 15 years after the first commercial sale of the licensed product in such country. The Company may terminate the License Agreement for convenience upon 180 days’ written notice to Agenus. Either party may terminate the License Agreement upon 60 days’ notice to the other party if, prior to the first commercial sale of a licensed product, the Company substantially ceases to conduct development activities of the licensed products for 12 consecutive months (and during such period, Agenus has complied with its obligations under the License Agreement) other than in response to a requirement of an applicable regulatory authority or an event outside of the Company’s control. In addition, either party may terminate the License Agreement in the event of an uncured material breach of the other party.

IMMUTEP PRESENTS POSITIVE INTERIM DATA FROM PHASE II TACTI-002 TRIAL AT SITC

On November 8, 2019 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported positive interim data from its open label TACTI-002 Phase II clinical trial, building on the first top line data reported on 26 September 2019 (Press release, Immutep, NOV 8, 2019, View Source [SID1234551037]). The data is being presented today at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) by principal investigator, Dr. Julio Antonio Peguero, MD of Oncology Consultants in Texas.

TACTI-002 is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada). It is evaluating the combination of Immutep’s lead product candidate eftilagimod alpha ("efti" or "IMP321") with MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in up to 109 patients with non-small cell lung cancer (NSCLC) in first and second line or second line head and neck squamous cell carcinoma (HNSCC).

TACTI-002 is an all comer study in terms of PD-L1 status determined by their Tumor Proportion Score (TPS), meaning patients were eligible to participate regardless of their PD-L1 status TPS which ranges from < 1%; 1-49% and ³50%. PD-L1 status TPS is a well-known predictive marker for response to pembrolizumab in first line NSCLC.

As of the data cutoff date of 16 October 2019, the results are:

1 Previously referred to as "cohort 1"

As of the data cutoff date, the ORR for patients in of Part A stage 1 was 41%. In total 13 patients (76.5%) had a reduction in target lesions. As announced in September, in 13 out of 17 patients tumours stopped growing (according to iRECIST), including seven patients with a partial response (41%), and six with stabilisation of disease (35%). This indicates a disease control rate (DCR) of 76.5%.

Patients have been participating in the study between 0.7 and 7.4 months with a median follow-up of 5.6 months for now. None of the responding patients (7/17) have shown disease progression so far and 12 patients are continuing treatment with median PFS not yet reached.

Immutep CSO and CMO, Dr Frederic Triebel said: "It’s exciting to see that median PFS has not yet been reached in stage 1 of Part A, with nine patients already on trial for more than 24 weeks. Also, the 41% response rate compares favorably to other standard of care treatments available for NSCLC first-line patients, specifically single agent pembrolizumab or doublet chemotherapy. As treatment continues, we are hopeful that patients with this highly aggressive tumour will continue to benefit from the combination therapy, irrespective of their PD-L1 status even though some patients are just at an earlier stage of treatment."

Comparison to other therapies

The TACTI-002 ORR of 41% is higher than would be expected from a PD-L1 all comer (where patients have a range low to high PD-L1 TPS expression) trial of pembrolizumab given that PD-L1 expression TPS is predictive for response to pembrolizumab (the higher the better). Typical ORR of pembrolizumab alone for patients with high (TPS ³ 50%) PD-L1 expression in the tumour, is 39%. For patients with TPS ³ 1% PD-L1 expression in the tumour the reported ORR is 27.2%. For pembrolizumab alone in patients with 1-49% PD-L1 the reported ORR is 16.7%.2

The TACTI-002 ORR is also higher than would be expected with a doublet chemotherapy regimen where typically response rates of around 26% are reported.3

Safety Results and Next Steps

Safety results across all Parts (A, B and C) is excellent, with no new safety signals being observed, confirming previous results in the TACTI-mel trial.

Immutep has now commenced the recruitment of an additional 19 patients with first line NSCLC, known as stage 2 of Part A. This follows the Data Monitoring Committee’s decision based on its review of preliminary safety and efficacy data. Recruitment is ongoing for Part B (second line NSCLC) with 8 out of 23 patients recruited and Part C (second line HNSCC) with 14 out of 18 patients recruited and showing encouraging early signs of efficacy. The staged approach to patient enrolment is based on the Simon’s two-stage clinical trial design.

The Company expects to report more mature data from TACTI-002 in Q1 of 2020.

2 KN042

3 KN189; CM227 trials

The SITC (Free SITC Whitepaper) poster presentation of the TACTI-002 interim data summarised above is available on our website at View Source

About TACTI-002

TACTI-002 (Two ACTive Immunotherapies) is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada). The study is evaluating the combination of Immutep’s lead product candidate eftilagimod alpha ("efti" or "IMP321") with MSD’s KEYTRUDA (or pembrolizumab, an anti-PD-1 therapy) in up to 109 patients with second line head and neck squamous cell carcinoma or non-small cell lung cancer in first and second line. The trial is a Phase II, Simon’s two-stage, non-comparative, open-label, single-arm, multicentre clinical study that is taking place in up to 13 study centres across the U.S., Europe and Australia.

Entry into a Material Definitive Agreement.

On November 8, 2019, Humanigen, Inc. (the "Company") reported that it has entered into a purchase agreement (the "Purchase Agreement") and a registration rights agreement (the "Registration Rights Agreement") with Lincoln Park Capital Fund, LLC ("LPC"), pursuant to which the Company has the right to sell to LPC up to $20,000,000 in shares of the Company’s common stock, $0.001 par value per share (the "Common Stock"), subject to certain limitations and conditions set forth in the Purchase Agreement (Filing, 8-K, Humanigen, NOV 8, 2019, View Source [SID1234551036]).

Under the Purchase Agreement, the Company has the right, from time to time at its sole discretion and subject to certain conditions, to direct LPC to purchase up to 100,000 shares of Common Stock, with such amounts increasing based on certain threshold prices but not to exceed $750,000 in total proceeds on any purchase date. The purchase price of shares of Common Stock pursuant to the Purchase Agreement will be based on the market prices of the Common Stock at the time of such purchases as set forth in the Purchase Agreement. Such sales of Common Stock by the Company, if any, may occur from time to time, at the Company’s option, over the 36-month period commencing on the date that a registration statement, which the Company agreed to file with the Securities and Exchange Commission (the "SEC") pursuant to the Registration Rights Agreement, is declared effective by the SEC and a final prospectus in connection therewith is filed and the other terms and conditions of the Purchase Agreement are satisfied.

In addition to regular purchases, as described above, the Company may also direct LPC to purchase additional amounts as accelerated purchases if the closing sale price of the Common Stock is not below certain threshold prices, as set forth in the Purchase Agreement. In all instances, the Company may not sell shares of its Common Stock to LPC under the Purchase Agreement if it would result in LPC beneficially owning more than 4.99% of the Common Stock then outstanding.

LPC represented to the Company, among other things, that it was an "accredited investor" (as such term is defined in Rule 501(a) of Regulation D under the Securities Act of 1933, as amended (the "Securities Act")), and the Company sold the securities to LPC pursuant to the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) of, and Regulation D under, the Securities Act.

The Purchase Agreement and the Registration Rights Agreement contain customary representations, warranties, agreements and conditions to completing future sale transactions, indemnification rights and obligations of the parties. The Company has the right to terminate the Purchase Agreement at any time, at no cost or penalty. During any "event of default" under the Purchase Agreement, all of which are outside of LPC’s control, LPC does not have the right to terminate the Purchase Agreement; however, the Company may not initiate any regular or other sale of shares to LPC until such event of default is cured.

Actual sales of shares of Common Stock to LPC under the Purchase Agreement will depend on a variety of factors to be determined by the Company from time to time, including, among others, market conditions, the trading price of the Common Stock and determinations by the Company as to the appropriate sources of funding for the Company and its operations. In consideration for entering in the Purchase Agreement, the Company has agreed to pay to LPC a commitment fee in shares of Common Stock. The Company will not receive any cash proceeds from the issuance of these shares.

The net proceeds under the Purchase Agreement to the Company will depend on the frequency and prices at which the Company sells shares of its stock to LPC. The Company expects that any proceeds received by the Company from such sales to LPC will be used for working capital and general corporate purposes.

This current report on Form 8-K shall not constitute an offer to sell or a solicitation of an offer to buy any shares of Common Stock, nor shall there be any sale of shares of Common Stock in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

Entry into a Material Definitive Agreement

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.

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.