Termination of a Material Definitive Agreement

As previously disclosed, on July 13, 2020, Bio-Path Holdings, Inc. (the "Company") entered into an At-The Market Offering Agreement (the "Offering Agreement") with H. C. Wainwright & Co., LLC ("Wainwright"), as sales agent and/or principal, pursuant to which the Company could offer and sell, from time to time, through or to Wainwright, shares of the Company’s common stock, par value $0.001 per share ("Common Stock") (Filing, Bio-Path Holdings, DEC 9, 2022, View Source [SID1234625298]).

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On December 7, 2022, the Company received written notice from Wainwright that Wainwright had elected,
pursuant to Section 8(b) of the Offering Agreement, to terminate the Offering Agreement effective as of December 7, 2022. The Company will not incur any material early termination penalties in connection with the termination of the Offering Agreement.

As of immediately prior to the termination of the Offering Agreement, offers and sales of shares of Common
Stock under the Offering Agreement were being made pursuant to a shelf registration statement on Form S-3 filed with the U.S. Securities and Exchange Commission (the "Commission"), which was declared effective by the Commission on June 14, 2022 (File No. 333-265282) (the "2022 Shelf Registration Statement"), and a related prospectus filed with the Commission on June 14, 2022, as supplemented and amended pursuant to a prospectus supplement filed with the Commission on July 29, 2022 (as supplemented and amended, the "ATM Prospectus"). The ATM Prospectus covered the offer and sale of shares of Common Stock having a maximum aggregate offering price of up to $3.0 million.

As of immediately prior to the termination of the Offering Agreement, all $3.0 million of shares of Common
Stock remained available for sale pursuant to the ATM Prospectus and the Offering Agreement. As a result of the
termination of the Offering Agreement, the Company will not offer or sell any additional shares of Common Stock under the ATM Prospectus or the Offering Agreement, and the entire $3.0 million of shares of Common Stock included in ATM Prospectus will be available for sale in other offerings pursuant to the 2022 Shelf Registration Statement.

A copy of the Offering Agreement was filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K
filed with the Commission on July 14, 2020. The description of the Offering Agreement contained in this Current Report on Form 8-K does not purport to be complete and is qualified in its entirety by reference to the Offering Agreement.

Termination of a Material Definitive Agreement

On December 9, 2022, Vor Biopharma Inc. (the "Company") notified Jefferies LLC ("Jefferies") of its decision to terminate the Open Market Sale AgreementSM, dated as of March 14, 2022, (the "Sales Agreement") between the Company and Jefferies, effective as of December 22, 2022 (the "Termination Date") (Filing, 8-K, Vor BioPharma, DEC 9, 2022, View Source [SID1234625275]). The Sales Agreement provided for the offer and sale of the Company’s common stock, par value $0.0001 per share ("Common Stock"), from time to time through Jefferies as its sales agent, subject to the maximum aggregate dollar amount registered pursuant to the applicable prospectus supplement. Sales of shares of Common Stock through Jefferies were to be made (A) in negotiated transactions with the consent of the Company or (B) by any other method permitted by law deemed to be an "at-the-market" offering as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended, including block transaction, sales made directly on the Nasdaq Global Select Market or sales made into any other existing trading market for the shares of Common Stock. Through the Termination Date, the Company sold an aggregate of 856,030 shares of Common Stock under the Sales Agreement for net proceeds of $4.3 million.

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The foregoing description of the Sales Agreement is not complete and is qualified in its entirety by reference to the full text of the Sales Agreement, a copy of which was filed as Exhibit 1.2 to the Company’s Registration Statement on Form S-3 filed with the SEC on March 14, 2022.

Entry into a Material Definitive Agreement

On December 9, 2022, Seres Therapeutics, Inc. (the "Company") entered into the First Amendment to Lease (the "First Amendment") with BMR-Sidney Research Campus LLC (f/k/a BMR 200-Sidney Street LLC), a Delaware limited liability company (the "Landlord"), which amends the Lease Agreement, dated November 11, 2015, by and between the Company and the Landlord (as amended, the "Lease"), pursuant to which the Company leases approximately 83,396 rentable square feet of office, laboratory, and pilot manufacturing space located at 200 Sidney Street, Cambridge, Massachusetts (the "Existing Premises") (Filing, 8-K, Seres Therapeutics, DEC 9, 2022, View Source [SID1234625269]).

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The First Amendment provides for (i) effective as of November 12, 2023, the surrender by the Company to the Landlord of an aggregate area of approximately 14,760 rentable square feet of the Existing Premises, (ii) the extension of the expiration date of the term of the Lease with respect to the remaining 68,636 rentable square feet of the Existing Premises (the "Renewal Premises") from November 13, 2023 to January 13, 2030 and (iii) effective as of November 13, 2023, the adjustment of the base rent the Company is obligated to pay the Landlord for the Renewal Premises to $122.00 per rentable square foot of the Renewal Premises per year, subject to an annual adjustment.

The foregoing description of the First Amendment does not purport to be complete and is qualified in its entirety by reference to the full text of the First Amendment, which is attached hereto as Exhibit 10.1 and incorporated herein by reference.

Entry into a Material Definitive Agreement

On December 9, 2022, Puma Biotechnology, Inc. (the "Company") entered into a Securities Purchase Agreement (the "Purchase Agreement") with Alan H. Auerbach, the Company’s President, Chief Executive Officer and Chairman of the Board (the "Purchaser"). Pursuant to the Purchase Agreement, the Company agreed to sell 568,181 shares of its common stock, par value $0.0001 per share (the "Shares"), to the Purchaser for aggregate gross proceeds of approximately $2.5 million before deducting any offering expenses (the "Private Placement") (Filing, 8-K, Puma Biotechnology, DEC 9, 2022, View Source [SID1234625221]). The purchase price for each Share was $4.40, which was equal to the closing price of the Company’s common stock on NASDAQ on the date of the Purchase Agreement. The Private Placement closed on December 12, 2022.

The Private Placement is exempt from registration pursuant to the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"). The Shares were not registered under the Securities Act or any state securities laws and may not be reoffered or resold in the United States absent registration with the SEC or an applicable exemption from the registration requirements.

The foregoing description of the transaction does not purport to be a complete description of the Purchase Agreement and is qualified in its entirety by reference to the complete text of the Purchase Agreement, a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated by reference herein.

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Sermonix Shares Two Posters at SABCS 2022 on ER+/HER2- Metastatic Breast Cancer Patient Survey About Knowledge of NGS and ESR1 Mutations, Quality of Life Concerns

On December 9, 2022 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative targeted therapeutics to specifically treat ESR1-mutated metastatic breast and gynecological cancers, reported two poster presentations at the 2022 San Antonio Breast Cancer Symposium (SABCS) evaluating the results of an online survey of ER+/HER2- metastatic breast cancer (mBC) patients (Press release, Sermonix Pharmaceuticals, DEC 9, 2022, View Source [SID1234625144]). The survey’s objectives were to better understand this patient population’s knowledge of next-generation sequencing (NGS) and ESR1 mutations, and to learn about the group’s treatment goals and quality of life (QOL) concerns.

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The QOL-focused poster also received a GRASP Advocate Choice Award. GRASP, which stands for Guiding Researchers and Advocates to Scientific Partnerships, connects patient advocates with cancer researchers to make faster and more impactful progress to improve cancer treatments. The Sermonix poster will be discussed Dec. 15 during a post-SABCS virtual session.

Conducted in June 2022, the 42-question online EQUALS (ESR1 QUAlity of Life Survey) survey drew 474 respondents. Most respondents had some knowledge of NGS, but knowledge of ESR1 mutations was lower, and discordance between physician discussion of NGS and liquid biopsies was observed. Awareness of NGS and ESR1 mutations analyzed by demographics data also suggests socioeconomic disparities in patient education and knowledge.

Other key takeaways included that patients received medical information from medical sources as well as other mBC patients; that patients are nearly equally concerned about disease progression, qualify of life and treatment side effects; that disparities in quality of life and support at home exist based on ethnicity, age and income gaps; and that mBC advocacy groups can help reach ethnically diverse populations, which may help with clinical trial recruitment or disseminating patient education.

"The foremost concerns of ER+/HER2- metastatic breast cancer patients, as well as their understanding of the rapidly changing treatment and biomarker testing environment, has not been greatly studied, especially with respect to diverse populations," said Dr. Elizabeth Attias, Sermonix chief strategy and development officer, and a co-author of the SABCS posters. "As NGS testing becomes an increasingly important component of metastatic breast cancer treatment and the molecular patient journey, the EQUALS survey results underscore the need for further education on NGS and ESR1 mutations for all patients."

Noteworthy NGS/ESR1 mutation results:

Most patients’ oncologists (63%) had discussed tumor NGS by a blood test or tumor biopsy with them, but only 50% of them had explained liquid biopsy (assessment of circulating tumor DNA from a blood draw).
Patients knew a lot/moderate amount about NGS (65%), less so of liquid biopsies (57%).
When asked if they knew what an ESR1 mutation was, just 47% knew a lot/moderate amount; only 45% of patients thought they had been tested for an ESR1 mutation.
Noteworthy QOL results:

About half of patients (48%) reported good/very good QOL, with 22% reporting poor/very poor QOL. Common side effects mostly/moderately impacting QOL were: fatigue (54%), joint pain (50%), vaginal atrophy/dryness (47%) and vasomotor symptoms (46%).
Worry about disease progression occurred often: every day (26%), a few times a week (19%) or month (28%), or only before scans (18%).
Upon progression, patients worried slightly more about efficacy of new treatment (63%) and having additional options (58%) than they did about side effects (57%).
Patients’ current treatment goals were: control cancer growth/spread (69%), prolong life (68%), tolerate side effects (67%), maintain QOL (65%) and relieve suffering/pain (60%); similar to their goals at diagnosis.
Since diagnosis, major/moderate life impacts were: side effects (57%), mental health/stress (57%), QOL (54%), finances (45%) and inability to engage in activities (41%).
Most patients (60%) thought their mBC or treatment impacted their intimate/sexual relationship negatively and more than half (62%) worried about sexual intimacy. Only 39% of patients were comfortable discussing intimacy/sexual side effects with their medical team.
Most (91%) were concerned that their treatments may have a negative impact on their bones.
"The EQUALS Survey was able to illustrate the experiences of a remarkably diverse patient population thanks to the support of patient advocacy groups such as The Chrysalis Initiative and FORCE," said Kelly Shanahan, director at Metavivor Research and Support, Inc., and a co-author of the posters. "While that itself is a success, it is also important to note that all women in the survey report a high level of anxiety and stress regardless of color."

The EQUALS Steering Committee was comprised of Shanahan; Sarah Sammons, M.D., adjunct assistant professor in the Department of Medicine at Duke University and member of the Duke Cancer Institute; Jane Meisel, M.D., associate professor of hematology and medical oncology, and associate vice chair of faculty development and promotions at Winship Cancer Institute of Emory University; and Timothy Pluard, M.D., director of the Saint Luke’s Cancer Institute and the Koontz Center for Advanced Breast Cancer.