On May 17, 2021 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage biotechnology company focused on discovering and developing novel small molecule drugs for the treatment of cancer and other life-threatening diseases, and Antengene Corporation, Ltd. (SEHK: 6996.HK), a leading clinical-stage R&D driven biopharmaceutical company focused on innovative medicines for oncology and other life-threatening diseases, reported an exclusive, worldwide license agreement for the development and commercialization of CB-708, Calithera’s small molecule inhibitor of CD73 (Press release, Calithera Biosciences, MAY 17, 2021, View Source [SID1234580113]).

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"This agreement validates the capabilities of our drug discovery engine and represents a significant milestone for our CD73 program," said Susan Molineaux, PhD, president and chief executive officer of Calithera. "Antengene brings significant enthusiasm and proven global capabilities to the development and future commercialization of CB-708, a potential best-in-class oral small molecule CD73 inhibitor. This licensing agreement enables the continued advancement of this promising program, while allowing Calithera to focus our resources on our more advanced clinical programs evaluating telaglenastat in non-small cell lung cancer and CB-280 in cystic fibrosis."

CB-708 is a highly potent, selective, orally-bioavailable small molecule inhibitor of CD73. Preclinical data presented at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting and the 2019 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting demonstrated that CB-708 has immune-mediated, single agent activity in syngeneic mouse tumor models. In preclinical studies, CB-708 was well-tolerated and showed enhanced anti-tumor activity when combined with either an anti-PD-L1 immunotherapy or with chemotherapeutic agents, such as oxaliplatin or doxorubicin. CB-708 has completed GLP toxicology studies and is poised to advance into clinical development.

"We are excited to continue the advancement of CB-708 through our deep experience in global clinical development and extensive track record in commercialization in major markets around the world," said Dr. Jay Mei, Founder and Chief Executive Officer of Antengene. "CB-708 is a highly differentiated oral small molecule CD73 inhibitor with best-in-class potential. Antengene will continue to complete the GMP manufacturing of CB-708 and advance it into clinical trials for the treatment of multiple cancers including solid tumors and hematologic malignancies. This agreement brings a great addition to our synergistic portfolio of 12 assets with combinatory potential, is a testament to our abilities in accelerating global development, and represents another step in realizing our mission of treating patients beyond borders."

Under the terms of the license agreement, Calithera will receive an upfront payment and potential development, regulatory and sales milestones of up to $255.0 million. Additionally, Calithera is eligible to receive tiered royalties on sales of the licensed product up to low double-digits. Antengene Investment Ltd, a wholly owned subsidiary of Antengene Corporation, will receive exclusive, worldwide rights to develop and commercialize CB-708.

On May 17, 2021 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported its recent accomplishments and financial results for the quarter ended March 31, 2021 (Press release, Soligenix, MAY 17, 2021, View Source [SID1234580153]).

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"This year continues to be an exciting year of progress for Soligenix," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We recently announced presentation of clinical data from our successful pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) clinical trial for HyBryte (SGX301) in the treatment of cutaneous T-cell lymphoma (CTCL) at both the American Academy of Dermatology, where HyBryte was designated "Top 12 late-breaking research," and the Society for Investigative Dermatology. We also received U.S. Food and Drug Administration (FDA) conditional acceptance of HyBryte as the proposed brand name for SGX301 (synthetic hypericin), as we continue to prepare for a new drug application (NDA) submission and U.S. commercialization for this novel first-in-class photodynamic therapy for treatment of early stage CTCL. Under our Public Health Solutions business segment, supported by non-dilutive government funding, we continue to advance multiple therapeutic and vaccine candidates. CiVax, our heat stable COVID-19 vaccine, recently demonstrated that the proprietary subunit protein antigen, locked into its receptor-binding configuration, was immunogenic in both mice and non-human primates, which is an important step in advancing CiVax towards human clinical trials."

Dr. Schaber continued, "With approximately $30 million in cash, not including our non-dilutive government funding, we anticipate having sufficient capital to achieve multiple inflection points as we advance our rare disease pipeline, including NDA filing and U.S. commercialization of HyBryte in CTCL, where we estimate peak U.S. annual net sales to exceed $90 million and the total U.S. revenues during the 10-year forecast period to be greater than $700 million."

Soligenix Recent Accomplishments

On May 10, 2021, the Company announced that HyBryte (hypericin) was awarded an "Innovation Passport" for the treatment of early stage CTCL in adults under the United Kingdom’s (UK’s) Innovative Licensing and Access Pathway (ILAP). To view this press release, please click here.
On April 28, 2021, the Company announced that its Senior Vice President and Chief Scientific Officer, Oreola Donini, PhD, delivered a presentation demonstrating the potency of the CiVax (COVID-19 vaccine) development program in mice and non-human primates (NHPs), at the Annual Conference on Vaccinology Research, held April 26-27, 2021. To view this press release, please click here.
On April 26, 2021, the Company announced that Ellen Kim, MD, Medical Director, Dermatology Clinic, Perelman Center for Advanced Medicine, Professor of Dermatology at the Hospital of the University of Pennsylvania, and the Lead Principal Investigator for the Phase 3 FLASH study, delivered a presentation at the American Academy of Dermatology Association Virtual Meeting Experience, held April 23-25, 2021, expanding on data related to the efficacy and safety of HyBryte in the treatment of CTCL. To view this press release, please click here.
On April 7, 2021, the Company announced that the FDA had conditionally accepted HyBryte as the proposed brand name for SGX301 (synthetic hypericin), the Company’s novel first-in-class photodynamic therapy for first-line treatment of early stage CTCL. To view this press release, please click here.
On March 30, 2021, the Company announced its recent accomplishments and financial results for the year ended December 31, 2020. To view this press release, please click here.
Financial Results – Quarter Ended March 31, 2021

Soligenix’s revenues for the quarter ended March 31, 2021 were $0.1 million as compared to $0.9 million for the quarter ended March 31, 2020. Revenues included payments on a contract in support of RiVax, our ricin toxin vaccine candidate, and grants received to support the development of: SGX943 for treatment of emerging and/or antibiotic-resistant infectious diseases; ThermoVax, our thermostabilization technology; and CiVax, our vaccine candidate for the prevention of COVID-19.

Soligenix’s basic net loss was $2.4 million, or ($0.06) per share, for the quarter ended March 31, 2021, as compared to $7.6 million, or ($0.32) per share, for the quarter ended March 31, 2020. This decrease in net loss was primarily due to a $5.0 million success milestone due to Hy Biopharma that was paid in common stock (based upon an effective per share price of $2.56) as a result of SGX301 demonstrating statistically significant treatment response in the pivotal Phase 3 clinical trial Inc. during the three months ended March 31, 2020.

Research and development expenses were $1.4 million as compared to $2.7 million for the quarters ended March 31, 2021 and 2020, respectively. The decrease in research and development spending for the quarter ended March 31, 2021 was primarily attributable to the reduction in expense due to the completion of the HyBryte and SGX942 clinical trials.

General and administrative expenses were $0.9 million for both the three months ended March 31, 2021 and 2020.

As of March 31, 2021, the Company’s cash position was approximately $30.5 million.

On May 17, 2021 Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, reported its financial results for the first quarter ended March 31, 2021, and provided a business update (Press release, Nuvation Bio, MAY 17, 2021, View Source [SID1234580171]).

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"Nuvation Bio continues to make meaningful progress on advancing our deep pipeline of therapies for difficult-to-treat cancers and remains on track to submit five additional Investigational New Drug (IND) applications by 2026," said David Hung, M.D., founder and chief executive officer of Nuvation Bio. "We also continue to enroll and dose patients in our Phase 1/2 study of NUV-422, our lead cyclin-dependent kinase (CDK) 2/4/6 inhibitor, in high-grade gliomas and expect top-line data from the Phase 1 portion of this study in 2022. Our strong cash, cash equivalents and marketable securities of $824.7 million at the end of the first quarter provides us sufficient resources to continue to execute on our robust clinical development plan and grow our pipeline of novel and mechanistically distinct cancer treatments."

Recent Business Highlights

Enrollment ongoing in Phase 1/2 study of NUV-422. Nuvation Bio continues to enroll and dose patients in the Phase 1/2 study of its lead investigational compound, NUV-422, a CDK 2/4/6 inhibitor, in adult patients with recurrent or refractory high-grade gliomas, including glioblastoma multiforme (GBM). The Phase 1 dose escalation portion of the study is designed to evaluate safety and tolerability, as well as to determine a recommended Phase 2 dose based on the tolerability profile and pharmacokinetic properties of NUV-422. The Phase 2 dose expansion portion of the study is expected to initially focus on patients with high-grade gliomas and is designed to evaluate overall response rate, duration of response and survival. Data from the Phase 1 portion of this study is expected in 2022.
First Quarter 2021 Financial Results

As of March 31, 2021, Nuvation Bio had cash, cash equivalents, and marketable securities of $824.7 million.

For the three months ended March 31, 2021, research and development expenses were $15.9 million, compared to $7.3 million for the three months ended March 31, 2020. The increase of $8.6 million was due to an increase in third-party costs related to research services and manufacturing to advance our current preclinical programs and Phase 1/2 clinical trial. Also, the current period includes approximately $3.7 million related to the issuance of common stock as consideration for the purchase of in-process research and development.

For the three months ended March 31, 2021, general and administrative expenses were $4.6 million, compared to $1.9 million for the three months ended March 31, 2020. The increase of $2.7 million was due to increased personnel-related costs driven by an increase in headcount, as well as increases in professional fees, insurance costs and tax expense.

For the three months ended March 31, 2021, Nuvation Bio reported a net loss of $20.4 million, or $(0.12) per share. This compares to a net loss of $8.7 million, or $(0.10) per share, for the comparable period in 2020.

Restatement of Panacea Financial Statements

Nuvation Bio also announced that, as reported in a Current Report on Form 8-K filed with the SEC on May 14, 2021, as a result of guidance provided by the SEC on April 12, 2021 regarding the accounting for warrants issued by special purpose acquisition companies (SPACs), it is restating the previously issued 2020 consolidated financial statements of Panacea Acquisition Corp. (Panacea). Panacea combined with Nuvation Bio Inc. (Legacy Nuvation Bio) and changed its name to Nuvation Bio Inc. on February 10, 2021 (the Merger).

The restatement pertains to the accounting treatment for Panacea’s public and private placement warrants that were outstanding on December 31, 2020, as well as the forward purchase agreement (the "FPA") with certain anchor investors, which provided for the potential future issuance of securities, including additional warrants. Consistent with market practice among SPACs, Panacea had been accounting for the warrants and the FPA as equity under a fixed accounting model. However, in light of the recent SEC guidance, we are restating Panacea’s historical financial statements for the year ended December 31, 2020 such that the warrants and the FPA are accounted for as liabilities and marked-to-market each reporting period. In general, under the mark-to-market accounting model, we measure the fair value of the liability-classified warrants and the FPA at the end of each reporting period and recognize any changes in their fair value in our operating results. As of December 31, 2020, Panacea had 4,954,167 warrants outstanding and subject to reclassification. Upon completion of the Merger, an additional 833,333 warrants were issued pursuant to the FPA.

The change in accounting treatment does not impact the historical financial statements of Legacy Nuvation Bio, which became the historical financial statements of the combined company upon completion of the Merger. In addition, Nuvation Bio currently expects that the reclassification of the warrants will have no impact on the liquidity or cash or cash equivalents in the historical financial statements of Panacea.

On May 17, 2021 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to treat ESR1-mutated metastatic breast and gynecological cancers, reported the publication of its scholarly article, "Lasofoxifene as a potential treatment for therapy-resistant ER-positive metastatic breast cancer," in the peer-reviewed journal Breast Cancer Research (Press release, Sermonix Pharmaceuticals, MAY 17, 2021, View Source [SID1234580244]). The paper details positive findings from a preclinical study of lasofoxifene, a selective estrogen receptor modulator (SERM), in mouse models of endocrine therapy-resistant breast cancer.

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In this study, luciferase-GFP tagged MCF7 cells bearing wild-type, Y537S or D538G estrogen receptor alpha (ERα) mutations were injected into the mammary ducts of NSG mice, which were subsequently treated with lasofoxifene or fulvestrant as single agents or in combination with palbociclib, a CDK4/6 inhibitor that blocks cell-cycle progression. Tumor growth and metastasis were monitored with in vivo and ex vivo luminescence imaging, terminal tumor weight measurements and histological analysis.

As a monotherapy, lasofoxifene was found to be more effective in this preclinical model than fulvestrant at inhibiting primary tumor growth and reducing metastases. Adding palbociclib improved the effectiveness of both lasofoxifene and fulvestrant for tumor suppression and metastasis prevention at four distal sites (lung, liver, bone and brain), with the combination of lasofoxifene/palbociclib showing more potency than that of fulvestrant/palbociclib.

"The results of this study demonstrate, for the first time, the anti-tumor activity of lasofoxifene in mouse models of endocrine therapy-resistant breast cancer harboring ESR1 mutations, and its superiority to fulvestrant in this preclinical model," said Barry Komm, Ph.D., Sermonix chief scientific officer and co-author of the manuscript. "These findings support continued development of this promising compound in a clinical setting. I look forward to data from our ongoing ELAINE 1 Phase 2 clinical study, which is evaluating lasofoxifene versus fulvestrant, early next year."

Endocrine therapy resistance, driven in part by more widespread use of aromatase inhibitors, represents a significant challenge in the treatment of ER+ metastatic breast cancer and highlights the urgent need for more effective interventions, according to Dr. Geoffrey Greene, the study’s lead investigator.

"The results of this study convincingly demonstrate that lasofoxifene suppresses tumor growth and metastases in human-derived xenograft models harboring the Y537S and D538G ESR1 mutations, the most commonly observed ERα mutations," said Dr. Greene, M.D., Ph.D., chair of the Ben May Department for Cancer Research at the University of Chicago. "I believe this compound, with notable activity on breast cancer models with ESR1 mutations, combined with a long half-life and high bioavailability, has the potential to present a differentiated profile to current hormonal treatments in overcoming the acquired resistance that limits their long-term effectiveness. I am eager to see results from in-human studies."

The paper can be accessed online at: View Source

On May 17, 2021 Vyant Bio, Inc. (the "Company") (Nasdaq: VYNT), is an innovative biotechnology company reported that focused on partnering with pharmaceutical and other biotechnology companies to identify novel and repurposed therapeutics through the integration of human-derived biology with data science technologies and IND-enabling expertise (Press release, Cancer Genetics, MAY 17, 2021, View Source [SID1234580114]).

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RECENT STRATEGIC AND OPERATIONAL HIGHLIGHTS IN Q-1 2021

■Rebranded the Company from Cancer Genetics to Vyant Bio (Nasdaq: VYNT)
■Completed merger with StemoniX, Inc.
■Completed two equity financing rounds to raise $27.5 million in cash, entered into Q2 with $33.1 million of cash on the balance sheet
■Investing in research and development to optimize drug discovery capabilities
■Launched commercial stage, novel disease models in Rett Syndrome and CDKL5
■Initially focusing on novel and repurposed drugs to treat Rett Syndrome and CDKL5

Jay Roberts, Chief Executive Officer of Vyant Bio stated, "in Q1 2021, we reached an important milestone with the closing of the merger with StemoniX, uniquely positioning the combined company to focus our business on discovering applications for novel and repurposed therapeutics. We believe that drug discovery needs to progressively evolve as we know the traditional methods and models for predicting safe and effective drugs have under-performed, as evidenced by the billions of dollars and years of time it takes to bring novel drugs to market. With this as a backdrop, we are focusing our business on converging an impactful approach to drug discovery with data science and biology-driven technologies at the core with engineering disciplines and regulatory expertise."

"Vyant Bio has commercialized the development, engineering and manufacturing of disease models, built on its induced pluripotent stem cell ("iPSC") technology, and has developed neural and cardiac screening platforms, which are used to screen novel and repurposed compound targets", stated Ping Yeh, Vyant Bio’s Chief Innovation Officer. "The most mature disease models are being used to find therapeutic candidates in the central nervous system with its microBrain, driven by a focus on Rett Syndrome and CDKL5 neurological disorders. With the addition of the vivoPharm cancer cell-line assets and scientific expertise in oncology, the Company believes it can also advance models targeting Glioblastoma and Parkinson’s disease. The team has also made progress with our microHeart platform, so we believe there will be continued interest from partners with an interest in Cardiac Fibrosis and Rett Syndrome", Mr. Yeh continued.

"Our human-derived models, combined with the latest data science and software techniques, can identify and rank order repurposed and novel compounds by target. In our current drug discovery efforts, we aim to leverage our iPSC technology to identify drug candidates for licensure or clinical development. We are in active discussions with prospective pharma partners to offer exclusive licenses to certain disease models, and expect to enter into similar license agreements for access to both novel and repurposed therapies. The Company is striving to receive a mix of upfront payments, licensing fees, milestone-based fees and ongoing royalty payments", Mr. Yeh concluded.

The Company filed its quarterly report for Q1 2021 on Form 10-Q today with the Securities and Exchange Commission. The Company formerly known as Cancer Genetics, Inc., StemoniX and CGI Acquisition, Inc. ("Merger Sub") entered into a merger agreement on August 21, 2020, which was amended on February 8, 2021 and February 26, 2021(as amended, the "Merger Agreement"). Pursuant to the terms of the Merger Agreement, Merger Sub was merged ("the Merger") with and into StemoniX on March 30, 2021, with StemoniX surviving the Merger as a wholly owned subsidiary of the Company. The Merger was accounted for as a reverse acquisition with StemoniX being the accounting acquirer of CGI using the acquisition method of accounting.

FIRST QUARTER 2021 FINANCIAL RESULTS

As StemoniX was deemed to have acquired CGI for accounting purposes and the Merger closed on March 30, 2021, the Company’s first quarter financial results are primarily the StemoniX operations.

Cash and cash equivalents totaled approximately $33.1 million as of March 31, 2021.

Total revenues increased 32%, or $54 thousand, to $222 thousand for the three months ended March 31, 2021, as compared with $168 thousand for the three months ended March 31, 2020.

Cost of goods sold – service aggregated $89 thousand and $132 thousand, respectively, for the three months ended March 31, 2021 and 2020, resulting in a cost of goods sold of 77% and 97%, respectively, of service revenues.

Cost of goods sold – product aggregated $396 thousand and $166 thousand for the three months ended March 31, 2021 and 2020, respectively, resulting in a cost of goods sold gross margin deficit of $290 thousand and $134 thousand. Our product manufacturing capabilities currently have excess capacity to support future growth.

Research and development expenses decreased by 19%, or $189 thousand to $820 thousand for the three months ended March 31, 2021 from $1.0 million for the three months ended March 31, 2020.

Selling, general and administrative expenses increased by 46%, or $383 thousand, to $1.2 million for the three months ended March 31, 2021, as compared with $833 thousand for the three months ended March 31, 2020.

Merger related costs for the three-month period ended March 31, 2021 were $2.1 million.

Total other expense for the three months ended March 31, 2021 was $2.9 million, which consisted of a number of non-recurring non-cash items related to the conversion of the StemoniX’s capital structure to StemoniX common stock and exchange for Company common stock.