On September 15, 2021 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage precision oncology company focused on developing targeted drugs to inhibit frontier targets that drive and sustain RAS-addicted cancers, reported that the company will participate in the upcoming 3rd Annual RAS-Targeted Drug Development Summit being held September 21-23, 2021 (Press release, Revolution Medicines, SEP 15, 2021, View Source [SID1234587745]). Steve Kelsey, M.D., president, research and development, will serve as chairperson for one of the conference’s scientific tracks and moderate a panel discussion during the virtual event. In addition, Jan Smith, Ph.D., senior vice president, biology and Bob Nichols, Ph.D., project lead for RMC-6291, the company’s development-stage KRASG12C(ON) inhibitor, will each deliver a scientific presentation as part of the conference.

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Details of Revolution Medicines’ participation in the 3rd Annual RAS-Targeted Drug Development Summit are as follows:

Presentations:

Title: Targeting KRASG12C(ON) & Potential Application to Overcoming Drug Resistance in RAS-Addicted Tumors
Presenter: Bob Nichols, Ph.D., project lead for RMC-6291
Date: Wednesday, September 22, 2021
Time: 11:55 a.m. Eastern

Title: Combination Strategies to Defeat RAS-Addicted Cancers
Presenter: Jan Smith, Ph.D., senior vice president, biology
Date: Wednesday, September 22, 2021
Time: 2:00 p.m. Eastern

Panel Discussion:

Title: On the Horizon – Discussing the Post-Approval Landscape for Successful RAS Drugs Beyond AMG510
Moderator: Steve Kelsey, M.D., president, research and development
Date: Thursday, September 23, 2021
Time: 4:15 p.m. Eastern

Scientific Track:

Title: Validating Robust Combination Strategies
Chairperson: Steve Kelsey, M.D., president, research and development
Date/Time: Wednesday, September 22, 2021; 11:30 a.m. – 5:00 p.m. Eastern
Thursday, September 23, 2021; 11:00 a.m. – 12:30 p.m. Eastern

Additional information on the Digital RAS-Targeted Drug Discovery Summit is available through the conference website at https://ras-drugdevelopment.com/

On September 15, 2021 GammaDelta Therapeutics Ltd. (GDT), a biotechnology company pioneering the discovery and development of allogeneic gamma delta T cell therapies for cancer, reported that it has initiated a first-in-human Phase I clinical trial evaluating GDX012 for the treatment of acute myeloid leukaemia (AML) (Press release, GammaDelta Therapeutics, SEP 15, 2021, View Source [SID1234587763]). GDX012 is an allogeneic, non-engineered, variable delta 1 (Vδ1) gamma-delta (γδ) T cell therapy manufactured from healthy donor blood.

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AML is the most common form of acute leukaemia in adults with an estimated 20.000 new cases per year in the US. Despite progress in the development of targeted therapies over the recent years the prognosis for patients with AML remains poor, with an average overall 5‐year survival rate of approximately 30%1.

"The unique biological characteristics of non-engineered Vδ1 γδ T cells potentially open a new modality for innate cell therapy. Vδ1 γδ T cells provide a basis for ‘off-the-shelf use’ and the platforms developed by our team further support gene engineering of these cells to enable the foundations of our allogeneic cell therapy pipeline for haematological malignancies and solid tumours", said Dr. Paolo Paoletti, CEO of GDT.

GDT’s Phase I trial, conducted in the U.S., is an open-label, multi-centre study of GDX012 enrolling adults diagnosed with AML and presenting with measurable residual disease (MRD) after standard of care (SOC) treatment. The objectives of the trial are to evaluate the safety, tolerability, pharmacokinetics, anti-leukaemic activity and maximum tolerated dose of GDX012

Dr. Michael Koslowski, Head of R&D and Chief Medical Officer of GDT added: "This is an important milestone in the development of our lead product candidate, GDX012, for patients with AML that present with MRD after SOC treatment. Supported by encouraging preclinical data we believe that GDX012 can provide an attractive treatment option for these AML patients that are at high risk of relapse. We are very excited to bring GDX012 into clinical development and we look forward to advancing our growing pipeline of allogeneic, ‘off-the-shelf’ Vδ1 γδ T cell products for solid and haematological tumours."

GDT is advancing its novel T cell platforms under an ongoing collaboration with Takeda Pharmaceutical Company Limited formed in 2017. GDT’s technology platforms are based on pioneering world-class research funded in part by Cancer Research UK, conducted by Professor Adrian Hayday and Dr Oliver Nussbaumer, at King’s College London and the Francis Crick Institute and Professor Bruno Silva-Santos at the University of Lisbon. GDT was formed in 2016 by Abingworth with support from Cancer Research UK’s commercial partnership team.

Vδ1 γδ T cells are a unique subset of T cells that specifically recognise and are activated by molecular patterns of dysregulation on cancer cells. The non-MHC-restricted activity of Vδ1 γδ T cells makes them a unique cell type for the development of fully allogeneic, ‘off-the-shelf’ cell therapies.

GDT has developed proprietary technologies to generate both blood-and tissue-derived allogeneic immunotherapies based on Vδ1 γδ T cells for the treatment of haematological malignancies and solid tumours. Both platforms have enabled the creation of non-engineered and genetically engineered allogeneic cell therapies, which demonstrate cellular activity and tumour cell killing capacity in pre-clinical models.

On September 15, 2021, Vaxart, Inc. ("Vaxart" or the "Company") reported that entered into a Controlled Equity OfferingSM Sales Agreement (the "Sales Agreement") with Cantor Fitzgerald & Co. ("Cantor") and B. Riley Securities Inc. ("B. Riley") and, together with Jefferies, the "Sales Agents"), pursuant to which Vaxart may offer and sell, from time to time through the Sales Agents, shares of the Company’s common stock, par value $0.0001 per share (the "Common Stock"), having an aggregate offering price of up to $100.0 million (the "Shares") (Filing, 8-K, Vaxart, SEP 15, 2021, View Source [SID1234587809]). The Shares will be sold pursuant to an effective registration statement on Form S-3 (Registration Statement No. 333-239751), as previously filed with the U.S. Securities and Exchange Commission (the "Commission"). The Company filed a prospectus supplement, dated September 16, 2021, with the Commission in connection with the offer and sale of the Shares.

Under the Sales Agreement, the Sales Agents may sell the Shares by any method permitted by law and deemed to be an "at the market offering" as defined in Rule 415 promulgated under the Securities Act of 1933, as amended (the "Securities Act"), including sales made directly on the Nasdaq Capital Market, on any other existing trading market for the Common Stock. In addition, under the Sales Agreement, the Sales Agents may sell the Shares in privately negotiated transactions with the Company’s consent and in block transactions. Under certain circumstances, Vaxart may instruct the Sales Agents not to sell the Shares if the sales cannot be effected at or above the price designated by the Company from time to time

Vaxart is not obligated to make any sales of the Shares under the Sales Agreement. The Sales Agreement may be terminated by either party at any time upon ten days’ notice to the other party, or by Cantor or B. Riley at any time under certain circumstances.

The Sales Agreement contains customary representations, warranties and agreements by Vaxart, and customary indemnification and contribution rights and obligations of the parties. Vaxart will pay the Sales Agents an aggregate commission rate equal to up to 3% of the aggregate gross proceeds from each sale of the Shares. Vaxart will also reimburse the Sales Agents for certain specified expenses in connection with entering into the Sales Agreement.

The Sales Agreement is filed as Exhibit 1.1 to this Current Report on Form 8-K, and the description of the terms of the Sales Agreement is qualified in its entirety by reference to such exhibit. A copy of the opinion of Thompson Hine LLP relating to the legality of the issuance and sale of the Shares is attached as Exhibit 5.1 hereto.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any offer, solicitation, or sale of the securities 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.

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On September 15, 2021 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported it has entered into a definitive securities purchase agreement for the sale of common stock and prefunded warrants, as described below, in a private placement with certain institutional and other accredited investors for gross proceeds to Alpine of approximately $91 million, before deducting offering expenses (Press release, Alpine Immune Sciences, SEP 15, 2021, View Source [SID1234587730]). The private placement is being led by Frazier Life Sciences Public Fund with participation from Decheng Capital, BVF Partners, TCG X, Avidity Partners, OrbiMed, Omega Fund, and Logos Capital, among others.

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"As a long-term backer of Alpine, we are impressed by the company’s progress and their emergence as a leader in both immunology and immuno-oncology," said James Topper, M.D., Ph.D, Managing General Partner of Frazier’s Life Sciences team. "This financing will help the company to pursue a focused and rapid development plan for ALPN-303, a potentially best-in-class inhibitor of the BAFF and APRIL pathways, and will also support the ongoing development of ALPN-202 as it enters monotherapy expansion cohorts next year and expands its development efforts in combination with Keytruda. We are pleased to lead this syndicate of strong investors and look forward to supporting the company in this next phase of growth."

Pursuant to the terms of the securities purchase agreement, at the closing of the private placement, Alpine will issue approximately 6.5 million shares of common stock and approximately 3.2 million prefunded warrants to purchase the same number of shares of common stock. Both the common stock and prefunded warrants will be sold at a price of $9.40 per share or prefunded warrant, respectively. The prefunded warrants will have a per share exercise price of $0.001 and will be exercisable at any time on or after the closing date. The price of the common stock and prefunded warrants is at a 4.4% premium to the closing price of $9.00 per share of Alpine’s common stock on the Nasdaq Global Market on September 14, 2021.

The private placement is expected to close on or about September 17, 2021, subject to the satisfaction of customary closing conditions. Additional details regarding the private placement will be included in a Form 8-K to be filed by Alpine with the Securities and Exchange Commission ("SEC").

Alpine intends to use the net proceeds to support the expansion of its pipeline, including the development of ALPN-303 in lupus and other B cell-mediated inflammatory diseases. In addition, net proceeds will be used to support the further clinical development of ALPN-202 as well as Alpine’s discovery programs and general corporate purposes.

In connection with the entry into the securities purchase agreement, an affiliate of Frazier Life Sciences Public Fund entered into an exchange agreement with Alpine, pursuant to which Alpine will exchange an aggregate of 1.2 million shares of common stock currently held by the affiliate of Frazier Life Sciences Public Fund for prefunded warrants to purchase an aggregate of 1.2 million shares of common stock, which prefunded warrants have identical terms to the prefunded warrants sold pursuant to the securities purchase agreement. After giving effect to the exchange of 1.2 million shares of common stock and the issuance of the approximately 6.5 million shares pursuant to the securities purchase agreement, the number of shares of Alpine’s outstanding common stock immediately after this offering would be approximately 29.2 million as of July 30, 2021. The closing of the exchange is subject to customary closing conditions and is contingent upon and will occur immediately following the closing of the private placement.

The securities being sold in the private placement have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements. Alpine has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable in connection with the private placement and upon exercise of the prefunded warrants.

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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On September 15, 2021 Aptorum Group Limited (NASDAQ: APM, Euronext Paris: APM) ("Aptorum Group" or the "Company"), a clinical stage biopharmaceutical company dedicated to meeting unmet medical needs in oncology and infectious diseases, reported that financial results for the six months ended June 30, 2021 (Press release, Aptorum, SEP 15, 2021, View Source [SID1234587764]).

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"During the first half of 2021, we remained focused on advancing the development of our therapeutic programs. As announced in early 2021, our ALS-4 program (targeting infections caused by Staphylococcus aureus including MRSA) commenced a Phase 1 clinical study in Canada. We are pleased that 5 total cohorts, which represent the essential part of the single ascending dose ("SAD") portion of the trial, have been completed without any serious adverse events being observed. On the basis of ALS-4’s favourable safety profile, we are commencing the multiple ascending dose ("MAD") portion of the trial in Q3, 2021. Our other lead program SACT-1 (targeting neuroblastoma), has also received clearance from the US FDA to commence clinical trials in the United States. SACT-1 will be our second therapeutic program entering into the clinical phase. Our RPIDD program (liquid biopsy based approach to infectious disease rapid diagnostics) is also progressing well and we are very pleased to continue its clinical validation currently in collaboration with A*Star. Finally, we are excited to continue with our efforts of commercialising our NativusWell DOI product, a novel supplement targeting woman’s health including menopausal symptoms. We are also excited to continue to identify and progress on certain other potential novel therapeutic candidates, including our ongoing assessment of a number of novel immunomodulators developed by Yale University targeting major autoimmune diseases, as we announced earlier in the year," said Mr. Ian Huen, Chief Executive Officer and Executive Director of Aptorum Group Limited.

Clinical Pipeline Update and Upcoming Milestones

In September 2021, Aptorum Group received clearance from the US FDA to open an IND to conduct clinical trials on SACT-1, an orally administered small molecule repurposed drug for the treatment of neuroblastoma. The IND-opening study is a bioavailability/Food Effect study, followed by a Phase 1b/2a trial in neuroblastoma patients which is subject to further FDA approval.

In May 2021, Aptorum Group announced its ongoing Phase I clinical trial for one of its lead programs, ALS-4, an orally administered small molecule drug for the treatment of infections caused by Staphylococcus aureus including MRSA, under which two initial cohorts of the SAD portion of the trial in healthy male and female adult subjects have been completed with no serious adverse events observed. In July 2021, the Company further announced two additional cohorts (Cohort C & D) of the SAD portion have been completed with no serious adverse events observed. In total, up to 6 cohorts for SAD and 3 cohorts for MAD have been planned. The MAD study is commencing in Q3, 2021.

In May 2021, Aptorum Group entered into an agreement with Exeltis regarding Aptorum’s preclinical asset targeting women’s health and gynaecological conditions, including endometriosis, in the European Union and Latin America. Aptorum retained development rights in the rest of the world.

In April 2021, Aptorum Group entered into a material transfer and license option agreement with Yale University to evaluate a group of preclinical stage novel immunomodulators that could represent first-in-class therapeutics in treating autoimmune and oncology diseases, among other indications.

Corporate Highlights

In May 2021, Jurchen Investments Limited, purchased an aggregate of 1,387,925 of the Company’s Class A Ordinary Shares at $2.882 per share, representing 10% premium to the last closing price.

On March 26, 2021, Aptorum Group entered into a Sales Agreement with H.C. Wainwright & Co., LLC, acting as the Company’s sales agent, pursuant to which the Company may offer and sell, from time to time, through the Sales Agent, Class A Ordinary Shares for an aggregate offering price of up to $15,000,000.

Financial Results for the Six Months Ended June 30, 2021

Aptorum Group reported a net loss of $17.1 million for the six months ended June 30, 2021 compared to $7.0 million for the same period in 2020. The increase in net loss in the current period was driven by loss on investments in marketable securities, net of $7.6 million, and there was a gain on non-marketable investment of $1.6 million in the same period in 2020 while there was no such gain in current period.

Research and development expenses were $5.5 million for the six months ended June 30, 2021 compared to $4.3 million for the same period in 2020. The increase in research and development expenses was mainly due to the increase in services provided by contracted research organizations as a result of our projects’ development.

General and administrative fees were $2.6 million for the six months ended June 30, 2021 compared to $2.1 million for the same period in 2020. The increase in general and administration fees was mainly due to a one-off reversal of over-provision in relations to bonus payables to our directors, employees, external consultants and advisors in the last period. It was partly offset by the decrease in travelling expenses due to the outspread of COVID-19 and the decrease in amortization and depreciation due to the disposal of fixed assets in the second half of 2020.

Legal and professional fees were $1.2 million for the six months ended June 30, 2021 compared to $1.5 million for the same period in 2020. The decrease in legal and professional fees was mainly due to the decrease in consultancy services during current period.

As of June 30, 2021, cash and restricted cash totalled approximately $20.1 million and total equity was approximately $26.5 million.

Aptorum Group expects that its existing cash and restricted cash together with undrawn line of credit facility from related parties, will enable it to fund its operating and capital expenditure requirements for at least the next 12 months.