On November 10, 2021 Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX), reported that strategic, financial, and operational updates for the third quarter ended September 30, 2021 (Press release, Heat Biologics, NOV 10, 2021, View Source [SID1234595090]).

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Jeff Wolf, Chief Executive Officer of Heat, commented, "Our clinical and preclinical programs are progressing well. In September, we expanded dosing in our Phase 1 clinical trial of monoclonal antibody PTX-35 in patients with solid tumors, and are planning a clinical development pathway to utilize PTX-35 in the context of inflammatory disease. We are also preparing for an end of Phase 2 meeting with the FDA for HS-110 to discuss potential Phase 3 registration pathways."

"Additionally, we recently announced our new biosecurity/biodefense initiative, which leverages our gp96 platform against known or unknown future biological threats. In the short time since launching this program, we have filed patents to protect our proprietary technology and have established collaborations with leading institutions to advance our research. At the same time, we’ve assembled a knowledgeable and experienced biothreat advisory board that is well-versed on our biothreat platform. We plan to provide further updates on our biodefense efforts in the near future."

"Our strategic vision is to become a fully integrated, immune system-focused biopharmaceutical company, and we continue to evolve in that direction. In August we announced the groundbreaking of our new wholly-owned Scorpion biomanufacturing and bioanalytic subsidiary, which is designed to support our internal manufacturing needs as we advance our programs as well as to offer much-needed biomanufacturing/bioanalytic services to other biotech and pharmaceutical clients. Our ultimate goal is to reduce development costs, accelerate development timelines, and ensure the highest levels of quality by controlling the entire process internally. Overall, we have maintained a solid balance sheet and are well positioned to execute on a number of key milestones that we believe will drive significant value for shareholders."

Third Quarter 2021 Financial Results

Recognized $0.5 million of grant revenue for qualified expenditures under the CPRIT grant for the quarter ended September 30, 2021 compared to $0.8 million for the quarter ended September 30, 2020. The decrease in grant revenue in the current-year period primarily reflects the expected timing of completion of deliveries under the current phase of the contracts. As of September 30, 2021, we had a grant receivable balance of $0.9 million for CPRIT proceeds not yet received but for which the costs had been incurred or the conditions of the award had been met. We continue our efforts to secure future non-dilutive grant funding to subsidize ongoing research and development costs.
Research and development expense was $4.4 million and $3.2 million for the three months ended September 30, 2021 and 2020, respectively.
General and administrative expense was $3.4 million and $6.6 million for the three months ended September 30, 2021 and 2020. The decrease was primarily due to a decrease in stock-based compensation expense of $3.9 million.
Net loss attributable to Heat Biologics was approximately $7.4 million, or ($0.30) per basic and diluted share for the quarter ended September 30, 2021 compared to a net loss of approximately of $8.9 million, or ($0.43) per basic and diluted share for the quarter ended September 30, 2020.
As of September 30, 2021, the Company had approximately $108.9 million in cash, cash equivalents and short investments.

On November 10, 2021 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (the "Company") reported that the company will deliver a corporate presentation during the 2021 Jefferies London Healthcare Conference — November 16-19, 2021 (Press release, Aurinia Pharmaceuticals, NOV 10, 2021, View Source [SID1234595089]). The presentation will be available to all conference attendees on demand (link here) beginning on Thursday, November 18 at 8 am GMT/3 am EST through Friday, November 19 at 5 pm GMT/12 pm EST.

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Interested parties can also register and access the on-demand webcast through the Investor section of the Aurinia corporate website – www.auriniapharma.com, under "News/Events."

On November 10, 2021 Silverback Therapeutics, Inc. (Nasdaq: SBTX) ("Silverback"), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases, reported financial results for the third quarter ended September 30, 2021, and provided a business update (Press release, Silverback Therapeutics, NOV 10, 2021, View Source [SID1234595088]).

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"In the third quarter, we provided our first interim clinical update for the dose escalation arms of the SBT6050-101 trial, establishing proof-of-mechanism for SBT6050 as evidenced by the activation of the innate and adaptive immune system in patients," said Laura Shawver, Ph.D., chief executive officer of Silverback. "In a short period of time, we have accumulated a robust clinical data set that has informed our development strategy. We are focused on advancing SBT6050 in patients with HER2-expressing cancers such as gastroesophageal and non-small cell lung, in combination with agents that we believe will maximize the therapeutic potential of our first-in-class TLR8 agonist conjugate. We also look forward to continuing to advance our pipeline, including SBT6290 for patients with bladder, triple negative breast, non-small cell lung, and head & neck cancers, and SBT8230 for patients with chronic hepatitis B virus."

Recent Business Updates:

SBT6050 (HER2-TL8 ImmunoTAC)

Interim clinical data presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2021 Annual Meeting. In September 2021, Silverback presented interim clinical results from the ongoing Phase 1/1b study of SBT6050, including data that establish proof-of-mechanism through SBT6050’s ability to activate myeloid, T and NK cells, as well as evidence of SBT6050 payload localization in the tumor microenvironment. Adverse events reported were consistent with on-mechanism immune activation, and early signals of anti-tumor activity were observed.
Selected go forward dose of 0.3 mg/kg SBT6050 in combination with anti-PD-1 therapy in expansion cohorts. Silverback is prioritizing combination with Libtayo in gastroesophageal and non-small cell lung cancers and plans to initiate these expansion cohorts in the fourth quarter of 2021.
SBT6050 expanded clinical development strategy announced, leveraging combination with trastuzumab-containing regimens. In the first quarter of 2022, Silverback plans to initiate SBT6050-201, a Phase 1/2 study of SBT6050 combined with Enhertu, or with Herceptin and Tukysa with or without capecitabine, in patients with HER2-expressing or HER2-amplified cancers.
SBT6290 (Nectin4-TL8 ImmunoTAC)

SBT6290 Investigational New Drug application submitted to the U.S. Food and Drug Administration. Silverback remains on track to initiate the phase 1/1b trial in the first quarter of 2022, and plans to enroll patients with bladder, non-small cell lung, triple negative breast, and head and neck cancers in dose escalation.
SBT8230 (ASGR1-TLR8 ImmunoTAC for chronic HBV)

SBT8230 preclinical development continues with GLP toxicology studies expected to commence in the first quarter of 2022. Silverback will be providing a preclinical update on the SBT8230 program at the American Association for the Study of Liver Diseases (AASLD) 2021 conference held from November 12-14, 2021.
Third Quarter Financial Results

For the third quarter ended September 30, 2021, Silverback reported a net loss of $22.7 million, compared to a net loss of $8.1 million for the comparable period in 2020. For the nine months ended September 30, 2021, Silverback reported a net loss of $66.0 million, compared to a net loss of $19.9 million for the comparable period in 2020. Included in the net losses for the three and nine months ended September 30, 2021 were $5.0 million and $14.0 million of non-cash stock-based compensation, respectively, compared to $0.2 million and $0.4 million for the same periods in 2020, respectively.

Research and development expenses for the third quarter ended September 30, 2021 were $15.6 million, compared to $6.2 million for the same period in 2020. Research and development expenses for the nine months ended September 30, 2021 were $45.6 million compared to $15.7 million for the same period in 2020. The increases in the Company’s research and development expenses in 2021 were primarily attributable to the advancement of pipeline programs, including SBT6290 and SBT8230, through preclinical development and the continued clinical development of SBT6050. Silverback also incurred additional personnel-related expenses as operations grew in support of program advancements.

General and administrative expenses for the third quarter ended September 30, 2021 were $7.0 million, compared to $1.9 million for the same period in 2020. General and administrative expenses for the nine months ended September 30, 2021 were $20.4 million, compared to $4.1 million for the same period in 2020. The increases in general and administrative expenses were primarily attributable to an increase in personnel-related expenses due to increased headcount in 2021, including new executives, as well as increases in salaries, bonuses, and stock-based compensation. The increases in general and administrative expenses were also due to an increase in legal fees, professional fees, and other various general and administrative expenses as we now operate as a public company.

As of September 30, 2021, Silverback reported cash, cash equivalents, and investments of $340.6 million compared to cash and cash equivalents of $386.6 million at December 31, 2020, which is expected to fund operating expenses and capital expenditure requirements into 2024.

On November 10, 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 financial results for the third quarter ended September 30, 2021 (Press release, Alpine Immune Sciences, NOV 10, 2021, View Source [SID1234595087]).

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"We continue to make considerable progress across our portfolio and anticipate opportunities to share clinical updates for both ALPN-202 and ALPN-303 in the first half of 2022," said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine. "Importantly, the recently completed private placement will enable us to accelerate and expand development plans for both of these molecules, as well as our discovery pipeline, as we work to advance innovative therapies to treat cancer, autoimmune and inflammatory diseases."

Third Quarter 2021 and Recent Corporate and Clinical Updates

ALPN-303: Dual APRIL/BAFF inhibitor (autoimmune/inflammation)
Data demonstrating the superior efficacy of ALPN-303 in preclinical models was shared in an oral presentation in the Plenary III session of the American College of Rheumatology (ACR) Convergence 2021 Annual Meeting.
A first-in-human, phase 1 study of ALPN-303 is expected to begin enrolling in the fourth quarter of 2021 with topline results expected in the first half of 2022. The randomized, placebo-controlled study in healthy adult participants will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenously and subcutaneously administered ALPN-303.
ALPN-202: Conditional CD28 co-stimulator and dual checkpoint inhibitor (oncology)
A trial-in-progress presentation on NEON-2, a phase 1 study of ALPN-202 in combination with KEYTRUDA (pembrolizumab) in patients with advanced malignancies, will be shared at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting on Friday, November 12, 2021. The poster (#497) will be available both on site and as an ePoster.
NEON-1, a phase 1 study of ALPN-202 monotherapy in patients with advanced malignancies, continues to proceed, with completion of dose escalation anticipated in the fourth quarter of 2021. Further updates are anticipated for the first half of 2022.
Corporate: $91M securities offering completed September 2021
Completed a private placement of common stock and prefunded warrants, for gross proceeds of approximately $91.0 million, which was 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.
Third Quarter 2021 Financial Results

As of September 30, 2021, we had cash, cash equivalents, restricted cash, and investments totaling $219.9 million. We recorded net losses of $13.5 million and $6.1 million for the quarters ended September 30, 2021 and 2020, respectively.

Collaboration revenue for the quarter ended September 30, 2021 was $8.5 million compared to $1.9 million for the quarter ended September 30, 2020. The increase was primarily attributable to the revenue recognized under our AbbVie Agreement.

Research and development expenses for the quarter ended September 30, 2021 were $18.3 million compared to $6.2 million for the quarter ended September 30, 2020. The increase was primarily attributable to clinical trial activities for the acazicolcept and ALPN-202 studies, direct research activities, contract manufacturing and process development of our product candidates, and personnel-related expenses.

General and administrative expenses for the quarter ended September 30, 2021 were $3.5 million compared to $2.7 million for the quarter ended September 30, 2020. The increase was primarily attributable to personnel-related expenses to support the growth and expansion of our business.

Alpine expects that its current cash resources are sufficient to fund Alpine’s planned operations through 2023.

On November 10, 2021 Rain Therapeutics Inc. (NasdaqGS: RAIN), (Rain), a late-stage company developing precision oncology therapeutics, reported financial results for the third quarter and nine months ended September 30, 2021, along with an update on the company’s key developments, business operations and upcoming milestones (Press release, Rain Therapeutics, NOV 10, 2021, View Source [SID1234595086]).

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"Rain has had a number of important recent accomplishments including data presentations at various medical conferences and announcement of plans to progress our lead candidate, milademetan, into a Phase 2 trial for patients with Merkel cell carcinoma," said Avanish Vellanki, co-founder and chief executive officer of Rain. "We continue to view milademetan as having a differentiated therapeutic index and will remain focused on strategies to further enhance its value for patients with MDM2-dependent cancers."

Key Developments and Operational Updates

Phase 2 Basket Trial (MANTRA-2) of Milademetan for MDM2-Amplified Advanced Solid Tumors
Rain anticipates enrolling the first patient in its multicenter, open-label Phase 2 basket trial (MANTRA-2) this quarter, evaluating milademetan, an oral mouse double minute 2 (MDM2) inhibitor for the treatment of MDM2-amplified advanced solid tumors.
Non-Clinical Data on Milademetan Presented at IASLC 2021 (Sept. 8-14, 2021) and AACR (Free AACR Whitepaper)-NCI-EORTC ("Triple Cancer Conference") 2021 (Oct. 7-10, 2021)
Rain, in collaboration with certain research partners, presented non-clinical data on milademetan in MDM2-amplified tumors, Merkel cell carcinoma, GATA3-mutant ER+ breast cancer, and mesothelioma models.
Rain Highlights Plans for Phase 2 Trial for Milademetan in Merkel Cell Carcinoma (MANTRA-3)
On the strength of recent non-clinical data from the Dana-Farber Cancer Institute presented at the Triple Cancer Conference, Rain is now prioritizing a Phase 2 clinical trial of milademetan as monotherapy in MCC patients failing first-line checkpoint inhibitors, with a trial start anticipated in mid-2022. The Phase 2 MCC clinical trial will replace the previously planned Phase 2 clinical trial of milademetan in intimal sarcoma.
Research and Development (R&D) Day
Rain hosted a R&D Day webinar on November 9, 2021 which featured several key opinion leaders in oncology, along with members of Rain’s management team, who discussed the Company’s R&D program, as well as select clinical and preclinical data. A replay of the event is archived on the Company’s corporate website here.
Anticipated Near-term Milestones

Milademetan MDM2-Amplified Phase 2 Basket Trial (MANTRA-2)
Phase 2 trial anticipated to commence enrollment this quarter
Interim data anticipated in the second half of 2022
Milademetan MCC Phase 2 Trial (MANTRA-3)
Phase 2 trial anticipated to commence in mid-2022
Milademetan Dedifferentiated Liposarcoma Phase 3 Trial (MANTRA)
Data anticipated in 2023
RAD52 Research Program
Lead candidate selection anticipated in 2022
Third Quarter Financial Results
For the three and nine months ended September 30, 2021, Rain reported a net loss of $18.4 million and $33.4 million, respectively, as compared to a net loss of $10.4 million and $15.6 million for the same periods in 2020, respectively. Net loss per share for the three and nine months ended September 30, 2021, was $0.70 and $1.96, respectively, as compared to a net loss per share of $3.05 and $4.73 for the same periods in 2020, respectively.

R&D expenses were $15.3 million and $26.1 million for the three and nine months ended September 30, 2021, respectively, as compared to $7.9 million and $11.2 million for the same periods in 2020, respectively. The increases were primarily driven by development milestone fees to Daiichi Sankyo Co., Ltd, R&D costs for Rain’s lead candidate, milademetan, mainly for its on-going Phase 3 pivotal trial in dedifferentiated liposarcoma, as well as personnel costs. Non-cash stock-based compensation expenses included in R&D expenses were approximately $0.7 million and $1.4 million in the three and nine months ended September 30, 2021, respectively, as compared to $0.2 million and $0.4 million in the same periods in 2020, respectively.

General and administrative (G&A) expenses were $3.2 million and $7.3 million for the three and nine months ended September 30, 2021, respectively, as compared to $0.6 million and $2.3 million for the same periods in 2020, respectively. The increases were primarily due to increases in various third-party G&A costs, including legal costs, outside consulting fees and accounting and audit fees associated with maintaining compliance with exchange listing and SEC requirements as a public company, as well as personnel costs. Non-cash stock-based compensation expense included in G&A expenses were approximately $0.1 million and $0.4 million for the three and nine months ended September 30, 2021, respectively as compared to $0.1 million and $0.2 million for the same periods in 2020, respectively.

Total non-cash stock-based compensation expenses were approximately $0.8 million and $1.8 million in the three and nine months ended September 30, 2021, respectively, as compared to $0.3 million and $0.6 million for the same periods in 2020, respectively.

As of September 30, 2021, Rain had $150.1 million in cash, cash equivalents and short-term investments. Rain expects that its quarter-end cash position will provide runway to continue advancing its R&D pipeline and complete all three planned clinical trials of milademetan.

As of September 30, 2021, Rain had approximately 26.5 million shares of common stock outstanding.

The Company continues to expect its full year 2021 net cash used in operating activities to be approximately $50 million to $60 million and a projected year end cash balance of approximately $137 million to $147 million in cash, cash equivalents and short-term investments.

Third Quarter 2021 Results Conference Call and Webcast Details
The management of Rain Therapeutics will host a conference call and webcast for the investment community today, November 10, 2021, at 1:30 p.m. PT (4:30 p.m. ET). The conference call can be accessed by dialing 1 (833) 562-0127 (U.S. Toll Free) / 1 (661) 567-1105 (U.S. Toll). The passcode for the conference call is 1985710. A live webcast may be accessed by visiting the "Investors" section of the Rain Therapeutics’ website at www.rainthera.com. The call will be recorded and available for replay on the Company’s website for approximately 30 days after the call.

About Milademetan

Milademetan is a small molecule, oral inhibitor of MDM2, which is oncogenic in numerous cancers. Milademetan has already demonstrated meaningful antitumor activity in an MDM2-amplified subtype of liposarcoma (LPS) and other solid tumors in a Phase 1 clinical trial, validating a rationally-designed dosing schedule to mitigate safety concerns and widen the therapeutic window of MDM2 inhibition. Milademetan is being evaluated in an ongoing Phase 3 clinical trial in patients with LPS (MANTRA) with a planned Phase 2 tumor-agnostic basket trial in certain solid tumors (MANTRA-2) anticipated to start in the fourth quarter of 2021. Rain Therapeutics also anticipates commencing a Phase 2 clinical trial of milademetan (MANTRA-3), for the treatment of patients with Merkel cell carcinoma refractory to immune checkpoint inhibition (ICI), in mid-2022. Milademetan has received U.S. Food and Drug Administration Orphan Drug Designation for patients with LPS.