On August 14, 2019 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of novel cancer therapies, reported the pricing of an underwritten public offering of 6,750,000 shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) and warrants to purchase up to an aggregate of 6,750,000 shares of common stock (Press release, DelMar Pharmaceuticals, AUG 14, 2019, View Source [SID1234538723]). Each share of common stock (or pre-funded warrant) is being sold together with one warrant to purchase one share of common stock at a combined effective price to the public of $1.00 per share and accompanying warrant. Gross proceeds, before underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $6.8 million.

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The warrants will be immediately exercisable at a price of $1.00 per share of common stock and will expire five years from the date of issuance. The shares of common stock (or pre-funded warrants) and the accompanying warrants, can only be purchased together in the offering, but will be issued separately and will be immediately separable upon issuance. The offering is expected to close on or about August 16, 2019, subject to customary closing conditions.

Maxim Group LLC is acting as the book-running manager and Dawson James Securities, Inc. is acting as a co-manager in connection with the offering.

DelMar has granted the underwriters a 45-day option to purchase up to an additional 1,012,500 shares of common stock and/or warrants to purchase up to 1,012,500 shares of common stock, at the public offering price less discounts and commissions.

The Securities and Exchange Commission (the "SEC") declared effective a registration statement on Form S-1 (File No. 333-232931) relating to these securities on August 14, 2019. A final prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at View Source The offering is being made only by means of a prospectus forming part of the effective registration statement. Electronic copies of the prospectus relating to this offering, when available, may be obtained from Maxim Group LLC, 405 Lexington Avenue, 2nd Floor, New York, NY 10174, at (212) 895-3745. Before investing in this offering, interested parties should read in their entirety the registration statement that the Company has filed with the SEC, which provides additional information about the Company and this offering.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor may there be any sale of these securities 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 jurisdiction.

On August 14, 2019 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended June 30, 2019 (Press release, Cel-Sci, AUG 14, 2019, View Source [SID1234538742]). The Company also reported key clinical and corporate developments achieved during the quarter.

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Clinical and Corporate Developments included:

CEL-SCI’s Phase 3 head and neck cancer study continued to follow all 928 patients who were enrolled. The Company is now awaiting final study results. All that remains to be done in this pivotal Phase 3 study, the largest in the world in head and neck cancer, is to continue to track patient survival until it can be determined if the primary endpoint of the study, a 10% improvement in overall survival of the Multikine* treatment regimen plus Standard of Care (SOC) vs. SOC alone will be met. The primary endpoint will be determined after a total of 298 events (deaths) have occurred in the two main comparator arms of the study and have been recorded in the study database. These final results could be available soon since the last cancer patients were treated in September 2016, and the first cancer patients in the study were treated in early 2011.
On May 11, 2019 and July 3, 2019, new data was presented on CEL-SCI’s experimental LEAPS therapeutic antigen-specific treatment for rheumatoid arthritis. The work was performed in conjunction with researchers at Rush University Medical Center, Chicago, Illinois.
On June 3-6, 2019, CEL-SCI was an exhibitor and showcased its presentation at the BIO International Convention. CEL-SCI was selected to be part of the Innovation Zone sponsored by the U.S. National Institutes of Health (NIH). The focus was the Company’s experimental LEAPS platform technology and CEL-SCI’s ongoing development of a LEAPS based therapeutic antigen-specific treatment for rheumatoid arthritis. The NIH has funded research studies for CEL-SCI’s LEAPS technology in the treatment of rheumatoid arthritis through a $1.5 million grant. There was a lot of corporate interest in the LEAPS technology for rheumatoid arthritis.
On June 28, 2019, CEL-SCI joined the broad-market Russell 3000 Index that was effective after the US market opened on July 1, 2019.
Following this quarter, between July 1, 2019 and August 13, 2019, the Company received over $2.5 million through the exercise of warrants to purchase shares of the Company’s common stock.
"We look forward to the readout of our Phase 3 data, as we believe Multikine immunotherapy may increase the success rate of the first ‘intent to cure’ cancer treatment regimen by adding the tumor cell killing ability of the still healthy immune system to the known anti-tumor effects of surgery, radiation and chemotherapy. Multikine is unique in cancer immunotherapy because it can potentially be effective when administered for just three weeks, right after diagnosis and prior to surgery, as compared to other immuno-oncology drugs on the market today that are used to treat people with recurrent cancer, or end stage disease," stated CEL-SCI CEO, Geert Kersten. "Our experimental LEAPS vaccine platform continues to show promise as we continue IND-enabling studies in conjunction with the NIH."

CEL-SCI reported a net loss of $17.3 million for the nine months ended June 30, 2019 versus a net loss of $16.9 million for the nine months ended June 30, 2018. The net loss increase was in large part due to the change in value of the non-cash derivative instruments that were caused mainly by fluctuation in the share price of the Company’s common stock.

During the three months ended June 30, 2019, the Company’s cash increased by approximately $4.0 million, as compared to the second quarter of fiscal 2019, to $9.5 million. Significant components of this increase included net proceeds from the exercise of warrant and stock options of approximately $8.4 million and the purchase of common stock by officers and directors of approximately $0.2 million. The increase was offset by net cash used to fund the Company’s regular operations, including its Phase 3 clinical trial, of approximately $4.6 million.

On August 14, 2019 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported financial results and corporate updates for the first half of 2019 (Press release, Evotec, AUG 14, 2019, View Source;announcements/press-releases/p/evotec-se-reports-first-half-year-2019-results-and-corporate-updates-5843 [SID1234538724]).

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STRONG FINANCIAL PERFORMANCE
Group revenues up 16% to € 207.1 m (H1 2018: € 178.9 m)
Adjusted Group EBITDA up 51% to € 58.2 m (H1 2018: € 38.6 m)
Unpartnered R&D expenses of € 18.7 m (H1 2018: € 10.0 m)
Strong liquidity position of € 341.8 m (31 December 2018: € 149.4 m) following issue of € 250 m promissory note (Schuldschein) and final repayment of € 140 m acquisition bridge facility
STRONG OPERATIONAL PERFORMANCE
Strong performance across all business lines and important milestone achievements; multiple new and extended drug discovery and development agreements with Pharma, biotech, and foundations
Very important progress in co-owned clinical pipeline; P2x3 antagonist shows positive proof-of-concept results in Phase II Bayer trial in chronic cough (after period-end); very good progress in multiple other co-owned clinical, pre-clinical and discovery projects; termination of SGM-1019 programme by partner Second Genome and full impairment – all rights returned back to Evotec
Good progress and multiple new partnership agreements in EVT Innovate, and good progress in building infectious diseases footprint
Continued focus on expansion of iPSC platform: Acquisition of IP portfolio, iPSC-based products and experienced stem cell team from Ncardia AG (after period-end)
New academic BRIDGE LAB10x and progress in existing BRIDGE initiatives; equity participation (Eternygen); formation of spin-off company Breakpoint Therapeutics GmbH focused on DNA damage response (after period-end)
IMPORTANT STRATEGIC BUSINESS EXPANSION
Strategic expansion into biologics space through closing of the acquisition of Seattle-based Just.Bio – Evotec Biologics effective 02 July 2019
CORPORATE
Extension of Management Board contracts, election of new Supervisory Board
Conversion of the Company into European Company (SE)
FINANCIAL GUIDANCE 2019 INCREASED
Strong underlying business outlook and integration of Just.Bio – Evotec Biologics revenues support the increase of revenue and EBITDA guidance
Group revenues from contracts with customers without revenues from recharges are expected to increase by approx. 15% (previously: approx. 10%) (2018: € 364.0 m)
Adjusted Group EBITDA is expected to increase by >10% (previously: approx. 10%) (2018: € 92.0 m)
Guidance on unpartnered R&D expenses remains unchanged at € 30-40 m (2018: € 22.9 m)

1. STRONG FINANCIAL PERFORMANCE

In H1 2019, Evotec’s Group revenues significantly increased by 16% to € 207.1 m (H1 2018: € 178.9 m). This increase was driven primarily by the very strong performance in the base business across all business lines as well as higher milestone and licence revenues, also supported by favourable FX rates. Total revenues from milestones, upfronts and licences significantly increased to € 19.1 m in comparison to the previous year (H1 2018: € 15.5 m) and included, amongst others, payments from Bayer, Boehringer Ingelheim, and Celgene.

The gross margin in the first half of 2019 amounted to 30.8% (H1 2018: 28.1%). This increase in margin compared to 2018 reflects significant milestone and licence contributions and good margins in the base business.

Evotec focused its unpartnered R&D expenses of € 18.7 m primarily on internal initiatives in the fields of metabolic diseases, oncology, and neurology as well as academic BRIDGE initiatives in the first half of 2019. Its partnered R&D expenses of € 10.6 m on its infectious disease portfolio were fully reimbursed under other operating income by its partner Sanofi. This split into unpartnered and partnered R&D expenses had not been applied in H1 2018, where total R&D expenses of € 10.0 m were recorded compared to € 29.3 m in the reporting period.

The Group’s selling, general and administrative ("SG&A") expenses increased subproportionately by 10% to € 29.9 m (H1 2018: € 27.1 m) in the first half of 2019. This increase primarily reflects expenses of Evotec ID (Lyon) for six months as well as an increase in headcount in response to overall Company growth and transaction-related expenses.

In the first six months of 2019, impairments of intangible assets and goodwill of € 11.9 m were recorded (H1 2018: impairment of intangible assets of € 4.2 m). The SGM-1019 programme was fully impaired (€ 10.3 m) as the project was discontinued by Evotec’s partner Second Genome. This impairment of intangible assets in addition triggered a goodwill impairment of € 1.3 m of the cash-generating unit Evotec (US) Innovate. All rights of the underlying asset will be returned to Evotec.

The significant increase in the adjusted Group EBITDA in H1 2019 to € 58.2 m (H1 2018: € 38.6 m) resulted mainly from the very strong performance in the base business, considerably higher milestone and licence contributions, and effects from the first-time application of the new accounting standard IFRS 16 (+€ 6.4 m), yielding an adjusted EBITDA margin of 28.1% (H1 2018: 21.6%).

Evotec’s operating result increased to € 24.0 m in H1 2019 (H1 2018: € 21.7 m) being positively impacted by reimbursed R&D expenses from Sanofi and R&D tax credits. The Company’s net result in H1 2019 amounted to € 10.7 m (H1 2018: € 17.9 m) and was affected by the one-off effect of the impairments on intangible assets and goodwill as well as tax expenses in the first half of 2019.

Evotec ended H1 2019 with a strong liquidity of € 341.8 m (31 December 2018: € 149.4 m), which was composed of cash and cash equivalents (€ 322.3 m) and investments (€ 19.5 m). In the first half of 2019, liquidity was primarily affected by the completion of the repayment of the € 140 m debt bridge facility drawn down in context of the acquisition of Aptuit in August 2017, the successful issue of the Company’s debut promissory note (Schuldschein) worth € 249.1 m, net, at very attractive interest rates of below 1.5%, as well as new bank loan agreements and the draw-down of another tranche of the European Investment Bank R&D loan.

2. STRONG OPERATIONAL PERFORMANCE – EVT EXECUTE & EVT INNOVATE
The EVT Execute segment continued its strong progress of previous quarters in the first half of 2019. Evotec signed multiple new (e.g. Astex, Exscientia, Yale) and extended (e.g. Dermira, Enterprise Therapeutics, Fibrocor, STORM Therapeutics) drug discovery and development agreements and recorded milestone achievements in the first half of 2019, such as in the chronic cough alliance with Bayer and the pain alliance with Boehringer Ingelheim, contributing to the strong performance of this segment. All business lines recorded a very strong performance in the first half of 2019 and efficiency and quality improvement initiatives continued to be undertaken at various sites.

EVT Innovate again recorded the acceleration of first-in-class science across various ventures in H1 2019. Existing co-owned clinical, pre-clinical and discovery pipeline projects continued to record strong progress in the first half of 2019 (e.g. Phase II start in Carrick alliance, initiation of toxicology testing with lead compound in Evotec/Exscientia alliance). After period-end, Evotec was notified by its partner Bayer about positive Phase II proof-of-concept results with a P2X3 antagonist for the treatment of chronic cough. However, the SGM-1019 programme with Second Genome was terminated in H1 2019, triggering a full impairment of this programme and all rights of the underlying asset will be returned to Evotec. New agreements were signed in the first half of 2019, e.g. with Galapagos, Indivumed, and The Mark Foundation. In addition, Evotec continued to broaden its infectious disease footprint and entered into new alliances with GARDP, GNA NOW (after period-end), Helmholtz Centre for Infection Research, and The Bill & Melinda Gates Foundation.

Regarding its strong focus on its iPSC research, Evotec continued to invest in the further development of its iPSC platform to prepare internal projects for future partnering and achieved further important progress in its iPSC-based Celgene alliance. Furthermore, after period-end and effective 01 July 2019, Evotec acquired certain assets from the stem cell company Ncardia AG to advance its iPSC platform, including intellectual property relevant for iPSC-based phenotypic drug discovery, an existing cellular product business around iPSC-derived cells, as well as a strong team of 15 stem cell biology experts operating from laboratories at the BioCampus Cologne.

Furthermore, Evotec’s BRIDGE model gained even more momentum in H1 2019 with the initiation of the Digital BRIDGE LAB10x with Sensyne Health plc, the University of Oxford, Oxford University Innovation Ltd, and Oxford Sciences Innovation and further projects being selected in its existing BRIDGE initiative LAB150. Following its strategy of spinning-off promising assets into virtual biotech companies, Evotec spun off Breakpoint Therapeutics GmbH with a VC consortium (total volume of € 30 m in series A funding round) shortly after period-end. This new company focuses on the further development of Evotec’s DNA damage response portfolio, comprising discovery-stage assets and drug targets that promise broad therapeutic application in a variety of cancers. Evotec holds below 50% of the company. In the first half of 2019, Evotec also participated in a further financing round of its portfolio company Eternygen.

3. IMPORTANT STRATEGIC BUSINESS EXPANSION
Effective 02 July 2019 (after period-end), Evotec closed the transaction to acquire Just Biotherapeutics (Just.Bio – Evotec Biologics), which had been signed on 20 May 2019. The Seattle site is currently being integrated into Evotec’s global offering, strengthening Evotec’s multimodality approach to R&D by adding biologics to its current offering in small molecules and cell therapy.

4. CORPORATE
EXTENSION OF MANAGEMENT BOARD CONTRACTS, ELECTION OF NEW SUPERVISORY BOARD

In the first half of 2019, the Supervisory Board extended the existing contracts with the Management Board members Dr Cord Dohrmann (CSO) for a term of five years and Enno Spillner (CFO) for a term of three years. Furthermore, Evotec’s shareholders at the Annual General Meeting 2019 elected a new Supervisory Board for a term of five years. The existing members Prof. Dr Wolfgang Plischke (Chairman), Prof. Dr Iris Löw-Friedrich (Vice Chairman), Dr Michael Shalmi and Dr Elaine Sullivan were re-elected. Dr Mario Polywka, Evotec’s COO until 31 December 2018, and Roland Sackers, CFO and Managing Director of QIAGEN N.V., were elected as new members of the Supervisory Board.

CONVERSION OF THE COMPANY INTO EUROPEAN COMPANY (SE)

Effective 29 March 2019, Evotec completed its conversion into a company under European law (Societas Europaea, "SE") with its registration in the commercial register.

5. FINANCIAL GUIDANCE 2019 INCREASED
The strong underlying business outlook and the integration of Just.Bio – Evotec Biologics revenues support the increase of revenue and EBITDA guidance.

Webcast/Conference Call
The Company is going to hold a conference call to discuss the results as well as to provide an update on its performance. The conference call will be held in English.

Conference call details

Date: Wednesday, 14 August 2019

Time: 02.00 pm CEST (08.00 am EDT, 01.00 pm BST)

From Germany: +49 69 201 744 220

From France: +33 170 709 502

From Italy: +39 02 3600 6663

From the UK: +44 20 3009 2470

From the USA: +1 877 423 0830

Access Code: 37215683#

A simultaneous slide presentation for participants dialling in via phone is available at View Source

On August 14, 2019 Cardax, Inc. (OTCQB:CDXI) reported filed its Quarterly Report on Form 10-Q for the quarter ended June 30, 2019 (Press release, Cardax Pharmaceuticals, AUG 14, 2019, View Source [SID1234538743]).

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Recent developments include:

CHASE Clinical Trial Update

Cardax plans a pre-specified interim review in September 2019 of the aggregate data by treatment group from its CHASE human clinical trial. The CHASE trial is evaluating the effect of ZanthoSyn on cardiovascular inflammatory health, as measured by C-Reactive Protein or "CRP," as a primary endpoint. Other data collected includes secondary inflammatory health markers as well as safety parameters. Positive results could not only support ZanthoSyn marketing but serve as an important proof-of-concept for the Company’s pharmaceutical program and provide additional intellectual property protection.

Interim Financing Update

Cardax also announced today that it raised $1,675,000 in additional capital since the beginning of Q2 2019 ($750,000 in Q2 2019 and $925,000 in Q3 2019 to date), using a combination of convertible notes, equity units (stock and warrants), and loans, the proceeds of which are being used for general corporate purposes.

ZanthoSyn Update

As reported previously, in Q1 2019 retail "sell-through," defined as retail sales of ZanthoSyn to customers at General Nutrition Corporation ("GNC") stores, surpassed all previous periods and Q2 2019 continued at strong levels as the third best performing quarter since launch. In addition, ZanthoSyn is the top-selling product nationwide in GNC’s antioxidant category for 2019 year-to-date as well as the top-selling overall product in GNC’s Hawaii stores. Notwithstanding, GNC continued to trim the inventory sell-in substantially in Q2 2019. "Sell-in" is defined as wholesale orders of ZanthoSyn by GNC less sales incentives, promotions, discounts, and refunds. As a result, Cardax net revenues were $45,391 and $210,363 for the 3 and 6 months ended June 30, 2019 compared to $272,049 and $585,359 for the 3 and 6 months ended June 30, 2018.

While ZanthoSyn sell-in to GNC in Q3 2019 to date has already exceeded the total Q2 2019 sell-in, Cardax provided notice to GNC that its "U.S. brick-and-mortar retail store" exclusivity contract with GNC for ZanthoSyn would not automatically renew in October 2019. Cardax may expand ZanthoSyn distribution to mass market retailers, other specialty nutrition stores, pharmacies, and other retailers.

Cardax plans to expand its direct-to-consumer e-commerce efforts by capitalizing on one of the most important lessons learned from its sales and marketing program: "Conversations Create Customers." Whether at GNC stores, directly with Cardax personnel, or at conferences for healthcare professionals, thousands of ZanthoSyn customers have been created by understanding and experiencing the benefits of ZanthoSyn firsthand. Cardax plans to implement strategies that it believes may create a similar customer experience more broadly, with fulfillment online, where margins are greater than retail stores.

"As inflammatory health becomes ever more important to the scientific, medical, and financial communities, we look forward to the interim review of our CHASE clinical trial," said David G. Watumull, Cardax President and CEO. "We are also pleased to see ZanthoSyn’s strong retail sales at GNC drive an increase in wholesale orders in Q3 and look forward to expanding our ZanthoSyn marketing and distribution more broadly."

On August 14, 2019 Aethlon Medical, Inc. (Nasdaq: AEMD), a therapeutic technology company focused on unmet needs in global health, reported financial results for its first quarter ended June 30, 2019 and provided an update on recent developments (Press release, Aethlon Medical, AUG 14, 2019, View Source [SID1234538744]).

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Company Updates

Aethlon Medical, Inc. (Company or Aethlon) is continuing the development of its proprietary Hemopurifier, which is a first in class therapeutic device designed for the single use depletion of circulating viruses and cancer-promoting exosomes. The Hemopurifier has previously been designated a Breakthrough Device by the FDA for the treatment of glycosylated viruses, including Ebola and other hemorrhagic fever viruses, and in late 2018 was additionally designated as a Breakthrough Device "…for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease….".

Aethlon is currently preparing for the initiation of clinical trials in patients with advanced and metastatic cancers. The Company is initially focused on the treatment of solid tumors, including head and neck cancer, gastrointestinal cancers and other cancers. Following discussions and a meeting with the FDA, the Company is preparing to file an Investigational Device Exemption (IDE) application with the FDA to initiate clinical trials in cancer.

On June 30, 2019, the Company entered into a cross-licensing agreement with SeaStar Medical, Inc. to jointly develop Aethlon’s and SeaStar’s combined medical devices to address the care and management of critically ill patients. Under this agreement, Aethlon and SeaStar are now initiating development of systems for the transplant, oncology and infectious disease settings.

Financial Results for First Quarter Ended June 30, 2019

The Company’s net loss was approximately $2.1 million, or $(0.11) per share, for the first quarter ended June 30, 2019, compared to a net loss of approximately $1.1 million, or $(0.06) per share, for the quarter ended June 30, 2019.

At June 30, 2019, the Company had a cash balance of approximately $2.5 million.

The Company’s consolidated operating expenses for the quarter ended June 30, 2019 were approximately $1.6 million, compared to $1.25 million for the June 2018 quarter. This increase of approximately $350,000, in 2019 was due to increases in general and administrative expenses of approximately $188,000, professional fees of approximately $158,000 and payroll and related expenses of approximately $3,000.

The $188,000 increase in general and administrative expenses in 2019 was primarily due to the combination of a $120,000 increase in our clinical trial expense, primarily costs associated with the manufacturing of Hemopurifiers for an expected clinical trial in the cancer space, a $39,000 increase in our lab supplies expense, primarily related to our breast cancer grant, and a $39,000 increase in travel expense.

The $158,000 increase in our professional fees in 2019 was primarily due to a $152,534 increase in our legal fees.

The $3,000 increase in payroll and related expenses was primarily due to a $63,374 increase in stock-based compensation, which was partially offset by a $59,944 reduction in our cash-based compensation expense.

The Company’s other expense during the quarter ended June 30, 2019 consisted of interest expense and a loss on debt extinguishment and, during the three months ended June 30, 2018, consisted of interest expense only. Other expense for the three months ended June 30, 2019 was approximately $501,000, in comparison with other expense of approximately $55,000 for the quarter ended June 30, 2018.

The Company recorded government contract and grant revenue in the first quarters ended June 30, 2019 and 2018. This revenue arose from work performed under two government contracts with the National Institutes of Health (NIH). In the quarter ended June 30, 2019, the Company recorded $30,000 in aggregate revenue from its Breast Cancer grant and in the quarter ended June 30, 2018, the Company recorded approximately $150,000 in revenue from its Melanoma Cancer contract with the NIH.

The unaudited condensed consolidated balance sheet for June 30, 2019 and the unaudited condensed consolidated statements of operations for the first quarter ended June 30, 2019 and 2018 follow at the end of this release.

Conference Call

The Company will hold a conference call today, Wednesday, August 14, 2019 at 4:30 p.m. Eastern Time to review financial results and recent corporate developments. Following management’s formal remarks, there will be a question and answer session.

To listen to the call by phone, interested parties within the U.S. should call 1-844-836-8741 and International callers should call 1-412-317-5442. All callers should ask for the Aethlon Medical, Inc. conference call.

A replay of the call will be available approximately one hour after the end of the call through August 21, 2019. The replay can be accessed via Aethlon’s website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada Toll Free at 1-855-669-9658. The replay conference ID number is 10134273.