Ampio Pharmaceuticals, Inc. Announces Third Quarter 2021 Financial Results and Provides Business Update

On November 10, 2021 Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunomodulatory therapies for common inflammatory conditions, reported results for the three- and nine-month periods ended September 30, 2021 and provided a corporate overview and business update (Press release, Ampio, NOV 10, 2021, View Source [SID1234595153]).

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Ms. Holli Cherevka, President and Chief Operating Officer, commented, "This quarter marked an exciting period of growth for drug development in the Ampion platform therapy, both in clinical and preclinical development.

We have locked the osteoarthritis Phase 3 pivotal trial database, and are currently analyzing the data, which may provide a significant treatment option for an unmet medical need in severely disabled patients.

We have commenced the enrollment and treatment of COVID-19 patients in India for the Phase 2 AP-019 study utilizing inhaled Ampion therapy compared to control.

Furthermore, we continue to investigate Ampion’s potential in new indications within the preclinical space, most recently publishing data supportive of application in acute kidney injury, and in the autoimmune space relating to lupus nephritis. This early data suggests we may still be just scratching the surface of Ampion’s potential."

Ms. Holli Cherevka, President and Chief Operating Officer, Howard Levy, M.B.B.Ch., Ph.D., M.M.M., Chief Medical Officer, David Bar-Or, MD, Director and Founder, and Mr. Daniel Stokely, Chief Financial Officer will be hosting a Conference Call for the Investment Community this afternoon beginning at 4:30 PM ET (see details below).

The key areas of focus during the call will be clinical and preclinical updates, as well as the financial results for the three and nine-month period ended September 30, 2021.

SEPTEMBER 30, 2021 FINANCIAL RESULTS

Cash and cash equivalents totaled $17.1 million as of September 30, 2021, compared to $17.3 million on December 31, 2020. The decrease of $0.2 million, or 1%, is primarily attributable to cash required to fund the operating activities of $10.4 million; partially offset by net proceeds received from the utilization of the at-the-market equity offering program and stock option / warrant exercises of $10.0 million and $0.2 million, respectively.

Research and Development Expenses: R&D expenses for the three months ended September 30, 2021 increased by $0.9 million, or 57%, from R&D expenses for the three months ended September 30, 2020. The increase was primarily attributable to costs associated with the continuation of the Phase I / II COVID studies and outsourced CRO efforts focused on finalizing the validation and quality review of the AP-013 study database.

R&D expenses for the nine months ended September 30, 2021 increased by $0.1 million, or 2%, from R&D expenses for the nine months ended September 30, 2020. The net increase was primarily attributable to an overall increase in pre-clinical research and production of clinical trial product totaling $ 0.8 million. These increases were partially offset by a decrease in clinical trial and sponsored research expenses during the current period of $0.5 million, attributable to the pause of the AP-013 study in April 2020, which was partially offset by the incremental costs associated with the validation and quality review of AP-013 database and incremental costs associated with the Phase I / II COVID-19 studies conducted during the current period.

General and Administrative Expenses: G&A expenses for the three months ended September 30, 2021, decreased by approximately $0.4 million, or 24%, from G&A expenses for the three months ended September 30, 2020. G&A expenses for the nine months ended September 30, 2021, decreased by approximately $0.7 million, or 15%, from G&A expenses for the nine months ended September 30, 2020. The decrease for both periods was primarily attributable to a decrease in litigation-related legal costs and commercial insurance costs.

The total shares of common stock outstanding were 200,458,263 on September 30, 2021, compared to 193,378,996 on December 31, 2020.

Financial Guidance

Based on its current projection and expected access to equity financing, Ampio expects to have cash and cash equivalents along with access to external sources of liquidity sufficient to fund its business operations through the first quarter of 2023.

Conference Call & Webcast:

In order to submit questions, participants must have internet connectivity, as questions will only be addressed via the webcast. The conference call line will be in listen only mode.

The conference call and webcast can also be accessed from the Investor Relations section of the Company’s website at www.ampiopharma.com and will be archived there shortly after the live event.

Sapience Therapeutics to Present at the Piper Sandler 33rd Annual Healthcare Conference

On November 10, 2021 Sapience Therapeutics, Inc., a biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, reported that the company will present at the Piper Sandler 33rd Annual Healthcare Conference, taking place virtually on November 29, 2021 (Press release, Sapience Therapeutics, NOV 10, 2021, View Source [SID1234595152]).

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Members of Sapience’s management team will present a company overview and will also participate in one-on-one meetings with life science investors during the event.

Tyra Biosciences to Present at the 2021 Jefferies London Healthcare Conference

On November 10, 2021 Tyra Biosciences, Inc. (Nasdaq: TYRA), a precision oncology company focused on developing purpose-built therapies to overcome tumor resistance and improve outcomes for patients with cancer, reported that TYRA management will participate in a fireside chat and host one-on-one investor meetings during the virtual portion of the 2021 Jefferies London Healthcare Conference, taking place November 18-November 19, 2021 (Press release, Tyra Biosciences, NOV 10, 2021, View Source [SID1234595151]). The fireside chat will be available on-demand for attendees during the virtual conference beginning on Thursday, November 18, 2021.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A webcast of the fireside chat will be available on the Company’s website at View Source in the "For Investors" section following conclusion of the conference.

Compass Reports Third Quarter 2021 Results

On November 10, 2021 Compass, Inc. (NYSE: COMP) reported its consolidated financial and operational results for the three months ended September 30, 2021 (Press release, Compass Therapeutics, NOV 10, 2021, View Source [SID1234595150]). 3Q21 Revenue grew 47% year-over-year to $1.74 billion, with a GAAP Net Loss of $100 million and an Adjusted EBITDA of $12 million. Compass’ technology and services platform helped the company deliver 36% transaction growth compared to the prior year. The company remains confident in achieving Adjusted EBITDA profitability in full-year 2022.

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Complete results can be found in the company’s 3Q21 Shareholder Letter on the Investor Relations section of Compass’ website at View Source

"For the third consecutive quarter as a public company, Compass agents outperformed in a highly competitive market delivering $69.1 billion in Gross Transaction Value, a 45% increase year over year, and revenue of $1.74 billion, up 47% year over year," said Robert Reffkin, Founder, Chairman, and CEO of Compass. "The Compass platform, services and support continue to create business value and growth for our agents, who delivered a 36% increase in transactions, outperforming the industry where transactions decreased 1% during the same period. Our national market share was 5.4% in the quarter, up from 4.1% in the same quarter last year."

3Q21 Financial Highlights:

Revenue increased by 47% year-over-year to a third quarter record of $1.74 billion as transactions increased 36%.
GAAP Net Loss was $(100) million, compared to $(14) million in 3Q20.
GAAP Net Loss margin was (5.7%), compared to (1.1%) in 3Q20.
Adjusted EBITDA1 was $12 million, compared to $11 million in 3Q20.
Adjusted EBITDA margin was 0.7%, compared to 0.9% in 3Q20.
Adjusted EBITDA increased year-over-year even with continued planned investments in agents, the platform, market expansion, and the scaling of Adjacent Services.
3Q21 Operational Highlights:

Agents: Average Number of Principal Agents was 11,616, an increase of 987 from 2Q21.
Transactions: Compass agents closed a third quarter record 62,349 Total Transactions, up 36% year-over-year, compared to a 1% decline in transactions for the residential real estate market2. Each of our Principal Agents generated on average 5.4 transactions on our platform in the quarter, up 3% year-over-year.
Gross Transaction Value ("GTV")3: GTV of $69.1 billion increased by 45% year-over-year. This was a third quarter record for Compass, reflecting strong transaction volume and higher average transaction values. GTV per average principal agent was $5.9 million, up 10% year-over-year.
Markets: In 3Q21, Compass entered 5 new markets, bringing the total markets served to 67 at the end of the quarter. Compass’ national market share was 5.4%4 in 3Q21, up from 4.1% in 3Q20.
3Q21 Platform Highlights:

Compass is simplifying today’s complex, paper-driven, antiquated workflow to empower real estate agents to deliver an exceptional experience to every buyer and seller. Our platform is a combination of integrated software as well as value-added services, all tailored to the needs of the real estate industry.
Total sessions on the platform grew by 31% year-over-year.
Major feature enhancements during the quarter included an expansion of team collaboration capabilities, the introduction of a video messaging tool, and improved search.
Title and Escrow: Since the close of the second quarter, Compass expanded its Title & Escrow offering into 4 new states, increasing our coverage to approximately half of our Total Transaction volume, effectively giving us more opportunities to drive incremental revenue on each of our transactions. Compass’ Title & Escrow services were utilized on a mid-single digit percentage of our Total Transactions in 3Q21.
Mortgage: In 2Q21, Compass announced the formation of OriginPoint, a mortgage origination joint venture. OriginPoint has obtained the required licenses to provide mortgage services in 6 states to date, is hiring loan officers, and has set up its first warehouse line of credit. We are on track to originate our first mortgage in 4Q21 as planned.
Guidance for 4Q21 and FY2021:

FY2021 Revenue of $6.375 billion to $6.425 billion, compared to prior guidance of $6.15 billion to $6.35 billion.
FY2021 Adjusted EBITDA of $(25) million to $(5) million, compared to prior guidance of $(85) million to $(45) million.
4Q21 Revenue of $1.575 billion to $1.625 billion.
4Q21 Adjusted EBITDA of $(75) million to $(55) million.
We remain confident in achieving Adjusted EBITDA profitability in 2022.
We have not reconciled our guidance for Adjusted EBITDA to GAAP Net Loss because stock-based compensation expense cannot be reasonably calculated or predicted at this time. Accordingly, a reconciliation is not available without unreasonable effort.

Conference Call Information

Management will conduct a conference call to discuss the third quarter results and outlook for 2021 at 4:30 p.m. ET on November 10, 2021. The conference call will be accessible via the Internet on the Compass Investor Relations website View Source You can also access the audio webcast via the following link: Compass Inc. 3Q21 Earnings Conference Call.

An audio recording of the conference call will be available for replay shortly after the call’s completion. To access the replay, visit the Events and Presentations section on the Compass Investor Relations website at View Source

Precigen to Present at the Stifel 2021 Virtual Healthcare Conference

On November 10, 2021 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, reported that Helen Sabzevari, PhD, President and CEO of Precigen, will participate in the Stifel 2021 Virtual Healthcare Conference on Wednesday, November 17, 2021 at 10:40 AM ET (Press release, Precigen, NOV 10, 2021, View Source [SID1234595149]).

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Participants may register and access the webcast for this event through Precigen’s website in the Events & Presentations section at investors.precigen.com/events-presentations.