On July 13, 2020 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported that it intends to offer and sell, subject to market and other conditions, shares of its common stock in an underwritten public offering and, to certain investors in lieu thereof, pre-funded warrants to purchase shares of its common stock (Press release, Altimmune, JUL 13, 2020, View Source [SID1234561857]). Altimmune also expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of shares of common stock plus the shares of common stock underlying the pre-funded warrants sold in connection with the public offering. All of the securities in the offering will be sold by Altimmune. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Altimmune anticipates using the net proceeds from the offering for general corporate purposes, which may include, but are not limited to, scale up of manufacturing and advanced clinical trials of AdCOVID, a single dose intranasal COVID vaccine candidate; the continued development of ALT-801, its dual GLP-1/glucagon receptor agonist for the treatment of non-alcoholic steatohepatitis (NASH), including manufacturing and clinical trials; and for capital expenditures and working capital.

Jefferies, Evercore ISI and Piper Sandler are acting as joint book-running managers for the offering. Roth Capital Partners is acting as co-manager for the offering.

The securities described above are being offered by Altimmune pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was previously filed with and became effective by rule of the Securities and Exchange Commission (SEC) on April 12, 2019. A preliminary prospectus supplement and accompanying prospectus related to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering, when available, may be obtained by contacting: Jefferies LLC, Attention: Equity Syndicate Prospectus Departments, 520 Madison Avenue, 2nd Floor, New York, NY 10022; by phone at (877) 821-7388; or by email at [email protected]; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, New York, NY 10055, by telephone at (888) 474-0200 or by email at [email protected]; or Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN, 55402, Attention: Prospectus Department, by telephone at (800) 747-3924 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On July 13, 2020, Bio-Path Holdings, Inc. (the "Company") reported that it has entered into an At-The-Market Offering Agreement (the "ATM Agreement") with H.C. Wainwright & Co., LLC, ("Wainwright"), as sales agent, pursuant to which the Company may offer and sell, from time to time, through Wainwright shares of its common stock, $0.001 par value per share (Filing, 8-K, Bio-Path Holdings, JUL 13, 2020, View Source [SID1234561845]).

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The Company is not obligated to sell any shares under the ATM Agreement. Subject to the terms and conditions of the ATM Agreement, Wainwright will use commercially reasonable efforts consistent with its normal trading and sales practices, applicable state and federal law, rules and regulations and the rules of the Nasdaq Capital Market to sell shares from time to time based upon the Company’s instructions, including any price, time or size limits specified by the Company. Under the ATM Agreement, Wainwright may sell shares by any method deemed to be an "at the market" offering as defined in Rule 415 under the U.S. Securities Act of 1933, as amended, or any other method permitted by law, including in privately negotiated transactions. Wainwright’s obligations to sell shares under the ATM Agreement are subject to satisfaction of certain conditions, including customary closing conditions for transactions of this nature. The Company will pay Wainwright a commission of up to 3% of the aggregate gross proceeds from each sale of shares and has agreed to provide Wainwright with customary indemnification and contribution rights. The Company has also agreed to reimburse Wainwright for certain specified expenses.

Sales of shares of common stock under the ATM Agreement will be made pursuant to the registration statement on Form S-3 (File No. 333-231537), which was declared effective by the U.S. Securities and Exchange Commission (the "SEC") on June 5, 2019, and a related Prospectus Supplement filed with the SEC on July 13, 2020, for an aggregate offering price of up to $7,000,000.

The foregoing summary of the ATM Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the ATM Agreement, which is filed herewith as Exhibit 10.1.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy any shares under the ATM Agreement, nor shall there be any sale of such shares in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

On July 13, 2020 Kyowa Kirin, Inc., an affiliate of Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151) a global specialty pharmaceutical company, reported that it is establishing a general grant program to support the education of African-American patients about cutaneous T-cell lymphomas (CTCL) and address racial disparities in diagnosis, treatment and outcomes (Press release, Kyowa Hakko Kirin, JUL 13, 2020, View Source [SID1234561837]). Studies have shown that African-American patients present symptoms of CTCL at an earlier age, and overall survival is significantly shorter for African-American patients with MF, when compared to patients of European descent.1,2 The goal of the grant program is to identify and fund meaningful projects that can help diminish these disparities.

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With this RFP, we seek to identify and fund patient education grants to educate African American patients about CTCL and help address existing racial disparities in diagnosis, treatment and patient outcomes.
With this RFP, we seek to identify and fund patient education grants to educate African American patients about CTCL and help address existing racial disparities in diagnosis, treatment and patient outcomes.
Kyowa Kirin is seeking project proposals that can help to close gaps in awareness and understanding of CTCL among African-American communities, including its prevalence and epidemiology, risk factors, diagnosis and care pathways, and improve outreach. Applications for funds are due by August 20, 2020.

"New data, targeted outreach and education is needed to address barriers and increase awareness among African-Americans so they can be diagnosed at an earlier stage," says Lauren Walrath, Senior Director, Head of Public Affairs, North America. "Kyowa Kirin is seeking to sponsor work that can have a profound patient impact. We hope this grant program will encourage researchers and organizations with an interest in helping the African-American patient community improve outcomes."

Kyowa Kirin encourages proposals from the following individuals or organizations who are focused on a mission related to patient education and/or healthcare improvement: Patient advocacy organizations or non-profit foundations; organizations dedicated to African-American empowerment and/or healthcare; public health/social work/nursing/pharmacy schools or students within these schools; healthcare institutions (both large and small); and other entities with a mission related to patient education and/or healthcare improvement.

Kyowa Kirin will make $100,000 available in funds to support these initiatives over a six-month period, starting October 1, 2020. Individual projects requesting up to $35,000 will be considered.

Proposals and questions should be submitted to the North America Grant Review Committee mailbox at [email protected] by August 20, 2020.

On July 13, 2020 Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported preliminary financial and operating results for its first fiscal quarter ended June 30, 2020 (Press release, TYME, JUL 13, 2020, View Source [SID1234561836]). During first quarter fiscal 2021, the Company presented a growing body of preclinical and clinical data at major international medical meetings; continued enrolling patients in multiple studies including, second and third-line pancreatic cancer trials and the HopES Sarcoma Phase II trial; advanced planning for clinical trials in metastatic breast cancer and hematological cancers; and continued ongoing preclinical and mechanism data studies.

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As of June 30, 2020, the Company had approximately $21.3 million in cash and cash equivalents compared to $26.7 million as of March 31, 2020.

TYME’s operational cash burn rate for the first quarter of fiscal year 2021 was $6.7 million compared to $5.9 million for the fourth quarter of fiscal year 2020 and $6.2 million for the first quarter of fiscal 2020. The burn rate was below our previous projections and predominantly reflected costs associated with our ongoing TYME-88-Panc Phase II trial, as well as the launch of the pivotal phase of our TYME-88-Panc trial to evaluate SM-88 as a potential treatment for patients with third-line pancreatic cancer. Based on active clinical trials and other business developments, TYME continues to anticipate that its quarterly cash usage, or "cash burn rate", will average between $7.0 to 8.0 million per quarter for fiscal year 2021.

Anticipated Upcoming Key Events

TYME currently expects the following key events in calendar year 2020:

Continue to advance enrollment in TYME-88-Panc pivotal study
Continue to advance enrollment in the HopES Sarcoma Phase II Trial
Continue to advance enrollment in PanCAN’s Precision PromiseSM adaptive randomized Phase II/III registration-intent trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy
Publish final data for SM-88 Phase II prostate study
Initiate plans for SM-88 clinical programs into other tumor types potentially including metastatic breast, recurrent prostate and/or hematological cancers
Provide guidance on PanCAN’s Precision Promise SM adaptive Phase II/III trial evaluating SM-88 in patients with first-line pancreatic cancer in combination with gemcitabine (Gemzar ) and nab-paclitaxel (Abraxane )
Present and/or publish final data from Part 1 of TYME-88-Panc study
Continue proof-of-concept and IND-enabling activities for TYME-18
Summary of Recent Developments

TYME Presents New Preclinical Data Supporting SM-88 Mechanism of Action at AACR (Free AACR Whitepaper) 2020

TYME announced new preclinical findings that describe the unique mechanism of action of its lead cancer metabolism-based candidate, SM-88 (racemetyrosine). The data were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2020 Virtual Meeting from June 22 to June 24, 2020. Key highlights are as follows:

Preclinical data demonstrated statistically significant tumor reduction in SM-88 treated arms versus controls
Builds on confirmed tumor responses achieved in human clinical studies across 15 different cancer types
Multiple monotherapy effects of SM-88 were shown, including increased oxidative stress, disruption of autophagy, and tumor immunomodulation
Preclinical results were demonstrated across multiple tumor types including, pancreatic, colon, breast, and ovarian
Reduction of immunosuppressive cells in the tumor microenvironment supports exploring combination with immuno-oncology treatments
Oral SM-88 is designed to selectively disrupt cancer’s metabolic process and cause cancer cell death; SM-88 is currently in a pivotal trial for third-line pancreatic cancer
TYME-18 Demonstrates Anti-Cancer Effect in New Preclinical Data Presented at AACR (Free AACR Whitepaper) 2020

TYME announced new preclinical findings that described the unique anti-cancer effects of its cancer metabolism-based pipeline candidate, TYME-18. The data were presented at the AACR (Free AACR Whitepaper) 2020 Virtual Meeting from June 22 to June 24, 2020. Key highlights are as follows:

TYME-18 leverages unique metabolism of cancer to create an intra-tumoral treatment for inoperable cancers
Preclinical animal studies demonstrated TYME-18’s potential to dramatically shrink and/or resolve tumors
TYME-18 treatment resulted in a 91.6% (11/12) complete resolution of established tumors within two weeks
Novel mechanism of action contributes to a strong anti-cancer effect while minimizing systemic and local toxicity
Preclinical studies are ongoing with a goal of identifying an IND-enabling program
TYME Announced Health Economic Research Study Presented at ISPOR and Published in the Journal Value in Health Demonstrated Reduction in Total Cost of Care with Increased Use of New Medicines for Treatment of Patients with Pancreatic Cancer

The results of a health economic outcomes study demonstrated that the therapeutic benefit of increasing the use of novel medicines is so great that it is driving a decrease in the actual total cost of healthcare. The supporting data from the study were presented at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Virtual Meeting held from May 18 to May 20 and published in the Society’s journal, Value in Health.

The study looked at treatment inflation-adjusted expenses per patient for pancreatic cancer care between 2009 and 2016 and found that for every additional $1 spent on medicines for pancreatic cancer in 2016, there was a reduction in non-drug spending of $8-$9.

About SM-88

SM-88 is an oral investigational modified proprietary tyrosine derivative that is believed to interrupt the metabolic processes of cancer cells by breaking down the cells’ key defenses and leading to cell death through oxidative stress and exposure to the body’s natural immune system. Clinical trial data have shown that SM-88 has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, lung, breast, prostate and sarcoma cancers with minimal serious grade 3 or higher adverse events. SM-88 is an investigational therapy that is not approved for any indication in any disease.

About TYME-18

TYME-18 is composed of a proprietary surfactant delivery agent with a specific sulfonic acid component1. It is designed for intra-tumoral administration of difficult to treat tumors and leverages the acidic tumor microenvironment and signaling pathways to kill cancer cells. TYME-18 is distinct in composition, but like SM-88, aims to leverage susceptibilities of a cancer that are related to its altered metabolism. Initial preclinical data for TYME-18 in animal tumor models demonstrate rapid and complete tumor regression, with no reported local or systemic toxicities. TYME-18 continues to be studied as a potential therapy for difficult to treat tumors that may not be eligible for surgical or other interventions.

About TYME-88-Panc Pivotal Trial

The TYME-88-Panc pivotal trial applies the latest advances in the field of cancer metabolism by evaluating the efficacy and safety of an oral investigational compound that targets the metabolic mechanisms of the disease at its source. A prospective, open label pivotal trial in metastatic pancreatic cancer for patients who have failed two lines of any prior systemic therapy. The trial is designed to evaluate the safety and efficacy of SM-88 used with MPS (methoxsalen, phenytoin and sirolimus) in advanced pancreatic cancer and will measure multiple endpoints, including overall survival, progression free survival, relevant biomarkers, quality of life, safety, and overall response rate.

On July 13, 2020 Gilead Sciences, Inc. (Nasdaq: GILD) and Arcus Biosciences, Inc. (NYSE: RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapeutics, reported the closing of their option and co-development and co-commercialization partnership agreement signed on May 27, 2020 (Press release, Gilead Sciences, JUL 13, 2020, View Source [SID1234561835]).

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The closing occurred following the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

Under the terms of the agreements, the closing of this transaction triggered a payment of $175 million by Gilead to Arcus. In addition, Gilead made an equity investment in Arcus of approximately $200 million by purchasing shares at a price of $33.54 per share. As a result of this investment and Gilead’s participation in Arcus’s follow-on offering on May 28, 2020, Gilead now owns nearly 8.2 million shares of common stock of Arcus, representing approximately 13 percent of Arcus’s outstanding shares.