On August 14, 2019 Heat Biologics, Inc. (Nasdaq:HTBX), a biopharmaceutical company developing therapeutics designed to activate a patient’s immune system against cancer, reported financial and clinical updates for the second quarter ended June 30, 2019 (Press release, Heat Biologics, AUG 14, 2019, View Source [SID1234538761]).

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Jeff Wolf, Heat’s CEO, commented, "We recently announced that we completed recruitment for our Phase 2 clinical trial investigating HS-110 for advanced non-small cell lung cancer (NSCLC) in combination with Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, Opdivo (nivolumab) or with Merck’s KEYTRUDA (pembrolizumab) with approximately 120 patients enrolled in the trial. Importantly, we reported promising interim results from the study showing that the addition of HS-110 to nivolumab may restore anti-tumor activity in patients whose disease has progressed after checkpoint inhibitor therapy. Our data showing tumor shrinkage in 35% of patients and disease control in 55% of patients whose disease has progressed after treatment with a checkpoint inhibitor (CPI) supports our mechanistic hypothesis that the broad, T-cell mediated immune response activated by HS-110 may reestablish positive clinical outcomes for patients who have lost the benefit of treatment with a CPI. We are encouraged by the positive results and look forward to reporting additional data later this year."

"Earlier this week, we announced that the FDA has cleared our Investigational New Drug (IND) application to initiate a Phase 1 clinical trial of HS-130, in combination with HS-110, for patients with advanced solid tumors refractory to standard of care. Up to 30 patients are expected to be enrolled in the trial. HS-130 is the first allogeneic, "off-the-shelf" cell line engineered to express the extracellular domain of OX40 ligand fusion protein (OX40L-Fc), a key costimulator of T cells, with the potential to augment antigen-specific CD8+ T cell response."

"We ended the quarter with approximately $19.5 million of cash, cash equivalents and short-term investments. These funds combined with an additional $6.9 million in grant funds from Cancer Prevention Research Institute of Texas (CPRIT) that we expect to receive after filing our IND for PTX-35 should provide us sufficient capital to fund Heat through our HS-110 data release, as well as other clinical programs."

Second Quarter 2019 Financial Results

Recognized $0.3 million of grant revenue for qualified expenditures under the CPRIT grant.
Research and development expenses decreased approximately 2% to $3.4 million for the quarter ended June 30, 2019 compared to $3.5 million for the quarter ended June 30, 2018. The decrease of approximately $56,000 is due to the lower PTX-35 expense for 2019, primarily reflecting decreased manufacturing costs, offset by the increased enrollment in the Phase 2 portion of our multi-arm NSCLC clinical trial and stock-based compensation.
General and administrative expense increased approximately 37% to $1.9 million for the quarter ended June 30, 2019 compared to $1.4 million for the quarter ended June 30, 2018. The $0.5 million increase is primarily attributable to increased personnel costs, including stock-based compensation expense.
Net loss attributable to Heat Biologics was approximately $4.8 million, or ($0.14) per basic and diluted share for the quarter ended June 30, 2019 compared to a net loss of approximately $3.8 million, or ($0.26) per basic and diluted share for the quarter ended June 30, 2018.
As of June 30, 2019, the Company had approximately $19.5 million in cash, cash equivalents and short investments with an additional $6.9 million in grant funds from Cancer Prevention Research Institute of Texas (CPRIT) that it expects to receive after filing our IND for PTX-35.
About Heat Biologics, Inc.

Heat Biologics is a biopharmaceutical company developing immunotherapies designed to activate a patient’s immune system against cancer using of CD8+ "Killer" T-cells. Our T-Cell Activation Platform (TCAP) produces therapies designed to turn "cold" tumors "hot" and be administered in combination with checkpoint therapies and other immuno-modulators to

On August 14, 2019, DelMar Pharmaceuticals, Inc. (the "Company") reported that it has entered into an underwriting agreement (the "Underwriting Agreement") with Maxim Group LLC and Dawson James Securities, Inc. (the "Representatives"), as representatives of the several underwriters named therein, relating to the sale of 6,750,000 shares of its common stock, par value $0.001 per share (the "Common Stock") (or pre-funded warrants to purchase Common Stock in lieu thereof) and common warrants to purchase up to an aggregate of 6,750,000 shares of Common Stock (the "Offering") (Filing, 8-K, DelMar Pharmaceuticals, AUG 14, 2019, View Source [SID1234538810]). Each share of Common Stock or pre-funded warrant, as applicable, was sold together with a common warrant to purchase one share of Common Stock at a combined effective price to the public of $1.00 per share and accompanying common warrant. The Offering is expected to close on or about August 16, 2019.

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The Company expects the net proceeds from the Offering will be approximately $6.0 million after deducting underwriting discounts and commissions and other estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the Offering for its clinical trials and for general corporate purposes, which may include working capital, capital expenditures, research and development and other commercial expenditures. In addition, the Company may use the net proceeds from the Offering for investments in businesses, products or technologies that are complementary to its business.

The common warrants are exercisable immediately at an exercise price of $1.00 per share and will expire five years from the date of issuance. The pre-funded warrants are exercisable immediately at an exercise price of $0.01 per share and will remain outstanding until they are exercised in full. The exercise price and number of shares of Common Stock issuable upon exercise of the common warrants and pre-funded warrants will be subject to adjustment in the event of any stock split, reverse stock split, stock dividend, recapitalization, reorganization or similar transaction, among other events as described in the common warrants and pre-funded warrants. The shares of Common Stock or pre-funded warrants, as applicable, and the accompanying common warrants can only be purchased together in this Offering but will be issued separately.

The Company has granted the underwriters a 45-day option, ending September 28, 2019, to purchase up to an additional 1,012,500 shares of Common Stock and/or common warrants to purchase up to 1,012,500 shares of Common Stock, at the public offering price less discounts and commissions.

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, which was a firm commitment underwritten public offering pursuant to a registration statement on Form S-1 (Registration No. 333-232931) that was declared effective by the Securities and Exchange Commission (the "SEC") on August 14, 2019. The Offering was made only by means of a prospectus forming a part of the effective registration statement. The Company will pay the underwriters a commission equal to 8.0% of the gross proceeds of the Offering and other expenses. As additional compensation, the Company will issue warrants to the Representatives to purchase a number of shares equal to five percent (5%) of the total number of shares of Common Stock sold in the Offering (the "Underwriter Warrants"). The Underwriter Warrants will have an exercise price of $1.15 per share, will be exercisable for three years from the date of the Underwriting Agreement and may be exercised on a cashless basis in certain circumstances specified therein.

The Underwriting Agreement contains customary representations, warranties, and agreements by the Company, and customary conditions to closing, indemnification obligations of the Company and the underwriters, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties, and termination provisions. Pursuant to the Underwriting Agreement, the Company agreed, subject to certain exceptions, not to offer, issue or sell any shares of Common Stock or securities convertible into or exercisable or exchangeable for shares of Common Stock for a period of ninety (90) days following the Offering without the prior written consent of the Representatives.

In connection with the Offering, on August 14, 2019, certain purchasers entered into leak-out agreements with the Company (each a "Leak-Out Agreement" and collectively, the "Leak-Out Agreements"). Pursuant to the Leak-Out Agreements, for a period beginning on the date of the Underwriting Agreement and ending on September 24, 2019 (the "Leak-Out Period"), if any of the purchasers that are signatory to the Leak-Out Agreements decide to sell any securities during the Leak-Out Period, they will only be permitted to sell securities in such amount as shall equal up to 35% in the aggregate of the average daily volume of the Common Stock on any given trading day, as reported by Bloomberg, LP. However, the foregoing restriction shall not apply to (a) any sales of the common warrants sold in the Offering or (b) any actual "long" (as defined in Regulation SHO of the Securities Exchange Act of 1934, as amended) sales of Common Stock by the purchaser or any of the purchaser’s affiliates at a price per share greater than $2.25 (in each case, as adjusted for stock splits, stock dividends, stock combinations, recapitalizations or other similar events occurring after the pricing date).

On August 14, 2019, the Company also entered into a Warrant Agency Agreement (the "Warrant Agency Agreement") with Mountain Share Transfer, LLC (the "Transfer Agent") pursuant to which the Transfer Agent agreed to act as transfer agent with respect to the common warrants.

The foregoing descriptions of the Underwriting Agreement, the Warrant Agency Agreement, the Underwriter Warrants, the common warrants and the pre-funded warrants are not complete and are qualified in their entirety by reference to the full text of the Underwriting Agreement, the Warrant Agency Agreement and the forms of the Underwriter Warrant, common warrant and pre-funded warrant, copies of which will be filed as exhibits to an amendment to this Current Report on Form 8-K.

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 13, 2019 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, reported financial results for the second quarter ended June 30, 2019 (Press release, Alpine Immune Sciences, AUG 13, 2019, View Source [SID1234538631]).

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"I am proud of the progress Alpine has made in the first six months of the year and the momentum we’ve built heading into a potentially transformative year ahead," said Mitchell H. Gold, MD, Executive Chairman and Chief Executive Officer of Alpine. "The Phase I trial of ALPN-101 in healthy volunteers has advanced through the single-ascending dose cohorts, enabling initiation of the multiple-ascending dose cohorts. This is an important milestone for our first-in-class dual ICOS/CD28 blocker which we believe has the potential to deliver meaningful remissions in inflammatory diseases. We expect to have completed the critical portions of the Phase 1 trial of ALPN-101 by the end of 2019 and look forward to initiating our studies in acute GVHD and Psoriatic Arthritis."

Recent Pipeline and Company Highlights

ALPN-101 Update:

Phase I Trial Successfully Progresses Through the Single-Ascending Dose (SAD) Cohorts: Dosing of all planned SAD cohorts in the Phase I healthy volunteer study has been successfully completed. Enrollment has begun on the multiple-ascending dose cohorts.
"The safety, pharmacokinetic and pharmacodynamic data so far have been encouraging and we believe this study, once complete, will allow us to select an appropriate dose(s) for Phase II studies," said Stanford Peng, MD, PhD, Alpine’s President and Head of Research and Development. "We expect to have these data before the end of the year and hope to present the data publicly in the first half of 2020."

Trials in patients with GVHD and Psoriatic Arthritis are on track to begin following completion of the Phase I healthy volunteer study.
Alpine plans to present additional preclinical data supporting the potential role of ALPN-101 in additional indications at an upcoming scientific conference in the fourth quarter of 2019, supporting the potential broad utility of ALPN-101.
ALPN-202 Update:

Alpine anticipates submitting for regulatory authorization to begin clinical trials by the end of 2019. Alpine believes ALPN-202 will be the first clinical trial of a conditional T-cell agonist targeting CD28 while also providing checkpoint blockade.
Alpine expects to present new mechanistic data in the fourth quarter of 2019 supporting the unique mechanism of action of ALPN-202.
Corporate Update:

Initiated New Collaboration with Adaptimmune: Alpine entered into a collaboration and license agreement with Adaptimmune Therapeutics (NASDAQ:ADAP) in May 2019. The new partnership aims to utilize Alpine’s secreted and transmembrane immunomodulatory protein (termed SIP and TIP) technology in an effort to further enhance the design and development of Adaptimmune’s next-generation SPEAR T-cell therapies.
Expanded Management Team:

Alpine announced the addition of Wayne Gombotz, PhD as Chief Technology Officer of Alpine. With over 30 years of biotechnology and pharmaceutical experience, most recently as Chief Development Officer at Immune Design, Dr. Gombotz will help advance Alpine’s programs into and through each stage of clinical development.

Remy Durand, PhD was also appointed as Vice President, Business Development during the second quarter of 2019. Remy brings with him deep experience in biotechnology strategy, company formation, and investor relations. Prior to joining Alpine, Remy was a Vice President on the investment team at Frazier Healthcare Partners. He received his PhD from Stanford University in Bioengineering.

Financial Results for Second Quarter and First Six Months of 2019

As of June 30, 2019, Alpine had cash, cash equivalents, and short-term investments totaling $55.6 million compared to $52.3 million as of December 31, 2018. Alpine recorded a net loss of $11.9 million and $7.9 million for the three months ended June 30, 2019 and 2018, respectively, and $24.2 million and $13.2 million for the six months ended June 30, 2019 and 2018, respectively.

Research and development expenses for the second quarter ended June 30, 2019 were $10.2 million compared to $5.7 million for the second quarter ended June 30, 2018. For the six months ended June 30, 2019 and 2018, research and development expenses were $20.5 million and $9.5 million, respectively. The company expects a continued increase to research and development activities to support the clinical advancement of its ALPN-101 and ALPN-202 programs.

General and administrative expenses for the second quarter ended June 30, 2019 were $2.6 million compared to $1.9 million for the second quarter ended June 30, 2018. For the six months ended June 30, 2019 and 2018, general and administration expenses were $4.9 million and $4.0 million, respectively. The increase was primarily attributable to professional and legal fees, in addition to personnel-related expenses and the costs associated with expanding the company’s operations as we continue to increase development and clinical activities.

Cash Guidance

Alpine expects to have sufficient cash to fund operations and drive the clinical advancement of Alpine’s lead programs, ALPN-101 in autoimmune/inflammatory diseases and ALPN-202 in oncology, into 2021.