On July 13, 2020 iCo Therapeutics Inc. (TSXV: ICO) (OTCQB: ICOTF) ("iCo" or "the Company"), reported financial results for the quarter ended March 31, 2020 (Press release, iCo Therapeutics, JUL 13, 2020, View Source [SID1234562021]). Amounts, unless specified otherwise, are expressed in Canadian dollars and presented under International Financial Reporting Standards ("IFRS").

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Stated William Jarosz, CEO of iCo Therapeutics Inc., "We were pleased with the positive outcome from our Phase 1b study of our oral Amphotericin B asset during the quarter and that we were able to complete the study with encouraging results and minimal disruption given the current Covid-19 pandemic. On iCo-008, we continue to work closely with our partner Alexion in advancing the program."

Q1 2020 Operational and Financial Highlights

In January 2020, the assignment of the IMMUNE sublicense to Alexion was completed. Under the terms of the assignment, Alexion was required to pay US$6 million into the Court in the settlement of IMMUNE’s creditor claims in exchange for IMMUNE’s rights under the IMMUNE License Agreement.

On February 25, 2020 we announced the successful completion of our Phase 1b study with no serious adverse events. On April 15, 2020, we announced the pharmacokinetic data from this study which showed a doubling in the AUC (0-inf), a measure of drug accumulation, after 10 days dosing compared to day 1 dosing.

On March 9, 2020 Andrew Rae, MBA, resigned from his roles as both President & CEO and Director. Ms. Susan Koppy, a member of iCo’s board of directors since 2015, assumed the role of President and Mr William Jarosz, a member of iCo’s board of directors since 2006, assumed the role of CEO.

Financial results for Quarter ended March 31, 2020

We incurred a total comprehensive loss of $ 645,570 for the quarter ended March 31, 2020 compared to a total comprehensive loss of $353,680 for the quarter ended March 31, 2019, representing an increased loss of $291,890. The increase in the loss is primarily the result of higher research and development expenses offset by lower general and administrative expenses and higher research and development tax credits recognized in Q1 2020.

Research and development expenses were $670,690 for the quarter ended March 31, 2020 compared to $85,095 for the quarter ended March 31, 2019, representing an increase of $585,595. The increase related to higher contract research expenses for clinical trials conducted on the Oral Amp B program in the quarter ended March 31, 2020.

The Phase 1b study was conducted in Australia, which provides refundable tax credits for qualifying research and development activities conducted there. The refundable tax credit is calculated at 43.5% of the qualifying expenditures and the Company recognized $238,258 in other income as its estimate of the tax refund related to qualifying expenditures for the quarter ended March 31, 2020.

For the quarter ended March 31, 2020 general and administrative expenses were $216,436 compared to $278,767 for the quarter ended March 31, 2019, representing a decrease of $62,331. The decrease reflects lower professional fees during the period. The Company’s participation in the IMMUNE bankruptcy process last year caused an increase in professional fees in the corresponding quarter of the prior year.

Liquidity and Outstanding Share Capital

As at March 31, 2020, we had cash and cash equivalents of $479,005 compared to $989,937 as at December 31, 2019.

As at July 13th, 2020, we had an unlimited number of authorized common shares with 153,747,713 common shares issued and outstanding.

On July 13, 2020 Revitope Oncology Inc ("Revitope Oncology")., a biotechnology company advancing a new class of precision cancer immunotherapies, its wholly-owned subsidiary Revitope Limited (Revitope Limited, together with Revitope Oncology, "Revitope") and Junshi Biosciences (1877.HK, 688180.SH), a leading innovation–driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, reported the companies have entered into a strategic research collaboration (Press release, Revitope Oncology, JUL 13, 2020, View Source [SID1234561859]). Revitope will leverage its proprietary protein engineering platform together with Junshi’s novel antibody components to develop first-in-class dual-antigen targeting cancer therapies. Revitope is granting Junshi a world-wide exclusive license on products arising from the research collaboration and will receive up to $160 million in development and commercialization milestone payments for each T Cell Engaging Antibody Circuit (TEAC) molecule selected by Junshi, plus tiered royalties. Junshi also commits to making a direct equity investment in Revitope Oncology in the amount of $10M for 9.99% of total Revitope Oncology shares on an as-converted basis with terms and conditions to be mutually agreed and subject to compliance with all applicable laws.

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"By leveraging Revitope’s unique two component T-cell immunotherapy platform and our in-house antibody capabilities reaching from discovery to commercialization, dual targeting precision-based novel cancer immunotherapies can be brought into clinical trials in the near future," commented Dr. Sheng YAO, Vice President of Junshi Biosciences. "As an innovation-driven company, we believe the collaboration with Revitope will empower us to generate a new generation of first-in-class immunotherapy compounds designed to improve both safety and clinical efficacy."

Revitope’s proprietary T Cell Engaging Antibody Circuit (TEAC) technology platform exploits co-expressed tumor antigens to enable the development of highly specific cancer drugs with improved safety and efficacy over conventional immunotherapeutic approaches. Revitope’s unique approach is based on a pair of tumor-targeted antibodies with a shared T-cell engaging domain which act as inactive pro-drugs unless they encounter cancer cells co-expressing both antigens.

"We are excited to partner with Junshi , a company with state-of-the-art antibody discovery technologies and world-class development capabilities, to advance our unique two-component T-cell engager therapies that have the ability to target tumor cells and deliver more efficacious and safer drugs to patients," said Steve Arkinstall, PhD, CEO, Revitope Oncology.

Under the terms of the Collaboration and License Agreement, Junshi and Revitope will identify development candidate TEAC pairs against agreed upon targets. Revitope will leverage its TEAC protein engineering platform to develop up to five novel TEAC pairs using proprietary sequences from Junshi’s antibodies with best-in-class pharmacological and therapeutic activity. Junshi will receive a world-wide license to the TEAC pairs and will have sole responsibility for IND enabling studies as well as clinical development, manufacturing and commercialization. Revitope will receive up to $160M in clinical development and commercialization milestone payments for each TEAC molecule selected, plus tiered royalties on net sales.

About Revitope’s T-Cell Engaging Antibody Circuit Technology (TEAC): Tumor-specific Immunotherapies

Because tumors typically do not express cell surface proteins unique to the tumor, conventional bispecific antibody therapeutics can generate unwanted and substantial "on-target, off-tumor" toxicity. Revitope’s two-component T-cell engaging antibody circuits (TEACs) are designed to permit specific recruitment and activation of T-cells exclusively by tumor cells. Though developed with traditional tumor targeting domains, TEAC therapies split the CD3 paratope (the T-cell recognition domain) into two halves, with one half on one molecule and the other half on the other molecule. This allows for true dual-antigen targeting to a unique tumor-specific address – two inputs coming together to enable one precision targeted output, i.e. a true "and" gate safety feature. Only when the two molecules come together through binding to their different tumor targets on the same tumor cell can the two halves of the CD3 binding domain recombine and create a fully functional anti-CD3 domain (a TEAC). Normal cells expressing only one or neither of the targeted antigens will not elicit activation of a TEAC pair thereby avoiding unwanted toxicity in healthy tissues.

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.