On May 14, 2024 TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, reported financial results for the first quarter ended March 31, 2024 (Press release, Tracon Pharmaceuticals, MAY 14, 2024, View Source [SID1234643241]). The Company will host a conference call and webcast today at 4:30 PM Eastern Time / 1:30 PM Pacific Time.

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"With ENVASARC fully enrolled we are focused on leveraging our Product Development Platform to generate non-dilutive capital through either an additional license or by replacing a CRO and executing clinical trials for partners at a lower cost compared to a CRO but still at a premium to our costs using a pay for performance model," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We look forward to reporting the final response assessment data in all patients from the ENVASARC Phase 2 pivotal trial, which are expected in the third quarter."

Recent Corporate Highlights

In April, we announced updated interim safety and efficacy data from the ENVASARC Phase 2 pivotal trial in 73 patients treated with single agent envafolimab. The objective response rate (ORR) was 11% by investigator review and 5.5% by blinded independent central review (BICR), all of which were confirmed responses. Envafolimab monotherapy was generally well tolerated and median duration of response by BICR was greater than six months. The primary endpoint of the study is achievement of an ORR by BICR in nine of 82 patients (11%) treated with envafolimab and median duration of response of greater than six months is a key secondary endpoint.
In April, the Company announced that the Nasdaq Hearings Panel granted the Company’s request for an extension to demonstrate compliance with all applicable criteria for continued listing on The Nasdaq Capital Market, including the $1.00 bid price and $2.5 million stockholders’ equity requirements, through June 3, 2024, provided the Company execute a reverse stock split and file an S-1, both of which the Company executed in April. The Company continues to consider alternatives to address the $2.5 million stockholders’ equity requirement on or before June 3, 2024.
Expected Upcoming Milestone

Report the final response assessment data including duration of response in all patients from the ENVASARC Phase 2 pivotal trial, which are expected in the third quarter of 2024.
First Quarter 2024 Financial Results

Cash, cash equivalents and restricted cash were $8.0 million at March 31, 2024, compared to $8.6 million at December 31, 2023, which is expected to fund the Company late into the third quarter of 2024.
Research and development expenses for the first quarter of 2024 were $1.9 million, compared to $5.0 million for the first quarter of 2023. The decrease was primarily related to completing enrollment of the ENVASARC Phase 2 pivotal trial in 2024.
General and administrative expenses for the first quarter of 2024 were $1.4 million, compared to $2.3 million for the first quarter of 2023.
Net loss for the first quarter of 2024 was $3.2 million, compared to $8.5 million for the first quarter of 2023.
Conference Call Details

To access the call by phone, please register using this link and you will be provided with dial-in details.

A live webcast of the conference call will be available online from the Investor/Events and Presentation page of the Company’s website at www.traconpharma.com.

After the live webcast, a replay will remain available on TRACON’s website for 60 days.

About Envafolimab

Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology and licensed by TRACON, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the ENVASARC Phase 2 pivotal trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines. TRACON has received orphan drug designation from the U.S. Food and Drug Administration for envafolimab for patients with soft tissue sarcoma and fast track designation from the U.S. Food and Drug Administration for envafolimab (KN035) for patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) who have progressed on one or two prior lines of chemotherapy.

About ENVASARC (NCT04480502)

The ENVASARC Phase 2 pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States and the United Kingdom that began dosing in December 2020. TRACON enrolled patients in ENVASARC with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor. A total of 82 evaluable patients have received treatment with single agent envafolimab at 600 mg every three weeks. The primary endpoint is objective response rate by central review in nine of 82 patients (11%) with duration of response a key secondary endpoint.

On May 14, 2024 Synlogic, Inc. (Nasdaq: SYBX), a biopharmaceutical company advancing novel therapeutics to transform the care of serious diseases, reported financial results for the first quarter 2024 and provided a corporate update (Press release, Synlogic, MAY 14, 2024, View Source [SID1234643239]).

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In March 2024, the Company retained Lucid Capital Markets, LLC to act as its financial advisor to explore and evaluate strategic options for maximizing shareholder value. Potential strategic alternatives that may be explored or evaluated as part of this process include the potential for an acquisition, merger, business combination or other strategic transaction involving the Company. The Board has not set a timetable for the conclusion of this review, nor has it made any decisions related to any further actions or potential strategic options at this time. There can be no assurance, however, that this process will result in any such transaction.

First Quarter 2024 Financial Results

As of March 31, 2024 Synlogic had cash, cash equivalents, and short-term marketable securities of $32.3 million.

Revenue was $0.01 million for the three months ended March 31, 2024, compared to $0.2 million for the corresponding period in 2023. Revenue for the three months ended March 31, 2024 was related to a material transfer agreement and revenue for the corresponding period in 2023 was associated with the prior research collaboration with Roche. Research and development expenses were $7.7 million for the three months ended March 31, 2024, compared to $12.5 million for the corresponding period in 2023. General and administrative expenses for the three months ended March 31, 2024 were $2.9 million compared to $4.0 million for the corresponding period in 2023. Restructuring and other charges were $28.2 million for the three months ended March 31, 2024, as a result of the Company’s decision in February 2024 to discontinue Synpheny-3, its pivotal study of labafenogene marselecobac (SYNB1934) in phenylketonuria (PKU) and evaluate strategic options for the Company.

For the three months ended March 31, 2024 Synlogic reported a consolidated net loss of $31.6 million, or $2.60 per share, compared to a consolidated net loss of $15.6 million, or $3.39 per share, for the corresponding period in 2023.

On May 14, 2024 Sonnet Biotherapeutics presented its corporate presentation (Presentation, Sonnet BioTherapeutics, MAY 14, 2024, View Source [SID1234643238]).

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On May 14, 2024 Scorpius Holdings, Inc. (NYSE American: SCPX), ("Scorpius", or the "Company"), an integrated contract development and manufacturing organization (CDMO), reported the pricing of its underwritten public offering of 60,000,000 common units and/or pre-funded units in lieu thereof (Press release, Scorpius BioManufacturing, MAY 14, 2024, View Source [SID1234643237]). Each common (or pre-funded) unit is being offered at a public offering price of $0.10 per unit (inclusive of the pre-funded warrant exercise price) and consists of one share of common stock (or pre-funded warrant to purchase one share of common stock in lieu thereof) and a common warrant to purchase one share of common stock. The common warrants will have an exercise price of $0.12 per share and will be immediately exercisable upon issuance for a period of five years following the date of issuance. The gross proceeds to the Company from the offering are expected to be approximately $6,000,000, before deducting underwriting discounts and offering expenses. In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 9,000,000 shares of common stock (and/or pre-funded warrants) and/or up to an additional 9,000,000 common warrants solely to cover over-allotments, if any. All of the shares of common stock (and/or pre-funded warrants) and associated common warrants are being offered by the Company. The offering is expected to close on May 16, 2024, subject to satisfaction of customary closing conditions.

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The Company intends to use the net proceeds of the offering to fund working capital, general corporate purposes, and the repayment of a $750,000 non-convertible promissory note, plus accrued and unpaid interest.

ThinkEquity is acting as sole book-running manager for the offering.

A registration statement on Form S-1 (File No. 333-279092), as amended, including a preliminary prospectus, relating to the securities being offered was filed with the Securities and Exchange Commission ("SEC") and became effective on May 13, 2024. This offering is being made only by means of a prospectus. Copies of the preliminary prospectus and final prospectus, when available, may be obtained from ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. The final prospectus will be filed with the SEC and will be available on the SEC’s website located at View Source

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On May 14, 2024 Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical stage company focused on developing next generation therapeutics to target difficult-to-treat cancers, reported financial results for the first quarter ended March 31, 2024, and provided a corporate update (Press release, Pyxis Oncology, MAY 14, 2024, View Source [SID1234643236]).

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PYX-201, a first-in-concept tumor stroma targeting antibody-drug conjugate (ADC) against the stromal Extradomain-B Fibronectin (EDB+FN) target, has dosed 42 patients in 8 cohorts since initiating the Phase 1 trial in March 2023 with continued enthusiasm for this agent by global investigators.

"Based on encouraging early responses with late-stage patients across multiple tumor types, we are actively studying dose ranges from 5.4 mg/kg to 8 mg/kg, refining our understanding of PYX-201’s therapeutic window. We are on track to report the comprehensive dataset in the fall of 2024, and we look forward to the potential future robust development plan supported by our strong balance sheet," said Lara S. Sullivan, M.D., President and CEO of Pyxis Oncology.

Dr. Sullivan added, "We plan to dose an additional 16 patients with a focus on five tumor types of interest based on an assessment of factors including immunohistochemistry target expression, stromal volume, unmet medical need, and clinical judgment. Patient recruitment at these dose levels focuses on head and neck squamous cell carcinoma (HNSCC), non-small cell lung cancer (NSCLC), ovarian cancer, soft tissue sarcoma, and pancreatic ductal adenocarcinoma cancer (PDAC). We look forward to sharing the monotherapy development path for PYX-201 this fall alongside the dose escalation phase 1 dataset presentation. PYX-201 safety data continues to support go-forward monotherapy and potential combination development strategies."

Pyxis Oncology continues to expand our understanding of PYX-201, and we were excited to share our latest preclinical data at the 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in San Diego, California, held from April 5 to 10, 2024. The preclinical data presented (Figure 1. Abstract #742) supports that PYX-201 is designed to have improved plasma stability, better potency, and tumor permeability due to optimized auristatin payload (Aur-0101) and improved linker stability through site-specific conjugation to engineered cysteine residues for a target DAR of 4. Across a panel of approximately 100 preclinical patient-derived xenograft (PDX) models representing ten tumor types, PYX-201 demonstrated broad, deep, and durable anti-tumor activity.

Another poster (Figure 2. Abstract #2908) Pyxis Oncology presented on PYX-201 detailed the development of an immunohistochemistry (IHC) assay to detect our novel EDB+FN protein target and shared our scoring method to quantify expression in tumor stroma. This research further supports that EDB+FN is broadly and predominantly expressed in tumor-induced stroma across multiple cancer indications (10 tumor types) with virtually no expression in healthy tissues.

Given the observed anti-tumor activity for our non-internalizing mechanism of action, Pyxis Oncology also had the opportunity to review insights from a legacy 2014 AACR (Free AACR Whitepaper) poster (Figure 3. Abstract #4837) on the extracellular cleavage of ADCs that promotes bystander cell killing. This poster described mechanisms of extracellular proteolytic cleavage of ADCs and, for an EDB+FN-targeted ADC specifically, the release of Aur-0101 payload capable of bystander cell killing, which provides support for our novel mechanistic approach of payload cleavage in the extracellular matrix.

In summary, Pyxis Oncology’s preclinical data provides insights into the mechanism associated with this novel agent observed across multiple solid tumors. PYX-201 has potential applications in both monotherapy and combination therapy and maintains a well-tolerated safety profile based on the lack of EDB+FN expression in healthy cells.

Concurrently, Pyxis Oncology is actively enrolling our Phase 1 study evaluating PYX-106, a fully human immunotherapy antibody candidate aimed at inhibiting Siglec-15 activity in non-small cell lung cancer, colorectal cancer, breast cancer, and other tumors of interest. We plan to share the initial PYX-106 clinical results in the second half of 2024 after our PYX-201 results.

Pyxis Oncology is also delighted to announce the appointment of Stephen Worsley as its new Chief Business Officer. With a wealth of experience in the biotechnology and pharmaceutical sectors, Stephen brings invaluable expertise to Pyxis Oncology’s leadership team.

In his role, Stephen will oversee Pyxis Oncology’s business development strategies and forge partnerships to advance the company’s assets, PYX-201 and PYX-106. His proven track record in fostering successful collaborations and executing strategic initiatives aligns seamlessly with Pyxis Oncology’s mission to develop breakthrough treatments for patients with difficult-to-treat cancers. As a business development executive, Stephen has led negotiations of transformative and award-winning technology and clinical product partnerships for leading therapeutics companies, focused primarily on oncology with antibody and ADC modalities. These include global co-development agreements on behalf of Abgenix with Immunex/Wyeth (led to acquisition by Amgen for $2.7B) with Vectibix (panitumumab); on behalf of Peregrine a deal with Oncologie Inc. for clinical Phase III level bavituximab; on behalf of Zosano Pharmaceutical with Asahi Kasei Pharma Corporation (AKP) Asahi Kasei Pharma Corporation (AKP) on ZP-PTH; on behalf of Raven Biotechnologies with B7-H3 & B7-H4 mAbs with Macrogenics (leading to the merger of the two companies); and also on behalf of Raven with Abbott (AbbVie) a collaboration focused on five key mAbs (for ADC development) programs.

"We are thrilled to welcome Stephen to Pyxis Oncology as our Chief Business Officer," said Dr. Sullivan. "Stephen’s extensive experience, proven track record of transaction execution, and strategic vision will be instrumental as we continue the clinical development of our lead asset, PYX-201, a first-in-concept tumor stroma targeting ADC against EDB-fibronectin."

"Joining Pyxis Oncology is an extraordinary opportunity to contribute to a company that stands at the forefront of ADC research and development," said Stephen. "I am excited to work with the team to build on their strong foundation and to help drive the development of transformative cancer treatments that could significantly impact patients’ lives."

Stephen joins Pyxis Oncology from Lytix Biopharma, where he was the Chief Business officer and led numerous successful business development endeavors. His appointment underscores Pyxis Oncology’s commitment to attracting top talent to drive its mission of transforming cancer care through innovation.

Program and Corporate Updates

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PYX-201 in the PYX-201-101 trial: To date, 42 subjects have been dosed, and the Company will enroll an additional 16 patients. Pyxis Oncology expects to report study results, including efficacy, safety, pharmacokinetics (PK), preclinical insights, further development plans, and the expected timing of the next anticipated milestones in the fall of 2024.
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PYX-106 in the PYX-106-101 trial: This is a phase 1 trial focusing on NSCLC and other tumor types. Study dosing is ongoing, with 24 subjects dosed to date. Preliminary data are anticipated in 2H 2024.
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AACR Poster Presentations. Presented new PYX-201, PYX-106 and PYX-102 preclinical data at the AACR (Free AACR Whitepaper) Annual Meeting.
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Expanded Executive Leadership Team with the appointment of Stephen Worsley as Senior Vice President, Chief Business Officer.

Anticipated Upcoming Milestones

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PYX-201: Report preliminary Phase 1 data and PK/PD results in fall of 2024
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PYX-106: Report preliminary Phase 1 data and PK/PD results in 2H 2024, following the release of PYX-201 results

First Quarter 2024 Financial Results

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As of March 31, 2024, Pyxis Oncology had cash and cash equivalents, including restricted cash, and short-term investments of $158.5 million. During Q1 2024, the Company raised gross proceeds of $10.8 million via an at-the-market ("ATM") offering, completed a $50 million private placement, and sold the Company’s rights to royalties from the commercialization of Beovu (brolucizumab-dbll) and another asset for a one-time payment of $8 million to Novartis. Pyxis Oncology expects to have the cash runway to fund operations into 2H 2026.
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Revenues for the quarter ended March 31, 2024 were $16.1 million, compared to $0 for the quarter ended March 31, 2023. During the quarter, we entered into a settlement agreement with Novartis, pursuant to which we transferred our rights to future royalties on the net sales of Beovu to Novartis for a one-time amount of $8.0 million and Novartis also agreed to forgo its right to reclaim royalties previously paid of $8.1 million to us and Apexigen. Both of these amounts were recognized as revenues, upon execution of the settlement agreement during the quarter ended March 31, 2024.
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Research and development expenses were $13.0 million for the quarter ended March 31, 2024, compared to $11.9 million for the quarter ended March 31, 2023. The period-over-period increase was primarily due to increased clinical trial-related expenses for our ongoing Phase 1 clinical trials of PYX-201 and PYX-106.
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General and administrative expenses were $8.2 million for the quarter ended March 31, 2024, compared to $9.1 million for the quarter ended March 31, 2023. The period-over-period decline was primarily due to lower professional and consultant fees.
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Net loss was $3.3 million, or ($0.06) per common share, for the quarter ended March 31, 2024, compared to $19.2 million, or ($0.54) per common share, for the quarter ended March 31, 2023. Net losses for the quarters ended March 31, 2024 and 2023 included $4.3 million and $4.9 million, respectively, related to non-cash stock-based compensation expense.
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As of May 13, 2024, the outstanding number of shares of Common Stock of Pyxis Oncology was 58,888,473.