On March 10, 2021 XOMA Corporation (Nasdaq: XOMA) reported its fourth quarter and full-year 2020 financial results and business highlights (Press release, Xoma, MAR 10, 2021, View Source [SID1234576415]).

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"Our success in 2020 is a direct reflection of our strategy at work. As a result of the commitment by our partners to improve human health, we saw multiple programs advance further in the clinic. Novartis, Merck, Takeda, Incyte, Rezolute, and an undisclosed partner individually launched Phase 2 clinical studies with an asset in the XOMA portfolio. XOMA’s shareholders benefited from the milestones we received as our partners made these advancements, highlighted by the $25 million milestone we earned as Novartis initiated its Phase 2 development of NIS793, an anti-TGFβ monoclonal antibody, in patients with metastatic pancreatic cancer," stated Jim Neal, Chief Executive Officer at XOMA.

"Our business model is unique in that we are able to expand our portfolio by taking a long-term view of the development process and potential associated economics. As an example, in 2019 we acquired interests in two exciting platform technologies that we believe will produce multiple clinical candidates to further increase our royalty license portfolio. One of those arrangements with Bioasis led to our acquisition in November of the economic rights to four lysosomal storage disorder enzymes the Chiesi Group is exploring for rare disease indications.

"We are pleased to report XOMA is in a strong financial position with more than $84.2 million in cash at the end of 2020. Our operating expenses remain at our targeted levels. Our recent perpetual preferred equity offering provided us with additional capital to continue to acquire milestone and royalty assets to further increase the potential value of our portfolio."

Business Highlights

XOMA recognized revenue of $29.4 million in 2020 and reduced its Novartis debt obligation to $9.1 million.
XOMA acquired the milestone and royalty economics associated with four lysosomal storage disorders that Chiesi Group licensed from Bioasis Technologies.
XOMA and Zydus announced IL-2-based immuno-oncology therapy licensing agreement.
XOMA raised more than $24 million in a perpetual preferred stock offering, which is listed on the NASDAQ market under the symbol XOMAP, paying a quarterly dividend of 8.625%.
The Company’s stock was added to the Russell 2000 and Russell 3000 in June.
Updates About Partnered Assets in Development
"Even in an exceptionally challenging environment, our partners made significant progress in their clinical development programs. We thank those who volunteer to be part of these clinical studies, as their participation is an important component of our partners’ process to bring novel treatments to patients in need," Mr. Neal continued. "We congratulate Sesen Bio for their recent announcement that the Food and Drug Administration has accepted the Biologics Licensing Application for Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer and granted it a Priority Review."

2020 Phase 2 launches:

Novartis’ NIS793 study in patients with metastatic pancreatic cancer
Takeda’s mezagitamab (TAK-079) studies in patients with myasthenia gravis and thrombocytopenia
Rezolute’s RZ358 study in patients with congenital hyperinsulinism
Merck’s MK-4830 study in patients with non-small cell lung cancer
Incyte’s INCAGN1876 study in patients with recurrent glioblastoma
One undisclosed partner
Financial Results
XOMA recorded total revenues of $27.6 million for the fourth quarter of 2020, compared to $0.4 million for the fourth quarter of 2019. For the full year of 2020, XOMA recorded revenues of $29.4 million, compared to $18.4 million for the full year of 2019. Revenues for the full year of 2020 reflect $25.0 million in milestone revenue earned under the Company’s Anti-TGFβ Antibody License Agreement with Novartis International and $2.0 million earned under XOMA’s collaboration agreement with Takeda. Revenues for the full year of 2019 reflect $14.0 million recognized under the Company’s license agreement and common stock purchase agreement with Rezolute and $2.5 million in revenue earned from a one-time payment under XOMA’s license agreement with Janssen.

Research and development (R&D) expenses were $0.03 million for the fourth quarter of 2020, compared to $0.1 million for the fourth quarter of 2019. R&D expenses for the full year of 2020 were $0.2 million, compared to $1.3 million for the same period in 2019. The $1.1 million decrease between the periods was primarily due to a $0.5 million decrease in salary and related expenses resulting from a shift in employee duties from R&D to a general and administrative (G&A) department and a $0.5 million decrease in license fee expenses.

G&A expenses were $3.7 million for the fourth quarter of 2020, including $0.7 million in stock-based expenses, compared to $4.3 million for the fourth quarter of 2019. G&A expenses were $16.8 million for the full year of 2020, including $4.0 million in stock-based expenses, compared to $21.0 million for the full year of 2019. The $4.2 million decrease in 2020 as compared with 2019 was primarily due to a $3.9 million reduction in facilities costs due to the termination of our legacy leases and a $1.2 million reduction in salary and related expenses. The decreases in 2020 were partially offset by a $1.4 million increase in consulting and legal costs.

The Company’s net cash provided by operations during the quarter was $17.7 million. XOMA’s net cash provided by operations in 2020 was $10.1 million.

Interest expense for the fourth quarter of 2020 was $0.4 million, as compared to $0.6 million for the fourth quarter of 2019. For the full year of 2020, interest expense was $1.8 million, compared with $1.9 million reported in the full year of 2019. The decrease in interest expense during 2020 is due to a reduction in interest rates and lower outstanding debt balances.

Other expense, net was $0.8 million for the fourth quarter of 2020, compared to other income, net of $0.3 million in the corresponding quarter of 2019. Total other income, net was $1.2 million for the full year of 2020, compared to $3.8 million for the corresponding period of 2019. The decrease in 2020 primarily reflects the termination of XOMA’s legacy leases in 2019 and the sublease income the Company associated with those leases, offset by a $1.0 million increase in the fair value of equity securities XOMA holds in Rezolute, Inc.

Net income for the fourth quarter of 2020 was $22.7 million, compared to net loss of $4.3 million for the fourth quarter of 2019. Net income for the full year of 2020 was $13.3 million, compared to net loss of $2.0 million for the full year of 2019.

On December 31, 2020, XOMA had cash of $84.2 million compared with $56.7 million on December 31, 2019. The Company’s current cash position is expected to be sufficient to fund its operations for multiple years.

On March 10, 2021 Oncorus, Inc. (Nasdaq:ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, reported fourth quarter and full year 2020 financial results and provided business highlights (Press release, Oncorus, MAR 10, 2021, View Source [SID1234576414]).

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"2020 was a year of significant evolution for Oncorus as we successfully transitioned to a clinical-stage and publicly-traded company," said Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer of Oncorus. "In addition to moving our lead viral immunotherapy candidate, ONCR-177, into a clinical trial, we continued to advance multiple pipeline candidates across our oncolytic Herpes Simplex Virus (oHSV) and Synthetic Virus Platforms. We also began to plan operational and manufacturing scale-up to support our anticipated growth in the coming years."

Dr. Ashburn continued, "Bolstered by a strong cash position, we anticipate multiple milestones in 2021 that will further advance Oncorus’ leadership in the viral immunotherapy space. These include the initial interim data readout from our ongoing ONCR-177 clinical trial, the nomination of our first intravenously administered synthetic virus clinical candidates as well as our second intratumorally administered oHSV clinical candidate, and the completion of the first buildout phase of our GMP clinical manufacturing facility. We look forward to continued growth throughout 2021, driven by our mission to realize the full promise of viral immunotherapy for cancer patients."

Oncorus anticipates reporting interim data from its ongoing Phase 1 clinical trial of its lead oHSV-based clinical candidate ONCR-177 in patients with solid tumor indications in the second half of 2021 through the second half of 2022. The company plans to nominate its first synthetic virus clinical candidates, coxsackievirus A21 and Seneca Valley Virus programs, in the first half of 2021 and its second oHSV clinical candidate, which will specifically target brain cancer, including glioblastoma multiforme, in the second half of 2021.

Fourth Quarter and Full Year 2020 and Recent Highlights

Recent Highlights

Recently completed public offering of common stock. In February 2021, Oncorus completed an underwritten public offering of common stock, at a public offering price of $19.00 per share, raising $57.0 million in aggregate gross proceeds.
Announced buildout of Good Manufacturing Practice (GMP) viral immunotherapy clinical manufacturing facility. In January 2021, Oncorus announced the signing of a 15-year lease to build a state-of-the-art, 88,000 square foot GMP viral immunotherapy clinical manufacturing facility in Andover, Mass. The facility is intended to provide a comprehensive solution for Oncorus’ Chemistry, Manufacturing and Controls (CMC) development needs, enabling the manufacture, quality, control and supply of clinical-grade viral immunotherapies for investigational new drug (IND)-enabling studies and clinical studies. Oncorus anticipates the first phase of the facility’s buildout will be completed in late 2021, including process development and quality control, with GMP multi-product manufacturing capabilities and full operation commencing in early 2023. Oncorus plans to continue partnering with contract manufacturing organizations to provide additional support and capacity. The company expects to employ up to 100 Oncorus team members at the site.

Announced publication of ONCR-177 preclinical data demonstrating potent and durable antitumor activity. In January 2021, Oncorus announced the recent publication of preclinical data supporting the clinical development of ONCR-177. In the paper, entitled, "ONCR-177, an Oncolytic HSV-1 Designed to Potently Activate Systemic Antitumor Immunity" (Haines, et al., 2020), published online in the journal Cancer Immunology Research, ONCR-177 demonstrated potent and durable antitumor activity in multiple immune-competent tumor models. The preclinical activity of ONCR-177 was shown to be driven by Oncorus’ unique combination of five complementary immunomodulatory transgene payloads in addition to its retention of γ34.5. A herpes simplex virus 1 (HSV-1) gene, γ34.5 allows the virus to replicate in the presence of host antiviral immune responses.
Fourth Quarter and Full Year 2020 Highlights

Appointed Steve Harbin as Chief Operating Officer (COO) and Chief of Staff. In December 2020, Oncorus appointed Steve Harbin as COO and Chief of Staff, to lead planning and execution of its anticipated operational and manufacturing scale-up. Mr. Harbin brings more than 30 years of diverse operational experience in biotech, pharmaceuticals and in-vitro diagnostics. His experience includes serving in several executive committee roles at Moderna, Inc. for six years, where he was a key driver of the company’s successful growth strategy, overseeing clinical and non-clinical manufacturing operations, supply chain, facilities and human resources. Previously Mr. Harbin served as Senior Vice President, Global Operations for France-based bioMérieux SA, and also held multiple leadership roles within Eli Lilly and Company globally.

Expanded Board of Directors with appointment of Scott Canute. In December 2020, Oncorus expanded its Board with the appointment of Scott Canute. Mr. Canute has nearly 40 years of broad experience in the biopharmaceutical industry, including leading global manufacturing and operations strategy and execution for Genzyme Corporation and Eli Lilly and Company.

Completed initial public offering. In October 2020, Oncorus completed the initial public offering of shares of its common stock at a public offering price of $15.00 per share, and raised $98.4 million in aggregate gross proceeds, including shares sold to the underwriters pursuant to a partial exercise of their option to purchase additional shares. On October 2, 2020, Oncorus’ common stock commenced trading on the Nasdaq Global Market under the ticker symbol "ONCR".
Publication of preclinical data characterizing ONCR-177’s safety strategies. In September 2020, ONCR-177’s safety strategies and their ability to enhance oHSV tolerability without impeding potency were characterized in a paper published in Molecular Therapy on ONCR-159, the unarmed version of ONCR-177, titled, "Design of an Interferon-Resistant Oncolytic HSV-1 Incorporating Redundant Safety Modalities for Improved Tolerability." (Kennedy et al., 2020). Oncorus’ oHSV platform incorporates two complementary and proprietary safety approaches, including a microRNA attenuation strategy to allow unencumbered viral replication in tumor cells while preventing replication in healthy tissues, and engineered proprietary mutations into UL37 to eliminate the virus’ ability to transport, replicate and establish latency inside neurons.
Announced clinical trial collaboration with Merck. In July 2020, Oncorus entered into a clinical trial collaboration and supply agreement with Merck (NYSE:MRK), known as MSD outside of the United States and Canada, through a subsidiary, to evaluate the combination of ONCR-177 with KEYTRUDA (pembrolizumab), as part of the ongoing Phase 1 clinical trial of ONCR-177 in adult patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors.
Initiated Phase 1 clinical trial of ONCR-177. In June 2020, Oncorus initiated a Phase 1 clinical trial of its lead product candidate, ONCR-177, an intratumorally administered oHSV viral immunotherapy being developed for multiple solid tumor indications. The Phase 1 open-label, multi-center, dose escalation and expansion clinical trial is designed to evaluate the safety and tolerability of ONCR-177 and to determine the recommended Phase 2 dose, as well as its preliminary anti-tumor activity, alone and in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors. Oncorus anticipates reporting interim data from the Phase 1 clinical trial in the second half of 2021 through the second half of 2022.
Fourth Quarter Financial Results

Cash and cash equivalents were $130.3 million as of December 31, 2020 compared to $45.3 million as of December 31, 2019.
Research and development expenses for the quarter ended December 31, 2020 were $7.6 million compared to $5.9 million for the corresponding period in 2019. The increase in research and development expenses was mainly attributable to increases in clinical trial costs for the company’s Phase 1 clinical trial as well as increased personnel-related expenses driven by increased headcount.
General and administrative expenses for the quarter ended December 31, 2020 were $4.0 million compared to $3.1 million for the corresponding period in 2019. The increase in general and administrative expenses was primarily attributable to increases in personnel-related expenses driven by increased headcount as well as increased costs associated with the Company’s transition to a public company in the fourth quarter of 2020.

Net loss attributable to common stockholders for the quarter ended December 31, 2020 was $(11.8) million, or $(0.56) per share, compared to a net loss attributable to common stockholders of $(11.5) million, or $(11.78) per share for the same period in 2019. The share and loss per share amounts in the fourth quarter of 2020 reflect the impact of the company’s IPO, which closed in October 2020.
Financial Guidance

Based upon its current operating plans and cash and cash equivalents at December 31, 2020, plus the net proceeds from the public offering of common stock in February 2021, the company expects to have sufficient capital to fund its operating expenses and capital expenditure requirements into late 2023.

On March 10, 2021 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported its financial results for the year ended December 31, 2020 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, MAR 10, 2021, View Source [SID1234576413]).

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"Throughout 2020, we made significant progress advancing our DNAbilize platform technology in a variety of important indications, bringing us one step closer to bringing this potentially lifesaving therapy to patients with limited treatment options," stated Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "We are particularly proud to have made these advances amidst the backdrop of the global pandemic, knowing that cancer continues to be a leading killer with an ongoing great need for new therapies."

"We recently strengthened our intellectual property portfolio and our balance sheet, giving us the patent protection and financial underpinning to support these clinical programs through to a number of value-creating inflection points," continued Mr. Nielsen.

Recent Corporate Highlights

Raised $13.0 Million in Public Offering. In February, Bio-Path announced the closing of a public offering for the offering of 1,710,600 shares of common stock at a price to the public of $7.60 per share, for aggregate gross proceeds to the Company of approximately $13.0 million, before deducting the fees and estimated offering expenses payable by the Company.

Received Third U.S. Patent Grant Related to Manufacture of Platform Technology. In February, Bio-Path announced that the United States Patent and Trademark Office granted U.S. Patent No. 10,898,506 titled, "P-ethoxy nucleic acids for liposomal formulation." The new patent builds on earlier patents granted that protect the platform technology for DNAbilize, the Company’s novel RNAi nanoparticle drug.

Announced First Patient Dosed in Phase 1 Clinical Trial of BP1002. In November, Bio-Path announced the enrollment and dosing of the first patient in a Phase 1 clinical trial evaluating the ability of BP1002 to treat refractory/relapsed lymphoma and chronic lymphocytic leukemia (CLL) patients.
Financial Results for the Year Ended December 31, 2020

The Company reported a net loss of $10.9 million, or $2.83 per share, for the year ended December 31, 2020, compared to a net loss of $8.6 million, or $3.24 per share, for the year ended December 31, 2019.

Research and development expenses for the year ended December 31, 2020 increased to $6.6 million, compared to $4.6 million for the year ended December 31, 2019, primarily due to increased enrollment for our Phase 2 clinical trial of prexigebersen in AML, startup costs related to our Phase 1 clinical trials for BP1002 in lymphoma and prexigebersen-A in solid tumors, increased preclinical expenses for BP1003 and increased drug material manufacturing activities.

General and administrative expense for the year ended December 31, 2020 increased to $4.3 million, compared to $4.1 million for the year ended December 31, 2019, primarily due to increased franchise tax expense.

As of December 31, 2020, the Company had cash of $13.8 million, compared to $20.4 million at December 31, 2019. Net cash used in operating activities for the year ended December 31, 2020 was $11.0 million compared to $8.4 million for the comparable period in 2019. Net cash provided by financing activities for the year ended December 31, 2020 was $4.3 million.
Conference Call and Webcast Information

Bio-Path Holdings will host a conference call and webcast today at 8:30 a.m. ET to review these full-year 2020 financial results and to provide a general update on the Company. To access the conference call please dial (844) 815-4963 (domestic) or (210) 229-8838 (international) and refer to the conference ID 6296959. A live audio webcast of the call and the archived webcast will be available in the Media section of the Company’s website at www.biopathholdings.com.

On March 10, 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, reported that the Company’s fourth quarter 2020 financial results will be released on Tuesday, March 16, 2021 (Press release, Calithera Biosciences, MAR 10, 2021, View Source [SID1234576412]). Company management will host a conference call on Tuesday, March 16, 2021 at 2:00 p.m. Pacific Time/ 5:00 p.m. Eastern Time to discuss the financial results and other recent corporate highlights.

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The press release and live audio webcast can be accessed via the Investor section of the Company’s website at www.calithera.com. The conference call can be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international) and refer to conference ID 6250035. Please log in approximately 5-10 minutes before the event to ensure a timely connection. The archived webcast will remain available for replay on Calithera’s website for 30 days.

On March 10, 2021 AIM ImmunoTech Inc. (NYSE American: AIM) reported that Thomas K. Equels, AIM’s Chief Executive Officer, has been invited to present at the Inaugural Emerging Growth Virtual Conference, presented by M Vest LLC and Maxim Group LLC (Press release, AIM ImmunoTech, MAR 10, 2021, View Source [SID1234576411]).

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The conference will take place March 17-19, from 9:00 am to 5:00 pm ET, and feature roundtable discussions with C-suite executives moderated by Maxim Research Analysts, fireside chats with live Q&A, and presentations from hundreds of issuers, both domestically and internationally.

During this virtual conference, AIM ImmunoTech will present along with many other important voices in the health care industry. To attend and access exclusive content, sign up to become an M-Vest member HERE and stay tuned for more updates. The presentation will be available on the investor relations section of AIM’s website at View Source