On May 16,2022 Allarity Therapeutics, Inc. ("Allarity" or the "Company"), a clinical-stage pharmaceutical company developing novel oncology therapeutics together with drug-specific DRP companion diagnostics for personalized cancer care, reported financial results for the fourth quarter and year ended December 31, 2021, and provided a corporate update (Press release, Allarity Therapeutics, MAY 16, 2022, View Source [SID1234614753]).

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"2021 was a momentous year for Allarity Therapeutics," said Steve Carchedi, President and Chief Executive Officer. "We advanced our clinical-stage assets, raised a record amount of new investment for the Company, and completed our listing on the U.S. Nasdaq stock exchange. We are grateful for the collective support of our internal team, shareholders, and advisors, who are enabling the further development of our prioritized programs to address significant unmet needs within difficult-to-treat cancers. As we await further feedback from the United States Food and Drug Administration (FDA) regarding our NDA application for dovitinib, we remain steadfast in our mission to pair promising cancer therapeutics with our proprietary companion diagnostic technology to help significantly improve treatment outcomes for patients suffering from cancer. We look forward to sharing further updates on dovitinib and our other two priority clinical programs throughout the year."

A delay in filing the Company’s Form 10-K triggered a notification of non-compliance by Nasdaq concerning Listing Rule 5250(c)(1), as announced on April 22, 2022. Issuing a promissory note to Novartis to replace an unenforceable note issued by one of the Company’s Danish subsidiaries in 2018 and an error in the calculation of a tax Net Operating Loss allowance led to a restatement of the Company’s Form 10-Q dated September 30, 2021, and financial statements for the twelve months ended December 31, 2020, were the primary cause of the delay. The Company has filed the restated Form 10-Q for September 30, 2021, and its Form 10-K for 2021 today with the U.S. Securities and Exchange Commission (SEC). With these filings completed, the Company expects to regain compliance with Nasdaq Listing Rule 5250(c)(1) in the near future. The restatement of our financial statements for the year ended December 31, 2020, also resulted in a "Triggering Event" under our Certificate of Designations for our Series A Preferred Stock (the "Preferred Stock") because of the requirement to file a post-effective amendment to the Company’s Form S-1 registration statement that registers shares of our common stock issuable upon conversion of the Preferred Stock. As previously disclosed, the Investor that holds all of our Preferred Stock and the Company entered into a Forbearance Agreement and Waiver, dated April 27, 2022, providing the Company a forbearance period until June 4, 2022, in order to have the post-effective amendment declared effective by the SEC.

Full Year 2021 and Recent Highlights

In March 2022, entered into two agreements amending the LiPlaCis program. As a result of this amendment, Allarity will be exempt from any future financial obligation associated with the further development of LiPlaCis, including the cancellation of outstanding liability of $971million. Allarity will also maintain its ability to receive possible future milestone payments of up to $3.5 million
Scheduled a Type C meeting with the FDA, to be held in Q2 2022, to discuss potential paths to approval for dovitinib. This action followed the FDA’s issuance of Refusal to File (RTF) letters in February 2022 in response to the Company’s New Drug Application (NDA) and related Pre-Market Approval (PMA) application for dovitinib
Announced licensing agreements with Oncoheroes Biosciences, which will fund and advance the clinical development of both dovitinib and stenoparib in pediatric cancers utilizing Allarity’s DRP companion diagnostics
Completed listing on the U.S. Nasdaq Stock Market under the trading symbol "ALLR"
Received a $20 million PIPE investment from an institutional investor in conjunction with U.S. Nasdaq listing
Entered into an agreement with Lonza Group for the manufacturing of dovitinib to meet anticipated future commercial production needs
Entered, in July 2021, into an agreement for the sale of our irofulven program and assets to Lantern Pharma, Inc., under which Allarity received a $1 million upfront payment; the Company is eligible to receive an additional $1 million in payments plus up to U.S. $16 million in milestone payments from Lantern over the life of the program, in addition to royalties on future commercial net sales of the product. In Q1 2022, the Company received a fee payment from Lantern Pharma under the this agreement
Completed an oversubscribed rights issue, raising SEK 102.8 million ($12.1 million) before issue costs to further finance the development of Allarity’s three priority pipeline programs
Announced positive preclinical data in osteosarcoma in which dovitinib increased the median survival time in animals by 50% compared to the control group
Initiated a Phase 2 trial of IXEMPRA in Europe for the second-line treatment of metastatic breast cancer (mBC), with trial sites opened in a number of European countries
Expanded enrollment in an ongoing Phase 2 trial of stenoparib for the treatment of ovarian cancer (OC), with new trial sites opened or planned in the U.S. and Europe.

Anticipated Milestones in 2022

Announcing results of the Type C meeting with the FDA and outlining future development plans for dovitinib and its DRP-Dovitinib companion diagnostic
Initiation of prospective clinical study of dovitinib in metastatic Renal Cell Carcinoma together with its DRP-Dovitinib companion diagnostic
Interim data readout of Phase 2 clinical trial for IXEMPRA in mBC anticipated in Q4 2022
Interim data readout of Phase 2 clinical trial for stenoparib in OC anticipated in Q4 2022
Fourth Quarter and Full Year 2021 Financial Results

Balance Sheet: As of December 31, 2021, Allarity’s cash was $19.6 million, as compared to $298 thousand as of December 31 2020. This includes net proceeds from the Company’s December 2021 initial public offering in the U.S. The Company’s current cash, are expected to fund operations through 2022.

R&D Expenses: Research and Development (R&D) expenses were $9.5 million for the three months ended December 31, 2021, and $14.2 million for the full year 2021, compared to $1.7 million and $4.2 million for comparable periods in 2020, respectively.

G&A Expenses: General and Administrative (G&A) expenses were $6.2 million for the three months ended December 31, 2021, and $12.4 million for the full year 2021, compared to $856 thousand and $4.1 million for comparable periods in 2020, respectively.

Net Loss: Net loss was $16.8 million for the three months ended December 31, 2021, and $26.6 million for the full year 2021, compared to $1.7 million and $6.6 million for comparable periods in 2020, respectively.

On May 16, 2022 Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in cell therapy to treat cancer, reported that it is presenting preclinical proof-of-concept data from its second next-generation SPEAR T-cell (ADP-A2M4N7X19) targeting MAGE-A4, and novel tumor-infiltrating lymphocytes (TILs) expressing IL-7 (ADP-TILIL7) at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) annual meeting (Press release, Adaptimmune, MAY 16, 2022, View Source [SID1234614752]). The Company is presenting the two posters today at 5:30 p.m. EDT during the Cell Therapies I and Targeted Gene and Cell Therapy I sessions.

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"We have seen impressive clinical results with our first-generation product, afami-cel, in sarcoma, and we set a goal to increase potency to achieve responses in additional indications," said Elliot Norry, Adaptimmune’s Chief Medical Officer. "To that end, we delivered our first next-gen product into the clinic incorporating CD8 and have shown responses across a broad range of solid tumor types in our SURPASS program. We have now presented preclinical data at ASGCT (Free ASGCT Whitepaper) from our second next-gen therapy designed to improve durability and persistence of SPEAR T-cells that supports clinical investigation."

New next-generation SPEAR T-cells show potential for enhanced clinical activity with improved proliferation, survival, and infiltration of immune cells into tumors in preclinical studies

The Company aimed to enhance durability and persistence by engineering a new next-gen SPEAR T-cell targeting MAGE-A4 to secrete IL-7 and CCL19 (ADP-A2M4N7X19) using "Proliferation-Inducing and Migration- Enhancing" (PRIME)1 technology
IL-7 stimulates T-cell proliferation and survival, and CCL19 induces infiltration of immune cells
Naturally occurring T-cells do not express IL-7 or CCL19
Next-generation ADP-A2M4N7X19 SPEAR T-cells were shown to produce IL-7 and CCL19 only in the presence of the MAGE-A4 cancer target
IL-7 production by ADP-A2M4N7X19 SPEAR T-cells enhanced T-cell survival, and CCL19 production induced infiltration of immune cells

Based on these data, Adaptimmune will initiate a Phase 1 clinical trial with ADP-A2M4N7X19 in multiple solid tumor indications
TILs engineered to produce IL-7 may result in a more effective therapy for people with metastatic melanoma with preclinical data demonstrating enhanced TIL survival

TIL therapy has shown some of the most favorable responses in refractory metastatic melanoma2
Adaptimmune applied their lentiviral technology to TILs engineering them to express IL-7 (ADP-TILIL7) with the aim to improve clinical responses

Data indicate that these engineered TILs produce biologically relevant amounts of IL-7; a factor that the TILs cannot produce on their own

IL-7 is known to support T-cell proliferation and survival, which may increase clinical activity and durability of T-cells

Based on these data, a single-center, Phase 1 clinical trial will be initiated at CCIT in Denmark with ADP-TILIL7 to treat patients with metastatic melanoma
The Company will also present a poster entitled "A Novel Flow Cytometry Method for Rapid Assessment of Lentiviral Detection" on May 19th.

On May 16, 2022 Elicio Therapeutics, a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer and other diseases, reported that it has entered into a clinical supply agreement with Regeneron to evaluate the safety and efficacy of Elicio’s lead asset, ELI-002, an investigational KRAS-targeted cancer vaccine, in combination with Regeneron’s Libtayo (cemiplimab), a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells, in patients with KRAS-driven tumors (Press release, Elicio Therapeutics, MAY 16, 2022, View Source [SID1234614734]). The combination therapy will be studied in KRAS-driven tumors including Stage III and IV non-small cell lung cancer (NSCLC), Stage IV colorectal cancer (CRC) and unresectable, locally advanced or oligometastatic pancreatic ductal adenocarcinoma (PDAC). The study, which is expected to begin in 2023, will be conducted by Elicio Therapeutics. Each party will provide their respective agent for the trial. Libtayo is being jointly developed by Regeneron and Sanofi.

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"We’re investigating ELI-002’s immune education in combination with the ability of Libtayo to block PD-1 and potentially activate the ELI-002-induced T cells to target cancers. This combination may provide a new treatment option for patients living with these difficult to treat cancers," said Dr. Christopher Haqq, Executive Vice President, Head of Research and Development, and Chief Medical Officer at Elicio. "ELI-002 includes mutated KRAS peptides that are delivered directly to the lymph nodes, ‘the schoolhouse of the immune system.’ The AMP technology allows for ELI-002 to be delivered in high quantities to the lymph nodes and remain there, where it will ‘educate’ the immune cells to target tumor cells for killing."

Dr. Annette Matthies, Chief Business Officer at Elicio, added, "Regeneron is a leading biotech company, and this clinical supply agreement supports the development of our ELI-002 therapeutic cancer vaccine program as well as our AMP platform. With the ongoing Phase 1 trial studying ELI-002 as a monotherapy and this upcoming combination study, we believe that ELI-002 has the potential to make a difference in the often-challenging KRAS space."

About ELI-002

ELI-002 is a structurally novel investigational AMP therapeutic vaccine targeting mutant KRAS-driven cancers. KRAS mutations are among the most prevalent human cancers. KRAS drives 32% of lung cancers, 40% of colorectal cancers and 85% to 90% of pancreatic cancer cases. ELI-002 is comprised of AMP-modified mutant KRAS peptide antigens and ELI-004, an AMP-modified immune-stimulatory oligonucleotide CpG adjuvant. The AMP mKRAS peptides and AMP CpG are targeted to the lymph node where they can potentially enhance the action of key immune cells.

ELI-002 is currently being studied in a Phase 1 trial (AMPLIFY-201) in patients with early-stage KRAS-driven solid tumors, following surgery and chemotherapy. Enrollment in the Phase 1 study continues, following the dosing of the first patient at MD Anderson in October 2021, with the expectation to move from Cohort 2 to Cohort 3 in the next quarter, and the Phase 1b/2 trial planned for early 2023. This trial will study the broad spectrum 7-peptide formulation of ELI-002. This formulation is designed to provide immune response coverage against seven of the most common KRAS mutations, thereby increasing the potential patient population for ELI-002 and potentially reducing the chance of bypass resistance mechanisms.

About the Amphiphile Platform

Our proprietary Amphiphile, or AMP, platform delivers investigational immunotherapeutics directly to the "brain center" of the immune system – the lymph nodes. We believe this site-specific delivery of disease-specific antigens, adjuvants, and other immunomodulators may efficiently educate, activate, and amplify critical immune cells, potentially resulting in induction and persistence of potent adaptive immunity required to treat many diseases. In preclinical models, we have observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function, and durability. We believe our AMP lymph node-targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes.

Our AMP platform, originally developed at the Massachusetts Institute of Technology, or MIT, has broad potential across cancers, infectious diseases, and other disease indications to advance a number of development initiatives through internal activities, in-licensing arrangements or development collaborations and partnerships.

The Amphiphile platform is thought to deliver immunotherapeutics directly to the lymph nodes by latching on to the protein albumin, found in the bloodstream, as it travels to lymphatic tissue. In preclinical models, we have observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function, and durability.

On May 16, 2022 Caring Cross, a 501c(3) non-profit dedicated to accelerating the development of advanced medicines and enabling access to cures for all patients, everywhere, reported that Rimas Orentas, Ph.D., Scientific Director of Caring Cross, and Kim Anthony-Gonda, Ph.D., Director of Cell & Gene Therapy at Caring Cross, will be presenting two posters at the American Society of Gene & Cell Therapy Annual Meeting (ASGCT) (Free ASGCT Whitepaper) 2022 (Press release, Caring Cross, MAY 16, 2022, View Source [SID1234614733]). The meeting will be a hybrid event with participants online and in-person in Washington, D.C., on May 16-22, 2022.

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Details of the posters are as follows:

Poster 1 CAR T-Cell Antigen-Non-Specific Killing (CTAK), CAR-T NK-Like
Killing, and CD22 CAR-T Mediated Killing Are All Optimized by
Bryostatin Treatment of Pre-B Acute Lymphocytic Leukemia Cell
Lines
Session: Cancer – Immunotherapy, Cancer Vaccines I
Board No.: M-213
Date: May 16th, 2022
Time: 1730-1830 EDT
Speaker: Dr. Rimas Orentas

Poster 2 IND-enabling Studies Towards an Open Phase I/IIa Trial to
Evaluate the Safety and Efficacy of Anti-HIV DuoCAR-T Cell
Therapy
Session: Gene & Cell Therapy Trials in Progress
Board No.: Tu-299
Date: May 17th, 2022
Time: 1730-1830 EDT
Speaker: Dr. Kim Anthony-Gonda
Register View Source
The first poster details the results of a study conducted in partnership with the University of Washington Department of Pediatrics and the Ben Towne Center for Childhood Cancer Research, Seattle Children’s Research Institute, which defined a new property of chimeric antigen receptor therapy (CAR-T). When the CAR-T cells are activated by the signals used to produce therapeutic cell populations, they were found to mediate non-CAR-directed cytolysis, which the investigators termed CAR T-cell antigen-non-specific killing (CTAK). Importantly, the mediated killing from the CAR-T manufacturing process is distinguishable from that exhibited by natural killer (NK) cells – white blood cells that target tumors and cells infected by viruses – or lymphokine-activated killer (LAK) cells, those stimulated by cytokines alone to kill tumor cells.

"This discovery is a significant milestone in our mission to increase the efficacy of CAR-T therapies," commented Dr. Orentas. "Increasing our knowledge of how bryostatin effects are disease-type specific, even within hematologic malignancies, will contribute to our development of curative therapies. Moreover, many of the side-effects attributed to CAR-T may be due to CTAK activity. We are excited to share our findings at ASGCT (Free ASGCT Whitepaper) and use this opportunity to collaborate with others and strengthen the efforts of the Caring Cross network to provide place of care infrastructure for effective gene therapies to areas where it is most needed."

The second poster highlights results from an IND-enabling study examining whether Caring Cross’ Anti-HIV DuoCAR-T cell technology can travel to the spleen of humanized mice with active HIV infection and inhibit replication of the virus. Data from the study concluded that intravenously administered Anti-HIV DuoCAR-T cells travelled from the peripheral blood to the spleen and demonstrated potent and durable suppression of HIV replication after a single injection of Anti-HIV DuoCAR-T cells.

"It is the Caring Cross mission to create accessible, curative therapies. There is currently no such cure for HIV, only long-term drug therapies," stated Dr. Anthony-Gonda. "Our Anti-HIV DuoCAR-T cell therapeutic candidate is designed to be a curative treatment option that eliminates HIV-infected cells and safely suppresses HIV infection long-term in the body after a single infusion of Anti-HIV DuoCAR-T cells. We are grateful to ASGCT (Free ASGCT Whitepaper) for hosting our presentation, we are determined to investigate our technology further in a Phase 1/2a clinical trial."

On May 16, 2022, Inhibikase Therapeutics, Inc. (the "Company") reported that entered into an Equity Distribution Agreement (the "Agreement") with Piper Sandler & Co., as sales agent (the "Agent"), pursuant to which the Company may, from time to time, issue and sell shares of its common stock, par value $0.001 per share, in an aggregate offering price of up to $9,801,287 (the "Shares") through the Agent (Filing, 8-K, Inhibikase Therapeutics, MAY 16, 2022, View Source [SID1234614730]).

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The offer and sales of the Shares made pursuant to the Agreement, if any, will be made under the Company’s effective "shelf" registration statement on Form S-3 (File No. 333-262551) dated February 11, 2022, the base prospectus contained therein, and a prospectus supplement related to the offering of the Shares dated May 16, 2022.

Under the terms of the Agreement, the Agent may sell the Shares at market prices by any method that is deemed to be an "at the market offering" as defined in Rule 415 under the Securities Act, as amended.

Subject to the terms and conditions of the Agreement, the Agent will use its commercially reasonable efforts to sell the Shares from time to time, based upon the Company’s instructions. The Company has no obligation to sell any of the Shares, and may at any time suspend sales under the Agreement or terminate the Agreement in accordance with its terms. The Company has provided the Agent with customary indemnification rights, and the Agent will be entitled to a fixed commission of 3.0% of the aggregate gross proceeds from the Shares sold. The Agreement contains customary representations and warranties, and the Company is required to deliver customary closing documents and certificates in connection with sales of the Shares. The Company has agreed to reimburse the Agent for the fees and disbursements of its counsel, payable upon execution of the Equity Distribution Agreement, in an amount not to exceed $75,000 in connection with the establishment of this at-the-market offering program plus an additional amount of up to $15,000 for each quarterly period thereafter.

The legal opinion of McDermott Will and Emery LLP, counsel to the Company, relating to the Shares is filed as Exhibit 5.1 hereto.

The foregoing description of the Agreement is not complete and is qualified in its entirety by reference to the full text of such agreement, a copy of which was filed as Exhibit 10.1 hereto and incorporated herein by reference.

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